1152 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

DEPARTMENT OF LABOR

Occupational Safety and Health

Administration

29 CFR Parts 1910 and 1926

[Docket No. H–049]

RIN 1218–AA05

Respiratory Protection

AGENCY: Occupational Safety and Health

Administration (OSHA), Department of

Labor.

ACTION: Final rule; Request for comment

on paperwork requirements.

SUMMARY: This final standard, which

replaces the respiratory protection

standards adopted by OSHA in 1971 (29

CFR 1910.134 and 29 CFR 1926.103),

applies to general industry,

construction, shipyard, longshoring, and

marine terminal workplaces. The

standard requires employers to establish

or maintain a respiratory protection

program to protect their respiratorwearing employees. The standard

contains requirements for program

administration; worksite-specific

procedures; respirator selection;

employee training; fit testing; medical

evaluation; respirator use; respirator

cleaning, maintenance, and repair; and

other provisions. The final standard also

simplifies respirator requirements for

employers by deleting respiratory

provisions in other OSHA health

standards that duplicate those in the

final standard and revising other

respirator-related provisions to make

them consistent. In addition, the

standard addresses the use of respirators

in Immediately Dangerous to Life or

Health (IDLH) atmospheres, including

interior structural firefighting. During

interior structural firefighting (an IDLH

atmosphere by definition), selfcontained breathing apparatus is

required, and two firefighters must be

on standby to provide assistance or

perform rescue when two firefighters are

inside the burning building.

Based on the record in this

rulemaking and the Agency’s own

experience in enforcing its prior

respiratory protection standards, OSHA

has concluded that compliance with the

final rule will assist employers in

protecting the health of employees

exposed in the course of their work to

airborne contaminants, physical

hazards, and biological agents, and that

the standard is therefore necessary and

appropriate. The final respiratory

protection standard covers an estimated

5 million respirator wearers working in

an estimated 1.3 million workplaces in

the covered sectors. OSHA’s benefits

analysis predicts that the standard will

prevent many deaths and illnesses

among respirator-wearing employees

every year by protecting them from

exposure to acute and chronic health

hazards. OSHA estimates that

compliance with this standard will avert

hundreds of deaths and thousands of

illnesses annually. The annual costs of

the standard are estimated to be $111

million, or an average of $22 per

covered employee per year.

DATES: The final rule becomes effective

April 8, 1998.

Compliance: Start-up dates for

specific provisions are set forth in

§ 1910.134(n) of the regulatory text.

However, until the Department of Labor

publishes in the Federal Register the

control numbers assigned by the Office

of Management and Budget (OMB),

affected parties are not required to

comply with the new or revised

information collection requirements

contained in the following paragraphs:

§ 1910.134(c) written procedures for

selecting respirators, medical

evaluations, fit testing, use of

respirators, maintaining respirators,

training, and periodically evaluating the

effectiveness of the program; (e)(3)–(6)

medical questionnaire, examination,

and information for the physician or

other licensed health care professional

(PLHCP); (f)(1) fit testing; (i)(4) tagging

sorbent beds and filters; and (m)(1)–(2)

and (4) recordkeeping. Publication of

the control numbers notifies the public

that the OMB has approved these

information collection requirements

under the Paperwork Reduction Act of

1995. Although affected parties will not

have to comply with the revised

standard’s information collection

requirements until these have been

approved by OMB, they must comply

with those requirements of 29 CFR

1910.134 (OSHA’s existing respirator

protection standard) that have already

been approved by the OMB under the

Paperwork Reduction Act. Approved

requirements include the written

program, emergency-use respirator

certification records, and emergency-use

respirator compartment marking.

Comments: Interested parties may

submit comments on the information

collection requirements for this

standard until March 9, 1998.

ADDRESSES: In compliance with 28

U.S.C. 2112(a), the Agency designates

the Associate Solicitor for Occupational

Safety and Health, Office of the

Solicitor, Room S–4004, U.S.

Department of Labor, 200 Constitution

Avenue, N.W., Washington, D.C. 20210,

as the recipient of petitions for review

of the standard.

Comments on the information

collection requirements of this final rule

(see SUPPLEMENTARY INFORMATION) are to

be submitted to the Docket Office,

Docket No. ICR 97–5, U.S. Department

of Labor, Room N–2625, 200

Constitution Avenue, N.W.,

Washington, D.C. 20210, telephone

(202) 219–7894. Written comments

limited to 10 pages or less in length may

also be transmitted by facsimile to (202)

219–5046.

Copies of the referenced information

collection request are available for

inspection and copying in the Docket

Office and will be mailed immediately

to persons who request copies by

telephoning Adrian Corsey at (202) 219–

7075. For electronic copies of the

Respiratory Protection Final Standard

and the Information Collection Request,

contact OSHA’s WebPage on the

Internet at http://www.osha.gov/.

FOR FURTHER INFORMATION CONTACT:

Bonnie Friedman, Director, OSHA

Office of Public Affairs, Room N–3647,

U.S. Department of Labor, 200

Constitution Avenue, N.W.,

Washington, D.C. 20210; Telephone

(202) 219–8148. For additional copies of

this regulation contact: OSHA, Office of

Publications, U.S. Department of Labor,

Room N–3101, 200 Constitution

Avenue, N.W., Washington, D.C. 20210;

Telephone (202) 219–4667.

SUPPLEMENTARY INFORMATION:

1. Collection of Information: Request

for Comment

This final Respiratory Protection

standard contains information

collection requirements that are subject

to review by OMB under the Paperwork

Reduction Act of 1995 (PRA95), 44

U.S.C. 3501 et seq. (see also 5 CFR

1320). PRA95 defines collection of

information to mean, ‘‘the obtaining,

causing to be obtained, soliciting, or

requiring the disclosure to third parties

or the public of facts or opinions by or

for an agency regardless of form or

format.’’ [44 U.S.C. § 3502(3)(A)]

The title, the need for and proposed

use of the information, a summary of the

collections of information, description

of the respondents, and frequency of

response required to implement the

required information collection are

described below with an estimate of the

annual cost and reporting burden (as

required by 5 CFR 1320.5 (a)(1)(iv) and

§ 1320.8 (d)(2)). Included in the estimate

is the time for reviewing instructions,

gathering and maintaining the data

needed, and completing and reviewing

the collection of information.
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1153

OSHA invites comments on whether

the proposed collection of information:

• Ensures that the collection of

information is necessary for the proper

performance of the functions of the

agency, including whether the

information will have practical utility;

• Estimates the projected burden

accurately, including whether the

methodology and assumptions used are

valid;

• Enhances the quality, utility, and

clarity of the information to be

collected; and

• Minimizes the burden of the

collection of information on those who

are to respond, including the use of

appropriate automated, electronic,

mechanical, or other technological

collection techniques or other forms of

information technology, e.g., permitting

electronic submissions of responses.

Title: Respiratory Protection, 29 CFR

1910.134.

Description: The final Respiratory

Protection standard is an occupational

health standard that will minimize

occupational exposure to toxic

substances. The standard’s information

collection requirements are essential

components that will protect employees

from occupational exposure to these

toxins. The information will be used by

employers and employees to implement

the protection required by the standard.

OSHA will use some of the information

to determine compliance with the

standard.

Respondents: The total number of

respondents for the first year is

1,300,000, and for the second year

1,430,000 (1,300,000 (1st year) plus 10%

(130,000)).

Average Time Per Response: 2.21

hours (this is the result of dividing the

total number of responses (19,767,461)

by the total number of burden hours

(8,926,558)).

Average Time Per Firm: 6.87 hours

(this represents the average time a firm

would need to comply with all of the

information collection provisions,

including the written respiratory

protection program. This is a result of

dividing the total number of burden

hours (8,926,558) by the total number of

firms (1,300,000)).

SUMMARY OF THE COLLECTIONS OF INFORMATION

Information collection

requirement

No. of

responses

(Yr 1)

No. of

responses

(Yr 2)

Frequency of responseTime per

response

Total 1st year

burden

Estimated

cost

(1st year)

Respiratory Protection Program

1910.134(c).

1,274,000 26,000 All Existing Firms

to Update Existing Program.

2 Hours for Small

Firms; 4 Hours

for Large Firms.

2,652,000 $60,916,440

127,400 2,600 Initially for New

Employers.

8 Hours to Develop.

Updates (Every 5

Years).

30 Minutes for

Small Firms; 1

Hour for Large

Firms.

Questionnaire Administration

1910.134(e)(3).

5,000,000 575,000 All Employees Will

Receive in the

First Year.

50% of those Receiving Exams

Will Receive

Follow-up Questionnaires.

15 Minutes for

Employees to

Complete.

740,000 $13,593,800

Medical Examinations 1910.134(e)(4) 1,150,000 287,500 23% of the Existing Employees.

2nd & Recurring

Yrs—25% of the

23% would receive Follow-up

Exams.

All Medical Exams

will Take 1.5

Hours to Complete which includes travel

time.

1,021,200 $18,759,444

Information Provided to PLHCP

1910.134(e)(5).

1,150,000 287,500 Dependent on the

Number of

Exams.

15 Minutes for

Each Employee.

170,200 $2,358,972

Fit Testing 1910.134(f)(1) .................... 4,335,000 4,335,000 346,800 Employees to Receive

Quantitative Fit

Tests.

799,640 Employees to Receive

Qualitative Fit

Tests.

3,188,560 Employees to Receive

In-House Fit

Tests.

4,335,000 Total

Employees.

30 Minutes for

Employees to

be Fitted (Quantitative and

Qualitative Fit

Testing).

30 Additional Minutes for Employers to Conduct

(Only for InHouse Fit Testing).

3,780,140 $76,813,315

Emergency-Use Respirator Marking

1910.134(h)(2)(ii)(B).

0 260,000 Only New Employers E.

xisting Employers

Have Already

Complied (Old

Requirement).

5 Minutes per

Emergency-Use

Respirator.

0 $0
1154 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

SUMMARY OF THE COLLECTIONS OF INFORMATION—Continued

Information collection

requirement

No. of

responses

(Yr 1)

No. of

responses

(Yr 2)

Frequency of responseTime per

response

Total 1st year

burden

Estimated

cost

(1st year)

Emergency-Use Respirator Certification 1910.134(h)(3)(iv)(A)&(B).671,880 67,200 Currently, 27,995

Employers

Using Emergency-Use Respirators (1st

Year).

2nd Year = 1st

Year Employers

plus 10%.

Assuming 2 Per

Employer: 10

Minutes (Total

Time Per

Month).

114,220 $2,098,221

Certificate of Analysis of Cylinders

1910.134(i)(4)(i)(B).

0 0 All Existing and

New Employers.

Provided by Supplier, therefore

no burden incurred.

0 $0

Sorbent Beds and Filters

1910.134(i)(4)(iii)(B).

74,181 74,181 Currently, 24,727

Compressors in

Use.

3 Changes Per

Year, assuming

5 minutes per

change.

5,934 $109,008

Medical Records 1910.134(m)(1) ........ 1,150,000 287,500 Dependent on the

Number of

Exams.

5 Minutes Per Employee Examined.54,464 $754,871

Fit Testing Records 1910.134(m)(2) .... 4,335,000 4,335,000 Dependent on the

Number of Fit

Tests.

5 Minutes Per Fit

Test.

348,400 $4,828,824

Employee Access 1910.134(m)(4) ...... 500,000 500,000 10% of the Total

Number of Employees.

5 Minutes per Request.40,000 $554,400

Totals ........................................ 19,767,461 11,037,481 ......................... ......................... 8,926,558 $180,787,295

MARGINAL DIFFERENCES IN BURDEN HOURS AND COSTS (I.E., BETWEEN THE EXISTING AND REVISED STANDARDS)

Information collection

requirement

Current OMB

inventory existing

1910.134

Adjustment (to

1st year only)

1st yr. burden

revised

1910.134

Estimated cost

2nd & recurring yr. burden

revised

1910.134

Estimated cost

Respiratory Protection Program ............... 395,489 2,256,511 2,652,000 $60,916,440 1,570,400 $36,072,088

Questionnaire Administration .................... – 740,000 740,000 $13,593,800 85,100 $1,563,287

Medical Examinations ............................... – 1,021,200 1,021,200 $18,759,444 255,300 $4,689,861

Information Provided to PLHCP ............... – 170,200 170,200 $2,358,972 42,550 $589,743

Fit Testing ................................................. – 3,780,140 3,780,140 $76,813,315 3,780,140 $76,813,315

Emergency-Use Respirator Marking ......... 433 –433 0 $0 448 $8,230

Emergency-Use Respirator Certification .. 785,842 –671,622 114,220 $2,098,221 11,424 $209,859

Certificate of Analysis of Cylinders ........... – 0 0 $0 0 $0

Sorbent Beds and Filters .......................... – 5,934 5,934 $109,008 5,934 $109,008

Medical Records ....................................... – 54,464 54,464 $754,871 13,616 $188,718

Fit Testing Records ................................... – 348,400 348,400 $4,828,824 348,400 $4,828,824

Employee Access ..................................... – 40,000 40,000 $554,400 40,000 $554,400

Hour Kept in Inventory for Revised

1910.134 ................................................ 1 –1 0 $0 0 $0

Totals .............................................. 1,181,765 7,744,793 8,926,558 $180,787,295 6,153,312 $125,627,333

Under the column for ‘‘Current OMB Inventory,’’ dashes denote burdens that were not taken for the Existing Respiratory Protection Standard,

but are counted in the Revised Respiratory Protection Standard. Both Medical Examinations and Fit Testing are required by the existing standard; however, because these requirements are not accompanied by a recordkeeping requirement, no burden was taken. In the revised standard,

recordkeeping is required for these provisions, and thus burden is counted for these provisions.

Interested parties are requested to

send comments regarding this

information collection to the OSHA

Docket Office, Docket No. ICR 97–5 ,

U.S. Department of Labor, Room N–

2625, 200 Constitution Avenue, N.W.,

Washington, D.C. 20210. Written

comments limited to 10 pages or fewer

may also be transmitted by facsimile to

(202) 219–5046.

Comments submitted in response to

this notice will be summarized and

included in the request for Office of

Management and Budget approval of the

final information collection request;

they will also become a matter of public

record.

Copies of the referenced information

collection request are available for

inspection and copying in the OSHA

Docket Office and will be mailed to

persons who request copies by

telephoning Adrian Corsey at (202) 219–

7075. Electronic copies of the

Respiratory Protection Final information

collection request are available on the

OSHA WebPage on the internet at http:/

/www.osha.gov/ under Standards.
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1155

2. Federalism

This final standard has been reviewed

in accordance with Executive Order

12612 (52 FR 41685, October 30, 1987),

regarding Federalism. This Order

requires that agencies, to the extent

possible, refrain from limiting state

policy options, consult with states prior

to taking any actions which would

restrict state policy options, and take

such actions only when there is clear

constitutional authority and the

presence of a problem of national scope.

The Order provides for preemption of

state law only if there is a clear

Congressional intent for the Agency to

do so. Any such preemption is to be

limited to the extent possible.

Section 18 of the Occupational Safety

and Health Act (OSH Act) expresses

Congress’ clear intent to preempt state

laws relating to issues on which Federal

OSHA has promulgated occupational

safety and health standards. Under the

OSH Act, a state can avoid preemption

only if it submits, and obtains Federal

approval of, a plan for the development

of such standards and their

enforcement. Occupational safety and

health standards developed by such

Plan-States must, among other things, be

at least as effective in providing safe and

healthful employment and places of

employment as the Federal standards.

Where such standards are applicable to

products distributed or used in

interstate commerce, they may not

unduly burden commerce and must be

justified by compelling local conditions

(see OSH Act, Section 18(c)).

The final Federal standard on

respiratory protection addresses hazards

which are not unique to any one state

or region of the country. Nonetheless,

states with occupational safety and

health plans approved under Section 18

of the OSH Act will be able to develop

their own state standards to deal with

any special problems which might be

encountered in a particular state.

Moreover, because this standard is

written in general, performance-oriented

terms, there is considerable flexibility

for state plans to require, and for

affected employers to use, methods of

compliance which are appropriate to the

working conditions covered by the

standard.

In brief, this final standard addresses

a clear national problem related to

occupational safety and health in

general industry, construction, and

maritime employment. Those states

which have elected to participate under

Section 18 of the OSH Act are not

preempted by this standard, and will be

able to address any special conditions

within the framework of the Federal Act

while ensuring that the state standards

are at least as effective as that standard.

3. State Plans

The 25 states and territories with their

own OSHA-approved occupational

safety and health plans must adopt a

comparable standard within six months

of the publication date of a final

standard. These 25 states are: Alaska,

Arizona, California, Connecticut, New

York (for state and local government

employees only), 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. Until such time as a state

standard is promulgated, Federal OSHA

will provide interim enforcement

assistance, as appropriate, in these

states.

4. Unfunded Mandates

The final respiratory protection rule

has been reviewed in accordance with

the Unfunded Mandates Reform Act of

1995 (UMRA) (2 U.S.C. 1501 et seq.) and

Executive Order 12875. As discussed

below in the Summary of the Final

Economic Analysis (FEA) (Section VI of

this document), OSHA estimates that

compliance with the revised respiratory

protection standard will require the

expenditure of more than $100 million

each year by employers in the private

sector. Therefore, the final rule

establishes a Federal private sector

mandate and is a significant regulatory

action, within the meaning of section

202 of UMRA (2 U.S.C. 1532). OSHA

has included this statement to address

the anticipated effects of the final

respiratory protection rule pursuant to

section 202.

OSHA standards do not apply to state

and local governments, except in states

that have voluntarily elected to adopt an

OSHA State Plan. Consequently, the

respiratory protection standard does not

meet the definition of a ‘‘Federal

intergovernmental mandate’’ (Section

421(5) of UMRA (2 U.S.C. 658(5)). Thus,

the final respiratory protection standard

does not impose unfunded mandates on

state or local governments.

The anticipated benefits and costs of

this final standard, and other issues

raised in section 202 of the UMRA, are

addressed in the Summary of the FEA

(Section VI of this preamble), below,

and in the FEA (Ex. 196). In addition,

pursuant to section 205 of the UMRA (2

U.S.C. 1535), having considered a

reasonable number of alternatives as

outlined in the preambles to the

proposal and the final rule and in the

FEA (Ex. 196), the Agency has

concluded that the final rule is the most

cost-effective alternative for

implementation of OSHA’s statutory

objective of reducing significant risk to

the extent feasible. This is discussed in

the FEA (Ex. 196) and in the Summary

and Explanation (Section VII of this

preamble) for the various provisions of

the final standard.

5. Executive Order 13045—Protection of

Children From Environmental Health

and Safety Risks

Executive Order 13045, signed by the

President on April 21, 1997, requires

that for certain Federal agency

‘‘regulatory actions submitted to OMB’s

Office of Information and Regulatory

Affairs (OIRA) for review pursuant to

Executive Order 12866, the issuing

agency shall provide to OIRA the

following information developed as part

of the Agency’s decisionmaking process,

unless prohibited by law:

(a) An evaluation of the

environmental health or safety effects of

the planned regulation on children; and

(b) An explanation of why the

planned regulation is preferable to other

potentially effective and reasonably

feasible alternatives considered by the

agency.’’

‘‘Covered Regulatory Actions’’ under

this Order are rules that may:

(a) Be ‘‘economically significant’’

under Executive Order 12866 (a

rulemaking that has an annual effect on

the economy of $100 million or more or

would adversely affect in a material way

the economy, a sector of the economy,

productivity, competition, jobs, the

environment, public health or safety, or

State, local, or tribal governments or

communities); and

(b) Concern an environmental health

risk or safety risk that an agency has

reason to believe may

disproportionately affect children.

‘‘Environmental health risks and

safety risks’ mean risks to health or to

safety that are attributable to products or

substances that the child is likely to

come in contact with or ingest (such as

the air we breathe, the food we eat, the

water we drink or use for recreation, the

soil we live on, and the products we use

or are exposed to).

The final standard on respiratory

protection does not concern

‘‘Environmental health risks and safety

risks’’ to children as defined under the

Executive order. The respirator standard

is only concerned with means of

limiting employee exposures to toxic

substances. The Agency believes,

therefore, that the requirement noted

above to provide OIRA with certain

information does not apply since the

respiratory protection standard is not a
1156 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

‘‘covered regulatory action’’ under

Executive Order 13045.

Section 6(b) (8) of the OSH Act

requires OSHA to explain ‘‘why a rule

promulgated by the Secretary differs

substantially from an existing national

consensus standard,’’ by publishing ‘‘a

statement of the reasons why the rule as

adopted will better effectuate the

purposes of the Act than the national

consensus standard.’’ In compliance

with the requirement, the Agency has

reviewed the standards proposed

through this rulemaking with reference

to the ANSI Z88.2–1992 standard for

Respiratory Protection. OSHA has

discussed the relationship between

individual regulatory provisions and the

corresponding consensus standards in

the Summary and Explanation of the

final rule.

6. Reasons Why the Revised Rule Will

Better Effectuate the Purposes of the Act

Than the Existing Consensus Standard

This process was facilitated by the

fact that the previous OSHA standards

on respiratory protection were start-up

standards adopted directly from the

ANSI Z88.2–1969 standard, ‘‘Practices

for Respiratory Protection’’ under

section 6(a) of the OSH Act, 29 U.S.C.

655(a). Therefore, even with subsequent

revisions to the ANSI standards and the

Agency’s consideration of a widely

varied and substantial body of

information in the rulemaking record,

the requirements of the OSHA final rule

would tend to resemble the

corresponding provisions of the current

ANSI standards. In a number of

instances, OSHA has utilized language

identical to that in the current ANSI

standard. These instances are noted in

the Summary and Explanation. Where

the Agency has determined that the

pertinent ANSI language is not

appropriate for this OSHA standard, the

Summary and Explanation provides the

basis for that decision.

I. General

The preamble accompanying this final

standard discusses events leading to the

final rule, the types of respiratory

hazards experienced by employees, the

degree and significance of the risk

presented by failure to comply with this

revised standard, the Final Economic

Analysis, and the rationale behind the

specific provisions set forth in the final

standard. The discussion follows this

outline:

I. General

II. Pertinent Legal Authority

III. Events Leading to the Final Standard

A. Regulatory History

B. Justification for Revising the Previous

Standard

1. Purpose of Revision

2. Respirator Use and Hazards

C. Responses to Advisory Committee

D. Assigned Protection Factors

E. Small Business Considerations

IV. Certification/Approval Procedures

V. Significance of Risk

VI. Summary of the Final Economic Analysis

And Environmental Impact Assessment

VII. Summary And Explanation of the Final

Standard

A. Permissible Practice

B. Definitions

C. Respiratory Protection Program

D. Selection of Respirators

E. Medical Evaluation

F. Fit Testing Procedures

G. Use of Respirators

H. Maintenance and Care of Respirators

I. Breathing Air Quality and Use

J. Identification of Filters, Cartridges, and

Canisters

K. Training

L. Respiratory Protection Program

Evaluation

M. Recordkeeping and Access to Records

N. Dates

O. Appendices

P. Revisions to Specific Standards

VIII. Authority And Signature

IX. Amended Standards

II. Pertinent Legal Authority

The purpose of the Occupational

Safety and Health Act, 29 U.S.C. 651 et

seq. (‘‘the Act’’) is to ‘‘assure so far as

possible every working man and woman

in the nation safe and healthful working

conditions and to preserve our human

resources.’’ 29 U.S.C. 651(b). To achieve

this goal, Congress authorized the

Secretary of Labor to promulgate and

enforce occupational safety and health

standards. U.S.C. 655(a) (authorizing

summary adoption of existing

consensus and Federal standards within

two years of Act’s enactment), 655(b)

(authorizing promulgation of standards

pursuant to notice and comment),

654(b) (requiring employers to comply

with OSHA standards).

A safety or health standard is a

standard ‘‘which requires conditions, or

the adoption or use of one or more

practices, means, methods, operations,

or processes, reasonably necessary or

appropriate to provide safe or healthful

employment or places of employment.’’

29 U.S.C. 652(8).

A standard is reasonably necessary or

appropriate within the meaning of

section 652(8) if it substantially reduces

or eliminates significant risk or prevents

it from developing, and is economically

feasible, technologically feasible, cost

effective, consistent with prior Agency

action or supported by a reasoned

justification for departing from prior

Agency actions, supported by

substantial evidence, and is better able

to effectuate the Act’s purposes than any

national consensus standard it

supersedes. See 58 FR 16612–16616

(March 30, 1993).

A standard is technologically feasible

if the protective measures it requires

already exist, can be brought into

existence with available technology, or

can be created with technology that can

reasonably be expected to be developed.

American Textile Mfrs. Institute v.

OSHA, 452 U.S. 490, 513 (1981)

(‘‘ATMI’’), American Iron and Steel

Institute v. OSHA, 939 F.2d 975, 980

(D.C. Cir. 1991)(‘‘AISI’’).

A standard is economically feasible if

industry can absorb or pass on the cost

of compliance without threatening its

long term profitability or competitive

structure. See ATMI, 452 U.S. at 530 n.

55; AISI, 939 F. 2d at 980.

A standard is cost effective if the

protective measures it requires are the

least costly of the available alternatives

that achieve the same level of

protection. ATMI, 453 U.S. at 514 n. 32;

International Union, UAW v. OSHA, 37

F.3d 665, 668 (D.C. Cir. 1994)(‘‘LOTO

III’’).

All standards must be highly

protective. See 58 FR 16614–16615;

LOTO III, 37 F.3d at 668. However,

standards regulating exposure to toxic

substances or hazardous physical agents

must also meet the ‘‘feasibility

mandate’’ of Section 6(b)(5) of the Act,

29 U.S.C. 655(b)(5). Section 6(b)(5)

requires OSHA to select ‘‘the most

protective standard consistent with

feasibility’’ that is needed to reduce

significant risk when regulating these

hazards. ATMI, 452 U.S. at 509.

Section 6(b)(5) also directs OSHA to

base health standards on ‘‘the best

available evidence,’’ including research,

demonstrations, and experiments, 29

U.S.C. 655(b)(5). OSHA shall consider

‘‘in addition to the attainment of the

highest degree of health and safety

protection * * * the latest scientific

data * * * feasibility and experience

gained under this and other health and

safety laws.’’ Id.

Section 6(b)(7) of the Act authorizes

OSHA to include among a standard’s

requirements labeling, monitoring,

medical testing and other information

gathering and transmittal provisions. 29

U.S.C. 655(b)(7).

Finally, whenever practical, standards

shall ‘‘be expressed in terms of objective

criteria and of the performance

desired.’’ Id.

Respiratory protection is a backup

method which is used to protect

employees from toxic materials in the

workplace in those situations where

feasible engineering controls and work

practices are not available, have not yet

been implemented, are not in

themselves sufficient to protect
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1157

employee health, or in emergencies. The

revisions to the respirator standard

made in this rulemaking are intended to

ensure that, when employers require

employees to wear respirators to be

protected from significant risk,

protective respirators will be selected

and those respirators will be used

effectively to meet their design

capabilities. Otherwise respirators will

not reduce significant risk. The

standard’s provisions are designed to be

feasible and cost effective, and are

expressed in terms of objective criteria

and the performance desired.

Further authority is provided by

section 8(c)of the Act, which authorizes

OSHA to require employers to maintain

certain records. Section 8(g)(2)

authorizes OSHA ‘‘to prescribe such

rules and regulations as (it) may deem

necessary to carry out its

responsibilities under the Act.’’

III. Events Leading to the Final

Standard

A. Regulatory History

Congress created the Occupational

Safety and Health Administration

(OSHA) in 1970, and gave it the

responsibility for promulgating

standards to protect the health and

safety of American workers. As directed

by Congress in the Occupational Safety

and Health Act of 1970 (OSH Act; 29

U.S.C. 651 et seq.), OSHA adopted

existing Federal standards and national

consensus standards developed by

various organizations such as the

American Conference of Governmental

Industrial Hygienists (ACGIH), the

National Fire Protection Association

(NFPA), and the American National

Standards Institute (ANSI). The ANSI

standard Z88.2–1969, ‘‘Practices for

Respiratory Protection,’’ is the basis of

the first six sections of OSHA’s previous

standard, 29 CFR 1910.134,

‘‘Respiratory Protection.’’ The seventh

section was a direct, complete

incorporation of ANSI Standard K13.1–

1969, ‘‘Identification of Gas Mask

Canisters.’’ OSHA’s previous

construction industry standard for

respiratory protection, 29 CFR 1926.103,

was promulgated in April 1971. On

February 9, 1979, 29 CFR 1910.134 was

formally recognized as also being

applicable to the construction industry

(44 FR 8577). Until the adoption of

these standards by OSHA, most

guidance on respiratory protective

device use in hazardous environments

was advisory rather than mandatory.

OSHA’s maritime standards were

originally promulgated in the 1960s by

agencies that preceded OSHA. The

original OSHA code designations of

these standards and their promulgation

dates are: Shipyards—29 CFR 1915.82,

February 20, 1960 (25 FR 1543); Marine

Terminals—29 CFR 1917.82, March 27,

1964 (29 FR 4052); and Longshoring—

29 CFR 1918.102, February 20, 1960 (25

FR 1565). Section 1910.134 was

incorporated by reference into OSHA’s

Marine Terminals standard (part 1917)

on July 5, 1983 (48 FR 30909). OSHA

has recently updated and strengthened

its Longshoring and Marine Terminal

standards, and both standards

incorporate 29 CFR 1910.134 by

reference.

OSHA did not propose to expand

coverage of 29 CFR 1910.134 to

agricultural workplaces covered by 29

CFR part 1928, and this final

Respiratory Protection standard, like the

proposal, does not apply to agricultural

operations. The prior standard likewise

did not apply to agricultural operations.

(See 29 CFR 1928.21.) OSHA received

no public comment requesting a change

in coverage. Accordingly, the issue of

respirator use during agricultural

operations was not a part of this

rulemaking. OSHA notes, however, that

respirator use during pesticide

operations and handling is covered by

EPA’s Worker Protection Standard, 40

U.S.C. part 170, adopted under the

authority of the Federal Insecticide,

Fungicide, and Rodenticide Act, as

amended (7 U.S.C. 136–136y).

Under OSHA’s previous standard,

employers needed to follow the

guidance of the Z88.2–1969 ANSI

standard to ensure proper selection of

respirators (see discussion 59 FR

58887). OSHA published an Advance

Notice of Proposed Rulemaking (ANPR)

to revise the respirator standard on May

14, 1982 (47 FR 20803). Part of the

impetus for this notice was OSHA’s

inclusion of new respirator

requirements in comprehensive

substance-specific standards

promulgated under section 6(b) of the

Act, e.g., fit tests; use of powered airpurifying respirators (PAPRs) upon

request; change of the filter elements of

a respirator whenever an increase in

breathing resistance is detected;

employee permission to wash faces and

respirator facepieces; and referral to a

physician trained in pulmonary

medicine for an employee who exhibits

difficulty breathing, either at fit testing

or during routine respirator use (see, e.g,

29 CFR 1910.1025 (lead standard)). The

respirator provisions in these substancespecific standards took account of

advances in respirator technology and

changes in related guidance documents,

particularly the recognition that

standardized fit testing protocols greatly

increase the effectiveness of respirators.

OSHA’s 1982 ANPR sought

information on the effectiveness of the

current respiratory protection

provisions, the need for revision of

those provisions, and the substance of

the revisions. Responses were received

from 81 interested parties. The

commenters generally supported

revising OSHA’s respiratory protection

provisions and provided suggestions for

approaches the Agency might take (Ex.

15).

On September 17, 1985, OSHA

announced the availability of a

preliminary draft of the proposed

Respiratory Protection standard. The

preproposal draft standard reflected the

public comments received on the May

1982 ANPR, and OSHA’s own analysis

of changes needed in the standard to

take into account the current state-ofthe-art for respiratory protection.

Responses were received from 56

interested parties (Ex. 36), and their

comments were reviewed in preparing

the proposal.

On November 15, 1994, OSHA

published the proposed rule to revise 29

CFR 1910.134, and announced its

intention to convene an informal public

hearing on the proposal (59 FR 58884).

The informal public hearing was

convened on June 6, 1995, pursuant to

notice and in accordance with Section

6(b) of the OSH Act, 29 U.S.C. 655(b)(3).

Post-hearing submissions of data from

parties at the hearing were received

through September 20, 1995.

On November 7, 1995, OSHA

reopened the record (60 FR 56127) and

requested additional comment on a

study performed for OSHA by Dr. Mark

Nicas titled ‘‘The Analysis of Workplace

Protection Factor Data and Derivation of

Assigned Protection Factors.’’ That

study, which was placed in the

rulemaking docket on September 20,

1995, addressed the use of statistical

modeling for determining respirator

APFs. Comments on the Nicas study

were received through the end of

January 1996. The Nicas report, and

comments received in response to the

November 1995 notice, have convinced

OSHA to deliberate further on the

complex issues surrounding the

establishment of APFs.

The entire record including 200

exhibits, more than 3,000 individual

items, and approximately 2,300

transcript pages, was certified by the

presiding administrative law judge on

June 30, 1997, in accordance with 29

CFR 1911.17. Copies of materials

contained in the record may be obtained

from the OSHA Docket Office, Room N–

2439, U.S. Department of Labor, 200

Constitution Avenue, N.W.,
1158 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

Washington, D.C. 20210; (202) 219–

7894.

The final revisions to 29 CFR

1910.134 are based on consideration of

the entire record of this proceeding,

including materials discussed or relied

upon in the proposal, the record of the

informal hearing, and all written

comments and exhibits received.

B. Justification for Revising the Previous

Standard

1. Purpose of the Revision

The intent of this revision is to

enhance the protection of worker health,

promote more effective use of

respirators, provide greater compliance

flexibility, and clarify the policies and

procedures employers must follow

when implementing a respiratory

protection program. Evidence in the

record, including case reports and

studies of respirator use among workers,

indicates that selecting or using

respirators improperly can result in

employee illness and even death. (See

discussion below.) The revised standard

is therefore expected to reduce the

number of occupational illnesses and

deaths among workers who wear

respirators. OSHA is also consolidating

many of its respirator-related provisions

in other substance-specific health

standards into one standard to make

these provisions easier for employers to

administer. Through consolidation,

repetitive and duplicative respirator

requirements have been deleted from

many existing OSHA health standards,

and future health standards will

reference the revised final rule for many

respirator requirements.

Advances in technology also made the

previous standard out-of-date in many

areas. Nearly all rulemaking

participants, including representatives

of private industry, other Federal

agencies, respirator manufacturers, and

unions, agreed that revision is necessary

to address these advances (e.g., NIOSH,

Ex. 28; Eastman Chemical Co., Ex. 54–

245; 3M, Ex. 54–218A; AFL–CIO, Ex.

54–315; Building and Construction

Trades Department/AFL–CIO, Ex. 29;

American Petroleum Institute, Ex. 37;

ISEA, Ex. 54–363). (See also 59 FR

58889.) Other agencies and committees

have already updated their guidance on

respirator use. For example, the ANSI

standard has been revised twice (Exs.

10, 50), and NIOSH has revised its

certification standard (42 CFR part 84;

60 FR 30336; 6/8/95), as well as

developed a Respiratory Decision Logic

(1987) to provide guidance to employers

on the selection of respirators.

OSHA’s experience in enforcing the

previous standard also indicated that

some of that standard’s requirements

were not understood clearly by the

regulated community, and so were not

adequately effective in protecting

workers. The clarifications in this new

standard will contribute to enhanced

compliance by reducing

misinterpretations and inconsistencies.

A review of OSHA enforcement data for

1994 and 1995 revealed that failure to

comply with the previous standard was

a critical factor in at least 47 fatalities

and 126 catastrophic injuries. The most

frequently cited deficiencies included

failure to provide respirators at all or to

have standard operating procedures

governing respirator use, and failure to

train or fit test respirator users

adequately [Source: OSHA’s Federal

Inspection Compliance Data (IMIS; 10/

92 to 12/95)].

In addition, considerable research has

been performed to determine the extent

to which respirators used in workplaces

actually reduce the quantity of

contaminant breathed by the respirator

user. Researchers have compared the inmask concentrations of contaminants to

the concentration levels outside the

masks. This work was begun by NIOSH

during the mid-seventies to assess

respirator effectiveness in coal mines

and abrasive blasting operations (Ex.

64–5) and spray paint operations (Ex.

64–68). The studies assessed the

effectiveness of respirators under

various conditions, and measured

employee exposure in situations when

respirators were not worn. The

effectiveness ratings obtained in these

studies are usually termed ‘‘Effective

Protection Factors’’ (EPF).

More recent studies by NIOSH and

private researchers have monitored

respirator use even more closely to

isolate variables that may affect the

levels of respirator performance. Many

of these studies concerned the

performance of powered air-purifying

respirators (PAPRs), which were not

achieving in workplaces the levels of

performance that had been predicted

based on laboratory tests (see, e.g., Exs.

64–46, 64–42, and 64–47).

A third group of studies, ‘‘workplace

protection factor studies,’’ conducted

mostly by manufacturers and other

private interests, was designed to

determine the optimum performance of

respirators by eliminating the impact of

program defects under very tightly

supervised workplace conditions. The

results of these studies may overstate

the degree of respirator effectiveness

most employers can expect under

conditions of workplace use because

study conditions are rarely replicated in

the field; nevertheless, these studies

show the potential for respirators to

reduce employee exposure to workplace

contaminants (see, e.g., Exs. 64–25, 64–

42, 64–47, 64–513).

This revised standard is intended to

take account of up-to-date knowledge

and technology and to make the

requirements in the standard easier to

understand. The standard now reflects

current technology and research, as well

as the findings and guidance of other

expert bodies. OSHA has also included

a new definitions section to enhance

clarity. The revised standard includes

detailed protocols for performing fit

tests and lists the topics in which

respirator users must be trained. It also

contains provisions addressing skin and

eye irritation, both of which must be

considered in respirator selection.

Wherever possible, OSHA has used

performance-oriented language to allow

for flexibility in accommodating future

changes in respirator technology and to

address the needs of small businesses

and unusual operations. Through these

improvements, OSHA expects to reduce

the number of respirator-related

illnesses, fatalities, and catastrophic

injuries occurring among respirator

wearers in U.S. workplaces.

2. Respirator Use and Hazards

The purpose of a respirator is to

prevent the inhalation of harmful

airborne substances or oxygen-deficient

air. Basically, a respirator is an

enclosure that covers the nose and

mouth or the entire face or head.

Respirators are of two general ‘‘fit’’

types: (1) Tight-fitting (quarter masks,

which cover the mouth and nose; half

masks, which fit over the nose and

under the chin; and full facepiece,

which cover the face from the hairline

to below the chin); and (2) loose-fitting

(hoods, helmets, blouses, or full suits

which cover the head completely).

There are also two major classes of

respirators: air-purifying respirators

(which remove contaminants from the

air), and atmosphere-supplying

respirators (which provide clean

breathing air from an uncontaminated

source). In general, atmospheresupplying respirators are used for more

hazardous exposures.

Effective respirator use can protect

employees from exposure to a wide

variety of toxic chemicals. In 1994,

approximately 215 deaths, or five

percent of all workplace fatalities,

occurred as a result of exposure to

harmful substances and environments

[CFOI, BLS, 6/11/96; CFOI/FAX]. There

are a number of workplace situations

that involve toxic substances and for

which engineering controls may be

inadequate to control exposures, and

respirators are used in these situations
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1159

as a back-up method of protection.

Substances that have been associated

with death or serious incidents include

carbon monoxide, trichloroethylene,

carbon dioxide, chromic acid, coal tar,

several toxic metal fumes and dusts,

sulphur dioxide, wood dust, and

welding fumes; these substances cause

adverse health effects ranging from

transient, reversible effects such as

irritation or narcosis, through disabling

diseases such as silicosis and asbestosis,

to death caused either by acute exposure

or by a cancer resulting from chronic

exposures (Rom, W., Environmental and

Occupational Medicine, 2nd ed., Little,

Brown & Co., Boston; 1992, p. 598.)

Respirators are available that can

provide protection against inhalation of

these toxic substances.

Airborne contaminants may also be

radioactive (‘‘Radiologic Health in

Occupational Medicine Practice,’’

George L. Voelz, pg. 500 in

Occupational Medicine, Carl Zenz, ed.,

Year Book Medical Publishers, Inc.,

Chicago, 1975; Jacob Shapiro, Radiation

Protection, 3rd ed., Harvard University

Press, Cambridge, MA, 1990, pg. 273).

(See also 29 CFR 1910.1096.) Exposure

to ionizing radiation can cause acute

effects such as nausea and vomiting,

malaise and fatigue, increased

temperature, and blood changes. More

severe delayed effects include leukemia,

bone and lung cancer, sterility,

chromosomal and teratogenic damage,

shortened life span, cataracts, and

radiodermatitis, a dry, hairless, red,

atrophic skin condition which can

include skin cracking and

depigmentation (George L. Voelz, M.D.,

‘‘Radiologic Health in Occupational

Medicine Practice’’, in Zenz,

Occupational Medicine, pp. 513–519;

Herman Cember, Introduction to Health

Physics, 2nd edition, Pergamon Press,

New York, 1983, pg. 181–194).

Respirators to provide protection against

the inhalation of radioactive particles

are commonly used by workers exposed

to these hazards.

‘‘Bioaerosols’’ are airborne

contaminants that are alive or were

released from a living organism (OSHA

Docket No. H–122; ACGIH Guidelines;

Ex. 3–61C, page 1; 1994). Pulmonary

effects associated with exposure to

certain bioaerosols include rhinitis,

asthma, allergies, hypersensitivity

diseases, humidifier fever, and

epidemics of infections including colds,

viruses, tuberculosis, and Legionnaires

Disease. Cardiovascular effects

manifested as chest pain, and nervous

system effects manifested as headache,

blurred vision, and impaired judgment,

have occurred in susceptible people

following exposure to bioaerosols. Viral

infections caused by the inhalation of

bioaerosols can result in health effects

that range in intensity from undetected

or mild to more severe and even death.

Bacterial infections resulting from

inhalation of bacteria and their products

cause a range of diseases, including

tuberculosis, Legionnaires Disease, and

hypersensitivity pneumonitis. Among

workers in sewage treatment plants,

health-related problems can be

associated with occupational exposures

to protozoa [Burge, H., 1990,

‘‘Bioaerosols: Prevalence and health

effects in the indoor environment,’’ J.

Allergy and Clinical Immunology; 86

(5); see also Exs. 3–61B and 3–61C in

Docket No. H–122.] Allergic asthma and

allergic rhinitis can be induced by

chronic exposure to low levels of

antigens. Hypersensitivity pneumonitis

can occur when a worker inhales

concentrated aerosols of particles

released by bacteria, fungi, and protozoa

(Exs. 3–61B and 3–61C in Docket No.

H–122). In 1994, the Centers for Disease

Control reported 41 deaths of workers

for which there was evidence of workrelated hypersensitivity pneumonitis

(Work-Related Lung Disease

Surveillance Report, 1994; USDHHS,

CDC, DHHS (NIOSH) Number 94–120).

Respirators to protect against the

inhalation of biological agents are

widely used in healthcare and other

workplace settings where exposure to

such agents presents a hazard to

workers.

Respirators can also provide

protection from oxygen-deficient

atmospheres. Human beings must

breathe oxygen in order to survive, and

begin to suffer adverse health effects

when the oxygen level of their breathing

air drops below the normal atmospheric

level. Below 19.5 percent oxygen by

volume, air is considered oxygendeficient. At concentrations of 16 to

19.5 percent, workers engaged in any

form of exertion can rapidly become

symptomatic as their tissues fail to

obtain the oxygen necessary to function

properly (Rom, W., Env. Occup. Med.,

2nd ed; Little, Brown; Boston, 1992).

Increased breathing rates, accelerated

heartbeat, and impaired thinking or

coordination occur more quickly in an

oxygen-deficient environment. Even a

momentary loss of coordination may be

devastating to a worker if it occurs

while the worker is performing a

potentially dangerous activity, such as

climbing a ladder. Concentrations of 12

to 16 percent oxygen cause tachypnea

(increased breathing rates), tachycardia

(accelerated heartbeat), and impaired

attention, thinking, and coordination

(e.g., Ex. 25–4), even in people who are

resting.

At oxygen levels of 10 to 14 percent,

faulty judgment, intermittent

respiration, and exhaustion can be

expected even with minimal exertion

(Exs. 25–4 and 150). Breathing air

containing 6 to 10 percent oxygen

results in nausea, vomiting, lethargic

movements, and perhaps

unconsciousness. Breathing air

containing less than 6 percent oxygen

produces convulsions, then apnea

(cessation of breathing), followed by

cardiac standstill. These symptoms

occur immediately. Even if a worker

survives the hypoxic insult, organs may

show evidence of hypoxic damage,

which may be irreversible (Exs. 25–4

and 150; also reported in: Rom, W.,

Environmental and Occupational

Medicine, 2nd ed; Little, Brown; Boston,

1992).

A number of workplace conditions

can lead to oxygen deficiency. Simple

asphyxiants, or gases that are

physiologically inert, can cause

asphyxiation when present in high

enough concentrations to lower the

oxygen content in the air. Other toxic or

chemical asphyxiants poison

hemoglobin, cytochromes, or other

enzyme systems (Rom, W.,

Environmental and Occupational

Medicine, 2nd ed., Little, Brown, and

Co., Boston, 1992). A number of

asphyxiants are gases that can evolve

from explosions, combustion, chemical

reactions, or heating. A hightemperature electrical fire or arc

welding accident causing a complete

flashover in an enclosed area can

temporarily eliminate oxygen from that

area. Asphyxiation and the severe lung

damage it can cause are major concerns

for firefighters; of 30 firefighter deaths

investigated by OSHA recently, five

resulted from either asphyxiation,

smoke inhalation, or flashovers (IMIS; 8

State plan states; 10/91–3/97). (See also

mortality study of causes of death

among firefighters, Guidotti, 37 JOEM

1348, 1995.)

In 1994, 110 employees died from

oxygen deficiency [National Census of

Fatal Occupational Injuries (CFOI); BLS;

CFOI/FAX; 6/11/96)], i.e., about two

percent of the total number of

employees who died of occupational

injuries. OSHA believes that many of

these deaths could have been prevented

if the victims’ employers had realized

that respirators were needed (BLS;

CFOI/FAX, 6/96).

In some cases, respirator use itself can

cause illness and injury to employees.

There are a number of physiological

burdens that are associated with the use

of certain types of respirators. The
1160 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

weight of the respirator, breathing

resistances during both normal

operation and if the air-purifying

element is overloaded, and rebreathing

exhaled air from respirator ‘‘dead

space’’ can all increase the physiologic

burden of respirator use (Exs. 113, 22–

1, 64–427). Job and workplace

conditions, such as the length of time a

respirator must be worn, the level of

physical exertion required of a

respirator user, and environmental

conditions, can also affect the

physiological burden (Exs. 113, 64–363).

In addition, workers who wear glasses

or hearing aids may have problems

achieving appropriate fit with some

respirator facepieces.

Evidence of Adverse Health Effects

From Respiratory Hazards. There is

ample evidence that the previous

standard was not doing an adequate job

of protecting workers from these

respiratory hazards, and that exposure

to these hazards has continued to cause

adverse health effects among exposed

workers. An analysis of OSHA

inspection data from 1976 through 1982,

when the previous standard had been in

effect for between five and eleven years

(Ex. 33–5), found that in most cases

(55.6%) where respirators were used to

protect employees from excessive levels

of air contaminants, respiratory

protection programs were deficient in

one or more elements, thus increasing

the potential for employee exposure.

Even more significant was the fact that

in 72.1% of inspections in which an

overexposure to a substance listed

under 29 CFR 1910.1000 was cited,

respirator use did not comply with the

respiratory protection standard. OSHA

performed a similar analysis of

enforcement data for 1990–1996, and

found similar levels of noncompliance.

[See also Work-Related Lung Disease

Surveillance Report, 1994; USDHHS,

CDC, DHHS (NIOSH) Number 94–120.]

The provisions of the new respirator

standard are designed to regulate how

an employer selects, maintains, fit tests,

and trains employees in the proper use

of respiratory equipment, and to provide

employers with the tools needed to

implement an effective respiratory

protection program. OSHA has

concluded that the new standard will

eliminate many of the unnecessary

illnesses and deaths described in this

section.

C. Responses to Advisory Committee on

Construction Safety and Health

The revised respirator standard

replaces the previous respiratory

protection standard in the construction

industry (29 CFR 1926.103). Since this

revision affects the construction

industry, the September 1985

preproposal draft standard was

presented to the Advisory Committee

for Construction Safety and Health

(ACCSH) for its comments. The ACCSH

comments, combined with the other

comments received, were considered in

preparing a revision of the September

1985 draft proposal.

As part of the Notice of Proposed

Rulemaking (NPRM) approval process,

the revised NPRM was presented at the

March 1987 ACCSH meeting and the

Committee’s comments were presented

to OSHA at the August 1987 meeting

(Ex. 39). OSHA responded to the

Committee’s comments in the NPRM,

published in November, 1994. As noted

in that response, OSHA modified the

draft proposal to respond to the

concerns of the Committee (59 FR

58931–58935).

The final standard replaces the

previous construction industry standard

for respiratory protection, 29 CFR

1926.103, with an amended 29 CFR

1926.103. The provisions of the

previous respiratory protection standard

(29 CFR 1926.103) are deleted by this

action. The title, Respiratory Protection,

will remain in the Code of Federal

Regulations but will now be followed by

the statement ‘‘Respiratory protection

for construction employment is covered

by 29 CFR 1910.134.’’ The full text of

this new standard will be printed in the

general industry standards, and the

construction standard will reference the

revised 29 CFR 1910.134.

The Agency’s responses to the

Committee’s specific concerns follow:

Paragraph (a)—Permissible Practice

The Construction Advisory

Committee recommended that

paragraph (a)(1) of the standard be

changed to require that all feasible

engineering controls be used by

employers and that the employer

demonstrate that engineering controls

are not feasible before respirators may

be used. The recommended change also

would have eliminated the requirement

that appropriate respirators be used

while engineering controls are being

installed. OSHA has stated elsewhere in

the summary and explanation section of

this preamble that paragraph (a)(1) of

the previous standard remains

unchanged in the new final standard

because this paragraph was not

proposed for revision and was therefore

not a subject of rulemaking in this

proceeding. The purpose of the

Respiratory Protection standard is to

improve the level of protection provided

to employees who use respirators to

protect them from respiratory hazards,

regardless of whether that use occurs in

an environment where engineering

controls are in place.

The Committee proposed that

paragraph (a)(2) be modified to require

that employers provide respirators to

employees exposed to contaminant

concentrations when the concentration

reaches one-half the PEL or TLV, and

that employees be required to wear

them before the PEL is exceeded. To

accompany this revision the Committee

proposed a new definition establishing

an ‘‘action level’’ of one-half the PEL for

all regulated substances. OSHA has not

adopted this ACCSH recommendation

because the recommended changes are

beyond the scope of this rulemaking.

Paragraph (b)—Definitions

ACCSH suggested that OSHA add a

definition for ‘‘Grade D breathing air’’ to

the standard. The properties of Grade D

breathing air are listed in paragraph (i)

of the final standard, Supplied Air

Quality and Use. OSHA believes that

repeating these elements in the

definition section is redundant and

unnecessary.

The Committee also recommended

that the rule include a definition for

‘‘competent person,’’ as defined in 29

CFR 1926.32(f). The competent person

would review the respiratory protection

program and perform the function of the

respiratory program administrator

required in paragraph (c)(2) of the

proposal. OSHA has not included a

definition of competent person in the

standard because 29 CFR 1926.32(f)

already has such a definition. OSHA

recognizes, however, that, in

construction settings, the competent

person is often also the administrator of

the respirator program.

The Committee also recommended

that the NIOSH Recommended

Exposure Limits (RELs) be used along

with the TLVs, to define a hazardous

exposure level in the absence of a PEL.

This point is no longer relevant because

the concept of ‘‘hazardous exposure

level’’ is not included in the final

respiratory protection standard.

The proposal would have limited the

use of air-purifying respirators for

hazardous chemicals with poor or

inadequate warning properties. ACCSH

recommended a change to the

definitions of ‘‘inadequate warning

properties’’ and that OSHA add a new

definition for ‘‘odor threshold.’’ Because

the final standard takes a different

approach to determining when airpurifying respirators are appropriate,

OSHA has not adopted the changes

recommended by ACCSH.

ACCSH also suggested that OSHA

revise the proposed definition of

maximum use concentration (MUC). In
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1161

the final standard the definition of MUC

has been reserved, pending completion

of a subsequent stage of this rulemaking

that will concentrate on establishing

OSHA Assigned Protection Factors

(APFs).

The Construction Advisory

Committee also recommended replacing

the proposal’s definition of ‘‘respirator;’’

because the final standard contains no

definition of ‘‘respirator,’’ this

suggestion has not been adopted. The

Committee also recommened revising

the proposed definition of ‘‘service life.’’

However, since OSHA’s definition of

this term has been broadened in the

final rule and the rule contains detailed

requirements for change schedules for

cartridges and canisters, ACCSH’s

concerns have largely been addressed.

Paragraph (c)—Respirator Program

Paragraph (c)(1) of the proposal

contained a requirement that the

employer establish a respirator program

that ‘‘covers’’ certain elements, as

applicable. OSHA has followed the

Commitee’s recommendation that

OSHA change the word ‘‘cover’’ to

‘‘include’’ but not removed the phrase

‘‘as applicable,’’ as recommended by the

Committee, because not all elements of

the program apply in all situations, and

thus the ‘‘as applicable’’ language is

appropriate.

The Committee also recommended

that OSHA add an element to the

written respirator program on

procedures for monitoring the work

environment, using monitoring results

when selecting respirators, and selecting

the most protective respirators in

situations where monitoring cannot be

performed (as is often the case in

construction). OSHA considered this

comment in drafting the final standard,

which permits the employer to make

reasonable estimates of exposure as part

of the respirator selection process. In

most cases, as discussed in the summary

and explanation of paragraph (d),

monitoring results will form the basis of

a reasonable estimate. Where the

employer cannot estimate exposure, the

atmosphere must be considered

immediately dangerous to life or health

(IDLH). For IDLH atmospheres, the most

protective respirators are required.

One of the elements in the written

respirator program, paragraph (c)(1)(vi),

states that the program shall include

procedures to ensure proper air quality

for atmosphere-supplying respirators.

ACCSH asked OSHA to add the words

‘‘quantity and flow’’ to provide more

direction for employers on what the

procedures should cover. OSHA agrees

and has revised the wording of this

element accordingly.

ACCSH recommended that OSHA

substitute the term ‘‘competent person’’

in paragraph (c)(2) for the language

‘‘person qualified by appropriate

training and/or experience.’’ This

recommendation has already been

discussed above, in connection with

ACCSH’s comments on paragraph (b).

The written respiratory protection

program, in paragraph (c)(3), is required

to reflect current workplace conditions

and respirator use. The Committee

urged OSHA to add the term ‘‘training’’

to this element. OSHA has not done so

because training is addressed in another

program element. The Committee also

recommended that OSHA add to

paragraph (c) a provision allowing

employees and designated

representatives access to exposure and

medical records maintained by the

employer. Because this requirement is

already included in 29 CFR 1910.1020,

the medical and exposure records access

standard, and referenced in this final

respiratory protection standard, the

Agency has not done so.

Proposed paragraph (c)(5) required

employers to make the written program

available to affected employees,

designated representatives, and OSHA.

The Committee requested that

employers be required to send a copy of

the program to the OSHA Special

Assistant for Construction. However, the

proposed requirement has been moved

to paragraph (m) of the final standard,

which requires that all written materials

maintained under the standard be made

available upon request to affected

employees and the Assistant Secretary.

This requirement should meet any need

that may arise for copies of the written

program.

The Committee further recommended

that the written respirator program be

maintained and made available to

employees at the job site, and that the

medical and monitoring results

pertaining to respirator use be available

at the work site as well. The final

standard in paragraph (m) now requires

employers to allow employees to

examine and copy written programs

upon request. Access to medical and

monitoring records for employees

exposed to toxic substances or harmful

physical agents is regulated by OSHA in

a separate standard, 29 CFR 1910.1020.

That standard applies to construction

workplaces as well as general industry

workplaces and requires the employer

to ensure that access to medical and

monitoring records is provided in a

reasonable time, place, and manner

(1910.1020(e)(1)(i)). Nothing in the final

respiratory protection standard is

intended to alter this requirement.

Paragraph (d)—Selection of Respirators

In its review of paragraph (d) of the

proposal on selection of respirators, the

Committee requested OSHA to add a

new provision that would require

monitoring for contaminants when airpurifying respirators are used. This

request is related to the

recommendation for mandatory

monitoring, discussed above. The final

standard requires that employers make

reasonable estimates of employee

exposure levels when selecting all

respirators, not just air-purifying ones.

Even if current monitoring results are

unavailable, employers must base their

exposure estimates on reliable data,

which might include, for example, the

results of past monitoring for similar

construction jobs. Extensive discussion

of this issue is contained in the

summary and explanation section of

this preamble for paragraph (d). OSHA

believes that allowing exposure

estimates that may be based on past

monitoring and other representative

data makes sense for the construction

industry, where jobs are often shortlived and current monitoring data

relating to specific employees/

operations may not be available when

respirators must be selected. Because

the final standard allows employers to

rely on reasonable estimates of exposure

as well as monitoring results, OSHA has

not added a requirement to the standard

mandating that employers ‘‘obtain’’

needed information, as recommended

by the Committee.

The Committee also recommended

removal of the proposed phrase ‘‘when

they exist’’ to modify the requirement

that employers select only NIOSHapproved respirators. Instead, the

Committee recommended use of the

most protective respirator available, an

SCBA or supplied air respirator, in cases

where no approved air-purifying

respirator exists. OSHA has removed the

phrase ‘‘when they exist’’ from the final

standard, for reasons explained in the

summary and explanation discussion

relating to paragraph (d).

The Committee urged OSHA to

include poor odor warning properties as

a reason for prohibiting the use of airpurifying respirators, and to remove

proposed paragraph (d)(6)(ii), which,

under limited circumstances, would

have allowed their use with substances

with poor odor warning properties.

Final paragraph (d)(3) modifies the

proposal, and places many limitations

on air-purifying respirator use with

gases and vapors, regardless of the

existence of warning properties.

The Committee objected to the use of

air-purifying respirators in an
1162 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

atmosphere with an oxygen content of

19.5 percent at altitudes of 14,000 feet

or below; in the Committee’s view,

supplied air respirators should be

required in this situation. OSHA

continues to treat atmospheres at

altitudes of 14,000 feet or below that

have oxygen concentrations of at least

19.5% as non-oxygen-deficient, and to

require atmosphere-supplying

respirators in these atmospheres.

OSHA’s reasons for this determination

are detailed in the summary and

explanation section for paragraph (d).

Paragraph (e)—Medical Evaluations

The Committee recommended that a

mandatory medical examination be

required in accordance with ANSI

Z88.2, and that the standard include a

list of diseases and conditions that

should be considered in determining an

individual’s ability to wear a respirator.

The final standard allows employers to

rely on a screening questionnaire to

identify employees with specified

conditions that will require follow-up

medical examinations. The

questionnaire specifies medical

conditions that OSHA has determined

often relate to an employee’s ability to

use a respirator. OSHA believes that this

provision responds to the Committee’s

concern.

Based on the comments of ACCSH

and others, OSHA has decided to

eliminate the proposed exemption for

employees wearing respirators for no

more than 5 hours per week, for the

reasons explained below in the

Summary and Explanation. The final

rule also reflects the Committee’s

recommendation that the medical

opinion provided to the employer

include only limitations on the

employee’s ability to use a respirator.

The Committee recommended that

OSHA add a provision to this paragraph

requiring the employer to inform the

person performing the medical

examination of the atmospheric

contaminants to which the employee

would be exposed. The final standard

meets this concern by requiring that the

physician or other licensed health care

professional (PLHCP) receive a copy of

the employer’s written respirator

program, and information about other

environmental conditions an employee

may encounter; this information will

allow the medical professional to judge

whether the employee is medically

capable of wearing the respirator.

The final rule allows an employer

who has, within the preceding 12

months, provided his or her employees

with a medical evaluation that fulfills

the requirements of the revised standard

to rely on the results of that evaluation.

OSHA believes that this provision is

responsive to the Committee’s concern

that limitations be placed on the

‘‘portability’’ of medical evaluations.

The Committee recommended that

OSHA add a new provision to paragraph

(e) to require that the employer provide

a powered air-purifying respirator or

atmosphere-supplying respirator to any

employee found medically unable to

wear a negative pressure respirator but

otherwise able to perform the task to be

done. The final standard requires the

employer to provide a PAPR to an

employee when the PLHCP informs the

employer that the employee has a

medical condition that may place the

employee’s health at increased risk of

material impairment if the employee

uses a negative pressure respirator

(paragraph (e)(6)(ii)) and is thus

responsive to the Committee’s concern.

Paragraph (f)—Fit Testing

With respect to fit testing procedures,

the Committee recommended that

proposed paragraph (f)(1) be rewritten to

state that respirators must fit the

employee so as to ensure that no

exposure above the TLV or ceiling level

occurs. OSHA agrees with the

Committee’s emphasis on fit testing and

believes that the final rule’s fit testing

requirements and the fit test protocols

in an appendix to the standard will

ensure that employees are protected

from the overexposures of concern to

the Committee.

The Committee also suggested

clarifying that a fit test is required

whenever a different make or size

respirator is used or when the facial

characteristics of the employee change.

The final rule addresses both of these

points.

The Committee recommended

limiting the fit testing requirements to

tight-fitting negative pressure

respirators. This issue, and OSHA’s

reasons for requiring fit testing of all

tight-fitting respirators, is discussed in

the fit testing section of the Summary

and Explanation. OSHA has also deleted

the proposed provision, objected to by

the Committee, that would have allowed

the employer to use a qualitative fit test

for selecting respirators for employees

who require fit factors greater than 10 in

situations where outside contractors

who do the quantitative fit testing are

not available.

Paragraph (g)—Respirator Use

Paragraph (g)(1) of the final standard

adopts the proposed provision

prohibiting the use of respirators that

rely on a tight facepiece fit when facial

conditions such as a beard or scarring

would prevent such fits. The Committee

urged OSHA to extend this provision to

cover loose-fitting respirators as well as

tight-fitting ones. OSHA explains in the

Summary and Explanation for this

paragraph that conditions such as a

beard or facial scarring would have no

effect on the performance of loose-fitting

hoods or helmets, and OSHA therefore

does not regard it as appropriate to

make this change.

Employees who wear glasses were

required in proposed paragraph (g)(4) to

wear them in a manner that does not

interfere with the facepiece seal of the

respirator. The final standard continues

this requirement (paragraph (g)(l)(ii)).

The Committee suggested an additional

requirement stating that, where the

employee must wear corrective lenses

and the respirator requires that these be

of special design, the employer provide

the lenses at no cost to the employee.

OSHA believes, however, that such a

requirement is not necessary because, in

most cases where negative pressure

respirators may be worn, half-masks are

acceptable, and half-masks eliminate the

concern about corrective glasses

interfering with facepiece seal. Because

the final standard allows contact lenses

to be worn, full facepiece respirators can

be worn by persons needing corrective

lenses; contact lenses obviously do not

interfere with facepiece seal. Thus, the

final rule gives employers several

options for addressing this concern of

the Committee’s.

Paragraph (h)—Maintenance and Care of

Respirators

The Committee urged OSHA to add

the phrase ‘‘on paid time’’ to this

paragraph to ensure that employers not

require employees to clean their

respirators on their own time. OSHA

has decided in the final rule simply to

require employers to ensure that

respirators are cleaned according to

mandatory procedures or their

equivalents. OSHA believes that this

approach is appropriate because the

record demonstrates that on-site,

employer-supervised cleaning is the

prevalent cleaning procedure and the

standard’s rigorous requirements for

cleaning respirators will limit off-site

cleaning of respirators by employees.

Paragraph (k)—Training

The training section of the proposal

would have required that employers

provide a training program for

employees who are required to wear

respirators. The Committee urged OSHA

to add language to paragraph (k)(1) to

require employers to provide, conduct

and document the effectiveness of the

training program. The final standard

takes a more integrated approach in that
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1163

it requires employers to evaluate the

entire respiratory protection program

rather than the training program

specifically.

Paragraph (m)—Recordkeeping

OSHA has adopted the Committee’s

recommendation to add the phrase ‘‘and

make available’’ to proposed paragraph

(m)(1)(iii), which required employers to

maintain records of medical evaluations

in accordance with 29 CFR 1910.1020,

the Access to Employee Exposure and

Medical Records standard (see

paragraph (n)(1) of the final rule).

Appendix B—Recommended Practices

Appendix B–1 of the standard

contains practices for performing

positive and negative pressure faceseal

checks. Respirator wearers are required

by paragraph (g)(iii) to perform a

faceseal check before entering the work

area either by following the mandatory

faceseal check methods in Appendix B–

1 or by following the respirator

manufacturer’s recommended method,

if the employer shows that the

manufacturer’s method is as effective as

the required methods. The Committee

urged OSHA to add new fit check

methods to Appendix B–1, and OSHA

has responded to this recommendation

by allowing the methods suggested by

the Committee if they are as effective as

the methods in the Appendix.

ACCSH also recommended that

OSHA issue a separate respirator

standard for the construction industry.

OSHA has reviewed the Committee’s

comments to identify which

construction-specific concerns call for

provisions that differ from those

applicable to general industry. First,

many of the final standard’s provisions

are stated in performance language,

which is flexible enough to

accommodate differences in particular

workplaces or industries. For example,

approved fit test systems, both

quantitative and qualitative, are portable

and can be used on construction work

sites as well as in fixed industrial

facilities. Another example is the final

rule’s requirement for medical

surveillance; the frequency of medical

reevaluation is now event driven, which

will greatly simplify evaluations for

employees who frequently change

employment, as is the case with many

construction workers. Thus, OSHA

believes that the final rule is responsive

to the Committee’s concerns about the

uniqueness of the construction industry

and is sufficiently flexible to be used on

worksites in this sector.

D. Assigned Protection Factors

OSHA is reserving the sections of this

standard addressing assigned protection

factors (APFs) pending further

rulemaking. OSHA is working diligently

to complete the reserved portions of the

standard. In the interim, OSHA expects

employers to take the best available

information into account in selecting

respirators. As it did under the previous

standard, OSHA itself will continue to

refer to the NIOSH APFs in cases where

it has not made a different

determination in a substance-specific

standard.

E. Small Business Considerations

Pursuant to 5 U.S.C. 605(b) of the

Regulatory Flexibility Act, OSHA

certified to the Small Business

Administration that the proposed

respiratory protection standard would

not have a significant impact on a

substantial number of small entities.

For the purposes of fulfilling the

requirements of the Regulatory

Flexibility Act, the Agency in its

Preliminary Regulatory Impact Analysis

(PRIA) [Ex. 57] examined the impact of

the standard on a number of different

small establishment-size classes (1–7

employees, 8–19 employees, etc).

Although some economies of scale

associated with the proposed standard

were noted, the Agency found that,

given the modest costs per

establishment and the limited impact of

the proposed regulatory revisions as a

whole, the standard would not impose

a significant economic impact on a

substantial number of small entities.

These findings were summarized in the

NPRM (59 FR 58894). At the time that

OSHA published the NPRM for this

rulemaking (Nov. 15, 1994), the Agency

transmitted the certification setting forth

this conclusion, along with the full

PRIA, to the Small Business

Administration.

In developing the final standard, the

Agency has conducted a screening

analysis to identify any significant

impacts on a substantial number of

small entities. The details of the

screening analysis are presented in the

Final Economic Analysis, which is

available in the docket; a summary of

the analysis appears in section VI. Based

on this screening OSHA has again

determined that the final rule will not

impose a significant impact on a

substantial number of small entities.

The costs of the standard will equal no

more than 0.02 percent of revenues for

small firms in any affected industry, and

will therefore pose no threat of business

disruption, whether these costs are

absorbed by affected firms or passed on

to consumers. OSHA therefore certifies

that the final rule will not have a

significant impact on a substantial

number of small entities.

Nevertheless, the Agency has

designed the standard to minimize

impacts on all affected establishments,

and particularly on small entities.

OSHA’s special consideration of small

businesses is in accord with the

Agency’s continuing policy to remain

sensitive to the needs of small entities

affected by Agency regulations.

Provisions that recognize the special

needs of small businesses are discussed

in more detail under specific sections of

the Summary and Explanation of the

standard, Section VIII. Examples of

provisions where consideration was

given to small businesses in making

regulatory decisions include:

—Reduction in the number of repeat fit

tests required for quantitative fit

testing;

—Allowing employers to use a

questionnaire (Appendix C is an

example) as a minimal medical

evaluation tool to ascertain an

employee’s ability to use respirators,

rather than requiring a hands-on

physical examination;

—Allowing medical evaluations to be

conducted either by a physician or by

another licensed health care

professional (PLHCP), which will

reduce medical surveillance costs

without compromising employee

protection;

—Making the frequency of medical

evaluations, after the initial

assessment, event-related instead of

time-related, e.g., only requiring such

evaluations when specific conditions

indicate a need for a reevaluation;

—Reducing the amount of paperwork

required in connection with medical

evaluations. OSHA’s previous

standard required a physician to

determine pertinent health and

physical conditions, and further

required that the respirator user’s

medical status be reviewed

periodically (for instance, annually).

Historically, employers have had

physicians evaluate their employees’

physical conditions, and have

maintained records documenting

those evaluations;

—Revising the requirements for

disinfecting respirators from ‘‘after

each use’’ to ‘‘as necessary to be

maintained in a sanitary condition’’ to

allow flexibility for small businesses;

—Requiring only that tags be used to

document respirator inspections,

rather than requiring written records;

and

—Allowing the employer to obtain a

certificate of analysis of breathing gas
1164 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

from the supplier rather than

requiring employers to conduct gas

analyses themselves.

In the Small Business

Administration’s Annual Report to

Congress, a summary of SBA’s

comments to the respirator docket (Ex.

54–318) was provided. (Note that these

comments pertain to the proposed

rather than final rule.) SBA’s comments

have been examined alongside others

with regard both to the proposal and its

supporting economic analysis. As

indicated, many of SBA’s suggestions

have been adopted; the SBA’s comments

on the Preliminary Regulatory Impact

Analysis are discussed in detail in the

economic impact chapter of the Final

Economic Analysis.

Revised 29 CFR 1910.134 is intended

to serve as a ‘‘building block’’ standard

with respect to future standards that

may contain respiratory protection

requirements; that is, future standards

that regulate respirator use in

controlling employee exposure to

hazardous conditions will refer to

provisions in the final respiratory

protection standard. Further, OSHA has

found that the respirator provisions of

existing substance-specific standards

(Asbestos, Cadmium, Lead, etc.) were

especially in need of revision in view of

newly revised § 1910.134. Except for a

limited number of respirator provisions

unique to each substance-specific

standard, the remaining regulatory text

on respirators now reads virtually the

same for each of these standards. For

example, all provisions addressing

respirator use, selection, and fit testing

were deleted from the substancespecific standards, making these

standards consistent with the final

respiratory protection standard with

respect to these requirements. The

Agency believes that the revisions being

made to 29 CFR 1910.134 are

sufficiently comprehensive to allow

deletion of those provisions in the

substance-specific standards that

duplicated provisions in the revised

final rule. A provision was retained only

when it addressed conditions (for

example, medical evaluation) that were

unique and/or integral to the substancespecific standard.

The Agency concludes that deletion

of duplicative provisions from the

substance-specific standards will

enhance compliance, especially for

small businesses, and will thus will

improve the protection afforded to

employees who use respirators.

IV. Certification/Approval Procedures

Section 1910.134(b)(8) of the previous

standard required that only those

respirators approved jointly by NIOSH

and MSHA be used by the employer.

The current respirator testing and

approval regulation, 30 CFR 11, which

authorized the Bureau of Mines and

NIOSH to jointly approve respiratory

protection devices, was promulgated on

March 25, 1972 at 37 FR 6244. On

November 5, 1974 the Mine

Enforcement Safety Administration

(MESA) succeeded the Bureau of Mines

and joined NIOSH in jointly approving

respirators. Following the transfer of

MESA to the Department of Labor,

where it became the Mine Safety and

Health Administration (MSHA),

authority was transferred on March 24,

1978 to MSHA for joint approval with

NIOSH of respirators. Most of the

Bureau’s respiratory testing methods,

developed in the 1950s or earlier, were

changed in the 1970s to reflect changes

in testing technology.

NIOSH initiated revision of 30 CFR 11

in 1980. A public meeting was held in

July 1980 to address the certification

program. On August 27, 1987, NIOSH

published a notice of proposed

rulemaking (52 FR 32402) that would

have allowed NIOSH to certify

respirators under the new 42 CFR part

84 regulations, replacing the current

joint NIOSH/MSHA 30 CFR 11

certification regulations. The proposed

NIOSH certification regulations

contained new and revised

requirements for testing and

certification of respirators, and included

a set of assigned protection factors for

various classes of respirators. Public

hearings on the first draft of the NIOSH

proposal were held in January 1988. On

the basis of the comments received,

NIOSH prepared a revised proposal for

further public comment. On June 8,

1995 NIOSH published revised

respirator certification procedures for

particulate respirators (60 FR 30336)

and recodified the previous certification

standards for the other respirator classes

as 42 CFR Part 84. These certification

procedures address N, P and R class

particulate respirators at 95%, 99%, and

99.7% levels of effectiveness.

Additional public comment was sought

at public meetings convened in June

1996 to assist NIOSH in preparation of

future rulemakings that will continue

the revision of the certification

procedures for other classes of

respirators. In October 1997, NIOSH

announced the intended priority order

for these future rulemakings. Relevant

aspects of these proceedings are

discussed in the Summary and

Explanation.

V. Significance of Risk

Respirators are used by American

workers as a means of protection against

a multitude of respiratory hazards that

include chemical, biological, and

radiological agents. Situations in which

respirators are relied upon to provide

protection from these hazards include

those that involve immediately lifethreatening situations as well as routine

operations where engineering controls

and work practices are not able to

provide sufficient protection from these

hazards. In these situations, respirators

must ‘‘seal off’’ and isolate the worker’s

respiratory system from the

contaminated environment. The risk

that a worker will experience an adverse

health outcome when relying on

respiratory protection is a function of

the toxicity or hazardous nature of the

air contaminants present, the

concentrations of the contaminants in

the air, the duration of exposure, and

the degree of isolation provided by the

respirator. When respirators fail or do

not provide the degree of protection

expected by the user, the user is placed

at an increased risk of any adverse

health effects that are associated with

exposure to the respiratory hazards

present. Therefore, it is critical that

respirators perform as they are designed

to do to ensure that users are not at an

increased risk of experiencing adverse

effects caused by exposure to respiratory

hazards.

OSHA has discussed the nature of

adverse health effects caused by

exposure to airborne chemical hazards

many times in previous rulemaking

efforts (see, for example, Appendix A of

the Hazard Communication standard, 29

CFR 1910.1200 and the preambles to

any of OSHA’s single substance

standards codified in 29 CFR 1910.1001

to 1910.1052). In all instances where

OSHA has promulgated new or revised

PELs for chemical air contaminants,

OSHA has determined that the health

effects associated with exposure to the

contaminants represent material

impairment of health because the effects

are life-threatening, cause permanent

damage, or significantly impair the

worker’s ability to perform his or her job

in a safe manner. As discussed in

Section VI of this preamble, OSHA

expects that thousands of illnesses and

hundreds of fatalities that are presently

being caused by exposure to hazardous

substances will be avoided annually

among respirator wearers as a result of

improvements and clarifications made

to the earlier standard by this final rule.

Evidence on current workplace

exposure levels confirms that respirators

are needed in many work situations to

protect workers against serious workrelated illness. To illustrate, OSHA

identified several substances that

represent a range of adverse effects and
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1165

for which OSHA’s Integrated

Management Information System (IMIS)

database has documented workplace

exposures that exceed the current PELs

for these substances. The effects

represented by this subset of the IMIS

and the associated substances for which

there are documented overexposures

include:

—Sudden death/asphyxiation—carbon

monoxide, carbon dioxide;

—Loss of lung function—wood dust,

welding fume, manganese fume,

copper fume, cobalt metal fume,

silica;

—Central nervous system

disturbances—carbon monoxide,

trichloroethylene;

—Cancer—chromic acid, wood dust,

silica; and

—Cardiovascular effects—carbon

monoxide.

When respirators are used during

operations where exposures exceed

OSHA’s PEL, OSHA believes that there

is little or no margin that would protect

the worker in the event that the

respirator does not perform as well as

designed or expected. For all of the

substances for which OSHA has

promulgated a comprehensive health

standard (i.e., Arsenic, 29 CFR

1910.1018; Asbestos, 29 CFR 1910.1001;

Benzene, 29 CFR 1910.1028; Lead, 29

CFR 1910.1025; Ethylene Oxide, 29 CFR

1910.1047), OSHA has determined that

exposure above the PEL is associated

with a significant risk of material

impairment of health, and believes as a

matter of policy that exposures below

the PEL may be associated with risk

levels that are significant. That is, there

is no exposure level near or somewhat

above the PEL that can be considered to

be at a low or insignificant risk level.

Therefore, where workers perform jobs

that result in exposures above the PEL

for any of these substances, use of

properly functioning respirators is

essential to ensure that workers are not

placed at significant risk of material

impairment of health.

Throughout this preamble, OSHA has

demonstrated that adequate fit testing,

proper respirator selection, worker

training, and thorough inspection and

maintenance are essential elements of a

respirator program. Without these

requirements, OSHA believes that there

is a greater chance that a respirator user

will inhale potentially dangerous air

contaminants, either by improper

selection of equipment, excessive

respirator leakage, improper use of the

respirator, or any combination of these.

This section presents an analysis

conducted by OSHA to evaluate the

improved protection to workers who use

respiratory protection equipment by the

type of effective respirator program

required by the final rule.

In the context of a respiratory

protection program, the health risk

presented to workers can be represented

as the risk that a respirator will fail to

provide some minimum expected level

of protection, which increases the

possibility that the user of the respirator

will be overexposed to a harmful air

contaminant. This presumes that

respirators will be selected and used in

work settings where exposure to

ambient concentrations of air

contaminants poses an unacceptable

health risk, and, if the respirator

performs as expected, the wearer will be

protected from that risk. For example,

an employer who provides a half-mask,

chemical cartridge respirator for

employee use might typically assume

that the respirator will filter out 90

percent of the contaminant and base his

or her choice of respirator on that

assumption. If the respirator performs

less effectively than expected, the

employer’s expectation that the

respirator will provide effective

protection will not be fulfilled.

This concept of risk differs from that

used by OSHA in its substance-specific

health standards, in which the Agency

typically defines risk as the probability

that a worker will acquire a specific

work-related illness. Quantifying that

kind of risk requires the analysis of data

that relates the magnitude or intensity of

exposure to the incidence or prevalence

of adverse effects seen among exposed

populations or experimental animals. In

contrast, the kinds of hazardous

situations covered by the final

respiratory protection standard are

varied in terms of the nature of the

hazard present (i.e., acute, chronic, or

both), the frequency and magnitude of

exposure, and the types of illnesses

associated with exposure to those

hazards. As a consequence, the health

risks addressed by the final rule cannot

be described in terms of an illnessspecific risk, but instead relate to the

more general probability that a

respirator will provide insufficient

protection causing the wearer to be

exposed to a dangerous level of one or

more air contaminants.

Certain studies, referred to as

‘‘workplace protection factor’’ (WPF)

studies, have attempted to measure the

effectiveness of respirators under actual

conditions of use in the workplace. The

WPF is a measure of the reduction in

exposure achieved by using respiratory

protection and is represented by an

estimate of the ratio of the concentration

of a contaminant found in the

workplace air to the concentration

found inside the respirator facepiece

while the respirator is being worn. As

the degree of protection afforded by the

respirator increases, the WPF increases.

Alternatively, the degree of protection

provided by a respirator can be

expressed as a penetration value, which

is the reciprocal of the WPF and reflects

the ratio of the concentration of

contaminant inside the facepiece to the

concentration outside. For example, a

WPF of 50 equates to a penetration

value of 0.02 and means that the

concentration inside the respirator

facepiece is one-fiftieth of the ambient

level.

Because WPF studies are designed to

evaluate the field effectiveness of

respiratory protection equipment, study

protocols usually have been designed to

minimize factors that can reduce

respirator performance. Such factors

include selecting the wrong type of

respirator for the working conditions

under which the study is being

conducted, use of poorly fitting

respirator facepieces (i.e., testing of

respirator fit is routinely done in wellconducted WPF studies), inadequate

training of wearers in proper respirator

adjustment and use, or excessive

leakage caused by malfunctioning or

dirty respirator parts. Typically, WPF

study protocols include procedures for

properly selecting respirators and

ensuring that they are in good working

order, assigning respirators to workers

on the basis of valid qualitative or

quantitative fit tests, training wearers on

how to adjust strap tension properly and

use the respirator, and ensuring that

neither facial hair nor other personal

protective equipment is likely to

interfere with respirator fit. In addition,

workers included in WPF studies are

usually monitored throughout the

period that respirators are worn to verify

that the equipment is being properly

used. All of these conditions reflect the

principal elements of a strong respirator

program in which respirator

performance is optimized; therefore, the

results from a good WPF study can

mirror the results obtained by an

employer who implements a well-run

respiratory protection program.

To quantitatively evaluate the impact

of implementing a good respirator

program on respirator performance,

OSHA identified several WPF studies

that were conducted using methods that

reflect a comprehensive program, and

compared these results to other

workplace studies that did not employ

all of the elements of a good program.

Quantitative approaches are used to

develop (1) aggregate estimates of

respirator effectiveness in both the

presence and absence of a good
1166 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

respiratory protection program, and (2)

estimates of the frequency with which

workers are likely to achieve inadequate

protection while using a respirator,

given the presence or absence of a good

underlying program. All of the studies

used in this analysis pertain to the

effectiveness of half-mask, negativepressure respirators, and all are

contained in OSHA’s rulemaking docket

(H–049).

Many of the well monitored WPF

studies conducted were reviewed by

Nelson et al. in 1995 (Ex. 64–514); these

authors selected data from seven such

studies to evaluate the overall field

effectiveness of half-mask, negativepressure respirators. Each of the studies

described by Nelson et al. ensured

selection of properly fitted respirators

either by an accepted qualitative fit test

(QLFT) (i.e., isoamyl acetate or

saccharin) or by a quantitative fit test

(QNFT) where only respirators that

provided a minimum protection factor

to the wearer of at least 100 were

selected. Each of these studies provided

for worker instruction in proper

respirator use, and workers were

monitored during each study to ensure

proper use. An additional six studies

were reviewed by Nelson et al. but were

rejected either because they allegedly

used biased sampling methods to

determine ambient and in-facepiece

contaminant concentrations or because

the authors believed that improper or

invalidated fit test procedures were

employed.

In the studies selected by Nelson et al.

for analysis, workers used elastomeric

or disposable respirators equipped with

dust-mist, dust-mist-fume, or highefficiency particulate (HEPA) filters, and

the collection of studies represented a

range of workplace exposure situations,

including pigment production, metals

refining, asbestos exposure during

brake-repair work, welding, and spray

painting. Geometric Mean (GM) WPF

values from these studies ranged from

47 to 3,360, with an overall GM WPF of

290. The 5th percentile WPF from the

data set was estimated to be 13, with a

95% confidence interval of 10–18.

Nelson et al. concluded from the

analysis of the overall data set that the

assigned protection factor of 10 for halfmask, negative-pressure respirators was

reasonable given that a WPF of less than

10 would not likely occur more than 5

percent of the time. In addition, Nelson

et al. found no significant difference in

the field performance of disposable

respirators compared to elastomeric

models. OSHA has not conducted a

detailed comparative evaluation of WPF

values obtained from disposable vs.

elastomeric respirators; if, in fact,

disposable respirators provide less

protection than elastomeric respirators,

the WPFs that can be achieved under a

good respirator program will be

overstated in this analysis since Nelson

et al.’s compiled data reflect the use of

both types of respirators.

Each of the studies reviewed by

Nelson involved worker exposures to

dusts. OSHA could identify only one

WPF study, by Galvin et al. in 1990 (Ex.

64–22), that examined respirator

effectiveness against exposure to a

vapor-phase contaminant rather than a

particulate. In this study, WPF

measurements were taken on a group of

13 styrene workers who used half-mask,

air-purifying respirators equipped with

chemical cartridge filters. All employees

were assigned respirators based on

passing an irritant smoke fit test, and all

were trained on how to properly don the

respirator and conduct fit checks. Inmask and ambient styrene

concentrations were measured over onehour periods, during which employees

were instructed not to readjust the

facepiece. Chemical cartridges were

changed with each new sampling period

to ensure that there was no

breakthrough. In-mask styrene

concentrations were adjusted upwards

by 40 percent to account for pulmonary

retention, which avoided potentially

overestimating the WPF. The GM WPF

for the overall cohort was reported to be

79, with a geometric standard deviation

(GSD) of 3.51. There was no significant

difference in WPF values between those

workers engaged in relatively physical

operations, such as spraying, compared

to those performing less physical work

tasks. The GM WPF found by Galvin et

al. for styrene-exposed workers lies

within the range of GM WPF values

reported in the studies reviewed by

Nelson for worker cohorts exposed to

particulate-contaminated environments.

Nelson in his 1995 report (Ex. 64–514)

excluded the Galvin et al. study from

his analysis because fit tests were

performed using the irritant smoke

protocol. As discussed in the Summary

and Explanation section of this

preamble, OSHA has determined that

the irritant smoke qualitative fit test

provides a valid, effective test of

respirator facepiece fit. The procedures

used by Galvin et al. to ensure adequate

worker training and respirator use are

consistent with the elements of a

permissible respirator program, and

OSHA, therefore, finds it appropriate to

include this study in the set of WPF

studies that are representative of

effective respiratory program practices.

In contrast, OSHA has identified three

studies where investigators also

determined WPF values for half-mask,

negative-pressure respirators, but where

few steps were taken to ensure

maximum respirator performance.

OSHA believes that these studies

illustrate the relative lack of protection

afforded by respirators when certain

critical elements of the respiratory

protection program are missing or

inadequate. The studies identified by

OSHA are those by Toney and Barnhart

in 1972 (Ex. 64–68), Moore and Smith

in 1976 (Ex. 64–49), and Harris et al. in

1974 (Ex. 27–11).

Toney and Barnhart (Ex. 64–68)

conducted a WPF study to evaluate the

effectiveness of half-mask, chemicalcartridge respirators on reducing

exposures of spray painters to solvent

vapors and aerosols. Data were obtained

from painters working at 39 different

sites and included both in-mask and

ambient concentrations. WPFs were

found to be low; from the raw data

presented in the study, OSHA

calculated a GM WPF of 3.8 for solvent

exposure (GSD=2.28, N=39) and a GM

WPF of 11.4 for aerosol exposure

(GSD=4.12, N=40). Penetration tests

performed on unused respirator

cartridges of the same types used in the

field indicated that the poor WPFs

achieved in the field tests were caused

by poor respirator fit and a lack of

respirator maintenance, and were not

due to any inherent defect in the

cartridges. The authors concluded that

respirators being used by painters were

not effective and cited several reasons,

all pointing to the lack of a respiratory

protection program at the facilities

tested. For example, 28 percent of

respirators used by the painters were

poorly maintained. Some of the

conditions found by the investigators

included deteriorating rubber on the

facepieces, the presence of stuck or

warped valves, missing head straps, and

evidence of leakage around the cartridge

seal. In addition, it was apparent that

some of the cartridges had not been

changed for extended periods of time.

Many of the facilities studied supplied

non-approved respiratory protective

devices (respirators were approved by

the Bureau of Mines at the time of the

study), and most had no formal training

or maintenance program in place. The

authors found that ‘‘* * * management

and workers are extremely uninformed

on the subject of selection, use, and care

of respiratory protective devices.’’ (Ex.

64–68, p. 93).

The second study, conducted by

Moore and Smith in 1976 (Ex. 64–49),

measured WPF values obtained by

workers exposed to sulfur dioxide (SO2)

during a furnace charging operation at a

copper smelter. Three models of halfmask, chemical cartridge respirators
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1167

were tested on each of nine workers; inmask and ambient SO2 concentrations

were measured during the furnace

charging operation while the respirators

were worn. There is no indication in the

study that qualitative or quantitative fit

testing was performed to verify adequate

facepiece fit. A total of 81 samples were

collected, 5 of which were excluded

from the analysis because the subjects

removed or lifted the respirator

facepiece during the sampling period.

Average ambient SO2 concentrations

varied in the range of 53 to 61 mg/m3

(20.4 to 23.5 ppm) during the sampling

period. Geometric mean WPF values

reported for each of the three models of

respirator were 22.1 (SD=22.6), 18.4

(SD=14.2), and 12.9 (SD = 11.0). Moore

and Smith concluded that the overall

protection afforded by the respirators

was poor, and that between one-third

and one-half of the protection factors

achieved would be below 10, the

accepted minimum protection factor for

that type of respirator. Reasons given by

the authors for the poor fits observed

among the subject workers included the

possibility that strap tension was not

properly adjusted (the authors did not

control or monitor strap tension),

variation in facial hair (despite the lack

of beards or wide sideburns), and

normal work activities that caused head

motion and deep breathing associated

with heavy work.

The third study is that of Harris et al.

in 1974 (Ex. 27–11), who evaluated the

performance of five half-mask dust

respirators among 37 miners working in

4 coal mines. In-mask and ambient dust

measurements were made throughout

the workshifts, during which miners

intermittently used respiratory

protection. Thus, this study differs from

the others described above in that the

ratio of in-mask to outside

concentrations included periods of time

where the respirator was not worn, in

contrast to the typical WPF study. The

ratio of in-mask to outside concentration

determined during periods of

intermittent respirator use, termed the

‘‘effective protection factor’’ (EPF), is

not directly comparable to WPF values

because, to the extent that workers

spend time in contaminated

atmospheres without respiratory

protection, the WPF will tend to

understate the actual protection

obtained while the respirator is being

worn. However, according to

Poppendorf in 1995 (Ex. 54–512), it is

possible to use EPF data to estimate the

WPF that was likely to have been

achieved during periods of respirator

use if both of the following are known

or can be estimated: (1) The fraction of

time during which the respirator was

not worn by the subject, and (2) the ratio

of contaminant concentration in areas

where the respirator was worn to that in

areas where the respirator was not worn.

Poppendorf (Ex. 54–512) described the

mathematical relationship between the

EPF and WPF and suggested that the

likely range of average WPF values

achieved by the miners during periods

of respirator use was 3.6 to 5.7. This

estimate of WPF is based on an

observation by Harris et al. that miners

wore their respirators about half of the

time during the sampling periods, and

an assumption by Poppendorf (Ex. 54–

512) that the dust levels in the air while

respirators were worn were at least 5

times higher than airborne dust levels

during periods of respirator non-use.

OSHA believes that the latter

assumption is reasonable given that

Harris et al. reported that, for the most

part, miners wore their respirators only

when visible airborne dust was present.

Harris et al. noted that the hard hats

worn by the miners interfered with

proper respirator strap positioning and

adjustment; OSHA believes that this

factor, as well as the apparent lack of fit

testing, is likely to have contributed to

the low protection factors experienced

by the miners.

OSHA believes that the studies

described above demonstrate that

improved respirator performance can be

achieved under actual workplace

conditions if fit testing is used to select

respirators, if respirators are clean and

in good working order, and if employees

are properly trained and supervised in

their use. This is evident when the

summary statistics from aggregate

protection factor data obtained from

field studies on groups of employees

using respirators in the absence of a

strong respirator program (i.e., Moore

and Smith, Toney and Barnhart, Harris

et al.) are compared with those obtained

from cohorts using respirators under the

condition of a strong program (i.e., the

studies reviewed by Nelson and the

study by Galvin et al.). Summary

protection factor data from these studies

are presented in Table V–1 as geometric

mean and mean WPF values, and the

geometric standard deviation (GSD) of

the distribution of WPF values. From

these summary statistics, OSHA

computed a weighted geometric mean

WPF across cohorts exposed to

particulate contaminants to compare the

central tendency in protection factors

achieved both with and without an

adequate underlying respirator program

(see footnote on Table V–1).

In general, groups of employees using

respirators against particulate exposures

under a strong program achieved an

overall GM protection factor about 25-

fold higher than groups using

respirators without the elements of a

strong respiratory protection program.

In studies that did not implement all of

these elements, mean WPF values

among the particulate-exposed worker

cohorts tested ranged from about 6 to

22. Mean WPF values for particulateexposed worker cohorts included in the

WPF studies where elements of a good

program were implemented ranged from

72 to 2,400, with the mean WPF from

one study estimated to be 11,500. The

results from studies that examined

respirator effectiveness against gas or

vapor, also included in Table V–1, show

an 8-fold difference in overall GM WPF

values. With only one exception, the 95

percent confidence intervals around the

GM WPF values computed from the

studies reflecting inadequate program

practices do not overlap with those

computed from the studies reflecting

strong program elements (see Table V–

1); thus, the hypothesis that there are no

differences in the GM WPF values

between the two groups of studies is

rejected. This analysis suggests that

implementation of a good respiratory

protection program containing the

elements described by the final rule can

contribute to a substantial increase in

the overall performance of respirators

used in actual workplace settings, as

measured by the mean WPF across

groups of workers.
1168 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

TABLE V–1.—SUMMARY RESULTS FROM WORKPLACE PROTECTION FACTOR (WPF) STUDIES AND ESTIMATED FREQUENCIES OF RESPIRATOR FAILURE, BASED ON A ONE-FACTOR ANOVA ANALYSIS OF DATA FROM WORKPLACE PROTECTION FACTOR (WPF) STUDIES

Study Geometric mean

WPF (95% C.I.1)

Geometric

standard

deviation

Mean

WPF

Estimated percent of workers with:

Mean

WPF ≤10 2

Mean

WPF ≤2 2

WPF ≤10

at least

5% of the

time 3

WPF ≤2 at

least 5%

of the

time 3

Studies Reflecting Inadequate Program Elements

Particulate Exposure

Toney and Barnhart [1972] (Ex. 64–68) ..... 4 11.4 (3.2–39.6) 4 4.12 31.1 76.8 9.0 100 60.4

Harris et al. [1974] (Ex. 27–11)

Low Estimate ....................................... 5 3.6 (1–17.9) 5 2–93 6.4 99.7 38.8 100 96.4

High Estimate ....................................... 5 5.7 (1.6–20.4) 5 2.93 10.2 97.0 12.5 100 82.3

Weighted Geometric Mean .............. 6 5.6

Gas/Vapor Exposure

Moore and Smith [1976] (Ex. 64–69)

Respirator A ......................................... 15.29 (8.3–28.1) 7 2.36 22.1 36.2 <0.01 98.9 1.9

Respirator B ......................................... 13.72 (7.7–24.4) 7 2.15 18.4 41.3 <0.01 99.7 0.5

Respirator C ......................................... 9.59 (4.8–19.2) 7 2.16 12.9 83.1 <0.01 100 9.0

Toney and Barnhart [1972] (Ex. 64–68) ..... 4 3.8 (1.2–11.9) 4 2.28 5.3 100 14.7 100 95.7

Weighted Geometric Mean .............. 6 9.4

Studies Reflecting Good Program Elements

Particulate Exposure

Dixon and Nelson [1984] 8 .......................... 3360 (3101–3640) 4.8 11,498 <0.01 <0.01 <0.01 <0.01

Gaboury and Burd [1989] 8 ......................... 47 (31–72) 2.5 72 0.2 <0.01 30.1 <0.01

Lenhart and Campbell [1984] 8 ................... 166 (120–228) 3.8 405 0.1 <0.01 9.0 0.02

Nelson and Dixon [1985] 8 .......................... 258 (192–347) 5.2 1004 0.7 <0.01 14.5 0.3

Gosselink et al. [1986] 8 .............................. 96 (75–123) 2.3 136 <0.01 <0.01 0.1 <0.01

Colton and Mullins [1992] 8 ......................... 147 (117–185) 2.5 224 <0.01 <0.01 0.1 <0.01

Myers [1990] 8 ............................................. 346 (256–468) 7.2 2,428 2.8 0.1 22.2 1.7

Weighted Geometric Mean .............. 6 142

Gas/Vapor Exposure

Galvin et al. [1990] (Ex. 64–22) .................. 79 (54–115) 3.5 173 1.1 <0.01 31.7 0.2

1 95% confidence interval of the geometric mean WPF calculated as follows for simultaneous confidence intervals: y ̃±SD÷√Ñn tn¥1,1¥α/2,

α=1¥(1¥0.05)1/N

where n is the number of WPF measurements in each study and N is the number of studies being compared (i.e., 10 for particulate studies

and 5 for gas/vapor studies). 2 Calculated from equation 9 as described in the text; δ = 0.1 for WPF = 10, δ = 0.5 for WPF = 2. 3 Calculated from equation 10 as described in the text; κ = 0.1 for WPF = 10, κ = 0.5 for WPF = 2. 4 Calculated by OSHA from raw data presented by the authors.

5 Range of WPF values estimated by Popendorf [1995] (Ex. 54–512), from effective protection factor values (EPF) reported by Harris et al.

GSDs calculated by OSHA from median and mean EPF values reported by Harris et al. 6 Calculated as a weighted geometric mean as follows: exp[(∑lnGM/(lnGSD)2)/∑(1/(lnGSD)2)]. 7 Calculated by OSHA from median and mean WPF values reported by Moore and Smith.

8Studies reviewed by Nelson [1995] (Ex. 64–514).

The three WPF studies representing

deficient program practices were all

conducted 10 to 20 years earlier than

the WPF studies reflecting good

program elements. Thus, differences

between the two groups of studies in

working conditions, processes and

exposures, or respirator equipment and

technology could confound the

comparison of respirator effectiveness

measures. OSHA is not aware of any

recent studies that have been conducted

that were designed to evaluate the

impact of respirator program elements

on respirator effectiveness, nor are

recent studies available that have

attempted to measure respirator

effectiveness under conditions of a poor

respiratory protection program. OSHA

believes that this analysis of program

impacts on respirator performance is

based on the best available data.

However, OSHA has considered

whether confounding factors related to

the elements of a good respirator

program may also have contributed to

the differences in respirator

performance reported by the two groups

of WPF studies. For example, respirator

fit can be adversely affected by vigorous

work activity requiring head motion and

deep breathing. Heavy work loads also

contribute to respirator discomfort,

which may cause a worker to wear a

respirator too loosely. The nature of the

air contaminant affects respirator

performance in that different types of

respirator filters have different

capabilities in purifying contaminated

air and gas-phase contaminants and

small-particulate aerosols pass more

readily through leak points than do

aerosols comprised mostly of larger

particles.

OSHA does not believe that any

systematic differences in working

conditions or respirator technology

contribute substantially to the

differences in respirator effectiveness

found between the two groups of studies

included in the analysis. For example,

both groups of studies represent a range

of workplace situations that involve

strenuous and non-strenuous work. In

the studies that do not reflect good

program practices, workers were

engaged in active, strenuous work

(smelter operations and coal mining) as

well as less active work (spray painting).

Similarly, studies that reflect good

program practices have also been

conducted on worker cohorts engaged in

both active work (metals refining) and

less active work (spray painting, brake

repair). Both groups of studies also

involve a range of contaminants,

including both gas-phase and various

kinds of particulate. Some of the studies

reviewed by Nelson included

information on the size distribution of
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1169

particulates to which workers were

exposed, with the range across these

studies including both respirable and

non-respirable particles. Other studies

included in the Nelson analysis

reported that workers were exposed to

both dust and fume. Therefore, the

differences in WPFs found between the

two groups of studies cannot be

explained by differences in particulate

sizes or characteristics. Both groups of

studies also represent a variety of halfmask respirator designs and filters,

including single-use respirators and

respirators equipped with dust/mist

(i.e., non-HEPA) filters. OSHA believes

it unlikely that the 14-fold difference in

overall WPFs between the two groups of

studies can be primarily attributed to

any fundamental differences in

respirator equipment or technology.

Therefore, OSHA finds that the

differences in WPF values obtained

from the two groups of studies are more

likely to reflect differences in how well

the respirators fit the subject workers,

the condition of the respiratory

equipment used, and the extent to

which the equipment was used

properly, rather than any confounding

caused by systematic differences in

work settings, the nature of the

exposures, or the age of the WPF

studies.

The kinds of summary statistics

presented in Table V–1 have been used

by several investigators to demonstrate

how poorly or how well respirators can

protect workers under actual conditions

of use (see, for example, Moore and

Smith (Ex. 64–69), Nelson et al. (Ex. 64–

514)). However, such descriptive

measures can only provide information

on the aggregate frequency distribution

of protection factor values in a group of

workers. Although it is useful to rely on

summary statistics from aggregate

protection factor data to make general

statements about the effectiveness of

respirators, such measures do not

adequately convey information on the

number or proportion of workers who

remain at risk of overexposure to air

contaminants despite the use of

respiratory protection, or how

frequently an individual worker might

experience poor fits.

Nicas (Ex. 156) and Nicas and Spear

in 1992 (Ex. 64–425) have suggested that

using statistics from aggregate

protection factor data does not

adequately describe the true risk of

overexposure to workers using

respirators because the approach fails to

recognize that there are two different

sources of variability that account for

the overall variation in protection factor

values measured from a given cohort of

workers. One source of variability in

protection factors is the variation

typically experienced by a single worker

from one day to the next; this is termed

within-worker variability. The second

source of variability reflects the

observation that different workers

within a group will achieve different

average protection factors over a given

period of time; this is termed betweenworker variability. In a peer-reviewed

article, Nicas and Spear (Ex. 64–425)

have described a statistical model that

accounts for both sources of variability.

This model has been used by OSHA to

estimate the following from the

protection factor studies described

above to better characterize risks to

workers who use respirators both in the

absence of and under a strong

respiratory protection program:

(1) The proportion of workers who fail to

achieve a long-term average protection factor

at or above some specified target level,

exposing the worker to an increased risk of

a chronic health hazard (i.e., a health hazard

that is typically associated with long-term

cumulative exposure); and

(2) The proportion of workers who achieve

a protection factor below some specified

target level at least 5 percent of the time that

the respirator is worn, thus increasing the

frequency with which a worker may be

exposed above an effect concentration

associated with an acute health hazard.

The Nicas and Spear model (Exs. 64–

425, 156) used by OSHA in this analysis

is a one-factor analysis of variance and

is described briefly as follows. Let P

denote a penetration value experienced

by the wearer of a respirator during a

randomly selected wearing time (P is

defined as the reciprocal of the

protection factor PF measured in the

workplace, or 1/PF). For example, a P

value of 0.1 for a respirator wearer

reflects that a protection factor of 10 was

achieved in the workplace for that

individual. If one were to measure the

penetration values among members of a

group of workers over time and

aggregate the results, the total

distribution of P values can be described

by the following parameters:

( )

( ) [ ] [ ] [ ]

( ) [ ] exp ln [ ] ln [ ]

1

2

3 2 2

P B W

GM P GM B GM W

GSD P GSD B GSD W

p

p

= × ×

= × ×

= + 

 

μ

μ

Where:

P = the penetration value for a worker

for a particular wearing period,

μp = the arithmetic mean penetration

value for the population,

B = a lognormally distributed factor that

transforms μp to the arithmetic

mean penetration value for the

individual worker, and

W = a lognormally distributed factor

that transforms μp × B to the P value

experienced by the individual

worker for a particular wearing

time.

The factors W and B describe withinworker variability and between-worker

variability, respectively.

Since workplace protection factor

studies typically report the geometric

mean and geometric standard deviation

of protection factor values obtained

from a cohort of respirator wearers (i.e.,

GM[P] and GSD[P]), the parameters

described above for within-worker and

between worker variability can be

estimated as follows if the relationship

between GSD[B] and GSD[W] are known

or assumed. Let R represent the ratio of

GSD[W]/GSD[B]; then GSD[B] can be

estimated from GSD[P] and R by the

relationship

( ) [ ] exp ln ln ln ( ) ln . 4 1

2

1

2

2 2 2 2 GSD B R R GSD P R = −



 



 + + − ( ) 



 









 




1170 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

GSD[W], GM[B], and GM[W] are

estimated by:

( ) [ ] [ ]

( ) [ ] /exp . ln ,

( ) [ ] /exp . ln .

5

6 1 0 5

7 1 0 5

2

2

GSD W GSD B R

GM W GSD W

GM B GSD B

= ∗

= ∗ ( ( ) [ ]

= ∗ ( ( ) [ ]

and

The arithmetic mean of the total

distribution of penetration values across

the whole cohort, μp, is estimated by:

( ) [ ]

( [ ] [ ])

8 μ p

GM P

GM B GM W = ∗

Nicas (Ex. 156) defines two additional

values, δ and κ, that are based on the

parameters described above. The value

δ represents the 95th percentile of the

between-wearer distribution of average

penetration values among a cohort of

respirator wearers; thus, there is a 5

percent chance that a respirator wearer

in the cohort could have an average

penetration value of δ or higher. If δ is

set to some penetration value reflecting

some minimum acceptable value of

protection, the probability that a

respirator wearer would fail, on average,

to achieve the minimum acceptable

penetration value is Pr(Z>z), where

( )

ln ln ln [ ]

ln [ ]

9 z

GM B

GSD B

p

= ( ) δ μ − + ( )

and Z is the standard normal deviate. By

estimating the parameters μp, GM[B],

and GSD[B] from WPF data, one can

estimate the probability that a respirator

wearer could have an average

penetration value greater than some

specified value δ.

The value κ is defined by Nicas (Ex.

154) based on the distribution of each

worker’s 95th percentile P value and

represented the P value experienced at

least 5 percent of the time by 95 percent

of workers in the cohort. If κ is set to

some minimum acceptable P value, the

estimated probability that a respirator

wearer could fail to achieve the

minimum P value at least 5% of the

time is Pr(Z>z), where

( )

ln ln ln [ ] . ln [ ] . ln [ ]

ln [ ]

10

1 645 0 5 2

z

GM B GSD W GSD W

GSD B

p

=

κ μ − + + [ ] ( ) − ( )

and Z is the standard normal deviate.

Thus, the proportion of workers who

fail to achieve a P value of κ at least 5

percent of the time can be determined

by estimating the parameters μp, GM[B],

and GSD[W] from WPF data.

The following hypothetical example

illustrates OSHA’s use of the model to

estimate the risk to workers of

experiencing an overexposure while

using respiratory protection. Suppose

that the WPF values obtained from a

group of workers using half-mask,

negative-pressure respirators are found

to have a geometric mean of 50 (i.e.,

GM[P] = 1/50 = 0.02) and a geometric

standard deviation of 3.0 (GSD[P] = 3.0).

Furthermore, from one of the WPF

studies reviewed by OSHA (Galvin et

al.) (Ex. 64–22), it was reported that

within-worker variability exceeded

between-worker variability in workplace

protection factors, with the ratio

GSD[W]/GSD[B] = 1.5. From equations 4

through 7 above, and assuming that R =

1.5, then GSD[B] = 1.73, GSD[W] = 2.60,

GM[W] = 0.63, and GM[B] = 0.86. The

arithmetic average of the cohort’s P

values, μp, is estimated from equation 8

to be 0.037. If a protection factor of less

than 10 (the NIOSH minimum assigned

PF for half-mask respirators) is

considered to place the worker at risk of

an overexposure, then equation 9

predicts a probability of 1.8 percent that

a worker in the group would be

expected to have an average WPF value

of 10 or less (i.e., δ is set to 0.1 in

equation 9); that is, 1.8 percent of the

group of respirator wearers would

frequently encounter situations where

they are working in a hazardous

environment without the minimum

protection expected from the respirators

being used. By equation 10, there is a

substantial probability (47 percent) that

a worker in the cohort would not

achieve a minimum protection factor of

10 at least 5 percent of the time that

respirators are used (i.e., κ is set to 0.1

in equation 10).

OSHA used the Nicas and Spear

model, the summary data from the WPF

studies reviewed above, and the method

outlined in the example described above

to estimate the probability that a

respirator wearer would fail to receive

adequate protection from their

respirator; the detailed results of this

analysis appear in Table V–1, and

summary findings are listed in Table V–

2. From the studies that reflect the lack

of an adequate respiratory protection

program, the Nicas and Spear model

predicts a high probability (between 36

and 100 percent) that a wearer would
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1171

not achieve an average protection factor

of 10. Data from two of these studies by

Toney and Barnhart (Ex. 64–68), and

Harris et al. (Ex. 27–11), when used in

the model, suggest a probability of

between 13 and 39 percent that the

average WPF for a respirator wearer

could be 2 or less, which may be

considered equivalent to receiving no

long-term protection at all. In contrast,

workers included in the studies

reflecting good respirator program

elements would be expected to

experience low WPFs much less

frequently. The probability that a wearer

would attain an average WPF of 10 or

less is estimated to be between <0.01

and 3 percent. Results from the studies

that reflect good respiratory program

practices also indicate that long-term

average WPF values at or below 2 would

rarely occur. The results from this

analysis demonstrate that deficiencies

in implementing a good respirator

program can greatly increase the chance

that the wearer of a negative-pressure

respirator will receive less than the

minimum expected average protection

from the respirator over the long-term,

thus increasing the chance that the

worker will be exposed to a higher

chronic health risk.

TABLE V–2.—SUMMARY ESTIMATES OF THE PROBABILITY OF ACHIEVING INADEQUATE FITS FOR HALF-MASK, NEGATIVEPRESSURE RESPIRATORS UNDER DEFICIENT AND GOOD RESPIRATORY PROTECTION PROGRAMS

Quality of respirator program

Percent probability that wearer will

achieve

Average workplace fit factor of

less than 10

Workplace fit factor of less than 10

at least 5 percent

of time that respirator is worn

Deficient ....................................................................................................................................................... 36–100 99–100

Good ............................................................................................................................................................. <0.01–3 <0.01–32

OSHA’s analysis (Tables V–1 and V–

2) also demonstrates that workers using

respiratory protection under a deficient

program will be exposed more

frequently to higher concentrations of

airborne contaminants, which may

increase the risk that the worker will

experience acute health effects. The

Nicas and Spear model applied to the

studies that reflect inadequate respirator

programs predicts nearly a 100 percent

chance that a protection factor of less

than or equal to 10 would be

experienced at least 5 percent of the

time. Under conditions of a good

respirator program, use of the model

suggests no more than a 32 percent

chance that WPFs of less than or equal

to 10 will occur more than 5 percent of

the time.

OSHA finds that, without an adequate

respiratory protection program in place,

a substantial fraction of respirator users

are at risk of being overexposed to

hazardous air contaminants due to poor

respirator performance. The studies

conducted under conditions of a poor

respirator program, when analyzed

using the Nicas and Spear model,

suggest a greater than 50 percent

probability that the wearer of a halfmask, negative-pressure respirator will

regularly fail to attain the expected

minimum level of protection, and that

the chance of receiving essentially no

protection is substantial. OSHA

considers these risks of overexposure to

be significant. The studies reviewed by

Nelson and the Galvin study indicate

that these risks are considerably lower

in situations where respirators are used

in conjunction with the implementation

of strong respiratory protection program

elements such as appropriate fit testing,

adequate employee training, use of

clean respirators in good working order,

and regular monitoring of employees to

ensure proper respirator use. Thus,

OSHA finds that implementation of a

comprehensive respiratory protection

program, such as the one prescribed by

the final rule, will substantially reduce

the risk of overexposure that is due to

respirator failure. Because such

overexposures can place workers at a

significant risk of health impairment, as

described earlier in this section, OSHA

also finds that promulgation of the final

rule will substantially reduce the

significant health risks associated with

those overexposures.

VI. Summary of the Final Economic

Analysis

In the Final Economic Analysis,

OSHA addresses the significant issues

related to technological and economic

feasibility and small business impacts

raised in the rulemaking process. This

analysis also explains in detail the

Agency’s findings and conclusions

concerning pre-standard (baseline)

conditions, such as respirator program

practices, in establishments in the

regulated community, and discusses

how and why the requirements of the

standard are expected to reduce

employee exposures. The preamble to

the revised rule and the Final Economic

Analysis are integrally related and

together present the fullest statement of

OSHA’s reasoning concerning this

standard. The Final Economic Analysis

has been placed in the rulemaking

docket.

This analysis of OSHA’s revised

Respiratory Protection standard (29 CFR

1910.134) has been conducted in

accordance with Executive Orders (EOs)

12866 and 12875, the Regulatory

Flexibility Act (as amended in 1996),

the Small Business Regulatory

Enforcement Fairness Act (SBREFA),

the Unfunded Mandates Reform Act

(UMRA) and the Occupational Safety

and Health Act. The standard is a

‘‘significant’’ rule as defined by EO

12866, a ‘‘major’’ rule as defined by Sec.

804 of SBREFA, and a ‘‘significant’’ rule

as defined by UMRA.

The purposes of this Final Economic

Analysis are to:

• Describe the need for a revised

standard governing the use of

respirators;

• Identify the establishments,

industries and employees potentially

affected by the standard;

• Evaluate the costs, benefits,

economic impacts and small business

impacts of the standard on affected

firms;

• Assess the technological and

economic feasibility of the standard for

affected establishments, industries, and

small businesses; and

• Identify the availability of effective

non-regulatory and alternative

regulatory approaches.

OSHA’s final Respiratory Protection

standard covers the use of respiratory

protection in general industry,

construction and shipyard employment,

as well as marine terminals and

longshoring. In all, about 5 million
1172 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

1Approximately 5% of these respirator-using

employees would be subject to OSHA’s substancespecific health standards rather than to thisstandard.

employees are estimated to use

respirators. 1 Workers use respirators to

protect themselves from a wide variety

of occupational exposures. Respirators

are used, at least to some extent, in

virtually every industry, although the

extent of respirator use varies by

industry. Manufacturing and

construction have relatively heavy

respirator use; in contrast, use in many

service industries is very limited.

Chapter II of the economic analysis

describes the pattern of respirator use

within each affected industry. To

develop this profile, the Agency

analyzed the results of several OSHAsponsored nationwide surveys. The

results of OSHA’s analysis appear in

Table VI–1. The Agency estimates that

approximately five percent of workers

wear respirators at some time, and that

approximately 1.3 million

establishments, or about 20 percent of

all establishments, have employees who

use respirators. Approximately 900,000

of these establishments are very small,

i.e., have fewer than 20 employees. For

a discussion of the number of firms

identified by the Small Business

Administration (SBA) as small, see

Chapter V.

TABLE VI–1.—NUMBER OF RESPIRATOR USERS AND THEIR EMPLOYERS BY INDUSTRY

SIC and industry Total employment

Number of

respirator

wearers

Total number

of establishments

Number of establishments

with respirator

wearers

07 Agricultural services .................................................................................. 555,686 48,262 95,956 25,464

08 Forestry ..................................................................................................... 17,716 2,764 2,251 950

13 Oil and gas extraction ............................................................................... 257,694 46,180 18,502 3,313

15 General contractors and operative builders ............................................. 1,096,289 202,284 180,998 70,835

16 Heavy construction, except building ......................................................... 679,578 99,668 34,332 13,403

17 Special trade contractors .......................................................................... 2,731,774 491,928 382,528 115,380

20 Food and kindred products ....................................................................... 1,498,078 87,589 21,049 8,899

21 Tobacco products ..................................................................................... 37,189 2,022 119 47

22 Textile mill products .................................................................................. 615,683 66,989 6,245 1,937

23 Apparel and other textile products ............................................................ 972,060 26,431 24,293 5,238

24 Lumber and wood products ...................................................................... 675,081 89,970 37,087 15,922

25 Furniture and fixtures ................................................................................ 476,488 56,141 11,515 7,675

26 Paper and allied products ......................................................................... 627,746 41,313 6,478 2,616

27 Printing and publishing ............................................................................. 1,500,580 19,185 65,416 6,393

28 Chemicals and allied products .................................................................. 851,720 230,405 12,371 10,744

29 Petroleum and coal products .................................................................... 112,984 29,647 2,117 1,398

30 Rubbber and miscellaneous plastics products ......................................... 915,166 53,800 16,048 6,805

31 Leather and leather products .................................................................... 104,747 4,406 2,025 324

32 Stone, clay, and glass products ............................................................... 471,639 69,904 16,208 8,798

33 Primary metal industries ........................................................................... 655,556 133,012 6,726 4,105

34 Fabricated metal products ........................................................................ 1,371,072 124,289 36,416 17,134

35 Industrial machinery and equipment ......................................................... 1,749,735 96,161 54,436 25,545

36 Electronic and other electronic equipment ............................................... 1,424,351 65,930 17,073 6,895

37 Transportation equipment ......................................................................... 1,601,554 185,783 11,420 7,649

38 Instruments and related products ............................................................. 878,379 35,188 11,419 4,207

39 Miscellaneous manufacturing industries ................................................... 375,501 22,751 17,183 6,793

40 Railroad transportation .............................................................................. 49,200 1,790 1,000 225

41 Local and interurban passenger transit .................................................... 366,657 13,337 18,603 4,194

42 Trucking and warehousing ........................................................................ 1,633,543 59,497 115,531 26,049

44 Water transportation ................................................................................. 162,478 7,458 8,412 605

45 Transportation by air ................................................................................. 344,822 12,543 11,436 822

46 Pipelines, except natural gas .................................................................... 17,143 2,808 811 521

47 Transportation services ............................................................................. 363,103 22,428 47,858 3,441

48 Communication ......................................................................................... 1,299,658 15,176 40,399 3,457

49 Electric, gas, and sanitary services .......................................................... 924,373 187,298 21,040 10,148

50 Wholesale trade—durable goods ............................................................. 3,414,441 373,644 317,418 118,387

51 Wholesale trade—nondurable goods ....................................................... 2,504,260 289,619 185,908 70,196

52 Building materials and garden supplies .................................................... 696,228 95,688 69,965 19,822

53 General merchandise stores ..................................................................... 2,141,964 21,420 35,646 3,565

54 Food stores ............................................................................................... 3,027,828 30,278 181,850 18,185

55 Automotive dealers and service stations .................................................. 1,992,774 245,662 198,905 80,121

56 Apparel and accessory stores .................................................................. 1,194,121 15,788 143,526 14,353

57 Furniture and homefurnishings stores ...................................................... 754,024 12,348 112,254 11,225

58 Eating and drinking places ....................................................................... 6,727,618 67,276 441,512 44,151

59 Miscellaneous retail .................................................................................. 2,422,923 38,734 352,129 35,213

60 Depository institutions ............................................................................... 2,095,049 20,950 102,622 10,262

61 Nondepository institutions ......................................................................... 483,133 4,831 41,869 4,187

62 Security and commodity brokers .............................................................. 449,826 4,498 34,325 3,433

63 Insurance carriers ..................................................................................... 1,570,356 15,704 43,784 4,378

64 Insurance agents, brokers, and service ................................................... 656,007 13,452 122,292 12,229

65 Real estate ................................................................................................ 1,335,048 25,846 234,961 23,496

67 Holding and other investment offices ....................................................... 254,172 3,016 27,420 2,742

70 Hotels and other lodging places ............................................................... 1,527,126 15,271 52,874 5,287
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1173

2OSHA believes that, for the purposes of this

rulemaking, the most reasonable way to summarize

the uncertainties in benefits estimates via a single

numerical estimate is to use the expected value;

that is, the average of all plausible values weighted

by their relative probabilities. For simplicity’s sake,

OSHA will refer to this point estimate as the ‘‘best

estimate.’’

3Because this regulation will not directly affect

the benefits for the estimated 5% of employees who

wear respirators as a result of OSHA’s substancespecific health standards (except to the extent that

uniformity of provisions improve compliance), and

these respirator-wearing employees are included in

the benefits estimates presented here, the benefits

of the revised respiratory protection standard are

somewhat overestimated. In particular, deaths and

illnesses caused by exposures to such OSHAregulated substances as asbestos and lead may in

fact account for a disproportionate share (more than

5%) of the occupational illnesses and deaths

attributed by this analysis to the respirator

standard. This means that OSHA’s benefits

estimates are likely to be overstated by more than

5%. Nevertheless, OSHA believes that the

substantial majority of the benefits resulting from

appropriate respirator use can be properly

attributed to the respirator standard.

4Because this regulation does not directly affect

the costs for the estimated 5% of employees who

wear respirators as a result of OSHA’s substancespecific health standards, and these respirator users

are included in the cost estimates, the costs are

somewhat overestimated. Because costs are

approximately proportional to the number of

employees affected, the magnitude of this

overestimate is likely to be about 5%.

TABLE VI–1.—NUMBER OF RESPIRATOR USERS AND THEIR EMPLOYERS BY INDUSTRY—Continued

SIC and industry Total employment

Number of

respirator

wearers

Total number

of establishments

Number of establishments

with respirator

wearers

72 Personal services ...................................................................................... 1,252,777 45,854 200,520 23,848

73 Business services ..................................................................................... 5,832,261 255,034 322,668 38,375

75 Auto repair, services, and parking ............................................................ 903,806 110,528 174,635 70,345

76 Miscellaneous repair services ................................................................... 439,495 5,103 72,763 3,810

78 Motion pictures .......................................................................................... 500,889 5,009 42,457 4,246

79 Amusements and recreation services ...................................................... 1,201,248 12,012 88,077 8,808

80 Health services ......................................................................................... 10,403,118 217,118 471,873 108,337

81 Legal services ........................................................................................... 962,374 17,417 158,335 15,834

82 Educational services ................................................................................. 1,967,024 19,670 42,867 4,287

83 Social services .......................................................................................... 2,028,694 20,287 145,998 14,600

84 Museums, botanical, zoological gardens .................................................. 73,874 739 3,607 361

86 Membership organizations ........................................................................ 2,062,501 26,275 238,868 23,887

87 Engineering and management services ................................................... 2,589,839 27,483 249,846 24,985

89 Services, n.e.c. ......................................................................................... 84,960 1,607 14,606 1,461

92 Fire Departments (State Plan States) ...................................................... 126,500 126,500 9,283 9,283

Other public sector (State Plan States) .................................................... 7,677,000 114,570 203,158 20,316

Total ....................................................................................................... 98,768,281 4,953,568 6,494,122 1,281,945

Sources: DOL, OSHA Office of Regulatory Analysis; County Business Patterns, 1993; OSHA’s respirator, PEL, PPE, and Construction PEL

surveys.

The new standard is programmatic in

nature, reflects current practice at many

facilities, and does not require the use

of new technology. Thus, OSHA finds

that the standard is clearly

technologically feasible for affected

firms of all sizes.

The benefits that will accrue to

respirator users and their employers are

substantial and take a number of forms.

Chapter IV of the analysis describes

these benefits, both in quantitative and

qualitative forms. The standard will

benefit workers by reducing their

exposures to respiratory hazards.

Improved respirator selection

procedures, better fit test procedures,

and improved training, all areas

strengthened by the revised standard,

will contribute substantially to greater

worker protection. Estimates of the

benefits of the standard are complicated

by uncertainties about the effectiveness

of the standard and the number of

covered work-related illnesses. The

Agency estimates that the standard will

avert between 843 and 9,282 workrelated injuries and illnesses annually,

with a best estimate (expected value) 2 of

4,046 averted illnesses and injuries

annually. In addition, the standard is

estimated to prevent between 351 and

1,626 deaths annually from cancer and

many other chronic diseases, including

cardiovascular disease, with a best

estimate (expected value) of 932 averted

deaths from these causes.3

The annual costs employers in the

affected establishments are estimated to

incur to comply with the revised

respirator standard total $111 million.4

These costs, which are presented in

detail in Chapter III of the full economic

analysis, are annualized over a 10-year

horizon at a discount rate of 7 percent;

Table VI–2 shows annualized costs by

provision of the standard. The most

costly provisions are those requiring

annual fit testing of respirators and

annual refresher training. These two

provisions together account for

approximately 90 percent of the

standard’s compliance costs. As a rule,

costs are largely determined by the

extensiveness of respirator use in

affected establishments. This analysis

did not attempt to factor in the offsetting

value of cost savings from regulatory

changes, such as dropping the existing

standard’s prohibition against contact

lens use, providing for greater

uniformity for substance-specific health

standard respirator provisions, or

allowing employers to use licensed

health care providers in addition to

physicians to perform medical

evaluations.
1174 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

TABLE VI–2.—ANNUAL COST OF RESPIRATOR STANDARD REVISIONS FOR RESPIRATOR-USING ESTABLISHMENTS, BY

PROVISION

SIC and industry

Revision

written

plans

Annual fit

testing

Annual

training

Certification for

emergency

respirator

inspections

Labeling

for sorbent

bed

changes

Recordkeeping Total

07 Agricultural services .......................................... $31,755 $441,836 $298,047 $0 $0 $35,858 $807,497

08 Forestry ............................................................. 1,228 25,475 13,849 0 0 2,054 42,606

13 Oil and gas extraction ....................................... 8,769 734,048 315,180 41,551 0 34,312 1,133,860

15 General contractors and operative builders ...... 141,534 2,992,402 1,909,631 0 479 150,297 5,194,342

16 Heavy construction, except building ................. 32,027 1,534,132 736,976 0 2,109 74,053 2,379,297

17 Special trade contractors .................................. 256,681 7,820,459 4,340,977 0 1,344 365,502 12,784,963

20 Food and kindred products ............................... 21,109 1,006,778 428,004 86,371 0 65,078 1,607,339

21 Tobacco products .............................................. 210 37,254 16,252 0 0 1,502 55,218

22 Textile mill products .......................................... 4,349 728,823 286,222 9,703 0 49,773 1,078,870

23 Apparel and other textile products .................... 7,864 226,658 101,380 0 0 19,638 355,540

24 Lumber and wood products .............................. 27,997 972,293 489,510 16,750 0 66,848 1,573,397

25 Furniture and fixtures ........................................ 13,119 623,774 289,781 53,627 0 41,712 1,022,013

26 Paper and allied products ................................. 8,373 877,037 280,715 66,279 105 30,696 1,263,205

27 Printing and publishing ...................................... 15,217 221,275 139,295 0 0 14,255 390,041

28 Chemicals and allied products .......................... 33,159 4,194,240 1,656,678 741,170 763 171,191 6,797,201

29 Petroleum and coal products ............................ 4,699 646,431 277,684 108,927 16 22,028 1,059,785

30 Rubber and miscellaneous plastics products ... 14,100 676,734 284,187 2,068 0 39,974 1,017,063

31 Leather and leather products ............................ 456 37,208 15,800 1,502 0 3,274 58,239

32 Stone, clay, and glass products ........................ 20,743 1,018,192 464,833 28,365 11 51,939 1,584,083

33 Primary metal industries .................................... 14,028 2,263,416 951,396 44,664 28 98,828 3,372,360

34 Fabricated metal products ................................. 41,510 1,663,770 765,562 178,892 0 92,346 2,742,081

35 Industrial machinery and equipment ................. 64,626 1,498,968 786,251 0 868 71,447 2,422,161

36 Electronic and other electronic equipment ........ 17,103 917,414 388,929 24,483 657 48,986 1,397,572

37 Transportation equipment ................................. 23,876 3,413,486 1,568,463 100,401 8,775 138,037 5,253,038

38 Instruments and related products ..................... 10,299 516,278 230,813 1,626 333 26,145 785,493

39 Miscellaneous manufacturing industries ........... 12,007 250,490 136,104 0 176 16,904 415,682

40 Railroad transportation ...................................... 937 37,818 16,134 0 0 1,330 56,219

41 Local and interurban passenger transit ............ 9,002 167,510 86,710 0 0 9,910 273,131

42 Trucking and warehousing ................................ 64,666 791,301 511,259 570 0 44,206 1,412,003

44 Water transportation .......................................... 1,588 136,318 65,312 0 0 5,541 208,760

45 Transportation by air ......................................... 2,015 199,061 85,196 0 0 9,320 295,592

46 Pipelines, except natural gas ............................ 1,637 87,121 31,182 0 15 2,086 122,041

47 Transportation services ..................................... 6,150 256,532 135,948 0 0 16,664 415,294

48 Communication .................................................. 9,141 282,097 141,518 0 0 11,276 444,032

49 Electric, gas, and sanitary services .................. 32,542 3,736,483 1,662,243 359,209 4,581 139,162 5,934,220

50 Wholesale trade—durable goods ...................... 241,074 5,545,911 2,737,719 6,687 0 277,618 8,809,008

51 Wholesale trade—nondurable goods ................ 134,760 3,979,336 1,728,752 126,854 0 215,187 6,184,888

52 Building materials and garden supplies ............ 24,193 922,814 418,187 0 0 71,096 1,436,291

53 General merchandise stores ............................. 5,369 135,056 56,819 0 0 15,915 213,160

54 Food stores ....................................................... 27,336 208,820 154,036 0 0 22,497 412,689

55 Automotive dealers and service stations .......... 112,276 1,920,333 1,281,723 0 0 182,527 3,496,858

56 Apparel and accessory stores ........................... 19,022 91,801 92,713 0 0 11,730 215,266

57 Furniture and homefurnishings stores .............. 20,225 111,532 106,953 0 0 9,175 247,884

58 Eating and drinking places ................................ 47,123 257,557 214,860 0 0 49,986 569,526

59 Miscellaneous retail ........................................... 53,098 275,565 269,808 0 0 28,780 627,250

60 Depository institutions ....................................... 20,271 207,313 135,320 0 0 15,566 378,470

61 Nondepository institutions ................................. 10,608 51,626 53,951 0 0 3,590 119,776

62 Security and commodity brokers ....................... 10,508 64,998 58,550 0 0 3,342 137,397

63 Insurance carriers .............................................. 13,360 226,063 123,889 0 0 11,668 374,979

64 Insurance agents, brokers, and service ............ 36,394 200,209 199,277 0 0 9,995 445,875

65 Real estate ........................................................ 70,079 348,877 368,891 0 0 19,203 807,051

67 Holding and other investment offices ................ 8,272 43,583 43,970 0 0 2,241 98,066

70 Hotels and other lodging places ....................... 8,119 101,853 57,381 0 0 11,347 178,699

72 Personal services .............................................. 26,015 552,641 270,488 0 0 34,069 883,214

73 Business services .............................................. 58,974 3,325,952 1,172,726 0 0 189,490 4,747,142

75 Auto repair, services, and parking .................... 93,387 970,308 881,030 0 0 82,122 2,026,846

76 Miscellaneous repair services ........................... 5,735 61,214 54,759 0 0 3,791 125,499

78 Motion pictures .................................................. 11,425 62,923 61,091 0 0 3,722 139,160

79 Amusement and recreation services ................. 14,128 93,683 76,484 0 0 8,925 193,220

80 Health services .................................................. 183,206 2,510,780 1,948,071 0 0 161,319 4,803,376

81 Legal services ................................................... 47,661 253,320 256,703 0 0 12,941 570,625

82 Educational services ......................................... 10,933 259,816 125,365 0 0 14,615 410,729

83 Social services .................................................. 23,601 166,510 130,949 0 0 15,073 336,133

84 Museums, botanical, zoological gardens .......... 891 8,995 6,036 0 0 549 16,471

86 Membership organizations ................................ 57,115 316,483 304,939 0 0 19,523 698,060

87 Engineering and management services ............ 74,480 380,740 390,356 0 0 20,420 865,997

89 Services, n.e.c. .................................................. 4,082 28,754 22,201 0 0 1,194 56,231
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1175

TABLE VI–2.—ANNUAL COST OF RESPIRATOR STANDARD REVISIONS FOR RESPIRATOR-USING ESTABLISHMENTS, BY

PROVISION—Continued

SIC and industry

Revision

written

plans

Annual fit

testing

Annual

training

Certification for

emergency

respirator

inspections

Labeling

for sorbent

bed

changes

Recordkeeping Total

92 Fire Departments ............................................... 24,723 2,265,377 1,005,792 0 0 93,990 3,389,882

Other public sector ............................................ 48,361 49,739 1,147,899 0 0 85,126 1,331,125

Total .......................................................................... 2,501,319 67,033,593 35,865,707 1,999,699 20,259 3,680,501 111,101,079

Source: Department of Labor, Safety and Health Administration, Office of Regulatory Analysis.

Chapter V of the economic analysis

analyzes the impact of these compliance

costs on establishments in affected

industries. The standard is clearly

economically feasible: the cost in the

average affected establishment is 0.002

percent of sales and 0.03 percent of

profits; in the most heavily impacted

industry—business services, SIC 73—

annualized compliance costs amount to

only 0.1 percent of estimated sales and

1.22 percent of profits. In the next most

heavily impacted industry—Special

Trade Contractors, SIC 17—costs

amount only to 0.02 percent of sales and

0.46 percent of profits. These results are

shown in Table VI–3.

TABLE VI–3.—ANNUAL COST OF FINAL RESPIRATORY PROTECTION STANDARD AS A PERCENT OF SALES AND PROFITS

OF RESPIRATOR-USING ESTABLISHMENTS

SIC and industry

Average

compliance

cost/establishment

Average

sales/establishment

Average profit/establishment

Compliance

cost as a

percent of

sales

Compliance

cost as a

percent of

profits

07 Agricultural services ...................................................................... $32 $269,290 17,425 0.01 0.18

08 Forestry ......................................................................................... 45 897,908 69,720 0.00 0.06

13 Oil and gas extraction ................................................................... 364 11,234,630 1,021,330 0.00 0.04

15 General contractors and operative builders .................................. 73 1,131,765 52,585 0.01 0.14

16 Heavy construction, except building ............................................. 178 2,709,660 146,028 0.01 0.12

17 Special trade contractors .............................................................. 111 476,348 24,098 0.02 0.46

20 Food and kindred products ........................................................... 192 20,620,629 999,788 0.00 0.02

21 Tobacco products .......................................................................... 1,169 869,935,367 204,319,114 0.00 0.00

22 Textile mill products ...................................................................... 578 7,611,245 438,223 0.01 0.13

23 Apparel and other textile products ................................................ 68 3,228,588 194,177 0.00 0.03

24 Lumber and wood products .......................................................... 99 2,539,729 146,588 0.00 0.07

25 Furniture and fixtures .................................................................... 140 3,571,798 216,729 0.00 0.06

26 Paper and allied products ............................................................. 551 22,478,383 1,260,152 0.00 0.04

27 Printing and publishing .................................................................. 61 2,096,632 152,975 0.00 0.04

28 Chemicals and allied products ...................................................... 909 29,454,052 2,231,368 0.00 0.04

29 Petroleum and coal products ........................................................ 1,053 143,210,471 6,292,581 0.00 0.02

30 Rubber and miscellaneous plastics products ............................... 150 8,202,235 584,099 0.00 0.03

31 Leather and leather products ........................................................ 187 7,267,252 429,429 0.00 0.04

32 Stone, clay, and glass products .................................................... 183 4,184,931 228,219 0.00 0.08

33 Primary metal industries ............................................................... 864 18,123,180 1,015,996 0.00 0.08

34 Fabricated metal products ............................................................ 170 4,348,383 266,070 0.00 0.06

35 Industrial machinery and equipment ............................................. 95 6,924,099 482,589 0.00 0.02

36 Electronic and other electronic equipment ................................... 207 11,591,397 684,946 0.00 0.03

37 Transportation equipment ............................................................. 724 44,334,058 1,948,012 0.00 0.04

38 Instruments and related products ................................................. 187 10,720,444 763,426 0.00 0.02

39 Miscellaneous manufacturing industries ....................................... 61 1,568,937 111,245 0.00 0.06

40 Railroad transportation .................................................................. 249 NA NA NA NA

41 Local and interurban passenger transit ........................................ 65 1,014,732 43,699 0.01 0.15

42 Trucking and warehousing ............................................................ 54 1,286,872 58,437 0.00 0.09

44 Water transportation ...................................................................... 345 NA NA NA NA

45 Transportation by air ..................................................................... 359 3,106,975 197,717 0.01 0.18

46 Pipelines, except natural gas ........................................................ 234 13,802,633 585,566 0.00 0.04

47 Transportation services ................................................................. 121 23,585,180 8,076,137 0.00 0.00

48 Communication ............................................................................. 128 1,894,095 82,755 0.01 0.16

49 Electric, gas, and sanitary services .............................................. 677 15,622,527 2,485,402 0.00 0.03

50 Wholesale trade—durable goods .................................................. 74 14,371,043 1,350,007 0.00 0.01

51 Wholesale trade—nondurable goods ............................................ 89 2,282,652 102,134 0.00 0.09

52 Building materials and garden supplies ........................................ 72 4,447,849 172,734 0.00 0.04

53 General merchandise stores ......................................................... 60 1,075,912 36,708 0.01 0.16

54 Food stores ................................................................................... 23 8,648,964 471,762 0.00 0.00

55 Automotive dealers and service stations ...................................... 44 2,179,673 61,031 0.00 0.07

56 Apparel and accessory stores ...................................................... 15 2,010,075 47,296 0.00 0.03

57 Furniture and homefurnishings stores .......................................... 22 737,603 47,246 0.00 0.05

58 Eating and drinking places ............................................................ 13 672,234 34,798 0.00 0.04
1176 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

5The Agency also examined the impact of the

costs of compliance on governmental entities

serving communities with fewer than 50,000

people, and also found small impacts.

TABLE VI–3.—ANNUAL COST OF FINAL RESPIRATORY PROTECTION STANDARD AS A PERCENT OF SALES AND PROFITS

OF RESPIRATOR-USING ESTABLISHMENTS—Continued

SIC and industry

Average

compliance

cost/establishment

Average

sales/establishment

Average profit/establishment

Compliance

cost as a

percent of

sales

Compliance

cost as a

percent of

profits

59 Miscellaneous retail ....................................................................... 18 734,358 34,558 0.00 0.05

60 Depository institutions ................................................................... 37 547,141 30,254 0.01 0.12

61 Nondepository institutions ............................................................. 29 8,651,403 NA 0.00 NA

62 Security and commodity brokers .................................................. 40 9,094,686 1,419,322 0.00 0.00

63 Insurance carriers ......................................................................... 86 6,131,429 631,723 0.00 0.01

64 Insurance agents, brokers, and service ........................................ 36 65,412,387 NA 0.00 NA

65 Real estate .................................................................................... 34 674,913 NA 0.01 NA

67 Holding and other investment offices ........................................... 36 500,929 46,869 0.01 0.08

70 Hotels and other lodging places ................................................... 34 5,183,873 573,368 0.00 0.01

72 Personal services .......................................................................... 37 1,243,240 97,027 0.00 0.04

73 Business services ......................................................................... 124 128,952 10,164 0.10 1.22

75 Auto repair, services, and parking ................................................ 29 975,693 74,455 0.00 0.04

76 Miscellaneous repair services ....................................................... 33 358,494 22,775 0.01 0.14

78 Motion pictures .............................................................................. 33 181,478 11,743 0.02 0.28

79 Amusement and recreation services ............................................ 22 1,597,336 142,792 0.00 0.02

80 Health services .............................................................................. 44 631,398 31,198 0.01 0.14

81 Legal services ............................................................................... 36 1,167,682 71,435 0.00 0.05

82 Educational services ..................................................................... 96 421,539 67,758 0.02 0.14

83 Social services .............................................................................. 23 2,613,764 174,383 0.00 0.01

84 Museums, botanical, zoological gardens ...................................... 46 351,713 16,137 0.01 0.28

86 Membership organizations ............................................................ 29 560,217 40,331 0.01 0.07

87 Engineering and management services ....................................... 35 320,236 15,070 0.01 0.23

89 Services, n.e.c. .............................................................................. 38 1,030,962 81,876 0.00 0.05

92 Fire Departments .......................................................................... 365 NA NA NA NA

other public sector ..................................................................... 66 NA NA NA NA

Source: Department of Labor, Occupational Safety and Health Administration, Office of Regulatory Analysis.

In the Preliminary Regulatory Impact

Analysis developed in support of

OSHA’s 1994 Respiratory Protection

proposal [Ex. 57], the Agency examined

the impact of the proposal on different

sizes of establishments. Based on that

analysis, the Agency certified that the

proposed standard would not have a

significant economic impact on a

substantial number of small entities.

Upon review of comments and other

data submitted to the record of this

rulemaking, the Agency has analyzed

the final rule’s impact on small entities,

as defined by the Small Business

Administration (SBA) and in

accordance with the Regulatory

Flexibility Act. In addition, in order to

ensure that even the smallest entities are

not significantly impacted, the Agency

performed an analysis of impacts on the

smallest establishments, i.e., those with

fewer than 20 employees.

The impacts of the standard on sales

and profits did not exceed 1 percent for

small firms in any covered industry,

whether the analysis used the SBA’s

definitions or the fewer-than-20-

employee size class definition. Because

the incremental costs of the final rule

are primarily related to the number of

respirator users per establishment and

because small entities do not have a

higher percentage of respirator users

than large establishments, the standard

does not have a differential impact on

small entities. If the costs of compliance

were influenced by economies of scale,

such effects would have been

demonstrated by OSHA’s analysis of the

smallest firms, i.e., those with fewer

than 20 employees. However, no such

effects were seen, even among firms in

this smallest size-class. Therefore, the

Agency has no reason to believe that

establishments or firms in intermediate

size groupings, i.e., those in the range

between 20 employees and the

employment size cutoff for the

applicable SBA definition, would

experience larger impacts. Finding this,

the Agency certifies that the final

Respiratory Protection standard will not

have a significant adverse economic

impact on a substantial number of small

entities. The results of OSHA’s analysis

of small business impacts on firms 5

within the SBA’s size classifications are

shown in Table VI–4.

TABLE VI–4.—ANNUAL COST OF THE RESPIRATORY PROTECTION STANDARD AS A PERCENT OF SALES FOR RESPIRATORUSING SMALL FIRMS 1

SIC and industry Small business definition 1

Number

of affected

firms

Average

compliance

cost per

firm

Average

sales per firm

Compliance

cost as

a percent of

sales

Average profit per firm

Compliance

cost as

a percent of

profits

07 Agricultural services ........................................... $5 million 2 ............... 23,313 $36 $223,567 0.02 $14,466 0.25

08 Forestry .............................................................. $5 million ................. 860 41 470,247 0.01 36,513 0.11

13 Oil and gas extraction ........................................ 500 employees ....... 2,565 222 2,017,392 0.00 226,361 0.10
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1177

TABLE VI–4.—ANNUAL COST OF THE RESPIRATORY PROTECTION STANDARD AS A PERCENT OF SALES FOR RESPIRATORUSING SMALL FIRMS 1—Continued

SIC and industry Small business definition 1

Number

of affected

firms

Average

compliance

cost per

firm

Average

sales per firm

Compliance

cost as

a percent of

sales

Average profit per firm

Compliance

cost as

a percent of

profits

15 General contractors and operative builders ...... $17 million ............... 70,232 75 954,486 0.01 43,794 0.17

16 Heavy construction, except building .................. $17 million ............... 12,628 135 1,611,092 0.00 72,025 0.19

17 Special trade contractors ................................... $7 million ................. 114,097 117 490,343 0.02 24,806 0.47

20 Food and kindred products ................................ 500 employees ....... 5,583 143 7,070,622 0.00 288,666 0.05

21 Tobacco products .............................................. 500 employees ....... 27 434 419,423,746 0.00 98,271,892 0.00

22 Textile mill products ........................................... 500 employees ....... 1,306 243 4,485,467 0.00 236,814 0.10

23 Apparel and other textile products .................... 500 employees ....... 4,227 49 1,717,339 0.00 84,857 0.06

24 Lumber and wood products ............................... 500 employees ....... 13,854 96 1,520,435 0.00 80,494 0.12

25 Furniture and fixtures ......................................... 500 employees ....... 5,860 135 2,063,881 0.00 101,980 0.13

26 Paper and allied products .................................. 500 employees ....... 1,082 364 7,356,895 0.00 389,269 0.09

27 Printing and publishing ...................................... 500 employees ....... 4,612 63 1,349,101 0.00 82,533 0.08

28 Chemicals and allied products .......................... 500 employees ....... 3,794 388 7,758,606 0.00 573,110 0.07

29 Petroleum and coal products ............................. 500 employees ....... 373 505 11,906,004 0.00 523,143 0.10

30 Rubber and miscellaneous plastics products .... 500 employees ....... 3,926 192 4,132,970 0.00 252,124 0.08

31 Leather and leather products ............................ 500 employees ....... 224 246 2,312,572 0.00 106,106 0.23

32 Stone, clay, and glass products ........................ 500 employees ....... 5,529 209 2,337,003 0.00 101,728 0.21

33 Primary metal industries .................................... 500 employees ....... 2,260 530 6,447,895 0.00 359,703 0.15

34 Fabricated metal products ................................. 500 employees ....... 12,435 167 2,782,599 0.00 138,568 0.12

35 Industrial machinery and equipment ................. 500 employees ....... 18,625 152 2,001,196 0.00 118,786 0.13

36 Electronic and other electronic equipment ........ 500 employees ....... 4,356 237 3,836,835 0.00 184,646 0.13

37 Transportation equipment .................................. 500 employees ....... 5,999 281 3,362,262 0.00 120,155 0.23

38 Instruments and related products ...................... 500 employees ....... 3,266 163 3,239,263 0.00 211,242 0.08

39 Miscellaneous manufacturing industries ............ 500 employees ....... 5,149 102 1,539,311 0.00 95,981 0.11

40 Railroad transportation ...................................... 1500 employees ..... NA NA NA NA NA NA

41 Local and interurban passenger transit ............. $5 million ................. 2,582 106 417,934 0.01 17,701 0.60

42 Trucking and warehousing ................................ $18.5 million ............ 15,626 79 670,885 0.01 29,993 0.26

44 Water transportation .......................................... 500 employees ....... 187 243 1,781,166 0.01 90,917 0.27

45 Transportation by air .......................................... 1500 employees ..... 157 449 2,031,762 0.00 70,300 0.64

46 Pipelines, except natural gas ............................ 1500 employees ..... 11 888 15,403,556 0.00 5,274,551 0.02

47 Transportation services ..................................... $5 million ................. 879 55 377,507 0.02 15,544 0.35

48 Communication .................................................. 1500 employees ..... 1,279 172 2,132,980 0.01 335,309 0.05

49 Electric, gas, and sanitary services ................... $5 million ................. 3,809 65 883,319 0.01 72,099 0.09

50 Wholesale trade—durable goods ...................... 100 employees ....... 52,553 43 1,828,263 0.00 73,131 0.06

51 Wholesale trade—nondurable goods ................ 100 employees ....... 30,785 44 2,682,104 0.00 85,196 0.05

52 Building materials and garden supplies ............ $5 million ................. 13,619 19 712,058 0.01 24,294 0.08

53 General merchandise stores ............................. $5 million ................. 482 14 398,828 0.01 16,892 0.08

54 Food stores ........................................................ $5 million ................. 6,419 140 763,042 0.00 20,647 0.68

55 Automotive dealers and service stations ........... $5 million ................. 38,985 26 774,574 0.01 18,225 0.14

56 Apparel and accessory stores ........................... $5 million ................. 289 41 1,346,240 0.00 85,526 0.05

57 Furniture and homefurnishings stores ............... $5 milion ................. 438 71 1,685,231 0.00 87,235 0.08

58 Eating and drinking places ................................ $5 million ................. 16,852 24 374,691 0.00 17,633 0.14

59 Miscellaneous retail ........................................... $5 million ................. 12,619 18 406,958 0.01 22,502 0.08

60 Depository institutions ........................................ $5 million ................. 788 123 1,060,910 0.00 NA NA

61 Nondepository institutions .................................. $5 million ................. 840 25 728,626 0.00 106,401 0.02

62 Security and commodity brokers ....................... $5 million ................. 921 33 631,139 0.01 55,488 0.06

63 Insurance carriers .............................................. $5 million ................. 365 92 740,731 0.01 NA NA

64 Insurance agents, brokers, and service ............ $5 million ................. 5,583 54 335,823 0.01 NA NA

65 Real estate ......................................................... $5 million ................. 10,714 56 533,940 0.01 48,369 0.12

67 Holding and other investment offices ................ $5 million ................. 1,036 36 889,373 0.00 95,534 0.04

70 Hotels and other lodging places ........................ $5 million ................. 2,163 41 472,311 0.00 32,784 0.13

72 Personal services .............................................. $5 million ................. 9,786 80 190,546 0.02 15,019 0.53

73 Business services .............................................. $5 million ................. 14,343 160 517,986 0.01 37,783 0.42

75 Auto repair, services, and parking ..................... $5 million ................. 43,985 47 342,341 0.01 21,749 0.22

76 Miscellaneous repair services ........................... $5 million ................. 2,631 34 340,605 0.01 22,039 0.15

78 Motion pictures .................................................. $5 million ................. 1,494 29 350,142 0.01 24,304 0.12

79 Amusement and recreation services ................. $5 million ................. 4,052 46 469,977 0.00 23,222 0.20

80 Health services .................................................. $5 million ................. 39,536 82 521,074 0.01 31,877 0.26

81 Legal services .................................................... $5 million ................. 7,288 41 314,988 0.01 48,175 0.09

82 Educational services .......................................... $5 million ................. 1,739 99 649,462 0.01 35,911 0.28

83 Social services ................................................... $5 million ................. 5,194 43 354,060 0.01 16,245 0.26

84 Museums, botanical, zoological gardens .......... $5 million ................. 158 80 492,341 0.01 35,333 0.23

86 Membership organizations ................................. $5 million ................. 11,589 55 296,761 0.01 13,965 0.39

87 Engineering and management services ............ $5 million ................. 11,383 62 457,931 0.01 34,480 0.18

89 Services, n.e.c ................................................... $5 million ................. 679 58 423,854 0.01 36,402 0.16

1As defined by the Small Business Administration, 61 FR 3289.

2Annual receipts.
1178 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

Source: Department of Labor, Occupational Safety and Health Administration, Office of Regulatory Analysis.

Unfunded Mandates Analysis

The final Respiratory Protection

standard has been reviewed by OSHA in

accordance with the Unfunded

Mandates Reform Act of 1995 (UMRA)

(2 USC 1501 et seq.) and Executive

Order 12875. As discussed in Chapter V,

OSHA estimates that compliance with

the revised Respiratory Protection

standard will require expenditures of

more than $100 million each year by

employers in the private sector.

Therefore, the Respiratory Protection

final rule establishes a Federal private

sector mandate and is a significant

regulatory action within the meaning of

Section 202 of UMRA (2 U.S.C. 1532).

OSHA has included this statement to

address the anticipated effects of the

final rule pursuant to Section 202.

OSHA standards do not apply to state

and local governments except in states

that have voluntarily elected to adopt an

OSHA State plan and have then adopted

the specific standard in question or one

that has been deemed by OSHA to be

equally effective. Consequently, the

Respiratory Protection standard does

not impose a ‘‘federal intergovernmental

mandate’’ as defined by Section 421(5)

of UMRA (2 USC 658 (5)). The revised

Respiratory Protection standard

therefore does not impose an unfunded

mandate on state and local

governments.

Further, OSHA has found that the

costs incurred by state and local

governments in those states that choose

to adopt the standard will be small

compared to corresponding state and

local government expenditures. If Stateplan states adopt the standard, the

greatest impact in some states would be

on public fire departments. Bureau of

the Census data on the amount of

revenue dedicated to fire protection by

local governments indicate that $14.4

billion was spent on this service in

1992, the latest year for which such data

are available [Government Finances].

NFPA data indicate that 75.3 percent of

the U.S. population is served by fire

departments that employ at least some

career firemen [NFPA, p. 15]. This

means that approximately 37.7 percent

of the population (approximately half of

all state and local government

employees work in State-plan states) is

served by at least partly career fire

departments in State-plan states.

Assuming the expenditures for fire

protection are spread fairly evenly

across the population, approximately

$5.3 billion is spent on fire protection

annually by affected fire departments.

As indicated in the cost analysis (see

Table VI–2), the total annual cost of the

standard for public fire departments in

State-plan states is approximately $3.5

million, which means that the costs of

compliance constitute less than 0.1

percent of the revenue devoted by these

states to fire protection. Costs of this

magnitude are clearly an insignificant

portion of the total fire protection

budget.

The remainder of this section

summarizes OSHA’s findings, as

required by Section 202 of UMRA (2

USC 1532):

This standard is issued under Section

6(b) of the OSH Act.

This standard has annualized costs

estimated at $111 million, primarily in

the private sector, and is estimated to

save hundreds of lives per year from

cancer and cardiovascular disease.

Compliance will also prevent thousands

of illnesses annually that would have

been caused by acute and chronic

overexposures. The standard will

impose no more than minimal costs on

state, local or tribal governments,

substantially less than $100 million.

OSHA pays 50 percent of State plan

costs, although the Agency does not

provide funding for state, local or tribal

governments to comply with its rules as

employers.

OSHA does not anticipate any

disproportionate budgetary effects upon

any particular region of the nation or

particular state, local, or tribal

governments, or urban or rural or other

types of communities. The principal

costs of this standard are to control

worker exposures associated with

programmatic provisions such as annual

fit testing and training, activities that are

engaged in by thousands of

establishments in hundreds of SIC codes

that are widely distributed throughout

the country. Chapters III and V have

provided detailed analyses of the costs

and impacts of the standard on

particular segments of the private sector.

OSHA has analyzed the economic

impacts of the standard on the

industries affected and found that

compliance costs are no more than 0.1

percent of sales for establishments in

any industry, and consequently that no

plant closures or job losses are

anticipated in the affected industries. As

a result, impacts on the national

economy would be too small to be

measurable by economic models.

Pursuant to Section 205 of the UMRA

(2 USC 1535), after having considered a

variety of alternatives outlined in the

Preamble and in the Regulatory

Flexibility Analysis, the Agency has

concluded that the final rule is the most

cost-effective alternative for

implementation of OSHA’s statutory

objective of reducing significant risk to

the extent feasible.

Environmental Impact Analysis

The final Respiratory Protection

standard has been reviewed in

accordance with the requirements of the

National Environmental Policy Act

(NEPA) of 1969 (42 U.S.C. 4321 et seq.),

the regulations of the Council of

Environmental Quality (CEQ) (40 CFR

part 1500), and DOL NEPA procedures

(29 CFR part 11). As a result of this

review, OSHA has concluded that the

rule will have no significant

environmental impact.

References

Bureau of the Census, Government

Finances, Series GF, No. 5, annual, as

reported in the Statistical Abstract of the

United States, 1995. GPO, 1995.

VII. Summary and Explanation

This section of the preamble

summarizes and explains the provisions

of the final respiratory protection

standard. It describes changes made to

the rule since the proposal was issued,

discusses the comments received by the

Agency on the proposal, and presents

OSHA’s rationale for making these

changes. The record evidence

supporting each of the requirements of

the final rule is also described in detail

in this section.

This final rule clarifies, updates, and

strengthens OSHA’s previous

respiratory protection standard, which

was adopted by the Agency in 1971 and

has remained essentially unchanged

since that time. This rulemaking is thus

the first major revision to OSHA’s

respiratory protection standard in more

than 25 years. As discussed in

connection with several of the

individual paragraphs of the revised

standard, not all of the provisions of the

standard have been revised; in some

cases, OSHA found, and the record

supported, leaving individual

provisions unchanged.

The final respiratory protection

standard applies to respirator use in

general industry, construction,

shipyards, marine terminals, and

longshoring operations. When used

properly, respirators can help to protect

employees from the acute and chronic

effects of exposure to hazardous

airborne contaminants, whether in the

form of particulates, vapors, or gases.

Generally, OSHA requires respirators to

be used to protect employee health in
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1179

situations where engineering controls

and work practices are not feasible,

where such controls have not yet been

instituted, in emergencies, or where

such controls are not sufficient, by

themselves, to protect the health of

employees.

As noted above, this final standard

applies to respirator use in general

industry, construction, shipyards,

marine terminals, and longshoring

operations. In the 1994 proposal, OSHA

proposed to cover general industry,

shipyards and construction. The

longshoring and marine terminals final

rule (48 FR 30908) already made this

standard applicable to those industries

as well. To provide clarity, the final

respiratory standard explicitly contains

a note setting forth the scope of the

respirator standard.

The preamble to the proposed rule

asked for comments about the

appropriateness of applying the final

rule to construction and maritime

workplaces. In the case of the

construction industry, OSHA

specifically provided the Advisory

Committee for Construction Safety and

Health (ACCSH) with a copy of the

proposal for review and comment, and

ACCSH recommended that the revised

standard apply to construction industry

workplaces. OSHA’s responses to these

comments are discussed above in the

introduction to this preamble.

In response to the question raised

about the applicability of the standard

to the construction and shipyard

industries, OSHA received several

comments from participants concerned

about the rule’s impact on the

construction industry (Exs. 54–102, 54–

231, 54–288). These commenters noted

that the costs of the standard for

construction employers may be higher

than for their counterparts in general

industry because of the higher turnover,

decentralization of workplaces, and

multi-employer work arrangements

typical of construction sites. However,

as reported in the Final Economic

Analysis (Ex. 196), OSHA has

determined that the final rule is both

technologically and economically

feasible for employers in the

construction industry. There is no

question that many workers in this

industry need respiratory protection to

prevent material impairment of their

health; in fact, some of the most

hazardous exposures occur in this

industry. For example, workers engaged

in the abrasive blasting of bridges are

often exposed to high concentrations of

silica and other hazardous substances

(contained in the abrasive blasting

media), as well as to lead, chromates,

and other toxic materials (contained in

the paints, coatings, or preservatives

covering the substrate). Welders,

demolition workers, tunnel workers,

and painters are other examples of

construction trades that often involve

overexposure to toxic substances and

require respirators for control. In fact,

respirators may be even more necessary

in construction than in general industry

because the transient and constantly

changing nature of many construction

worksites makes the use of engineering

controls more difficult in these

environments. Finally, OSHA’s previous

respiratory protection standard has

applied to the construction industry

since 1971 (it is codified at 29 CFR

1926.103); removing this protection for

construction workers would thus

decrease existing safety and health

protections despite the significant risk

confronting construction workers in

many situations. Decreasing feasible

worker protections in the face of

significant risk of material impairment

of health would clearly be contrary to

the Agency’s mandate.

OSHA received no comments on the

applicability of the final rule to

shipyard employment. Like

construction workers, shipyard workers

have been covered by the Agency’s

previous standard since 1971. In

addition, employees in shipyards

engage in many of the same highly

hazardous operations as construction

workers, including abrasive blasting,

welding, painting, and drilling. The

Final Economic Analysis (Ex. 196) has

determined that it is both

technologically and economically

feasible for employers in shipyard

operations to achieve compliance with

the final rule.

OSHA has recently issued a revised

final rule for the Longshoring

(shipboard) portion of marine cargohandling operations, along with

revisions to the Agency’s Marine

Terminals (dockside) marine cargohandling standard. The scope and

application sections of both final

maritime rules specifically incorporate

OSHA’s respiratory protection standard

(29 CFR 1910.134) by reference. Thus,

consistent with the proposal, this final

respiratory protection standard will

apply to workplaces in general industry

and in the construction, shipyards,

longshoring, and marine terminals

industries.

At the public hearing, the

Brotherhood of Maintenance of Way

Employees (BMWE) submitted

testimony on the issue of OSHA’s

respiratory protection standard’s

coverage of railroad construction and

maintenance employees (Ex. 122). The

BMWE stated:

* * * the BMWE respectfully requests that

* * * formal recognition of the applicability

of OSHA 1910.134 for railroad employees be

published in the Federal Register to remove

any lingering questions regarding the

applicability of OSHA’s respiratory

protection standards to working conditions

which, although located within the railroad

industry, are in fact similar to those of any

industrial workplace.

In response to this comment, OSHA

notes that both the prior respiratory

protection standard and the final

revised standard being published will

apply to railway workers unless the

Federal Railroad Administration (FRA)

exercises statutory authority to issue a

separate respirator standard for those

workers. To date, the FRA has not

issued a respiratory protection standard

applicable to railway workers. Unless

and until it does, this standard will

apply to those workers.

This Summary and Explanation

section follows the order of the final

rule. The abbreviation ‘‘Ex.’’ denotes

exhibits in the docket for this

rulemaking, Docket H–049. The

abbreviation ‘‘Tr.’’ denotes the

transcripts of the hearings conducted in

connection with this rulemaking.

Paragraph (a)—Permissible practice

Paragraphs (a)(1) and (a)(2) of the final

rule are essentially unchanged from the

corresponding paragraphs of the prior

rule and the proposed rule. Indeed, in

the proposal OSHA explained that this

rulemaking was not intended to address

the substantive portion of paragraph

(a)(12). The only changes proposed by

OSHA to the regulatory language of

paragraph (a) were non-substantive: (1)

In the proposal, the Agency titled this

paragraph ‘‘Scope and Application’’

rather than ‘‘Permissible Practice,’’

which had been the title of this

paragraph since 1971; and (2) a crossreference to paragraph (b) in the prior

standard was proposed to be changed to

paragraph (c), because a new paragraph

(b), ‘‘Definitions,’’ was proposed to be

added to the final rule. In the final rule,

OSHA has determined that the original

title of paragraph (a), ‘‘Permissible

Practice,’’ better describes paragraph (a),

and thus this continues to be the title of

this paragraph. The proposed crossreference to paragraph (c) is retained in

the final rule.

Paragraph (a)(1) requires the use of

appropriate respiratory protection when

‘‘effective engineering controls are not

feasible, or while they are being

instituted.’’ This paragraph also

stipulates that the prevention of

atmospheric contamination caused by

‘‘harmful dusts, fogs, fumes, mists,

gases, smokes, sprays, or vapors’’ shall
1180 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

be accomplished, to the extent feasible,

by the use of engineering control

measures.

As stated in the preamble of the

proposed rule (59 FR 58895), OSHA did

not in this rulemaking open the record

on the issue of the hierarchy of

industrial hygiene controls; the

hierarchy language is merely brought

forward, verbatim, from this paragraph

of the prior rule. Paragraph (a)(1), which

was adopted by OSHA in 1971 from the

1969 American National Standards

Institute (ANSI) standard, Z88.2–1969,

established that a hierarchy of controls

is to be used to protect employees from

hazardous airborne contaminants.

According to this hierarchy, engineering

controls are the preferred method of

compliance for protecting employees

from airborne contaminants and are to

be implemented first, before respiratory

protection is used. According to

paragraph (a)(1), respirators are

permitted to be used only where

engineering controls are not feasible or

during an interim period while such

controls are being implemented.

Paragraph (a)(2) requires employers to

provide employees with respirators

‘‘when such equipment is necessary to

protect the health of the employee.’’ In

addition, this paragraph specifies that

the employer must provide employees

with respirators that are ‘‘applicable and

suitable’’ for the purpose intended, i.e.,

for the protection of employee health.

This paragraph thus clearly recognizes

that, when properly selected, used, and

maintained, respiratory protection can

play an essential role in preventing

adverse effects on the health of

employees exposed to hazardous

airborne contaminants.

By leaving paragraphs (a)(1) and (a)(2)

of the final rule unchanged from the

corresponding paragraphs of the

respiratory protection standard that has

been in effect since 1971, OSHA

accomplishes several objectives. First, it

continues the protection that employees

have relied on throughout OSHA’s

history. Second, it retains the language

that employers are familiar with and

thus will not require them to become

familiar with new regulatory language.

Third, leaving the regulatory text of

paragraphs (a)(1) and (a)(2) unchanged

allows OSHA and the affected public to

continue to rely on OSHA

interpretations, decisions, and case law

that have developed over the years.

As noted above, this standard is a

respiratory protection standard. OSHA

has enforced this standard when

employers fail to provide respirators,

when the respirators that are provided

are inappropriate for the form of the

contaminant or for the atmospheric

concentration of the contaminant, when

they are inappropriately used, and when

they are improperly maintained.

Although OSHA clearly stated in the

preamble to the proposal that the

hierarchy of controls was not an issue

in this rulemaking, the Agency did

receive comment on this provision. For

example, one commenter stated that, in

its opinion, OSHA has ‘‘a legal

obligation to provide interested parties

with an opportunity to comment on the

methods of compliance provisions’’ (Ex.

54–307). In the opinion of this

commenter, the American Iron and Steel

Institute (AISI), ‘‘Section 6(b)(2) of the

OSH Act requires that OSHA provide

interested persons an opportunity to

submit written data and comments on a

proposed rule in total’’ [emphasis

added].

The unchanged language of paragraph

(a)(1) was included in the proposed rule

only to enable interested parties to view

the rule as it would ultimately appear in

the Code of Federal Regulations in its

entirety. Since OSHA neither proposed

nor adopted modifications to paragraph

(a)(1), the Agency believes that it is not

legally required to reconsider this issue

at this time. OSHA has the authority to

identify which regulatory requirements

it is proposing to revise and which

issues are to receive regulatory priority.

Limiting this rulemaking to issues

concerning respirator programs is

appropriate because such programs are

the exclusive focus of this rulemaking

and to collect comments and data on

additional issues would divert resources

from the task at hand.

The preference for engineering

controls has been reaffirmed in each

substance-specific health standard

OSHA has published, most recently in

the Methylene Chloride standard (29

CFR 1910.1052). OSHA does not believe

that it is necessary or appropriate, in a

rulemaking dealing with respiratory

protection, to reconsider its longestablished policy with regard to the

hierarchy of controls.

A number of commenters raised

another issue in connection with

paragraph (a)(1), and that is whether

biological hazards, such as the hazard

posed by exposure to Mycobacterium

tuberculosis, the infectious agent that

causes tuberculosis (TB), are covered by

this paragraph (Exs. 54–213, 54–239,

54–249). In response, OSHA emphasizes

that this respiratory protection standard

does apply to biological hazards (see

Mahone Grain Corp., 10 OSHRC 1275,

1981). However, specifically with regard

to the use of respirators to protect

employees from the risk of occupational

exposure to M. tuberculosis, OSHA

stated at the public hearing on this

respiratory protection standard (Tr. 16–

17), that the Agency’s tuberculosis

standard, which has just been proposed

(62 FR 54160) would contain specific

requirements covering all aspects of

respirator use in environments where

occupational transmission of

tuberculosis is possible. As explained in

the preamble to that standard, OSHA is

committed to ensuring consistency

between the respirator requirements in

the two standards.

As stated at the hearing, ‘‘until the

final tuberculosis standard is

promulgated, we will continue to

enforce respirator usage for TB under

the current, unrevised respirator

standard, 1910.134.’’ (Tr. 18). There was

little comment on this issue during the

rulemaking. The entire previous

respiratory protection standard is being

redesignated as 29 CFR 1910.139. It will

be published in the next edition of the

Code of Federal Regulations under that

designation. OSHA’s enforcement

policy concerning required respirator

use for TB is set out in OSHA’s

Compliance Directive, ‘‘Enforcement

Procedures and Scheduling for

Occupational Exposure to Tuberculosis’’

(OSHA Instruction CPL 2.106). These

enforcement procedures are based, in

part, on the Centers for Disease Control

and Prevention’s (CDC) ‘‘Guidelines for

Preventing the Transmission of

Mycobacterium Tuberculosis in HealthCare Settings, 1994.’’ Like the CDC

recommendations, OSHA’s directive

clarifies that respiratory protection for

employees exposed to TB is required

when: (1) Workers enter rooms housing

individuals with suspected or

confirmed infectious TB; (2) workers are

present during the performance of highhazard procedures on individuals who

have suspected or confirmed infectious

TB; and (3) emergency medical response

personnel or others transport, in

enclosed vehicles, an individual with

suspected or confirmed infectious TB.

Under the directive, OSHA also enforces

the performance criteria recommended

by CDC for selecting a respirator

suitable for use against TB. OSHA’s

directive further specifies that where

respirator use is required against TB, the

program elements of OSHA’s respiratory

protection standard apply. A copy of

OSHA’s Compliance Directive can be

obtained from OSHA’s Office of

Publications (Telephone Number, 202–

219–4667). Copies of the CDC

Guidelines can be obtained by calling

CDC (Telephone Number, 1–800–342–

2437).

As noted above, paragraph (a)(2) of

the final rule is identical both to the

corresponding paragraph of the

respiratory protection standard in place
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1181

since 1971 and to proposed paragraph

(a)(2). It specifies that respirators must

be provided by the employer ‘‘when

such equipment is necessary to protect

the health of the employee.’’ OSHA

considers respirators to be necessary to

protect the health of the employee

whenever feasible engineering and work

practice controls are not available, are

not sufficient to protect employee

health, have not yet been instituted, in

emergencies, and where the health of an

employee is at risk (e.g., whenever

employee exposure exceeds an OSHA

permissible exposure limit (PEL)).

A violation of paragraph (a)(2) could

exist, for example, if it can be shown

that exposure to an airborne

contaminant could result in illness or

injury to the employee’s health and that

this could be prevented by the

appropriate selection and use of a

respirator. An OSHA Review

Commission case illustrates such a

situation: an employer was held to have

violated paragraph (a)(2) because his

employees either did not use respirators

when working in an atmosphere

contaminated with grain dust or used

respirators that were ‘‘so caked with

dust that employees could not breathe

through them’’ and contracted a

potentially fatal disease caused by the

inhalation of grain dust contaminated

with Histoplasma capsulatum spores

(Mahone Grain Corporation, 10 OSHRC

1275, 1981). Paragraph (a)(2) was cited

in this case even though OSHA has no

specific PEL for grain dust or for H.

capsulatum spores.

In the past 5 years, OSHA has issued

99 citations for violations of paragraph

(a)(2) in conjunction with a citation of

the General Duty Clause (i.e., Sec.

5(a)(1) of the Act). These citations

concerned various situations involving

the failure of the employer: (1) To

control exposures in emergencies; (2) to

control exposure to unknown

concentrations of a toxic substance; (3)

to control exposure to a contaminant

that was clearly a recognized hazard

even though no OSHA PEL existed; (4)

to provide and require the use of a

respirator for a confined space entry; or

(5) to ensure the proper use of a

respirator in a situation involving the

improper storage of a chemical(s).

OSHA will continue to view these

situations as citable under this standard

because they involve failure to

implement the appropriate exposure

control necessary to protect the health

of the employee from adverse effects.

As proposed, paragraph (a)(3) of

OSHA’s prior standard does not appear

in the final rule. This paragraph, which

was adopted by OSHA in 1971 from the

ANSI Z88.2–1969 standard, stated that

employees must use the respiratory

protection provided in accordance with

instructions and training they have

received.

Several commenters (Exs. 54–79, 54–

181, 54–226, 54–234, 54–295, 54–307,

54–334) urged OSHA to retain this

paragraph in the final rule. According to

these commenters, this paragraph is

necessary to ensure that employees take

responsibility for their actions and that

employees are actively involved in the

respirator program and conform to

program procedures. OSHA agrees that

active employee involvement in the

respirator program is essential to

program effectiveness but does not

believe that this principle should be

stated in the standard, for a number of

reasons. First, the OSH Act itself, at Sec.

5(b), states that ‘‘Each employee shall

comply with occupational safety and

health standards and all rules,

regulations, and orders issued pursuant

to the OSH Act which are applicable to

his own actions and conduct.’’ In

addition, the courts have repeatedly

held that employers are responsible

under Section 5(a)(2) of the Act (29

U.S.C. 654(a)(2)) for ensuring worker

protection (see, e.g., Brock v. City Oil

Well Service Co., 795 F.2d 507, 511 (5th

Cir. 1986)). In this case, the court held,

‘‘it is the employer’s responsibility to

ensure that the employees are protected.

It may accomplish this objective

through others if it chooses, but the duty

to provide the protection remains the

employer’s.’’ Accordingly, the final rule

does not contain this paragraph.

An issue raised by OSHA in

connection with paragraph (a) of the

proposal, the use of respirators by

employees when such use is required by

an individual employer or is chosen

voluntarily by employees but not

mandated by OSHA in this final rule, is

addressed below in connection with

paragraph (c) of this Summary and

Explanation.

Paragraph (b)—Definitions

The final standard includes

definitions of important terms used in

the regulatory text of the final rule. The

previous and proposed respiratory

protection standards contained no

definitions; however, OSHA is adding a

number of definitions to the final rule

because the Agency believes that

employers and employees will benefit

from this additional information. This is

consistent with the Agency’s desire to

clarify its respiratory protection

requirements, including those that are

not being substantively changed in this

rulemaking.

A number of the definitions relate to

specific types of respiratory protection

devices or to components or design

characteristics of those devices. For

example, the terms ‘‘air-purifying

respirator,’’ ‘‘filter or air-purifying

element,’’ and ‘‘positive pressure

respirator’’ are defined in the final rule.

These definitions, which are derived

from generally recognized sources such

as the current ANSI Z88.2–1992

respiratory protection standard, the

NIOSH requirements for particulate

respirators in 42 CFR part 84, and the

1987 NIOSH Respirator Decision Logic

(Ex. 38–20), have been revised for

clarity, consistency with compliance

interpretations of the Agency’s

respiratory protection standard, and to

respond to comments received during

the rulemaking.

A number of commenters (Exs. 54–

208, 54–218, 54–219, 54–410, 54–424)

suggested that OSHA adopt several of

the definitions in the ANSI Z88.2–1992

respiratory protection standard. The

regulated community is already familiar

with the ANSI definitions of these

terms, and OSHA agrees that the

potential for confusion will be reduced

if terms mean the same thing in both the

OSHA and ANSI standards. Therefore,

the ANSI definitions of ‘‘airline

respirator (supplied-air respirator or

airline respirator),’’ ‘‘canister or

cartridge,’’ ‘‘demand respirator,’’ ‘‘endof-service-life indicator,’’ ‘‘escape-only

respirator,’’ ‘‘filter,’’ ‘‘fit check (user seal

check),’’ ‘‘fit test,’’ ‘‘helmet,’’ ‘‘hood,’’

‘‘loose-fitting facepiece,’’ ‘‘negative

pressure respirator,’’ ‘‘pressure demand

respirator,’’ ‘‘powered air-purifying

respirator (PAPR),’’ ‘‘respiratory inlet

covering,’’ ‘‘self contained breathing

apparatus (SCBA),’’ ‘‘service life,’’ and

‘‘tight-fitting facepiece’’ have all been

added to the final standard, with some

minor word changes to improve clarity

and to recognize the mandatory nature

of OSHA standards. In other cases,

OSHA has substituted an ANSI

definition for one the Agency originally

proposed.

Several commenters urged OSHA to

add other definitions to those in the

proposal (Exs. 54–208, 54–218, 54–219,

54–222, 54–251 54–267, 54–283, 54–

289, 54–363, 54–410, 54–437, 54–455).

OSHA did not add some of the

suggested definitions, such as one for

‘‘health screening,’’ because the term is

no longer used in the standard. Other

terms, such as ‘‘medical evaluation,’’ are

defined where they appear in the

regulatory text.

The following discussion addresses

changes made since the proposed

standard.

Adequate warning properties. The

proposed definition of ‘‘adequate

warning properties’’ has not been
1182 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

retained in the final standard because

the term is no longer used in the

regulatory text. OSHA deleted the term

after concluding that the two major

warning properties, odor and irritation,

are unreliable or inappropriate to use as

indicators of sorbent exhaustion. This

issue is discussed further in this

Summary and Explanation in

connection with paragraph (d).

Air-purifying respirator. The final

standard defines the term ‘‘air-purifying

respirator’’ as ‘‘a respirator with an airpurifying filter, cartridge, or canister

that removes specific air contaminants

by passing ambient air through the airpurifying element.’’ Marc Evans of

Baxter Diagnostics, Inc. (Ex. 54–38)

stated that the proposed definition, ‘‘a

respirator which is designed to remove

air contaminants [i.e., dust, fumes,

mists, gases, vapors, or aerosols] from

the ambient air or air surrounding the

respirator,’’ was inaccurate since filter

elements can only remove air

contaminants when air passes through

the filters; he stated that the ANSI

definition was more accurate in this

regard.

Another commenter wanted to add

the term ‘‘biologicals’’ to the list of air

contaminants removed by air-purifying

respirators (Ex. 54–249). In response,

the definition has been revised to state

more clearly that an air-purifying

respirator removes specific

contaminants from the ambient air by

drawing air through appropriate filters,

cartridges, or canisters. Deleting the

proposed definition’s examples of air

contaminants makes clear that no type

of air contaminant, including biological

agents, is excluded from the definition.

Also, the term ‘‘filter’’ has been changed

to ‘‘filter or air-purifying element,’’

which is also defined in the standard,

and includes the broad range of filters,

cartridges, canisters and other airpurifying elements used with

respirators.

Assigned protection factor. The

definition of ‘‘assigned protection

factor’’ has been reserved as part of

OSHA’s decision to address the entire

Assigned Protection Factor (APF) issue

in a subsequent phase of this

rulemaking. OSHA proposed to

reference the NIOSH assigned

protection factors from the 1987 NIOSH

Respirator Decision Logic in the

respiratory protection standard and then

to adopt new APF values issued by

NIOSH after that Agency had conducted

rulemaking on APFs. In the course of

this rulemaking, OSHA has concluded

that it should instead develop its own

set of assigned protection factors based

on a thorough review and analysis of all

relevant evidence. Both the NIOSH and

the ANSI APFs, as well as all relevant

data and information, will be

considered by OSHA at that time.

Atmosphere-supplying respirator.

This term means ‘‘a respirator that

supplies the respirator user with

breathing air from a source independent

of the ambient atmosphere, and

includes supplied-air respirators (SARs)

and self-contained breathing apparatus

(SCBA) units.’’ As it has done in many

of the definitions in this section, OSHA

has substituted the term ‘‘breathing air’’

for a number of synonymous, but

confusingly diverse, terms used in the

proposal and in the ANSI Z88.2–1992

standard. The minor changes from the

proposed definition have been made

solely to enhance clarity.

Canister or cartridge. The final

standard adopts the ANSI Z88.2–1992

standard’s definition: ‘‘a container with

a filter, sorbent, or catalyst, or

combination of these items, which

removes specific contaminants from the

air passed through the container.’’

Several commenters suggested that this

definition be added to the final rule

(Exs. 54–208, 54–218, 54–219, 54–410,

54–424).

Demand respirator is defined as ‘‘an

atmosphere-supplying respirator that

admits breathing air to the facepiece

only when a negative pressure is created

inside the facepiece by inhalation.’’ This

term was not defined in the proposal

but is defined by ANSI, and several

commenters (Exs. 54–208, 54–218, 54–

219, 54–410, 54–424) urged that it be

included in the final rule. As in other

definitions, the phrase ‘‘breathing air’’

has been substituted for ‘‘respirable gas’’

for clarity.

The proposal’s definition of

‘‘demand’’ has been deleted from the

final standard because the addition of a

definition for ‘‘demand respirator’’

makes its inclusion unnecessary. (See

the definition of pressure demand

respirator below for the distinction

between the two types of respirator.)

Dust mask. See the definition for

‘‘filtering facepiece’’ below.

Emergency situation. In the final rule,

OSHA is adding this term to paragraph

(b) to clarify its use in the regulatory

text. ‘‘Emergency situation’’ is defined

as ‘‘any occurrence such as, but not

limited to, equipment failure, rupture of

containers, or failure of control

equipment that may or does result in an

uncontrolled substantial release of an

airborne contaminant.’’ Under this

definition, OSHA intends that a

potential release, and not just an actual

release, be considered an emergency

situation requiring appropriate

respiratory protection. This definition is

the same or similar to those used to

define emergency situations in other

OSHA health standards (e.g., 1910.1051,

Butadiene; 1910.1028, Benzene;

1910.1048, Formaldehyde).

Employee Exposure. OSHA has added

this term to paragraph (b) of the final

rule and has defined it to mean

‘‘exposure to a concentration of an

airborne contaminant that would occur

if the employee were not using

respiratory protection.’’ This is the same

definition that has been used in many

of OSHA’s substance-specific health

standards. It is included to clarify that

employee exposure is measured outside

any respiratory protection worn.

End-of-service-life indicator (ESLI)

means ‘‘a system that warns the

respirator user of the approach of the

end of adequate respiratory protection,

for example, that the sorbent is

approaching saturation or is no longer

effective.’’ This definition was not in the

proposal, but has been derived from the

definition in the ANSI Z88.2–1992

standard, as requested by several

commenters (Exs. 54–208, 54–218, 54–

219, 54–410, 54–424). OSHA has

included the example at the end of the

definition to clarify the function of an

ESLI.

Escape-only respirator. This term was

not defined in the proposal, but the final

standard defines an escape-only

respirator as ‘‘a respirator intended to be

used only for emergency exit.’’ The Dow

Chemical Company (Ex. 54–278) and

the Chlorine Institute (Ex. 54–439)

recommended adding definitions for an

‘‘escape’’ respirator and an ‘‘emergency’’

respirator. Partially in response to these

comments, and to clarify OSHA’s intent,

OSHA has described in paragraph (d)

the narrow function of an ‘‘escape-only

respirator,’’ and has added a definition

for ‘‘escape-only respirator’’ to this

paragraph (b). The definition of ‘‘escapeonly respirator’’ derives from the ANSI

Z88.2–1992 standard, with the phrase

‘‘egress from a hazardous atmosphere’’

replaced by the word ‘‘exit.’’

Filter or air-purifying element. The

final standard’s definition of this term is

‘‘a component used in respirators to

remove solid or liquid aerosols from the

inspired air.’’ The parallel definition in

the proposal used ‘‘filter’’ instead of

‘‘filter or air-purifying element’’ and has

been changed in response to comments

(Exs. 54–208, 54–218, 54–219, 54–410,

54–424). The phrase ‘‘or air-purifying

element’’ has been added to clarify that

this definition applies to all filtration

mechanisms, not only to mechanical or

electrostatic filtration of particulates.

The new definition derives from the

definition of ‘‘filter’’ in the ANSI Z88.2–

1992 standard.
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1183

Filtering facepiece (dust mask). The

definition of ‘‘filtering facepiece’’ in the

final rule is ‘‘a negative pressure

particulate respirator with a filter as an

integral part of the facepiece or with the

entire facepiece composed of the

filtering medium.’’ This new definition

is derived from the definition of

‘‘filtering facepiece’’ in the NIOSH

Respirator Decision Logic (Ex. 38–20).

As described in the discussion of

paragraph (c) below, employers who

allow the use of these respirators when

such use is not required need to comply

with only paragraph (c)(2) of this

standard, which requires that the

employer provide the employee with

the information contained in Appendix

D.

Fit factor. The definition of ‘‘fit

factor’’ in the final rule is a quantitative

estimate of the fit of a particular

respirator to a specific individual, and

typically estimates the ratio of the

concentration of a substance in ambient

air to its concentration inside the

respirator when worn. In the proposal,

OSHA’s definition included the terms

‘‘challenge agent’’ and ‘‘test chamber.’’

Several commenters (Baxter Diagnostics,

Ex. 54–38; American Subcontractors

Association, Ex. 54–293) stated that

using these terms would have the

unintended effect of prohibiting the use

of several existing QNFT test methods,

such as the TSI Portacount,TM and

recommended that OSHA rely on the

ANSI definition of ‘‘fit factor’’ instead.

OSHA agrees with this point, and the

final standard’s definition derives

primarily from the ANSI Z88.2–1992

standard’s definition, as commenters

suggested (Exs. 54–208, 54–218, 54–219,

54–410, 54–424). The final definition

uses the word ‘‘estimate’’ instead of the

ANSI definition’s word ‘‘measure’’

because fit factors estimate, rather than

measure, the fit obtained during use.

The phrase ‘‘specific individual’’ has

been substituted for ‘‘particular

individual’’ for clarity.

Fit test. A definition of ‘‘fit test’’ has

been added to the final rule and is

defined as ‘‘the use of a protocol to

qualitatively or quantitatively evaluate

the fit of a respirator on an individual.’’

(See also QLFT and QNFT.) This

definition has been added because

OSHA is of the opinion, based on

comments to the record, that such a

definition is needed (Exs. 54–208, 54–

218, 54–219, 54–410, 54–424). ANSI

also has a definition of fit test, but

OSHA’s definition differs from that in

the ANSI Z88.2–1992 standard in that

the term ‘‘challenge agent’’ has been

eliminated and replaced by the phrase

‘‘protocol to quantitatively or

qualitatively evaluate.’’ The use of the

term ‘‘challenge agent’’ would limit the

development of future fit test

technologies that do not involve a test

agent (Exs. 54–208, 54–250, 54–330, 54–

424).

Hazardous exposure level. Because

the final standard does not use the term

‘‘hazardous exposure level,’’ it is not

defined. The proposal defined such

levels as including the Permissible

Exposure Limits (PELs) contained in

OSHA’s Tables Z–1, Z–2, and Z–3 of 29

CFR 1910.1000; the American

Conference of Governmental Industrial

Hygienists (ACGIH) Threshold Limit

Values (TLVs), as published in the latest

edition of that organization’s

‘‘Threshold Limit Values for Chemical

Substances and Physical Agents,’’ for

those substances without an OSHA PEL;

the NIOSH Recommended Exposure

Limits (RELs) for those hazardous

chemicals without either an OSHA PEL

or ACGIH TLV; and any exposure level

based on available scientific

information, including Material Safety

Data Sheets, for those hazardous

chemicals for which no OSHA PEL,

ACGIH TLV, or NIOSH REL has yet

been published.

The proposed rule would have

required employers to identify the

‘‘hazardous exposure level’’ applicable

to each hazardous chemical in the

workplace and then to use this

information in selecting the appropriate

respirator to provide protection against

exposure to that chemical. The final rule

takes a different and much simpler

approach to assisting employers in the

selection of appropriately protective

respirators in those cases where OSHA

has not yet promulgated a PEL for a

hazardous chemical. OSHA has taken

the approach reflected in the final

standard because there was widespread

objection to the proposed approach

(Exs. 54–94, 54–175, 54–212, 54–226,

54–232, 54–275x, 54–283, 54–293, 54–

306, 54–312, 54–324, 54–334, 54–347,

54–352, 54–361, 54–397, 54–443, 54–

445). Some commenters (Exs. 54–91,

54–165, 54–181, 54–291, 54–316, 54–

347, 54–397, 54–445) interpreted the

proposed approach as an attempt by

OSHA to expand the number of

hazardous chemicals with OSHAenforceable exposure limits, while

others believed that implementing the

proposed approach would require

employers to have risk assessment

expertise or to perform complex

analyses, and pointed out that many

employers lacked such expertise (Exs.

54–106, 54–175, 54–210). In general,

rulemaking participants stated that

OSHA’s approach to this problem

should rely on the professional

judgment of employers, based on readily

available information (Exs. 54–206, 54–

210).

OSHA has decided, after a thorough

review of the record, to follow these

recommendations, and in the final rule

has adopted an approach that requires

employers to select appropriately

protective respirators on the basis of

informed professional judgment.

Accordingly, the final rule does not

identify the ACGIH TLVs or the NIOSH

RELs as references that would trigger

required respirator use. The approach

taken in the final rule provides

employers with the flexibility to rely on

professional judgment and available

data sources when selecting respirators

for protection against hazardous

chemicals that have no OSHA PEL.

OSHA believes that it is prudent in

such cases for employers to select more

rather than less protective respirators,

i.e., to select a respirator that will

reduce employee exposure to a level

below the concentration indicated as

hazardous by the scientific literature.

OSHA also believes that many

employers will choose to rely on the

ACGIH TLV or NIOSH REL in those

cases where OSHA has no PEL at the

present time. However, whatever

approach employers choose to take, the

respirator selected must ‘‘be applicable

and suitable for the purpose intended,’’

as required by paragraph (a).

Helmet. The final standard defines a

helmet as ‘‘a rigid respiratory inlet

covering that also provides head

protection against impact and

penetration.’’ This definition, which

was not in the proposal, has been added

to the final standard at the request of

several commenters ( Exs. 54–208, 54–

218, 54–219, 54–410, and 54–424). The

OSHA definition uses the term

‘‘respiratory inlet covering’’ instead of

the word ‘‘hood’’ used in the ANSI

definition in order to include helmetstyle powered air-purifying respirators

(PAPRs).

High efficiency particulate air (HEPA)

filter is defined as ‘‘a filter that is at least

99.97% efficient in removing

monodisperse particles of 0.3

micrometers in diameter. The

equivalent NIOSH 42 CFR 84 particulate

filters are the N100, R100, and P100

filters.’’ Although NIOSH has revised

the particulate filter descriptions under

the new 42 CFR Part 84 respirator

certification regulation, and no longer

uses the term HEPA, this definition is

included because ‘‘HEPA filter’’ is used

in many of OSHA’s substance-specific

standards. The definition, which is

similar to that used by ANSI, lists the

NIOSH 42 CFR part 84 particulate filters

that are equivalent, in terms of
1184 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

efficiency, to the HEPA filter, i.e., the

N100, R100, and P100 filters.

Hood. The final standard includes the

following definition of ‘‘hood’’: ‘‘a

respiratory inlet covering that

completely covers the head and neck

and may also cover portions of the

shoulders and torso.’’ This definition

has been added to the final standard in

response to commenters (Exs. 54–208,

54–218, 54–219, 54–410, and 54–424).

The definition derives from the ANSI

Z88.2–1992 standard; the word ‘‘also’’

has been added for clarity.

Immediately dangerous to life or

health (IDLH). The final standard

defines IDLH as ‘‘an atmosphere that

poses an immediate threat to life, would

cause irreversible adverse health effects,

or would impair an individual’s ability

to escape from a dangerous

atmosphere.’’ In the proposal, the

definition of IDLH was ‘‘an atmospheric

concentration of any toxic, corrosive, or

asphyxiant substance that poses an

immediate threat to life or would cause

irreversible or delayed adverse health

effects or would interfere with an

individual’s ability to escape from a

dangerous atmosphere.’’ In the final

rule, OSHA has decided that including

all atmospheres capable of causing the

listed health effects is more consistent

with OSHA’s intent than limiting the

definition to toxic, corrosive, and

asphyxiant atmospheres and has also

deleted the word ‘‘delayed’’ from the

definition because including it caused

considerable confusion among

commenters.

Under the final standard’s definition,

atmospheres where a short, one-time

exposure (i.e., an acute exposure) may

cause death or irreversible adverse

health effects immediately, within a few

hours, or within a few days or weeks are

considered IDLH atmospheres. The

severity of the adverse effects and the

certainty that health impairment will

occur following an acute exposure are

more important considerations in

defining a potential IDLH situation than

is the time course of the health effect.

For example, an atmosphere containing

life-threatening or health-impairing

concentrations of fluorides, cadmium

fumes, or radioactive substances would

be considered IDLH even though a

single exposure might not cause death

or permanent impairment for as long as

days or even weeks after the exposure.

On the other hand, many situations

involving atmospheres exceeding shortterm or ceiling exposure limits are not

IDLH atmospheres; most short-term or

ceiling limits are designed to reduce the

risk of less serious effects, such as

sensory irritation. Thus, only those

situations where the acute exposure

would threaten life, initiate an

irreversible process that threatens life or

health, or impede the ability of the

worker to escape from the atmosphere

would constitute IDLH conditions. In

contrast, if chronic exposure to a toxic

atmosphere is required to produce

health impairment or cause death, the

atmosphere is not IDLH. Thus, the

relatively low atmospheric

concentrations of carcinogenic

substances that cause work-related

cancers are not considered IDLH

atmospheres, even though the effect of

long-term exposure at such

concentrations is death or serious

illness.

Paragraphs (d) and (g) of the final

standard require employers whose

employees are exposed to an IDLH

atmosphere to provide them with the

most protective and reliable respiratory

protection, i.e., a full facepiece pressure

demand SCBA certified by NIOSH for a

minimum of a 30-minute service life, or

a combination full facepiece pressure

demand supplied-air respirator with

auxiliary self-contained air supply, and

to implement specific rescue

precautions and communication

procedures. Although OSHA’s prior

Respiratory Protection standard does

not explicitly use the term ‘‘IDLH,’’ it

does require that respirators used in

‘‘immediately dangerous’’ atmospheres

keep inward leakage to a minimum and

be highly reliable (See paragraph (c) of

prior 29 CFR 1910.134, which

incorporates this language from the

ANSI Z88.2–1969 standard by

reference).

Commenters raised a number of issues

specifically related to the proposed

definition of IDLH and to the IDLH

concept in general. These comments

addressed the following points:

• Whether the term IDLH should apply

to all delayed effects, some delayed

effects, or be restricted to immediate

effects;

• How OSHA’s definition of IDLH

differs from those of other

organizations and how it relates to the

definition of IDLH used in other

OSHA standards;

• How the presence of an IDLH or

potential IDLH atmosphere affects

respirator selection.

The following discussion addresses

each of these points in turn.

The proposed definition of IDLH

included the phrase ‘‘delayed adverse

health effects.’’ OSHA has omitted this

phrase from the final standard to

respond to comments received and to

remove a source of confusion. Many

commenters argued that the term IDLH

should cover only immediate, severe

adverse health effects, such as those

resulting from exposures to hydrogen

fluoride or oxides of nitrogen (e.g., Exs.

54–208, 54–219; 54–316), while others

favored taking chronic, delayed effects

into consideration when making an

IDLH decision (See, e.g., Exs. 54–202

and 54–437). For example, OCAW

stated that ‘‘OSHA’s IDLH and acute

hazard-based framework * * * does not

properly emphasize the need to

consider long-term and cumulative

health effects.’’

Most participants, however, argued

against including chronic health effects

in the IDLH definition because it would

make the definition too broad. These

participants feared that including this

term would mean that exposures

typically associated with chronic

effects, such as cancer, would be

designated IDLH (Exs. 54–67; 54–153;

54–175; 54–208; 54–218; 54–219; 54–

232; 54–266; 54–278; 54–307; 54–314;

54–316; 54–326). Typical of these

comments is one from the American

Iron and Steel Institute: ‘‘The proposed

definition, which includes ‘‘delayed

health effects,’’ is so broad that it goes

far beyond the accepted IDLH concept,

and would expand it beyond its

intended purpose’’ (Ex. 54–307).

Arguing along the same lines, the Exxon

Corporation stated that ‘‘the phrase

‘delayed health effects’ could include

chronic toxins like asbestos * * *’’ (Ex.

54–266).

Other commenters urged OSHA to

narrow the definition of IDLH by adding

the word ‘‘acute’’ before ‘‘adverse’’ in

the phrase ‘‘delayed adverse health

effects’’ or by making other language

changes that would achieve the same

effect (Exs. 54–67, 54–278, 54–326, 54–

208A). For example, the American

Industrial Hygiene Association (Ex. 54–

208A) stated that the only atmospheric

contaminants with delayed effects that

should be included in the definition are

those, such as the oxides of nitrogen,

that cause delayed-onset severe adverse

health effects (such as pulmonary

edema). Representatives of Pennzoil

suggested that ‘‘* * * the phrase

‘immediate or delayed irreversible

debilitating health effects’, be used’’ to

achieve the same end (Ex. 54–287).

These commenters objected to the

inclusion of ‘‘delayed health effects’’ in

the proposed definition because the

language suggested that effects typically

associated with long-term exposures,

such as cancer, would be included. The

definition in the final standard

recognizes that the effects of concern

must be the result of an acute

overexposure but does not specifically

limit the length of time between that

overexposure and the resulting effect.
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1185

Where very serious health effects may

arise from a single acute exposure, even

if such effects become apparent only

after a relatively long latency period,

e.g., hours, days, or even weeks, the

atmosphere associated with the effect

must be designated IDLH. OSHA is

confident that deleting the word

‘‘delayed’’ from the IDLH definition in

the final rule will reduce confusion but

will not affect the level of employee

protection provided by the standard.

Many commenters urged OSHA to

adopt an IDLH definition developed by

another organization, agency, or by

OSHA itself in other standards. Some

commenters (Exs. 54–153, 54–214, 54–

234, 54–251, 54–266, 54–278, 54–290,

54–330, 54–361, 54–363, 54–424, 54–

439) urged OSHA to adopt the ANSI

Z88.2–1992 standard’s definition of

IDLH: ‘‘any atmosphere that poses an

immediate hazard to life or poses

immediate irreversible debilitating

effects on health’’ (clause 3.33). For

example, Bell Atlantic (Ex. 54–361)

suggested that the ANSI definition be

used to ensure that ‘‘chronic toxins like

asbestos would not be considered

IDLH.’’ However, OSHA believes that

adopting the definition contained in the

current ANSI standard could reduce

employee protection because it states

that atmospheres are IDLH only in cases

where the adverse effects of exposure

occur immediately. An example of an

atmosphere that OSHA believes must be

considered IDLH but arguably would

not be so designated under the ANSI

definition is one containing high

concentrations of cadmium fume, which

may result in fatal collapse as long as

48–72 hours after an acute

overexposure.

The Exxon Corporation (Ex. 54–266)

objected to the phrase ‘‘ability to

escape’’ in OSHA’s proposed definition,

and suggested that OSHA instead adopt

the ANSI definition, which does not

refer to impairment of the ability to

escape. OSHA wishes to clarify that the

proposed terminology, ‘‘interfere with

an individual’s ability to escape’’ was

not meant to cover a minor or even

moderate degree of interference but to

address interference of a kind

sufficiently serious to impair the

individual’s ability to escape from

exposure to a dangerous concentration

of an air contaminant. To address

Exxon’s concern, the final rule’s

definition has been revised to read

‘‘impair the individual’s ability to

escape.’’ OSHA notes that it is

imperative for employees to be able to

escape. There are atmospheres, for

example one contaminated with a

severe eye irritant, that can effectively

incapacitate an individual in the short

term and prevent the individual from

escaping in time to avoid more serious

health consequences. OSHA has

therefore retained in the IDLH definition

language that addresses the need to

protect workers escaping from

dangerous atmospheres.

One commenter, Monsanto (Ex. 54–

219), expressed concern about the

consistency of IDLH definitions in

different OSHA standards. In response,

OSHA has reviewed the definitions of

IDLH used in its standards and believes

that the final standard’s definition is

largely consistent with those in the two

OSHA safety standards that use the

term: 29 CFR 1910.146, the PermitRequired Confined Space standard

(‘‘Confined Spaces standard’’) and 29

CFR 1910.120, the Hazardous Waste

Operations and Emergency Response

(HAZWOPER) standard.

Some commenters (Exs. 54–439, 54–

330, 54–278) asked which IDLH values

OSHA endorses or pointed to the

limitations of the available information

on IDLH concentrations. For example,

OCAW noted that ‘‘only a handful of

IDLH limits have been determined. In

most worker exposure, the IDLH limit is

unknown. Even when [an] IDLH limit

exists, workers do not have access to

this information. MSDSs rarely include

IDLH information’’ (Ex. 54–202).

The final rule does not contain a

prescribed list of IDLH values or require

employers to rely on any particular list.

Some commenters (Exs. 54–278, 54–

330, 54–361, 54–424, 54–439) criticized

the IDLH values listed in the 1994

NIOSH Pocket Guide to Chemical

Hazards (Ex. 54–278) or recommended

that the Emergency Response Planning

Guidelines (ERPGs) developed under

the auspices of the American Industrial

Hygiene Association be used instead.

OSHA is aware that published IDLH

values are not available for many

industrial contaminants and that

employers must therefore rely on their

own knowledge and judgment, and that

of safety and health professionals, when

deciding that a given atmosphere has

the potential to cause health effects of

the kind envisioned by OSHA’s IDLH

definition. During enforcement

inspections, OSHA will continue to

accept any published IDLH value that is

based on sound scientific evidence;

those published by NIOSH and the

AIHA would clearly meet this test.

OSHA’s final IDLH definition does

not separately mention ‘‘potential’’

IDLH atmospheres. Many OSHA

enforcement cases have involved the

failure of employers to provide

respirators in situations that were not

IDLH at the time workers entered the

area but became so thereafter. OSHA

intends employers to interpret the

respirator selection requirements in

paragraph (d)(1) proactively, i.e., where

employers are uncertain about the

adequacy of a given respirator for a

highly hazardous atmosphere, cannot

identify the atmospheric concentration

of a substance that poses a potentially

life-threatening or health-impairing risk,

or cannot maintain the concentration of

such a substance below life-threatening

or health-impairing levels, the employer

must consider the atmosphere IDLH and

select a respirator accordingly. For

example, an employer in a chemical

plant knows that inadvertent releases or

spills of highly hazardous chemicals

may occur at the facility and selects the

most protective respirators available for

employees who must enter a spill area

because, in an emergency, there is no

time to take airborne measurements to

determine whether or not the

concentration is IDLH. OSHA

encourages this kind of proactive

planning because it is protective of

employee health.

Interior structural firefighting. The

final respiratory protection standard

uses the OSHA definition for ‘‘interior

structural firefighting’’ contained in 29

CFR 1910.155, which applies to all

situations covered by Subpart L—Fire

Protection. The definition is as follows:

Interior structural firefighting means the

physical activity of fire suppression, rescue

or both, inside of buildings or enclosed

structures which are involved in a fire

situation beyond the incipient stage.

Loose-fitting facepiece. The final

standard now defines this term to mean

‘‘a respiratory inlet covering that is

designed to form a partial seal with the

face.’’ This definition was not in the

proposal, and has been added in

response to commenters such as the

AIHA (Ex. 54–208), 3M (Ex. 54–218),

Monsanto (Ex. 54–219), Martin Marietta

Energy Systems, Inc. (Ex. 54–410), and

ORC (Ex. 54–424), who recommended

that OSHA adopt several of the ANSI

Z88.2–1992 definitions for respirator

terms. OSHA has adopted only part of

the ANSI definition for loose-fitting

facepiece. The phrase in the ANSI

definition that states a loose-fitting

facepiece ‘‘does not cover the neck and

shoulders, and may or may not offer

head protection against impact and

penetration’’ has not been included.

This phrase from the ANSI definition

was not adopted as part of the OSHA

definition because adding this phrase

would not allow users to clearly

distinguish between hoods, helmets,

and loose-fitting respirators. It is

important for employers to be able to

distinguish loose-fitting from tight-
1186 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

fitting respirators in order to correctly

apply the fit testing requirements.

Maximum use concentration. OSHA

is not defining this term at this time

because the Agency has reserved the

issue of Assigned Protection Factors,

which is associated with Maximum Use

Concentrations, until a subsequent

phase of this rulemaking.

Negative pressure respirator (tight

fitting). The final standard defines this

term as ‘‘a respirator in which the air

pressure inside the facepiece is negative

during inhalation with respect to the

ambient air pressure outside the

respirator.’’ The proposed definition

was revised in response to comments

(Exs. 54–208, 54–218, 54–219, 54–410,

and 54–424) that recommended that

OSHA adopt the ANSI Z88.2–1992

standard’s definition. In the final rule,

OSHA has accepted the ANSI

definition, with two changes: (1) The

word ‘‘facepiece’’ has replaced the term

‘‘respiratory inlet covering’’ to make

clear that the facepiece is the area of

interest with negative pressure

respirators; and (2) the phrase ‘‘outside

the respirator’’ has been added after the

phrase ‘‘ambient air pressure’’ to clarify

that negative pressure exists only when

the outside air pressure is higher than

the air pressure inside the negative

pressure facepiece.

Oxygen-deficient atmosphere. The

proposed definition of an ‘‘oxygen

deficient atmosphere’’ was ‘‘an

atmosphere with an oxygen content of

less than 19.5% by volume at altitudes

of 8000 feet or below.’’ OSHA is

retaining the 19.5% definition of an

oxygen-deficient atmosphere in the final

rule, but is removing the reference to

altitudes. The use of a 19.5% oxygen

level is well established and has even

been incorporated by Congress into

other safety and health legislation (See

Federal Mine Safety and Health Act, 20

USC 863 (b), discussed in National

Mining Association v. MSHA, 116 F.3d

520 (D.C. Cir. 1997.) Paragraph d(2)(iii)

of the final rule requires employers to

consider all oxygen-deficient

atmospheres to be IDLH and to require

the use of pressure-demand SCBA or a

combination full-facepiece pressuredemand SAR with an auxiliary selfcontained air supply. However, this

paragraph also contains an exception

that would permit employers to use any

atmosphere-supplying respirator in

oxygen-deficient atmospheres where the

employer can demonstrate that oxygen

levels cannot fall below the altitudeadjusted concentrations prescribed in

Table II of paragraph (d).

The ANSI Z88.2–1992 standard,

NIOSH (Ex.164), and AIHA (Ex. 2098)

use an altitude-adjusted definition for

oxygen deficiency. Although there are

some small differences, these

organizations generally define oxygen

deficiency as an oxygen level of less

than 19.5% at altitudes up to 5,000 or

6,000 feet, and less than 20.9% at higher

elevations. OSHA chose not to adopt

this approach to defining oxygen

deficiency for several reason. First, as

was stated in the proposal (59 FR

58905), OSHA’s concern is that

employees not be exposed to

environments in which the oxygen

partial pressure is less than 100 mm Hg;

this partial pressure of oxygen is

generally regarded as an appropriate

IDLH level (Exs. 164, 208). OSHA

believes that using an oxygen

concentration of 19.5 percent as a

baseline oxygen level is appropriate

because exposure to such an atmosphere

does not pose a serious health risk at

elevations below 8,000 feet, i.e., the

oxygen partial pressure in such

atmospheres will remain above 100 mm

Hg (Ex.164). Although OSHA realizes

that the partial pressure of oxygen may

be at or above 100 mm Hg even at some

lower altitudes and lower oxygen

concentrations, these lower-altitude,

lower-concentration situations are

generally unstable and can quickly

deteriorate to life-threatening

atmospheres. OSHA has accounted for

those rare situations where the

employer controls the environment to

maintain a constant altitude-adjusted

oxygen level through the exception in

paragraph (d)(2)(iii) of the final rule.

OSHA’s definition of oxygen deficiency

is also consistent with the Compressed

Gas Association’s definition of Grade D

breathing air as air containing a

minimum of 19.5% oxygen. OSHA finds

that defining oxygen deficiency as an

atmosphere with an oxygen content

below 19.5% is both protective and

straightforward, and is consistent with

the definition that has been used by the

Agency in the past.

Oxygen-deficient IDLH atmosphere.

The proposal originally included a

definition of oxygen-deficient IDLH

atmosphere. Because the term has not

been used in the regulatory text of the

final rule, OSHA is deleting this term

from paragraph (b).

Physician or other licensed health

care professional (PLHCP) is defined as

‘‘an individual whose legally permitted

scope of practice (i.e., license,

registration, or certification) allows him

or her to independently provide, or be

delegated the responsibility to provide,

some or all of the health care services

required by paragraph (e) of this

section.’’ This definition has been added

because paragraph (e)(2) of the final

standard requires that all medical

evaluation procedures be performed by

a PLHCP.

OSHA has long considered the issue

of whether, and if so how, to specify the

qualifications of the particular

professionals who are permitted to

perform the medical evaluations

required by its standards. The Agency

has determined that any professional

who is licensed by state law to perform

the medical evaluation procedures

required by the standard may perform

these procedures under the respiratory

protection standard. The Agency

recognizes that this means that the

personnel qualified to provide the

required medical evaluation may vary

from state to state, depending on state

licensing laws. Under the final rule, an

employer has the flexibility to retain the

services of a variety of qualified

licensed health care professionals,

provided that these individuals are

licensed to perform a given service.

OSHA believes that this flexibility will

reduce cost and compliance burdens for

employers and increase convenience for

employees. The approach taken in this

final standard is consistent with the

approach OSHA has taken in other

recent standards (e.g., cadmium,

methylene chloride).

Positive pressure respirator. This term

has been redefined in the final standard

to mean ‘‘a respirator in which the

pressure inside the respiratory inlet

covering is positive with respect to

ambient air pressure outside the

respirator.’’ Consistent with the

recommendations of several

commenters (Exs. 54–208, 54–218, 54–

219, 54–410, and 54–424), the final

standard’s definition adopts the ANSI

Z88.2–1992 definition but adds the

phrase ‘‘outside the respirator’’ for

clarity.

Powered air-purifying respirator. The

final standard defines this term as ‘‘an

air-purifying respirator that uses a

blower to force the ambient air through

air-purifying elements to the inlet

covering.’’ This revision also reflects

commenters’ recommendations that

OSHA adopt ANSI Z88.2–1992 standard

definitions (Exs. 54–208, 54–218, 54–

219, 54–410, and 54–424). The term

‘‘ambient atmosphere’’ in the ANSI

definition has been replaced with the

term ‘‘ambient air’’ for simplicity.

Pressure demand respirator. This type

of respirator is defined as ‘‘a positive

pressure atmosphere-supplying

respirator that admits breathing air to

the facepiece when the positive pressure

is reduced inside the facepiece by

inhalation.’’ This language has been

taken verbatim from the ANSI Z88.2–

1992 standard’s definition, except that
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1187

the term ‘‘breathing air’’ has replaced

the term ‘‘respirable gas’’ for clarity.

Qualitative fit test (QLFT). This

definition has been revised to read ‘‘a

pass/fail fit test to assess the adequacy

of respirator fit that relies on the

individual’s response to the test agent.’’

OSHA has replaced the proposal’s QLFT

definition with one derived from the

ANSI Z88.2–1992 standard but has

added the phrase ‘‘to assess the

adequacy of respirator fit’’ to emphasize

the purpose of QLFT. In addition, the

OSHA definition uses the phrase ‘‘the

individual’s response’’ instead of the

ANSI definition’s phrase ‘‘subject’s

sensory response’’ for clarity.

Quantitative fit test (QNFT). This

definition has been revised and

simplified to accommodate both current

and yet-to-be-developed fit test

technology. The final standard defines a

quantitative fit test (QNFT) as ‘‘an

assessment of the adequacy of respirator

fit by numerically measuring the

amount of leakage into the respirator.’’

Commenters generally opposed the

proposed definition of QNFT, which

made reference to challenge agents,

because they feared that it might

interfere with the development of new

fit test methods (Exs. 54–5, 54–222, 54–

251, 54–266, 54–275x, 54–350, 54–208,

54–218, 54–219, 54–278, 54–316, 54–

424). OSHA agrees and has revised the

definition accordingly. OSHA believes

that the definition of QNFT must be

usable, enforceable, and

understandable, and accommodate

evolving technology.

Respiratory inlet covering. The final

standard defines this term, which is

often used in descriptions of respiratory

equipment, as ‘‘that portion of a

respirator that forms the protective

barrier between the user’s respiratory

tract and an air-purifying device or

breathing air source, or both. It may be

a facepiece, helmet, hood, suit, or a

mouthpiece respirator with nose

clamp.’’ This definition is adapted from

that in the ANSI Z88.2–1992 standard;

the phrase ‘‘that connects the wearer’s

respiratory tract’’ in the ANSI definition

has been modified to read ‘‘that forms

the protective barrier between the user’s

respiratory tract’’ in the OSHA

definition for clarity.

Self-contained breathing apparatus

(SCBA). The proposed definition of selfcontained breathing apparatus (SCBA)

has been revised slightly in the final

standard to read ‘‘an atmospheresupplying respirator for which the

breathing air source is designed to be

carried by the user.’’ This revised

definition was adopted from the ANSI

Z88.2–1992 standard’s definition of

SCBA.

Service life. The final standard defines

service life as ‘‘the period of time that

a respirator, filter, or sorbent, or other

respiratory equipment provides

adequate protection to the wearer.’’ This

definition eliminates a reference in the

proposal to substances ‘‘breaking

through’’ the cartridge or canister, and

deletes a statement that respirator

manufacturers are to determine service

life concentrations, since this is the

employer’s responsibility. The new

definition parallels ANSI’s except that it

contains additional language covering

filters, sorbents, and other respiratory

equipment. This definition is further

explained in the discussion of

paragraph (d) of the Summary and

Explanation.

Supplied-air respirator (SAR) or

airline respirator. OSHA has elected to

retain a definition for supplied-air

respirators, since the term is used by

NIOSH in the 42 CFR part 84

regulations. The final standard’s

definition reads: ‘‘Supplied-air

respirator (SAR) or airline respirator

means an atmosphere-supplying

respirator for which the source of

breathing air is not designed to be

carried by the user.’’ Participants (Exs.

54–208, 54–249) were more familiar

with this term than with the term ‘‘airsupplied respirator’’ recommended as

an alternative by some commenters

(Exs. 54–218, 54–219, 54–363, 54–434).

The language of this definition is

derived from the ANSI Z88.2–1992

definition for ‘‘airline respirator,’’ but

also applies to supplied-air respirators,

a term that NIOSH uses to certify this

class of respirators. OSHA believes that

using both names in the definition will

reduce confusion for respirator users.

Tight-fitting facepiece is defined as ‘‘a

respiratory inlet covering that forms a

complete seal with the face.’’ This term

was not defined in the proposal, but

numerous commenters requested that

OSHA add this definition (Exs. 54–222,

54–283, 54–363, 54–410, 54–424, 54–

428, 54–433, 54–455) to the final

standard.

User seal check is defined as ‘‘an

action conducted by the respirator user

to determine if the respirator is properly

seated to the face.’’ Such a check is

performed by the user each time the

respirator is donned or adjusted to

ensure that the tight-fitting respirator is

properly seated on the user’s face, i.e.,

that the proper seal has been achieved.

Several commenters recommended that

OSHA add the definition for ‘‘fit check’’

from the ANSI Z88.2–1992 standard to

replace the term ‘‘facepiece seal check’’

that was used in Appendix B of the

proposal (Exs. 54–208, 54–218, 54–219,

54–410, 54–424). The term ‘‘fit check’’

has proven confusing to those respirator

users who do not realize that a daily fit

check is not a substitute for an annual

fit test. The AIHA (Ex. 54–208)

recommended that OSHA add a

statement to Appendix B to the effect

that: ‘‘Fit checks are not substitutes for

qualitative or quantitative fit tests,’’ and

OSHA has done so in this final

standard. Because OSHA believes that

the similarity between the terms ‘‘fit

check’’ and ‘‘fit test’’ is responsible for

this confusion, OSHA has used the term

‘‘user seal check’’ rather than ‘‘fit

check’’ in the final standard. The

definition of ‘‘user seal check’’ derives

from the ANSI Z88.2-1992 standard’s

definition for ‘‘fit check,’’ except that

the word ‘‘action’’ has been substituted

for ‘‘test’’ to avoid any possible

confusion among respirator users.

Paragraph (c)—Respiratory Protection

Program

This paragraph of the final standard

requires employers to develop and

implement a written respiratory

protection program, with workplacespecific procedures addressing the

major elements of the program,

whenever respirators are necessary to

protect the health of the employee. In

addition, where an employer requires an

employee to wear a respirator, i.e., in a

situation where the standard does not

otherwise require such use, a written

program must be developed and

implemented. Employers who provide

respirators at the request of their

employees or who allow their

employees to bring their own respirators

into the workplace must ensure that the

respirator used does not present a

hazard to the health of the employee.

However, if the respirator voluntarily

worn is a filtering facepiece (dust mask),

the employer is not required to

implement a written program. Paragraph

(c)(1) also requires employers to update

the program when changes in the

workplace or in respirator use make

such updating necessary.

As in the proposed rule, the final

standard requires that the respiratory

protection program be written. OSHA’s

experience and that of the industrial

hygiene community have demonstrated

that health and safety programs can best

be effectively implemented and

evaluated when written. In addition,

because workplaces differ substantially,

each program must be tailored to the

specific conditions of the workplace if

it is to protect employee health, and

developing a written program is the

most efficient way of ensuring that the

program reflects the unique

characteristics of each workplace.

Developing and writing down worksite-
1188 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

specific procedures requires employers

to design their respiratory protection

programs to address the respiratory

hazards in their particular workplace,

and this process requires employers to

think about and document all relevant

information pertaining to the hazardous

atmospheres that their employees may

encounter under normal operating

conditions or during reasonably

foreseeable emergencies that may occur

in the workplace. Finally, OSHA’s

enforcement data indicate that

compliance with the previous standard

has not been optimal, particularly in

smaller workplaces, and a written

program will help employers,

employees, and compliance officers

gauge the adequacy of a given program.

Paragraphs (c)(1)(i) through (c)(1)(ix)

identify the elements that must be

included in the employer’s program

unless the particular element does not

apply to the employer’s workplace. The

previous OSHA respiratory protection

standard also required employers to

develop written standard operating

procedures that covered the selection,

use, cleaning, maintenance, inspection,

and storage of respirators and the

training and medical evaluation of

respirator users (paragraphs (b)(1),

(e)(1), and (e)(3), among other

provisions of the previous standard). In

the final standard, the general elements

of the written program have been

expanded, reordered and updated, and

the term ‘‘written standard operating

procedures (SOP)’’ used in the previous

standard has been replaced with the

words ‘‘worksite-specific procedures.’’

Thus, the standard identifies the basic

elements of written programs for all

workplaces, but the employer has the

flexibility to tailor these general

program elements to match the specific

workplace conditions and processes that

occur in that workplace. In the Agency’s

previous respiratory protection

standard, the requirement for written

standard operating procedures tended to

lead to the adoption of generic

procedures. Changing the terminology

from ‘‘SOPs’’ to ‘‘worksite-specific

procedures’’ gives employers the

incentive to develop procedures that are

unique and specific to the employer’s

workplace, to describe the particular

respirator selection process used in that

workplace, and to explain how

employees are to use respirators in that

setting.

OSHA has also revised the required

program elements themselves, for

several reasons. First, they have been

modified to reflect those provisions of

the final standard that have been added

or enhanced to reflect advances in

respiratory protection technology, such

as the development of atmospheresupplying respirators and the

widespread use of modern methods of

fit testing. Second, several of the

provisions of the previous standard

were vague and had caused compliance

difficulties for employers over the years.

OSHA wishes to provide employers

with clear notice of what elements

OSHA considers essential to an effective

respirator program. Third, OSHA has

adopted several changes suggested by

commenters.

OSHA also believes that clearer

program elements will improve

employer compliance. According to the

Minnesota Department of Labor and

Industry (Ex. 54–204), for example,

many employers have had difficulty

complying with OSHA’s previous

standard because they were unsure what

elements a program was required to

include. Several other data sources also

point to the lack of clarity in OSHA’s

previous standard; these include

OSHA’s inspection data and compliance

experience, comments to the record (Ex.

54–219), and studies of workers (Ex. 64–

65). As noted in the NPRM, data

collected on current respirator practices

and procedures in over 2300

manufacturing plants classified in 15

SIC codes were reviewed by the Agency

(See Summary of the Preliminary

Regulatory Impact Analysis, 59 FR

58892). This survey sample was used to

produce estimates of respirator-related

practices for about 123,200

manufacturing plants with regular and

occasional respirator use. Only 25.5% of

these plants were estimated to have

written standard operating procedures,

and only 7.9% had procedures that

addressed all eight of the program

elements required by the previous

standard (selection, use, cleaning,

maintenance, inspection and storage of

respirators, and the training and

medical evaluation of respirator users).

More than 80% of the very large plants

(those with 1000 or more employees)

had written procedures, while in small

plants (those with fewer than 50

employees), only about 22% had written

procedures. This survey clearly showed

that improving the clarity of the

elements to be addressed in standard

operating procedures would help

employers to develop and implement

better respiratory protection programs

and thus would provide greater

protection to workers as well.

Similarly, a study of OSHA citations

for violations of the previous OSHA

respirator standard from 1977 to 1982

showed that 13% of these citations were

issued because standard operating

procedures were either inadequate or

missing (Rosenthal and Paull; Ex. 33–5).

OSHA’s latest citation data for the

respiratory protection standard, for the

period October 1990 to December 1995,

show that the number of citations issued

for inadequate or missing written

respirator programs in general industry

has increased to 18.4% of all respirator

standard-related citations. These data

indicate that the conclusions reached by

Rosenthal and Paull are still valid. The

citation history for the construction

industry respiratory protection

standard, 29 CFR 1926.103, is similar,

with citations for inadequate respirator

programs representing 10.5% of all

respirator standard-related citations in

that industry. OSHA believes that the

percentages of respirator standardrelated citations reported in these

reviews substantially underestimate the

real incidence of deficient programs

because it is OSHA policy not to issue

citations for an inadequate program

unless an overexposure is also

documented.

Paragraphs (c)(1)(i) through (c)(1)(ix)

of the final standard provide additional

detail about each of the required

program elements but remain

performance based to enable employers

to adapt them to their workplaces. The

program elements have been

reorganized from those in the previous

standard so that they track the order of

the major paragraphs of the standard.

OSHA believes that reordering the

elements, as suggested by one

commenter (Ex. 54–204), is logical and

should make program development

easier. OSHA also believes that the

additional detail and greater clarity

provided by the final rule’s program

elements will reduce confusion over the

intent of these provisions, lead to higher

compliance rates, and result in better

respiratory protection for employees.

The ANSI Z88.2–1992 standard for

respiratory protection also states that

written procedures covering the

complete respirator program must be

established and implemented (Ex. 81).

Thus, like OSHA, ANSI recognizes the

need for a written respiratory protection

program and implementing procedures

to provide complete and consistent

protection to employees wearing

respirators. Although the ANSI standard

does not contain detailed instructions

on the content of these procedures, it

does describe, in clause 6, the elements

to be included in the program to cover

routine and emergency use of

respirators.

The program elements in the ANSI

Z88.2–1992 standard (i.e., program

administration, respirator selection,

training, respirator fit, maintenance,

inspection and storage) are similar to

those in paragraphs (c)(1)(i) through
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1189

(c)(1)(ix) of OSHA’s final standard. The

specific content of each element of the

written procedures is left to the

employer, who can tailor them to match

the conditions that occur in his/her

worksite. Although many of the program

elements are common to all respiratory

protection programs, such as respirator

selection, care, use, and program

evaluation, some elements, such as the

one addressing specifications for air

quality for atmosphere-supplying

respirators, apply only in workplaces in

which those types of respirator are used.

OSHA received many comments, both

on written programs in general and on

specific program elements. Some

commenters (Exs. 54–160, 54–187, 54–

238), questioned the need for a written

respirator program with worksitespecific procedures. For example,

Transtar Railroads (Ex. 54–160) stated

that written procedures do not

guarantee an effective respiratory

protection program and argued that

requiring additional written program

elements would not cause those

companies who presently disregard

OSHA’s existing standard to become

more conscientious. Motorola (Ex. 54–

187) urged OSHA to delete the

requirement for a written program and

instead simply to require that employers

ensure that respirators are properly

selected, fitted, used, and maintained as

necessary to protect employees when

respirators are required. However, the

requirement for a written respirator

program was widely supported by many

other participants in the rulemaking

(Exs. 54–204, 54–219, 54–304, 54–387,

54–389, 54–428, 54–435). For example,

the United Automobile Workers (Ex.

54–387) agreed that a written respiratory

protection program that is site-specific

and detailed (for example, that includes

specific procedures for determining

when a cartridge or filter needs to be

changed) should be required. The

American Federation of Labor and

Congress of Industrial Organizations

(AFL–CIO) (Ex. 54–428) strongly

supported the requirement for a written

respiratory program and identified such

a program as the fundamental core of

the standard:

The AFL–CIO strongly supports the

Agency’s proposal that employers who are

required to use respirators or voluntarily use

respirators in the workplace establish a

written respiratory protection program. The

written program constitutes an employer’s

plan for dealing with worker protection from

hazardous airborne contaminants that may be

present in the workplace, and as such, we

view these provisions as the fundamental

core of the standard. Requiring a written

program is essential in providing uniformity

and consistency while supplying the

maximum protection for workers who use

respirators in the workplace. (Ex. 54–428)

OSHA’s expert witness, James

Johnson of the Lawrence Livermore

National Laboratory, testified that

respiratory protection programs must be

written because of their complexity:

* * * A respirator program involves many

decisions. What kind of respirator do I use,

what kind of concentrations were measured,

what kind of contaminants were in the

workplace

* * * So all this information is important

to provide documentation and understanding

so that you can make sure the program is

adequate and you can make changes to it, to

improve it and to have it be a dynamic

operation as the workplace changes * * *

(Tr. 212)

Commenting in the same vein, the

National Pest Control Association (Ex.

54–435), which represents many small

businesses, agreed that requiring

employers to provide a written

respiratory program was sensible, and

the Cambrex Corporation (Ex. 54–389)

noted that ‘‘A performance approach in

defining written program requirements

will provide needed flexibility to

employee protection programs.’’ David

Lee, CIH, CSP (Ex. 54–304), strongly

supported the approach OSHA has

taken in the final rule; he stated that a

written respiratory protection program

should be required in all places where

respirators are used, regardless of the

circumstances, and that the program’s

contents should be specifically tailored

to conditions of use at the place of

employment.

OSHA agrees with these commenters

that it is appropriate to retain the

previous standard’s requirement for a

written program, and that the program

must be flexibly tailored to worksite

conditions. OSHA finds that comments

to the record, and the Agency’s own

compliance experience, strongly suggest

that many employers wish to comply

but are unsure about what is required;

for these employers, greater clarity and

guidance will enhance compliance and

enable them to provide their employees

with needed protection.

Paragraph (c)(1) of the final rule

requires employers to update the

program as necessary to reflect changes

in the workplace. This requirement has

been revised somewhat from the

proposal. The proposed standard stated

that ‘‘[t]he written program shall reflect

current workplace conditions and

respirator use’’ (59 FR 58939). OSHA

received several comments on this

provision (Exs. 54–278, 54–213, 54–

249). For example, the Dow Chemical

Company (Ex. 54–278) urged OSHA to

revise this language to require that the

program reflect only those current

workplace conditions ‘‘significantly

impacting respirator use.’’ In the final

rule, OSHA has moved this provision to

paragraph (c)(1) and revised it to require

that the program be ‘‘updated as

necessary to reflect those changes in

workplace conditions that affect

respirator use.’’ OSHA believes that this

change is responsive to Dow’s point. As

now written, when the workplace

changes in a way that may affect

respirator use, such as when new

processes are introduced, changes are

made in the types of chemicals used, or

the types of respirators being used

changes, employers must revise the

program as necessary to reflect these

new conditions.

One of the major issues raised in the

rulemaking dealt with situations in

which respirator use is not specifically

required by 29 CFR 1910.134 or other

OSHA statutory or regulatory

requirements, but instead is required by

employers as a condition of

employment or is permitted by

employers upon the request of

employees (i.e., voluntary use). The

preamble discussion for proposed

paragraph (a) stated that employers who

required employees to use respirators

would be covered by the standard (59

FR 58895). OSHA also recommended in

the NPRM that employers who permit

voluntary respirator use in their

workplaces implement the full

respiratory protection program. In the

final rule, paragraph (c)(1) requires that

a respiratory protection program be

developed and implemented ‘‘wherever

respirators are required by the

employer,’’ but has greatly reduced the

obligations of employers who allow

their employees to use respirators when

such use is not required.

In the preamble to the proposal,

OSHA discussed the reasoning behind

including employer-required respirator

use within the scope of the standard (59

FR 58895). OSHA stated that the

requirement was appropriate both

because the use of a respirator could in

itself present a health hazard to the

wearer, and because improper use of a

respirator in environments where

respiratory hazards are present would

not sufficiently protect employees from

those hazards. OSHA finds that these

are still valid reasons for requiring that

a respiratory protection program be

implemented where employers require

respirator use. All of the elements of a

respiratory protection program apply to

this situation. Employers must still

select respirators that are appropriate to

the workplace conditions and types of

respiratory hazards present to ensure

that respirators offer adequate

protection. Improperly selected
1190 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

respirators may afford no protection at

all (for example, use of a dust mask

against airborne vapors), may be so

uncomfortable as to be intolerable to the

wearer, or may hinder vision,

communication, hearing, or movement

and thus pose a risk to the wearer’s

safety or health.

Employees who are required by their

employers to wear respirators must also

be medically evaluated to determine

that they are capable of tolerating the

increased physiological load associated

with some respirator use. Proper fit

testing is necessary to ensure that

discomfort is minimized and that the

respirator selected is offering sufficient

protection. It is also necessary that

respirators required by employers be

cleaned, disinfected, stored, inspected,

and repaired according to the

procedures contained in the final rule to

ensure proper respirator functioning

and protection of employees from

dermatitis or exposure to hazardous

contaminants that may result from using

a dirty respirator. Compliance with the

provisions of the standard dealing with

supplied air quality and use is also

essential where employers require the

use of supplied-air respirators. When

employers require employees to use

respirators, OSHA believes it necessary

that employees be properly trained in

their use and care, and be informed of

the limitations of using respirators.

Paragraph (k) of the final rule makes

clear that employers must implement

the employee training requirements

contained in paragraph (k) if they

require their employees to use

respirators.

In contrast, not all of these protections

are necessary in the situation where an

employer allows, but does not require,

respirator use. OSHA has therefore

added a new paragraph (c)(2) to the final

rule, which applies when employers

allow employees to use respirators

when such use is not required by the

employer or by the standard. This

paragraph applies when employers

either provide respirators to employees

who request them or allow employees to

use their own respirators. In both

situations, paragraph (c)(2)(i) states that

employers must determine that the

employees that they allow to use

respirators are medically able to do so,

and that there are no other conditions

that could cause the respirator use to

create a hazard.

If the employer allows voluntary

respirator use, paragraph (c)(2)(i)

requires that the employer provide the

employee with the information

contained in Appendix D to this

standard, entitled ‘‘Information for

Employees Using Respirators When Not

Required Under the Standard.’’ In the

rare case where an employee is

voluntarily using other than a filtering

facepiece (dust mask) respirator

(paragraph (c)(2)(ii)), the employer must

implement some of the elements of a

respiratory protection program, e.g., the

medical evaluation component of the

program and, if the respirator is to be

reworn, the cleaning, maintenance, and

storage components. An exception to

this paragraph makes clear that, where

voluntary respirator use involves only

filtering facepieces (dust masks), the

employer is not required to implement

a written program.

Paragraph (c)(2) is necessary because

the use of respirators may itself present

a health hazard to employees who are

not medically able to wear them, who

do not have adequate information to use

and care for respirators properly, and

who do not understand the limitations

of respirators. Paragraph (c)(2) is

intended to allow employers flexibility

to permit employees to use respirators

in situations where the employees wish

to do so, without imposing the burden

of implementing an entire respirator

program. At the same time, it will help

ensure that such use does not create an

additional hazard and that employees

are provided with enough information

to use and care for their respirators

properly. This provision does not, of

course, preclude employers from

adopting additional program elements if

they believe such elements are

appropriate.

The great majority of voluntary use

situations involve the use of dust masks,

i.e., filtering facepieces, which are

provided for the employee’s comfort.

For example, some employees who have

seasonal allergies may request a mask

for comfort when working outdoors, or

an employee may request a dust mask

for use while sweeping a dusty floor.

There are no medical limitations on the

use of these respirators, so employers

who allow their use need only ensure

that the masks are not dirty or

contaminated, that their use does not

interfere with employees’ ability to

work safely, and that they provide the

employees with the information

contained in Appendix D, as required

by paragraph (k) of the final rule.

In rare cases where the employee

requests and the employer allows the

use of a negative-pressure respirator

(tight-fitting), or where the employee

brings such a respirator into the

workplace, the employer must

implement some provisions of the

respirator program described in

paragraph (c)(1) to ensure that such

respirator use will not affect the

employee’s health adversely. The

employer can include these elements in

its existing respiratory protection

program, if it is required to maintain

one. Some medical evaluation is

necessary to determine that the

employee is physically able to use a

tight-fitting negative pressure respirator.

In addition, if the respirators being used

voluntarily are reused, it is necessary to

ensure that they are maintained in

proper condition to ensure that the

employee is not exposed to any

contaminants that may be present in the

facepiece, and to prevent skin irritation

and dermatitis associated with the use

of a respirator that has not been cleaned

or disinfected. OSHA believes it

unlikely that voluntary use situations

will involve the use of supplied-air

devices, but such use would also trigger

these requirements of the standard.

These requirements are necessary

because use of a negative pressure

(tight-fitting) respirator imposes a

significant physiologic burden on a

respirator user, and it is crucial to

determine that the user can withstand

that burden without suffering adverse

health consequences. Similarly,

reusable tight-fitting negative pressure

respirators can become contaminated if

they are not cleaned, maintained, and

stored properly. Thus if an employer

allows use of this type of respirator, the

employer must implement the program

elements necessary to ensure that

contamination does not harm the

employee.

The hazards addressed by this

requirement are the same ones that are

already considered under OSHA’s

longstanding enforcement policy. The

Agency generally does not issue

citations for violations of its respirator

standards unless there is also evidence

of overexposure to a hazardous

substance, or some other hazard caused

by improper or inadequate respirator

use. (OSHA Field Inspection Reference

Manual (FIRM), Ch. III. Sec. C.3.c).

Other hazards referenced in the FIRM

include ingestion of harmful substances

that may remain on improperly cleaned

and maintained respirators, or

dermatitis caused by the same

condition. These are precisely the

hazards that the requirements of

paragraph (c)(2) are designed to prevent.

They can occur whether respirator use

is voluntary or required, and OSHA

does not believe it would be consistent

with the OSH Act to allow employees to

expose themselves to preventable

hazards, particularly where there are

fairly undemanding measures available

to prevent that exposure.

Requiring employers to undertake

these minimal obligations when they

allow voluntary respirator use is
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1191

consistent with the fact that employers

control the working conditions of

employees and are therefore responsible

for developing procedures designed to

protect the health and safety of the

employees. Employers routinely

develop and enforce rules and

requirements for employees to follow

based on considerations of safety. For

example, although an employer allows

employees discretion in the types of

clothing that may be worn on site, the

employer would prohibit the wearing of

loose clothing in areas where clothing

could get caught in machinery, or

prohibit the use of sleeveless shirts

where there is a potential for skin

contact with hazardous materials.

Similarly, if an employer determines

that improper or inappropriate

respirator use presents a hazard to the

wearer, OSHA finds that the employer

must exert control over such respirator

use and take steps to see that respirators

are safely used under an appropriate

program. It has been OSHA’s experience

that employers will be able to determine

whether employees are using their own

respirators in the workplace, just as they

are able to determine that employees are

adhering to all other procedures and

requirements established by the

employer.

Concomitantly, OSHA’s decision to

impose fewer requirements on voluntary

respirator use than on required use is

supported by the record. Many

comments addressed the issue of how

the final standard should treat these two

types of respirator use. Many

commenters (Exs. 54–96, 54–109, 54–

196, 54–222, 54–272, 54–341, 54–424,

145, 176, Tr. 2127, Tr. 2174 ) supported

the inclusion of employer-required

respirator use, but not of voluntary use,

within the full scope of the standard.

Many of these rulemaking participants

believed that voluntary respirator use

should require a minimal program

designed to provide information and

training to the employee, and that other

elements of the program should not be

made mandatory. Typical of these was

the post-hearing comment of

Organization Resources Counselors, Inc.

(ORC):

OSHA should not require a complete

respirator program for the voluntary use of

respirators by employees, when not required

by an OSHA standard, or by the employer.

Some employees will wish to use respirators

even though they are not required to protect

against overexposure to a toxic hazard. In

these instances the employer should be

required only to inform the employee of the

safe and proper use of such respirators and

any associated limitations on the particular

device chosen (Ex. 145).

In addition, some of these commenters

(Exs. 54–341, 176, Tr. 594, Tr. 2100)

suggested that requiring employers to

comply with all or most of the

requirements would discourage

employers from permitting voluntary

respirator use in their workplaces. For

example, in its post-hearing submission,

the North American Insulation

Manufacturers Association (NAIMA)

commented as follows:

NAIMA agrees with many other hearing

participants that employers should be

required to train voluntary respirator users in

the proper function and use of respirators

* * * OSHA should, however, tailor other

aspects of the Proposed Rule to ensure that

the more onerous and unnecessary additional

requirements, such as comprehensive

medical examinations, are not imposed in

truly voluntary use situations. Applying

unnecessary ancillary requirements to

voluntary use situations would discourage

employers from allowing workers such use

(Ex. 176).

OSHA believes that the final rule

provides for the kind of tailoring

suggested by NAIMA’s comment.

Employers who permit the voluntary

use of tight-fitting negative-pressure

respirators must utilize the procedures

necessary to address the health hazards

associated with the use of such

respirators, but in the vast majority of

voluntary-use situations where

employees are using dust masks

(filtering facepieces), the standard does

not require the employer to implement

a written respirator program to ensure

employee health. Thus, the final rule

does not require employers providing

dust masks (filtering facepieces) to their

employees to comply with the

requirements that NAIMA considers

‘‘onerous and unnecessary’’ in this

situation. However, where respirators

are used voluntarily by employees, and

the use of a given type of respirator, e.g.,

a tight-fitting negative pressure

respirator, is associated with an

increased health risk, OSHA finds that

applying relevant portions of the

respiratory protection program is

essential to ensure worker protection.

Other commenters (Exs. 54–214, 54–

218, 54–278, 54–389) believed that

application of the standard should be

limited in situations where there was no

exposure to a respiratory hazard,

regardless of whether respirator use is

required by employers in this situation

or is voluntary. In discussing this issue,

the 3M Company commented as

follows:

1. Any use of respirators or masks in the

workplace should trigger a requirement for at

least a minimal respiratory protection

program. Regardless of whether use is

required or recommended by an employer or

is self-imposed by an employee, the

employer should be responsible for the safe

use of respirators and masks in the

workplace.

2. Where it is documented by an employer

that no hazard exists—such as when used

against non-toxic materials, exposures well

below the permissible exposure limit (PEL)

or hazard level, or voluntary use against such

conditions as discomfort or allergies—the

rule should only require an abbreviated

respiratory protection program * * *. (Ex.

54–218)

In a similar argument, the Dow

Chemical Company (Ex. 54–278)

suggested that employers be exempt

from the standard’s requirements if they

require employees to use respirators as

a precautionary measure where

exposures are below the PELs.

OSHA did not adopt this approach in

the final rule because the Agency

believes that, in most cases of employerrequired respirator use, respirators are

being used as protection against actual

or potential exposure to a respiratory

hazard. In these cases, OSHA finds that

it is necessary and appropriate that the

employer implement all elements of the

respiratory protection program that

apply to the worksite-specific

conditions under which respirators are

used. If respirators are used as

protection against a real or potential risk

caused by exposure to a respiratory

hazard, OSHA believes it essential for

the employer to provide for proper

respirator selection, fit testing, medical

evaluation, and care and maintenance to

ensure that the respirator is providing

sufficient protection against the hazard

and that use of the respirator is not

imposing an additional health risk.

OSHA also believes that, by

distinguishing between employerrequired and voluntary respirator use in

the final rule, it will be easier for

employers to determine the extent to

which the standard will apply to their

specific workplaces.

Other rulemaking participants (Exs.

54–208, 177, Tr. 782, Tr. 1722) were of

the opinion that voluntary respirator use

should not be distinguished from

employer-required use in determining

how the standard should apply, or

reported that some employers already

implement a program for voluntary use.

The AIHA, in support of full coverage

of the standard for voluntary respirator

use, stated in written comment:

The position of AIHA is that all use of

respiratory protection should be covered by

an employer’s respiratory protection

program. That includes both voluntary use as

well as required use. Both groups should

participate in all elements of the respiratory

protection program. An individual desiring

to wear a respirator to obtain some level of

comfort or to further reduce their exposure to
1192 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

a chemical in the workplace should receive

the full benefits of an established program:

training to convey proper knowledge in

equipment selection, maintenance, and use;

medical evaluation to confirm that its use

will not present a risk to the individual; and

fit testing to confirm that the equipment fits

properly and workplace surveillance to

confirm that the equipment being utilized is

suitable for the exposure level. (Ex. 54–208)

At the public hearing, Larry Janssen of

the AIHA elaborated that ‘‘* * * there

should be some kind of a minimum

framework to prevent the misuse of

respirators in those voluntary use

situations, that you don’t do harm by

allowing a respirator to be used where

it’s not really needed’’ (Tr. 782).

Similarly, in a post-hearing comment,

the Industrial Safety Equipment

Association (ISEA) stated that it was

important to cover voluntary use in the

standard since ‘‘* * * [r]espirators that

are not used properly could present a

hazard’’ (Ex. 177). This practice is

already being implemented in some

workplaces; Richard Holmes of Union

Carbide, representing the Chemical

Manufacturers Association (CMA) at the

hearings (Tr. 1722), testified that ‘‘* * *

[w]e treat the voluntary user just like a

mandatory user so they’re in the

program just as though they were

required to wear the respirator and the

* * * medical surveillance is all

handled the same * * * [as is the

training].’’

As discussed above, OSHA agrees that

some voluntary respirator use (e.g., that

involving tight-fitting negative-pressure

respirators) may present a health hazard

to employees if the respirator is not

properly selected, maintained, and

used. Therefore, OSHA has revised the

final rule to ensure that employers who

permit voluntary use of such respirators

in their workplaces implement those

portions of the standard necessary to

protect employees from any health risks

associated with respirator use. The

position taken in the final rule also

reflects OSHA’s long-standing

enforcement policy with the previous

respiratory protection standard, as

stated in the FIRM and in several letters

of interpretation issued by the Agency

(See letters dated 10/2/87 from Thomas

J. Shepich, 4/11/91 from Patricia K.

Clark, 3/19/91 from Patricia K. Clark, 3/

4/93 from Roger A. Clark (2 letters), and

3/15/95 from Ruth McCully). For

example, in the letter of March 4, 1993

from Roger A. Clark, OSHA stated its

policy regarding the application of 29

CFR 1910.134 to the voluntary use of

respirators:

OSHA’s policy is that if the respirator itself

could present an adverse health condition if

a specific requirement of the respiratory

protection standard is not observed, then the

requirement applies. Examples may include

a dirty respirator that is causing dermatitis,

a worker’s health being jeopardized by

wearing a respirator due to an inadequately

evaluated medical condition, or a significant

ingestion hazard created by an improperly

cleaned respirator. This is so regardless of

whether the employee purchased the

respirator or the employer provides it.

OSHA also has determined that

complete training is not required for

employees using respirators voluntarily.

Instead, paragraph (k) of the final rule

requires employers to provide the

information contained in Appendix D to

ensure that employees are informed of

proper respirator use and the limitations

of respirators.

Paragraphs (c)(1)(i) through (c)(1)(ix)

list the elements of the respirator

program required by this standard.

Paragraph (c)(1)(i) requires the program

to contain procedures for the selection

of respirators appropriate to protect

employees from the respiratory hazards

present in the particular workplace.

This provision is unchanged from the

corresponding provision in the proposal

and is also similar to paragraph (b)(2) of

OSHA’s previous standard. Paragraph

(c)(1)(ii) addresses the medical

evaluation of employees required to

wear respirators and is unchanged from

the parallel requirement in the proposal.

The AIHA (Ex. 54–208) recommended

that paragraph (c)(1)(ii), which requires

employers to develop procedures

addressing ‘‘medical evaluations of

employees required to wear

respirators,’’ be changed to specify that

these procedures need only cover

employees who are ‘‘authorized by the

employer to wear respirators’’; the AIHA

wanted this word change to ensure that

employers understood that these

procedures must cover both voluntary

and required use. However, as

explained above, OSHA has decided to

require medical evaluation of employees

who use respirators voluntarily only

when such use may present a health

hazard to employees, e.g., in the case of

tight-fitting negative pressure

respirators. Therefore, OSHA has not

included the language suggested by the

AIHA in the final rule.

Paragraph (c)(1)(iii) covers the fit test

element of the program and has been

modified since the proposal to respond

to comments. The proposal would have

required the program to contain fit

testing procedures ‘‘for air-purifying

respirators and tight-fitting positive

pressure respirators.’’ The Service

Employees International Union (Ex. 54–

455) commented that this provision

only needed to address ‘‘tight-fitting

respirators’’ because this language

adequately describes the respiratory

equipment to be covered. Since OSHA

has revised the fit testing requirements

in paragraph (f) to cover all tight-fitting

respirators, the language in paragraph

(c)(1)(iii) has been revised accordingly.

Paragraph (c)(1)(iv) states that

employers shall include ‘‘Procedures for

proper use of respirators in routine and

reasonably foreseeable emergency

situations.’’ In the NPRM, this

requirement was addressed under

paragraph (g)(1), but it has been moved

into paragraph (c)(1) of the final rule to

ensure that employers are aware that

written workplace-specific procedures

must address both routine and nonroutine respirator usage, including that

in reasonably foreseeable emergency

situations. OSHA received no comments

on this provision.

Paragraph (c)(1)(v) requires the

workplace-specific procedures to cover

‘‘procedures and schedules for cleaning,

disinfecting, storing, inspecting,

repairing, discarding, and otherwise

maintaining respirators.’’ This provision

is unchanged from that proposed. The

American Iron and Steel Institute (AISI)

urged OSHA to remove the word

‘‘schedules’’ from paragraph (c)(1)(iv)

and to substitute the word

‘‘frequencies’’ instead. AISI stated that

the term ‘‘schedules’’ connotes a

requirement for extensive recordkeeping

and paperwork. OSHA does not agree.

Since OSHA requires the respirator

program to be written, as required under

the prior standard and as proposed and

supported by comments in this

rulemaking, it is OSHA’s conclusion

that including the employer’s schedule

for cleaning, disinfecting, or otherwise

maintaining respirators is not unduly

burdensome. A schedule is needed to

inform employees when they are to have

their respirators fit tested, cleaned, and

maintained. Therefore, OSHA is

retaining the word ‘‘schedule.’’

Representatives of the Service

Employees International Union [(SEIU)

Ex. 54–455)] strongly supported the

requirement for maintenance schedules

as proposed under paragraph (c)(1)(v) of

the NPRM for the same reason.

Paragraph (c)(1)(vi) is essentially

unchanged from the proposal and

requires ‘‘Procedures to ensure adequate

air quality, quantity, and flow of

breathing air for atmosphere-supplying

respirators.’’ Representatives from SEIU

(Ex. 54–455) supported OSHA’s

addition of ‘‘quantity and flow’’ to

paragraph (c)(1)(vi) in the NPRM. Proper

air quality and quantity are crucial to

the use of supplied air respirators to

protect worker health. The revised

provision has been slightly modified

from the provision in the NPRM that
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1193

read ‘‘* * * ensure proper air quality,

quantity, and flow * * *’’ for

atmosphere-supplying respirators. The

addition of the words ‘‘* * * for

breathing air * * *’’ is to clarify that

under no circumstances should air for

atmosphere-supplying respirators be of

less than Grade D breathing air quality.

Paragraph (c)(1)(vii), as proposed,

would have required employers to

include ‘‘[t]raining of employees in the

respiratory and health hazards of the

hazardous chemicals to which they are

potentially exposed as required under

the Hazard Communication standard (29

CFR 1910.1200).’’ Several commenters

questioned the need to cross-reference

an existing OSHA standard in the

respirator standard, and recommended

that this provision be deleted (Exs. 54–

154, 54–271, 54–278, 54–295, 54–307).

OSHA agrees that the cross-reference is

unnecessary, and the reference to the

Hazard Communication standard has

been removed from the final standard.

However, the requirement that

employers develop procedures that

address the ‘‘Training of employees in

the respiratory hazards to which they

are potentially exposed during routine

and emergency situations’’ remains,

because there are respiratory hazards,

such as biological hazards and

radioactive particles, that are not

covered by the Hazard Communication

standard.

Paragraph (c)(1)(viii) requires

employers to develop procedures for the

training of employees in the proper use

of respirators, including putting on and

removing them, the limitations of these

devices, and maintenance procedures

for respirators. OSHA received no

comments on this provision, which has

been revised slightly since the proposal

for clarity.

Paragraph (c)(1)(ix) states that the

program should include ‘‘Procedures for

regularly evaluating the effectiveness of

the program.’’ This provision is

basically the same as in the NPRM

except that the word ‘‘periodically’’ has

been deleted to avoid the suggestion

that OSHA has a fixed interval in mind.

This provision notifies employers that

their written workplace procedures

must include routine evaluation of the

program to ensure that it is effective, upto-date, and includes all necessary

provisions. In workplaces where

worksite-specific conditions are

relatively stable, such as a

manufacturing site, program evaluation

may be conducted on a fixed schedule.

In other workplaces where worksite

conditions are less stable, employers

must develop schedules for evaluating

the program that make sense in that

context.

In a general comment, the United

States Enrichment Corporation (Ex. 54–

283) stated that the final rule’s

requirements for work procedures in

paragraphs (c)(1)(i) through (c)(1)(ix)

implied that OSHA intended separate

documents to be developed to meet each

of the requirements, and asked OSHA to

clarify this. It has always been OSHA’s

intention that the employer can address

the required program elements and the

development of worksite-specific

procedures in a single document, the

written respiratory protection program.

OSHA believes that reorganizing the

elements of this program to track the

order of the standard will facilitate the

inclusion of all worksite-specific

procedures into one document.

In another general comment, Peter

Hernandez of the American Iron and

Steel Institute (AISI) (Ex. 54–307) urged

OSHA to revise paragraph (c) and other

paragraphs of the final rule to remove

the term ‘‘ensure,’’ which he interpreted

as imposing an impossible burden on

employers. OSHA disagrees with this

interpretation, however. OSHA

standards use the word ‘‘ensure’’

because they impose a mandatory

requirement to comply on employers

and because the OSH Act and

subsequent case law have made it clear

that it is the employer’s responsibility to

compel compliance. The reasoning

behind this body of case law is that it

is the employer, and not the employee,

who controls the conditions of work at

a given workplace. OSHA believes that

the word ‘‘ensure’’ is appropriate

because it indicates that the employer

must manage, lead by example, train,

direct, and, if necessary, set up a

disciplinary system so that employees

understand that they must follow safe

and healthful practices on the job.

However, case law also makes it clear

that employers are not the ‘‘insurers’’ of

their employees’ behavior. In other

words, if an employer establishes,

implements, trains employees in, and

enforces safe operating procedures, and

does so in a consistent manner, the

employer will not be liable for an

employee’s unforeseeable violation of

its safety rule.

Paragraph (c)(3) of the final rule

requires employers to designate a

person as program administrator and to

ensure that this person is qualified to

perform the responsibilities of this

position. The person can be qualified

either by appropriate training or

experience or both. The administrator is

also the person responsible for

evaluating the program, as stated in

paragraph (c)(3). This requirement is

essentially unchanged from the

proposal, although its language has been

clarified. The ANSI Z88.2–1992

respiratory protection standard (Ex. 81)

also contains a description of the

responsibilities of the program

administrator and a requirement that the

respirator program be ‘‘periodically

audited to ensure that (a) the program

procedures reflect the requirements of

current applicable regulations and

industry accepted standards and (b) the

program as implemented reflects the

written procedures’’ (See clause 5.3).

The ANSI standard recommends that

the audit be conducted by a

knowledgeable person not directly

associated with the program, rather than

by the program administrator. OSHA

has not adopted the ANSI

recommendation that periodic audits be

performed by knowledgeable outside

persons because the OSHA standard

requires the administrator to be

qualified to perform this task; thus, an

additional requirement for audits to be

performed by an outside party is

unnecessary and may prove unduly

burdensome for some employers.

The training requirements and

experience level necessary for the

program administrator were the subject

of substantial comment. OSHA

proposed that the program supervisor be

a person ‘‘qualified by appropriate

training and/or experience’’ to be

responsible for the respirator program.

Many commenters supported this

performance-based requirement (Exs.

54–68, 54–80, 54–91, 54–175, 54–187,

54–208, 54–219, 54–220, 54–222, 54–

252, 54–319, 54–352, 54–361, 54–435,

54–455). For example, the Service

Employees International Union (Ex. 54–

455) supported the proposed

‘‘performance-oriented qualifications for

the designated person (program

administrator).’’ Allied Signal (Ex. 54–

175) stated that ‘‘there should be no

specific minimum training for program

administrators. We believe the level of

training for the respirator program

administrator must be adequate to deal

with the complexity of the program.’’

Motorola (Ex. 54–187) commented that

‘‘Training requirements for those

individuals designated by the employer

to administer the program should be

commensurate with the type of

respirator program needed at the

workplace.’’

Several commenters urged OSHA to

add a phrase to this requirement in the

final rule to require that the level of

program supervisor training must be

adequate to deal with the complexity of

the program because the level of

training appropriate for a workplace

with extensive respirator use is

substantially different from one with

limited respirator use (Exs. 54–175, 54–
1194 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

187, 54–200, 54–206, 54–214, 54–219,

54–222, 54–245, 54–265, 54–266, 54–

275, 54–361). As Monsanto (Ex. 54–219)

stated:

An employer’s respirator usage may be

limited to dust respirators or may have a

wide variety of types covering both airpurifying and atmosphere-supplying

respirators. Program administrator training/

qualifications would need to cover a wider

range of topics in the latter case than in the

former case.

However, some commenters, e.g., the

Sparks Nevada Fire Department (Ex. 54–

129), wanted to avoid imposing overly

stringent requirements on choosing a

program administrator, while others,

e.g., the Grain Elevator and Processing

Society (Ex. 54–226), urged OSHA to

delete the phrase ‘‘qualified by training

and/or experience’’ on the grounds that

there are no widely accepted criteria for

determining such a program

administrator’s qualifications. A few

commenters acknowledged that since

the program administrator’s tasks often

vary by type of workplace, it would be

difficult for OSHA to establish a

required minimum level of training that

would be appropriate for all program

supervisors in all workplaces. Michael

Rehfield, Safety Officer for the

Westminster, Maryland Fire Department

(Ex. 54–68) stated:

I am in total agreement that the person

fulfilling this role and the ‘‘qualifications’’

should be ‘‘performance oriented’’. That

language should appear in this section. It is

imperative that the emergency response

community be represented by performance

oriented standards or regulations since the

associated tasks are so diverse.

A working group from the State

Universities of New York (Ex. 54–357)

felt that the performance language

regarding program supervisors was too

vague, and suggested that a

nonmandatory appendix be added to

identify the types of qualifications a

program supervisor would need. The

United Automobile, Aerospace &

Agricultural Implement Workers of

America (UAW) (Ex. 54–387) wanted

OSHA to define a body of knowledge

necessary to carry out the duties of a

qualified program administrator.

OSHA discussed these qualifications

in the preamble to the NPRM at 59 FR

58898–58899. That proposal discussion

reiterated many of the points that are

described above: that the level of

training appropriate for a workplace

with limited respirator use would be

quite different from another with

extensive use of different respirator

types, and that the program

administrator can work with a

workplace respirator committee, or

assign responsibility for portions of the

program to industrial hygienists, safety

professionals, or other respirator experts

while retaining overall responsibility for

the program. In other words, the level of

training of the program administrator

must be adequate to deal with the

complexity of the respirator program.

The AFL–CIO (Exs. 54–428, 255)

urged OSHA to add a new definition to

paragraph (b) for qualified person as

follows:

Qualified Person: This should be defined

as, someone who is capable of identifying

existing and predictable respiratory hazards

in the workplace and who maintains a

common knowledge of the respirator

standard. This individual should possess the

authority to take prompt corrective action to

eliminate hazards including the measures

required in subsection (c). The qualified

person shall be certified by the

manufacturer(s) for their ability to select and

maintain the type(s) of respirator(s) that is/

are used on the job site or possess the

experience and knowledge needed to

properly select respirators for the employees

and job situation.

Instead of adopting the AFL–CIO

definition for ‘‘qualified person,’’ OSHA

has relied on the type of wording used

in the ANSI standard, which is more

performance oriented. Specifying in

detail the type and extent of training

required for program administrators

depends upon the type of workplace

and is best left to the employer, in

OSHA’s opinion. For example, the level

of training that would be appropriate for

a workplace with limited respirator use

would be quite different from that

required at another workplace with

extensive respirator use for IDLH

atmospheres, highly toxic chemicals, or

other complex respirator use operations.

Therefore, OSHA has adopted a

definition of training and experience

that uses performance language and is

similar to the ANSI Z88.2–1992

standard’s requirement. However,

OSHA does require employers to ensure

that the level of training for the

respirator program administrator is

adequate to deal with the complexity of

the workplace.

In keeping with this approach, OSHA

has not established any one training

program, such as the NIOSH respirator

course, as the level of training program

administrators must achieve. OSHA

believes that NIOSH’s course is

excellent, and therefore more than

sufficient in most cases. However,

OSHA acknowledges commenters’

concerns that a general respirator

training course covers a broad range of

many different respirator types and

uses, and provides information that is

not tailored to any one particular

workplace (Exs. 54–220, 54–265, 54–

342, 54–435). Typical of these

comments is one by the United Parcel

Service (Ex. 54–220), which stated: ‘‘An

attempt to fashion uniform standards for

all administrators of all respiratory

programs could result in inadequate

training for administrators of

particularly sophisticated or specialized

programs and irrelevant training for

administrators of relatively simple

programs.’’ The North American

Insulation Manufacturers Association

agreed, stating (Ex. 54–342) ‘‘A

requirement that supervisors undergo a

rigid minimum training regimen, which

would require instruction on many

issues irrelevant to the supervisor’s own

situation, would be excessive and

beyond the rule’s intended objective.’’

For example, extensive training on

certain types of respirators such as

SCBAs would be inappropriate for

program administrators with simple

programs that don’t use SCBAs. In other

cases, respirator program administrators

with highly complex respirator

programs may need an even more

comprehensive course than that

provided by a general respirator training

course. Based on the above discussion,

OSHA has retained a performance-based

program approach. OSHA anticipates

that larger establishments will develop

training requirements for respirator

program administrators that fit the

needs of a workplace-specific respirator

program.

OSHA has prepared a Small Entity

Compliance Guide setting forth how a

small business owner, manager or an

employee of the small business can be

qualified to be a program administrator.

It also sets forth a sample respirator

program to guide small businesses. If

the employees of a small business are

only exposed to nuisance dusts and

relatively non-toxic chemicals and use

only a few types of relatively simple

respirators, knowledge of the guide and

materials supplied by the respirator

manufacturer may be sufficient for the

small business owner or an employee to

become qualified as a program

administrator. If more dangerous

chemicals or high exposures are present,

or sophisticated respirators are used, the

program administrator must have more

knowledge or experience. In these

circumstances, it may be necessary for

the administrator to seek out the

expertise needed or to obtain

appropriate training.

The need for a specific individual to

be in charge of the respirator program

was discussed by several commenters.

One commenter argued that requiring

that a specific person be selected as

program administrator requires the

equivalent of a full-time person to
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1195

manage the program and conduct

periodic reviews of its performance (Ex.

54–160). Motorola (Ex. 54–187) stated

that one overall program administrator

would be a problem for decentralized

workplaces. Motorola recommended

that OSHA permit a committee or

multiple employees to be responsible

for the respirator program, thus allowing

the employer to tailor the program to

meet the needs of each particular

workplace. Dow (Ex. 54–278) also

supported the use of a committee or

team with joint responsibility for the

respirator program at large sites. Duke

Power (Ex. 54–326) stated that at large

facilities, such as nuclear stations, it is

often necessary to designate more than

one program administrator to address

radiological and non-radiological use of

respirators. The Public Service Electric

and Gas Company (Ex. 54–196) said it

may be more effective to have a program

administrator for each ‘‘business unit’’

in a decentralized, diversified company,

particularly where each unit’s

respiratory protection needs are

different (Ex. 54–196). The AFL–CIO

(Ex. 54–428) wanted to have one

qualified person responsible for the

program, with a ‘‘site person’’ at each

work site, who would be responsible for

the program at that site, but who would

report to the qualified person. The

Department of Defense (Ex. 54–443),

specifically the Navy, urged OSHA to

add language to require that each

‘‘activity’’ designate a person

responsible for the respiratory

protection program because a single

program administrator would be a

potential problem for a large, multitiered employer with activities

throughout the world, such as the Navy.

The final standard continues to

require that a person qualified by

training or experience be designated to

be responsible for the overall

management and administration of the

program to ensure that the integrity of

the respiratory protection program is

maintained through the continuous

oversight of one responsible individual.

The program administrator may serve

largely in an oversight and coordination

role between the various subunits or

departments that perform duties in

support of the respiratory program.

Regardless of the number of subunits,

each employer must ensure that all

subunits report to one overall program

administrator for coordination of the

program. The program administrator can

use the assistance of industrial

hygienists, safety professionals, or other

respirator experts to help run the

respirator program. The program

administrator can work with a

committee or assign responsibility for

portions of the program to other

personnel, but the overall responsibility

for the operation of the program must

remain with the designated program

administrator. This approach promotes

coordination of all facets of the program.

For large companies or multiple

worksites, the program administrator

can delegate to a qualified person the

responsibility for the day-to-day

operation of the program at a specific

site or for a specific activity. However,

coordination between different

worksites is an important aspect of the

operation of a good program; therefore,

ensuring implementation of the overall

respirator program remains the duty and

responsibility of the program

administrator. For small and moderate

sized employers, OSHA believes that

the duties of a program administrator

will require only a small part of one

employee’s time.

Paragraph (c)(4) of the final rule

requires employers to provide

respirators at no cost to the employee.

This was included in the proposal in

paragraph (d)(1) and has been moved to

paragraph (c) of this final standard. This

provision reflects OSHA’s strong

orientation that the costs of complying

with safety and health requirements

must be borne by the employer. OSHA

has a long-standing policy that

employers are obligated to provide and

pay for necessary personal protective

equipment (PPE) such as respirators

used by employees on the job. A

compliance memorandum of October

18, 1994, titled ‘‘Employer Obligation to

Pay for Personal Protective Equipment’’

provides detailed guidance on this

issue. It is available online on the

Internet on OSHA’s home page at

http://www.OSHA.gov. The inclusion of

this provision is consistent with recent

OSHA standards, e.g., Cadmium, 29

CFR § 1910.1027; 1,3-Butadiene, 29 CFR

1910.1051; and Methylene Chloride, 29

CFR 1910.1052.

OSHA is aware that the Occupational

Safety and Health Review Commission

has not always agreed with the Agency

that standards requiring an employer to

‘‘provide’’ safety or health equipment

also require the employer to pay for that

equipment. See, e.g., Union Tank Car

Co., OSHRC No. 96–0563 (October 16,

1997). OSHA believes the Commission

is wrong about this issue. OSHA intends

the language ‘‘at no cost to the

employee’’ in paragraph (c)(4) to make

the employer’s obligation to pay for the

respiratory protection required by this

standard crystal clear.

The requirement that the employer

bear the costs of employee training and

medical evaluations has also been

moved to paragraph (c)(4) of the final

rule, in order to consolidate all similar

provisions of the standard that clarify

that, for these provisions, there is no

cost to the employee. Section 6(b)(7) of

the OSH Act requires that employers

provide medical exams and evaluations

at no cost to employees.

Paragraph (d)—Selection of Respirators

Overview

Paragraph (d) of the final rule

contains respirator selection criteria and

requirements. OSHA has included these

provisions in the final rule because the

record contains many examples of

workers using respirators that are

inappropriate for the type of respiratory

hazards present (e.g., wearing paper

dust masks where the exposure is to a

gas or vapor contaminant (UAW, Ex.

54–387); using half facepiece respirators

in acrylonitrile IDLH atmospheres of 20

ppm (International Chemical Workers

Union (ICWU), Ex. 54–427)). In

addition, OSHA’s long enforcement

experience has shown that employers

often lack the information necessary to

make informed choices about respirator

selection. OSHA stated in the proposal

(59 FR 58899) that a major deficiency of

the previous standard is that it did not

contain selection criteria; instead, it

merely referred employers to the ANSI

Z88.2–1969 standard.

No participant in this rulemaking

disagreed with OSHA’s decision that the

final standard should include

mandatory selection criteria. The record

does show, however, that there are

differences of opinion about how

restrictive and comprehensive the

required criteria should be, and how

much flexibility should be left to

employers in the selection process. For

example, the Association of American

Railroads (Ex. 54–286) stated that the

details of respirator selection should be

left to the regulated community and that

OSHA should only specify the outcome

desired, while the Service Employees

International Union (SEIU) (Ex. 54–455)

commented that OSHA should

‘‘strengthen the wording to make it clear

employers must obtain and account for

all of the factors listed.’’ OSHA believes

that those employers who employ onsite occupational health professionals

generally have the expertise to select

respirators that are appropriate for their

workers. The record contains a number

of examples of well-thought-out

selection programs (e.g., Exs. 142, 155,

163). These examples show that the

current practice of many employers

already conforms to the selection

requirements of paragraph (d). For other

employers, however, clearly stated
1196 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

respirator selection rules and guidance

are required.

OSHA notes that advice on the

selection of respirators is available from

many sources. NIOSH has developed a

respirator decision logic, widely

available and used since 1987, which

provides a schematic selection guide

covering all critical areas of respirator

selection (Ex. 9). The selection guide for

the ANSI Z88.2–1969 respirator

standard was incorporated by reference

into the previous OSHA standard, and

the 1992 Z88.2 ANSI standard contains

updated and comprehensive

recommendations on respirator

selection. OSHA believes that

employers will find useful information

in each of these guides on various

technical problems that this standard

may not cover explicitly. In addition,

information is provided by respirator

manufacturers who publish selection

guides relating to their models (See, e.g.,

Mine Safety Appliances Company

(MSA) Respirator Selection Guide, Ex.

150; and ISEA’s Respirator Buyers

Guide and Safety Video Resource List,

referenced in Ex. 147). Manufacturers

also provide selection advice through

telephone help lines, sales staff, verbal

communications or distribution of

company product information, and onsite evaluations of product use (See, e.g.,

Tr. at 1438–1439). Chemical

manufacturers also provide information

about respirator selection to help the

purchasers of their products (See CMA,

Tr. 1726–7; Union Carbide Corporation,

Ex. 54–255).

Because of the variety and detail of

selection information available, OSHA

believes it is necessary in the final rule

to specify broad performance criteria, in

addition to a few specific rules relating

to highly hazardous operations (i.e.,

IDLH situations). The final rule sets

forth general rules for selecting

respirators for routine operations,

prescribes specific kinds of respirators

for identified highly hazardous

atmospheres and emergency situations,

and specifies when air-purifying

respirators can reliably be used. OSHA

chose not to specify in the regulatory

text all the situations and respiratorrelated factors that an employer should

consider but instead to state

performance objectives. Only for

workplace situations widely accepted as

highly hazardous, such as those

associated with IDLH atmospheres, does

the standard require maximally

protective respirators.

Because paragraph (d) does not

address in detail all the relevant factors

that may affect employers’ selection of

particular respirators, employers should

rely on other information sources to

ensure that the respirators they select

are appropriate for conditions in their

specific workplaces. Respirator

manufacturers are the source of much

useful information, and the record of

this rulemaking indicates that much of

this information is both helpful and

reliable. Indeed, market mechanisms

work to encourage the dissemination of

accurate information. OSHA expects

that smaller employers will thus

generally be able to rely on the technical

assistance provided by manufacturers

on respirator selection and that doing so

will mean that they will usually be in

compliance with this standard. For

these reasons, paragraph (d)

concentrates on the minimum selection

criteria that the record shows must be

adhered to by all employers when

selecting respirators for their employees’

use.

In the following provision-byprovision summary and explanation,

OSHA explains the changes reflected in

the final rule, both from the provisions

proposed and those in the Agency’s

previous respiratory protection standard

(§ 1910.134).

Paragraph (d)(1)—General Requirements

Paragraph (d)(1) prescribes general

rules that apply to the selection of all

respirators. Paragraph (d)(1)(i) requires

the employer to select and provide an

appropriate respirator based on the

respiratory hazard(s) to which the

worker is or will be exposed and on the

workplace and user factors that have the

potential to affect respirator

performance and reliability. This

provision continues a requirement from

the previous standard: (‘‘respirators

shall be selected on the basis of hazards

to which the worker is exposed’’

(§ 1910.134(b)(2)) and clarifies that the

hazard must be viewed in the context of

the workplace and worker conditions

that may reduce or impair the

effectiveness of a respirator otherwise

appropriate for the hazard. There is

general agreement that taking working

conditions into account is crucial to

proper respirator selection: a respirator

that is protective under some conditions

of wear will fail under others, while a

respirator that is appropriate for a given

hazard may not be workable in a

particular workplace (e.g., an air

supplied respirator in a tightly

configured space). For example, a

worker wearing SCBA who is required

to perform extremely heavy work may

deplete the air supply of the respirator

well before its calculated service life is

reached. This means that the employer

must evaluate the employee’s level of

exertion in order to determine whether

to choose a supplied-air respirator

rather than a SCBA. The recent ANSI

standard also states that the purpose of

respirator selection is to determine

which respirator type or class will offer

‘‘adequate protection’’ (ANSI Z88.2–

1992).

Final paragraph (d)(1)(i) also requires

employers to consider workplace and

user factors that may affect the

respirator’s performance and reliability

when making a respirator selection.

Although other paragraphs of the

standard address the major factors

affecting respirator performance, i.e., fit,

faceseal leakage, and maintenance and

cleaning, factors specific to the job, user,

or worksite often play an important role

in respirator performance. OSHA noted

in the proposal (59 FR 58900) that work

activities and factors such as

temperature and humidity ‘‘also affect

the stress level associated with wearing

a respirator as well as the effectiveness

of respirator filters and cartridges;

employees using respirators for longer

periods of time [under such stressful

conditions] may need different types of

respirators for more comfortable wear.’’

Similarly, where the respiratorwearing employee must communicate

with other workers, perhaps to warn

them about the presence of workplace

hazards, the respirator must allow the

employee to perform this vital function.

OSHA thus agrees with ANSI that ‘‘it is

important to ensure that respirator

wearers can comfortably communicate

when necessary, because a worker who

is speaking very loudly or yelling may

cause a facepiece seal leak, and the

worker may be tempted to temporarily

dislodge the device to communicate’’

(ANSI Z88.2–1992, clause A.13).

Therefore, for example, the employer

must ensure that speaking will not

interfere with the fit of the negativepressure elastomeric respirator selected.

If the employees are using PAPRs or

SCBA, amplification devices, including

speaking diaphragms and microphones,

that can be worn with the respirators are

available.

The proposal (59 FR 58900) noted

another example in the proposal of

worksite conditions that could affect

respirator selection: ‘‘* * * airline

respirators should not be used by

mobile employees around moving

machinery unless entanglement of

airlines in equipment is easily avoided.’’

Employers have always been required

by OSHA to consider such factors as

these, because paragraph (a)(2) of the

previous respirator standard required

employers to select respirators that are

‘‘applicable and suitable for the purpose

intended.’’

Paragraph (d)(1)(i) applies whenever

employers provide respirators to their
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1197

employees and require their use,

whether or not an OSHA standard

mandates respirator use in the particular

environment. The preamble discussion

relating to paragraph (c)(1) discusses

employer-required respirator use in

more detail and explains OSHA’s

reasons for reaching this conclusion.

Paragraph (d)(1)(ii) requires the

employer to select a NIOSH-certified

respirator and to use the respirator only

in ways that comply with the conditions

of its certification. There was little

controversy about this requirement, and

there is no disagreement that respirators

must be tested and found to be effective

before they can be marketed. NIOSH has

performed this function in the past and

has begun to revise its certification

requirements to ensure that its

procedures continue to define the

performance capabilities of acceptable

respirator models, and to identify

unacceptable models. The ISEA (Ex. 65–

363), the trade association that

represents most major respirator

manufacturers, urged OSHA to require

that only NIOSH-certified respirators be

used to comply with this standard, and

other commenters agreed (Exs. 54–187,

54–213, 54–387, 54–428).

The wording of this provision of the

final rule differs slightly from that of the

proposed provision. The proposal

would have required that only NIOSH

‘‘approved and certified’’ respirators be

selected. For clarity, the reference to

NIOSH-approved respirators has been

replaced in the final rule by a

requirement that respirators be used

only in accordance with the conditions

of their certification. NIOSH approves

respirators by certifying them; however,

some certifications contain conditions

limiting the situations in which the

respirator may be used. This is

sometimes described as NIOSH

‘‘approval’’ of the respirator for a

particular use.

Increasingly, however, NIOSH does

not certify respirators for specific uses.

For example, NIOSH does not currently

certify respirators for use against

biological hazards. Where NIOSH has

not specifically certified any respirator

for use against the particular

contaminant present in the workplace,

the employer must select a NIOSHcertified respirator that has no

limitation prohibiting its use against

that contaminant. The respirator must

be appropriate for the contaminant’s

physical form and chemical state and

the conditions under which it will be

used. All respirators must be chosen

and used according to the limitations of

the NIOSH certification, which appears

on the NIOSH certification label.

The requirement for NIOSH

certification is unconditional in the

final standard, as it was in the proposal.

However, because OSHA stated in the

proposed preamble that this

requirement would apply only when

such respirators ‘‘exist’’ (59 FR 58901),

some commenters urged OSHA to state

in the regulatory text that the

requirement for NIOSH certification

applied only to existing certifications

(See, e.g., Ex. 54–434). For example, the

Department of the Army (Ex. 54–443)

urged OSHA to permit the use of

respirators not approved by NIOSH in

situations where another authority has

jurisdiction and the documentation to

attest to the adequacy of the respirator’s

effectiveness against the contaminant of

concern. The Army (Ex. 54–443D) stated

that its employees and contractors may

be exposed to certain ‘‘military unique

contaminants’’ for which no NIOSHapproved respirator exists but for which

military respirators, e.g., gas masks,

have specifically been developed and

tested and are being used by civilian

and contractor personnel in operations

subject to OSHA’s jurisdiction. The

Army urged OSHA to include in the

standard ‘‘approval authority of the

Secretary of the Army for military

respirators * * * for which no NIOSH

approved respirator exists’’ (Ex. 54–

443D).

OSHA recognizes that there are

unique contaminant situations, such as

those involving chemical warfare

agents, that involve primarily military

exposure and that may require

specialized respiratory protection

equipment. NIOSH certification for

respiratory protection specific to such

hazards does not exist and is not likely

to be forthcoming. OSHA also notes,

however, that, although the Department

of the Army argued strongly for OSHA

recognition of Army authority to test

and approve respirators, the Department

of the Air Force commented that it uses

only NIOSH-certified respirators, and

requested no exception (Ex. 54–443A).

OSHA will examine on a case-by-case

basis those situations involving civilian

contractors whose employees wear nonNIOSH tested respirators that they

believe protect employees adequately

and that have been tested and approved

by other Federal agencies for use against

unique contaminants.

A similar comment was raised by

DOE regarding radioactive hazards (Ex.

54–215). DOE stated that, in the nuclear

industry, no NIOSH-certified respirator

exists for tritium applications and

workers therefore must wear nonapproved supplied-air suits; this

equipment has been tested by Los

Alamos National Laboratory, and the

suits have been successfully used for

many years. The DOE administers its

own job-by-job approval system for

these suits. OSHA’s authority to enforce

the Agency’s safety and health

standards at gaseous diffusion plants

owned by DOE and leased to the United

States Enrichment Corporation was

established legislatively in 1992, and

OSHA has recently completed a

memorandum of understanding with

DOE on this issue (60 FR 9949, Jan. 31,

1995). OSHA is currently evaluating an

application from one of these facilities

for a variance relating to these suits. The

criteria set out in Section 6(d) of the

OSH Act will govern this determination.

OSHA is not determining the

acceptability of supplied-air suits as

part of this rulemaking proceeding,

because the Agency believes the

variance proceeding, which can focus

closer attention on the strengths and

limitations of these suits for the

particular use situations, is the

appropriate forum to decide this issue.

OSHA notes that NIOSH certification

is a minimum qualification. The

employer must still assess whether the

respirator meets all other selection

criteria in this standard before it can be

chosen for a particular application. For

example, as pointed out by an exchange

with Richard Duffy of the International

Association of Fire Fighters (IAFF),

NIOSH representatives acknowledged

that the employer must evaluate

whether NIOSH-certified equipment

will withstand the specific

environmental conditions for

firefighting because NIOSH flow rate

requirements do not consider the

stresses involved in firefighting, nor

does NIOSH currently evaluate

respirators for their ability to withstand

those stresses (Tr. 364–365).

In his testimony at the OSHA

hearings, Richard Duffy of the IAFF

recommended that OSHA require that

SCBAs used in firefighting meet the

requirements of the National Fire

Protection Association’s NFPA–1981

Standard on Open Circuit Breathing

Apparatus (Tr. 455). This NFPA

standard establishes more stringent

performance criteria for SCBAs used in

firefighting than those currently used by

NIOSH. NIOSH recognizes that its

current 42 CFR 84 respirator

certification standards may not be

protective enough for respirators used in

firefighting. In an October 7, 1997 letter

to all manufacturers and interested

parties, NIOSH announced its intent to

develop new technical modules to

update 42 CFR 84. One of the proposed

technical modules to which NIOSH

intends to give priority treatment will

address SCBAs, including the
1198 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

incorporation of NFPA performance

requirements for SCBAs. NIOSH also

intends to propose an Administrative/

Quality Assurance module on the use of

independent testing laboratories in the

certification program, another issue

raised by commenters in this

proceeding. OSHA believes that NIOSH

will resolve any deficiencies in its

current respirator certification standards

through these new 42 CFR 84

rulemaking modules. OSHA simply is

not equipped to take on the respirator

approval and certification process

currently performed by NIOSH.

Therefore, the final OSHA respirator

standard continues to require the use of

NIOSH-certified respirators and does

not incorporate the NFPA performance

requirements for SCBAs.

OSHA believes that carving out even

limited exceptions to NIOSH control of

respirator certification authority would

confuse the regulated community and

would not resolve the needs of the vast

majority of respirator users. Comments

by respirator users and worker

representatives support OSHA’s final

decision (See, e.g., Exs. 54–265, 54–118,

54–213, 54–387, 54–455). The final rule,

in paragraph (h), also requires that when

respirator parts are replaced or changed,

the replacement parts must be NIOSH

certified.

In the proposal (59 FR 58901), OSHA

stated that developing an OSHA

respirator approval mechanism to fill in

the gaps in NIOSH certification would

not be an efficient use of government

resources. Nonetheless, the Agency

asked for comment on this issue. There

was no consensus among the

participants who commented on this

point. Some commenters supported an

OSHA role in approval on a temporary

basis, while an employer waits for

NIOSH approval, or an alternative

governmental approval process (Exs.

54–213, 54–346, 54–443). Still others

opposed OSHA’s involvement in an

approval process (Exs. 54–278, 54–265,

54–118, 54–213, 54–387, 54–455). The

final rule is therefore similar to the

proposal, which also discussed limited

alternatives to NIOSH certification and

concluded that ‘‘it is inappropriate for

OSHA to try to correct problems with

present NIOSH/MSHA regulations in

the revised respirator standard’’ (59 FR

58891).

OSHA believes that NIOSH has

focused on closing any gaps in its

certification program. NIOSH’s ability

and experience in this area are

unparalleled, and OSHA believes that

NIOSH can best resolve any concerns

through its own proceedings. Further, as

stated in the proposal, OSHA lacks the

resources to perform respirator testing.

OSHA will, however, continue to

evaluate, on a case-by-case basis,

whether variance or compliance

interpretations are appropriate in cases

where employers claim that there are no

NIOSH-certified respirators for use in a

particular situation.

Paragraph (d)(1)(iii) of the final rule

requires the employer to identify and

evaluate the respiratory hazard(s) in the

workplace. To perform this evaluation,

the employer must make a ‘‘reasonable

estimate’’ of the employee exposures

anticipated to occur as a result of those

hazards, including those likely to be

encountered in reasonably foreseeable

emergency situations, and must also

identify the physical state and chemical

form of such contaminant(s). Where

conditions are such that the employer

cannot carry out such an evaluation,

e.g., where exposure monitoring or other

means of estimation cannot be used,

paragraph (d)(1)(iii) requires the

employer to treat the atmosphere as

IDLH. Many of the components of

paragraph (d)(1)(iii) of the final standard

have been required practice since 1971

because they were included in the

selection provisions of the 1969 ANSI

standard incorporated by reference into

OSHA’s previous respiratory protection

standard. Paragraph (d)(1)(iii) of the

new standard makes these provisions

clearer by stating them explicitly in the

regulatory text.

Identifying and evaluating the hazards

a respirator is to provide protection

against clearly play a pivotal role in

respirator selection. For example,

according to ANSI, ‘‘Respirator selection

involves reviewing each operation to

* * * determine what hazards may be

present (hazard determination)’’ (ANSI

Z88.2–1992, clause 7.2.2; See also AISI,

Tr. 639). Many other commenters

emphasized the important role of hazard

identification in respirator selection

(Exs. 54–168, 54–181, 54–186, 54–208,

54–234, 54–273, 54–307, 54–327, 54–

346, 54–426, 54–428). Once an

employer identifies the nature of the

respiratory hazard or hazards present,

the employer must evaluate the

magnitude of the hazard to determine

the potential exposure of each employee

and the extent to which respirators of

various types can reduce the harm

caused by that exposure.

There was extensive comment on the

selection process outlined in the

proposed paragraph dealing with hazard

evaluation (Exs. 54–154, 54–168, 54–

181, 54–202, 54–219, 54–245, 54–278,

54–428). Commenters representing

workers generally supported the

detailed approach taken in the proposal

toward hazard evaluation. For example,

the Service Employees International

Union ‘‘support[ed] the detailed list of

factors to be considered in respirator

selection * * * [which] successfully

incorporates the important framework

from the NIOSH decision logic criteria

in an easy-to-understand form’’ (Ex. 54–

428).

Some commenters, however (Exs. 54–

154, 54–168, 54–181, 54–219, 54–245,

54–278), stated that the scope and depth

of the hazard evaluation and the items

to be covered should be left to the

discretion of the employer. For example,

the Eastman Chemical Company (Ex.

54–245) and the Dow Chemical

Company (Ex. 54–278) requested that

OSHA make the requirement

‘‘performance oriented’’ and ‘‘flexible’’;

the Department of the Navy, Portsmouth

Naval Shipyard (Ex. 54–154), noted that

detailed analysis for each work situation

is not necessary for shipbuilding, and

that the timing and content of an

appropriate evaluation vary.

In response to these comments, OSHA

has revised paragraph (d)(1)(iii) to be

more performance oriented; this

provision of the final standard no longer

specifies precisely how employers are to

conduct the required evaluation. The

proposal (at paragraph (d)(3)) would

have required employers to ‘‘obtain and

evaluate’’ information on eleven specific

factors for each work situation. These

proposed factors were the nature of the

hazard; its physical and chemical

properties; its adverse health effects; the

occupational exposure level; the results

of workplace sampling; the work

operation; the time period of respirator

wear; the work activities and stresses on

the wearer; fit test results; warning

properties; and the capabilities and

limitations of respirator types. Although

OSHA continues to believe that each of

these factors is relevant to respirator

selection under some circumstances, a

review of the record has convinced

OSHA that each factor is not crucial in

every respirator selection process and

that the proposed requirement would

have led to needless duplication of

effort and unnecessarily detailed

evaluations.

The Oil, Chemical and Atomic

Workers International Union (OCAW)

(Ex. 54–202) urged OSHA to require a

written hazard assessment each time

that a respirator was selected. Paragraph

(d)(1)(iii) of the final rule does not

require a written assessment; this was

not proposed, and OSHA believes that

employers should be free to adopt the

best approach for justifying their

respirator selections, based on the

hazard assessment. The final rule

requires the employer to identify and

evaluate the respiratory hazards present,

determine their physical state and
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1199

chemical form (e.g., whether they are

present in the form of a gas or vapor;

what their valence state or condition is,

where relevant), and assess the

magnitude of the hazard they present to

workers under normal conditions of use

and in reasonably foreseeable

emergency conditions.

OSHA finds that it is essential for

employers to characterize the nature

and magnitude of employee exposures

to respiratory hazards before selecting

respiratory protection equipment. The

language contained in paragraph

(d)(1)(iii) of the final rule does not

specify how the employer is to make

reasonable estimates of employee

exposures for the purposes of selecting

respirators, nor does the standard

require the employer to measure worker

exposures to airborne hazards. OSHA

has always considered personal

exposure monitoring the ‘‘gold

standard’’ for determining employee

exposures because this is the most

reliable approach for assessing how

much and what type of respiratory

protection is required in a given

circumstance. This general view is also

shared by the industrial hygiene

community. All of OSHA’s

comprehensive substance-specific

health standards have required

employee exposure monitoring to

determine both the effectiveness of

existing control measures and the type

of respiratory protection needed.

OSHA continues to hold this view

with regard to assessing employee

exposure in connection with this

respiratory protection standard.

However, OSHA recognizes that there

are many instances in which it may not

be possible or necessary to take personal

exposure measurements to determine

whether respiratory protection is

needed. Although sampling and

analytical methods exist for the vast

majority of substances for which OSHA

has a PEL (29 CFR 1910.1000), there are

numerous other substances for which

there are no readily available methods

for personal sampling. In other cases,

the nature of the materials and products

being used in the workplace, and the

way in which they are used, make it

highly unlikely that an employee

working with them would be exposed in

a manner that would make respiratory

protection necessary. In these kinds of

situations, the final rule permits

employers to use other approaches for

estimating worker exposures to

respiratory hazards.

For example, employers may rely on

information and data that indicate that

use or handling of a product or material

cannot, under worst-case conditions,

release concentrations of a respiratory

hazard above a level that would trigger

the need for respirator use or require use

of a more protective respirator. This

approach is similar to that used in

several OSHA substance-specific health

standards, which permit employers to

use objective data in lieu of exposure

monitoring to demonstrate that their

employees cannot be exposed above an

action level (See, for example, 29 CFR

1910.1027, Cadmium; 1910.1048,

Formaldehyde; 1910.1047, Ethylene

Oxide; 1910.1028, Benzene). Objective

data can be obtained from an industry

study or from laboratory test results

conducted by manufacturers of products

or materials being used in the

workplace. To generalize from data in

an industry-wide survey to conditions

in a specific workplace, the survey must

have obtained data under conditions

closely resembling the processes, types

of materials, control methods, work

practices, and environmental conditions

in the workplace to which it will be

generalized, i.e., the employer’s

operation.

Data from industry-wide surveys by

trade associations for use by their

members, as well as from stewardship

programs operated by manufacturers for

their customers, are often useful in

assisting employers, particularly smallbusiness owners, to obtain information

on employee exposures in their

workplaces. For example,

representatives of the North American

Insulation Manufacturer’s Association

(NAIMA) testified (Tr. 597) that * * *

‘‘[w]e have conducted numerous

surveys on end use customers,

conducted research with Johns Hopkins

University, for example to provide

estimates of routine exposures and

* * * those data, when collected

appropriately and with organized labor

and with other industry groups, * * *

can assure that the right respirator is

selected.’’ NAIMA stated (Tr. 616, 618),

‘‘it is ultimately the employer’s

responsibility’’ to evaluate whether data

provided by suppliers or others relate to

their workplace conditions and

operations. However, it is clear that

such programs can often assist

employers to estimate workplace

exposures reliably enough to make

correct respirator choices without the

need for employee monitoring.

Another approach that can be used by

employers to estimate employee

exposures involves using mathematical

approaches and obtainable information.

Employers can use data on the physical

and chemical properties of air

contaminants, combined with

information on room dimensions, air

exchange rates, contaminant release

rates, and other pertinent data,

including exposure patterns and work

practices, to estimate the maximum

exposure that could be anticipated in

the workplace. Methods that utilize this

approach are readily available in several

textbook sources; for example, the

ACGIH Industrial Ventilation Manual

contains calculations that can be

applied to certain situations to estimate

worker exposures. Relying on such an

approach to estimate exposures requires

the use of safety factors to account for

uneven dispersion of the contaminant in

the air and the proximity of the worker

to the emission source. Usually, this

approach works best in situations where

employees use small amounts of a

chemical product intermittently, or

where contaminant releases are fairly

constant and predictable. This approach

must be used continuously, and the data

obtained should therefore be interpreted

conservatively (i.e., should err on the

side of worker protection).

In workplaces involving many

complex factors, the use of estimation

techniques to characterize worker

exposure is associated with a high

degree of uncertainty. In these

instances, OSHA recommends that

employers conduct exposure monitoring

instead of relying on estimation

techniques because they will then be

able to have confidence that the

appropriate respiratory protection

device has been selected and that they

are in compliance with the standard.

Furthermore, OSHA believes that in

workplaces where many complex

factors add uncertainty to exposure

estimates obtained through modeling,

employers will find it easier and less

costly to conduct personal exposure

monitoring to evaluate the need for

respiratory protection.

Many commenters urged OSHA not to

specifically require monitoring in the

standard because other means of

assessing potential exposures are

available (Exs. 54–153, 54–208, 54–219,

54–237, 54–273, 54–307, 54–327, 54–

443). These participants asked the

Agency instead to adopt the approach

taken in the ANSI standard Z88.2–1992,

clause 7.2.2.1(e), which allows

employers to estimate, as well as

measure, exposures in the workplace.

One commenter questioned the utility of

exposure monitoring data for respirator

selection because exposure sampling

provides only a ‘‘snapshot’’ of hazards

on any given day (Ex. 54–178). Other

commenters disagreed, however. For

example, Scott Schneider (Tr. 1520) of

the AFL–CIO stated, ‘‘In most

workplaces that I’ve been in there really

is very, very little exposure data to

know how much a person is exposed to

* * * exposures are quite variable from
1200 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

day to day. And from worker to

worker.’’ (See comments to same effect

by OCAW, Ex. 54–202.) Some

participants specifically asked OSHA to

make workplace sampling of airborne

concentrations of contaminants explicit

(Tr. 1009 and Ex. 54–428; Ex. 54–427).

That some exposure monitoring

results may be inadequate begs the

question of whether adequate

monitoring should be conducted.

OSHA’s experience in enforcing

permissible exposure limits in the Air

Contaminant standard, 29 CFR

1910.1000, and for substance-specific

standards, confirms that, unless

operations are highly repetitive,

conditions are constant, and estimates

based on ‘‘historical’’ and ‘‘objective

data’’ are made by experienced

industrial hygiene professionals, most

employers need exposure monitoring

results to estimate employee exposure

levels reliably. OSHA enforcement

experience also demonstrates that,

where exposures are highly variable,

fragmentary monitoring results may

mislead employees and employers,

unless they are based on competent

sampling strategies. The frequency and

duration of monitoring, the

representativeness of the employees and

operations sampled, and the skill with

which sampling and analysis are

performed all influence the reliability of

monitoring results. In making

reasonable estimates of employee

exposures to satisfy the requirements

contained in paragraph (d)(1)(iii), OSHA

expects employers to account for

potential variation in exposure and to

rely on data or information that reflect

such variation. This is accomplished by

using exposure data collected with a

strategy that recognizes exposure

variability, or by using worst-case

assumptions and estimation techniques

to evaluate the highest foreseeable levels

to which employees may be exposed.

The hazard assessment requirements in

final paragraph (d)(1)(iii) carry over

from the requirement of the previous

standard, which incorporates by

reference the ANSI Z88.2–1969 (clause

6.2) statement that ‘‘[a]ny erring in the

selection of respirators shall be on the

safe side.’’

Paragraph (d)(1)(iii) also requires an

employer to consider the environment

IDLH if employee exposures cannot be

estimated reasonably. This provision is

intended to address those limited

situations where neither exposure

monitoring, professional judgment, nor

estimation techniques can be relied on

to reliably select adequate respiratory

protection equipment. This provision

reflects a similar one in the 1992 ANSI

standard, which requires atmospheres to

be considered IDLH if it is not possible

‘‘to determine what potentially

hazardous contaminants may be present

* * * or if no exposure limit or

guideline is available, and estimates of

toxicity cannot be made’’ (ANSI Z88.2–

1992, clause 7.2.2.2 (b)(c)).

Several commenters (Exs. 54–381, 54–

352, 54–267) objected to OSHA’s

proposed requirement that atmospheres

be considered IDLH ‘‘where the

concentration of the hazardous chemical

is unknown’’ (59 FR 58939), and stated

that it would be neither practical nor

necessary to wear positive pressure

respirators in all such situations (Ex.

54–352). One commenter believed that

requiring the most protective respirators

for ‘‘every unknown hazardous

chemical atmosphere’’ would result in

95 percent of the workforce being

required to use them (Ex. 54–267).

OSHA did not intend the absence of

workplace-specific exposure

measurements automatically to trigger

selection of the most protective

respirator; instead, the Agency intends

employers to use such equipment when

they do not have confidence that a less

protective respirator is sufficient. An

example of the kind of situation that

should trigger the use of the most

protective respirator was provided by a

representative of CMA, who testified

(Tr. at 1707) that, when a maintenance

person opens a closed cycle

manufacturing process to work on it for

the first time, ‘‘we don’t know what the

air concentration is so we put people in

supplied-air respiratory protection

under those circumstances.’’ That is, the

company in this case assumes that

exposures will be extremely high and

selects a respirator accordingly. OSHA

believes that the language used in

paragraph (d)(1)(iii) of the final rule

makes OSHA’s intent clear, i.e., that

when reliable data or reasonable

estimates of exposure are not available,

the atmosphere must be considered

IDLH.

Finally, a few participants suggested

that exposure estimates should only be

made by credentialed individuals (See,

e.g., Ex. 54–327). OSHA agrees that

persons trained and experienced in

evaluating the respiratory hazards posed

by workplace atmospheres are the most

competent to evaluate exposure levels,

especially in the absence of current

exposure measurements. ANSI defines

an ‘‘occupational health professional’’

as ‘‘(a)n individual whom, by

experience and education, is competent

at recognizing, evaluating, and

controlling health hazards in the

workplace’’ (ANSI Z88.2–1992, clause

3.39). This is the person who is

responsible for performing expert

evaluations under ANSI’s recommended

standard. OSHA believes that this

definition has merit, and that employers

whose workplaces have highly toxic

respiratory hazards, or many different

hazardous chemicals or mixtures, as

well as other employers with the

resources to do so, should utilize such

professionals wherever possible.

However, OSHA is not specifically

including this requirement in the final

rule because reasonable estimations can

be conducted in many workplaces by

persons with the qualifications required

in the final rule for the respiratory

protection program administrator.

Paragraph (d)(1)(iv) requires that the

employer choose respirators from a

sufficient number of respirator models

and sizes so that the respirator is

acceptable to and correctly fits the

wearer. The 1992 ANSI standard

includes a similar requirement aimed at

achieving satisfactory fit and wearer

acceptance (Z88.2–1992, clause 9.3.1.

and 9.3.2.). This provision of the final

standard revises the corresponding

proposed provision, which would have

required employers to provide for fit

testing an array of three sizes and two

brands of respirators with elastomeric

facepieces. The dual intent of this

provision was to assure that wearer

acceptability plays a role in respirator

selection, and that the respirators

chosen maintain their fit over the period

of use.

OSHA continues to believe that these

goals for respirator selection are

appropriate. However, OSHA was

persuaded by this record that specifying

the number of sizes, models and brands

that an employer must provide is

unnecessary. Therefore, the final

provision deletes the specification

language for the number of sizes,

models and brands that must constitute

the selection pool. Since this provision

of the final standard applies to all

respirators, the proposal’s application

only to ‘‘elastomeric’’ facepieces has

been dropped.

Most participants (Exs. 54–1, 54–5,

54–75, 54–80, 54–91, 54–161, 54–208,

54–214, 54–237, 54–238, 54–246, 54–

263, 54–273, 54–280, 54–291, 54–287,

54–350, 54–363, 54–389) endorsed the

inclusion in the final rule of a

performance-based provision addressing

the selection of comfortably fitting

respirators. Thus, most comment on this

issue recognized that a sufficient

assortment of respirators must be

provided so that employees will obtain

acceptable fits, but that more flexibility

should be provided in the final rule.

Commenters also stated that, in some

cases, a single manufacturer has a

variety of respirator models sufficient to
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1201

provide acceptable fit for their

employees (Exs. 54–389, 54–150, 54–

161), although others provided only one

or two sizes of a particular model (Exs.

54–139, 54–38, 54–22, 54–163, 54–196).

Some rulemaking commenters stated

that mandating that respirators from two

manufacturers be available would be

costly and burdensome for small

employers (Exs. 54–161, 54–295), would

not provide any tangible improvement

in the respirator program (Ex. 54–154),

and would complicate training and

inventory functions (Ex. 54–156).

In the case of SCBAs, participants

pointed out that buying and storing two

brands for fitting would be extremely

costly, would create congested storage

areas, and would pose the risk that parts

could inadvertently be interchanged

(Exs. 54–208, 54–209, 54–214, 54–250,

54–300, 54–233, 54–331, 54–348, 54–45,

54–458). Even the AFL–CIO, which

generally supported the requirement

that employers have respirators from

different manufacturers available, stated

that requiring a multi-manufacturer

assortment was not feasible for SCBAs

(Ex. 54–428).

OSHA concludes that providing a

wide selection of sizes and models of

respirators will improve both fit and

acceptability, and most commenters

agreed. In light of the comments,

however, OSHA is making the final

rule’s provision more performanceoriented, and is not requiring a specific

number of types and sizes. As ANSI

noted, larger employers are more likely

to need a larger variety of respirators to

fit their employee population (Tr. 1426).

Concomitantly, this change will reduce

the burden on smaller employers who

will not need to maintain such a wide

array of respirator choices. OSHA

believes therefore that employers are in

the best position to determine whether

their employee population is so diverse

as to require the availability of

respirators from more than one

manufacturer. OSHA encourages

employers to offer employees as wide a

choice as practical when performing fit

tests.

In addition to the general requirement

of assuring that employers consider

employee acceptability, some

commenters requested that OSHA

require employers to offer PAPRs to

employees ‘‘who wear respirators for

long periods of time.’’ These

commenters stated that PAPRs are

cooler, more comfortable, and offer less

breathing resistance than negative

pressure respirators (Exs. 54–387, 54–

23). OSHA has included such

provisions in various substance-specific

standards based on evidence in those

records that proper respirator use is

likely to be increased if more

comfortable respirators are available

(See, e.g., Ex. 330 in Docket H–033C,

Asbestos in Construction standard,

discussed at 51 FR 22719, June 20,

1986). For example, OSHA stated in the

preamble to the Lead standard (43 FR at

52933, Nov. 14, 1978) that ‘‘PAPRs

provide greater protection to

individuals, especially those who

cannot obtain a good face fit on a

negative pressure respirator, and will

provide greater comfort when a

respirator needs to be worn for long

periods of time. OSHA believes

employees will have a greater incentive

to wear respirators if discomfort is

minimized.’’

OSHA continues to believe that under

some circumstances PAPRs provide

superior acceptability. These include

situations where employees wear

respirators for full shifts, where

employees frequently readjust their

negative pressure respirators to achieve

what they consider a more comfortable

or tighter fit, and where the air flow

provided by a PAPR reduces the

employee’s psychological and

physiological discomfort. However,

where ambient temperatures are

extremely high or low, PAPRs are often

unacceptable because of the temperature

of the airstream in the facepiece (See

preamble to Coke Oven standard, 41 FR

at 46774).

OSHA’s experience in enforcing

standards that contain a provision

requiring PAPRs to be supplied is that

the provision is rarely invoked by

employees, and even less rarely cited.

The Agency continues to believe that it

is good industrial hygiene practice to

provide a respirator that the employee

considers acceptable. Fit testing

protocols require that employees have

an opportunity to reject respirator

facepieces that they consider

unacceptable (See Appendix A).

However, this record does not provide

a sufficient basis for the Agency to

require PAPRs upon employee request

in all situations where the standard

applies. For example, Popendorf et al.

(Ex. 64–513) reported results from a

survey of respirator users in indoor

swine production, poultry production,

and grain handling facilities.

‘‘Acceptability among four classes of

respirators (disposable, quarter-mask,

half-mask and powered air-purifying

helmets), varied among the three user

groups. * * * Powered helmets were

rated best for breathing ease,

communication ease, skin comfort and

in-mask temperature and humidity,

while disposables were rated best for

weight and convenience.’’ OSHA

emphasizes, however, that if the

medical evaluation required by this

standard finds that an employee’s health

may be impaired by using a negative

pressure respirator, the employer must

provide a PAPR (See paragraph

(e)(6)(ii)).

Paragraph (d)(2)—Respirators for IDLH

Atmospheres

Paragraph (d)(2) covers respirators for

use in atmospheres that are immediately

dangerous to life or health (IDLH). The

comparable provision in the proposal

was paragraph (d)(10), which several

commenters stated was not clearly

written (Exs. 54–38, 54–167, 54–213,

54–280, 54–297, 54–309, 54–455).

OSHA has rewritten and reorganized the

provision so that paragraph (d)(2) of the

final rule covers all IDLH atmospheres,

and paragraph (d)(3) covers all nonIDLH atmospheres.

The standard requires that the most

protective and reliable respirators be

used for ILDH atmospheres: either a full

facepiece pressure demand SCBA

certified for a minimum service life of

thirty minutes, or a combination full

facepiece pressure demand supplied-air

respirator with an auxiliary selfcontained air supply (paragraph

(d)(2)(i)). The proposal would have

imposed the same requirement, except

for the addition of the requirement for

a minimum service life in the final rule.

OSHA has determined, as have most

respirator authorities, that IDLH

atmospheres require the highest level of

respiratory protection and reliability.

These atmospheres, by definition, are

the most dangerous environments in

which respirators may be used. As

OSHA explains in the summary and

explanation for the definition of

‘‘IDLH,’’ the term includes atmospheres

that pose an immediate threat to life or

health, would cause irreversible adverse

health effects, or would impair an

employee’s ability to escape. In these

atmospheres there is no tolerance for

respirator failure. This record supported

OSHA’s preamble statement that IDLH

atmospheres ‘‘require the most

protective types of respirators for

workers’’ (59 FR 58896). Commenters

and authorities, including NIOSH,

ANSI, and both labor and management,

agree that, for these atmospheres, the

most highly protective respirators, with

escape capability, should be required

(See the NIOSH Respirator Decision

Logic, pg. 10; ANSI Z88.2–1992, clause

7.3.2; Ex. 54–38).

Paragraph (d)(2)(ii) requires

employers to select respirators that are

to be used exclusively for escape from

IDLH atmospheres from those certified

by NIOSH for escape from the

atmosphere in which they will be used.
1202 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

This provision addresses the selection

of escape-only respirators from IDLH

atmospheres involving different

substances and situations. For example,

under current 29 CFR 1910.1050, the

standard covering exposure to

methylenedianiline (MDA), escape

respirators may be any full facepiece airpurifying respirator equipped with

HEPA cartridges, or any positive

pressure or continuous flow selfcontained breathing apparatus with full

facepiece or hood; for formaldehyde

exposure, escape respirators may be a

full facepiece with chin style, front, or

back-mounted industrial canister

approved against formaldehyde (29 CFR

1910.1048).

Paragraph (d)(2)(iii) requires

employers to consider all oxygendeficient atmospheres to be IDLH

atmospheres. An oxygen-deficient

atmosphere is defined in paragraph (b)

of the standard as one that contains less

than 19.5 percent oxygen. Below this

level, employers are required to use the

same respirators as are required for

IDLH atmospheres, i.e., a full facepiece

pressure-demand supplied-air respirator

with auxiliary SCBA or pressuredemand SCBA. This paragraph contains

an exception to permit employers to use

any supplied-air respirator, provided

that the employer demonstrates that

oxygen levels in the work area can be

maintained within the ranges specified

in Table II of the final rule, i.e., between

19.5 percent and a lower value that

corresponds to an altitude-adjusted

oxygen partial pressure equivalent to 16

percent oxygen by volume at sea level.

The language of paragraph (d)(2)(iii),

along with the exception, reflects the

same requirement as that proposed, but

avoids the potential confusion

associated with having separate

definitions and requirements for

oxygen-deficient, and oxygen-deficient

IDLH, atmospheres, as originally

proposed. The language used in the

final rule also reinforces OSHA’s belief

that all atmospheres containing less

than 19.5 oxygen must be considered

IDLH unless the employer has good

information that oxygen levels cannot

fall to dangerously low levels; in

atmospheres below this level but falling

within the ranges showin in Table II, a

SAR must be provided.

In the preamble discussion for

paragraph (b), OSHA provided several

reasons for the selection of the 19.5

percent cutoff to define oxygen

deficiency. First, OSHA believes that

consistency with the Agency’s confined

space standard is essential because most

oxygen-deficient atmospheres will be

associated with work in confined

spaces. In the preamble to the permitrequired confined space standard, 29

CFR 1910.146(b), OSHA used the term

‘‘asphyxiating atmosphere’’ when

referring to an atmosphere containing

less than 19.5 percent oxygen (58 FR

4466, January 14, 1993). In the confined

space standard itself, OSHA included

‘‘atmospheric oxygen concentrations [of]

less than 19.5 percent’’ within the

standard’s definition of ‘‘hazardous

atmosphere.’’ Using the same 19.5

percent cutoff point for defining an

IDLH oxygen-deficient atmosphere in

this respiratory protection standard will

reduce the potential for confusion. In

addition, OSHA’s use of a 19.5 percent

cutoff is consistent with the requirement

that Grade D breathing air contain a

minimum of 19.5 percent oxygen (See

paragraph (i)).

OSHA believes that employers will

only rarely have occasion to avail

themselves of the exception in

paragraph (d)(2)(iii), which allows the

use of any supplied-air respirator (SAR)

if oxygen levels can be maintained

within the ranges shown in Table II.

Except for confined spaces, there were

no examples in the record of work

operations being routinely conducted in

well-controlled atmospheres where

oxygen levels are below 19.5 percent.

Most atmospheres with oxygen content

between 16 and 19.5 percent are not

well-controlled, and a drop in oxygen

content could have severe

consequences. OSHA’s review of

enforcement data also confirms that,

except for confined spaces, such

atmospheres are uncommon, although

they occasionally occur when work is

conducted in basements, open pits, and

other enclosed spaces. If an employer

can meet the difficult evidentiary

burden of showing that the oxygen

content can be controlled reliably

enough to remain within the ranges

specified in Table II, the atmosphere is

not considered IDLH under this

standard, and the employer may provide

any SAR.

The low end of the ranges of oxygen

concentrations in Table II are the same

as those used to define oxygen-deficient

IDLH atmospheres in the proposal: 16

percent oxygen by volume for altitudes

from sea level to 3,000, and 19.5%

oxygen content for altitudes above 8,001

feet. For altitudes from 3,001 to 8,000

feet, the listed oxygen concentrations

correspond to an oxygen partial

pressure of 100 mm mercury (Hg).

OSHA explained in the proposal (59 FR

at 58906) that these values are

consistent with those in ANSI’s Z88.2–

1980 standard and with ANSI’s

definition of ‘‘oxygen deficiency—

immediately dangerous to life or health’’

as a partial pressure of 100 mm Hg at

sea level.

ANSI’s more recent 1992 standard

permits lower oxygen concentrations

before classifying an atmosphere as

IDLH, provided that the employer has

determined that the source of the

oxygen reduction is understood and

controlled. OSHA noted in the proposal

that IDLH oxygen deficiency is now

defined by ANSI as an oxygen content

at sea level that is equivalent to less

than 12.5% oxygen (i.e., an atmosphere

with an oxygen partial pressure of 95

mm Hg or less). However, there is

general agreement that employees could

be seriously and rapidly debilitated if

their supplied-air respirators should fail

in a 12.5% oxygen atmosphere. OSHA

stated in the proposal that that level

represents the ‘‘bare minimum safety

factor.’’ By choosing such a low oxygen

partial pressure as the ‘‘floor’’ for

oxygen-deficient IDLH atmospheres, the

ANSI standard effectively removes any

safety margin (59 FR 58905). ANSI

representatives (Tr. 1289) agreed with

OSHA during the hearing that OSHA’s

proposal offered a greater safety buffer

than the 1992 ANSI standard. In

addition, ANSI itself acknowledged in

Table A–1 of its Z88.2–1992 standard

(pg. 22, Ex. 54–50) that an oxygen level

of 12.5% at sea level would produce

effects such as ‘‘Very poor judgment and

coordination * * * impaired respiration

that may cause permanent heart damage

* * * nausea and vomiting.’’ OSHA

considers these effects unacceptable and

intends this standard to prevent their

occurrence. The ANSI table also states

that a 16% oxygen level would produce

effects such as ‘‘Increased pulse and

breathing rates * * * impaired thinking

and attention * * * reduced

coordination,’’ and at an oxygen level of

14% effects would include ‘‘Abnormal

fatigue upon exertion * * * emotional

upset * * * faulty coordination * * *

poor judgment.’’ All of these effects are

potentially incompatible with the safe

performance of duties.

The ANSI table shows that the

adverse health effects of oxygen

deficiency become significant at the

16% oxygen level, and that these effects

increase in severity as the oxygen level

decreases. ANSI chose the 12.5% level

because that level represents the point

below which significant reductions in

blood oxygen levels occur. As ANSI

stated in clause A.5.2 of the Z88.2–1992

standard ‘‘[t]his rapid rate of change

then can present an unforgiving

situation to an unprotected worker

where debilitating physiological

symptoms can appear suddenly,

without warning, after only relatively
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1203

small changes in ambient oxygen

levels.’’

The ANSI standard anticipates that all

atmospheres with reduced oxygen levels

would be treated as IDLH unless the

source of the oxygen reduction is

understood and controlled (Clause 7.3.1

ANSI Z88.2–1992). OSHA found that

situations with controlled reducedoxygen atmospheres (below 16% oxygen

by volume) are rare and are already

treated as an IDLH atmosphere by

employers. Outside of confined spaces,

such as in a pit or a basement, a

reduced-oxygen atmosphere is rarely

stable. Reduced-oxygen atmosphere

situations may result as a byproduct of

dynamic processes such as oxygenconsuming operations caused by the

combustion of fuels or the digestion of

organic matter. OSHA considers all

confined spaces with atmospheric

concentrations of less than 19.5%

oxygen hazardous, and does not permit

an oxygen level below 19.5% for

occupied confined spaces (See 29 CFR

1910.146(b)), because it is difficult to

ensure that, in a confined space, oxygen

levels will not drop precipitously with

little or no warning. The work being

performed can itself reduce the oxygen

levels, due to displacement of air by

asphyxiants or through consumption of

oxygen by work processes or by

employees performing the work. Such

sources of variability in oxygen content,

even in workplaces where employers

are attempting to stabilize the

atmospheric oxygen content, can cause

oxygen levels to drop to a lower level,

placing workers at risk. Furthermore,

the accurate monitoring of oxygen levels

can be difficult, since sampling

instruments test a limited number of

areas, and pockets of lower oxygen

content can exist inside a confined

space or in a basement that can cause a

worker to be overcome. Thus, OSHA has

chosen an oxygen level of 16% by

volume as the level at which SCBA or

an airline respirator with auxiliary air

supply must be used because that is the

level below which severe symptoms

from oxygen deprivation first appear,

because maintenance of oxygen levels

below 16% is difficult, and because

employees who are not protected risk

their lives if an employer mistakenly

believes oxygen content can be

controlled.

OSHA’s determination that, at

altitudes of up to 3,000 feet,

atmospheres containing less than 16%

oxygen must be considered IDLH was

based on evidence that NIOSH

submitted to the preproposal docket

(See 59 FR at 58905). NIOSH showed

that in an oxygen concentration of less

than 16% at sea level, employees may

experience impaired attention, thinking

and coordination. The American

Thoracic Society (Ex. 54–92) questioned

whether allowing work to be performed

in an atmosphere with as little as 16%

oxygen, with no supplemental oxygen

supply, at altitudes below 3000 feet is

sufficiently protective and suggested

that mandatory medical examinations

might be necessary in such

circumstances to avoid pulmonary or

cardiac disease complications. OSHA

believes that this comment reflects some

of the confusion among rulemaking

participants concerning the proposed

language covering oxygen deficiency.

OSHA wishes to make clear that, in both

the proposed and the final rules,

employees are not permitted to work in

atmospheres containing less than 19.5

percent oxygen without the use of a

supplied-air respirator. In the majority

of these cases, employers will be

obligated to provide highly protective

respirators that can be used in IDLH

conditions. In a few cases, employers

may be able to justify use of any

supplied-air respirator. In either case,

employees will be provided a

supplemental source of breathing air

when working in oxygen-deficient

atmospheres.

OSHA has not adopted NIOSH’s

recommendations that the IDLH

concentration of oxygen be increased to

a concentration above 19.5% for work

above 8,001 feet. OSHA’s experience

confirms the record evidence that most

work at higher altitudes is performed by

fully acclimated workers (Exs. 54–6, 54–

208). These provisions will allow

acclimated workers to continue to

perform their work without oxygensupplying respirators, at any altitude up

to 14,000 feet altitude, as long as the

ambient oxygen content remains above

19.5% and the employee has no medical

condition that would require the use of

supplemental oxygen.

As noted above, oxygen deficiency

frequently occurs in atmospheres that

are not well controlled, and OSHA’s

decision to consider all oxygen-deficient

atmospheres as IDLH except under

certain strict conditions is appropriate

for work conducted in such dangerous

conditions. The requirement to use the

most protective and reliable respirators

for IDLH atmospheres is proper to

protect workers from the dire

consequences of exposure to these

atmospheres.

Paragraph (d)(3)—Respirators for

Atmospheres That Are Not IDLH

Paragraph (d)(3) sets out criteria and

requirements for choosing respirators

for all non-IDLH atmospheres. These

provisions supplement the general

requirements in paragraph (d)(1). This

paragraph has been reordered from the

parallel paragraph of the proposed

standard.

Paragraph (d)(3)(i) requires the

employer to provide a respirator that is

adequate to reduce the exposure of the

respirator wearer under all conditions of

use, including in reasonably foreseeable

emergencies. Employers must also

provide respirators that will ensure

compliance with all other statutory and

regulatory requirements, such as the

permissible exposure limits (PELs) for

substances in 29 CFR 1910.1000,

substance-specific standards, and other

OSHA standards. For example, 29 CFR

1910.120 (g)(2) of OSHA’s Hazardous

Waste Operations and Emergency

Response standard has additional

exposure limits that apply to hazardous

waste sites and emergency response

operations. In addition, the general duty

clause (Sec. 5(a)(1)) of the OSH Act may

require employers to protect their

employees from substances that are not

regulated but that are known to be

hazardous at the exposure levels

encountered in the workplace. However,

as was discussed at length in the

‘‘Definitions’’ section of this summary

and explanation, the final standard does

not use the term ‘‘hazardous exposure

levels,’’ in part because the proposal

was widely misunderstood to require

compliance with ACGIH’s TLVs or

NIOSH’s RELs in the absence of an

OSHA standard. Moreover, as also noted

above, this rulemaking does not address

the hierarchy of exposure controls in

paragraph (a)(1). Thus, employers may

not rely on respirators to control

exposures when feasible engineering

controls are available and are sufficient

to reduce exposures.

As explained earlier, OSHA intends to

address the issue of assigned protection

factors (APFs) and their impact on

respirator selection in a subsequent

phase of this rulemaking. OSHA noted

in the proposal (59 FR 58901) that APFs

are ‘‘a recognition of the fact that

different types of equipment provide

different degrees of protection, and

equipment limitations must be

considered in selecting respirators.’’ A

respirator with a higher APF will

provide more protection than a

respirator with a lower APF.

Considerable information on APFs has

developed since OSHA adopted its

existing standard in 1971. OSHA

intends to promulgate APF provisions

in the future. Accordingly, paragraphs

(d)(3)(i) (A) and (B) are reserved at this

time and will be addressed in the next

phase of this rulemaking. In the interim,

OSHA expects employers to take the

best available information into account
1204 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

in selecting respirators. As it did under

the previous standard, OSHA itself will

continue to refer to the NIOSH APFs in

cases where it has not made a different

determination in a substance-specific

standard. In addition, where OSHA has

specific compliance interpretations for

certain respirators, e.g., respirators used

for abrasive blasting (such as for lead),

these should be followed.

Based on the Agency’s enforcement

experience with the previous standard,

OSHA does not believe that differences

in the APFs set by NIOSH and ANSI

will have a serious impact on respirator

selection, because the major differences

in NIOSH and ANSI APFs occur with

respirators having APFs of 25 or greater,

and most overexposures involve

exposures at relatively small multiples

of the PELs. An analysis of OSHA’s

Integrated Management Information

System (IMIS) data showed that only 2

percent of the measurements taken by

OSHA exceeded the PEL by more than

10 times.

Paragraph (d)(3)(ii) of the final

standard provides that the respirators

selected must protect employees against

the physical state and chemical form of

the particular contaminant or

contaminants present in the workplace.

For air-purifying respirator selection,

the form of the contaminant is a critical

factor. Different types of air filtration

respirators are needed for dusts and

gases, for example, and, among gases,

different types are needed for acid gases

and for carbon monoxide. If the

respirator is not equipped with a filter

suitable for the form of the contaminant

to which a worker is exposed, then the

worker has no protection against that

contaminant. No commenter opposed

this requirement. ANSI’s standard

acknowledges that this information is

critical to appropriate respirator

selection (ANSI Z 88.2–1992, clause

4.5.4.(b)).

Paragraph (d)(3)(iii) covers respirator

selection for protection against gases

and vapors. OSHA’s primary intent in

this paragraph is to ensure that airpurifying respirators are not used in

situations where a chemical cartridge or

canister becomes saturated such that the

gas or vapor contaminant can ‘‘break

through’’ the filter’s sorbent element

and enter the respirator and the

worker’s breathing zone. If this happens,

even correctly fitting, well-maintained

respirators provide no protection to

their users. This breakthrough problem

is avoided entirely by the use of

atmosphere-supplying respirators. Such

respirators do not rely on filter sorbents

and instead deliver clean outside air to

the wearer’s respirator.

This paragraph establishes the

requirements for selecting respirators for

protection against gas and vapor

contaminants. Paragraph (d)(3)(iii)(A)

allows the use of atmosphere-supplying

respirators against any gas or vapor, and

paragraph (d)(3)(iii)(B) specifies the

conditions under which air-purifying

respirators may be used. These

conditions protect users against the gas

or vapor contaminant breaking through

the canister/cartridge filter. Thus, this

paragraph allows an air-purifying

respirator to be used if it is equipped

with a NIOSH-approved end-of-service

life indicator (ESLI) (paragraph

(d)(3)(iii)(B)(1)) or if the employer

enforces a sorbent change schedule

based on reliable information and data

on the service life of cartridges and

canisters used by the employer

(paragraph (d)(3)(iii)(B)(2)).

These provisions differ significantly

from those in the proposal. In proposed

paragraphs (d)(8) and (d)(9), OSHA

would have allowed air-purifying

respirator use for gases and vapors with

‘‘adequate warning properties,’’ such as

odor or irritation, and would not have

imposed additional conditions on their

use. A substance would have been

considered to have adequate warning

properties if the threshold for detection

was no higher than three times the

hazardous exposure level. For

contaminants having poor warning

properties, the standard as proposed

would have required employers to use

an ESLI or develop a cartridge/canister

change schedule that would ensure

replacement of the sorbent element

before 80 percent of its useful service

life had expired.

Commenters expressed significant

dissatisfaction with the proposed

provisions, and some asked OSHA to

reevaluate them in major respects (Exs.

54–414, 54–249, 54–374). Many

rulemaking participants urged OSHA to

rely much more heavily on end-ofservice-life indicators (ESLIs) or

appropriate cartridge or canister change

schedules for air-purifying respirators,

and some suggested that OSHA require

NIOSH-certified ESLIs on these

respirators (Exs. 54–387, 54–443). Other

commenters opposed limiting the use of

air-purifying respirators equipped with

ESLIs or reliable change out schedules

to situations where the odor/irritation

threshold was less than three times the

PEL. However, the Occidental Chemical

Corporation (Ex. 54–346) stated that

adopting this restriction would prohibit

the use of air-purifying respirators for

benzene exposures in excess of 3 ppm

unnecessarily, and ‘‘counter 10 years of

effective employee protection that

industry has provided.’’

Many other participants criticized the

proposal’s reliance on sensory

thresholds such as odor and irritation to

indicate when a respirator’s filtering

capacity is exhausted, stating that there

is too much variation between

individuals, that there is no good

screening mechanism to identify

persons with sensory receptor problems,

and that the proposal would have

allowed employees to be overexposed to

hazardous air contaminants (Exs. 54–

151, 54–153, 54–165, 54–202, 54–206,

54–214, 54–414, 54–280, 54–386, 54–

410, 54–427). Still other commenters

suggested that the kind of respirator

required should depend on the severity

of the harm resulting from

overexposure, with exposure to more

serious hazards requiring supplied-air

respirators (Exs. 54–202, 54–212, 54–

347). Finally, some commenters

interpreted the proposed provision as

prohibiting the use of air-purifying

respirators against particulates ‘‘without

adequate warning properties’’ (Ex. 54–

309). This, according to the Associated

Builders and Contractors (Ex. 54–309),

would require, for example, a ‘‘pipefitter

who is torch cutting metal with a

galvanized coating to use an airsupplied respirator or SCBA—even

when working outdoors * * * [and]

could add one more item to the array of

electrical power cords, pneumatic lines,

and fall-protection devices already

attached to or trailing many

construction workers.’’

ORC testified (Tr. 2164–65) that in

general, the experience of most of its

member companies is that most toxic

substances do not have appropriate

sensory warning properties. Indeed, in

the preamble to its proposed Glycol

Ethers standard, OSHA noted that

reported values for the odor threshold of

any substance vary widely, both because

of differences between individuals’

ability to perceive a particular odor and

because of the methodology employed

in conducting the odor threshold

determination (58 FR 15526).

NIOSH’s ‘‘Guide to Industrial

Respiratory Protection—Appendix C’’

reports that on average, 95% of a

population will have a personal odor

threshold that lies within the range from

about one-sixteenth to sixteen times the

reported mean odor threshold for a

substance. As stated by Amoore and

Hautala(1983):

[t]he interpretation of these data * * * will

depend markedly on the individual

circumstances. The threshold data * * * are

based on averages for samples of the

population, presumably in good health.

Individuals can differ quite markedly from

the population average in their smell

sensitivity, due to any of a variety of innate,
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1205

chronic, or acute physiological conditions

* * * Continuing exposure to an odor

usually results in a gradual diminution or

even disappearance of the smell sensation.

This phenomenon is known as olfactory

adaption or smell fatigue. If the adaption has

not been too severe or too prolonged,

sensitivity can often be restored by stepping

aside for a few moments to an

uncontaminated atmosphere, if available.

Unfortunately, workers chronically exposed

to a strong odor can develop a desensitization

which persists up to two weeks or more after

their departure from the contaminated

atmosphere * * * Hydrogen sulfide and

perhaps other dangerous gases can very

quickly lose their characteristic odor at high

concentrations * * * Certain commercial

diffusible odor masking or suppressing

agents may reduce the perceptibility of odors,

without removing the chemical source.

Other commenters agreed that odor

threshold levels are so variable that it is

‘‘virtually impossible’’ to set general

rules for uniform application (MoldexMetric, Ex. 54–153; See also Phillips

Petroleum, Ex. 54–165 and Ex. 54–151).

OSHA notes that NIOSH, in its 1987

Respirator Decision Logic (Ex. 9 at pg.

3) stated that ‘‘[w]hen warning

properties must be relied on as part of

a respiratory protection program, the

employer should accurately, validly,

and reliably screen each prospective

wearer for the ability to detect the

warning properties of the hazardous

substance(s) at exposure levels that are

less than the exposure limits for the

substance(s).’’

In light of this evidence, OSHA has

reconsidered the conditions under

which air-purifying respirators may be

used. The final standard requires the

use of ESLIs where they are available

and appropriate for the employer’s

workplace, whether or not warning

properties exist for a contaminant. If

there is no ESLI available, the employer

is required to develop a cartridge/

canister change schedule based on

available information and data that

describe the service life of the sorbent

elements against the contaminant

present in the employer’s workplace

and that will ensure that sorbent

elements are replaced before they are

exhausted. Reliance on odor thresholds

and other warning properties is no

longer explicitly permitted in the final

rule as the sole basis for determining

that an air-purifying respirator will

afford adequate protection against

exposure to gas and vapor

contaminants.

To date, only five contaminantspecific ESLIs have been granted the

NIOSH approval necessary to allow

them to be used. To the extent that

NIOSH certified end-of-service life

indicators are available, OSHA finds

that there are considerable benefits to

their use. As a representative of the

Mine Safety Appliances Company

(MSA) testified (Tr. 821), ‘‘ESLIs * * *

simplify administration of the respirator

program. The idea of trying to

administer control on the change out

schedule for these cartridges leads to

human error or could lead to human

error. Where the end-of-service-life

indicator is a more active indicator for

the actual respirator user that his

cartridge needs replacement, it takes the

guesswork out of the respirator program

and change out schedule.’’

NIOSH has established rigorous

testing criteria for end-of-service life

indicators. An applicant must supply

NIOSH with data ‘‘demonstrating that

the ESLI is a reliable indicator of

sorbent depletion (equal to or less than

90% of service life). These shall include

a flow-temperature study at low and

high temperatures, humidities, and

contaminant concentrations which are

representative of actual workplace

conditions where a given respirator will

be used * * *. Additional data

concerning desorption of impregnating

agents used in the indicator, on the

effects of industrial interferences

commonly found, on reaction products,

and which predict the storage life of the

indicator’’ are also required (NIOSH

1987, Ex. 9 at 45–46). Other criteria

cover the durability of an ESLI, and

whether it interferes with respirator

performance or otherwise constitutes a

health or safety hazard to the wearer.

OSHA finds that these rigorous testing

requirements will ensure that employers

who can rely on ESLIs can be confident

that their employees are adequately

protected while using air-purifying

respirators against gas and vapor

contaminants, and is therefore requiring

their use in the final rule. One

commenter pointed out that the use of

cartridges with moisture-dependent

end-of-service life indicators will allow

dangerously high exposures in dry

atmospheres (Ex. 54–455). However, the

final rule requires the use of cartridges

and canisters equipped with an ESLI

only if its use is appropriate for the

conditions of the employer’s workplace.

Thus, employers would not be required

to rely on an ESLI if the employer could

demonstrate that its use presents a

hazard to employees.

There was much agreement in the

record that it would not be possible or

feasible to require replacement of

cartridges and canisters before 80

percent of the useful service life of the

sorbent element had expired, primarily

due to the lack of data available to

employers to make this determination

(Exs. 54–6, 54–48, 54–165, 54–178, 54–

181, 54–226, 54–231, 54–289, 54–374).

To implement this requirement as it was

proposed, the employer would need

quantitative information that describes

how long a cartridge or canister would

last when challenged with a specific

concentration of a gas or vapor. Such

studies are called ‘‘breakthrough

studies’’ and require the use of elaborate

instrumentation and rigid test protocols.

Several published breakthrough studies

of a few dozen commonly used

industrial chemicals are available in the

literature (See, for example, Exs. 21–5,

21–7, 21–8, 21–10, 38–13, 38–14, 38–

15). OSHA recently used breakthrough

data to develop a general cartridge and

canister change schedule for airpurifying respirators used against 1,3-

butadiene (61 FR 56817). Under Section

5 of the Toxic Substances Control Act

(TSCA), EPA’s Office of Pollution

Prevention and Toxics (OPPT) requires

manufacturers and importers of new

chemicals to conduct breakthrough

studies and develop cartridge/canister

change schedules based on this service

life testing.

As described above, however,

comments to the record indicate that

breakthrough test data are not likely to

be available for many hazardous gases

or vapors encountered in American

workplaces. For example, one

commenter agreed that, although there

is a need to protect employees against

contaminant breakthrough, it disagreed

with relying on employer-devised

schedules because there has not been

enough breakthrough testing (Laidlaw

Environmental Services, Ex. 54–178).

The American Electric Power Service

Corporation asked OSHA to provide

needed guidance on how to assess the

useful life of gas and vapor cartridges

under widely varying conditions (Ex.

54–181).

The record shows clearly that

respirator manufacturers, chemical

manufacturers, and even NIOSH must

provide more information about how

long respirator cartridges and canisters

can be expected to provide protection

for employees, as well as additional

tools to assess whether the cartridges are

still functioning. NIOSH’s certification

process does not require respirator

manufacturers to provide information

on the maximum or expected life span

for gas and vapor cartridges. Nor do

chemical manufacturers written

specifications routinely include this

information. The certification process

tests only for minimum service life,

which for most cartridges is 25 to 50

minutes, and for most canisters is 12

minutes (42 CFR part 84, Tables 6, 11).

Also, as stated by Cohen and Garrison

of the University of Michigan (Ex. 64–
1206 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

207, at 486), ‘‘(c)urrent certification by

NIOSH involves testing respirator

cartridges containing activated carbon

against carbon tetrachloride in the

presence of water vapor. Testing

cartridges with carbon tetrachloride

cannot predict how other organic vapors

will be adsorbed.’’

Alternatives to OSHA’s proposal that

were suggested by rulemaking

participants included adopting the

ANSI requirement to develop and

implement a cartridge change schedule

based on cartridge service data (which

would require the use of breakthrough

test data) and information on expected

exposure and respirator use patterns

(Ex. 54–273), or following

manufacturers’ recommendations for

cartridge and canister use (Ex. 54–6).

Therefore, in the final rule, OSHA is not

retaining the proposed requirement for

employers to ensure that chemical

cartridges and canisters be replaced

before 80 percent of their useful life.

Instead, OSHA is requiring that

employers develop cartridge/canister

change schedules based on available

data or information that can be relied

upon to ensure that cartridges and

canisters are changed before the end of

their useful service life. Such

information may include either

information based on breakthrough test

data or reliable use recommendations

from the employer’s respirator and/or

chemical suppliers.

Unlike the proposal, the requirement

in the final rule would not require the

employer to search for and analyze

breakthrough test data, but instead

permits the employer to obtain

information from other sources who

have the expertise and knowledge to be

able to assist the employer to develop

change schedules. OSHA has revised

the final rule from the proposal in this

manner to recognize that there may be

instances in which specific

breakthrough test data are not available

for a particular contaminant, but

manufacturers and suppliers may

nevertheless still be able to provide

guidance to an employer to develop an

adequate change schedule. If the

employer is unable to obtain such data,

information, or recommendations to

support the use of air-purifying

respirators against the gases or vapors

encountered in the employer’s

workplace, the final rule requires the

employer to rely on atmospheresupplied respirators because the

employer can have no assurance that

air-purifying respirators will provide

adequate protection.

Ideally, change schedules should be

based on tests of cartridge/canister

breakthrough that were conducted

under worst-case conditions of

contaminant concentration, humidity,

temperature and air flow rate through

the filter element. One such protocol is

described in the EPA Interim

Recommendations for Determining

Organic Vapor Cartridge Service Life for

NIOSH Approved Respirators (dated

May 1, 1991), as revised in May 1994.

This protocol requires breakthrough

testing at three different concentrations

at 80 and 20 percent relative humidity.

Additional testing is required if it is

determined that the substance may be

used in workplaces where there are

elevated temperatures, or where

breakthrough is evident at lower

humidity. The protocol also requires

manufacturers to develop change

schedules that incorporate a safety

factor of 60 percent of the measured

service life.

OSHA emphasizes that a conservative

approach is recommended when

evaluating service life testing data.

Temperature, humidity, air flow

through the filter, the work rate, and the

presence of other potential interfering

chemicals in the workplace all can have

a serious effect on the service life of an

air-purifying cartridge or canister. High

temperature and humidity directly

impact the performance of the activated

carbon in air-purifying filters. OSHA

believes that, in establishing a schedule

for filter replacement, it is important to

base the schedule on worst-case

conditions found in the workplace,

since this will provide the greatest

margin for safety in using air-purifying

respirators with gases and vapors. Thus,

to the extent that change schedules are

based on test data that were not

obtained under similar worst-case

conditions, OSHA recommends that

employers provide an additional margin

of safety to ensure that breakthrough is

not likely to occur during respirator use.

OSHA encourages respirator and

chemical manufacturers to perform their

own tests to provide appropriate

breakthrough test data to employers,

particularly to small companies with

limited resources, for those situations

where the data are not already publicly

available.

If breakthrough data are not available,

the employer may seek other

information on which to base a reliable

cartridge/canister change schedule.

OSHA believes that the most readily

available alternative is for employers to

rely on recommendations of their

respirator and/or chemical suppliers. To

be reliable, such recommendations

should consider workplace-specific

factors that are likely to affect cartridge/

canister service life, such as

concentrations of contaminants in the

workplace air, patterns of respirator use

(i.e., whether use is intermittent or

continuous throughout the shift), and

environmental factors including

temperature and humidity. Such

recommendations must be viewed by

the employer in light of the employer’s

own past experience with respirator use.

For example, reports by employees that

they can detect the odor of vapors while

respirators are being used suggest that

cartridges or canisters should be

changed more frequently.

Another potential approach involves

the use of mathematical models that

have been developed to describe the

physical and chemical interactions

between the contaminant and sorbent

material. Theoretical modeling has been

conducted to determine the effect of

contaminant concentration on

breakthrough time and other similar

relationships. It is generally agreed,

however, that the relationships between

contaminant concentrations, exposure

durations, breathing rates, and

breakthrough times are complex and

heavily dependent upon assumptions

concerning several factors, including

environmental conditions (See

references 1–8 in Ex. 64–331). As a

result, predictive models are probably

not likely to present an acceptable

alternative for most employers, and

their use would require that a

considerable margin of safety be

incorporated into any change schedule

developed from such estimation

techniques.

Research is also underway to develop

a field method for evaluating the service

lives of organic vapor cartridges using a

small carbon-filled tube to sample air

from the work environment. The

principal investigator for this research

stated in 1991 that ‘‘(a) field evaluation

of the method is currently underway. It

is expected to be the final step in

evaluating and validating the method

for predicting the service lives of

organic vapor respirator cartridges in

workplace environments’ (Ex. 64–208 at

42). Although OSHA cannot at this time

evaluate the utility of this method

because results of the field testing of

this device have not been reported, the

development of such tools to assist

employers to better estimate cartridge/

canister service times is encouraged,

and their use would be permitted under

the standard providing that the

reliability of such a method had been

appropriately demonstrated.

Representatives of CMA testified in

favor of requiring the employer to

provide some written documentation for

determining service life or a change out

schedule (Tr. 1736–1737). OSHA agrees

that it is important for the employer to
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1207

document the basis for establishing the

change schedule and has included in

paragraph (d)(3)(iii)(B)(2) a requirement

for the employer to do so as part of his

or her written respiratory protection

program. The written respirator program

is the proper place for employers to

document change schedules, since the

written program is the place where

employers give specific directions on

workplace-related operations and

procedures for their employees to

follow. The written program also

documents the exposure measurements

or reasonable estimates that were made,

which form the basis of the calculations

used to make the filter change

schedules. Developing a filter change

schedule involves a number of

decisions. The employer must evaluate

the hazardous exposure level, the

performance capacity of the filters being

used, and the duration of employee use

of the respirator, which impact on the

service life calculations. OSHA believes

that including the basis for the change

schedule in the written program will

cause employers to better evaluate the

quality and reliability of the underlying

information, and will prompt the

employer to obtain additional

information, ask additional questions of

their suppliers, or seek competent

professional help to develop a change

schedule that will ensure adequate

performance of cartridges and canisters

used in the employer’s workplace.

OSHA proposed in paragraph

(d)(3)(ii) that, as part of the required

selection evaluation, the employer

evaluate the physical properties of the

relevant contaminant and, in the

preamble, listed ‘‘the particle size for

dusts’’ as a factor affecting respirator

selection (59 FR 58900). ANSI

recommended in its 1992 standard

particle size/filter selection criteria as

follows: if the contaminant is an aerosol,

with an unknown particle size or a size

less than 2 μm, use a high efficiency

filter; if the contaminant is a fume, use

a filter approved for fumes or a high

efficiency filter; and if the contaminant

is an aerosol, with a particle size greater

than 2 μm, use any filter type (ANSI

Z88.2–1992, clause 7.2.2.2.j, k, and l).

NIOSH agreed with ANSI’s

recommendations insofar as particulate

filtering respirators certified under

former 30 CFR 11 are concerned.

However, NIOSH expressed particular

concern about very small particles:

‘‘Laboratory research beginning in the

early 1970s, and continuing into the

1990s, demonstrated that some, but not

all, members of the Dust Mist (DM) and

Dust Fume Mist (DFM) filter classes

allow significant penetration of

submicron-sized particles. Additionally

submicron particulates present special

medical concerns because they can

diffuse throughout the respiratory

system * * *’’ In NIOSH’s new 42 CFR

part 84, classes of particulate filters now

certified as filter series N, R, and P may

be used against any size particulate in

the workplace (Ex. 54–437).

Based on this evidence, OSHA has

determined that where employees are

exposed to submicron particles of a

respiratory hazard, OSHA will enforce

paragraph (d)(3)(iv) as limiting the use

of DM and DFM filters certified under

former 30 CFR 11 to employers who can

demonstrate that exposure in their

workplace is limited to particulates that

have a mass median aerodynamic

diameter of 2 μm or larger. OSHA notes

that employers have alternative choices

to using HEPA filters where the sizes of

particles are unknown or are less than

2 μm. The new filter media certified by

NIOSH under new 42 CFR part 84 as

series N, R and P, may be used for any

size particulate; however, where another

OSHA standard requires the use of

HEPA-filtered respirators, the employer

may only use HEPA filters defined

under 30 CFR 11 or N100, R100, or P100

filters defined under 42 CFR part 84.

Paragraph (e)—Medical Evaluation

Medical evaluation to determine

whether an employee is able to use a

given respirator is an important element

of an effective respiratory protection

program and is necessary to prevent

injuries, illnesses, and even, in rare

cases, death from the physiological

burden imposed by respirator use. The

previous standard stated, at 29 CFR

1910.134(b)(10), that employees should

not be assigned to tasks requiring the

use of respirators unless it has been

determined that they are physically able

to perform the work while using the

respiratory equipment. That standard

also provided that ‘‘the local physician

shall determine what health and

physical conditions are pertinent,’’ but

listed no specific medical or workplace

conditions to consider when making

such a determination. The previous

standard also stated that regular reviews

of the medical status of respirator users

should be undertaken, and suggested

that a once yearly evaluation would be

appropriate. Employers are thus aware

of the need for medical evaluations of

respirator users and have been

conducting such evaluations as part of

their respiratory protection programs for

years.

OSHA believes that, to ensure

employee protection, medical

evaluations for respirator use must be

conducted before initial respirator use,

and that such evaluations must consist

of effective procedures and methods.

Accordingly, the final standard’s

medical evaluation requirements for

respirator use identify who is to be

evaluated, and address the frequency

and content of these evaluations. It

authorizes licensed health care

professionals, both physicians and

nonphysicians, to evaluate employees

for respirator use to the extent

authorized by the scope of their state

licensure, and to conduct follow-up

medical evaluations based on specific

indicators of need.

In the proposal, OSHA described

three alternative approaches to medical

evaluation for respirator users. The first

proposed alternative in the regulatory

text would have required employers

annually to obtain a physician’s written

opinion for every employee using a

respirator for more than five hours in

any work week. The physician’s opinion

was to inform the employer whether or

not a medical examination of the

employee was necessary and, if so, was

to specify the content of the medical

examination.

The second proposed alternative

required a mandatory medical history

and examination, using questions and

procedures similar to those contained in

the ANSI standard on physical

qualifications for respirator use, ANSI

Z88.6–1984 (Ex. 38–4). This alternative

would have applied only to employees

using a respirator for more than five

hours during any work week. Medical

evaluation was to be performed

annually and whenever an employee

experienced breathing difficulty while

being fitted for, or using, a respirator.

The medical evaluation was to be

conducted by a physician or a health

care professional supervised by a

physician, who, in arriving at a decision

regarding the employee’s medical ability

for respirator use, was to consider a

number of respirator and workplace

conditions (e.g., type of respirator used,

duration and frequency of respirator

use, substances to which the employee

is exposed, work effort and type of

work, need for protective clothing, and

special environmental conditions (e.g.,

heat, confined spaces)) that could affect

the health and safety of respirator users.

The resulting medical opinion, which

was to be written by a physician, was

to recommend any medical limitation

on respirator use, and was to be

provided to both the employer and

employee. This proposed alternative

contained an exemption for employees

who had received a comparable medical

history and examination within the

previous year for the same respirator

and conditions of respirator use. OSHA

proposed a nonmandatory Appendix C
1208 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

with this alternative that specified the

elements of the medical evaluation.

The third proposed alternative would

have required that a medical

questionnaire be administered to every

respirator user, regardless of the

duration of respirator use. The medical

questionnaires could be administered by

health professionals or other personnel

who had been trained in medical

administration by a physician. If the

answers to the medical questionnaire

showed that a medical examination was

needed, the employee had to be

provided such an examination (see 59

FR 58911). Medical examinations were

to be mandatory for employees who

would be required to use SCBAs when

assigned to emergency or rescue

operations. Medical examinations were

to be conducted by physicians or

physician-supervised health care

professionals. The medical opinion was

to be written by a physician; consider

the same respirator and workplace

conditions specified for the second

alternative; specify any medical

limitations on respirator use; and be

provided to both the employer and

employee.

In addition to proposing three

medical evaluation alternatives, the

proposal requested comments on

medical removal protection, including

the need to provide alternative

respirators or job assignments to

employees found to be medically unable

to use the required respirator.

Overview of the Final Rule’s Provisions

The provisions of paragraph (e) in the

final Respiratory Protection standard are

based on an extensive review of the

comments received on the proposal,

especially comments regarding the three

proposed medical evaluation

alternatives. Final paragraph (e)(1)

specifies that every employee must be

medically evaluated prior to fit testing

and initial use of a respirator. Paragraph

(e)(2) states that employers must select

a physician or other licensed health care

professional (PLHCP) to conduct the

medical evaluation, which must consist

either of the administration of a medical

questionnaire or an initial medical

examination. Mandatory Appendix C

contains the medical questionnaire to be

administered to employees if the

medical questionnaire approach is

taken.

Paragraph (e)(3) requires the employer

to provide a follow-up medical

examination to an employee who

answers ‘‘yes’’ to any question among

questions 1 through 8 in Section 2, Part

A of the medical questionnaire in

Appendix C. The follow-up medical

examination is to consist of any tests,

consultations, or diagnostic procedures

that the PLHCP deems necessary.

Paragraph (e)(4) specifies that the

medical questionnaire and examinations

shall be administered confidentially and

at a time and place, during working

hours, that is convenient to the

employee, and that the employee

understands the content of the

questionnaire.

Paragraph (e)(5) requires the employer

to provide the PLHCP with specific

information needed to make an

informed decision about whether the

employee is able to use a respirator. The

information includes descriptions of the

respirator to be used and workplace

conditions that may impose

physiological burdens on respirator

users, or that may interact with an

existing medical condition to increase

the risk that respirator use will

adversely affect the employee’s health.

Final paragraph (e)(6) requires the

employer to obtain a written

recommendation from the PLHCP on

whether or not the employee is

medically able to use a respirator. The

recommendation must identify any

limitations on the employee’s use of the

respirator, as well as the need for

follow-up medical evaluations to assist

the PLHCP in determining the effects of

respirator use on the employee’s health.

The employee must receive a copy of

the PLHCP’s written recommendation.

The last provision of paragraph (e)(6)

requires that a powered air-purifying

respirator (PAPR) be provided to an

employee when information from the

medical evaluation shows that the

employee can use a PAPR but not a

negative pressure respirator. If the

PLHCP determines at a subsequent time

that the employee is able to use a

negative pressure respirator, the

employer is no longer required to

provide a PAPR to that employee.

Paragraph (e)(7) specifies

circumstances that require the employer

to provide additional medical

evaluations to respirator users. Medical

reevaluations must be provided under

the following conditions: when the

employee reports signs or symptoms

that are relevant to the employee’s

ability to use a respirator; when a

PLHCP, supervisor, or respirator

program administrator informs the

employer that an employee needs to be

reevaluated; when information from the

respirator program, including

observations made during fit testing or

program evaluation, indicates a need for

employee reevaluation; or if a change in

workplace conditions occurs that may

result in a substantial increase in the

physiological burden that respirator use

places on the employee. The following

paragraphs describe the comments

received in connection with each

medical evaluation requirement, and

discuss OSHA’s reasons for including

each requirement in the final rule.

Introduction

OSHA is including an introduction to

the regulatory text that provides a brief

rationale for requiring employers to

implement a medical evaluation

program as part of their overall

respiratory protection program. The

introduction is provided for

informational purposes, and does not

impose regulatory obligations on

employers.

The purpose of a medical evaluation

program is to ensure that any employee

required to use a respirator can tolerate

the physiological burden associated

with such use, including the burden

imposed by the respirator itself (e.g., its

weight and breathing resistance during

both normal operation and under

conditions of filter, canister, or cartridge

overload); musculoskeletal stress (e.g.,

when the respirator to be worn is an

SCBA); limitations on auditory, visual,

and odor sensations; and isolation from

the workplace environment (Exs. 113,

22–1, 64–427). Certain job and

workplace conditions in which a

respirator is used can also impose a

physiological load on the user; factors to

be considered include the duration and

frequency of respirator use, the level of

physical work effort, the use of

protective clothing, and the presence of

temperature extremes or high humidity.

Job- and workplace-related stressors

may interact with respirator

characteristics to increase the

physiological stress experienced by

employees (Exs. 113, 64–363). For

example, being required to wear

protective clothing while performing

work that imposes a heavy workload

can be highly stressful.

Specific medical conditions can

compromise an employee’s ability to

tolerate the physiological burdens

imposed by respirator use, thereby

placing the employee at increased risk

of illness, injury, and even death (Exs.

64–363, 64–427). These medical

conditions include cardiovascular and

respiratory diseases (e.g., a history of

high blood pressure, angina, heart

attack, cardiac arrhythmias, stroke,

asthma, chronic bronchitis,

emphysema), reduced pulmonary

function caused by other factors (e.g.,

smoking or prior exposure to respiratory

hazards), neurological or

musculoskeletal disorders (e.g., ringing

in the ears, epilepsy, lower back pain),

and impaired sensory function (e.g., a

perforated ear drum, reduced olfactory
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1209

function). Psychological conditions,

such as claustrophobia, can also impair

the effective use of respirators by

employees and may also cause,

independent of physiological burdens,

significant elevations in heart rate,

blood pressure, and respiratory rate that

can jeopardize the health of employees

who are at high risk for

cardiopulmonary disease (Ex. 22–14).

One commenter (Ex. 54–429)

emphasized the importance of

evaluating claustrophobia and severe

anxiety, noting that these conditions are

often detected during respirator

training.

The introduction states that the

medical evaluation requirements in

paragraph (e) of the final rule are

minimal requirements that OSHA

believes are necessary to protect the

health of respirator users.

Paragraph (e)(1)—General

This paragraph requires that

employees required to wear a respirator,

or those voluntarily wearing a negative

pressure air purifying respirator, be

medically evaluated, and that a

determination be made that they are

able to use the respirators selected by

the employer. A medical evaluation

must be performed on every employee

required to use a respirator, regardless

of the duration and frequency of

respirator use. In addition, as discussed

above in connection with paragraph

(c)(2), employers must provide a

medical evaluation to any employee

who elects to use a respirator that may

place a physiological burden on the

user, e.g., a negative pressure airpurifying respirator. By medically

evaluating employees prior to respirator

use, employers will avoid exposing

employees to the physiological stresses

associated with such use. Paragraph

(e)(1) is similar to a provision in the

American National Standards Institute

(ANSI) consensus standard Z88.2–1992

(‘‘American National Standard for

Respiratory Protection) that states: ‘‘any

medical conditions [of an employee]

that would preclude the use of

respirators shall be determined.’’

Commenters (Exs. 54–21, 54–307, 54–

361, 54–419, 54–420, 54–421, 54–441)

generally agreed that medical evaluation

should precede initial respirator use,

i.e., should take place before fit testing

and first time use of the respirator in the

workplace. For example, the

International Brotherhood of Electrical

Workers (Ex. 54–441) stated, ‘‘The

physical fitness of respirator users must

be known prior to them donning a

respirator, not after they become

injured.’’ Three other commenters (Exs.

54–419, 54–420, 54–421) agreed,

without elaboration, that medical

evaluations should be performed before

respirator use. One commenter (Ex. 54–

21) recommended that employees

receive medical evaluations after fit

testing but before actual use so that

difficulties with respirator use during fit

testing could be reported to the PLHCP,

and two other commenters (Exs. 54–307,

54–361) also suggested that the medical

evaluation be conducted prior to fit

testing.

OSHA believes that the initial

medical evaluation must be conducted

prior to fit testing to identify those

employees who have medical

conditions that contraindicate even the

limited amount of respirator use

associated with fit testing. If medical

problems are observed during fit testing,

the employee must be medically

reevaluated (see final paragraph (e)(7)).

Final paragraph (e)(1) requires the

medical evaluation of employees who

use respirators, regardless of duration of

use. This final requirement differs from

proposed alternatives 1 and 2, which

would have exempted from medical

evaluation those employees who used a

respirator for five or fewer hours during

any work week. The overwhelming

majority of commenters stated that the

exemption should be eliminated

entirely or be limited only to those

employees who are exposed to minimal

physiological stresses or workplace

hazards. These comments can be

grouped, and are summarized, as

follows:

(1) If the five-hours-per-week

threshold were used, employers would

avoid the proposed medical evaluation

requirement by rotating employees who

use respirators into jobs not requiring

respirators just short of the five-hour

limit (Exs. 54–5, 54–165, 54–178, 54–

419);

(2) Employees who use respirators

frequently for periods of less than five

hours per work week, or who use

respirators for more than five hours per

work week but do so infrequently, are

still at risk of the adverse health effects

potentially associated with respirator

use and, therefore, they should also be

medically evaluated (Exs. 54–163, 54–

178, 54–308, 54–345);

(3) The five-hour exemption should

not apply to respirator use that is known

to be physiologically burdensome (e.g.,

use of SCBAs by emergency responders)

or to use under the job or working

conditions (including hazardous

exposures) that impose a significant

physiological burden on employees

(Exs. 54–5, 54–68, 54–92, 54–107, 54–

137, 54–153, 54–158, 54–159, 54–187,

54–194, 54–195, 54–206, 54–208, 54–

213, 54–224, 54–247, 54–264, 54–265,

54-275, 54–283, 54–290, 54–327, 54–

342, 54–348, 54–363, 54–395, 54–415,

54–427, 54–429, 54–453);

(4) The five-hour exemption would be

too difficult for OSHA to enforce or

could not be administered effectively

and efficiently by employers (Exs. 54–

70, 54–136, 54–167, 54–196, 54-244, 54–

250, 54–267, 54–327, 54–348, 54–443);

(5) The health of employees with

preexisting medical problems would be

endangered because these problems may

go undetected until the five-hour limit

is reached (and, in some cases, may

never be detected if employees ‘‘selfselect’’ into jobs with little respirator

use because of their medical problems)

(Exs. 54–92, 54–159, 54–247, 54–415,

54–441, 54–455); and

(6) The five-hour exemption is not

appropriate because every employee

who uses a respirator should have a

medical evaluation (Exs. 54–6, 54–46,

54–79, 54–196, 54–202, 54–208, 54–214,

54–218, 54–233, 54–272, 54–275, 54–

287, 54–289, 54–295, 54–357, 54–394,

54–420, 54–424, 54–430, 54–434, 54–

453), or the exemption is arbitrary, has

no scientific basis, or would increase an

employer’s risk of liability (Exs. 54–188,

54–434).

Several commenters recommended

that medical evaluation not be required

for SCBA users (Exs. 54–68, 54–320, 54–

331, 54–353); that medical evaluations

for emergency responders be contingent

on respirator use exceeding five hours

per year (Ex. 54–429); or that emergency

responders be exempted from medical

evaluation requirements that are unique

to employees who use airline respirators

or SCBAs (Ex. 54–420).

Some commenters recommended

adopting the five hours per week

exemption (Exs. 54–14, 54–80, 54–91,

54–182, 54–220, 54–223, 54–224, 54–

252, 54–283, 54–319) to achieve cost

savings and improve the efficiency of

the respiratory protection program. Two

commenters (Exs. 54–177, 54–402)

stated that the five-hour limit

represented the point at which the

effects of job-related physical stress

should be medically evaluated.

Although generally endorsing the

provision, several commenters (Exs. 54–

168, 54–206, 54–209, 54–295, 54–357,

54–366) found the phrase ‘‘during any

work week’’ to be vague, confusing, or

in need of being defined.

Several commenters wanted the five

hours per week limit revised upwards.

One commenter (Ex. 54–300)

recommended that the limit be raised to

10 hours per week, while another

commenter (Ex. 54–249) endorsed a

limit of 30 days per year. A third

commenter (Ex. 54–116) stated that the

limit could be increased, without
1210 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

danger, to 10 hours per week for

firefighters who use SCBAs, but

presented no data to support this

position, while three other commenters

(Exs. 54–209, 54–254, 54–454) stated

that a 10 or 15-hour per week limit

could be tolerated without stress by

most employees who use respirators.

One commenter (Ex. 54–435) believed

that the exemption should be broadened

to cover seasonal employees because

medical evaluations are too difficult to

administer to these employees. Another

commenter (Ex. 54–263) opposed any

requirement for the medical evaluation

of employees who use respirators.

One commenter recommended that

medical evaluations not be required for

employees who use disposable halfmask or dust mask respirators,

regardless of workplace exposure

conditions (Ex. 54–329). A number of

commenters suggested eliminating

medical evaluations if employers choose

to provide respirators to their employees

(i.e., if they are not required by OSHA

to provide such respirators) (Exs. 54–69,

54–91, 54–265, 54–287, 54–295, 54–320,

54–327, 54–339, 54–346, 54–421); two

of these commenters (Exs. 54–69, 54–

339) expressed the concern that

employers may stop offering respirators

to their employees if medical evaluation

is required in these cases.

The final standard, as noted above,

provides an exception from the

requirement that employees who use

dust masks on a voluntary-use basis, as

defined in paragraph (c), must be

medically evaluated. OSHA based the

decision to require medical evaluation

for all employees required to use

respirators, and for those employees

voluntarily using negative pressure

respirators, on a number of scientific

studies, discussed below, which

demonstrated that adverse health effects

can result, in some cases, even from

short duration use of respirators. Several

experimental studies in the record show

that even healthy individuals using

what is generally believed to be a ‘‘low

risk’’ respirator for short periods can

experience adverse physiological and

psychomotor effects. In one experiment

(Ex. 64–388), 12 individuals using low

resistance, disposable half-mask

respirators under heavy workloads

(using a treadmill apparatus) for only

five minutes experienced statistically

significant elevations in heart and

respiratory rates, systolic and diastolic

blood pressure, and body temperatures

compared with these measures in the

same individuals under control (i.e., no

respirator use) conditions. Some of

these effects were observed while the

study participants were working at light

and moderate workloads. For two of

these individuals, the study’s author

classified blood pressure changes at

heavy workload levels as ‘‘clinically

important.’’ These results suggest that in

an individual with cardiac

insufficiency, such physiological stress

could cause fatal arrhythmia.

In another study (Ex. 64–444), 15

individuals used a full facepiece

respirator while performing light,

moderate, and heavy workloads on a

bicycle ergometer for 15 minutes.

Immediately following the 15 minute

exercise period, the ability of the

individuals to maintain their

equilibrium (i.e., postural stability) was

assessed using a special platform

designed for this purpose. Under every

workload condition, respirator use

resulted in significantly increased heart

rates and impaired equilibrium

compared to conditions when the

individuals did not use respirators.

A third study (Ex. 64–490) involved

12 individuals, each of whom exercised

for 30 minutes on a bicycle ergometer at

a light-to-moderate workload while

using one of three types of respirators,

i.e., disposable half-mask, negative

pressure half-mask, and full facepiece

airline respirators. After taking a 10

minute rest, the study participants

repeated the procedure until each

respirator type had been tested.

Compared to the control condition in

which the subjects exercised without

respirators, the individuals were found

to consume more oxygen while

exercising with the negative pressure

half-mask and full facepiece airline

respirators, and to have higher systolic

and diastolic blood pressures while

using the full facepiece airline

respirator. Under the test conditions of

this study, therefore, negative pressure

half-mask and full facepiece airline

respirators imposed significant

physiological stress on the respirator

users.

Louhevaara (Ex. 164, Attachment D),

after reviewing the available research

literature on respirator physiology,

concluded that the major physiological

effects of negative pressure respirators

and supplied-air respirators, as well as

SCBAs, are ‘‘alterations in breathing

patterns, hypoventilation, retention of

carbon dioxide, and [an] increase in the

work of breathing,’’ and that these

effects are worse under conditions of

increased filter resistance, poor

respirator maintenance, and heavy

physical work. Sulotto et al. (Ex. 164,

Attachment D) found that negative

pressure respirators resulted in higher

breathing resistances as physical

workload on a bicycle ergometer

increased, leading to substantially

reduced breathing frequency,

ventilation rate, oxygen uptake, and

carbon dioxide production.

One study (Ex. 164, Attachment D,

Beckett) that reviewed the scientific

literature on the medical effects of

respirator-imposed breathing resistance

among healthy young men noted that

‘‘[t]hese and other studies indicate no

clinically significant impairment of

normal respiratory function at

submaximal workloads with the loads

imposed by currently approved,

properly maintained, negative pressure

respiratory protective devices.’’ This

reviewer stated further, however, that

‘‘[r]elatively less is known about the use

of respirators by those with abnormal

physiology (for example, obstructive or

restrictive pulmonary diseases) and

about the use of respirators whose

resistance characteristics are altered by

excessively long use, such that

inspiratory resistance is increased by

the deposition of matter within the filter

or absorptive elements of the canister.’’

The Agency finds that these studies

demonstrate the potential for adverse

health effects resulting from respirator

use, even for healthy employees using

respirators designed for low breathing

resistance and used for short durations.

The Agency believes, therefore, that

respirator use would impose a

substantial risk of material impairment

to the health of employees who have

preexisting respiratory and

cardiovascular impairments. As the

earlier discussion of final paragraph

(e)(1) indicates, the record contains

overwhelming support for requiring

medical evaluation of respirator users;

many employers who provided

comments to the record have

established medical evaluation

programs for all employees who use

respirators (see, e.g., comments by

Organization Resources Counselors,

Inc., Ex. 54–424). Consequently, OSHA

finds, consistent with the results of

these studies and the entire record, that

the use of any respirator requires a prior

medical evaluation to determine fitness.

Other considerations that have caused

OSHA to make this decision are the

potential impairment of health that may

occur among employees with

preexisting medical problems if these

problems are not detected before

respirator use; the need to identify

medical problems that can arise even

from short term use of respirators of the

types known to impose severe physical

stress on employees (e.g., SCBAs); and

the administrative difficulties and

inefficiencies that employers would

experience if OSHA adopted a provision

that required medical evaluations only

of some respirator users, i.e., those using

certain types of respirators or those
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1211

using them for a specified number of

hours per week.

OSHA specifically disagrees with

those commenters who stated that no

medical evaluations are needed for

employees who only occasionally use

SCBAs. SCBAs create the highest

cardiovascular stress of any type of

respirator because of their weight, and

they are often used in high physical

stress situations, such as fires and other

emergencies. This combination of

stressors makes medical evaluation

necessary to avoid myocardial infarction

in susceptible individuals; at least 40

million people in the United States have

some form of heart disease (Levy, in 54

FR 2541).

One commenter (Ex. 54–284)

recommended that the required medical

evaluations should be discontinued

after an employee stops using

respirators. OSHA agrees with this

recommendation, and has revised final

paragraph (e)(1) accordingly.

Paragraph (e)(2)—Medical Evaluation

Procedures

Paragraph (e)(2)(i). This final

paragraph requires the employer to

identify a physician or other licensed

health care professional (PLHCP) to

perform medical evaluations using a

medical questionnaire or medical

examination. Two major issues were

raised in the rulemaking record: (1)

What must be done to evaluate

employees, and (2) who must perform

the evaluation. Proposed paragraphs

(e)(1) and (e)(3) would have required

physician involvement in the medical

evaluation process, with nonphysician

health care professionals permitted to

review the employee’s medical status

only under the supervision of a licensed

physician. The final rule allows the

evaluation to be performed either by a

physician or other licensed health care

professional (e.g., nurse practitioners,

physician assistants, occupational

health nurses), provided that their

license permits them to perform such

evaluations.

Many commenters, representing labor,

management, occupational nurses,

nurse practitioners, and physician

assistants, recommended that OSHA

permit the use of nonphysician health

care professionals (usually nurse

practitioners, physician assistants,

occupational health nurses, or registered

nurses) to take medical histories,

conduct physical examinations

(including pulmonary function tests),

and administer and review employee

responses to medical questionnaires,

provided that they do so under the

supervision of a licensed physician

(Exs.54–6, 54–7, 54–21, 54–134, 54–153,

54–157, 54–171, 54–176, 54–185, 54–

187, 54–205, 54–239, 54–240, 54–244,

54–245, 54–251, 54–267, 54–273, 54–

304, 54–357, 54–363, 54–381, 54–387,

54–389, 54–396, 54–424, 54–432, 54–

443, 54–453). Some commenters stated

that nonphysician health care

professionals are competent to conduct

medical assessments, while physician

supervision or involvement would

guarantee that quality control was

maintained over the assessment process

(Exs. 54–273, 54–363, 54–381, 54–443,

54–453). Two of these commenters (Exs.

54–278, 54–430) noted that any health

care professional could review medical

questionnaires without physician

supervision, but that physicians should

conduct or supervise any medical

examinations conducted on the basis of

answers to the medical questionnaires.

Many other commenters, representing

labor, management, and physicians,

preferred that only physicians be

involved in medical evaluation

programs (Exs. 54–14, 54–46, 54–70,

54–101, 54–107, 54–150, 54–151, 54–

165, 54–175, 54–180, 54–186, 54–189,

54–199, 54–217, 54–219, 54–220, 54–

249, 54–271, 54–295, 54–313, 54–352,

54–455). This preference was usually

based on the prior or current practices

of these commenters. For example, the

American College of Occupational and

Environmental Medicine (ACOEM) (Ex.

54–453) stated that the health status of

employees in a respiratory protection

program should be reviewed by

physicians with specific training and

experience in occupational medicine

because these medical specialists have

knowledge of the physical demands of

respirator use needed to make valid

decisions regarding an employee’s

medical ability for the program. A

similar recommendation was made by

the Service Employees International

Union (Ex. 54–455).

Some commenters recommended that

the employee’s medical ability to use a

respirator be evaluated solely by

nonphysician health care professionals

(Exs. 54–16, 54–19, 54–25, 54–32, 54–

79, 54–159, 54–184, 54–213, 54–222,

54–226, 54–253, 54–265, 54–272, 54–

278, 54–397). Most of these commenters

cited their favorable experiences with

nonphysician health care professionals,

and pointed to the cost savings of using

nonphysicians (Exs. 54–19, 54–79, 54–

184, 54–226, 54–253). Several of these

commenters provided additional

justifications. For example, one

commenter (Ex. 54–184) stated that

‘‘physician assistants, by education,

training, and state regulation, are well

qualified and legally able to perform all

aspects of a medical evaluation,’’ and

argued that the scope of practice with

regard to medical evaluations should

remain the prerogative of state licensing

boards.

Another commenter (Ex. 54–213)

noted that ‘‘many physicians are not

familiar with occupational health risks

as they relate to respiratory exposures,

types of respiratory protection available,

and work requirements.’’ This

commenter stated further that ‘‘nurse[s]

or other qualified health care

professional[s], operating within their

licensed scope of practice, [have]

clinical expertise and knowledge of the

work environment and can best evaluate

the physical requirements placed on the

user of respiratory protective

equipment’’ and that ‘‘[u]se of qualified

health care professionals other than

physicians is cost-beneficial to

employers, particularly [in] small

business settings’’ (Ex. 54–213).

The American Thoracic Society (Ex.

54–92), which recommended the use of

medical questionnaires rather than

medical examinations, stated that ‘‘there

is no demonstration that [physicianbased] examinations actually predict

who will develop difficulties with

respirator use’’ because ‘‘[v]ery few

physicians have in-depth knowledge of

respiratory protection and workplace

hazards sufficient to render a fully

reasoned view.’’

None of the commenters, including

those who used nonphysician health

care professionals to conduct medical

evaluations as part of their respiratory

protection programs, cited any data or

experience showing that the type of

PLHCP qualification and licensure, or

the manner in which PLHCPs are

involved in the medical evaluation

process, had compromised the medical

evaluation process or had resulted in

faulty medical evaluations.

After reviewing the entire record,

OSHA decided to allow any PLHCP to

evaluate an employee’s medical ability

to use a respirator, providing that the

PLHCP is authorized to do so by his or

her state license, certification, or

registration. Although OSHA agrees that

physicians with training and experience

in occupational medicine are highly

qualified to conduct medical

evaluations for respirator use, an

insufficient number (slightly more than

2,000 nationally) of these specialists are

available for this purpose (personal

communication, American Board of

Medical Specialties, to Vanessa

Holland, M.D., 5/29/97). In addition, in

circumstances where questions arise as

to the employee’s physical condition

and capability, OSHA believes that the

PLHCP can be relied on to consult with

an appropriate specialist or physician.
1212 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

After a review of the licensing

provisions of the 50 states and Puerto

Rico, OSHA concludes that state

licensing laws often require some

physician involvement in conducting

the medical evaluations required by the

final standard. For example, the

majority of states require that nurse

practitioners perform their medical

functions under a formal written

agreement with a physician. Only six

states (i.e., Montana, New Mexico,

North Dakota, Oregon, Vermont, and

Washington) and Puerto Rico allow

licensed nurse practitioners to function

independently of physician supervision.

Even these jurisdictions, however,

require licensed nurse practitioners to

refer patients to a physician for further

evaluation and treatment when a

medical problem beyond the nurse

practitioner’s level of expertise arises.

OSHA believes that the states are best

suited to judge the medical

competencies of those PLHCPs who

practice within their jurisdictions, and

to regulate the scope of practice of these

individuals.

To summarize, the final rule allows

any PLHCP to administer the medical

questionnaire or to conduct the medical

examination if doing so is within the

scope of the PLHCP’s license. The basis

for this decision includes the following:

(1) The record (Exs. 54–19, 54–79, 54–

92, 54–184, 54–253) generally supports

the position that properly qualified

PLHCPs, regardless of the type of health

care specialization, are competent to

assess the medical ability of employees

to use respirators using accepted

medical questionnaires or medical

examinations;

(2) Evidence in the record that

employers who operate respiratory

protection programs have successfully

used PLHCPS, including nonphysicians,

to conduct medical evaluations and to

make medical ability recommendations,

shows that nonphysicians have done so

safely and efficaciously (Exs. 54–213,

54–240, 54–389);

(3) Providing employers with ready

access, at reasonable cost, to the basic

medical assessment skills required to

perform at least the initial phases of

employee medical evaluation for

respirator use contributes to the efficient

and effective allocation health care

resources; and

(4) The lack of record support for a

requirement allowing medical

evaluations to be performed only by

physicians. The record (Exs. 54–6, 54–

7, 54–21, 54–134, 54–153, 54–157, 54–

171, 54–176, 54–185, 54–187, 54–205,

54–239, 54–240, 54–244, 54–245, 54–

251, 54–267, 54–273, 54–304, 54–357,

54–363, 54–381, 54–387, 54–389, 54–

396, 54–424, 54–432, 54–443, 54–453)

indicates that medical evaluations

performed independently by

nonphysician health care professionals,

as defined by this section, are effective

for at least the initial phases of an

employer’s medical evaluation program

(i.e., evaluating the medical

questionnaire or conducting an initial

medical examination), and protect

employee health as well as medical

evaluations conducted only by

physicians or with physician oversight.

Employers are free, however, to select

any PLHCP they wish to satisfy this

requirement, provided that the PLHCP

is qualified by license to do so. In some

cases, the medical condition of the

employee or the conditions of respirator

use may warrant physician

involvement, and OSHA is confident

that LHCPs faced with such situations

will seek such medical advice.

Paragraph (e)(2)(ii). Paragraph (e)(2)(i)

requires employers to identify a PLHCP

to perform the medical evaluations

required by the final rule. It also

specifies that employers may choose to

use the medical questionnaire in

Appendix C to conduct the initial

medical evaluation or provide a medical

examination that obtains the same

information as the medical

questionnaire. Employers are free to

provide respirator users with a medical

examination in lieu of the medical

questionnaire if they choose to do so,

but they are not required by the

standard to administer a medical

examination unless the employee gives

a positive response to any question

among questions 1 through 8 in Section

2, Part A of Appendix C (see paragraph

(e)(3)).

The approach taken in the final rule

thus resembles the third alternative

proposed by OSHA in the NPRM:

reliance on a medical questionnaire

(with medical examination follow-up if

positive responses are given to selected

questions on the medical questionnaire).

Those commenters (Exs. 54–3, 54–14,

54–46, 54–67, 54–107, 54–151, 54–168,

54–175, 54–180, 54–218, 54–220, 54–

224, 54–226, 54–227, 54–240, 54–244,

54–264, 54–292, 54–294, 54–295, 54–

324, 54–326, 54–327, 54–339, 54–346,

54–352, 54–366, 54–370, 54–210, 54–

432, 54–434, 54–443, 54–445, 54–453)

who preferred the other alternatives

(i.e., medical history and medical

examination for all respirator users, or

medical examination and written

opinion) supported their views with a

variety of opinions.

A number of the commenters who

recommended the medical history and

examination alternative (Exs. 54–153,

54–165, 54–218, 54–226, 54–227, 54–

263, 54–264, 54–294, 54–326, 54–327,

54–363, 54–443) favored this approach

only in those cases when employees

would be using SCBAs, while others

(Exs. 54–16, 54–220) stated that medical

questionnaires should be used only for

employees who use dust masks, and

that other respirator users should

receive a medical history and

examination regardless of the duration

of respirator use. Another commenter

(Ex. 54–101) recommended that medical

questionnaires be administered to

employees who use dust masks for

fewer than five hours per week, while

other employees should receive a

medical history and examination. One

commenter favored medical

questionnaires only for respirator users

who perform ‘‘isolated operations,’’

while recommending that respirator use

in other employment settings require a

medical history and/or examination (Ex.

54–46). Another commenter stated that

employees using respirators under

workplace exposure conditions

exceeding an OSHA PEL should receive

a medical history and examination,

while respirator users exposed to other

workplace atmospheres should only be

required to complete a medical

questionnaire (Ex. 54–339).

Those commenters (Exs. 54–7, 54–16,

54–21, 54–25, 54–32, 54–69, 54–91, 54–

92, 54–101, 54–134, 54–142, 54–153,

54–154, 54–157, 54–158, 54–165, 54–

170, 54–171, 54–172, 54–173, 54–176,

54–187, 54–190, 54–192, 54–154, 54–

197, 54–205, 54–206, 54–208, 54–209,

54–213, 54–14, 54–219, 54–222, 54–223,

54–234, 54–239, 54–241, 54–242, 54–

245, 54–251, 54–252, 54–253, 54–254,

54–262, 54–263, 54–265, 54–267, 54–

269, 54–272, 54–273, 54–275, 54–278,

54–284, 54–286, 54–289, 54–296, 54–

304, 54–309, 54–319, 54–320, 54–325,

54–330, 54–332, 54–334, 54–342, 54–

350, 54–357, 54–361, 54–363, 54–381,

54–389, 54–396, 54–401, 54–421, 54–

424, 54–426, 54–428, 54–429, 54–430,

54–441, 54–453, 54–455) recommending

medical questionnaires (proposed

alternative 3) objected to the medical

examination and written opinion

approaches because, in their view,

medical examinations and opinions are

difficult to obtain, have poor predictive

value, and are expensive, especially for

workplaces that have high employee

turnover. Regarding costs, the American

Iron and Steel Institute (Ex. 175) stated

that the medical opinion required by

alternative 1 would cost their industry

$195 per employee, including $150 for

the medical examination and opinion,

and $45 in lost work time for the

employee.

The record does not demonstrate that

any of the three alternatives were
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1213

superior in detecting medical conditions

that could potentially limit employee

use of respirators. Testimony at the

hearing by the United Steel Workers of

America (USWA) (Tr. 1059 and

following) in support of alternative 2

(medical history and examination)

provided information on the ability of

different medical assessment procedures

to detect disqualifying medical

conditions. This information showed

that, among 126 employees, 16 were

disqualified for respirator use because of

various medical conditions. Medical

histories identified six of the employees

with these conditions, while a medical

examination conducted by a physician

identified the remaining 10 employees.

The USWA attributed the reduced

effectiveness of the medical histories in

this instance to the lack of awareness

among employees of the medical

conditions that could potentially limit

such use.

The United Steel Worker’s testimony

(Tr. 1059 and following) also described

a study in which physicianadministered medical examinations

were found to be about 95 percent

accurate and medical questionnaires

were found to be 60 to 70 percent

accurate in identifying specific medical

problems. The final rule is designed to

overcome this problem to some extent

by requiring that employees be trained

to recognize the medical signs and

symptoms associated with the

physiological burden imposed by

respirator use; see paragraph (k)(1)(vi).

A number of commenters supported

the medical questionnaire option on the

grounds that this approach is more

efficient and effective. The United

States Air Force (Ex. 54–443G) stated,

‘‘After working under the provisions of

[proposed] alternative 2 for several years

and comparing the Air Force’s

occupational health and cost savings by

reducing unnecessary medical

evaluations and freeing physician time

under [proposed] alternative 3, the Air

Force supports [proposed] alternative

3.’’ Similarly, the CITGO Petroleum

Corporation (Ex. 54–251) endorsed

medical questionnaires as more costeffective than medical examinations.

CITGO administered medical

examinations to a sample of 1634

employees in 1994 to detect respiratory

disorders, a major medical concern for

respiratory protection programs, and

identified only one abnormal case that

was confirmed after referral for followup medical examination.

An additional study involving

validation of medical questionnaires

was described by Organization

Resources Counselors, Inc. (ORC) (Ex.

54–424). One of ORC’s member

companies, a large, diversified

manufacturing organization, recently

reviewed approximately 700 records of

employee respirator medical

examinations to determine the

effectiveness of using a medical

questionnaire as a screening tool. This

company currently gives all respirator

users a full medical examination in

addition to having them fill out a

medical questionnaire. The records

review revealed that, out of 700

examinations, only 10 (less than 2%)

required medical limitations on

respirator use. These limitations were

due to claustrophobia, asthma, and

heavy smoking. All of these limitations

would have been identified, in the

company’s view, by a medical

questionnaire. The employees identified

through the medical questionnaire

could then have been given a complete

medical examination. By using the

medical questionnaire as a screening

tool, this company believes it could

have eliminated unnecessary

examinations for 98% of its worker

population.

A private physician and three

management groups (Exs. 54–32, 54–

424, 55–29, 155) submitted medical

questionnaires to the record and

expressed satisfaction with these

medical questionnaires, in terms of both

the medical conditions that were

detected and the administrative

efficiency of the process; these

commenters, however, recommended

that physicians be involved in

reviewing the medical questionnaires.

Several commenters (Exs. 54–70, 54–

159, 54–215) endorsed the medical

evaluation procedures specified in the

American National Standard Institute’s

(ANSI) consensus standard Z88.6–1984,

titled ‘‘American National Standard for

Respiratory Protection—Respirator

Use—Physical Qualifications for

Personnel.’’ This ANSI standard

recommends that a medical history

questionnaire be administered to

employees who are enrolled in

respiratory protection programs, and

that a physician review each employee’s

responses to the medical questionnaire

to determine if additional medical

examinations are required.

OSHA concludes that information in

the record supports the use of medical

questionnaires for detecting medical

conditions that may disqualify

employees from, or limit employee

participation in, respiratory protection

programs. OSHA believes that the ORC

study (Ex. 54–424) provides support for

the conclusion that medical

questionnaires are an efficient and

effective means of screening employees

for subsequent medical examination.

OSHA also believes that the training

required by paragraph (k)(1) of the final

rule, which requires that employees

understand the limitations of respirator

use and recognize the signs and

symptoms of medical problems

associated with respirator use, will

increase employee awareness and

overcome the problems that the USWA

(Tr. 1059 and following) noted in its

testimony. A number of commenters

(Exs. 54–107, 54–151, 54–153, 54–165,

54–190, 54–218, 54–251, 54–253, 54–

272, 54–339, 54–361, 54–401) stated

that medical questionnaires had several

advantages over the other alternatives,

including simplicity and efficiency of

use, completeness and accuracy of the

medical information obtained, and

adaptability (i.e., easily revised to

accommodate new or different medical

problems, different employee groups,

and changing job, workplace, and

respirator conditions). An additional

advantage of medical questionnaires is

lower cost, most notably in terms of

development, administration, and

analysis.

Employers are free to use medical

examinations instead of medical

questionnaires, but are not required by

the standard to do so (see paragraph

(e)(2) of the final standard). OSHA also

recognizes that medical examinations

are necessary in some cases, e.g., where

the employee’s responses to the medical

questionnaire indicate the presence of a

medical condition that could increase

the risk of adverse health effects if a

respirator is used. Examples of such

cases are employees who report a

history of smoking, pulmonary or

cardiovascular symptoms or problems,

eye irritation, nose, throat, or skin

problems, vision or hearing problems

(for employees who use full facepiece

respirators), and musculoskeletal

problems (for employees who use

SCBAs). In addition, certain workplace

conditions or job requirements, such as

SCBA use, being an emergency

responder or a member of a HAZMAT

team, working in an IDLH atmosphere,

wearing heavy protective clothing, or

performing heavy physical work, may

warrant a medical examination. In the

future, however, OSHA may, on a caseby-case basis, require medical

examinations to detect respirator-related

conditions in its substance-specific

standards, depending on the particular

circumstances and physiological effects

of the toxic substance being regulated.

The medical questionnaire in

Appendix C of the final standard is

based on the medical history

questionnaire contained in ANSI Z88.6–

1984, as well as medical questionnaires

submitted to the record by commenters
1214 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

(Exs. 54–32, 54–424, 55–29). The

medical questionnaire is designed to

identify general medical conditions that

place employees who use respirators at

risk of serious medical consequences,

and includes questions addressing these

conditions. These medical conditions

include seizures, diabetes, respiratory

disorders and chronic lung disease, and

cardiovascular problems. As the

discussion of the Introduction and

paragraphs (e)(1) and (5) in this

Summary and Explanation demonstrate,

these conditions have been found to

increase the risk of material impairment

among employees who use respirators.

A question asking about fear of tight or

enclosed spaces was included in the

medical questionnaire because

claustrophobia and anxiety associated

with such spaces were mentioned by a

commenter as the most frequent medical

problem detected during respirator

training (Ex. 54–429); additionally,

research submitted to the record (Ex.

164, Attachment D, Morgan) indicates

that more than 10 per cent of ‘‘normal’’

young men experience dizziness,

claustrophobia, or anxiety attacks while

exercising during respirator use.

Questions 10 through 15 of the

medical questionnaire in Appendix C

must be answered only by employees

who use a full facepiece respirator or

SCBA. These questions ask about

hearing and vision impairments, as well

as back and other musculoskeletal

problems. Employees who use full

facepiece respirators, for example, must

be asked about eye and hearing

problems because the configuration of

these respirators (e.g., helmets, hoods)

can add to the limitations associated

with existing visual and auditory

impairments, resulting in an elevated

risk of injury to employees with such

impairments, as well as to other

employees who may rely on the

impaired employee to warn them of

emergencies (Ex. 164, Attachment D,

Beckett). The heavy weight and rangeof-motion limitations of SCBAs may

prevent employees who have existing

problems in the lower back or upper or

lower extremities from using these

respirators.

A physician (Ex. 54–16) commented

that an employee’s medical history

should be considered by the PLHCP in

making a recommendation about the

employee’s ability to use respirators.

This commenter specified a number of

prior medical conditions, including

those involving cardiovascular and

respiratory health, psychological

variables, neurological and sensory

organ status, endocrine function, and

the use of medications that would be

useful to PLHCPs in arriving at a

medical ability recommendation. OSHA

believes that these variables, especially

cardiovascular and respiratory fitness,

are important determinants of

respiratory fitness, and, therefore,

included items specific to these medical

conditions in the medical questionnaire.

OSHA concludes that the employee’s

answers to the medical questionnaire

will provide an adequate medical

history for the PLHCP.

Two commenters (Exs. 54–222, 54–

251) requested that OSHA define

medical evaluation procedures and

provided sample definitions. OSHA

believes that the regulatory text of the

final rule, which has been clarified and

simplified since the proposal, provides

clear guidance and that these definitions

are, therefore, not necessary. As used in

the final rule, ‘‘medical evaluation’’

means the use of subjective (e.g.,

medical questionnaires) or objective

methods (e.g., medical examinations), as

well as other available medical,

occupational, and respirator

information, to make a determination or

recommendation about an employee’s

medical ability to use respirators;

‘‘medical examination’’ means the use

of objective methods (i.e., manipulative,

physiological, biochemical, or

psychological devices, techniques, or

procedures) to directly assess the

employee’s physical and mental status

for the purpose of making a

recommendation regarding the

employee’s medical ability to use the

respirator.

Paragraph (e)(3)—Follow-up Medical

Examination

Paragraph (e)(3) addresses follow-up

medical examinations and states that

the employer must provide such

examinations to any employee who

gives a positive response to any

question among questions 1 through 8

in Section 2, part A in Appendix C. The

PLHCP is free to include any medical

tests, consultations, or diagnostic

procedures that he or she determines to

be necessary to assist him or her in

making a final determination of the

employee’s ability to use a respirator.

OSHA expects that the number of cases

where PLHCPs will have to provide

follow-up examinations will be small,

because it is generally possible to

recommend against respirator use, or

determine the limitations to place on an

employee’s use of respirators, on the

basis of responses to the medical

questionnaire. However, where difficult

medical issues are involved, such as the

need to make a differential diagnosis or

to assess an employee’s ability to handle

the physical stress imposed by an extrahazardous job, a medical examination

and involvement of a physician may be

needed. Many commenters (Exs. 54–92,

54–101, 54–134, 54–171, 54–223, 54–

278, 54–304, 54–363, 54–389) endorsed

this requirement. Two commenters (Exs.

54–151, 54–189) stated that medical

examinations should not be limited to

answers on the medical questionnaire

that indicate a need for medical

examinations. A few commenters (Exs.

54–153, 54–176, 54–218) recommended

that a mandatory medical examination

requirement based on the employee’s

responses to the medical questionnaire

is wasteful and unnecessary.

OSHA agrees that PLHCPs should be

permitted to obtain any medical

information they believe would be

useful in arriving at a final medical

recommendation, and they should not

be limited to investigating problems

associated only with answers on the

medical questionnaire. Information from

medical examinations may also be

needed to validate an answer that a

PLHCP believes is incorrect. Also, as

recommended by ORC (Ex. 54–424), a

PLHCP should be free to investigate

through medical examination any

medical conditions related to respirator

use that may not have been addressed

by the medical questionnaire or may not

have been obtained from other sources.

Paragraph (e)(4)—Administration of the

Medical Questionnaire and

Examinations

Paragraph (e)(4)(i). This paragraph

sets out the procedures employers must

follow when administering the medical

questionnaire or examinations required

by paragraph (e)(2). Paragraph (e)(4)(i)

requires employers to administer the

required medical questionnaire or

examinations in a manner that protects

the confidentiality of the employee

being evaluated. In addition, the

evaluation must be administered during

normal work hours or at a time and

place convenient to the employee, and

in a manner that ensures that the

employee understands the questions on

the medical questionnaire. Although

this requirement was not specifically

proposed, it is consistent with OSHA

policy and with Section 6(b)(7) of the

Act. OSHA has included similar

requirements in a number of substancespecific health standards (see, e.g., the

Cadmium standard, 29 CFR 1910.1027,

the Lead standard, 29 CFR 1910.1025,

and the Benzene standard, 29 CFR

1910.1043). If an employee must travel

off-site for medical evaluation, travel

arrangements must be made, and costs

incurred paid or reimbursed, by the

employer.

The final standard differs from the

proposal in that it does not specify who
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1215

must supervise the administration of the

medical questionnaire. Alternative 3 in

the proposal would have required that

the medical questionnaires be

administered by ‘‘a health professional

or a person trained in administering the

questionnaire by a physician.’’ (See 59

FR 58911.) Commenters (Exs. 54–25,

54–69, 54–153, 54–165, 54–190, 54–218,

54–251, 54–253, 54–272, 54–339, 54–

361, 54–401) recommended that persons

performing this function have various

qualifications, e.g., be a trained designee

of the employer, a safety or health

professional, a physician, or a

nonphysician health care professional

operating under the supervision of a

physician. Some commenters (Exs. 54–

25, 54–101, 54–214, 54–389, 54–421)

recommended that a PLHCP be present

during administration of the medical

questionnaire to ensure the accuracy

and validity of the employee’s answers.

Others (Exs. 54–69, 54–361) stated that

the medical questionnaire should be

designed so as to be easily

comprehended by the employee and

simple to administer, thereby requiring

only minimal involvement by an

employer. OSHA agrees with those

commenters (Exs. 54–69, 54–361) who

urged that the medical questionnaire be

easy to understand, and has developed

the medical questionnaire in Appendix

C accordingly. OSHA does not believe

that oversight is necessary because the

standard requires that the medical

questionnaire be understandable to the

employee and that the employee be

given an opportunity to ask questions of

the PLHCP administering the

questionnaire.

Although the OSHA medical

questionnaire is designed to be easily

comprehended by employees, paragraph

(e)(4)(i) of the final standard specifically

requires that employers ensure that

employees understand the medical

questionnaire. For employees who are

not able to complete the medical

questionnaire because of reading

difficulty, or who speak a foreign

language, OSHA requires that the

employer take action to ensure that the

employee understands the questions on

the medical questionnaire. Language

and comprehension deficits could

invalidate the answers of such

employees and result in inaccurate

determinations. Under these

circumstances, the PLHCP may assist

the employee in completing the medical

questionnaire (perhaps with the aid of

an employer-supplied interpreter). The

employer also may have the medical

questionnaire translated into the

employee’s language or administer a

physical examination that meets the

requirements of paragraph (e)(2) of the

final standard. In fulfilling this

requirement, OSHA is not requiring

employers to hire professional

interpreters. Instead, employers may use

an English-speaking employee who can

translate the medical questionnaire into

the questionnaire taker’s native

language, or other nonprofessional

translators who can perform the same

function (for example, a friend or family

member of the test taker).

Paragraph (e)(4)(ii). This paragraph

requires the employer to permit the

employee to discuss the medical

questionnaire results with a PLHCP.

Employees who are uncertain of the

significance of the questions asked will

thus be able to obtain clarification. One

commenter, Dr. Ross H. Ronish, Site

Medical Director for the Hanford

Environmental Health Foundation (Ex.

54–151), agreed that the opportunity for

discussion between the PLHCP and the

employee would improve the usefulness

of the medical questionnaire. The

standard does not require the employer

to follow a specific procedure in

providing employees with the

opportunity to discuss the medical

questionnaire with a PLHCP. Employers

must, however, at least inform

employees that a PLHCP is available to

discuss the medical questionnaire with

them and notify the employees how to

contact the PLHCP. For example, the

employer could post the PLHCP’s name

and telephone number in a conspicuous

location, or include this information on

a separate sheet with the medical

questionnaire.

Paragraph (e)(5)—Supplemental

Information for the PLHCP

Paragraph (e)(5)(i). The first

requirement in this paragraph requires

employers to provide the PLHCP with

specific information for use in making a

recommendation regarding the

employee’s ability to use a respirator.

OSHA had proposed a similar

requirement, stating that ‘‘[i]n advance

of the medical examination the

employer shall provide the examining

professional with [supplemental]

information * * *’’ OSHA received four

comments (Exs. 54–181, 54–234, 54–

330, 54–445) on this proposed

requirement. These commenters stated

that only supplemental information

requested by the PLHCP should be

provided because PLHCPs can best

determine what information they need

to make medical-ability

recommendations; additionally, limiting

the requirement to information

requested by the PLHCP would lower

the associated paperwork burden. The

Boeing Company (Ex. 54–445), for

example, stated, ‘‘The employer should

not be required to provide additional

information unless requested to do so by

the examining physician.’’ Another

commenter (Ex. 54–434) stated that the

proposed supplemental information

might not be meaningful to every

PLHCP.

OSHA believes that the supplemental

information specified is important to the

PLHCP in making a recommendation

regarding the employee’s medical ability

to use the respirator. However, as

indicated in paragraph (e)(5)(ii) of the

final standard, this information need

only be provided once to the PLHCP

unless the information differs from what

was provided to the PLHCP previously,

or a new PLHCP is conducting the

medical evaluation.

With few exceptions, the

supplemental information that must be

provided by the employer to the PLHCP

is the same information listed in the

proposed regulatory language for

alternative 3 (59 FR 58911, paragraphs

(e)(vi) (A) to (G)). Three commenters

(Exs. 54–160, 54–191, 54–287) endorsed

the entire list of supplemental

information items in the proposal. Most

of the commenters who took exception

to the proposed list disagreed with the

item requiring that information be

provided to the PLHCP on the

substances to which the employee will

be exposed (i.e., paragraph (e)(vi)(B) of

proposed alternative 3); two

commenters (Exs. 54–352, 54–453),

however, believed it was important to

specify these substances so that the

PLHCP would be aware of the hazards

in the workplace. One commenter (Ex.

54–339) stated that information on

substance exposure would be useful to

the program administrator for fit testing,

but was not needed by the PLHCP.

Another commenter (Ex. 54–208) stated

that information about these substances

was unnecessary because OSHA

intended to propose a separate rule for

medical surveillance, and one

commenter (Ex. 54–273) wanted this

item to be deleted and replaced by an

item informing the PLHCP about the

employee’s use of impervious clothing

because such clothing, if worn, may

impose serious heat stress on the

employee.

The record also contains an article by

Dr. William S. Beckett advising

occupational health professionals on

medical evaluations for respirator use

(Ex. 164, Attachment D). The article

addressed the need to provide these

professionals with exposure

information: ‘‘An employer’s inability to

provide this basic information

[regarding employee exposure levels] on

which a respirator choice has been
1216 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

made should throw the adequacy of the

respiratory protection program into

serious doubt.’’ Dr. Beckett explained

that such information was necessary

because preexisting lung impairments

make some employees ‘‘more sensitive

to the effects of some occupational

agents and [these employees] may thus

suffer further impairment at exposure

concentrations that would not affect a

normal worker.’’ In explaining these

effects, Dr. Beckett stated that

employees who have become

‘‘sensitized immunologically to a

workplace substance may not be able to

attain protection factors using usual

respirator precautions even though the

same respirator might be adequate for

individuals not sensitized to the

substance.’’ Dr. Beckett noted that ‘‘the

worker sensitized to toluene diisocyanate (TDI) * * * will experience

alterations in pulmonary function at an

air concentration of 0.001 ppm TDI

while normal individuals will not

experience symptoms at 20 times this

concentration.’’

In response to these comments, OSHA

has modified the proposed requirement

specifically requiring employers to

inform PLHCPs of the substances to

which employees may be exposed.

Under paragraph (e)(5)(iii) of the final

rule, employers must provide the

PLHCP with a copy of the written

respiratory protection program. As

required by paragraph (c)(1)(i) of the

final rule, the written program must

specify the procedures for selecting

respirators for use in the workplace;

accordingly, these procedures must

describe the workplace exposure

conditions that require respirator use.

OSHA believes these descriptions will

provide the necessary information,

while imposing little additional burden

on employers.

These requirement are necessary, the

Agency concludes, because employees

can have medical conditions that

predispose them to respond adversely to

the workplace substances to which they

are exposed, and the resulting effects

can impair an employee’s ability to use

some types of respirators. Consequently,

providing PLHCPs with information

about the workplace substances to

which employees are exposed will assist

the PLHCPs in determining if these

substances may interact with

preexisting medical conditions to

impair an employee’s ability to use the

respirator. In addition, the Agency

believes that knowledge about the

substances to which employees are

exposed will provide an indirect means

of determining the effectiveness of the

overall respiratory protection program.

If employees experience signs and

symptoms typically associated with

exposure to the workplace substances

documented in the written respiratory

protection program, the PLHCP can alert

the employer to these effects, and

corrective action can be taken.

In response to the commenter who

urged OSHA to include information on

impervious clothing, OSHA notes that

the final standard requires employers to

provide information on other protective

clothing and equipment to be worn by

the employee. This item will provide

information on impervious clothing,

and, therefore, addresses the

commenter’s concerns regarding the

heat stress imposed on employees by

such clothing.

One commenter (Ex. 54–214) stated

that descriptions of the type of work

performed and physical work effort

should be dropped from the list, while

another commenter (Ex. 54–445)

believed that information about the type

of respirator would not be useful to the

PLHCP. As noted in the discussion of

final paragraph (e)(1) in this Summary

and Explanation, cardiovascular and

respiratory fitness are important

variables in determining the ability of

an employee to use a respirator. The

physical work effort required by the

employee’s job, in combination with the

characteristics of the respirator (e.g.,

weight, breathing resistance,

interference with range of motion), are

variables that must be considered by a

PLHCP in making a recommendation

regarding the employee’s fitness to use

the respirator.

A study conducted by NIOSH (Ex. 64–

469) found that tolerance to work

conditions, heart rate, and skin

temperature were affected by three

variables: the type of personal protective

clothing worn, the weight of the

respirator, and the level of physical

work effort. In the NIOSH study, nine

healthy young men who had prior

experience with respirators and

personal protective clothing (most of

them were firefighters), exercised on a

treadmill at low and high physical

workloads under each of the following

conditions: wearing light work clothing

and using a low-resistance disposable

half-mask respirator (LT condition);

wearing light work clothing and using

an SCBA (SCBA condition); wearing

firefighter turnout gear and using an

SCBA (FF condition); and wearing

chemical protective clothing and using

an SCBA (CBC condition). While

exercising at low physical workloads

under the LT, SCBA, FF, and CBC

conditions, the study participants

tolerated these work conditions for 167,

130, 26, and 73 minutes, respectively; at

high physical workloads, the four

protective clothing conditions were

tolerated for 91, 23, 4, and 13 minutes.

Heart rates and skin temperatures rose

as tolerance diminished. At the high

workload level, testing under the SCBA,

FF, and CBC conditions had to be

terminated early because the heart rates

of the study participants reached

critically high levels (i.e., 90% of the

predicted maximal heart rate). At low

physical workloads, heart rate rose

progressively under the SCBA

conditions (about 15 beats per minute)

compared to the LT condition, then

remained steady. Under high physical

workloads, heart rates rose sharply and

never reached a steady level until after

the testing was terminated.

The authors of the NIOSH study noted

that the work tolerance, heart rate, and

skin temperature effects found in the

study would be more severe among

individuals who were not as healthy or

experienced as the study participants.

They attributed these effects both to the

weight of the respirator and to the poor

evaporative cooling properties of the

personal protective clothing (i.e., the

capacity to remove body heat under the

humid conditions generated inside the

protective clothing as a result of

physical work). Based on these findings,

the authors concluded that ‘‘[the study

participants] wearing protective

clothing and respirators during exercise

exhibited a significant degree of

cardiorespiratory and thermoregulatory

stress * * *’’

The conclusion reached by the NIOSH

study is supported by other researchers

who have tested the physiological

effects of personal protective clothing

combined with SCBA use among

healthy men performing exercise or

simulated work tasks under light to

moderate levels of physical exertion.

(See Ex. 164, Attachment D, Smolander

et al. (1984), and Smolander et al.

(1985).) These researchers found that

personal protective clothing

substantially increased oxygen

consumption and carbon dioxide

production, and recommended careful

evaluation of the cardiovascular health

and heat tolerance of workers who must

wear personal protective clothing.

In another study (Ex. 64–445), healthy

young men (average age: 29 years), older

men (average age: 47 years), and women

(average age: 29 years) used airpurifying respirators while performing

the following simulated, low physical

workload, mining task: lifting a shovel

weighing 3.1 lbs. (6.8 kg.) from the floor

to the top of a table (a distance of 3 feet

(90 cm)), releasing the shovel’s grip,

then lifting the shovel from the table

back to the floor and releasing the grip

again. The task was performed at a rate
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1217

of 10 cycles per minute for 20 minutes

at temperatures of 73° F (23° C) and 104°

F (40° C). The study participants wore

appropriate mining clothing (i.e., pants,

heavy shirt, gloves, leather apron, and

safety helmet) while performing the

task. The results showed that respirator

use and heat combined to raise the heart

rate substantially more than either

variable alone, and that this effect was

especially pronounced for the women.

This study, and the NIOSH study

described earlier, demonstrated that

information regarding such

physiological stressors as physical work

effort, respirator type and weight,

personal protective clothing, and

temperature and humidity conditions

must be provided to PLHCPs who are

responsible for medically evaluating

employees for respirator use. The

studies found that these stressors,

especially respirator weight, impose

physiological burdens that result in

substantial impairment to functional

capacity, even among healthy respirator

users. OSHA believes, therefore, that

information on respirator type and

weight, personal protective clothing,

and temperature and humidity must be

provided to, and be considered by,

PLHCPs to ensure that only employees

who can endure these stressors without

adverse medical consequences are

recommended for the respiratory

protection program; consequently, these

items were included in paragraph

(e)(5)(i) of the final standard.

The United Steelworkers (Tr. 1057)

stated that ‘‘[PLHCPs should be]

mandated to have knowledge of the

workplace, and possibly to have visited

it at some point in time.’’ OSHA agrees

that familiarity with the workplace is

important, and believes that many

employers will make such visits a

requirement. OSHA believes, however,

that making such visits a requirement is

unnecessary because the information

required to be given to the PLHCP by

the standard will be sufficient for the

PLHCP to make a valid recommendation

regarding the employee’s ability to use

the respirator.

Other revisions made to the proposed

paragraph include a requirement that

the weight of the respirator be provided

to the PLHCP, principally to inform the

PLHCP of the physical stress that a

heavy respirator may impose on an

employee’s cardiovascular and

respiratory systems. This revision was

made in response to the number of

commenters (Exs. 54–153, 54–165, 54–

218, 54–226, 54–227, 54–263, 54–264,

54–294, 54–326, 54–327, 54–363, 54–

443) who recommended that employees

using SCBAs and other heavy

respirators be administered medical

examinations, largely because of the

additional workload associated with

using these respirators. A physician (Tr.

398) testified that SCBAs in particular

increased an employee’s workload by 20

percent. The studies just discussed also

demonstrate that respirator weight plays

a significant role in the increased

burden that a respirator places on the

user. In addition, scientific evidence

obtained by Louhevaara et al. (Ex. 164,

Attachment D) demonstrates that use of

SCBAs by experienced firefighters

performing light to moderate exercise on

a treadmill substantially reduces tidal

volume and increases heart rate, oxygen

consumption, and ventilation rate.

These physiological effects led Kilbom

(Ex. 164, Attachment D) to recommend

that no firefighter over the age of 50 be

assigned tasks that require SCBA use.

In the NPRM, OSHA asked whether

information on the duration and

frequency of respirator use should be

provided to the PLHCP. No comments

were received on this subject. The

research studies described earlier in this

Summary and Explanation show that

duration and frequency of respirator use

interact with other respirator use

conditions (e.g., respirator weight,

protective clothing, temperature and

humidity) in imposing pulmonary and

cardiovascular stress on respirator users.

OSHA believes that information about

the duration and frequency of respirator

use will be important to PLHCPs in

making medical ability

recommendations, and concludes that

this information must be included in the

information required to be provided to

the PLHCP.

Paragraph (e)(5)(ii). As noted above,

OSHA received recommendations from

several commenters (Exs. 54–181, 54–

234, 54–330, 54–445) to reduce the

amount of information required to be

submitted to the PLHCP. In responding

to this recommendation, OSHA first

reduced the number of items required.

Second, OSHA revised the requirement

so that employers only need to provide

the supplemental information once to

the PLHCP, unless the information

differs from the information provided to

the PLHCP previously or a new PLHCP

is conducting the medical evaluations.

Under the revised provision, therefore,

the employer must ensure that: the

PLHCP retains the supplemental

information that is provided by the

employer; the supplemental information

is updated appropriately and in a timely

fashion; and a new PLHCP is provided

with the required supplemental

information. The requirement to provide

the new PLHCP with the appropriate

information does not mean that the new

PLHCP must medically reevaluate

employees, only that the new PLHCP

obtains the information required under

this paragraph. The employer can meet

this requirement by either providing the

relevant documents to the new PLHCP

or ensuring that the documents are

transferred from the former PLHCP to

the new PLHCP.

Paragraph (e)(5)(iii). OSHA believes

that the requirement for employers to

provide a copy of the final standard and

a copy of the written respiratory

program to the PLHCP, although not

included in the proposed standard, is

needed to assure that PLHCPs have a

thorough understanding of their duties

and responsibilities in the medical

evaluation process, thereby enhancing

their ability to make a sound medical

recommendation on an employee’s

ability to use the respirator. The written

program is site-specific, and will inform

the PLHCP of the working conditions

the employee will encounter during

respirator use. This information is

critical if the PLHCP is to make a

thorough and accurate evaluation of the

employee’s ability to use the assigned

respirator. The PLHCP’s ability to

conduct appropriate medical evaluation

will also be aided by knowledge of the

standard, which sets forth the

requirements of the medical evaluation

program, as well as other requirements

that affect the employee’s respirator use.

Consequently, this requirement will

help ensure that medical evaluations

conducted by PLHCPs are thorough and

accurate; recommendations regarding an

employee’s medical ability to use the

respirator are valid; employees are

informed of these recommendations;

and the privacy and confidentiality of

employees are maintained. OSHA

believes that this requirement is

necessary to ensure that the objectives

and other requirements of final

paragraph (e) are fulfilled.

As noted in the previous discussion of

paragraph (e)(5)(ii), this information

must be provided to the PLHCP only

once for all employees who are involved

in the employer’s respiratory protection

program. This information does not

have to be provided again to the same

PLHCP unless the standard or the

employer’s respiratory protection

program is substantially revised. For

example, the information does not have

to be provided again when only minor

revisions have been made to either the

standard or the respiratory protection

program. When the employer hires a

different PLHCP to conduct medical

evaluations, the employer must ensure

that the new PLHCP has this

information, by either providing the

new PLHCP with the appropriate

documents or ensuring that the
1218 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

documents are transferred from the

former PLHCP to the new PLHCP.

Paragraph (e)(6)—Medical

Determination

Paragraph (e)(1) of the NPRM

proposed that the employer be

responsible for making the final

determination regarding the employee’s

ability to use the respirator. The

proposed regulatory language required

the physician (now a PLHCP) to deliver

a medical opinion regarding the

employee’s medical ability to use the

respirator, including any recommended

limitations on this use, to the employer.

OSHA proposed, consistent with its

substance-specific standards, to make

the employer responsible for the final

determination regarding an employee’s

ability to use the respirator. This

determination was to be based on all of

the information available to the

employer, including the physician’s

opinion and recommendations. The

final standard follows this approach,

although the final rule’s requirements

have been revised to reflect the record.

Paragraph (e)(6)(i). This provision

states that the ‘‘employer shall obtain a

written recommendation regarding the

employee’s ability to use the respirator

from the PLHCP * * * ‘‘ Because the

PLHCP’s recommendation is an

important element in the employer’s

determination as to whether it is

hazardous for an employee to use a

respirator, the recommendation needs to

be clear and in writing.

Final paragraph (e)(6)(i) requires that

the PLHCP’s recommendation be

restricted to the three elements listed in

paragraphs (e)(6)(i)(A) through (C) (i.e.,

‘‘[t]he recommendation shall provide

only the following information’’)

[emphasis added]. This requirement is

similar to the proposed regulatory

language for paragraph (e)(1) and

paragraph (e)(1)(v) of proposed

alternative 3. The purpose of this

limitation is to protect employee

privacy with regard to medical

conditions not relevant to respirator use.

Several commenters (Exs. 54–92, 54–

455) supported the need for privacy but

recommended further that the basis of

the PLHCP’s medical recommendation

not be disclosed to employers because

such information could be used by an

employer to remove an employee from

the workforce. The AFL–CIO (Ex. 54–

428) stated that ‘‘[medical] reports to

employers should contain only a

statement of approval or disapproval for

employees who are tested.’’ The

Brotherhood of Maintenance of Way

Employees (BMWE) (Ex. 122) supported

limiting the medical information

provided to the employer to whether or

not the employee can perform the

required work while using the

respirator, and whether or not

restrictions need to be applied to the

employee’s respirator use. The BMWE

stated further that no information

should be provided on the specific

medical conditions detected during the

medical evaluation.

OSHA believes that protection of

employee privacy and confidentiality is

important to obtain accurate and candid

responses from employees about their

medical conditions. OSHA has retained

this requirement in the final standard

and believes that, as worded, it strikes

the proper balance between the need to

provide sufficient information to the

employer to make a decision on

respirator use and the need to protect

employee privacy.

Paragraph (e)(6)(i)(A) in the final

standard also specifies the information

the PLHCP is to include in the

recommendation to the employer: ‘‘Any

limitations on respirator use related to

the medical condition of the employee,

or relating to the workplace conditions

in which the respirator will be used,

including whether or not the employee

is medically eligible to use the

respirator.’’ OSHA’s experience in

enforcing standards with similarly

worded provisions indicates that this

language is appropriate; also, OSHA

believes a statement regarding the

employee’s medical ability to use the

respirator will assist both the employer

and employee in determining the final

medical disposition of the employee.

Paragraph (e)(6)(i)(B) of the final

standard specifies that the PLHCP must

state whether there is a need for followup medical evaluations. This provision

was added to the final standard for

several reasons. First, the initial medical

evaluation may indicate that there is a

possibility that the employee’s health

may change in a way which would

reduce the employee’s ability to use a

respirator. In these circumstances, the

PLHCP is required to specify

appropriate follow-up medical

evaluations. Second, the final standard

does not provide for periodic (such as

annual) evaluations, as most other

OSHA health standards do. It is

therefore important that the PLHCP

specify whether an employee requires

follow-up medical evaluation so that the

employee’s ability to use a respirator

can be carefully monitored by the

PLHCP. This requirement will ensure

that employees are using respirators that

will not adversely affect their health.

Paragraph (e)(6)(i)(C) requires that the

employee be provided with a copy of

the PLHCP’s written recommendation.

No comments were received by the

Agency on this proposed requirement.

OSHA believes that a copy of the

PLHCP’s written recommendation will

provide employees with information

necessary to ensure that they are using

respirators that will not adversely affect

their health.

The employer may either transmit the

PLHCP’s written recommendation to the

employee or arrange for the PLHCP to

do so. The employer shall allow the

employee, consistent with paragraph

(e)(4)(ii) of the final standard, to discuss

the recommendation with the PLHCP.

During the discussion, the PLHCP may

inform the employee of the basis of the

recommendation, as well as other

medical conditions that are indicated by

the results of the medical evaluation but

that are not directly related to the

employee’s medical ability to use the

respirator. OSHA believes that the

additional information provided to the

employee by the PLHCP should be

determined by the legal, professional,

and ethical standards that govern the

PLHCP’s practice and, therefore, should

not be regulated by the final standard.

Paragraph (e)(6)(ii). If the PLHCP’s

medical evaluation finds that use of a

negative pressure respirator would place

the employee at increased risk of

adverse health effects, but that the

employee is able to use a powered airpurifying respirator (PAPR), this

paragraph requires employers to provide

the employee with a PAPR. The

rationale for this provision was

discussed in the proposal (59 FR 58906).

Negative pressure respirators can result

in sufficient cardiovascular and

respiratory stress to make employees

medically unable to use this class of

respirators. The use of PAPRs involves

lower cardiovascular and respiratory

stress, and PAPRs can often be tolerated

by employees when negative pressure

respirators cannot. Consequently, OSHA

believes that this requirement is

consistent with the requirements of

paragraph (a)(2) of the final standard,

which states that ‘‘employers [must]

provide the respirators which are

applicable and suitable for the purpose

intended.’’

Several commenters endorsed this

provision (Exs. 54–101, 54–363, 54–

455). ISEA (Ex. 54–363) recommended

that ‘‘employers ensure that all

alternative types [of respirators] be

considered and made available’’ to

employees found to be medically unable

to use the respirator selected initially by

the employer. The proposal was

consistent with this recommendation in

requiring that alternative respirators be

selected from among existing positive

pressure respirators, including

supplied-air respirators. OSHA has
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1219

determined, however, that supplied-air

respirators should not be listed as

alternative respirators in the final

standard because, as noted earlier in

this Summary and Explanation, these

respirators impose many of the same

pulmonary and cardiovascular burdens

on employees as negative pressure

respirators. The Brotherhood of

Maintenance and Way Employees

(BMWE) (Ex. 126) found that PAPRs

would be an effective substitute for

negative pressure respirators, and

endorsed issuing PAPRs to employees

who were found to be medically unable

to use negative pressure respirators. In

making this endorsement, the BMWE

estimated that less than 1 percent of its

membership would require such an

upgrade. Consequently, OSHA removed

the requirement for supplied-air

respirators from the final standard, and

now requires only that employers

provide PAPRs to employees who are

medically unable to use negative

pressure respirators but who are able to

use PAPRs. In addition, paragraph

(e)(6)(ii) of the final standard specifies

that if a subsequent medical evaluation

finds that the employee is able to use a

negative pressure respirator, then the

employer is no longer required to

provide that employee with a PAPR.

Paragraph (e)(7)—Additional Medical

Evaluations

Paragraph (e)(7) of the standard

requires the employer to provide

additional medical evaluations

whenever there is any indication that a

reevaluation is appropriate. At a

minimum, this would occur: if the

employee reports any signs or

symptoms that are related to the ability

to use a respirator; if the PLHCP,

program administrator or supervisor

determines that a reevaluation is

necessary; if information from the

respiratory protection program indicates

a need for reevaluation; or if a change

in workplace conditions could affect the

physiological burden placed on the

employee. This is a significant change

from the proposal, which in alternatives

2 and 3 would have required

reevaluation on an annual basis of

employees subject to medical

evaluation. Although this would not

necessarily have required a medical

examination, proposed paragraph (e)(3)

and alternative 3 would have required a

written medical opinion. The provision

in the final standard is similar to the

requirement in several of OSHA’s

substance-specific standards that

employees be medically reevaluated if

they experience breathing difficulties

during fit testing or under other

respirator use conditions (see, e.g., the

Cadmium standard at 29 CFR

1910.1027(l)(6)(iii)).

OSHA also made a specific request for

comments on the appropriateness of

requiring medical evaluations at the agerelated intervals used by ANSI or

NIOSH. ANSI and NIOSH recommend

that older employees should be

screened more frequently than younger

employees because of the heightened

risk of cardiovascular and respiratory

disease associated with age. The ANSI

Z88.6–1984 consensus standard

recommends medical evaluations at the

following age intervals: every five years

below age 35, every two years for

employees aged 35 to 45, and annually

thereafter. NIOSH’s Respirator Decision

Logic (Ex. 9) calls for medical

evaluations at similar intervals, except

that employees over 45 years old should

be evaluated every one to two years.

One commenter (Ex. 54–394) stated that

age-based medical evaluations are

important because the American

workforce is aging.

The proposed requirement that

medical reevaluation be conducted

annually resulted in numerous

comments, most of which recommended

that the requirement be revised. Eight

commenters (Exs. 54–219, 54–224, 54–

253, 54–264, 54–348, 54–421, 54–441,

54–455) endorsed the proposed

requirement without revision. Three

commenters (Exs. 54–70, 54–326, 54–

357) stated that cost concerns and the

administrative burden should limit

annual medical evaluations to

employees who use SCBAs. Other

commenters (Exs. 54–70, 54–185, 54–

206, 54–326, 54–357, 54–429)

recommended that annual medical

evaluations be administered to

employees who use non-SCBA

respirators only if such use is on a daily

basis, for more than 50 per cent of the

work week, or at least five hours per

work week. A few commenters (Exs. 54–

220, 54–244, 54–327, 54–424, 54–429)

recommended annual medical

evaluations if the evaluations consisted

entirely of a medical questionnaire.

The Boeing Company (Ex. 54–445)

was one of the commenters

recommending that OSHA reconsider

the requirement for annual medical

examinations. Boeing stated:

[Our] experience with annual review has

been that approximately 1–2% of [our]

employees reviewed per year are restricted

from respirator use. Very rarely to never are

these restrictions due to a medical condition

that would make respirator use dangerous for

an employee. Rather, the restrictions are

related to other aspects of an employee’s job

or to administrative reasons, such as failure

to undergo the review or employee

preference.

The American Iron and Steel Institute

(AISI) (Ex. 175) also provided limited

evidence that regular (e.g., annual)

medical examinations are ineffective.

AISI cited an industry study in which

2,195 medical examinations were

administered to 1,816 employees

subsequent to their initial medical

examination; the elapsed interval,

however, was unspecified. The medical

reevaluations found only two employees

who had unknown (to the employees)

medical conditions; one of the

employees had claustrophobia, and the

other employee had reduced pulmonary

function and an abnormal chest x-ray.

AISI recommended that the frequency of

medical reevaluation be ‘‘determined by

a licensed medical provider or to verify

a suspected functional disability that

might affect the ability to wear a

respirator.’’

The statements and recommendations

made by commenters who believed that

the requirement should be revised or

eliminated are summarized as follows:

(1) An annual interval is arbitrary or

unnecessary (Exs. 54–234, 54–263, 54–

267);

(2) A biannual interval should be used

(Exs. 54–191, 54–278, 54–326);

(3) The intervals should be age-based,

using either the ANSI or NIOSH age

intervals (Exs. 54–66, 54–172, 54–215,

54–245, 54–250, 54–273, 54–318, 54–

374, 54–381, 54–388, 54–426, 54–441,

54–450, 54–451, 54–452, 54–453), the

age intervals recommended by the

National Fire Protection Association

(NFPA) under NFPA standard 1582 (Ex.

54–155), or unspecified age intervals

(Exs. 54–67, 54–218, 54–240, 54–271,

54–326, 54–327, 54–342, 54–346, 54–

361, 54–363, 54–429, 54–445, 54–454);

(4) Medical reevaluation should be

conducted only at the request of the

PLHCP (Exs. 54–70, 54–150, 54–180,

54–217, 54–224, 54–313, 54–348, 54–

350, 54–361, 54–432, 54–448, 54–449,

54–450, 54–451, 54–452), employers

(Ex. 54–251), employees (Ex. 54–157), or

employees trained to recognize

respirator-induced medical effects (Exs.

54–181, 54–219, 54–242);

(5) Medical reevaluation should be

event-driven, with the events specified

as a combination of age, physical

condition or medical symptoms

(including breathing difficulty), job

conditions, respirator type, frequency of

respirator use, medical history, or type

of exposure (Exs. 54–79, 54–187, 54–

189, 54–217, 54–218, 54–219, 54–220,

54–242, 54–253, 54–265, 54–275, 54–

278, 54–318, 54–319, 54–342, 54–357,

54–381, 54–395, 54–439), or when job

conditions or the type of respirator used

by the employee increase the risk of
1220 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

adverse effects on the employee’s health

(Exs. 54–151, 54–153).

Several commenters (Exs. 54–38, 54–

191, 54–388) stated that medical

reevaluation should not be conducted

when employees experience breathing

difficulties during respirator use

because these effects usually occur as a

result of canister or filter overloading

rather than an employee’s medical

condition.

The commenters who endorsed the

proposed requirement for an annual

medical evaluation stated that annual

medical evaluations would identify or

prevent medical problems that may

arise as a result of less frequent or eventdriven medical evaluations. After

carefully reviewing the entire record,

OSHA decided to revise the proposed

requirement and to make medical

reevaluation contingent on specific

events that may occur during respirator

use, regardless of the duration of

respirator use. OSHA also has

determined that a rigid approach to

medical reevaluation based on age may

ignore serious medical conditions

among younger employees that could be

aggravated by continued respirator use.

As noted by Dr. Ross H. Ronish, Site

Medical Director for the Hanford

Environmental Health Foundation (Ex.

54–151), ‘‘[m]edical conditions which

can affect the ability of an individual to

use various types of respirator occur

even in young people.’’

This approach is appropriate because

medical problems requiring evaluation

by a PLHCP can occur after any period

of respirator use and in workers of any

age, and the requirement for medical

reevaluation must be sufficiently

flexible to accommodate this variability.

In addition, the employee, supervisor,

and program administrator are in a

position to note conditions, such as

breathing difficulty, which would

trigger the need for a medical

reevaluation.

The events described in paragraph

(e)(7) of the final standard include

significant medical, occupational, and

respirator use conditions that warrant

medical reevaluation because these

conditions are known to impose

additional physiological stress on

employees, or are recognized indicators

of medical problems associated with

respirator use. This paragraph,

therefore, will provide for flexible and

prompt detection of medical problems

among employees who use respirators.

The specific events OSHA has listed

in paragraphs (e)(7)(i), (ii), (iii) and (iv)

that trigger medical reevaluation are

based on OSHA’s experience with

substance-specific standards and the

record of this rulemaking. OSHA

believes that these events cover most

situations in which employees are at

risk of experiencing adverse health

effects because of respirator use and in

which the employee’s underlying

medical conditions or workplace

conditions have changed sufficiently to

make the initial medical evaluation

obsolete. As noted earlier in the

discussion of this paragraph, these

variables were considered by many

commenters to be important in

determining the frequency with which

employees should be medically

reevaluated.

Medical Removal Protection

The proposed rule did not include a

provision for medical removal

protection (MRP). Such a provision

requires employers to provide

employees who are unable to use

respirators with alternative jobs at no

loss of pay and other benefits. In the

notice of proposed rulemaking (59 FR

58912), the Agency noted that MRP

provisions had been included in some

earlier substance-specific standards, but

stated that insufficient information had

been provided in response to the ANPR

to include in the proposed rule an MRP

provision that would be applicable to all

workplaces in which respirators are

used. To enable it to evaluate whether

an MRP provision might be appropriate

for this generic respirator standard,

OSHA asked for comments and

information about cases in which

employees were found to be unable to

use respirators in their jobs. The Agency

specifically requested information about

the frequency of cases in which

employees were found to be unable to

use respirators and the details of such

cases, including how the determination

of an employee’s inability to use a

respirator affected the worker’s job

responsibilities.

Numerous comments were received

on this issue. Most of the commenters

who addressed the issue (Exs. 54–92,

54–206, 54–220, 54–240, 54–250, 54–

267, 54–273, 54–286, 54–295, 54–342,

54–381, 54–435, 54–443) suggested that

a provision requiring employers to

provide alternative jobs as a

consequence of medical removal be

excluded from the final standard,

although some (Exs. 54–213, 54–387,

54–427, 54–428, 54–455) endorsed such

a provision. The commenters who

opposed the provision argued that:

employees already receive adequate

protection against medically related job

displacement and unemployment

through existing federal, state, and local

law (e.g., the Americans with

Disabilities Act and the Rehabilitation

Act of 1973); the requirement exceeded

OSHA’s statutory authority; and OSHA

failed to justify the provision adequately

in the proposal. Commenters who

favored MRP believed that such a

provision was needed for medical

evaluation to be effective. They stated

that employees will refuse necessary

medical evaluation if they believe their

jobs might be placed in jeopardy. The

Brotherhood of Maintenance of Way

Employees (BMWE) (Ex. 126) endorsed

MRP, claiming that in most cases such

protection is feasible on both a

temporary and permanent basis for the

railroad industry; infeasible or

inconvenient cases could be resolved,

according to this commenter, under

their collective bargaining agreement.

The BMWE also recommended that

employees who have been determined

by employers to be unable to use

respirators be allowed to seek a second

medical opinion (i.e., to have multiple

physician review) ‘‘unencumbered by

ulterior motives on the part of the

employer.’’

As noted above, OSHA has included

MRP in some of its existing substancespecific standards for employees who

are unable to use respirators. In the

Cotton Dust standard, for example,

OSHA provided that if a physician

determines that an employee is unable

to use any type of respirator, the

employee must be given the opportunity

to transfer to an available position in

which respirator use is not required,

with no loss of wages or benefits (50 FR

51154–56). OSHA specifically found,

based on the evidence in the Cotton

Dust rulemaking record, that some

employees would be reluctant to reveal

information necessary for proper health

care if the employee feared that the

information might result in transfer to

lower paying jobs. Similar MRP

provisions for employees unable to use

respirators have been included in

OSHA’s Asbestos and Cadmium

standards. However, MRP provisions for

workers unable to use respirators have

not been included in most of OSHA’s

substance-specific standards, even

though all such standards require that

employees who use respirators undergo

medical evaluation to determine their

ability to do so (e.g., the 1,3-Butadiene,

Formaldehyde, Ethylene Oxide,

Acrylonitrile, Benzene, and Lead

standards).

OSHA believes that a number of

provisions of the final standard will

effectively avoid any disincentive on the

part of employees to cooperate with

medical evaluation. Paragraph (e)(1)

requires the employer to provide

medical evaluation to an employee

before the employee uses a respirator in

the workplace. Therefore, employees
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1221

cannot refuse to undergo medical

evaluation and continue in a job that

requires respirator use. All employees

who use SCBAs, the type of respirator

that imposes the greatest physiological

burden on the user, must receive

medical examinations, and the PLHCP

who conducts the examination has

discretion to determine the tests,

consultations, and diagnostic

procedures to be included in the

examination. Given this discretion on

the part of the PLHCP, and the PLHCP’s

awareness of the considerable

physiological burden that SCBA use

places on the user, OSHA believes that

the PLHCP will be able to evaluate the

employee’s ability to use an SCBA even

if the employee is reluctant to cooperate

fully with the examination.

Moreover, paragraph (e)(7) requires

the employer to medically reevaluate an

employee when a PLHCP, supervisor, or

program administrator observes that the

employee is having a medical problem

during respirator use and they inform

the employer of their observation. Many

of the jobs in which SCBA use is

required are strenuous, and any undue

physiological burden the respirator

places on an employee will often be

readily observable by the employer,

PLHCP, supervisors, or program

administrator. Paragraph (e)(7),

therefore, will help ensure that an

employee who is medically unable to

use a respirator, whether a SCBA or

another type of respirator, cannot avoid

medical evaluation by refusing to

cooperate.

The final standard also encourages

cooperation in medical evaluation by

employees who are assigned to use

negative pressure respirators. Some

employees will be unable to use

negative pressure respirators because of

breathing resistance caused by medical

conditions such as asthma and

bronchitis. The final standard provides

these employees with a strong incentive

to cooperate with medical evaluation by

requiring the employer to provide them

with a powered air-purifying respirator

(PAPR) when the PLHCP who conducts

the evaluation determines that the

employees cannot use a negative

pressure respirator but can use a PAPR.

OSHA believes that many workers who

are medically unable to use a negative

pressure respirator will be able to use a

PAPR, which offers considerably less

breathing resistance than a negative

pressure respirator. Therefore, those

employees who are concerned about

their medical ability to use a respirator

will have a strong incentive to cooperate

fully with the medical evaluation

because they are likely to be provided

with a less physiologically burdensome

respirator that will enable them to

continue in their jobs.

Paragraph (f)—Fit Testing

Introduction

The final rule requires that, before an

employee is required to use any

respirator with a negative or positive

pressure tight-fitting facepiece, the

employee must be fit tested with the

same make, model, style and size of

respirator that will be used. The ANSI

Z88.2–1992 respiratory protection

standard also recommends such testing

before respirator use. Employers who

allow employees to voluntarily use

respirators need not provide fit testing

for those employees, although OSHA

encourages them to do so.

It is axiomatic that respirators must fit

properly to provide protection. If a tight

seal is not maintained between the

facepiece and the employee’s face,

contaminated air will be drawn into the

facepiece and be breathed by the

employee. The fit testing requirement of

paragraph (f) seeks to protect the

employee against breathing

contaminated ambient air and is one of

the core provisions of the respirator

program required by this standard.

In the years since OSHA adopted the

previous respirator standard, a number

of new fit testing protocols have been

developed and tested (Exs. 2, 8, 24–2,

24–12, 24–20, 46, 49). During the same

period manufacturers have developed

multiple sizes and models of respirator

facepieces in order to provide better fits

for the variety of facial sizes and shapes

found among respirator users.

Incorporation of these advances into the

standard is particularly important

because facepiece leakage is a major

source of in-mask contamination.

Studies show that lack of fit testing

results in reduced protection. In a

health hazard evaluation (HHE)

conducted by NIOSH at a medical

center (Ex. 64–56), NIOSH found that

workers using disposable respirators

were not getting adequate protection

because the respirators had not been fit

tested. Other HHEs conducted by

NIOSH show that workers who used

respirators where there was no fit

testing suffered adverse health effects

resulting from overexposure to airborne

contaminants (See HETAs 81–283–1224

and 83–075–1559).

Based on the record evidence, OSHA

concludes that poorly fitting facepieces

expose workers to contaminants and

that the use of an effective fit testing

protocol is the best way of determining

which respirator facepiece is most

appropriate for each employee. Indeed,

the need to include fit testing

requirements in the standard, and to

specify the proper method of

accomplishing such testing, were among

the major reasons OSHA proposed to

revise the existing respirator standard.

Fit testing may be either qualitative or

quantitative. Qualitative fit testing

(QLFT) involves the introduction of a

gas, vapor, or aerosol test agent into an

area around the head of the respirator

user. If the respirator user can detect the

presence of the test agent through

subjective means, such as odor, taste, or

irritation, the respirator fit is

inadequate. In a quantitative respirator

fit test (QNFT), the adequacy of

respirator fit is assessed by measuring

the amount of leakage into the

respirator, either by generating a test

aerosol as a test atmosphere, using

ambient aerosol as the test agent, or

using controlled negative pressure to

measure the volumetric leak rate.

Appropriate instrumentation is required

to quantify respirator fit in QNFT.

OSHA’s prior respirator standard

required training that provided

opportunities for each user to have the

respirator ‘‘fitted properly’’ and to wear

it in a test atmosphere. However, it did

not specify the test protocols to be used.

The previous standard also required that

employees be trained to check the fit

each time the respirator is put on,

although without specifying how the fit

check was to be performed or the types

of fit checks that were acceptable.

OSHA’s own compliance experience,

and the experience gained from

respirator research over the past 25

years, demonstrates that the existing

standard’s limited fit testing

requirements do not provide employers

with adequate guidance to perform

appropriate fit testing.

The substance-specific standards that

have been issued over the past 20 years

show the evolution of OSHA’s

recognition of the need for fit testing

guidance. The early standards, such as

the 1978 Acrylonitrile standard (29 CFR

1910.1045) and the 1978 Lead standard

(29 CFR 1910.1025), required

quantitative fit tests but did not provide

specific protocols. Subsequently, in

1982, the lead standard was amended to

allow qualitative fit testing for half mask

negative pressure respirators, provided

that one of three specified protocols was

followed (47 FR 51110). These specified

qualitative fit testing (QLFT) protocols

use isoamyl acetate, irritant smoke, or

saccharin as the test agents. They have

been used in all subsequent standards

(e.g., Cadmium, § 1910.1027; 1–3

Butadiene, § 1910.1051; Methylene

Chloride, § 1910.1052) with fit testing

requirements.
1222 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

One of the major changes from

requirements in the previous standard

made by this final standard is its

requirement that fit testing be

conducted according to specific

protocols and at specific intervals or on

the occurrence of defined triggering

events. Paragraphs (f)(1) and (f)(2) of the

standard require employers to ensure

that each employee using a tight-fitting

facepiece respirator passes an

appropriate fit test before using such a

respirator for the first time and

whenever a different respirator

facepiece is used, as well as at least

annually thereafter. Paragraph (f)(3)

requires the employer to provide an

additional fit test whenever the

employee reports, or the employer,

PLHCP, supervisor, or program

administrator observes, changes in the

employee’s physical condition that

could affect respirator fit. Examples of

conditions causing such changes could

be the wearing of new dentures,

cosmetic surgery, or major weight loss

or gain. Paragraph (f)(4) specifies that if

an employee who has passed a fit test

subsequently notifies the employer,

program administrator, supervisor, or

PLHCP that the fit of the respirator is

unacceptable, the employee must be

given a reasonable opportunity to select

a different respirator facepiece and to be

retested. Paragraph (f)(5) requires that

the fit test be administered according to

one of the protocols included in

mandatory Appendix A.

Paragraph (f)(6) limits qualitative fit

testing to situations where the user of a

negative pressure air-purifying

respirator must achieve a minimum fit

factor of 100 or less. Paragraph (f)(7)

explains that a quantitative fit test has

been passed when the fit factor, as

determined through an OSHA accepted

protocol, is at least 100 for tight-fitting

half masks or 500 for tight-fitting full

facepiece respirators.

Paragraph (f)(8) requires that all QLFT

or QNFT fit testing of tight-fitting

atmosphere-supplying respirators and

tight-fitting powered air-purifying

respirators be performed with

respirators in the negative pressure

mode, even if they are to be used in

positive pressure mode in the

workplace, and contains additional

requirements for measuring fit testing

results. It also requires that all

facepieces modified to perform a fit test

be restored to their NIOSH-approved

configuration before being used in the

workplace.

Detailed discussions of each of the

paragraphs related to fit testing follow.

Fit Testing—Paragraph (f)(1)

Paragraph (f)(1) of the final standard

requires that all tight-fitting respirators

be fit tested in accordance with the

requirements of the final standard. The

ANSI Z88.2–1992 standard has a similar

fit testing requirement, as did proposed

paragraph (f)(3). The need to fit test

‘‘negative pressure’’ respirators was

widely supported (Exs. 54–5, 54–38, 54–

67, 54–153, 54–158, 54–167, 54–172,

54–173, 54–185, 54–208, 54–219, 54–

263, 54–273, 54–278, 54–313, 54–330,

54–424). No comments opposing this

requirement were received.

However, the record contains

comments both supporting and

opposing the need to require the same

type and frequency of fit testing for

‘‘positive pressure’’ respirators, which

are defined in the final standard as

respirators ‘‘in which the pressure

inside the respiratory inlet covering

exceeds the ambient air pressure outside

the respirator.’’ A number of

commenters stated that positive

pressure atmosphere-supplying

respirator users should not be required

to pass a fit test (Exs. 54–271, 54–280,

54–290, 54–297, 54–314, 54–324, 54–

330, 54–339, 54–346, 54–350, 54–352,

54–361, 54–424). These commenters

believed that fit testing of such

respirators was not needed because the

positive pressure inside the facepiece

would prevent contaminated ambient

air from leaking from the outside

atmosphere to the area inside the

facepiece.

For example, the Southern California

Edison Company (Ex. 54–316) stated

that there was no need to fit test tightfitting positive pressure respirators

because ‘‘[t]he chances of these type of

respirators becoming negative pressure

under normal use conditions are very

slim and generally occur only when

there has been a restriction or failure of

the air supply system.’’ The Alabama

Power Company (Ex. 54–217) similarly

stated that there was no need to fit test

tight-fitting supplied air respirators

(SARs) or powered air-purifying

respirators (PAPRs) because the chance

was slight that a negative pressure

condition would occur during normal

use. The Reynolds Metals Company (Ex.

54–222) stated that, with positive

pressure respirators, gross leaks were

unlikely to occur if the user was trained.

Beaumont & Associates (Ex. 54–246)

stated that a well trained user of

pressure demand or continuous flow

respirators would quickly be aware of

any gross leakage. Eric Jaycock, CIH,

(Ex. 54–419) questioned whether

requiring the fit testing of positive

pressure respirators would cause

employers to choose other, less

protective, respirators. The County of

Rockland Fire Training Center (Ex. 54–

155) stated that positive pressure SCBAs

may, theoretically, leak around the seal,

but that, in its experience, this was

unlikely to happen in normal working

situations. It recommended that positive

pressure SCBAs be exempted from the

fit test requirement if the user passes a

negative pressure fit check upon

donning to ensure an effective seal.

Other evidence in the record,

however, demonstrates that, even with

positive pressure respirators, facepiece

leakage can occur when the high

inhalation rates associated with

increased workloads cause the facepiece

pressure to become negative in relation

to the outside atmosphere. An

evaluation of the performance of

powered air-purifying respirators

equipped with tight-fitting half masks

by the Lawrence Livermore National

Laboratory (Ex. 64–94) demonstrated

what its authors called the ‘‘Myth of

Positive Pressure.’’ The study found

that, at the NIOSH-required flow rate of

4 cubic feet/minute (cfm), a half mask

PAPR tested at an 80% work rate had a

negative facepiece pressure during

inhalation for all subjects. The authors

concluded that the respirator protection

that the device can provide is

dependent in large part on the tightness

of the seal to the face of the wearer.

Dahlback and Novak (Ex. 24–22) also

found negative pressure inside the

facepieces of pressure-demand

respirators when workers engaged in

heavy work and had inhalation peak

flow rates of 300 liters a minute.

Workers in this study who had not been

fit tested developed negative pressure

inside their masks much more

frequently than those who had been fit

tested.

Some commenters (Exs. 54–214, 54–

217, 54–222, 54–232, 54–234, 54–245,

54–251, 54–278, 54–330, 54–424) stated

that any negative pressure due to leaks

on inhalation can be countered by the

increased air flow of a positive pressure

respirator. While increased air flow can

reduce the number of negative pressure

episodes (Ex. 64–94), OSHA does not

believe that the realities of respirator

usage allow exclusive reliance on this

mechanism to substitute for fit testing.

Moreover, the air pressure that positive

pressure respirators provide inside the

facepiece is intended to overcome the

momentary leakage that may occur even

with a properly fitting facepiece. This

positive airflow alone is not an adequate

substitute for a properly fitting

facepiece, and cannot be relied upon to

overcome the leakage that can occur

into poorly fitting facepieces.
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1223

Requiring fit tests for positive

pressure respirators is also necessary

because the consequences of facepiece

leakage into positive pressure

respirators can be extremely serious.

Positive pressure respirators are usually

worn in more hazardous situations than

those in which negative pressure

respirators are worn. For example, only

positive pressure respirators can be

worn in IDLH atmospheres. By

definition, there is little tolerance for

facepiece leakage in such atmospheres.

Positive pressure respirators also are

used when the concentration of the

toxic substance is many times greater

than the permissible exposure limit.

Even where positive pressure respirators

are worn in lower risk situations, they

are often selected because the hazardous

gas or vapor in the atmosphere lacks

adequate sensory warning properties,

clearly a factor calling for the minimum

amount of facepiece leakage. Employees

also may believe that they can afford to

use less care in using a respirator that

appears to be highly protective; they

may ignore seal checks and strap

tensioning because they are relying on

air flow to overcome any leaks. Fit

testing demonstrates to employees that

positive pressure respirators can leak,

and offers an opportunity for the

employee to see, via quantification,

what actions (e.g., bending at the waist,

jerking the head, talking) relating to fit

will decrease protection.

Similarly, although a negative or

positive pressure user seal check is

important to ensure proper donning and

adjustment of the respirator each time it

is put on, it is not a substitute for the

selection of an adequately fitting

respirator through fit testing. Most

respirator fit testing is preceded by a

user seal check, but experience with

respirator fit testing has shown that

some individuals who pass this user

seal check with what they think is an

adequately fitting facepiece

subsequently fail their fit test due to

poor respirator fit. As John Hale of

Respirator Support Services (Ex. 54–5)

stated, ‘‘Yes, there is some information

to be obtained about gross facepiece-toface leakage by performing these checks.

But, there are no performance criteria,

there is no known correlation between

the result of this check and respirator fit

or performance * * * .’’

A number of experts and consensus

organizations supported the proposal’s

requirement for fit testing of all tightfitting respirators. The Washington State

Department of Labor and Industries (Ex.

54–173), the Aluminum Company of

America (Ex. 54–317) and the United

Auto Workers (Ex. 54–387) endorsed fit

testing for positive pressure respirators

because these respirators do not always

maintain positive pressure due to

overbreathing or physical exertion. The

Industrial Safety Equipment Association

(ISEA)(Ex. 54–363) supported OSHA’s

proposal for fit testing of all tight-fitting

respirators, stating that it was consistent

with the ANSI Z88.2-1992 standard’s

requirements. Fit testing for all tightfitting respirators is found in clause

9.1.2 of the ANSI Z88.2–1992 respirator

standard (Ex. 81), which requires that

positive pressure respirators with tightfitting facepieces be qualitatively or

quantitatively fit tested in the negative

pressure mode. The National Fire

Protection Association (NFPA)

standards 1500 and 1404 also require

that firefighters using SCBAs pass a fit

test (Tr. 479). The American Industrial

Hygiene Association (Ex. 54–208) also

supported the fit testing of all tightfitting respirators. Moreover, workplace

protection factor studies conducted by

respirator manufacturers, NIOSH,

national laboratories and others always

fit test subjects to reduce the effect of

facepiece leakage that is unrelated to

design and construction (See, e.g., Exs.

64–14, 64–36, 64–94).

This record has convinced OSHA that

it is necessary to require the fit testing

of both positive and negative pressure

tight-fitting respirators. Even positive

pressure respirators do not always

maintain positive pressure inside the

facepiece, particularly when facepiece

fit is poor, strenuous work is being

performed, and overbreathing of the

respirator occurs (Exs. 64–94, 64-101).

Leakage must be minimized so that

users consistently achieve the high

levels of protection they need. Most

workplace use of positive pressure

atmosphere-supplying respirators

occurs in high hazard atmospheres (e.g.,

emergencies, spills, IDLH conditions,

very high exposures, abrasive blasting),

where a high degree of certainty is

required that the respirator is maximally

effective. Positive pressure respirators,

like negative pressure respirators, come

in a variety of sizes and models, each

with its own unique fit characteristics.

The only reliable way to choose an

adequately fitting facepiece for an

individual user from among the

different sizes available is by fit testing.

The problem of leakage due to poor

facepiece fit can be minimized by

choosing good fitting facepieces through

fit testing for positive pressure

respirator users. OSHA concludes that

the requirement to fit test tight-fitting

positive pressure respirators is

appropriate to reduce leakage into

facepieces, and to improve the

protection that all kinds of tight-fitting

respirators provide in the workplace.

Frequency of Fit Testing—Paragraph

(f)(2)

Final paragraph (f)(2), like the

proposal, requires that fit testing be

performed prior to an employee’s initial

use of a respirator in the workplace;

whenever a different model, size, make,

or style of respirator facepiece is used;

and at least annually thereafter. Only

the requirement to conduct fit testing

annually was disputed in the

rulemaking. Commenters generally

agreed that some additional fit testing

beyond an initial test was necessary, but

opinions varied widely on the

appropriate intervals at which such tests

should be performed. A few

participants, including the UAW (Ex.

54–387), urged that fit testing be

required every six months, since

changes in weight, facial hair and

scarring, dental work, and cosmetic

surgery may alter respirator fit. The

UAW also stated that visual observation

was not a reliable way to identify the

presence of these changes.

A number of commenters suggested

that longer intervals, generally two to

three years, would be appropriate. For

example, Allied Signal (Ex. 54–175)

recommended ‘‘periodic’’ or ‘‘every twoyears’’ as the fit testing interval. Public

Service Electric and Gas Co. (Ex. 54–

196) stated that a ‘‘two year time frame

strikes a good balance between safety

concerns and practicality.’’ The Texas

Chemical Council (Ex. 54–232) stated

that, in its members’ experience, ‘‘* * *

virtually no individuals fail fit tests a

year after initial testing for a given

chemical exposure using the same

manufacturer’s respirator.’’ The Exxon

Company (Ex. 183), in response to

questions asked at the June hearings,

reported that of the 230 employees at

their Baton Rouge refinery given an

annual QNFT in 1995, a year after their

initial respirator selection in 1994, less

than one percent (two employees)

changed their respirator size because of

failing the annual QNFT. Exxon stated

that few employees change the size of

their respirator from year to year, and

that ‘‘the data suggest that annual

quantitative fit-testing should not be

necessary and such testing may be done

on a less frequent basis than once per

year.’’ The Peco Energy Company (Ex.

54–292) stated that its experience

showed that a three year interval is

sufficient to ensure a proper fit,

provided that mandatory refitting is

conducted if there are changes in the

respirator user’s physical condition. The

Eastman Chemical Co. (Ex. 54–245)

recommended that the time limit be not
1224 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

less than two years. The International

Paper Co. (Ex. 54–290) stated that ‘‘biannual (sic) [every two years] fit-testing

with proper training should be

adequate’’ and that proper training

would require that employees report to

the employer facial feature changes that

have occurred or failure to get an

adequate seal during the positive/

negative pressure seal check.

Other participants believed that fit

testing beyond initial fit testing should

be required only when an employee

switches to a different respirator, or

when a significant change occurs in an

employee’s physical condition that may

interfere with obtaining an adequate

facepiece seal (Exs. 54–177, 54–187, 54–

190, 54–193, 54–197, 54–214, 54–286,

54–297, 54–396, 54–397, 54–435, 54–

323, 54–422, Ex. 123). The American

Iron and Steel Institute (Ex. 54–307, Ex.

175) stated that annual fit testing was

unnecessary, and that the steel industry

experience shows that once a wearer has

been fit tested and has an acceptable fit,

subsequent fit tests demonstrate

consistent fit factors. Mallinckrodt

Chemical (Ex. 54–289) questioned the

need for annual fit testing for those

employees who may use a respirator

infrequently, such as once or twice a

year.

However, a large number of

rulemaking participants supported

OSHA’s proposal to require the testing

of respirator fit on an annual basis (Exs.

54–5, 54–6, 54–20, 54–153, 54–167, 54–

172, 54–179, 54–219, 54–273, 54–289,

54–293, 54–309, 54–348, 54–363, 54–

410, 54–428, 54–455, Ex. 177; Tr. 1573,

1610, 1653, 1674). The comments of

these participants and other evidence in

the rulemaking record convince OSHA

that the annual testing requirement is

appropriate to protect employee health.

Annual retesting of respirator fit

detects those respirator users whose

respirators no longer fit them properly.

The Lord Corporation, which already

performs annual fit tests, reported that

of its 154 employees who wear

respirators, one to three (2 percent or

less) are identified each year as needing

changes in model or size of mask (Ex.

54–156). Hoffman-LaRoche only

performs fit tests at two-year intervals,

and it reported a much higher incidence

of fit test failures. Sixteen of the 233

people tested in a recent two year cycle

of fit testing (6.86%) needed a change in

their assigned respirators (Ex. 54–106).

The Lord experience (Ex. 54–156)

indicates that annual retesting of

facepiece fit detects poorly fitting

facepieces, while the Hoffman-LaRoche

evidence demonstrates that waiting two

years for retesting can result in the

discovery that quite a high percentage of

workers have been relying on poorly

fitting respirators. Extending the retest

interval to more than one year would

allow those individuals with poor fits

that could have been detected by annual

fit testing to wear their respirator for a

second year before the poor fit is

detected.

This evidence also supports OSHA’s

view that triggering the requirement to

retest only by certain events, such as a

change in the worker’s condition, and

not including a required retest interval,

would allow poor fits to continue.

Changes in a worker’s physical

condition, such as significant weight

gain or loss, new dentures or other

conditions, can cause alterations in

facial structure and thus respirator fit.

Physiological changes that affect

facepiece fit can occur gradually over

time and are easily overlooked by

observers, and by the users themselves.

Individuals with poorly fitting

respirators were often detected only

through fit testing, and not by other

methods such as observation of changes

in facepiece fit, failure to pass a user

seal check, or an employee reporting

problems with the fit of the respirator.

Retesting facepiece fit solely on the

basis of physical changes in individual

respirator users would not be a reliable

substitute for fit testing on an annual

basis. These changes in an individual’s

physical condition do, however,

indicate the need for retesting that

individual’s facepiece, and paragraph

(f)(3) requires additional fit testing

whenever any of these changes is

detected.

Moreover, fit testing not only

determines whether a facepiece seal is

adequate; it also provides an

opportunity to check that fit is

acceptable, permits the employee to

reduce unnecessary discomfort and

irritation by selecting a more

comfortable respirator, and reinforces

respirator training by providing users

with a hands-on review of the proper

methods of donning and wearing the

respirator. Therefore, as well as

providing the opportunity to detect

poorly fitting respirator facepieces, the

annual fit testing requirement

complements OSHA’s requirement for,

and may partially fulfill, annual training

under final paragraphs (k)(1), (k)(3) and

(k)(5). For the reasons presented above,

and based on a thorough review of the

record, OSHA has included an annual

fit test requirement in the final rule.

Refitting Due to Facial Changes—

Paragraph (f)(3)

Paragraph (f)(7) in the proposal

addressed the need to refit respirators

when changes in the employee’s

physical condition occur. The proposal

identified facial scarring, cosmetic

surgery, or an obvious change in body

weight as conditions requiring refitting.

Some commenters (Exs. 54–280, 54–

428, 54–455) suggested that dental work

affecting facial shape should also trigger

refitting. The International Chemical

Workers Union (ICWU) suggested that a

change of five percent in body weight or

twenty pounds should be regarded as an

obvious change in body weight that

requires refitting (Ex. 54–427). One

commenter opposed requiring the

employer to determine whether an

employee’s physical change should

trigger refitting, stating that the

responsibility for reporting physical

changes should rest with the employee

(Ex. 54–357).

The language of the proposed

paragraph has been revised in the final

rule to provide greater clarity and to

account for these comments. Because

weight loss or gain affects the facial

configuration of different individuals

differently, OSHA does not believe it

possible to stipulate a given weight

change ‘‘trigger’’ for requiring a new fit

test. The final standard thus retains the

proposed language regarding an obvious

change in body weight. In response to

the comments that dental work can

affect facial shape and respirator fit, the

language in final paragraph (f)(3) has

been revised to add dental changes as

another item that can trigger a new fit

test requirement. The provision has

been modified to trigger retests based on

employee reports of facial changes, in

addition to changes observed by the

employer, supervisor, program

administrator, or PLHCP that may affect

facepiece fit. Employer observations of

potential problems with fit, along with

self-reported problems with facepiece fit

or changes in facial configuration,

would trigger a respirator fit retest

under final paragraph (f)(3).

Paragraph (f)(3) requires employers to

conduct an additional fit test whenever

an employee reports changes, or there

are observations of changes, in the

employee’s physical condition that

could affect respirator fit. This provision

addresses the rare situation in which an

employee’s facial features change to the

extent that a respirator that once fit

properly may no longer fit. The

conditions listed in the standard that

may cause such changes in facial

features—facial scarring, dental

changes, cosmetic surgery, or an

obvious change in body weight—will

generally be observable by the

employer. If the employee reports facial

changes that are not readily observable,

the employer may require verification of
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1225

the changes before offering an

additional fit test.

Retesting for Unacceptability—

Paragraph (f)(4)

Paragraph (f)(4) of the final standard

requires retesting whenever the

respirator becomes ‘‘unacceptable’’ to

the employee. An employee who

notifies the employer, the program

administrator, supervisor, or the PLHCP

that the fit of the respirator is

unacceptable must be given a reasonable

opportunity to be retested and to select

a different respirator facepiece. This

requirement was derived from

paragraph (f)(8) in the proposal, which

required refitting within the first two

weeks of respirator use for masks that

become ‘‘unacceptably uncomfortable.’’

Although some commenters wanted

to delete this provision on the grounds

that a properly fitted and trained worker

should have no reason to exchange the

respirator (Exs. 54–6, 54–20, 54–156,

54–209, 54–215), others urged that the

employee be allowed to request a refit

at any time a respirator becomes

unacceptable. These commenters saw

no reason to limit this period to two

weeks (Exs. 54–154, 54–165). The utility

of the two week period was specifically

questioned for situations where

respirators are not routinely used for

long periods of time (Ex. 54–66), or are

used only occasionally (Ex. 54–220).

Exxon (Ex. 54–266) stated that the two

week provision was too restrictive, and

that employees should be allowed to

select another respirator or facepiece as

necessary . Dow (Ex. 54–278) also

suggested dropping the two week

limitation. The American Petroleum

Institute (Ex. 54–330) recommended

revised performance language for this

provision. The Occidental Chemical

Company (Ex. 54–346) saw no reason to

specify a two week period, and stated

that employees should be permitted to

select a new respirator facepiece at any

time because of unacceptable

discomfort.

In the final rule, OSHA has deleted

the two week limitation on the time in

which an employee may have a

respirator retested. In addition, the term

‘‘unacceptable’’ has been substituted for

the term ‘‘uncomfortable,’’ which was

used in the proposal and was objected

to by several commenters (Exs. 54–154,

54–266, 54–278, 54–330). A respirator

may be unacceptable if it causes

irritation or pain to an employee or if,

because of discomfort, the employee is

unable to wear the respirator for the

time required.

Fit Testing Protocols—Paragraph (f)(5)

Paragraph (f)(5) in the final standard,

which is substantively the same as

proposed paragraph (f)(3), requires that

the employer use an OSHA-accepted

QLFT or QNFT protocol for fit testing.

These protocols are described in

mandatory Appendix A. Appendix A

also describes the methods OSHA will

use to determine whether to approve

additional fit test methods. The

provisions in proposed paragraphs

(f)(3), (f)(4), and (f)(5) that referenced

alternative fit test procedures therefore

have been removed from the final rule.

For qualitative fit testing (QLFT), Part

I of Appendix A contains the OSHAaccepted qualitative fit testing protocols

for the isoamyl acetate QLFT protocol;

the saccharin QLFT protocol; and the

irritant smoke QLFT protocol, which

were first adopted in the Lead standard

(29 CFR 1910.1025). In addition,

Appendix A contains an OSHAaccepted protocol for the BitrexTM

(Denatonium benzoate) QLFT method,

which was submitted to the rulemaking

record and commented on during this

rulemaking.

Appendix A also lists three protocols

for the QNFT methods that are OSHAaccepted. The first is the traditional

generated aerosol QNFT method in

which a test atmosphere (corn oil,

DEHS, or salt) is generated inside a test

enclosure and the concentration inside

and outside the mask is measured. The

second method is the ambient aerosol

QNFT method, commonly called the

PortacountTM method, which uses a

condensation nuclei counter to measure

the ambient aerosol concentrations

inside and outside the mask. The third

method that has been added is the

controlled negative pressure (CNP)

QNFT method (Dynatech Nevada

FitTester 3000TM), which was the

subject of comments during this

rulemaking. These OSHA-accepted

QLFT and QNFT methods are described

further in the discussion of Appendix A

that follows.

The only fit test method that

generated any controversy during the

rulemaking proceeding was the irritant

smoke QLFT protocol. OSHA is

continuing to accept the irritant smoke

QLFT protocol for use under this

standard because the method is valuable

when used properly and is often used

by small employers because it is

relatively inexpensive. Moreover, it is

also the only QLFT method where

facepiece leakage elicits an involuntary

response, which can eliminate the

possibility that a wearer could pretend

to pass the fit test in order to be eligible

for a job requiring respirator use.

Nevertheless, OSHA is aware that

high levels of irritant smoke can be

produced during a fit test and that these

concentrations can be dangerous.

Employees exposed to excessive

concentrations of irritant smoke have

suffered severe reactions (Ex. 54–437;

Tr. 390). For this reason, it is

particularly important that employers

using the irritant smoke protocol ensure

that test operators are well trained in

this method and comply with all the

steps in the OSHA protocol. To ensure

that any leakage will be as minimal as

possible, the test must not be performed

until the employee has passed a user

seal check. In performing the sensitivity

check necessary to determine that the

particular user is sensitive to irritant

smoke, it is extremely important to

assure that the employee is exposed to

the least amount of irritant smoke

necessary to trigger a response.

Appendix A is a mandatory appendix,

and failure to comply completely with

its protocols will constitute a violation

of this standard.

QLFT Limits—Paragraph (f)(6)

Paragraph (f)(6) of the final standard

limits qualitative fit testing to situations

where the user of a negative pressure

air-purifying respirators must achieve a

minimum fit factor of 100 or less. A

similar limitation was contained in the

proposal (paragraph (f)(6)(i)(A)). This

limitation is based on the fact that the

existing evidence only validates the use

of qualitative fit testing to identify users

who pass the QLFT with a respirator

that achieves a minimum fit factor of

100. Dividing the fit factor of 100 by a

standard safety factor of 10 means that

a negative pressure air-purifying

respirator fit tested by QLFT cannot be

relied upon to reduce exposures by

more than a protection factor of 10. The

safety factor of 10 is used because

protection factors in the workplace tend

to be much lower than the fit factors

achieved during fit testing; the use of a

safety factor is a standard practice

supported by most experts to offset this

limitation. For example, the ANSI

Z88.2–1992 standard states, in clause

9.1.1, ‘‘If a quantitative fit test is used,

a fit factor that is at least 10 times

greater than the assigned protection

factor (table 1) of a negative-pressure

respirator shall be obtained before that

respirator is assigned to an individual.

If a qualitative test is used, only

validated protocols are acceptable. The

test shall be designed to assess fit factors

10 times greater than the assigned

protection factor.’’

The only objection to this limitation

was expressed by a few commenters

(Exs. 54–153, 54–178) who noted that in
1226 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

the future, new QLFT protocols may be

developed allowing the measurement of

higher fit factors. If new methods are

developed that permit QLFT use for

higher fit factors, OSHA will, as part of

the acceptance process for these new

methods, adjust this requirement

appropriately.

QNFT Minimum Fit Factors—Paragraph

(f)(7)

Paragraph (f)(7) of the final standard

lists the minimum fit factors required to

be achieved during quantitative fit

testing. These minimum fit factors were

listed in paragraphs (f)(6)(i)(B) and

(f)(6)(ii)(B) of the proposal. Half masks

are required to achieve a minimum fit

factor of 100 during QNFT, and full

facepiece respirators must achieve a

minimum fit factor of 500. Paragraph

(f)(7) in the final standard consolidates

the minimum QNFT fit factors for half

mask and full facepiece respirators into

one provision. The safety factor of ten

used for full facepiece respirators is the

same as that for half masks.

The minimum fit factors in the final

standard for QNFT are the same as those

that were proposed, and are identical to

the minimum fit factors required in

OSHA substance-specific standards that

require QNFT (See e.g., Asbestos, 29

CFR 1910.1001; Cadmium, 29 CFR

1910.1027; Benzene, 29 CFR 1910.1028;

Formaldehyde, 29 CFR 1910.1048; 1,3-

Butadiene, 29 CFR 1910.1051).

Most participants who commented on

the issue agreed with these minimum fit

factors. A few participants argued for

higher minimum fit factors (Exs. 67, 54–

405). For example, Robert da Roza,

citing his study on the reproducibility of

QNFT (Ex. 24–9), stated in his

testimony at the OSHA hearings on

minimum fit factors that ‘‘What I feel

confident in is that you do need

something higher than a ten. It may be

as high as 800. I’m suggesting that some

statistician look at this a little more

rigorously and come up with some

better number.’’ (Tr. 102)

TSI, Inc. (Ex. 54–405), in discussing

the pass/fail levels for QNFT,

recommended the following:

The proposed requirement that a

successful QNFT achieve a fit factor of at

least 100 for a half mask and 500 for a fullface mask should be raised. The proposed

values allow employers to accept what in

reality is a very poor fit compared to what

can be achieved with proper employee

training * * * We feel that a fit factor of at

least 1000 for half masks and at least 2000

for full face respirators is justifiable and

readily achievable with minimal extra effort

by the employer.

However, empirical data or statistical

analyses that supported the need to

increase the minimum fit factors

proposed were not presented. Although

fit factors substantially higher than the

minimum values are frequently

achieved, OSHA’s experience enforcing

the substance-specific standards that

have similar requirements to the

minimum fit factors contained in the

final respiratory protection standard

shows that these factors are adequate to

distinguish well fitting respirators from

those that fit poorly, which is the

purpose of fit testing. Accordingly,

OSHA is retaining the proposed fit

factors in the final standard.

Testing Positive Pressure Respirators—

Paragraph (f)(8)

Paragraph (f)(6)(iii)(B) in the proposal

required that fit testing of positive

pressure respirators be conducted

without any of the air-supplying

equipment or attachments that produce

a positive pressure inside the facepiece

during respirator use. Thus, the

proposal required positive pressure

respirators to be tested under negative

pressure. Final paragraph (f)(8) similarly

requires that positive pressure tightfitting respirators be fit tested in the

negative pressure mode. Fit testing

seeks to measure the tightness of the

facepiece seal. If the air pressure inside

the facepiece is higher than that outside,

the pressure differential reduces the

amount of ambient air leaking into the

facepiece, and the measurements

obtained during the fit test do not

represent the tightness of the seal

between the face and the facepiece.

Many tight-fitting respirator facepieces

are available in both air-purifying

models and atmosphere-supplying

units. For these, fit testing can be

performed using an identical negative

pressure air-purifying respirator

facepiece, with the same sealing

surfaces, as a surrogate for the

atmosphere-supplying facepiece the

employee will actually be using. Where

an identical negative pressure facepiece

is unavailable, the employer may

convert the facepiece of the employee’s

unit to allow for qualitative or

quantitative fit testing. Many SCBA

manufacturers (e.g., MSA, Interspiro

and Survivair) sell fit testing adaptors

for this purpose that allow for fit testing

of their SCBA facepieces.

Final paragraphs (f)(8)(i) and (f)(8)(ii)

describe the specific ways in which

these alternatives apply for performing

QLFT and QNFT measurements,

respectively. If the respirator facepiece

has been modified for fit testing, final

paragraph (f)(8)(iii) requires that the

modifications must be completely

removed and the respirator restored to

its NIOSH-approved configuration

before it is used in the workplace. These

requirements replace the similar

provisions in proposed paragraph (f)(6),

and should clearly inform employers of

the requirements for fit testing tightfitting atmosphere-supplying or

powered air-purifying respirators. These

provisions are designed so that the

testing reflects the conditions of

respirator use as accurately as possible.

There were no significant objections to

this provision in the record.

Proposed Paragraph (f)(9)—Interim Use

of QLFT

The final standard deletes proposed

paragraph (f)(9), which would have

allowed an employer initially to

perform a qualitative fit test to fit the

respirator user where an assigned

protection factor greater than 10 is

required if the employer had an outside

party conduct quantitative fit testing

within 30 days. OSHA proposed this

provision to address those few instances

when contractors were not available to

test employees who had been hired after

the annual fit testing for a given

establishment had been conducted.

There was considerable opposition to

this provision. John Hale of Respirator

Support Services (Ex. 54–5)

recommended that this provision be

eliminated because the provision could

be abused. The Exxon Company (Ex.

54–266) also recommended that the

provision be deleted, suggesting that full

facepiece respirators fit tested using a

QLFT be limited to use in atmospheres

containing 10 times the exposure limit

of a hazardous substance until an

adequate QNFT is performed. Other

commenters stated that retaining the

provision could result in overexposure

of the employee to workplace

contaminants (Exs. 54–280, 54–303, 54–

408). The Los Alamos National

Laboratory (Ex. 54–420) criticized the

provision on the basis that it is the

employer’s responsibility to provide

appropriate fit testing prior to assigning

employees to work where respirators are

required. The U.S. Army (Ex. 54–443D)

stated that if employers have a

functioning respirator program and

know of the requirement for annual

testing, then they should be able to

schedule fit testing appropriately, with

no need for an extra 30 days.

Some participants who supported the

proposed requirement stated that QNFT

has not been shown to be a better

predictor of workplace protection than

QLFT, and recommended that QNFT be

an optional, rather than a required

method, when fit factors greater than 10

are needed. Moldex Metric Inc. (Ex. 54–

153) recommended that the provision be

broadened to allow the employer some
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1227

latitude in selecting which fit testing

methods must be used. Bayer

Corporation (Ex. 54–210) recommended

the period be extended to 90 days, and

that the provision be broadened to

include repair and/or calibration of fit

testing instruments; other participants

also recommended a 60 or 90 day period

(Exs. 54–222, 54–278, 54–330, 54–361,

54–424, Ex. 54–430).

OSHA has concluded that the

rulemaking record demonstrates that

proposed paragraph (f)(9) is

unnecessary. Contractors who perform

QNFT services are located throughout

the country, and an employer can

arrange a schedule to ensure that fit

testing will be available when required.

QNFT instruments are also available for

rent and can be used by employers

themselves after appropriate training if

no contractor is available. Several

different types of reasonably priced

QNFT instruments are manufactured,

and OSHA believes many employers

can readily purchase one to perform

their own QNFT. The instruments are

highly portable and can be readily

shipped to where they are needed. As

the Army points out (Ex. 54–433D), an

employer with a respirator program that

requires annual fit testing can readily

schedule fit testing appropriately.

In addition, the comments OSHA

received urging that the provision be

expanded increase OSHA’s concern that

leaving the option in the standard could

expose employees unnecessarily to

excessive concentrations of hazardous

substances. The QNFT exemption as

proposed was intended to be narrow in

scope and to apply only when

contractors were not readily available to

test new employees who were hired

after the annual fit testing session. The

reasons advanced for extending this

QNFT exemption were not convincing.

OSHA believes that there are other ways

to address the concerns raised by

commenters in support of this QNFT

exemption. For example, employers can

schedule QNFT instrument calibration

during times when fit testing is not

scheduled and can obtain a substitute

QNFT instrument when their own unit

needs repair. OSHA concludes that this

provision is not appropriately included

in the final standard.

Appendix A—Mandatory Fit Test

Protocols

Appendix A contains the fit test

protocols that employers must follow in

performing qualitative and quantitative

fit testing for tight-fitting respirators.

The Appendix also contains procedures

OSHA will use to evaluate ‘‘new’’ fit

testing methods. Proposed Appendix A

addressed the same subjects. Employers

who have in the past performed fit tests

pursuant to a substance-specific

standard must now follow the protocols

for OSHA-accepted fit tests that are set

out in Appendix A. OSHA has removed

the fit testing protocols in the substancespecific standards to eliminate

duplication and consolidate all fit

testing protocols in Appendix A.

Appendix A has been reorganized

from its proposed format to improve

clarity and usefulness. The provisions

dealing with administering OSHAaccepted fit testing protocols have been

moved to part I.

Section A of part I contains general

provisions and test exercises that apply

to both QLFT and QNFT.

Section B contains the OSHAaccepted QLFT protocols for isoamyl

acetate, saccharin, Bitrex, and irritant

smoke fit tests.

Section C contains the OSHAaccepted QNFT protocols for generated

aerosol, ambient aerosol (CNC), and

controlled negative pressure (CNP) fit

tests.

Part II addresses the methodology

OSHA will use to evaluate new fit test

methods and technology.

Appendix A provides general

instructions for performing fit testing

which have been simplified and

clarified by combining the common

elements for both QLFT and QNFT and

presenting them in Section A of Part I.

This includes directions for such

procedures as selecting a respirator for

fit testing and performing the required

test exercises. By combining common

elements and eliminating the

duplication of fit test protocols in the

substance-specific standards, OSHA has

reduced the number of pages in its

regulations dedicated to fit testing. The

purpose of the OSHA fit testing

protocols is to tell fit test operators how

to perform fit testing to ensure that an

adequately fitting facepiece is selected.

The protocols reflect the fit test

elements (i.e., equipment and basic

procedures) that were performed during

the validation testing that initially led to

their acceptance by OSHA. The

protocols do not contain specific

instructions on operating any particular

fit test instrument because each

instrument has specific manufacturer’s

operating instructions that must be

followed to obtain valid results.

The fit testing procedures and specific

requirements in the QLFT and QNFT

protocols in Sections B and C of part I

reflect both the experience that has been

gained in performing fit testing and the

validation testing that was done initially

in order for each method to be accepted

by OSHA. The OSHA-accepted methods

were evaluated by comparing their

performance with that of another

accepted fit test to demonstrate that

each new method would reliably

identify adequately fitting facepieces.

The OSHA-accepted protocols reflect

the specific procedures and equipment

that were used in validation testing, and

they must be followed to ensure

minimum reproducibility. These

elements in the OSHA protocols are not

written in performance-oriented

language, since any significant variation

from the required protocols would

invalidate the reliability testing that was

performed initially to gain OSHA

acceptance and would add uncertainty

to the validity of fit test results.

Fit Testing Procedures—General

Requirements

The general requirements for fit

testing contained in Appendix A, part

I.A apply to all OSHA-accepted fit test

methods, both QLFT and QNFT. These

provisions contain general requirements

and instructions for both the person

being fit tested, and the person

conducting the fit testing. The

provisions have been modified slightly

from the proposal.

Provision A.1 requires that the test

subject be afforded a selection of

respirators of various sizes and models

from which to pick the most acceptable.

The revised language of this provision

reflects the substitution of the term

‘‘acceptable’’ for ‘‘comfortable’’ in

paragraph (d)(1)(iv). Provision A.2 is

identical to that proposed. The test

operator shows the person being fit

tested how to don the respirator

properly. This instruction may

complement the training required by

paragraph (k) of this standard.

Provisions A.3 to A.7 contain

instructions for selecting the most

acceptable respirator for fit testing.

Provision A.8 requires the subject to

perform a ‘‘user seal check’’ before the

fit test is performed. The language in

this provision has been modified to

reflect the use of the new definition for

‘‘user seal check.’’ Provision A.9 restates

that fit testing shall not be conducted if

there is any hair growth between the

skin and sealing surface of the

respirator. If the test subject exhibits

breathing difficulty during fit testing,

provision A.10 requires that he or she be

referred to a PLHCP. Minor revisions to

this provision reflect changes made to

paragraph (e) of the standard on medical

evaluation. Provision A.11 requires

retesting whenever the employee finds

the fit unacceptable. Provision A.12 of

Appendix A, Part II of the proposal

regarding fit testing records has been

moved to paragraph (m) of the final
1228 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

standard to consolidate all

recordkeeping provisions.

Provisions A.12 through A.14 of this

final standard describe the specific

exercises to be performed under all

qualitative and quantitative fit tests

protocols. The exercises are mostly the

same; however, the grimace exercise is

not performed for QLFT protocols. In

addition, a separate test regimen is

prescribed in Section C for the CNP

quantitative fit test. Except for minor

modifications, the exercises are

identical to those in the proposal and to

those in OSHA’s substance-specific

health standards. Participant comments

focussed on a few issues: the number

and duration of fit test exercises (Exs.

54–158, 54–187, 54–206, 54–218, 54–

219, 54–261, 54–271, 54–273, 54–350,

54–325, 155), and the need for the

grimace, bending over/jogging-in-place,

and talking exercises (54–153, 54–173,

54–175, 54–179, 54–208, 54–218, 54–

219, 54–261, 54–273, 54–317, 54–363,

54–408, 54–420, 54–424). These

comments are addressed below.

Provision A.14 requires the employee

being fit-tested to perform eight

exercises. Seven of the exercises must

be performed for one minute, while the

grimace exercise lasts for only 15

seconds. The test exercises and exercise

sequence are: normal breathing; deep

breathing; turning the head side to side;

moving the head up and down; talking;

grimacing; bending over (or jogging in

place if the test unit is not large enough

for the test subject to bend at the waist);

and normal breathing.

Some participants complained that

the number and length of the exercises

required to be performed were

excessive. For example, the 3M

Company stated that OSHA has made

numerous changes to accepted protocols

without verifying the effect of the

changes on test performance (Ex. 54–

218). According to 3M, OSHA arbitrarily

altered the fit tests by requiring the test

exercises to be performed for one

minute, rather than 30 seconds, and by

including the grimace and the bending

over/jogging-in-place exercises, and that

this alteration violates the original

validation of the fit test protocols. In

fact, the protocols in this standard are

virtually identical to those in other

OSHA health standards that have been

promulgated over the past fifteen years.

The isoamyl acetate (IAA) QLFT test

that was evaluated and adopted in the

lead standard in 1982 has six exercises.

Five of the exercises must be performed

for one minute, and the talking exercise

is performed for ‘‘several’’ minutes.

Thus, the total test time for the six

exercises is seven to eight minutes,

compared to the seven minutes and 15

seconds that completion of the exercises

in this standard will take. Since the

length of the two test protocols is

similar, OSHA concludes that the IAA

concentration at the end of the fit test

under this standard would be the same

as if the fit test was performed under the

IAA QLFT protocol contained in the

lead standard.

The grimace exercise drew a number

of comments. The test is intended to

simulate the type of normal facial

movements that could break a respirator

seal. It was developed in the asbestos

standard in 1986 and has been

incorporated into subsequent OSHA

standards. Participants questioned the

need for the grimace exercise,

particularly with QLFT, where a break

in the facepiece seal could cause

sensory fatigue (Exs. 54–153, 54–208,

54–218, 54–219, 54–263, 54–273, 54–

363, 54–408, 54–424). Several

commenters (Exs. 54–173, 54–179, 54–

261, 54–317) stated that the grimace

exercise cannot be described so that its

effects are standardized and

reproducible. DuPont (Ex. 54–350)

recommended that the standard

incorporate only six exercises, deleting

both the grimace and bending/jogging

exercises. DuPont stated that if the

grimace remained in the fit test

protocol, it should be performed last,

with the results excluded from the

calculations. Allied Signal (Ex. 54–175)

also recommended that the grimace

exercise be deleted; however, if

retained, it should be performed at the

completion of the other test exercises. In

contrast, the Los Alamos National

Laboratory (Ex. 54–420), which

originated fit testing protocols, stated

that their researchers included the

grimace exercise as part of the test

exercises for full facepieces in the early

1970s. Los Alamos stated that an

exercise that simulates a worker’s

normal facial movements should not be

excluded from the test exercises, and

recommended that it be retained.

These comments have persuaded

OSHA to delete the grimace exercise as

one of the required fit testing exercises

for QLFT, but to retain it for QNFT. A

break in the facepiece seal during a

QLFT could cause sensory fatigue that

would invalidate the results of the

grimace test and any remaining fit test

exercises. Performing the exercise as the

final element of the qualitative fit test

would not address this concern because

one purpose of the test is to determine

whether the respirator reseals after the

seal has been broken, and performing

the grimace test after all the others have

been completed will not allow a

determination of whether the respirator

has resealed effectively after the test.

The concern about sensory fatigue

does not exist with quantitative fit tests,

however, and OSHA believes the

grimace exercise is a valuable aspect of

these tests. Because the exercise stresses

the facepiece seal, it allows the test to

determine whether the facepiece reseats

itself during subsequent exercises. The

results from the grimace exercise are not

to be used in calculating the fit factor for

QNFT (provision C(2)(h)(1)), since

breaking of the seal would necessarily

produce a low fit factor for the grimace

exercise. However, if the respirator

facepiece fails to reseat itself, the fit

factors measured for the subsequent

exercises would reflect this failure,

causing the employee to fail the fit test.

Therefore the grimace exercise has been

retained as one of the required QNFT fit

testing exercises.

The Air Conditioning Contractors of

America (Ex. 54–248) questioned the

need to require employees to read from

a text, such as the Rainbow Passage.

Members of the association stated that

their technicians had their own methods

of determining fit. As stated above,

however, OSHA believes that

standardized fit testing protocols

provide important safety benefits to

employees. To the extent that employers

develop other valid fit test methods,

Part II of Appendix A provides a

procedure through which they can seek

OSHA approval of those fit test

protocols. The talking exercise

requirement is also not onerous. To

perform this exercise, the employee

must either read from a prepared text

such as the Rainbow Passage, count

backward from 100, or recite a

memorized poem or song. These

alternatives provide employers and

employees with some flexibility when

performing this exercise.

Qualitative Fit Test (QLFT) Protocols—

Appendix A, Paragraph B

B.1. General. Provision B.1.(a) of Part

I of Appendix A on qualitative fit test

protocols contains two general

provisions relating to QLFT. The

provisions are substantively the same as

in the proposal. The term ‘‘assure’’ has

been replaced by ‘‘ensure,’’ reflecting a

change that has been made throughout

the regulatory text.

Provision B.1.(a) requires the

employer to ensure that the person

administering QLFT be able to perform

tests correctly, to recognize invalid tests,

and to ensure that the test equipment is

in proper working order. This applies

regardless of whether the tester works

directly for the employer or for an

outside contractor. When QLFT is

performed by the employer’s own

personnel, the testers must be properly
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1229

trained in the performance of the

particular QLFT protocol that will be

used. If outside contractors are used to

provide fit testing support, the employer

must ensure that the test operators

performing the fit testing protocols are

trained, and can competently administer

the QLFT according to the OSHA

protocols. This provision is performance

oriented, since it lists the abilities the

test operator needs, but does not

describe a specific training program.

The type of QLFT operator training

needed is specific to the QLFT method

selected, and new methods may be

developed in the future that require

additional training.

The second provision, B.1.(b),

requires that the QLFT equipment be

kept clean and well maintained so it

operates within its designed parameters.

For example, the nebulizers used for the

saccharin and Bitrex QLFT protocols

can clog when not properly cleaned and

maintained, resulting in invalid tests.

The test operator must maintain the

equipment used for fit testing to ensure

proper performance. The requirement is

again performance oriented, since the

QLFT equipment used will vary with

the type of QLFT selected.

There are four qualitative fit test

protocols approved in this Appendix.

The isoamyl acetate (IAA) test

determines whether a respirator is

protecting a user by questioning

whether the user can smell the

distinctive odor of IAA. Both the

saccharin and Bitrex tests involve

substances with distinctive tastes,

which should not be detected through

an effective respirator. The irritant

smoke test involves a substance that

elicits an involuntary irritation response

in those exposed to it.

B.2—Isoamyl acetate protocol. The

IAA test protocol included in the final

standard evolved out of the IAA

protocol OSHA originally adopted for

the lead standard (29 CFR 1910.1025). It

requires that an employee first be tested

to determine if the employee can detect

the odor of IAA, often called banana oil

because it gives off a distinctive bananalike smell. The fit test is only to be

conducted on employees who can detect

this odor. An employee passes the fit

test with a particular respirator if he/she

cannot detect the IAA odor while

wearing the respirator. The primary

drawback of the test is the strong ability

of IAA to induce ‘‘odor fatigue,’’ so that

an individual quickly loses the ability to

detect the odor if exposed to it for any

period of time. Odor sensitivity is the

key to the IAA fit test, and any decrease

in the employee’s odor sensitivity due

to background levels of IAA could

invalidate IAA fit testing. For this

reason several provisions of the protocol

are intended to minimize the possibility

of background exposure to IAA that

could impair the test subject’s ability to

detect the odor in the fit test.

IAA vapor easily penetrates a

particulate filter, and the IAA protocol

therefore cannot be used to fit test

particulate respirators unless the

respirator is equipped with an organic

vapor filter. The protocol requires that

separate rooms be used for the odor

screening and fit tests, and that the

rooms be ventilated sufficiently to

ensure that there is no detectable odor

of IAA prior to a test being conducted.

In prior standards, OSHA has required

that separate ventilation systems, in

addition to separate rooms, be used for

these functions (e.g., Lead [47 FR

51114]). OSHA proposed to do the same

in this standard. However, OSHA has

been convinced by the comment of

Mobil Oil Corporation (Ex. 54–234) that

this elaborate precaution against odor

fatigue and general background

contamination is burdensome and

unnecessary. OSHA agrees with Mobil

that the ventilation simply needs to be

adequate to prevent IAA odor from

becoming evident in the rooms where

odor sensitivity testing and respirator

selection and donning take place, and

that the need to have separate

ventilation systems for IAA fit testing

will make it unnecessarily difficult to

find an acceptable building in which to

perform fit testing. OSHA is therefore

removing the requirements that the odor

threshold screening test and fit test

rooms not be connected to the same

ventilation system. Instead, the

ventilation requirement is stated in

performance language in the final

standard: the testing rooms must be

sufficiently ventilated to prevent the

odor of IAA from becoming evident to

the employee to be tested. OSHA

believes that this performance-based

language will be sufficient to alert

employers to the requirement to prevent

olfactory fatigue among workers being

fit tested by preventing a buildup of IAA

in the general room air.

The proposed IAA protocol required

that the test atmosphere be generated by

wetting a paper towel or other absorbent

material with 0.75 cc of pure IAA and

suspending the towel from a hook at the

tip center of the test chamber. Two

commenters stated that the standard

should also allow the test atmosphere to

be generated by the use of commercially

prepared test swabs or IAA ampules as

long as these methods generate the

required airborne concentrations of IAA

(Mobil Oil (Ex. 54–234); Bath Iron

Works (Ex. 54–340)).

OSHA agrees that alternative methods

of generating the IAA test atmosphere

should be permitted as long as those

methods have been shown to

reproducibly generate the minimum

concentration of IAA needed for a

successful fit test. The National Bureau

of Standards (Ex. 64–182), in its report

on fit testing of half mask respirators

using the IAA protocol in the OSHA

lead standard, found that the minimum

IAA concentration inside the test

chamber was 100 ppm during fit testing.

Accordingly, the IAA protocol in

Appendix A of the final standard has

been modified to permit the use of test

swabs or ampules as long as these have

been shown to generate a test

atmosphere concentration comparable

to that generated by the towel-saturation

method in the proposed standard. An

employer who wishes to use test swabs

or ampules would need to demonstrate

that the swabs or ampules generate an

acceptable test atmosphere. For this

purpose, the employer may rely on data

obtained from the manufacturer of the

swabs or ampules as long as the

employer uses the products in a way

that reproduces the concentrations

obtained by the manufacturer under the

manufacturer’s test conditions.

OSHA has also added a provision

recommended by the American

Industrial Hygiene Association (Ex. 54–

208) to reduce the possibility of test area

contamination from used paper towels.

AIHA recommended that B.2.(b)(10) be

revised to ensure that the used towels

are stored in self-sealing bags to prevent

test area contamination. OSHA adopted

the language changes the AIHA

proposed; the final standard requires

that used IAA towels be removed from

the test chamber to avoid test area

contamination.

AIHA (Ex. 54–208) also recommended

that OSHA remove the language in

B.2.(b)(2) of the IAA fit test protocol

requiring that organic vapor cartridges

be changed at least weekly. AIHA stated

that a fit test operator who is competent

to implement an adequate QLFT

program will be able to determine an

adequate cartridge change schedule.

OSHA agrees, and has removed the

language requiring weekly filter

changes, because weekly changes may

overstate or understate appropriate

frequencies. However, the program

administrator or the fit test operator

must replace the cartridges as

appropriate to ensure their proper

function.

After the close of the NPRM comment

period and the hearings, during the

post-hearing comment period, the ISEA

(Ex. 54–363B) submitted a report on fit

testing for full facepiece respirators
1230 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

using an IAA QLFT protocol for which

the test concentration of IAA was raised

to 10 times the concentration used in

the OSHA-accepted IAA protocol. ISEA

reported that the pass/fail cutoff for the

modified IAA QLFT was a required fit

factor of 1000, and that this increased

IAA concentration fit test could

therefore be used to test full facepiece

respirators for use where ambient

exposures were 100 times the PEL. ISEA

stated that the validation data that it

submitted for this new IAA fit test meet

the validation requirements of the

September 17, 1989 ANSI Z88.10 draft

standard entitled ‘‘Respirator Fit Test

Methods.’’ OSHA notes, however, that

all draft provisions of the draft ANSI fit

testing standard are still subject to

change until published as part of the

final ANSI Z88.10 standard. Further,

ISEA did not indicate that the test met

the validation criteria proposed by

OSHA. In addition, no comments were

received from the regulated community

on this modified IAA protocol. Since

the proposed, ISEA-modified, IAA

qualitative fit test was submitted as a

post-hearing comment, an opportunity

did not exist for the regulated

community to comment on it as part of

this rulemaking record. The revised IAA

fit test, therefore, has not received the

review and public comment to which

the other new fit tests (i.e., Portacount,

CNP, Bitrex) were subjected during this

rulemaking. Accordingly, OSHA is not

adding the modified IAA fit test for full

facepieces to the final standard’s fit test

protocols. This Appendix establishes

procedures for OSHA acceptance of new

fit test protocols, and a proponent of the

modified IAA fit test may submit it for

review under those procedures.

B.3 and B.4—Saccharin Solution and

BitrexTM (Denatonium benzoate)

Solution Aerosol Protocols. The

protocols for the saccharin and Bitrex

solution aerosol fit test methods are

similar. Both involve test agents that a

test subject will taste if his or her

respirator is not functioning effectively.

Saccharin is a sugar substitute with a

sweet taste, and Bitrex is a bitter tasteaversion agent. In both cases, the

subjects are first tested to ascertain that

they are in fact able to taste the test

agent being used, and then are tested

with a respirator. During the fit test the

subjects are instructed to breathe with

their mouths slightly open and their

tongues extended. If they can taste the

test agent during the fit test, the test has

failed.

The proposal included the saccharin

protocol but not the Bitrex protocol,

which was not validated until after the

proposal was issued. The saccharin

protocol was identical to that contained

in the Lead standard (29 CFR 1910.1025,

Appendix D II; 29 CFR 1910.1027

(Cadmium); 29 CFR 1910.1028

(Benzene); 29 CFR 1910.1048

(Formaldehyde); 29 CFR 1910.1050

(Methylenedianaline); 29 CFR

1910.1051 (1–3 Butadiene)). Several

commenters (Exs. 54–208, 54–218, 54–

219, 54–363) recommended minor

revisions to the language of the protocol

to correct specific problems, and to

clarify the procedures. In response to

these comments, the formula for

preparing the threshold check solution

has been revised to remove an error in

dilution contained in the lead standard

protocol. OSHA has also changed the

requirement that employees being tested

open their mouths wide to a

requirement that they open their mouths

slightly, since opening the mouth wide

could distort normal facepiece fit and

invalidate the test results. Opening the

mouth slightly is sufficient to allow the

employee to detect leakage of the test

agent into the respirator when testing

for facepiece seal leakage.

The final standard also does not

restrict employers to using a DeVilbiss

Model 40 nebulizer but also allows

them to use an equivalent test nebulizer.

Allowing the use of alternative

nebulizers that can produce an

acceptable test atmosphere is a change

from the lead standard protocol, which

allowed only the use of the DeVilbiss

nebulizer. Finally, the protocol now

states clearly that, to elicit a taste

response, a minimum of ten nebulizer

squeezes is required during the

threshold screening. This matches the

minimum number of squeezes of the fit

test nebulizer required by the protocol.

NIOSH (Ex. 54–437) was the only

participant to object to the saccharin

aerosol protocol. NIOSH is concerned

that saccharin is a potential carcinogen,

and it believes that Bitrex is an

acceptable alternative test agent.

Although saccharin is suspected of

being a carcinogen when ingested in

large quantities over long periods of

time, it is not a substance that OSHA

has regulated, and even NIOSH does not

have a Recommended Exposure Limit

for it. A test subject would be exposed

to saccharin only for a brief time during

the pre-test sensitivity check, and again

either upon failing the test or during the

post-test sensitivity check. Either

exposure would likely occur only once

a year. These exposures would be very

low, at or near the threshold of

detectability, and it is extremely

unlikely that they pose a significant risk

to the health of employees or that they

would exceed any realistic exposure

limit that may be established.

Moreover, although the Bitrex fit test

protocol is an acceptable alternative for

situations in which the saccharin

protocol is used, Bitrex is not as widely

available as saccharin, and the test is

not as widely accepted. The Bitrex

QLFT protocol was developed by 3M

(Ex. 54–218). The test protocol is

essentially the same as that for the

saccharin QLFT, with changes made in

preparing the threshold check solution

and the fit test solution to account for

the non-linear taste sensitivity of Bitrex.

A recent paper by Mullins, Danisch, and

Johnston (Ex. 178) in the November

1995 AIHA journal describes the

development of the Bitrex QLFT

method. Validation testing consisted of

150 paired qualitative and quantitative

fit tests, with test volunteers using half

mask respirators. The Bitrex fit test was

evaluated against the saccharin fit test

and found to have a test sensitivity of

0.98 and a predictive value for passing

of 0.98 at a fit factor of 100. The overall

test results were identical for the Bitrex

and saccharin fit test methods.

Only one rulemaking participant

objected to the possibility that OSHA

would approve the Bitrex test. Robert

daRoza of the Lawrence Livermore

Laboratory (personal communication

with John Steelnack, OSHA, 6/4/97)

stated that this method has not been

adequately tested by multiple facilities,

and that the ratio of the concentrations

specified does not follow the same logic

used in the saccharin method. Until the

method is validated by multiple

facilities and the logic of the specified

concentrations determined, Mr. daRoza

believes that the test should not be

incorporated into the final standard.

In contrast, NIOSH has recommended

Bitrex as an acceptable alternative test

agent for saccharin (Ex. 54–437). OSHA

has reviewed the validation studies (Ex.

178) in depth, and believes that they

establish the Bitrex protocol as an

appropriate fit test method. Therefore,

OSHA is approving this protocol.

Irritant Smoke (Stannic Chloride)

Protocol

The irritant smoke protocol (also

called irritant fume) uses stannic

chloride smoke tubes to produce a

smoke containing hydrochloric acid.

Exposure to this test agent causes

irritation resulting in coughing. Because

the response to irritant smoke is

involuntary, the irritant smoke fit test is

the only QLFT method that does not

rely on the subjective response of the

employee being tested (Exs. 54–325, 54–

424). The protocol contains a number of

provisions intended to minimize

employee exposure to the irritant
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1231

smoke, which can be harmful to some

individuals at high exposure levels.

Irritant smoke is the oldest method of

fit testing still in use. It was developed

at the Los Alamos National Laboratory

more than fifty years ago (Ex. 25–4).

OSHA has approved the protocol in all

of its health standards that allow QLFT

(See 29 CFR 1910.1025 (Lead); 29 CFR

1910.1027 (Cadmium); 29 CFR

1910.1028 (Benzene); 29 CFR 1910.1048

(Formaldehyde)).

The irritant smoke protocol also has

the drawback, however, that excessive

exposure to irritant smoke can cause

severe irritation and, in some cases,

permanent harm. For this reason,

NIOSH (Ex. 54–437) recommended

against the continued use of irritant

smoke for qualitative fit testing. NIOSH

has conducted the only study known to

OSHA that assessed the concentrations

of hydrogen chloride produced from

irritant smoke tubes. When smoke tubes

were attached to an aspirator bulb,

NIOSH measured concentrations of

hydrochloric acid that ranged from 100

ppm (measured at a distance of six

inches from the end of the smoke tube)

to 11,900 ppm (measured at a distance

of two inches). The use of a low-flow

pump produced hydrogen chloride

concentrations ranging from 1500 ppm

to more than 2000 ppm within 10

seconds of turning on the pump. NIOSH

did not measure the amount of irritant

smoke inside any respirator facepieces

(Tr. 411). The OSHA PEL for hydrogen

chloride is a ceiling limit of 5 ppm,

which may not be exceeded at any time

(29 CFR 1910.1000(a)). NIOSH has

established an IDLH value of 50 ppm

and notes that a concentration of 309

ppm has been reported as the level of

hydrogen chloride causing a severe

toxic endpoint in laboratory animals.

NIOSH also cited a recommendation by

a National Academy of Sciences

committee to limit emergency exposure

to 20 ppm (Ex. 54–437R at p. 6).

NIOSH performed these

measurements after evaluating irritant

smoke testing at the request of the

Anchorage Alaska Fire Department (Ex.

54–437R) because four firefighters had

reported experiencing either skin or eye

irritation during irritant smoke fit

testing inside a test enclosure. NIOSH

additionally described a telephone

report it had received of vocal chord

damage caused by exposure to

hydrochloric acid during an irritant

smoke fit test. OSHA notes, however,

that this fit test was performed inside a

test enclosure and that the test subject

failed four consecutive fit tests using

this challenge agent (Tr. 411).

TSI, Inc. (Ex. 54–303), the

manufacturer of the Portacount QNFT

system, also recommended that the

irritant smoke QLFT protocol be deleted

from the final standard. Like NIOSH,

TSI was concerned that employees

being fit tested may be exposed to

hydrochloric acid in excess of the PEL

and, sometimes, in excess of the IDLH

level. TSI also stated that the proposed

protocol did not contain a threshold test

to measure the employee’s sensitivity to

irritant smoke, and does not provide a

means for generating a stable test-agent

concentration. The 3M Company (Ex.

137), citing the NIOSH recommendation

that irritant smoke not be used for fit

testing, also recommended against its

use. In addition, 3M stated that ‘‘the

irritant smoke test has not yet been

completely validated. Neither the level

of smoke necessary to evoke a response

nor the challenge concentration during

the fit test have been measured and

shown to be reproducible.’’

In contrast, OSHA received comments

urging that it continue to approve the

irritant smoke protocol. The

Organization Resources Counselors, Inc.

(ORC) (Ex. 54–424) noted that the

irritant smoke protocol is generally

considered to be one of the easiest,

cheapest, quickest, and most effective

QLFT methods available, although ORC

recognized that precautions must be

taken to minimize exposures. For

example, ORC pointed out that irritant

smoke fit testing should not be

performed in a small chamber, such as

an inverted plastic bag or hood, since

this could allow the accumulation of

high concentrations of hydrogen

chloride. SEIU (Ex. 54–455) supported

the use of irritant smoke QLFT because

of the benefits of its involuntary

response. The SEIU stated:

SEIU objects to the use of non-irritant

challenge agents (isoamly acetate and

saccharine). We have found that many of our

members are pressured to complete fit tests

quickly and get back to work, and hence will

not acknowledge when a respirator has

leaked during a fit test. The reaction to an

irritant fume is very difficult to disguise.

Willson Safety Products (Ex. 54–86)

also supported the use of the irritant

smaoke fit test, citing ‘‘the thousands of

businesses who now use the irritant

smoke fit test procedure with a 50 ml

squeeze bulb. They find the irritant

fume protocol the least complicated and

most easily performed of the QLFT

protocols.’’

All of the comments urging OSHA not

to approve the irritant smoke protocol

were based on the possibility that the

test could expose employees to high

levels of hydrogen chloride. The irritant

smoke protocol in Appendix A has been

carefully designed to minimize such

exposures. The initial and post fit-test

sensitivity checks must be performed

with ‘‘a small amount’’ of ‘‘a weak

concentration’’ of irritant smoke, with

care being taken to use ‘‘only the

minimum amount of smoke necessary to

elicit a response.’’ (See provisions

I.B.5(a)(4); and 5(b)(3)). Test subjects are

to be instructed to close their eyes to

prevent eye irritation during the test.

The test must be performed in a wellventilated area to prevent any build-up

of irritant smoke in the general

atmosphere (provision I.B.5(a)(5)).

Unlike other QLFT methods, the irritant

smoke test may not be performed inside

a test enclosure or hood (provision

I.B.5(a)(3)).

Persons being fit tested must pass a

user seal check before the fit testing

begins (See provision I.A.8). The irritant

smoke fit test starts with a small amount

of the irritant smoke being produced

from a smoke tube, and the person being

tested wafting a small portion of the

smoke toward his or her breathing zone

to determine if any gross facepiece

leakage occurs. Only after determining

that the initial fit is adequate does the

operator direct smoke at the facepiece

seal area, starting at least 12 inches

away from the head and working around

the seal area and gradually approaching

the test subject’s face. Because the test

is performed in an open area, the person

being tested can step back into clean air

any time irritant smoke is detected

within the mask. This limits the

maximum exposure to as little as one

breath of irritant smoke.

Following this protocol would have

avoided both of the adverse reaction

incidents NIOSH described. In the

Anchorage case, positive pressure

SCBAs were fit tested by placing the

users inside a test enclosure and

pumping it full of irritant smoke. The

users were apparently not warned to

close their eyes during the fit test. The

use of a test enclosure is expressly

prohibited in the OSHA protocol, as is

exposing test subjects to more than the

minimum amount of smoke necessary to

elicit a response. And test subjects must

be instructed to close their eyes during

testing. The test subject in the second

incident who suffered damage to her

vocal cords was also tested inside a test

enclosure; in addition, she failed four

consecutive fit tests involving this

agent. Repeated testing of a subject who

fails the test not once, but four

consecutive times, inside a test

enclosure filled with irritant smoke is

prohibited by the OSHA protocol.

Following the OSHA-accepted protocol

would have reduced to substantially

lower levels the exposures received by

these employees.
1232 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

In approving this fit test protocol,

OSHA is not discounting the evidence

that irritant smoke can cause adverse

reactions in test subjects. All of the

cases OSHA is aware of, however,

involve tests that were not done in a

way that OSHA considers acceptable,

and consequently exposed the test

subjects to excessive concentrations of

irritant smoke. OSHA emphasizes the

critical importance of following its

approved protocol, including all of the

safeguards against excessive exposure,

when this test is used. Indeed,

paragraph (f)(5) requires that employers

follow these protocols and failure to do

so constitutes a violation of the

standard.

Participants also made a number of

suggestions about specific aspects of the

protocol. The proposed irritant smoke

protocol, which was derived from

protocols promulgated in other

standards (29 CFR 1910.1025 and

subsequent health standards), required

the use of a low-flow air pump set to

deliver 200 milliliters of irritant smoke

per minute. Several participants

commented that an aspirator bulb

should be acceptable for generating an

irritant smoke test agent, and that

further justification was needed for

requiring a low-flow air pump (Exs. 54–

38, 54–86, 54–135, 54–309, 54–316, 54–

324, 54–363, 54–424). The Coastal

Corporation (Ex. 54–272) said that

requiring only the low-flow air pump

would impose an unnecessary financial

burden, and recommended that OSHA

allow for alternative methods, such as

an orifice adapter on a compressed air

system, for delivering a uniform stream

of irritant smoke. The ISEA (Ex. 54–363)

stated that its members were not aware

of a commercially available low-flow air

pump, and also recommended that an

aspirator bulb, which it said was now

used by many fit test operators, be

allowed instead.

In response to these comments, the

requirement that only a low-flow pump

may be used to generate the irritant

smoke has been changed in the final

standard. In addition to the low-flow

pump, an aspirator squeeze bulb may be

used to generate the irritant smoke for

fit testing. However, care must be taken

by the fit test operator to ensure that the

aspirator bulb produces irritant smoke

at the required flow rate of 200 ml/

minute. Since aspirator bulbs vary in

size, the person performing the fit test

must know the volume of the aspirator

bulb being used to push air through the

smoke tube. The number of bulb

squeezes per minute will vary

depending on bulb volume. For

example, a large 50 ml bulb would need

four squeezes per minute to produce the

required volume of irritant smoke, while

a smaller 25 ml bulb would need eight

squeezes per minute. The squeezes

should be uniform, and evenly spaced

out through each minute to maintain a

relatively constant flow of irritant

smoke. The use of an aspirator bulb to

deliver the test agent at a stable,

constant rate requires some skill on the

part of the test operator, since each

squeeze can be different, and care must

be taken by the fit test operator to

produce a steady stream of irritant

smoke. An aspirator bulb can produce a

large amount of irritant smoke during a

single squeeze. However, the squeeze

bulb method when properly performed

can be an effective fit test for

determining facepiece fit. Willson

Safety Products (Exs. 54–86) submitted

a March 4, 1991 letter of interpretation

it had received from Thomas Shepich of

the OSHA Directorate of Technical

Support regarding the use of a squeeze

bulb for performing the irritant smoke

QLFT under the asbestos, lead, benzene

and formaldehyde standards. Mr.

Shepich stated:

In your letter you indicated that a majority

of your customers use a 50 ml rubber squeeze

bulb that is capable of delivering a flow of

200 ml of air per minute if used correctly.

You also express concern over the need to

spend $500.00 or more to use a mechanical

pump since the rubber squeeze bulb can

adequately meet the intent of the OSHA

standard.

The QLFT method is a pass/fail test. Since

a rubber squeeze bulb generated challenge

agent can be as effective as a mechanically

aspirated one, the intent of the standards has

been met. The training of individuals

administering QLFT by the rubber squeeze

bulb method must include techniques on the

proper number of compressions per minute

necessary to generate an appropriate air flow.

A few other modifications to the

protocol have also been made. As the

ISEA (Ex. 54–363) recommended, the

term ‘‘irritating properties’’ has been

substituted for ‘‘characteristic odor’’ in

the irritant smoke protocol in Appendix

A, since the term better describes what

the employee experiences. Based on

ORC recommendations (Ex. 54–424), the

reference to the MSA smoke tube has

been removed, and language has been

added requiring that the end of the

smoke tube be covered with a short

length of tubing to prevent injury from

any jagged glass where the tube has

been opened. As the AIHA (Ex. 54–298)

recommended, the description

‘‘involuntary cough’’ has been added to

the description of the response to

irritant smoke. A clear statement that no

form of test enclosure or hood is to be

used with irritant smoke has been

added, as supported by ORC (Ex. 54–

424), and in response to the problems

described by NIOSH and TSI (Exs. 54–

303; 54–437R).

Quantitative Fit Test (QNFT)

Appendix A includes three

quantitative fit test protocols, the

generated aerosol protocol, the

Portacount TM protocol that uses

ambient aerosol as the test agent and a

condensation nuclei counter (CNC) as

the test instrumentation, and the

controlled negative pressure (CNP)

protocol (i.e., the Dynatech FitTester

3000 TM). Only the generated aerosol

protocol was included in the proposal.

Each QNFT method is described in a

separate section of Appendix A.

Part I of section C contains general

requirements for QNFT. The employer

is to ensure that the individuals who

perform the QNFT, whether employees

or contractors, are able to calibrate

equipment and perform tests properly,

recognize invalid tests, calculate fit

factors properly and ensure that test

equipment is in proper working order.

The employer is also responsible for

ensuring that the QNFT equipment is

cleaned, maintained, and calibrated

according to the manufacturer’s

instructions so that it will operate as

designed.

Respirators used for QNFT must be in

proper working condition. Respirators

are to be rejected if leakage is detected

from exhalation valves that fail to reseat

adequately, near the probe or hose

connections, or if the respirator is

missing gaskets. The requirement in

paragraphs (h)(1)(iv) and (h)(3)(i)(A) that

all respirators used in non-emergency

situations be inspected for defects

before each use and cleaned after each

use also apply to fit testing. The test

operator must inspect the test respirator

for: cracking, holes, or tears in the

rubber body of the facepiece; cracks or

tears in valve material and in the

inhalation and exhalation valve

assemblies; foreign material between the

valve and valve seats; proper

installation of the valve body in the

facepiece; and warped or wrinkled

valves. Respirators with any of these

defects cannot be used for fit testing.

A user seal check must be conducted

prior to starting QNFT to ensure that the

respirator facepiece is properly

adjusted. The use of an abbreviated, or

screening, QLFT before QNFT fit testing

to identify poorly fitting respirators is

optional.

Paragraph 2—Generated Aerosol QNFT

The procedures for conducting the

generated aerosol quantitative fit test are

widely recognized and accepted by the

industrial hygiene community. The test

is performed inside a test unit such as
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1233

a hood, portable booth, or chamber. An

aerosol of a test agent is generated

inside the enclosure. A stable ambient

test agent concentration must be

achieved prior to beginning the test

exercise regimen. The test unit must be

large enough to permit the employee

being tested to freely perform the QNFT

exercise regimen without disturbing the

test agent concentration, and the unit

must effectively contain the test agent in

a uniform concentration.

During the test, the respirators are

fitted with filters, such as high

efficiency HEPA, or P100 filters, that

offer 99.97% efficiency against 0.3

micron aerosols as defined by NIOSH in

30 CFR part 11 or 42 CFR part 84.

Therefore, virtually any measurable

leakage should be the result of leaks

between the respirator sealing surface

and the respirator user’s face. If test

agents other than particulates are used,

the sorbent/filters must offer a similar

degree of collection efficiency against

the test agent. The concentration of the

test agent is measured both inside and

outside the respirator. Commonly used

detection methods include forward

light-scattering photometry or flame

photometry.

Three methods were proposed for

using the results of these measurements

to calculate fit factors: the average peak

penetration method; the maximum peak

penetration method; and the use of an

integrator to calculate the area under the

individual peak for each exercise (59 FR

58919). OSHA proposed that the fit

factor derived from QNFT using test

agents be calculated by dividing the

average test agent concentration inside

the chamber (i.e., the ambient

concentration) by the average test agent

concentration inside the respirator for

each test exercise (excluding the

grimace exercise). The average ambient

concentration is derived from the

measurement of the test agent

concentration in the test chamber (i.e.,

outside the respirator) at the beginning

and end of the test. TSI, Inc. (Ex. 54–8)

stated that while the language proposed

for determining the average test

chamber concentration was correct,

better accuracy could be obtained by

averaging the chamber concentration

before and after each exercise, and by

allowing for continuous chamber

concentration measurements. OSHA

agrees that the standard should allow

for these other methods of measuring

average test chamber concentration, and

has adopted the revised language

submitted by TSI.

In the proposal, the average test agent

concentration inside the respirator was

to be determined from the aerosol

penetration during each test exercise

using one of three approved methods for

calculating the overall fit factor. TSI,

Inc. (Ex. 54–8) noted that the intuitive,

but algebraically incorrect, method of

computing the arithmetic average of the

fit factors for all exercises (i.e., for

instruments that report their exercise

results as fit factors instead of peak

penetrations) would result in an

overestimation of the overall fit factor.

This commenter suggested that OSHA

adopt the equation from the draft ANSI

Z88.10 fit testing standard that correctly

states how to perform the fit factor

calculation for instruments that report

results as exercise fit factors instead of

peak penetration values. OSHA agrees

and has added this equation to

Appendix A in the final standard.

The test aerosol penetration measured

for the grimace exercise is not to be used

in calculating the average test agent

concentration inside the respirator (See

provision I.C.2(b)(8)(i)). The purpose of

the grimace exercise is to determine

whether the respirator being fit tested

will reseat itself on the face after the

respirator seal is stressed during the

exercise. With a properly fitting

respirator, the test instrumentation

should record a rise in test agent

concentration inside the mask during

the grimace exercise, and a drop in test

agent concentration when the respirator

reseats itself. If the respirator fails to

reseat itself following the grimace

exercise, the subsequent normal

breathing exercise will show excessive

leakage into the mask and result in a

failed fit test. Since even a properly

fitting respirator may show increased

test agent penetration during part of the

grimace exercise, the penetration value

measured during the grimace exercise is

not to be used in calculating the overall

fit factor.

A clear association is required

between an event taking place during

testing and the record of the event. This

requirement is critical for the proper

calculation of aerosol penetration for

specific test exercises. Short duration

leaks (displayed as peaks on the

recording instrument) can occur during,

and as a result of, each fit test exercise,

and these leaks indicate poor respirator

fit. These penetration peaks are used to

determine the fit factor. An inability to

measure these penetration peaks could

result in the fit factor being

overestimated, since averaging all the

test exercise penetration peaks may

obscure the high penetration levels that

occur during a test exercise. An inability

to clearly associate the exercise event

with the recording makes correct

calculation of the fit factor impossible.

Several factors can affect the time

interval between an exercise event

occurring during QNFT and the

recording of the event, such as the

diameter of the sampling line, sampling

rate, and the length of the sampling line.

Response time will increase with an

increase in the length and/or diameter

of the sampling line. Therefore, the

length and inside diameter of the

sampling line should be as small as

possible. The line used for sampling the

test chamber test agent concentration,

and the line used for testing the test

agent concentration inside the

respirator, must have the same length

and inside diameter so that aerosol loss

caused by aerosol deposition in each

sample line is equivalent for the two

lines.

To minimize both contamination of

the general room atmosphere and test

operator exposure to the test agent, the

generated aerosol protocol requires that

air exhausted from the test unit must

pass through a high-efficiency filter (or

sorbent).

Since the relative humidity in the test

chamber may affect the particle size of

sodium chloride aerosols, the protocol

further requires that the relative

humidity of the test unit be kept below

50 percent. This requirement is

consistent with manufacturer’s

instructions for sodium chloride units.

Prior to beginning the generated

aerosol QNFT, a stable test agent

concentration must be achieved inside

the test unit. The concentration inside

small test booths or waist-length hoods

may be diluted significantly when the

employee enters the booth. Normally,

the test agent concentration will

stabilize within two to five minutes.

Adjustments to the respirator must

not be made during the QNFT. Any

facepiece fit adjustments must be made

by the employee before starting the

exercise regimen. This requirement will

prevent manipulation of the respirator

during fit testing to achieve higher fit

factors. The fit test is to be terminated

whenever any single peak penetration

exceeds two percent for half masks and

quarter facepiece respirators, and one

percent for full facepiece respirators.

Such leaks correspond to fit factors

below 100 for half masks and 500 for

full facepiece respirators, and indicate

an unacceptable respirator fit. In such

cases, the respirator may be refitted or

adjusted, and the employee retested. If

a subsequent QNFT test performed after

the respirator has been refitted or

adjusted is terminated because of

excessive penetration, then the

respirator fit for that individual must be

considered unacceptable, and a different

respirator must be selected and tested.

OSHA had proposed that an employee

successfully complete three separate fit
1234 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

tests with the same respirator using a

QNFT protocol. The proposed

requirement was derived from the fit

testing protocols in OSHA’s substancespecific standards, e.g., the Benzene

standard (29 CFR 1910.1028). This

proposed provision received more than

150 comments. Many commenters

stated that only a single QNFT was

needed, and that the additional tests

would only increase the cost of fit

testing without a corresponding

improvement in attaining a successful

fit (Exs. 54–11, 54–26, 54–35, 54–37,

54–41, 54–44, 54–63, 54–83, 54–114,

54–124, 54–139, 54–208, 54–289, 54–

316, 54–359, 54–363). Some said that

requiring three tests for QNFT would

discourage employers from adopting

QNFT (Ex. 54–164), or would force

employers to use the less protective

QLFT, which requires only one fit test

(Exs. 54–316, 54–359, 54–363, 54–434).

One commenter stated that three fit tests

for QNFT would only be needed if

OSHA allows higher APFs based on the

results (Ex. 54–84). (OSHA notes that

the concept of increasing the APF based

on repeated fit testing, originally

contained in the ANSI Z88.2–1980

respirator standard, was subsequently

removed from the Z88.2–1992 revision

of that standard (Ex. 54–443)). The Bath

Iron Works (Ex. 54–340) stated that the

variation between separate fit tests is

significant, and recommended that this

problem could be resolved by increasing

the safety factor beyond 10. Other

commenters suggested that increasing

the fit factor required for passing a

single QNFT was an alternative to

requiring three fit tests (Exs. 54–139,

54–154, 54–173, 54–340).

The final standard does not include

the requirement to perform three

successful QNFTs because performing

three tests has not been shown in this

record to better detect poor respirator

fit. Increasing the safety factor of 10,

thereby raising the minimum fit factor

required to pass a QNFT, also has not

been adopted by OSHA because

experience indicates a safety factor of

ten is sufficient. While many employers

have, on their own, decided to require

higher fit factors during fit testing, data

in the record do not support the

suggestion that increasing the safety

factor beyond 10 is appropriate. Using a

safety factor of 10 is current practice in

fit testing, and is used to account for the

variability in fit testing procedures, as

well as other variables (e.g., differences

in respirator fit between the workplace

and during fit testing).

The results of the fit test must be at

or above the minimum fit factor

required for that class of tight-fitting airpurifying respirator. The required fit

factors are established by applying a

safety factor of 10 to the APFs for that

class of respirator. For example, quarter

and half mask air-purifying respirators

with an APF of 10 must achieve at least

a fit factor of 100, and full facepiece airpurifying respirators with an APF of 50

require a minimum fit factor of 500.

Paragraph 3—Condensation Nuclei

Counter (CNC) QNFT

A protocol for the ambient aerosol

condensation nuclei counter (CNC)

quantitative fit testing protocol (i.e., TSI,

Inc. Portacount TM) has been added to

the final standard as an accepted QNFT

method. Many commenters pointed to

the need for a CNC QNFT protocol.

Commenters, (Exs. 54–216, 54–326, 54–

359) noted that the Portacount is the

most commonly used method, and that

sufficient data have been developed

over the past several years to validate its

effectiveness. The use of the Portacount

has been allowed by OSHA under a

compliance interpretation published in

1988. Commenters urged that the

ambient aerosol CNC method be

included in the list of accepted QNFT

methods in the final standard (Exs. 54–

216, 54–326, 54–359). OSHA agrees

with these comments. The written

instructions for performing the fit test in

Appendix A are essentially the same as

the instructions provided by the

manufacturer.

Paragraph 4—Controlled Negative

Pressure (CNP) QNFT

The protocol for the controlled

negative pressure (CNP) quantitative fit

test method (Dynatech Nevada FitTester

3000 TM) has also been added to the list

of accepted QNFT methods. This fit test

method involves the use of a fit test

instrument to generate a controlled

negative pressure inside the facepiece of

the respirator to measure the resulting

leak rate.

This fit test protocol is the same

protocol allowed by OSHA under a

compliance interpretation letter issued

in 1994 and based on various studies on

the performance of the CNP method

conducted by its developer, Dr. Cliff

Crutchfield (Exs. 71, 54–436). These

studies reported results that were

validated by comparing them to results

from the existing aerosol fit test systems.

The data showed that the fit factors

measured with CNP are always lower

than the fit factors measured with an

aerosol QNFT. OSHA had reviewed

these studies before issuing its

compliance letter. OSHA believes that

the CNP method, based on Dr.

Crutchfield’s validation data, constitutes

adequate support for the method’s

reliability in rejecting bad fits. Although

no body of data is available that

describes employer experience using the

CNP method in the workplace, OSHA is

confident that the extensive validation

data showing consistently conservative

results using CNP means that this

method will identify bad fits at least at

the same rate as other accepted fit test

protocols.

Several commenters urged OSHA to

provide a protocol for the CNP method

and to list it as approved (See, e.g., Exs.

54–167, 54–216). In addition, NIOSH in

its comments and testimony stated that

‘‘NIOSH recommends that OSHA

recognize * * * the following fit test

procedures as acceptable * * *

Quantitative fit tests using controlled

negative pressure and appropriate

instrumentation to measure the

volumetric leak rate of a facepiece to

quantify the respirator fit’’ (Tr. 359, Ex.

54–437). NIOSH further stated in its

comment (Ex. 54–437) that ‘‘[o]nly the

controlled negative pressure fit test

system, which has been excluded in the

OSHA proposal, has been subjected to

limited validation’’ (Decker and

Crutchfield, 1993). The State of

Washington Department of Labor and

Industries (Ex. 54–173) requested that

OSHA provide performance criteria so

that methods such as ‘‘Dynatech test

equipment’’ described as ‘‘proven’’ and

‘‘accepted’’ may more easily be used.

Penelec/Genco reported favorable

experience using the CNP method (Ex.

54–167). As stated in its comment:

Penelec/Genco recently quantitatively fit

tested approximately 1500 employees on

both half and full face respirator facepieces

using the Dynatech/Nevada FitTester 3000.

For the past 10 years we have performed fit

tests using particle counting equipment. We

are most pleased with the results provided by

the FitTester 3000 * * * We believe that the

science is sound, the equipment is reliable,

and the results are valid. When used as part

of a complete respiratory protection program,

we believe controlled negative pressure fit

testing is an effective way of matching each

person with the best-fitting, most comfortable

facepiece respirator.

All the peer-reviewed studies consistently

show that controlled negative pressure

equipment and protocols always produce

more conservative fit test results than particle

counting equipment and protocols. Our

experience totally supports this.

We find the Dynatech/Nevada FitTester

3000 to be durable, reliable and easy to use.

Results are always reproducible, with

minimum variation. Employee acceptance is

excellent, especially because they get a direct

perception of fit (leaks or lack of) which

corresponds well to the machine’s fit results.

Using the FitTester 3000 we are able to

select more comfortable, better fitting

respirators for our employees. We believe

that certain respirator brands are far superior

to others in terms of fit and comfort. As a

result, we have switched brands. Our
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1235

employees are far more satisfied with the fit

and comfort of their new respirators * * *

(Ex. 54–167)

TSI, Inc. (Exs. 54–229, 54–302) stated

that OSHA should reject the CNP

method as a valid QNFT, since

employees who are tested using this

method must hold their breath and

remain motionless during the

measurement, i.e., they cannot perform

the required exercises simultaneously

with the measurement. According to TSI

(Ex. 171), dynamic exercises are

necessary to simulate the face seal

stresses imposed by workplace

conditions. Dr. Crutchfield, in his posthearing submission (Ex. 134), responded

to statements made by Jeff Weed of TSI

at the hearing and in TSI’s submissions

to the record regarding the CNP fit test

method. He discussed the ability of

aerosol-based fit test methods to

measure transient leaks, stated that

leakage occurs with inhalation, and that

the CNP method measured more

respirator leakage than aerosol-based

systems, and further, that CNP fit factors

‘‘tend to align more closely with

workplace protection factors than do

aerosol-based fit factors.’’ Dr.

Crutchfield stressed the importance of

being able to effectively measure

fundamental leakage into the respirator,

stating that ‘‘most dynamic exercises do

not seem to have a statistically

significant effect on measured fit

factors.’’

OSHA recognizes the need to perform

fit testing exercises to stress the

facepiece seal, and has included a full

range of exercises in the CNP protocol

in Appendix A. They differ from the

exercises for the CNC method, since test

results are not taken while the test

exercise is being performed, but are

taken after the exercise is completed.

However, since the CNP method cannot

distinguish changes in facepiece volume

that are related to movement during an

exercise from leakage into the facepiece

caused by poor respirator fit, the CNP

protocol requires that the employee

remain motionless during the short

sampling period that is required after

each exercise. OSHA believes that any

changes in fundamental fit caused by

the test exercises should, consequently,

be measured by the CNP method during

the 10-second sampling period

following each exercise, and that this

does not affect the test’s ability to detect

poor fits when the seal is stressed.

In addition to the OSHA-accepted

CNP fit test protocol, Dr. Crutchfield

(Tr. 254) testified about a new fit test

protocol for the CNP method. This new

protocol is substantially different from

the OSHA-accepted protocol, which

requires the performance of test

exercises followed by CNP

measurements. The new protocol was

also described in detail in a letter from

Senator John McCain of Arizona on

behalf of Dr. Crutchfield (Ex. 54–460).

The new protocol submitted after the

close of the post-hearing comment

period is described as consisting of

three exercises and two redonnings. The

first exercise measured ‘‘fundamental

respirator fit’’ with the head facing

forward. The second exercise was a

bending exercise, with the respirator

parallel to the floor. The third exercise

consisted of vigorously shaking the head

from side-to-side for three seconds,

followed by a ‘‘fundamental fit’’

measurement. The respirator user then

is required to remove and redon the

respirator twice, with ‘‘fundamental fit’’

measured after each redonning. This

protocol results in five CNP

measurements, from which a harmonic

mean fit factor is calculated and used to

make a pass-fail determination for the fit

test.

The information on the new protocol

was not submitted to the rulemaking

docket in time to allow an opportunity

for public comment. OSHA, therefore,

cannot include it in this final standard.

Appendix A, Part II establishes

procedures by which OSHA will

approve new fit testing protocols after

allowing opportunity for public

comment. A proponent of the revised

CNP fit test protocol may submit it for

approval in accordance with Appendix

A, Part II.

Proposed part (II)(A)(12) of Appendix

A required that the employer maintain

a record of the qualitative or

quantitative fit test administered to an

employee. This requirement has been

moved to paragraph (m)(2) in the final

standard to consolidate the standard’s

recordkeeping requirements. The fit test

record must include the date and type

of fit test performed, employee

information, and type of respirator.

When a QNFT is administered, a record

of the test (e.g., strip charts, computer

integration) must be retained. The fit

test records are to be maintained until

the next fit test is administered. A

record is necessary for OSHA to

determine compliance by verifying that:

the employee has been fit tested, both

prior to starting respirator use and at

least annually thereafter; the tested

employee passed the qualitative fit test

or achieved a sufficiently high fit factor

to pass the quantitative fit test for the

required assigned protection factor; the

quantitative fit test was correctly

performed, and the fit factor calculated

properly; and the model and size of the

respirator used during fit testing are the

same as the model and size of the

respirator used by the employee in the

workplace.

New Fit Test Protocols

Paragraph (f)(3) of the proposed rule

stated that OSHA would evaluate new

fit test protocols under criteria specified

in Section I of Appendix A and would

initiate rulemaking under section 6(b)(7)

of the OSH Act if the proponent of a

new fit test method submitted the

method and validation testing data to

OSHA for evaluation. The section listed

detailed criteria OSHA would apply in

determining whether to approve the

new protocol.

Some commenters recommended

alternative approaches for approving

new fit test protocols. Mobil Oil (54–

234) and the American Petroleum

Institute (Ex. 54–330) suggested that

NIOSH should be the reviewer of

alternative fit test methods. Exxon (Ex.

54–266) questioned the role OSHA

would have in the approval of new fit

test protocols, stating that NIOSH or

other agencies or laboratories could

better review new fit test methods. The

American Association of Occupational

Health Nurses (Ex. 54–213) supported

the use of other new fit test methods,

provided that they have been

demonstrated to be statistically

equivalent to the existing OSHAaccepted methods, but stated that the

administrative rulemaking procedure

OSHA had proposed would result in

delays and paperwork that would

discourage the development of new

methods. The Composites Fabricators

Association (Ex. 54–295) also stated that

subjecting new fit test methods to

rulemaking would discourage an

employer from developing or adopting

any fit test method not already approved

by OSHA. The Society of the Plastics

Industry (Ex. 54–310) stated that

rulemaking on new methods was

unnecessary, and that OSHA should

publish criteria for fit tests and allow

employers to adopt new methods

without cumbersome rulemaking. The

National Association of Manufacturers

(Ex. 54–313) proposed that publication

of a new fit test method in a peerreviewed journal should be prima facie

evidence that the method had been

validated.

OSHA cannot accept the suggestion

by some commenters that it should

accept new fit test protocols without

following the OSH Act’s rulemaking

procedures. Appendix A was adopted

under the OSH Act’s rulemaking

procedures and, under section 6(b) of

the Act, can only be modified through

the same rulemaking procedures.

Modifications to Appendix A to add

new fit test protocols would therefore
1236 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

have to undergo the same type of

rulemaking scrutiny, including the

opportunity for public comment, that

the approved protocols have received.

In response to comments received,

OSHA has modified Appendix A from

the version contained in the proposal.

These changes streamline the process of

approving new fit test protocols by

assuring that any new method proposed

is supported by data of high quality. As

modified, Appendix A also takes a more

performance-oriented approach to the

approval process than did the proposal.

Rather than listing the detailed criteria

a new fit test protocol must satisfy, final

Appendix A requires that a proposed

new protocol be supported either by test

results obtained by an independent

government research laboratory or by

publication in a peer-reviewed

industrial hygiene journal.

Both of these options will assure that

any new fit test protocol proposed will

have a sound scientific basis before

being submitted to OSHA. Government

research laboratories such as Los

Alamos National Laboratory and

Lawrence Livermore National

Laboratory have considerable expertise

in reviewing new fit test protocols to

determine whether they are safe,

accurate, and statistically valid. A

favorable recommendation by such a

laboratory, along with the supporting

data gathered by the laboratory, will

provide a solid basis on which OSHA

can base its evaluation. Moreover,

because the laboratory’s report and

recommendation will be in the public

record when the OSHA rulemaking

proceeding begins, the public will have

the opportunity to examine the data

supporting the proposed new method

and to provide any additional data

either in support of or in opposition to

the proposed method.

An application for a new test protocol

that has been published in a peerreviewed industrial hygiene journal will

similarly provide a sound basis for

rulemaking on the new method. Like

review by a national research laboratory,

the peer-review process assures that the

data supporting the method has been

scrutinized and found acceptable by a

neutral party with expertise in

evaluating fit test methods. The

published article would be available to

the public when the rulemaking

commences, and interested members of

the public would therefore be apprised

of all relevant aspects of the proposed

method and would be well-positioned

to comment on the method.

OSHA believes that the final rule’s

approach will streamline the process of

accepting new fit test protocols and

avoid discouraging the development of

new methods. A rulemaking on a new

protocol would thus only begin after the

protocol’s proponent has established a

solid basis for seeking the Agency’s

approval. At the time the rulemaking

begins, interested members of the public

would know the scientific basis on

which approval is sought and would be

able to afford OSHA the benefit of their

views. The rulemaking process should

therefore be able to proceed more

quickly than if OSHA were to evaluate

data that had not previously been

scrutinized by an expert body and were

to base the approval process on the

detailed criteria contained in Appendix

A of the proposed rule. And because the

rulemaking process can be expected to

proceed expeditiously once a qualifying

application has been submitted, parties

interested in developing new protocols

should not be discouraged from doing

so.

New fit test methods are to undergo

notice and comment rulemaking. This

decision reflects OSHA’s long

experience in evaluating fit test

methods, which includes, in this

rulemaking, such fit test methods as the

‘‘condensation nuclei counter’’ (CNC)

method and the ‘‘controlled negative

pressure’’ (CNP) method and, in past

rulemakings, the ‘‘saccharin QLFT’’

method and the ‘‘isoamyl acetate QLFT’’

method. In the past 20 years there have

only been a few new methods, but each

has required the evaluation of

supporting data, and each new method

has generated wide public interest and

comment. New fit test methods,

particularly those that involve new

scientific principles and new techniques

for evaluating respirator performance,

require full consideration and public

discussion of the issues by the regulated

community, competitive interests,

respirator experts, and labor groups. The

notice and comment rulemaking process

will ensure that OSHA receives the

necessary public input, as well as data

required for open evaluation, and that

all interested parties have a chance to

comment publicly on any new method.

Publishing a new fit test method in the

Federal Register should: elicit public

comment and debate over the merits of

the method; notify the regulated

community of the possible availability

of a new method; and solicit any

additional information that would be

relevant for consideration before OSHA

makes its final decision. OSHA does not

intend the rulemaking process to be

cumbersome or involved, but such a

process will ensure that all information

and comments are available to the

public, and that any known problems

with the new method are addressed

before final acceptance.

Adopting an approach that allows for

the acceptance of new fit test methods

is a fundamental change to this

standard. Fit test methods directly

impact a worker’s health, since fit tests

are designed to identify poorly fitting

respirators. Without the careful

evaluation that a new fit test method

will receive during the rulemaking

process, OSHA cannot be sure that a

flawed fit test method would not be

developed and marketed to respirator

users. If used to select respirators, a

flawed method would lead to

unnecessary worker exposure to

hazardous substances, since poorly

fitting respirators would not be detected

by the method. Determining the

reliability of new fit test methods

requires more evaluation, for example,

than do new respirator cleaning

methods or new user seal check

methods, which can be developed by

the respirator manufacturer (See

Appendix B). New cleaning methods

and user seal checks need not undergo

rulemaking to become accepted

methods. The more rigorous evaluation

through notice and comment is required

only for new fit testing methods, where

OSHA experience has shown the need

for a public review of performance.

Moldex (Ex. 54–153) Mobil Oil (Ex.

54–234), Exxon (Ex. 54–266), and the

American Petroleum Institute (Ex. 54–

330), recommended that OSHA allow

interested parties other than employers

to submit new fit test methods for

OSHA acceptance. In the past, OSHA

has allowed other interested parties,

such as the developers of new fit test

equipment, to submit new test protocols

and methods for OSHA approval, and

will continue to do so. To make this

explicit, the final rule states that a

proposed new protocol may be

submitted by any person.

Paragraph (g)—Use of Respirators

The final rule requires employers to

establish and implement procedures for

the proper use of respirators. Paragraph

(g)(1) contains specific requirements for

ensuring an adequate facepiece seal

each time a respirator is used. Paragraph

(g)(2) requires employers to reevaluate

respirator effectiveness when there are

changes in environmental or user

conditions, as well as requiring that

employees leave the respirator use area

if they detect any signs that respirator

effectiveness has been compromised or

to perform any adjustments. Paragraphs

(g)(3) and (g)(4) address procedures for

the use of respirators in IDLH

atmospheres and in interior structural

fire fighting, respectively.
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1237

Paragraph (g) of the proposal

addressed the same issues in the context

of requiring employers to develop and

implement written standard operating

procedures. As suggested by a number

of commenters, OSHA has deleted the

requirement for written procedures in

light of the fact that paragraph (c)

already requires a written respiratory

protection program (Exs. 54–38, 54–163,

54–226, 54–428). In addition, OSHA has

moved to paragraph (d), governing

respirator selection, the proposed

paragraph (g) requirement that

employers ensure that SCBAs are

certified for a minimum service life of

30 minutes if they are to be used in

IDLH atmospheres, for emergency entry,

or for fire fighting. Final paragraph (g)

thus contains only those requirements

necessary for the appropriate use of

respirators in non-IDLH, IDLH, and

interior structural fire fighting

atmospheres.

Paragraph (g)(1)—Facepiece Seal

Protection

Paragraphs (g)(1)(i) and (g)(1)(ii) are

intended to ensure that facial hair, other

conditions potentially interfering with

the facepiece seal or valve function, and

eyewear or other personal protective

equipment does not interfere with the

effective functioning of the respirator.

Paragraph (g)(1)(iii) requires employees

to perform a user seal check each time

they put on a respirator for use in the

workplace.

Paragraph (g)(1)(i)(A) prohibits an

employer from allowing respirators with

tight-fitting facepieces to be worn by

employees who have ‘‘facial hair that

comes between the sealing surface of the

facepiece and the face or that interferes

with valve function.’’ Paragraph

(g)(1)(i)(B) prohibits tight-fitting

facepieces to be worn by employees

who have any condition that interferes

with the face-to-facepiece seal or with

valve function. The prior standard

prohibited the wearing of respirators

‘‘when conditions prevent a good face

seal. Such conditions may be a growth

of beard [or] sideburns * * *.’’ The

proposed requirement would similarly

have prohibited employers from

allowing tight-fitting respirator

facepieces to be worn by employees

‘‘with conditions that prevent such fits.’’

‘‘Facial hair that interferes with the

facepiece seal’’ was listed as one

example of such a condition. The final

rule thus clarifies the language of the

NPRM.

OSHA’s final standard affords

employers more flexibility than the

ANSI Z88.2–1992 standard, Section

7.5.1, which prohibits the use of any

respirator equipped with a facepiece,

whether tight or loose-fitting, if the user

has facial hair that comes between the

sealing surface of the facepiece and the

face. Although some commenters

recommended that OSHA adopt the

language of the ANSI standard (Exs. 54–

218, 54–219), OSHA has determined

that it is only necessary to apply the

facial hair prohibition to tight-fitting

respirators.

The rulemaking record (Exs. 15–11,

15–26, 15–28, 15–27A, 15–30, 15–33,

15–35, 15–36, 15–41, 15–52, 15–58, 15–

62, 15–73, 15–77) also contains strong

evidence that facial hair can interfere

with tight-fitting facepiece seals.

According to the study by Hyatt and

Pritchard, discussed further below,

facial hair includes stubble (Ex. 23–5).

A number of studies and comments that

were submitted to the record (Exs. 23–

5, 36–49, 36–31, 36–45, 36–47, 54–

443D, 54–408) addressed the effect of

facial hair on respirator performance.

McGee and Oestenstad (Ex. 23–2) tested

eight volunteers on a closed-circuit,

pressure-demand, self-contained

breathing apparatus. The volunteers

were clean-shaven at the beginning of

the study. They underwent quantitative

fit tests at two-week intervals over an

eight-week beard growth period. Beard

growth had a profound, negative effect

on the observed fit factors. Most of the

volunteers started with fit factors of

20,000 when first fit tested; after eight

weeks, these same workers achieved fit

factors ranging only from 14 to 1067.

In another study, E.C. Hyatt, J.A.

Pritchard and others (Ex. 23–5)

investigated the effect of facial hair on

the performance of half-mask and fullfacepiece respirators. Quantitative fit

tests were performed on test volunteers

with varying amounts of facial hair,

including stubble, sideburns, and

beards. The results showed that facial

hair can have a range of effects on

respirator performance, depending on

factors such as the degree to which the

hair interferes with the sealing surface

of the respirator, the physical

characteristics of the hair, the type of

respirator, and facial characteristics. In

general, the presence of beards and wide

sideburns had a detrimental effect on

the performance of the respirators. The

authors concluded that:

• Individuals with excessive facial

hair, including stubble and wide

sideburns, that interfere with the seal

cannot expect to obtain as high a degree

of respirator performance as clean

shaven individuals.

• The degree of interference depends

on many factors (e.g., the length,

texture, and density of facial hair) and

the extent to which those factors

interfere with the respirator’s sealing

surface.

• Short of testing a bearded worker

for fit daily, the only prudent

approaches are to require that facial hair

not interfere with the respirator seal

surface (e.g., shave where the seal

touches the face) or to prohibit the

employee from working in areas

requiring respiratory protection.

Other fit testing studies also show that

non-bearded workers have significantly

higher fit factors than bearded workers.

Skretvedt and Loschiavo (Ex. 23–3)

tested both half-mask and full facepiece

respirators on 370 male employees who

were fit tested both qualitatively and

quantitatively; 67 of the employees had

full beards. The bearded workers

consistently failed qualitative fit testing.

Bearded employees using half-masks

had a median fit factor of 12, while

clean-shaven employees had a median

fit factor of 2950. For full facepiece

respirators, bearded workers had a

median fit factor of 30 and clean-shaven

employees had a fit factor of greater

than 10,000.

Only one study found no significant

difference in respirator performance for

employees with or without beards.

Fergin (Ex. 23–1) studied workplace

protection factors, but not fit factors, for

three different types of disposable

respirators used by carbon setters during

carbon setting and ore bucket filling

operations. The study, which involved a

total of 75 samples collected from 38

non-bearded and 22 bearded workers,

compared ambient concentrations with

‘‘in-mask’’ concentrations. Beard types

were classified as light, medium, heavy,

fine, soft, coarse, and curly. Results

showed no clear relationship between

type of beard and respirator protection

factor. The authors recommended that,

‘‘* * * where acceptable protection

factors can be demonstrated for subjects

with facial hair, the no-beard rule

should be waived.’’

OSHA does not find this study a

persuasive basis for changing its

position on facial hair. The fact that an

acceptable protection factor can be

obtained for a bearded respirator wearer

in a workplace protection factor study

does not mean that the worker can

achieve the same protection level each

time the respirator is used. First,

protection factor studies are designed to

minimize program defects and are often

conducted under very tight supervision,

which is generally not typical of

conditions in real workplaces. Second,

beards grow and change daily, resulting

in variability of protection from one day

to the next.

Fergin based his conclusion that

respirator performance is similar for
1238 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

bearded and non-bearded workers on a

statistical comparison of geometric

means, calculated separately for each

type of respirator for bearded and nonbearded workers. OSHA is more

concerned about the wide range of

values than the geometric mean values.

The protection factors observed by

Fergin varied greatly and ranged from

1–1041 (no beards) and 4–332 (beards)

for a 3M–9910 respirator; 12–36 (no

beards) and 7–30 (beards) for a 3M–8706

respirator; and 5–1006 (no beards) and

42–391 (beards) for a 3M–9906

respirator. OSHA notes that the

protection factors of 5 and lower that

Fergin achieved for both bearded and

clean-shaven workers are below the

NIOSH recommended protection factors

for disposable respirators of the types

tested by Fergin (NIOSH Respirator

Decision Logic, 1987, Ex. 9).

There are several other weaknesses in

this study that undermine its use as a

counterweight to so much other

evidence and expert opinion. The study

did not account for particle size or the

differences between protection factors

obtained when the respirators were used

in high as compared to low ambient

concentrations. Moreover, two of the

three respirators involved lacked

adjustable face straps, which makes any

sort of tightening impossible. Finally,

the author himself cautioned that facial

hair can significantly impair respirator

seal effectiveness in atmospheres that

are highly toxic or IDLH.

In fact, most rulemaking participants

(Exs. 3, 13, 15–50, 23–2, 23–3, 23–5)

agreed that facial hair can be a problem

for respirator users, although they

suggested different approaches to

address this issue. A few commenters

recommended that OSHA simply

prohibit the use of respirators by

bearded workers, based on the ANSI

rationale that beards interfere with the

functioning of all respirators (Exs. 54–

443, 54–408). In general, these

commenters were opposed to any

requirement in the standard that would

have required employers to provide

bearded workers with loose-fitting

respirators to accommodate their beards.

Other commenters stated that OSHA

should require employers to provide

loose-fitting respirators (e.g., suppliedair hoods, helmets, or suits) for use by

employees with beards (Exs. 15–14, 15–

31, 15–34, 15–46, 15–47, 15–48, 15–54,

15–55, 15–79, 15–81, 54–427, 54–387,

54–363). For example, NIOSH

recommended that, when the situation

permits, employers should be allowed

to accommodate bearded workers by

providing respirators that will not be

affected by facial hair (Ex. 54–437).

Daniel Shipp of the Industrial Safety

Equipment Association (ISEA) also

stated that, in situations where

employers do not intend to enforce

policies against facial hair, the ISEA

would recommend that employers

provide respirators that do not rely on

a tight facepiece fit (Ex. 54–363).

Richard Uhlar and Michael Sprinker

of the International Chemical Workers

Union (ICWU) stated that there should

be some provision in the standard to

notify employees that respirators other

than tight-fitting respirators can be used

by bearded workers (Ex. 54–427). This

comment is in basic agreement with

NIOSH’s recommendation that there

should be some provision in the

standard to notify employees that other

respirators that can be worn with beards

exist (Ex. 54–437).

In contrast, other commenters (Exs.

54–408, 54–443) recommended that

OSHA prohibit the wearing of beards by

employees who use respirators on the

grounds that employers should not have

to supply loose-fitting respirators

because an employee is unwilling to

shave off his beard. More specifically,

George Thomas of Duquesne Light

Company (Ex. 54–408) stated that his

company does not support a

requirement that employers should

provide workers with loose-fitting

respirators when employees have facial

hair. According to Mike Rush of the

Association of American Railroads,

requiring employers to provide

respirators other than tight-fitting airpurifying respirators would be costprohibitive, because PAPRs cost 50

times as much as half masks (Ex. 54–

286). A. Gayle Jordan of Norfolk

Southern Corporation quoted the cost of

a PAPR as $700 (Ex. 54–267).

This standard does not interfere

directly with employer policies

regarding facial hair. Instead, it requires

employers to take the presence or

absence of facial hair into consideration

in developing policies for a given

workplace; different policies may affect

the range of choices available. However,

OSHA notes that several respiratory

protection alternatives, such as loosefitting hoods or helmets, are available to

accommodate facial hair.

Some commenters focused on the

specific language in the proposal. One

commenter said that the term ‘‘any hair

growth’’ should be substituted for

‘‘facial hair’’ (Ex. 54–69). Another urged

OSHA to specify what acceptable facial

hair growth was (Ex. 54–138). OSHA

believes that the term ‘‘facial hair’’ is

appropriate because the record shows

that any facial hair, including beard

stubble, can interfere with facepiece seal

(Exs. 23–5, 54–69). By prohibiting hair

that ‘‘comes between the sealing surface

of the facepiece and the face,’’ as well

as hair that ‘‘interferes with valve

function,’’ OSHA believes it is being as

precise as possible. OSHA believes that

the second phrase is necessary because

employees with large beards may shave

the skin area where the facepiece of the

respirator seals to the face but the

fullness or length of the beard could still

block the valve or cause the valve to

malfunction.

In a standard that will apply as

broadly as this one will, it is not

possible for OSHA to specify every

condition under which respirator use

may be affected by an employee’s facial

hair. Workplace situations are variable,

as is hair growth. OSHA has instead

written the standard in performanceoriented terms, stressing the importance

of the face-to-facepiece seal and

conditions that might interfere with that

seal. The thrust of the entire standard is

on making sure that the fit and the

performance of the respirator are not

compromised. Employers, therefore,

must ensure that respirators fit and

perform properly.

Paragraph (g)(1)(i)(B) prohibits an

employer from allowing respirators with

tight-fitting facepieces to be worn by

employees who have any condition that

interferes with the face-to-facepiece seal

or valve function. Examples of these

conditions include, but are not limited

to, missing dentures, the presence of

facial scars, the wearing of jewelry, or

the use of headgear that projects under

the facepiece seal. As with the facial

hair requirements, the intent of this

provision is to prevent an employee

from wearing a respirator if there is any

factor that could prevent an adequate

facepiece-to-face seal. Therefore,

conditions such as missing dentures or

facial scars will not prevent an

employee from using a respirator where

it can be demonstrated that those

conditions do not prevent an adequate

seal.

Paragraph (g)(1)(ii) requires employers

to ensure that corrective glasses or

goggles or other personal protective

equipment is worn in a manner that

does not interfere with the seal of the

facepiece to the face of the user. The

proposal contained a similar provision

that addressed only eyewear. The prior

standard contained a similar provision,

but also prohibited the use of contact

lenses with respirators. Final paragraph

(g)(1)(ii) is consistent with the 1992

ANSI standard, which allows the use of

corrective lenses, spectacles, and face

protection devices, providing that these

items do not interfere with the seal of

the respirator; ANSI also allows the use

of contact lenses where the wearer has

successfully worn such lenses before
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1239

and practices wearing them with the

respirator.

Most comments supported the

proposed provision (Exs. 54–68, 54–266,

54–286, 54–150, 54–155, 54–177, 54–

189, 54–196, 54–209, 54–214, 54–219,

54–222, 54–346, 54–402, 54–408, 54–

267, 54–286, 54–361, 54–232, 54–234,

54–244, 54–245, 54–263, 54–265). Some

commenters, however, addressed

specific pieces of corrective eyewear.

For example, Barbara Price of the

Phillips Petroleum Company

recommended, based on the company’s

experience with successful quantitative

fit testing of employees while wearing

sports goggles, that prescription sports

goggles be permitted with full facepiece

respirators (Ex. 54–165). Darrell

Mattheis of the Organization Resources

Counselors (ORC) also supported the

use of prescription sports goggles, such

as the mask-adaptable goggles (MAG–1)

by Criss Optical, with a full facepiece

respirator, based on ORC companies’

successful quantitative fit testing

experience (Ex. 54–424).

Again, the standard is written in

performance terms so that any particular

piece of equipment may be used as long

as it does not interfere with the

facepiece seal. This has consistently

been OSHA’s position under the prior

standard as well. For example, in a

compliance interpretation letter dated

April 7, 1987, OSHA addressed the use

of eyeglass inserts or spectacle kits

inside full facepiece respirators. OSHA

stated that eyeglass inserts or spectacle

kits are acceptable if the devices: (1) Do

not interfere with the facepiece seal; (2)

do not cause any distortion of vision;

and (3) do not cause any physical harm

to the wearer during use (Ex. 64–519).

OSHA again addressed the

appropriateness of using the MAG–1

goggles with full facepiece respirators

and SCBAs in a September 20, 1995,

letter to the Excelsior Fire Department.

By 1995, OSHA had the benefit of four

quantitative fit testing studies of MAG–

1 goggles, two funded by the goggle

manufacturer and the other two funded

by OSHA itself. The letter to Excelsior

stated that since the MAG–1 straps

project under the facepiece, use of the

MAG–1 could in some cases violate

paragraph (e)(5)(i) of the previous

standard. The letter concluded that

obtaining a fit with these goggles is

quite complex because the respirator

user may be able in some cases to

control the factors determining whether

a seal can be obtained. (For a full

discussion, see letter, 9/20/95, Ex. 64–

520, Docket H–049a.) In a post hearing

comment submitted by the Exxon

Company, Steve Killiany commented

about Criss Optical Mag Spectacles with

thin rubber straps (Ex. 183). Mr. Killiany

stated that the spectacles can safely be

worn with full facepiece respirators as

long as users are fit tested with the

spectacles in place during fit tests. In its

program, Exxon prohibits eyeglasses

with temple pieces for users of full

facepiece respirators. Exxon also

prohibits hard contact lenses, but users

are allowed to wear soft contact lenses.

The NPRM contained a lengthy

explanation of OSHA’s proposal not to

include a prohibition against the use of

contact lenses with respirators in the

final rule (59 FR 58921, 11/15/94).

Although a few participants requested

that OSHA retain the prohibition, or at

least prohibit contact lenses in certain

situations (Exs. 54–334, 54–387, 54–

437), most of the commenters agreed

with OSHA’s conclusion that contact

lenses can be used safely with

respirators (Exs. 54–68, 54–266, 54–286,

54–150, 54–155, 54–177, 54–189, 54–

196, 54–209, 54–214, 54–219, 54–222,

54–232, 54–234, 54–244, 54–245, 54–

263, 54–265, 54–346, 54–402, 54–408,

54–267, 54–286, 54–361). For example,

NIOSH specifically recommended that

OSHA allow respirator users to wear

contact lenses (Ex. 54–437). Larry

DeCook, President of the American

Optometric Association, stated that the

Association was not aware of any

reports of injury because of the use of

contact lenses with respirators (Ex. 54–

235). Similarly, a study by the Lawrence

Livermore National Laboratory showed

that far fewer firefighters who wore

contact lenses with their SCBAs had

problems that necessitated the removal

of their facepieces than did firefighters

wearing glasses (Ex. 38–9). Finally,

OSHA’s review of the record identified

no evidence that the use of contact

lenses with respirators increases safety

hazards.

OSHA notes that employers of

employees who wear corrective eyewear

must be sure that the respirator selected

does not interfere with the eyewear,

make it uncomfortable, or force the

employee to remove the eyewear

altogether. Employers should use the

respirator selection process to make

accommodations to ensure that their

respirator-wearing employees can see

properly when wearing these devices.

In this final rule, OSHA has also

expanded the requirements of paragraph

(g)(1)(ii) to cover personal protective

equipment other than goggles and

glasses. Other forms of personal

protective equipment are required by

OSHA under specific circumstances

(See, e.g., Subpart I—Personal Protective

Equipment, and Section 1910.133—Eye

and face protection). Like eyewear, this

equipment may interfere with the fit of

respiratory protection equipment. The

generic phrase ‘‘other personal

protective equipment’’ applies to

faceshields, protective clothing, and

helmets, as well as to any other form of

personal protective equipment that an

employee may wear that could interfere

with safe respirator use.

Paragraph (g)(1)(iii) requires

employers to ensure that their

employees perform user seal checks

each time they put on a tight-fitting

respirator, using the ‘‘user seal check’’

procedures in Appendix B–1 or equally

effective procedures recommended by

the respirator manufacturer. The

proposal would also have given

employers the option of using either the

Appendix B–1 procedures or those

recommended by the manufacturer,

which is also the approach

recommended by the ANSI standard.

Although the prior standard also

required a fit check each time the

worker used a respirator, it mandated

that the manufacturer’s instructions be

followed when performing the check.

OSHA’s prior respirator standard

referred to respirators being ‘‘fit * * *

checked.’’ The NPRM used the phrase

‘‘facepiece seal check,’’ and this has

been changed in the final standard to

‘‘user seal check.’’ The three phrases are

synonymous, and all three were used

interchangeably by rulemaking

participants (e.g., Exs. 54–218, 54–219,

who recommended that the term ‘‘fit

check’’ be used to be consistent with the

ANSI Z88.2–1992 definition). Other

commenters (Exs. 54–5, 54–408) used

the term ‘‘seal check’’ or ‘‘facepiece seal

check.’’ The final standard uses the term

‘‘user seal check’’ because OSHA

believes that this phrase best describes

the actual procedure to be performed by

the respirator wearer. Also, commenters

stated that the similarity between the

terms ‘‘fit check’’ and ‘‘fit test’’ might

lead to confusion, causing employers

erroneously to conclude either that

complete fit testing must be done each

time an employee puts on a respirator

or that the fit check can be substituted

for a fit test.

In general, commenters (Exs. 54–221,

54–185, 54–321, 54–427, 54–414, 64–

521) agreed with OSHA that user seal

checks are necessary. Although these

checks are not as objective a measure of

facepiece leakage as a fit test, they do

provide a quick and easy means of

determining that a respirator is seated

properly. If a user seal check cannot be

performed on a tight-fitting respirator,

the final rule prohibits that respirator

from being used. Appendix B–1, which

derives from the 1992 ANSI standard,

contains procedures for user seal

checking of negative pressure and
1240 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

positive pressure devices. It states that

a check is to be performed every time

the respirator is donned or adjusted to

ensure proper seating of the respirator to

the face.

Participants expressed diverse views

on whether the negative/positive fit

check procedures in Appendix B–1

should be the exclusive means of

compliance with this requirement or

whether procedures recommended by

respirator manufacturers should also be

allowed. John Hale of Respirator

Support Services stated that the only

way to perform a fit check is to use the

negative/positive fit check methods in

Appendix B–1 (Ex. 54–5). George

Notarianni of Logan Associates also

recommended that reference to

manufacturers’ procedures for fit

checking be deleted, because he was

unaware of any effective fit check

methods other than those described in

Appendix B (Ex. 54–152). Richard

Miller of the E.D. Bullard Company,

however, stated that the manner in

which fit checks are conducted should

be left up to the manufacturer (Ex. 54–

221).

The positive/negative user seal checks

described in Appendix B–1 cannot be

performed on all tight-fitting respirators.

William Lambert of the Mine Safety

Appliances Company (MSA) (Ex. 54–

414) stated that respirators for which

negative or positive pressure tests

cannot be performed should not be

used. He also recommended that OSHA

work cooperatively with NIOSH to

develop a testing protocol that would

preclude approval of respirators that

cannot be easily checked using a

positive/negative fit check.

The rulemaking record, however,

contains evidence that effective user

seal checks can be performed in several

ways. OSHA reviewed a study by Myers

(1995) in which the authors described

several ANSI fit check methods, an

AIHA/ACGIH negative/positive pressure

check, and manufacturer-recommended

check methods (See Myers et al.,

‘‘Effectiveness of Fit Check Methods on

Half Mask Respirators,’’ in Applied

Occupational Environmental Hygiene,

Vol. 10(11), November 1995) (Ex. 64–

521). In addition, the authors briefly

explained that manufacturers of

disposable, filtering facepieces

recommended covering the mask with

both hands, exhaling, and checking for

air flow between the face and the

sealing surface of the respirator. Since it

was not the intent of the authors to

evaluate different fit check methods,

they did not present any comparison

data; however, they did conclude that

employing the manufacturer’s

recommended fit check procedure will

help detect and prevent poor respirator

donning practices. OSHA is also aware

that some manufacturers make a fit

check cup that can be used to perform

a user seal check even with valveless

respirators. The final rule thus allows

for the use of the methods in Appendix

B–1 as well as manufacturers’

recommended procedures for user seal

checks where these are equivalently

effective. This means that respirator

manufacturers’ recommended

procedures may be used for user seal

checking if the employer demonstrates

that the manufacturer’s procedures are

as effective as those in Appendix B–1.

The intent of the ‘‘equally effective’’

phrase is to ensure that the procedures

used have been demonstrated to be

effective in identifying respirators that

fit poorly when donned or adjusted.

OSHA believes that the use of

performance language will provide

incentives to respirator manufacturers to

develop new user seal check methods

and to develop respirators for which

user seal checks can be performed.

There are also respirators for which

no user seal checks can be conducted.

A number of rulemaking participants

argued that the inability to seal check a

respirator should disqualify these

respirators from use (See, e.g., Exs. 54–

152, 54–408, 54–427, 54–321). For

example, William Lambert of MSA (Ex.

54–414) pointed out that, since

respirators are not put on and taken off

the same way each time, the seal check

is essential to verify that the user has

correctly donned the respirator.

OSHA agrees with those commenters

who stated that OSHA should not allow

the use of respirators that cannot be fit

checked. Without the ability to perform

user seal checks, employees may be

overexposed to respiratory hazards as a

result of the respirator leakage caused

by multiple redonnings and

adjustments. OSHA believes that user

seal checks are important in assuring

that respirators are functioning

properly. If no method exists to check

how well a respirator performs during

multiple redonnings under actual

workplace conditions, OSHA does not

consider the respirator acceptable for

use.

Richard Olson of the Dow Chemical

Company raised another issue about

paragraph (g)(1)(iii). He stated that use

of the word ‘‘ensure’’ was inappropriate

in this instance, because employers

cannot ‘‘ensure’’ that user seal checks

are performed:

This is impossible for the employer to do

in all cases because the employer is not there.

Supervision is not at the work site at all

times, sometimes the employee is the only

person in the facility. The employee can be

trained to do this however the employer can

not personally be there to observe and ensure

every time the employee wears a respirator

(Ex. 54–278).

OSHA has stated consistently, in

connection with the use of the word

‘‘ensure’’ in other standards, that it is

not OSHA’s intent that each employee

be continually monitored. Further,

OSHA case law has held that employers

are required by the use of the word

‘‘ensure’’ to take actions that will result

in appropriate employee behavior.

These actions consist of: rules with

sanctions, training employees in

behaviors required, and exercising

diligence in monitoring the safety

behavior of their employees. The past

enforcement history of the use of the

word ‘‘ensure’’ in other OSHA

standards, including the respirator

provisions in substance specific

standards, shows that employers who

demonstrate this level of responsibility

are in compliance with provisions that

use the term ‘‘ensure.’’

Paragraph (g)(2)—Continuing Respirator

Effectiveness

Paragraph (g)(2) contains three subparagraphs. Paragraph (g)(2)(i) requires

employers to be aware of conditions in

work areas where employees are using

respirators. Paragraph (g)(2)(ii) requires

employers to ensure that their

employees leave the respirator use area

to perform any activity that involves

removing or adjusting a respirator

facepiece or if there is any indication

that a respirator may not be fully

effective. Paragraph (g)(2)(iii) requires

employers to replace, repair, or discard

respirators if there is any indication that

they are not functioning properly.

The prior standard did not contain

any of these provisions; however, OSHA

proposed them after including similar

requirements in a number of OSHA

substance-specific health standards.

OSHA believes that these provisions are

important because the effectiveness of

even the best respirator program is

diminished if employers do not have

procedures in place to ensure that

respirators continue to provide

appropriate protection.

Final paragraph (g)(2)(i), which states,

‘‘Appropriate surveillance shall be

maintained of work area conditions, and

degree of employee exposure or stress,’’

reiterates paragraph (b)(8) of the prior

standard. This means that employers are

required to evaluate workplace

conditions routinely so that they can

provide additional respiratory

protection or different respiratory

protection, when necessary. By

observing respirator use under actual

workplace conditions, employers can
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1241

note problems such as changes in the fit

of a respirator due to protective

equipment or conditions leading to skin

irritation. The employer can then make

adjustments to ensure that employees

continue to receive appropriate

respiratory protection.

Paragraph (g)(2)(ii) requires employers

to ensure that employees are allowed to

leave the respirator use area in several

circumstances. The intent of this

requirement is to ensure that employees

leave the area when necessary. The final

standard stipulates that, in these cases,

employees are to leave the ‘‘respirator

use’’ area, not the work area or

workplace. This language is intended to

give employers the flexibility to

establish safe areas in their workplaces

that will minimize interruptions in

work flow and production while

ensuring that the area where respirators

are removed is free of respiratory

hazards or contamination.

Paragraph (g)(2)(ii)(A) requires

employers to ensure that their

employees leave the respirator use area

to wash their faces and respirator

facepieces as necessary to prevent eye or

skin irritation; such irritation occurs

frequently with the wearing of tightfitting respirators. Many of OSHA’s

substance specific-standards, such as

the cadmium (29 CFR 1910.1027) and

arsenic (29 CFR 1910.1018) standards,

as well as the ANSI Z88.2–1992

standard, contain provisions allowing

employees to leave the respirator use

area to wash their faces and respirator

facepieces to prevent the skin irritation

that is often associated with the use of

respirators. Paragraph (g)(2)(ii) is thus

consistent with these requirements of

the Agency’s substance-specific

standards, as well as with the ANSI

Z88.2–1992 standard.

A number of participants (Exs. 54–6,

36–47, 54–362) questioned the need for

this provision, however. For example,

Christopher Seniuk of Lovell Safety

Management Company stated that

allowing employees to leave the area to

wash their faces is counterproductive

because allowing frequent breaks

increases the chance of contamination

while putting on and removing the

respirator (Ex. 54–6). Richard Boggs of

ORC (Ex. 36–47) also recommended that

this requirement be dropped, on the

grounds that the frequency with which

employees leave their work areas is a

‘‘labor relations’’ issue. Kevin Hayes of

ABB Ceno Fuel Operations (Ex. 54–362)

expressed a similar concern; he

suggested that employees be allowed to

leave the work area periodically, rather

than on an ‘‘as necessary’’ basis, and

asked that OSHA quantify the extent of

skin irritation that needed to be present

for employees to leave the area for

washing and cleaning. Mr. Hayes was

concerned that disgruntled employees

could use this requirement to ‘‘establish

a revolving door from the work area.’’

Dr. Franklin Mirer, director of safety

and health for the United Auto Workers,

supported this provision, however; he

stated that allowing employees to leave

the area to wash would lead to fewer

hygiene problems (Ex. 54–387). OSHA

agrees with Dr. Mirer: if employees are

allowed to wash their faces and

respirators, the amount of

contamination will be reduced,

employees’ hands and respirators will

be cleaner, and employees will be

donning cleaner respirators. OSHA

believes that, to protect employee

health, employees must be able to wash

their faces and facepieces as often as

necessary. The skin irritation caused by

dirty respirators can interfere with

effective respirator use (Ex. 64–65).

Clearly, any skin irritation that causes

the wearer to move the respirator in a

way that breaks the facepiece-to-face

seal is sufficient to warrant an employee

leaving the respirator use area to wash.

Whenever eye or skin problems interfere

with respirator performance, the wearer

should be able to leave the use area.

Paragraphs (g)(2)(ii)(B) and (C) require

the employer to ensure that employees

leave the respirator use area if they

detect vapor or gas breakthrough,

changes in breathing resistance, or

leakage of the facepiece, and to replace

the respirator or the filter, cartridge, or

canister elements when these have been

exhausted. These requirements are

consistent with the NIOSH Respirator

Decision Logic (Ex. 9, page 8), which

states that workers who suspect

respirator failure should be instructed to

leave the contaminated area

immediately to assess and correct the

problem. In addition, employees may

need to leave the respirator use area to

change the cartridge or canister when

the end-of-service-life indicator (ESLI)

or change schedule demands a change

in canister or cartridge. (See the

Summary and Explanation for

paragraphs (c) and (d).) The

requirements in paragraph (g)(2)(ii)(B)

are essential to ensure the continuing

effectiveness of the protection provided

to the wearer by the respirator. If, for

example, the wearer can detect the odor

or taste of a vapor or gas, the cartridge

or canister is clearly no longer providing

protection. Similarly, if a filter element

is so loaded with particulates that it

increases the work-of-breathing, it

clearly must be changed to continue to

be effective. The leakage of air through

the facepiece also requires immediate

attention, because it is a sign that the

facepiece-to-face seal has been broken

and that the wearer is breathing

contaminated air.

Paragraph (g)(2)(ii)(C) requires

employers to ensure that respirator

wearers leave the use area when the

filter element, cartridge, or canister

must be changed in order for it to

continue to provide the necessary

protection. In the proposal, the term

‘‘filter elements’’ was used instead of

the more specific language ‘‘cartridge’’

and ‘‘canister,’’ and the proposed

language generated several comments

requesting the Agency to clarify this

terminology (See, e.g., Ex. 54–173). A

representative from Monsanto Company

suggested that OSHA should change the

language from ‘‘filter’’ to ‘‘cartridge’’ or

‘‘canister’’ (Ex. 54–219) because filters

apply only to particulates, not vapors

and gases. Larry Zobel, Medical Director

of 3M, made a similar comment (Ex. 54–

218). OSHA has amended the language

in final paragraph (g)(2)(ii)(C) to make it

more precise, and the final rule uses the

terms ‘‘cartridge,’’ ‘‘canister,’’ and

‘‘filter’’ as these specifically apply.

Paragraph (g)(2)(iii) requires the

employer to replace, repair, or discard a

respirator that is not functioning

properly. This requirement applies in

addition to the provisions in paragraphs

(d) and (h) of this section that address

the routine replacement of respirators

and respirator parts. The language of

this paragraph has been changed from

the proposal to emphasize that a

malfunctioning or otherwise defective

respirator must be replaced or repaired

before the user returns to the work area.

Rulemaking participants agreed that

respirators should not be used if they

are defective in any way (See, e.g., Ex.

54–362, Kevin Hayes of ABB

Combustion Engineering Nuclear

Operations). However, one commenter,

Peter Hernandez of the American Iron

and Steel Institute, objected to the

proposal’s requirement that defective

respirators be repaired ‘‘immediately.’’

Mr. Hernandez stated that it is necessary

immediately to replace, but not

immediately to repair or discard, a

defective respirator (Ex. 54–307). OSHA

agrees that employers can delay

repairing or discarding respirators so

long as the affected employees have

been issued proper replacement

respirators. This was the intent of

paragraph (g)(8) in the NPRM, and this

point has been clarified in the final

regulation by placing the word

‘‘replace’’ first and deleting the word

‘‘immediately.’’ The intent of final

paragraph (g)(2)(iii) is to ensure that

employees receive the necessary

protection whenever they are in a

respirator use area. This paragraph
1242 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

means that employers must ensure that

employees in the respirator use area are

wearing respirators that are in good

working order.

The proposed rule would have

required disposables to be discarded at

the end of the task or workshift,

whichever came first (See paragraph

(g)(9) of the NPRM). A number of

commenters (See, e.g., Exs. 54–309, 54–

307, 54–442) discussed the use of, and

the criteria for discarding, disposable

respirators. OSHA has deleted specific

references to the term ‘‘disposable’’ in

the final rule and has instead required,

in paragraph (g)(2)(iii), that employers

replace, repair, or discard respirators if

employees detect vapor or gas

breakthrough, a change in breathing

resistance, or leakage of the facepiece, or

identify any other respirator defect,

before allowing the employee to return

to the work area. This requirement thus

focuses on the need for respirators to

function properly to provide protection

to employees rather than on a time

schedule for discarding particular

respirators.

Some commenters stated that

disposable respirators should be

allowed to be used until the physical

integrity of the respirator is

compromised, which may take longer

than one work shift (Exs. 54–190, 54–

193, 54–197, 54–205, 54–214, 54–222,

54–241, 54–253, 54–268, 54–271, 54–

307, 54–357, 54–171). For example,

Peter Hernandez, representing the

American Iron and Steel Institute, stated

that employees may perform 20

different tasks in a work day (Ex. 54–

307). The implication of Mr. Hernandez’

comment is that workers who perform

short duration tasks would have been

required by the proposed requirement to

use many disposable respirators in the

course of such a day, which would be

unnecessarily expensive. Suey Howe,

representing the Associated Builders

and Contractors, recommended that

employees be allowed to keep their

disposable respirators in clean

containers on days when the same task

may be performed intermittently (Ex.

54–309). Homer Cole of Reynolds

Metals Company stated that some

workplace situations exist where the

environment is clean enough for

disposable respirators to be reused (Ex.

54–222). Randy Sheppard, Battalion

Chief of Palm Beach County Fire-Rescue

(Ex. 54–442), stated that disposing of

HEPA disposable respirators after each

use would be extremely costly for large

fire departments that respond to many

emergency calls. He noted that these

respirators should be discarded,

however, when they are no longer in

their original working condition,

whether this condition results from

contamination, structural defects, or

wear. In a post hearing comment

submitted by the North American

Insulation Manufacturers Association

(NAIMA), Kenneth Mentzer, Executive

Vice President, and others stated that

OSHA should make it clear that NIOSHapproved disposable respirators may be

used when they provide adequate

protection factors for the exposures

encountered. The authors of this

submission also stated that NIOSHapproved disposable respirators provide

protection and have some advantages

over reusable respirators (Ex. 176).

Richard Niemeier of NIOSH (Ex. 54–

437) recommended that dust-mist and

dust-mist-fume disposable respirators

not be reused, on the grounds that many

of these models degrade in oil mist and

humid environments. He also

recommended that only filters approved

under 42 CFR Part 84 be considered for

use beyond one shift.

OSHA has considered all of these

comments in revising the language in

final paragraph (g)(2)(iii) to reflect a

more performance-oriented approach to

the replacement, repair, or discarding of

respirators. Nonetheless, employers still

have the responsibility, in paragraph

(a)(2), to ensure that respirators are

suitable for each use to which they are

put. [See also discussion in NPRM, 59

FR 58922.]

Paragraphs (g)(3) and (g)(4)—Procedures

for IDLH Atmospheres and Interior

Structural Fire Fighting

Paragraphs (g)(3) and (g)(4) of the final

rule contain requirements for respirator

use in IDLH atmospheres. Paragraph

(g)(3) addresses all IDLH atmospheres,

and paragraph (g)(4) contains three

additional requirements applicable only

to the extra-hazardous environments

encountered during interior structural

fire fighting. These two paragraphs,

which deal with requirements for

standby personnel outside the IDLH

atmosphere and communication

between those standby personnel and

the respirator users inside the

atmosphere, are intended to ensure that

adequate rescue capability exists in case

of respirator failure or some other

emergency inside the IDLH

environment.

Paragraphs (g)(3) (i), (ii), and (iii)

require that at least one employee who

is trained and equipped to provide

effective emergency rescue be located

outside the IDLH respirator use area,

and that this employee maintain

communication with the respirator

user(s) inside the area. Paragraphs (g)(3)

(iv) and (v) require, respectively, that

the employer or authorized designee be

notified before the standby personnel

undertake rescue activity and that the

employer or designee then provide

appropriate assistance for the particular

situation. Paragraph (g)(3)(vi) addresses

emergency equipment needed by the

standby personnel so that they can

perform their duties effectively.

The prior standard, § 1910.134(e), did

not distinguish between types of IDLH

atmospheres. Instead, it distinguished

between IDLH and potentially IDLH

atmospheres. It stated that only one

standby person was necessary when a

respirator failure ‘‘could’’ cause its

wearer to be overcome, but that standby

‘‘men’’ (plural) with suitable rescue

equipment were required when

employees must enter known IDLH

atmospheres wearing SCBA. Under this

provision, at least two standby

personnel were required for known

IDLH atmospheres (See, e.g., May 1,

1995 memo from James Stanley, Deputy

Assistant Secretary, to Regional

Administrators and state-plan

designees). In IDLH atmospheres where

airline respirators are used, the prior

standard required that users be

equipped with safety harnesses and

safety lines to lift or remove them from

the hazardous atmosphere and that ‘‘a

standby man or men,’’ equipped with

suitable SCBA, be available for

emergency rescue.

The proposal would have required

that, for all IDLH atmospheres, at least

one standby person, able to provide

emergency assistance, be located

outside any IDLH atmosphere, and that

this person must maintain

communication with the employee(s) in

the IDLH atmosphere.

The need for standby personnel when

workers use respirators in IDLH

atmospheres is clear. The margin for

error in IDLH atmospheres is slight or

nonexistent because an equipment

malfunction or employee mistake can,

without warning, expose the employee

to an atmosphere incapable of

supporting human life. Such exposure

may disable the employee from exiting

the atmosphere without help and

require an immediate rescue if the

employee’s life is to be saved.

Accordingly, the standard requires that,

whenever employees work in an IDLH

atmosphere, at least one standby person

must remain outside the atmosphere in

communication with the employee(s)

inside the atmosphere. It also requires

that the standby personnel be trained

and equipped to provide effective

emergency assistance.

A number of reports from OSHA’s

investigative files demonstrate the types

of failures that can give rise to the need

for immediate rescues of workers in
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1243

IDLH atmospheres. These cases

illustrate that the absence of properly

equipped standby personnel greatly

increases the risk to the employees who

enter the IDLH atmosphere. For

example, a fire in a cold-rolling mill

triggered a carbon dioxide fire

extinguishing system and created an

oxygen deficient atmosphere in the

mill’s basement. Two security guards

descended a stairway into the basement

to reset the system. Although the

employees had been provided SCBAs,

they left those respiratory devices in

their vehicle and took only a single selfrescuer with them. The workers

collapsed upon reaching the bottom of

the stairway. No standby personnel

were present and, as a result, the

workers were not discovered until 30

minutes had elapsed. Attempts to revive

them failed. This case illustrates that the

suddenness with which workers can be

disabled in an IDLH atmosphere can

prevent the workers from leaving the

atmosphere under their own power and

underlines the need for employers to

provide standby personnel whenever

workers enter such atmospheres. If a

properly trained and equipped standby

person had been present, that person

could have notified the employer that

help was needed when the two workers

collapsed and could have initiated

rescue efforts immediately.

In another case, two mechanics

entered a corn starch reactor to perform

routine maintenance and repair.

Employee No. 1 detected the odor of

propylene oxide and then observed the

chemical running out of an open vent.

Employee No. 1 managed to escape, but

employee No. 2 was overcome and died.

A standby person equipped with proper

rescue equipment would have been able

to provide immediate, effective

assistance once employee No. 2 was

overcome and might have saved that

employee’s life.

Some cases from OSHA’s

investigative files involve fatalities that

occurred when standby personnel were

present but were unable to prevent the

fatalities from occurring. These cases

illustrate both the types of failures that

can give rise to the need for immediate

rescue efforts in IDLH atmospheres and

the importance of standby personnel

being trained and equipped to provide

effective rescue capability.

In one case, an employee (No. 1) was

working in a confined space while

wearing an SCBA. A standby person

(No. 2) advised employee No. 1 that the

respirator’s air supply was low and that

he should leave the confined space.

However, employee No. 1 collapsed and

died before he could exit. Employee No.

2 had no equipment with which to

extricate employee No. 1 from the

confined space. This example

illustrates, first, that even an employee

who is properly equipped when

entering an IDLH atmosphere may need

to be rescued as a result of human error

and/or equipment failure. It also

illustrates the need for the standby

person to be equipped to be able to

provide effective emergency rescue.

In yet another case, an employee (No.

1) was sandblasting inside a rail car

wearing an airline respirator with an

abrasive blasting hood. A standby

person (No. 2) was stationed outside the

car. During the operation, employee No.

1 swallowed a dental appliance and lost

consciousness. Employee No. 2 had not

maintained constant communication

with employee No. 1 and only

discovered that employee No. 1 had

been overcome too late to save his life.

This case shows that the demanding

work often required by a worker

constrained by respiratory equipment in

an IDLH atmosphere may lead to

accidents that can disable the worker

and require immediate rescue efforts. It

also illustrates that the need for

emergency assistance can arise at any

time and without warning, and that

standby personnel must therefore

maintain constant communication with

the worker(s) inside the IDLH

atmosphere.

Standby personnel must also be

adequately trained and equipped to

protect themselves against the IDLH

atmosphere if an emergency arises. In a

recent case, two employees (Nos. 1 and

2) were installing a blind flange in a

pipeline used to transfer hydrogen

sulfide. As the flange was opened, the

hydrogen sulfide alarm sounded.

Employee No. 1 tried to remove his fullfacepiece respirator, was overcome, and

died. Employee No. 2 had previously

loosened the straps on his respirator to

test for the smell of hydrogen sulfide

and was also overcome. A standby

person (No. 3) equipped with an SCBA

was on the ground outside the area and

attempted an immediate rescue.

Unfortunately, his respirator caught on

an obstruction and tore as he attempted

to enter the atmosphere and he, along

with employee No. 2, was overcome and

required hospitalization. The case is

another example of the type of human

and equipment failures that can

endanger employees who must work in

IDLH atmospheres. Although the rescue

effort in this case faltered, the presence

of a standby person equipped with an

SCBA increased the chance that the

employees in the IDLH atmosphere

could have been rescued before they

were killed or seriously injured, and the

availability of appropriate respiratory

equipment reduced the risk to the

standby person who attempted the

rescue. It illustrates the benefit of

having standby personnel who can

undertake immediate rescue efforts and

the need for such personnel to be

trained and equipped properly for their

own protection as well as the protection

of the workers in the IDLH atmosphere.

The proposed provision would have

required only a single standby person in

most IDLH situations. However,

firefighter representatives urged OSHA

(Ex. 75, Tr. 468–469) to retain the prior

standard’s requirement for two standby

personnel and to expand the provision

to cover all IDLH atmospheres. OSHA

has determined, however, that outside

of the fire fighting and emergency

response situations, which are

discussed in connection with paragraph

(g)(4), environments containing IDLH

atmospheres are frequently well-enough

characterized and controlled that a

single standby person is adequate. In

most fixed workplaces, the atmosphere

is known, i.e., has been well

characterized either through analysis of

monitoring results or through a process

hazard analysis. For example,

employers in chemical plants have

conducted comprehensive process

hazard analyses as required by OSHA’s

Process Safety Management standard, 29

CFR 1910.119, to determine which of

their process units pose potential IDLH

hazards. In such situations, effective

communication systems and rescue

capabilities have been established. In

addition, in many industrial IDLH

situations, only one respirator user is

exposed to the IDLH atmosphere at a

time, which means that a single standby

person can easily monitor that

employee’s status. Even in situations

where more than one respirator user is

inside an IDLH atmosphere, a single

standby person can often provide

adequate communication and support.

For example, in a small pump room or

shed, even though two or three

employees may be inside an IDLH

atmosphere performing routine

maintenance activities such as changing

pump seals, one standby person can

observe and communicate with all of

them. In this type of situation, one

standby person is adequate and

appropriate.

In other cases, however, more than

one standby person may be needed;

paragraph (g)(3)(i) of the final standard

therefore states the requirement for

standby personnel in performance

language: ‘‘one employee or, when

needed, more than one employee * * *

[shall be] located outside the IDLH

atmosphere.’’ For example, to clean and

paint the inside of a multi-level, multi-
1244 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

portal water tower, a process that often

generates a deadly atmosphere as a

result of cleaning solution and paint

solvent vapors, employees often enter

the tower through different portals to

work on different levels. In such a

situation, there will be a need for good

communications at each entry portal,

and more than one standby person

would be needed to maintain adequate

communication and accessibility.

Several commenters (Exs. 54–6, 54–

38, and 54–266) requested clarification

of the proposed requirements that

employers ensure that communication

is maintained between the employee(s)

in the IDLH atmosphere and the standby

personnel located outside the IDLH

environment. For example, Exxon (Ex.

54–266) requested that OSHA make

clear that, in addition to voice

communication, visual contact and

hand signals may be used. In response,

paragraph (g)(3)(ii) of the final rule

clarifies that visual, voice, or signal line

communication must be maintained

between the employee(s) in the IDLH

atmosphere and the employee(s) located

outside the IDLH atmosphere.

Under final paragraph (g)(3)(iv),

employers must ensure that before

entering an IDLH environment to

provide emergency rescue, standby

personnel notify the employer, or a

designee authorized by the employer to

provide necessary assistance, that they

are about to enter the IDLH area. The

employer will have determined, in

advance, as part of the written respirator

program’s worksite-specific procedures,

the procedures standby personnel will

follow and whom they must notify in

rescue situations. The employer’s

emergency response team may provide

the necessary support, or other

arrangements may have been made with

local firefighting and emergency rescue

personnel. The language used requires

that the employer be notified, which

provides the employer great flexibility

in determining who will respond to

such emergency rescue situations.

Paragraph (g)(3)(iv) responds to

concerns expressed by several

participants (Exs. 54–6, 54–266, 54–307,

54–330) about the obligation of standby

personnel to provide effective

emergency rescue. A number of

comments emphasized that standby

personnel should not attempt any

rescue activities without making sure

that their own whereabouts are known

and monitored. According to Exxon (Ex.

54 266), ‘‘the ‘‘stand-by’’ person should

be able to summon effective emergency

assistance and only then provide the

assistance.’’ Christopher Seniuk of

Lovell Safety Management Company

also stated that a standby employee

should have a telephone or radio to

summon help and should not be

expected to enter an IDLH environment

for rescue until additional help arrives

(Ex. 54–6). The American Iron and Steel

Institute (Ex. 54–307) agreed, stating

that the standby person should be in

communication with the employee(s) in

the IDLH atmosphere and be ‘‘able to

assist in providing or obtaining effective

emergency assistance.’’ The American

Petroleum Institute (Ex. 54–330) also

stated that when the employee wears a

respirator in an IDLH atmosphere, the

employer must ensure that adequate

provisions have been made for rescue.

OSHA agrees that standby personnel

should contact the employer or

employer’s designee before undertaking

any rescue activities in an IDLH

atmosphere. Accordingly, final

paragraph (g)(3)(iv) includes an

employer or designee notification

requirement. Although this requirement

was not contained in the NPRM, a

similar requirement has been included

in other OSHA standards, e.g., the

Permit Required Confined Spaces

standard, 29 CFR 1910.146, and the

Hazardous Waste Operations and

Emergency Response standard, 29 CFR

1910.120. By including this

requirement, OSHA is pointing to the

need for the employer or authorized

designee to take responsibility for

ensuring that rescue operations are

carried out appropriately, that rescuers

are provided with proper respiratory

equipment, and that employees are

adequately prepared to facilitate rescue

attempts.

On the other hand, the notification

provision is not intended to suggest that

standby employees should wait

indefinitely for their employer or

designee to respond to notification

before entering the IDLH atmosphere

when employees inside are in danger of

succumbing and standby personnel are

appropriately trained and equipped to

provide assistance. OSHA is aware that

this practice is followed in fire fighting

situations (See paragraph 6–4.4, NFPA

1500 standard, 1997.) In the majority of

cases, however, rescuers should not

enter the IDLH environment until

receiving some response to the

notification that rescue is necessary, i.e.,

the employer or designee should know

that the rescuers are entering, and

emergency response units should be on

their way to the incident. OSHA

believes that these requirements are

consistent with current industry

practice (Exs. 54–266, 54–307, 54–6)

and with other OSHA standards (e.g.,

the permit-required confined spaces

standard).

This practice is consistent with

OSHA’s interpretations of other

standards. (See letter of interpretation of

the Hazardous Waste and Emergency

Response Standard 29 CFR 1910.120

regarding the number of standby

personnel present when there is a

potential emergency); ‘‘* * * process

operators who have (1) informed the

incident command * * * of the

emergency * * * (2) [have] adequate

PPE (3) [have] adequate training * * *

and (4) employed the buddy system,

may take limited action * * * once the

emergency response team arrives, these

employees would be restricted to the

action that their training level allows

* * * this has been OSHA’s long

standing policy for operators responding

to emergencies * * *’’ McCully to

Olson; July 11, 1996.

Failure to follow such practices can

result in employee death. For example,

recently, one employee (No. 1) was

working inside a reactor vessel,

attempting to obtain a sample of

catalyst. He was wearing a supplied air

respirator with an escape bottle. The

standby ‘‘attendant’’ informed the

employee inside that it was time to exit

to change the air supply cylinder;

witnesses said the inside employee (No.

1) did not appear to hear this

instruction. When the air supply

became critical, other workers outside

‘‘yelled’’ to the inside employee to hurry

outside; by then, the inside employee

was moving slowly and then fell. The

attendant tried to check the air pressure

while another employee, a bystander

welder (No. 2), entered the vessel

without a breathing apparatus and tried

to help the inside employee (No. 1). The

welder also fell down. Other bystanders

were partially overcome by the nitrogen

coming out of the vessel. The air hose

on the respirator on the inside employee

(No. 1) was disconnected. Neither the

first employee inside (No. 1) nor the

welder (No. 2) was wearing a harness or

lifeline. The inside employee later died.

[OSHA citation text abstracts for

unscheduled investigations of accidents

involving fatalities (one or more) and

catastrophic injuries during calendar

years 1994 and 1995].

Once the employer or designee has

been notified, paragraph (g)(3)(v)

requires the employer or designee to

provide the necessary assistance

appropriate to the situation. Such

assistance does not always require that

additional standby personnel enter the

hazardous atmosphere; in some cases,

the appropriate assistance could be, for

example, the provision of emergency

medical treatment. If standby employees

do need to enter the hazardous

environment to perform rescue
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1245

operations, however, the employer must

ensure that those rescuers are fully

protected.

Final paragraphs (g)(3)(vi) (A), (B),

and (C) require that standby personnel

have appropriate equipment to

minimize the danger to these personnel

during rescue efforts. They stipulate that

standby employees be equipped with

pressure demand or other positive

pressure SCBA, or a pressure demand or

other positive pressure supplied-air

respirator with auxiliary SCBA,

according to final paragraph

(g)(3)(vi)(A). This requirement was

contained in paragraph (g)(2)(i) of the

proposal, and was not objected to by

any participants. It is also consistent

with requirements in clause 7.3.2 of

ANSI Z88.2—1992.

The requirements that address

appropriate retrieval equipment and

means of rescue in paragraphs

(g)(3)(vi)(B)–(C) are written in

performance-based language.

Established rescue procedures are well

known, and retrieval equipment is

readily available. OSHA therefore

believes that it is necessary merely to

state that this equipment must be used

unless its use would increase the overall

risk associated with entry into or rescue

from the IDLH environment. OSHA

acknowledged in the Permit-Required

Confined Space standard, 58 FR 4530,

that situations exist in which retrieval

lines (harnesses, wristlets, anklets) may

pose an entanglement problem,

especially in areas in which air lines or

electrical cords are present in the work

areas in which the IDLH atmosphere

occurs. Most of the time, however,

rescue with retrieval equipment is

effective, and much safer for the

rescuers (Ex. 54–428).

Paragraph (g)(4) applies only to

respirator use in the ultra-hazardous

context of interior structural fire

fighting; the requirements in this

paragraph apply in addition to those in

paragraph (g)(3). OSHA has included

this provision in its standard in

response to the record evidence about

the extreme hazards of this activity.

Paragraph (g)(4)(i) requires that workers

engaged in interior structural fire

fighting work in a buddy system: at least

two workers must enter the building

together, so that they can monitor each

other’s whereabouts as well as the work

environment. In addition, for interior

structural firefighting, paragraph

(g)(4)(ii) retains the requirement that

there be at least two standby personnel

outside the IDLH respirator use area,

i.e., outside the fire area. Paragraph

(g)(4)(iii) requires that all personnel

engaged in interior structural fire

fighting use SCBA respirators. Finally,

the notes to paragraph (g)(4) clarify that

these requirements are not intended to

interfere with necessary rescue

operations, and the extent to which the

standby personnel can perform other

functions.

Paragraph (g)(4) of this Federal

standard applies to private sector

workers engaged in firefighting through

industrial fire brigades, private

incorporated fire companies, Federal

employees through Section 19 of the

OSH Act, and other firefighters. It

should be noted that Federal OSHA’s

jurisdiction does not extend to

employees of state and local

governments; therefore, public sector

firefighters are covered only in the 25

states which operate their own OSHAapproved occupational safety and health

state programs and are required to

extend the provisions of their state

standards to these workers. These states

and territories are: Alaska, Arizona,

California, Connecticut, Hawaii,

Indiana, Iowa, Kentucky, Maryland,

Michigan, Minnesota, Nevada, New

Mexico, New York, North Carolina,

Oregon, Puerto Rico, South Carolina,

Tennessee, Utah, Vermont, Virginia,

Virgin Islands, Washington, and

Wyoming . Eighteen (18) of these states

under certain circumstances also

consider ‘‘volunteers’’ to be employees

and thus may provide protection to

private or public sector volunteer

firefighters, subject to specific

interpretation of state law. State and

local government employees, including

firefighters, in States which do not

operate OSHA-approved state plans, are

not covered by these requirements,

unless voluntarily adopted for local

applicability.

Although the proposed rule did not

distinguish between interior structural

fire fighting and other IDLH situations,

OSHA decided to include separate

requirements for the former activity in

the final standard in response to

evidence in the record that safeguards

that may be adequate for well-controlled

and well-characterized IDLH situations

are not adequate in the uncontrolled

and unpredictable situation presented

by a burning building. The firefighting

community already recognizes that one

person alone cannot be sent safely into

a structure to fight a fire that is beyond

the incipient stage. The final rule’s

staffing requirements for fire fighting are

consistent with OSHA’s current

enforcement practice for employers

subject to federal OSHA enforcement,

and assure that firefighters will not be

subject to any diminution in protection

as a result of the more flexible

requirements for IDLH respirator use

included in other paragraphs of the final

rule.

OSHA has previously recognized that

emergency situations analogous to

interior structural fire fighting require

additional safeguards for employees

involved in emergency response

activities. For example, the Hazardous

Waste Operations and Emergency

Response (HAZWOPER) standard, at 29

CFR 1910.120(q), requires the use of a

‘‘buddy system’’ in responding to IDLH

atmospheres. This means that

employees involved in such operations

are to be organized into workgroups in

such a manner that each employee of

the work group is designated to be

observed continuously by at least one

other employee in the work group.

Paragraph (q)(3)(v) of § 1910.120

requires operations in hazardous areas

to be performed using the buddy system

in groups of two or more; paragraph

(q)(3)(vi) of that standard specifies that

back-up personnel shall stand by with

equipment ready to provide assistance

or rescue. OSHA has made clear that

these provisions require more than one

standby person to be present.

The final standard is also consistent

with relevant National Fire Protection

Association (NFPA) standards. The

NFPA is recognized internationally as a

clearinghouse for information on fire

prevention, fire fighting procedures, and

fire protection. A number of NFPA

standards require firefighters using

SCBA to operate in a buddy system.

NFPA 1404, ‘‘Fire Department SelfContained Breathing Apparatus

Program,’’ states, in paragraph 3–1.6,

that members using SCBA are to operate

in teams of two or more, must be able

to communicate with each other

through visual, audible, physical, safety

guide rope, electronic, or other means to

coordinate their activities, and are to

remain in close proximity to each other

to provide emergency assistance.

The NFPA 600 standard addressing

industrial fire brigades requires in

paragraph 5.3.5 that firefighters using

SCBA ‘‘operate in teams of two or more

who are in communication with each

other * * * and are in close proximity

to each other to provide assistance in

case of an emergency.’’ Although this

standard, which applies only to

industrial fire brigades where

firefighters are working in fixed

locations that are well characterized and

have established communications and

rescue systems, requires only one

standby person outside the fire area,

another standard, NFPA 1500,

‘‘Standard on Fire Department

Occupational Safety and Health

Programs,’’ which addresses fire

department safety and health programs
1246 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

in the general sense, requires at least

two standby personnel. This provision

first appeared in 1992, as a Tentative

Interim Amendment to NFPA 1500

requiring, in paragraph 6–4.1.1, that

‘‘[a]t least four members shall be

assembled before initiating interior fire

fighting operations at a working

structural fire.’’ In 1997, NFPA finalized

the Amendment. Paragraph 6–4 of the

current NFPA 1500 standard, ‘‘Members

Operating at Emergency Incidents,’’

addresses the number of persons

required to be present, and requires at

least four individuals, consisting of two

persons in the hazard area and two

individuals outside the hazard area, for

assistance or rescue (paragraph 6–4.4).

One standby member is permitted to

perform other duties, but those other

duties are not allowed to interfere with

the member’s ability to provide

assistance or rescue to the firefighters

working at the incident (paragraph 6–

4.2).

In addition, a 1994 CDC/NIOSH Alert,

titled ‘‘Request for Assistance in

Preventing Injuries and Death of

Firefighters,’’ also recommends the use

of a buddy system whenever firefighters

wear SCBAs. The recommendation

states:

Two firefighters should work together and

remain in contact with each other at all

times. Two additional firefighters should

form a rescue team that is stationed outside

the hazardous area. The rescue team should

be trained and equipped to begin a rescue

immediately if any of the firefighters in the

hazardous area require assistance.

Similarly, in testimony on H.R. 1783

before the Subcommittee on Economic

and Educational Opportunities, House

of Representatives, 104th Congress (July

11, 1995, Chairman: Cass Ballenger),

Harold A. Schaitberger, Executive

Assistant to the General President of the

International Association of Fire

Fighters (IAFF), stated that ‘‘* * * our

organization understood from the outset

that the regulation [29 CFR 1910.134(e)]

required firefighters wearing selfcontained breathing apparatus and

involved in interior structural fire

operations to operate in a ‘buddy

system,’ with two firefighters entering a

burning building and two firefighters

stationed outside the endangered area

for assistance or rescue, and for

accountability purposes * * * The twoin/two-out rule has been the industry

standard in the fire service for over 25

years.’’

The record in this rulemaking

provides strong support for including

this requirement in the final standard.

Richard Duffy, Director of Occupational

Health and Safety for the International

Association of Fire Fighters (IAFF),

argued strongly for provisions similar to

those in the HAZWOPER standard for

SCBA users working in IDLH situations.

In his written testimony (Ex. 75), Mr.

Duffy stated that the proposed

requirements in paragraph (g)(2)(ii),

which would not have required the

buddy system or that two standby

personnel be available outside the IDLH

atmosphere, would place workers using

respiratory protection in IDLH

situations at considerable risk.

The IAFF recommended that a

minimum of 4 individuals be present

any time employees are using SCBA in

an IDLH atmosphere: two individuals to

work as a team inside the IDLH

atmosphere and two identically trained

and equipped employees to remain

outside to account for, and be available

to assist or rescue, the team members

working inside the IDLH atmosphere

(Tr. 468–469). The inside employees

would use a buddy system and maintain

direct voice or visual contact or be

tethered with a signal line (Tr. 468–

469).

According to Mr. Duffy, these changes

were necessary:

to save workers’—specifically firefighters’—

lives. Since 1970 * * * 1,416 members of

[IAFF] have died in the line of duty.

Prohibiting employers from allowing

employees to work alone while working in

IDLH, potentially IDLH or unknown

atmospheres * * * would have saved many

of these firefighters’ lives * * * [I]f there was

a team in place that accounted for employees

while they were working in IDLH * * *

many more firefighters would have been

saved and [be] alive today (Ex. 75).

Mr. Duffy described several incidents in

which firefighters had been injured or

killed because of inadequate safety

practices, and particularly the failure to

have specific individuals assigned to

keep track of employees in IDLH

atmospheres. For example, he referred

to a recent occurrence (Tr. 470) in

which three firefighters died inside an

IDLH atmosphere. In this incident,

although many firefighters were on the

scene, no one could account for the

three firefighters who had been

overcome by the IDLH atmosphere.

Their bodies were later discovered

inside the burned building. It appears

that more stringent precautions, such as

a buddy system and standby personnel

specifically assigned to keep track of the

firefighters’ condition, could have

prevented these deaths.

In addition, the Oklahoma

Department of Labor submitted

comments stating that it supports a twoin/two-out rule, especially for

firefighters. Specifically, it stated that

‘‘Although we are not a state plan state,

we operate a fully functional OSHA

safety and health program in the public

sector * * * it would be unfortunate if

the new respiratory protection

standard’s interpretation of the ‘buddy

system’ * * * confused this issue (twoout for firefighters) [Ex. 187].’’ However,

some firefighter services and

organizations urged OSHA to abandon

its existing requirement for at least two

standby personnel. For example,

Truckee Meadows Fire Protection

District in Nevada (Ex. 384) stated that:

there are circumstances where a three person

* * * company can safely and efficiently

respond and aggressively attack a fire.

Similarly, there are occasions where

additional personnel and resources may be

required before initiating an attack * * * the

emphasis must be practically placed upon

assessment of the risk at the time of arrival

and throughout the incident to determine the

resources and precautions needed. The

overriding concern should be * * * safe

egress or recovery of personnel should

conditions change, regardless of the standby

crew assembled.

A similar opinion was expressed by the

fire chief of Sparks, Nevada (Ex. 54–

129).

Even a comment from the County of

Rockland Fire Training Center, Pomona,

New York (Ex. 54–155) recommending

removing the requirement for standby

personnel from the final rule, noted that

‘‘in operations during a fire or

emergency, it is a standard practice to

utilize the team approach.’’ The

comment went on to state, however, that

‘‘removing the restriction of having

persons outside the IDLH * * * and

allowing the incident commander the

flexibility of moving personnel around

as he or she sees fit at any given

situation * * * would actually enhance

the safety of our forces operating at the

scene of a fire or emergency.’’ As

discussed below, OSHA believes that

the requirements in the final standard

allow enough flexibility to maximize

safety.

OSHA concludes that, for interior

structural fire fighting, a buddy system

for workers inside the IDLH atmosphere

and at least two standby personnel

outside that atmosphere are necessary.

In fact, as noted above, OSHA has

previously explained that under the

prior standard and the OSH Act’s

general duty clause, there must be more

than one person present outside and at

least two firefighters inside when

conducting an interior attack on an

interior structural fire. Accordingly,

special provisions have been included

in this revised respiratory protection

standard to clarify that firefighters may

not enter an IDLH atmosphere alone

during interior structural firefighting,

and that two standby personnel are
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1247

required for all interior structural fire

fighting.

As discussed above, however, OSHA

does not believe that similar practices

are necessary in better controlled and

characterized IDLH situations, such as

those potentially arising in industrial

environments. In those cases, where

standby personnel can more easily track

the precise movements of the respirator

users and communication mechanisms

are in place, OSHA believes that one

standby person will often be sufficient,

although paragraph (g)(3)(i) clearly

recognizes that some nonfirefighting

IDLH situations will require multiple

standby personnel.

These additional requirements are

necessary because fire fighting ranks

among the most hazardous of all

occupations, and interior structural fire

fighting is one of the most dangerous

fire fighting jobs (See, e.g., Jankovic et

al. 1991). As the International

Association of Fire Chiefs (Ex. 54–328)

pointed out, ‘‘[t]he fire fighter is usually

operating in a hostile environment

where normal systems, facilities,

processes and equipment to ensure

safety have already failed.’’ A very basic

difference between firefighters—

particularly those involved in fighting

interior structural fires—and employees

in other occupations is that the work

site is always new and unknown.

Firefighters do not report to a fixed

location or work in a familiar

environment. Heat stress also affects

firefighters differently than other

workers. Petrochemical workers and

those in other high heat-stress

occupations, such as highway workers,

can deal with issues such as heat stress

through other options, including

acclimatization periods for new

employees, scheduling high exertion

work at night, and allowing frequent

breaks (Smith 1996). Firefighters do not

have these options.

Fire fighting is also extremely

stressful mentally because of the sense

of personal danger and urgency inherent

in search and rescue operations. A

firefighter regularly steps into situations

that others are fleeing, accepting a level

of personal risk that would be

unacceptable to workers in most other

occupations. Psychological stress is

caused by the firefighter’s need to focus

on the protection of lives and property,

as well as the need to maximize his or

her own personal safety and that of his/

her coworkers. Tenants and others in

the process of being rescued have also

been known to panic and attack

firefighters to obtain air from the

firefighter’s respirator in an attempt to

save their own lives (1994 NIOSH

Alert).

Fire fighting is a high-risk occupation

with a very narrow window of

survivability for those who lose their

orientation or become disabled on the

job. The terrible toll among firefighters

is recorded in many different national

data bases. For example, for the period

1980–1989, the NIOSH National

Traumatic Occupational Fatalities

(NTOF) Surveillance System reported

278 deaths among firefighters caused

just by work-related traumatic injuries;

NIOSH recognizes that this number is

an underestimate because of the

collection and reporting methods used

by NTOF, which limit the kinds of

events recorded. Data collected by the

IAFF for the period 1970–1994 report

1,369 firefighter deaths, and data

collected by the NFPA for the period

1990–1992 indicate that 280 firefighters

died in this 2-year period alone (1994

NIOSH Alert). OSHA believes that the

requirements of this respirator standard

may prevent a significant number of

these deaths and injuries. For example,

in a recent incident, a team of two

firefighters was operating inside a

structural fire. Rapidly deteriorating

conditions occurred in which there was

dense smoke. Confusion ensued and the

team lost contact, resulting in one

firefighter death. (Incident number 2;

OSHA Investigations of Firefighter

Fatalities; 10/1/91–3/17/97; IMIS) In

this situation, the need for additional

accountability and monitoring of

firefighters during interior structural fire

fighting is clear. Multiple standby

personnel and two-person teams inside

an IDLH atmosphere are therefore

necessary to check for signs of heat

stress, other illnesses, disorientation,

malfunctioning of respiratory and other

protective equipment, and to assist in

exit or rescue when needed (Smith,

1996).

OSHA emphasizes that the

requirement for standby personnel does

not preclude the incident commander

from relying on his/her professional

judgment to make assignments during a

fire emergency. Although the standard

requires at least two standby persons

during the attack on an interior fire,

there are obviously situations where

more than two persons will be required

both inside and outside the interior

structure, a decision ultimately to be

made by the incident commander. In

addition, as is the case under the

previous respiratory protection

standard, one of the standby personnel

may have other duties and may even

serve as the incident commander.

According to OSHA’s letter to Chief

Ewell, IFC, Oakland, CA, (J. Dear; 2/27/

96), ‘‘* * * one of the two individuals

outside the hazard area may be assigned

more than one role, such as incident

commander in charge of the emergency

or the safety officer. However, the

assignment of standby personnel of

other roles such as the incident

commander, safety officer, or operator of

fire apparatus will not be permitted if by

abandoning their critical task(s) to assist

in, or if necessary, perform a rescue

clearly jeopardizes the safety and health

of any firefighter working at the

incident.’’ OSHA has included specific

guidance regarding other duties of

standby personnel under paragraph

(g)(4). These duties are consistent with

OSHA’s past enforcement policy and

NFPA recommendations (NFPA 1500,

1977 Edition; Section 6–4.4.2).

It is important to have at least two

standby people available so that in the

event of an emergency in which both

members of the interior team need

rescue or other assistance, adequate

personnel are available for rescue. As

Harold A. Schaitberger testified, ‘‘* * *

The two-in/two-out rule has been the

industry standard in the fire service for

over 25 years. It is also based on

common sense. If there are two

firefighters inside a burning building

when a roof caves in, at least two

firefighters are required to assist and/or

rescue them (Testimony on H.R. 1783

before the Subcommittee on Economic

and Educational Opportunities, House

of Representatives, 104th Congress (July

11, 1995, Chairman: Cass Ballenger).’’

Whenever possible, the use of the buddy

system should also be maintained

during rescue operations.

Moreover, the ‘‘two-in/two-out’’

requirement does not take effect until

firefighters begin to perform interior

structural fire fighting. While the fire is

in the incipient stage, the incident

commander or other person in charge

may conduct an investigation or ‘‘size

up’’ the situation to determine whether

the fire has progressed beyond the

incipient stage. During this investigative

phase, the standard does not require

two-member teams inside and outside

the structure. Similarly, nothing in this

rule is meant to preclude firefighters

from performing rescue activities before

an entire team has assembled. If there

are fewer than four team members

available, and an individual inside the

burning structure must be rescued

immediately, this rule does not prevent

the rescue from occurring, as the Note

to the regulatory text makes clear.

However, once firefighters begin the

interior attack on an interior structural

fire, the atmosphere is assumed to be

IDLH and paragraph (g)(4) applies.

OSHA’s requirement in no way is

intended to establish staffing
1248 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

requirements with regard to, for

example, the number of persons on a

fire truck or the size of a fire company.

Rather, the 2 in / 2 out provision

specifies only the number of firefighters

who must be present before the interior

attack on an interior structural fire is

initiated. Firefighters may be assembled

from multiple companies, or arrive at

the scene at various times. All that is

intended is that an interior attack

should not be undertaken until

sufficient staff are assembled to allow

for both buddy and standby teams.

These requirements are consistent

with OSHA’s past enforcement policy.

OSHA has relied on the NFPA

recommendations as a basis for

determining an appropriate standard of

care in fire fighting situations under the

General Duty Clause of the OSH Act, 29

U.S.C. 654(a)(1). In its interpretative

memoranda addressing requirements

that are applicable to firefighters, OSHA

noted that occupational exposure to fire

is a well-recognized hazard, and that

firefighters using SCBA in hazardous

atmospheres should be operating in a

buddy system of two or more personnel.

The Agency explained that even under

OSHA’s previous respiratory protection

standard, a minimum of four personnel

should be used, with two members

inside the hazardous area and two

members outside the hazardous area

who are available to enter the area to

provide emergency assistance or rescue

if needed. One memorandum also

pointed out that there was no

prohibition against the outside standby

personnel having other duties, such as

functioning as incident commander or

safety officer, as long as it would not

jeopardize the safety and health of any

firefighter working at the incident if the

standby personnel left those duties to

perform emergency assistance and

rescue operations.

OSHA notes that the requirements of

paragraph (g)(4) apply in addition to the

requirements of OSHA’s specific fire

protection standards, subpart L of 29

CFR 1910. OSHA intends to begin

negotiated rulemaking on those fire

protection standards in the near future.

Paragraph (h)—Maintenance and Care of

Respirators

This final standard for respiratory

protection, in paragraph (h), addresses

the elements of respirator maintenance

and care that OSHA believes are

essential to the proper functioning of

respirators for the continuing protection

of employees. As OSHA stated in the

preamble to the NPRM (59 FR 58923),

‘‘a lax attitude toward this part of the

respiratory protection program will

negate successful selection and fit

because the devices will not deliver the

assumed protection unless they are kept

in good working order.’’ The

maintenance and care provisions, which

are divided into cleaning and

disinfecting, storage, inspection, and

repair, are essentially unchanged (with

the exception of the cleaning and

disinfecting provisions) from paragraph

(f) of OSHA’s prior respiratory

protection standard. Some

rearrangement and consolidation of the

regulatory text and minor language

changes have been made to this

paragraph to simplify and clarify the

requirements as a result of comments

and concerns that were raised in

response to the proposed rule.

Paragraph (h)(1) of the final standard

requires that employers provide each

respirator wearer with a respirator that

is clean, sanitary, and in good working

order. It further requires that employers

use the procedures for cleaning and

disinfecting respirators described in

mandatory Appendix B–2 or,

alternatively, procedures recommended

by the respirator manufacturer,

provided such procedures are as

effective as those in Appendix B–2. The

prior respiratory protection standard

required that employers clean and

disinfect respirators in accordance with

the maintenance and care provision of

paragraph (f), but offered no specific

guidance on how to perform these

procedures. Mandatory Appendix B–2

presents a method employers may use to

comply with the cleaning and

disinfecting requirements of final

paragraph (h)(1). The procedures listed

in Appendix B–2 were compiled from

several sources, including publications

of the American Industrial Hygiene

Association, ANSI Z88.2–1992 (clause

A.4, Annex A), and NIOSH. Other

methods may be used, including those

recommended by the respirator

manufacturer, as long as they are

equivalent in effectiveness to the

method in Appendix B–2. Equivalent

effectiveness simply means that the

procedures used must accomplish the

objectives set forth in Appendix B–2,

i.e., must ensure that the respirator is

properly cleaned and disinfected in a

manner that prevents damage to the

respirator and does not cause harm to

the user.

Several commenters (Exs. 54–267, 54–

300, 54–307) supported the cleaning

and disinfecting provisions in general

and the inclusion of manufacturers’

instructions in particular. The American

Iron and Steel Institute (AISI), for

example, suggested the following

language: ‘‘Respirators must be cleaned

and maintained in a sanitary condition.

The cleaning procedures recommended

by the respirator manufacturer or in

Appendix B, or a recognized standardsetting organization should be

followed’’ (Ex. 54–307).

The need for appropriate cleaning and

disinfecting procedures was also

supported during the hearings. For

example, James Johnson of Lawrence

Livermore National Laboratories

testified:

[P]rocedures and schedules for cleaning,

disinfecting, storing, inspecting, repairing, or

otherwise maintaining respirators * * * are

elements of the respiratory protection

program which are important and are

addressed in the rule * * *. I did some

personal evaluation on the disinfecting

procedures recommended by several U.S.

respirator manufacturers. I found that they

vary significantly. If you look in Appendix B

of the proposed rule, the hypochlorite or

bleach recommendation and the other

disinfectants outlined there are certainly

what is typically recommended and used (Tr.

184).

The Appendix B–2 procedures can be

used both with manual and semiautomated cleaning methods, such as

those using specially adapted domestic

dishwashers and washing machines. As

with most effective cleaning procedures,

Appendix B–2 divides the cleaning

process into disassembly of

components, cleaning and disinfecting,

rinsing, drying, reassembly and testing.

Recommended temperatures for

washing and rinsing are given in

Appendix B–2, as are instructions for

preparing effective disinfectants.

OSHA has made minor changes to the

contents of Appendix B–2 in the final

standard. For example, the cleaning

procedures listed in the final rule are

more consistent with the procedures

suggested in Clause A.4, Annex A of the

ANSI Z88.2–1992 standard than those

proposed, particularly with regard to the

temperatures recommended to prevent

damage to the respirator. Additionally,

automated cleaning, which is now being

used by many larger companies, is

allowed as long as effective cleaning

and disinfecting solutions are used and

recommended temperatures, which are

designed to prevent damage to

respirator components, are not

exceeded.

Commenters (Exs. 54–91, 54–187, 54–

330, 54–389, 54–309, Tr. 695) generally

supported the need for a respirator

maintenance program but took differing

approaches to the provisions proposed

in paragraph (h)(1) (i)–(iii) dealing with

the frequency of cleaning and

disinfecting respirators. One commenter

(Ex. 54–187) agreed with the provisions

as proposed. Others (Exs. 54–208, 54–

67, 54–91, 54–408) recommended a

more performance-oriented approach.
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1249

For example, Darell Bevis of Bevis

Associates International objected to the

proposed requirement that respirators

that are issued for the exclusive use of

an employee be cleaned and disinfected

daily by stating:

[D]iffering workplace conditions will

require that cleaning and disinfection may be

required more frequently or even less

frequently than daily. A requirement for

daily cleaning when unnecessary results in

considerable additional respirator program

costs with no benefit. A more realistic and

still enforceable requirement would be

routinely used respirators issued for the

exclusive use of an employee shall be

cleaned and disinfected as frequently as

necessary to ensure that the user has a clean,

sanitary, properly functioning respirator at

all times (Tr. 695).

Other commenters (Exs. 54–67, 54–91,

54–234, 54–271, 54–278, 54–286, 54–

289, 54–293, 54–334, 54–350, 54–374,

54–424, 54–435, Ex. 163) also objected

to cleaning and disinfecting respirators

at the end of each day’s use if the

respirator is issued for the exclusive use

of a single employee. These comments

were in general agreement with the

American Industrial Hygiene

Association’s statement:

The performance-oriented language of the

existing standard is more reasonable [than

the proposed language]. Cleaning and

disinfecting of individually assigned

respirators should be done ‘‘as needed’’ to

assure proper respirator performance and to

preclude skin irritation or toxicity hazards

from accumulation of materials. Disinfecting

an individually issued respirator is probably

not necessary at all unless the ‘‘contaminant’’

is biological in nature (Ex. 54–208).

Several other commenters (See, e.g.,

Exs. 54–330, 54–389, 309) were in favor

of cleaning individually assigned

respirators at the end of each day’s use,

but recommended disinfecting or

sanitizing only after longer periods or

when necessary. Michael Laford,

Manager of Industrial Hygiene and

Safety at Cambrex, commented as

follows:

It is important to clean all personal

protective equipment, preferably after each

use as needed, and not just once a day.

However, is the additional requirement for

daily disinfection * * * where respirators

are individually assigned, supported with

valid studies or data? In the absence of data

that supports a real benefit of this

requirement, the language should revert to

‘‘periodic’’ disinfecting of respirators (Ex. 54–

389).

The need for flexibility with respect

to maintaining clean and sanitary

respirators was also discussed during

the hearings. For example, in response

to a question asked by a member of the

OSHA panel regarding how often a

respirator mask should be cleaned,

James Centner, Safety and Health

Specialist with the United Steel

Workers of America (USWA), replied

that it depended on the length of time

the respirator is worn and the workplace

conditions. He stated, ‘‘If you’re

working in a smelter where it’s hot and

dirty and dusty, workers probably need

to take that respirator off about every 30

minutes and do a good, thorough job of

washing the grit and dirt off their face

and . . . do a quick maintenance cleanup job on the sealing surface of the

respirator so it maintains an adequate

fit’’ (Tr. 1068). Darell Bevis of Bevis

Associates International (Tr. 747–748)

responded similarly when asked this

question; he contrasted dusty

workplaces, such as fossil fuel power

generation plants where respirators

become filthy with hazardous

particulates, to workplaces involving

exposure only to gases and vapors

where respirators may remain clean for

long periods.

OSHA agrees with these commenters

that the necessary frequency for

cleaning a respirator can range from

several times a day to less than daily.

Therefore, OSHA has restated paragraph

(h)(1)(i) in performance-based language,

which will provide employers with

flexibility in maintaining clean and

sanitary respirators when the respirator

is used exclusively by a single

employee. Final paragraph (h)(1)(i) now

reads as follows: ‘‘Respirators issued for

the exclusive use of an employee shall

be cleaned and disinfected as often as

necessary to be maintained in a sanitary

condition.’’ Final paragraph (h)(1)(i) is

complemented by the respirator use

provision in final paragraph (g)(2)(ii)(A),

which requires that employers ensure

that workers leave the respirator use

area to wash their faces as necessary to

prevent eye or skin irritation. OSHA

believes that compliance with final

paragraphs (h)(1)(i) and (g)(2)(ii)(A), as

well as the training provisions in

paragraph (k) regarding maintenance of

the respirator, will provide effective

employee protection against hazardous

substances that accumulate on the

respirator, interfere with facepiece seal,

and cause irritation of the user’s skin.

Proposed paragraphs (h)(1)(ii)–(iii)

specified that respirators used by more

than one employee or respirators issued

for emergency use be cleaned and

disinfected after each use and were the

subject of a number of comments (See,

e.g., Exs. 54–67, 54–234, 54–361, 54–

408, 54–424 and Tr. 695). For example,

the Service Employees International

Union (Ex. 54–455) suggested that

OSHA replace the phrase ‘‘after each

use’’ with ‘‘before they are worn by

another user.’’ OSHA agrees with this

suggestion as it applies to the shared use

of respirators in non-emergency

situations, and has revised final

paragraph (h)(1)(ii) to require cleaning

and disinfecting of respirators prior to

their use by other individuals. OSHA

believes that this modification provides

flexibility in those areas where

respirators are assigned to more than

one employee. This requirement is also

consistent with the parallel provision of

ANSI Z88.2–1992. However, if the

respirator is to be used in an emergency

situation, it should be in a clean and

sanitary condition and immediately

ready for use at all times. Emergency

personnel cannot waste time cleaning

and sanitizing the respirator prior to

responding to an emergency. Thus, if

the respirator is one that is maintained

for emergency use, the final standard in

paragraph (h)(1)(iii) retains the

requirement to clean and disinfect the

respirator after each use.

Final paragraph (h)(1)(iv) requires the

cleaning and disinfecting of respirators

used in fit testing and training exercises.

This provision was added in response to

a recommendation made by the Public

Service Company of Colorado (Ex. 54–

179) that respirators be cleaned and

disinfected after each fit test.

Additionally, representatives of

Electronic and Information

Technologies (Ex. 54–161) pointed out

that, although the proposal addressed

cleaning and disinfecting procedures for

respirators worn during routine and

emergency use, it did not specify how

respirators should be cleaned/

disinfected during fit testing or training

activities. Since these conditions

involve shared use, OSHA has

emphasized in final paragraph (h)(1)(iv)

the need to properly clean and disinfect

or sanitize respirators used for training

and fit testing after each use.

OSHA noted in the proposal that it

was not stating who should do the

cleaning and disinfecting, only that it be

done (59 FR 58924). However, as with

all other provisions of the standard, the

employer is responsible for satisfying

the cleaning and disinfecting

requirements. The final standard

requires that the employer ensure that

cleaning is done properly, and that only

properly cleaned and disinfected

respirators are used. The employer is

allowed to choose the cleaning and

disinfecting program that best meets the

requirements of the standard and the

particular circumstances of the

workplace. Richard Uhlar, an industrial

hygienist for the International Chemical

Workers Union (ICWU), commented

that workers should be given paid time

to clean, disinfect, and inspect

respirators; otherwise, in the view of
1250 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

this commenter, respirators will not be

taken care of properly (Ex. 54–427).

OSHA notes that if the employer elects

to have employees clean their own

respirators, the employer must provide

the cleaning and disinfecting

equipment, supplies, and facilities, as

well as time for the job to be done.

Commenting on a preproposal draft of

the standard, the United Steelworkers of

America (USWA) (Ex. 36–46)

recommended that OSHA require the

employer to clean and repair respirators.

The USWA stated that programs in

which employers require employees to

return their respirators at the end of

each shift to a central facility for

inspection, cleaning, and repairs by

trained personnel are more effective

than programs in which employees are

responsible for cleaning their own

respirators. OSHA agrees that such a

centralized cleaning and repair

operation can ensure that properly

cleaned and disinfected respirators are

available for use, but this approach is

not the only way to fulfill this

requirement. For example, central

facilities may be inappropriate in

workplaces where respirator use is

infrequent, or where the number of

respirators in use is small.

Final paragraph (h)(2), which

establishes storage requirements for

respirators, does not differ substantively

from the corresponding requirements in

the proposal. However, some of the

proposed provisions have been

consolidated to simplify understanding

and interpretation of the requirements.

Final paragraph (h)(2)(i) sets forth the

storage requirements for all respirators,

while final paragraph (h)(2)(ii)

addresses additional requirements for

the storage of emergency respirators.

Specifically, final paragraph (h)(2)(i)

requires that all respirators be stored in

a manner that protects them from

damage, contamination, harmful

environmental conditions and damaging

chemicals, and prevents deformation of

the facepiece and exhalation valve.

Respirators maintained for emergency

use also must be stored in accordance

with the requirements of final paragraph

(h)(2)(i) and, in addition, must be kept

accessible to the work area, be stored in

compartments or covers that are clearly

marked as containing emergency

respirators, and be stored in accordance

with any applicable manufacturer’s

instructions (paragraph (h)(2)(ii)).

There was general support in the

record for the performance approach

that OSHA took in the proposal with

regard to storage requirements. For

example, the Industrial Safety

Equipment Association (ISEA)

commented: ‘‘[B]ecause the degree of

severity of an environmental condition

that would cause deterioration would be

related to the tolerance of the particular

equipment in question and would thus

vary from model to model, there is no

need to specify conditions of storage in

more detail’’ (Ex. 54–363). The comment

submitted by the Mobil Oil Corporation

(Ex. 54–234) agreed with OSHA’s

proposed approach on respirator

storage, but went further to state that

‘‘[t]o place storage requirements in

specific language may actually

contradict specific recommendations of

the manufacturer.’’ Other commenters

also supported OSHA’s provisions as

proposed (See Exs. 54–172, 54–250, 54–

273, 54–408, 54–424, and 54–455).

There were, however, some suggested

changes that commenters believed

would clarify final paragraph (h)(2). One

commenter (Ex. 54–32) suggested that,

in addition to requirements for

accessibility and maintenance of

emergency respirators, there should be a

requirement for specific ‘‘ awareness

training’’ to remind employees of the

location of such respirators. OSHA

agrees that such knowledge is vital. The

training specified in paragraph (k),

especially the provisions on how to use

a respirator in emergency situations

(final paragraph (k)(1)(iii)) and

procedures for the maintenance and

storage of respirators (final paragraph

(k)(1)(v)), are designed to do this. In

addition, paragraph (k) requires that

employers retrain employees where it

appears necessary to do so to ensure

safe respirator use.

Two commenters recommended that

employees, rather than employers, be

held responsible for cleaning, sanitizing,

and storing their respirators. The Grain

Elevator and Processing Society (Ex. 54–

226) recommended that, for most

operations, the maintenance and care of

respirators should be the responsibility

of the employee once the employee has

been trained. In another comment

specific to the storage provision, the

American Petroleum Institute (Ex. 54–

330) pointed out that employers

generally do not store respirators;

instead, respirator storage is the

responsibility of the employee. In

response, OSHA notes that section

5(a)(2) of the OSH Act and case law

interpreting that provision have

specifically placed the burden of

complying with safety and health

standards on the employer because the

employer controls conditions in the

workplace. The employer is, therefore,

responsible for the results of actions

taken by others at the direction of the

employer. For example, although an

employee may physically store a

respirator, a contractor may perform a fit

test, or a physician may examine an

employee at the employer’s direction,

the employer is ultimately responsible

for ensuring that these actions are taken

to comply with the standard.

Proposed paragraph (h)(2)(ii) would

have required that compartments be

built to protect respirators that are

stored in locations where weathering,

contamination, or deterioration could

occur. The Westminster, Maryland Fire

Department (Ex. 54–68) raised the

following concern about this proposed

provision:

This requirement may be appropriate for

manufacturing but is not practical given the

operations of the fire service. * * * As

OSHA is aware the fire service maintains its

breathing apparatus in a ready posture on the

apparatus. To require the apparatus to be

placed in a compartment would eliminate the

precious time saved by donning the

apparatus enroute to the emergency. This

operation has been the backbone of our

efficiency at rescue and suppression

operations.

Similar concerns were raised by the

National Volunteer Fire Council (Tr.

499) and the Connecticut Fire Chiefs’

Association, Inc. (Ex. 180). In response

to these concerns, OSHA has crafted

language that the Agency believes

fulfills the purpose of this provision and

maintains the efficiency of emergency

response workers such as firefighters.

Instead of requiring emergency

respirators to be stored only in

compartments, final paragraph

(h)(2)(ii)(B) permits them alternatively

to be stored in covers that are clearly

marked as containing emergency

respirators. Walk-out brackets with

covers that are mounted on a wall or to

a stable surface (e.g., on a fire truck)

may be used so long as the respirator is

covered to prevent damage when not in

use. Because a cover can be removed in

seconds, OSHA believes that this

change addresses the needs of

firefighters and other emergency

responders. It is important that the

walk-out brackets are mounted within

the vehicle. For example, they can be

mounted directly to the fire truck to

enable firefighters to rapidly don the

respiratory equipment when needed.

However, any means of storage used

must be secure. If walk-out brackets are

not mounted, there is a danger that the

unsecured respirators could become

damaged as a result of vehicle motion.

Final paragraph (h)(3) requires regular

inspections to ensure the continued

reliability of respiratory equipment. The

frequency of inspection and the

procedures to be followed depend on

whether the respirator is intended for

non-emergency, emergency, or escapeonly use.
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1251

Final paragraph (h)(3)(i)(A) requires

respirators for use in non-emergency

situations to be inspected before each

use and during cleaning. For respirators

designated for use in an emergency

situation, final paragraph (h)(3)(i)(B)

requires that they be inspected at least

monthly and in accordance with the

manufacturer’s instruction. In addition,

emergency respirators must be

examined to ensure that they are

working properly before and after each

use. Examining respirator performance

before and after each use is not intended

to be as extensive and thorough a

process as respirator inspection. A basic

examination conducted prior to each

use will provide assurance to the wearer

that the respirator which he/she is about

to don in an emergency situation will

work properly, e.g., that the cylinders

on the SCBA are charged, that air is

available and flowing. This examination

can be done fairly quickly, and OSHA

believes that this added measure of

employee protection is both necessary

and appropriate.

Respirators used for escape only are to

be inspected prior to being carried into

the workplace (paragraph (h)(3)(i)(C)).

The Dow Chemical Company (Ex. 54–

278) addressed the inspection of

emergency escape respirators, stating,

‘‘Emergency escape respirators such as

mouthbit respirators, usually stored in

the box or bag they come in, do not need

to be inspected monthly.’’ OSHA agrees

with this statement. Mouthbit or other

emergency escape respirators are carried

by an individual worker into the

workplace for personal use in an

emergency, and must be inspected for

proper condition prior to being carried

into the workplace. Additional monthly

inspections of emergency escape

respirators that are stored for future use

are unnecessary, since they will be

inspected prior to being carried into the

workplace. Final paragraph (h)(3)(i)(C)

therefore specifies that ‘‘escape-only’’

respirators need only be inspected

before being carried into the workplace.

Although no commenters were

opposed to the inspection requirements,

some participants raised the issues that

are discussed below with respect to

inspection frequency and procedures.

When respirators are inspected, the final

rule (paragraph (h)(3)(ii)(A)) requires

that the inspection include an

examination to ensure that respirators

are working properly, including an

examination of the tightness of

connections and the condition of the

various components. Two comments

were made with respect to respirator

inspection procedures. John Clarke of

Electronic and Information

Technologies (Ex. 54–162) stated that

checking for proper function

(examination to ensure that respirators

work properly) presents a dilemma if

use is to include sanitizing the

facepiece. He pointed out that SCBAs

reserved for use by multiple persons

presents a special problem. Likewise,

John O’Green of American Electric

Power (Ex. 54–181) asked that

‘‘functional check’’ be better defined

and clarified. He stated that requiring

the actual activation of the respirator,

including the flow of air to the

facepiece, could be time consuming for

all the emergency respirators in their

facilities. OSHA does not intend that the

respirator be physically placed on the

employee to examine the respirator to

ensure that it is working properly.

Visual inspection can detect factors that

would interfere with proper

performance, e.g., distortion in shape

(often the result of improper storage),

missing or loose components, blockage,

and improper connections. Alarms can

also be examined without actually

putting the respirator on the employee.

In addition, examining elastomer parts

for pliability and signs of deterioration,

as required by final paragraph

(h)(3)(ii)(B), can be performed without

wearing the respirator.

Under paragraph (h)(3)(iii) of the final

rule, SCBAs must be inspected monthly.

The employer must ensure that the

cylinders are fully charged. Recharging

is required when the pressure falls

below 90 percent of the manufacturer’s

recommended pressure level. The

Westminster, Maryland Fire Department

(Ex. 54–68) strongly recommended that

the apparatus be inspected at the

beginning of each shift or workday

rather than monthly. OSHA notes that

the final rule specifies only the

minimum requirements for an effective

respiratory protection program.

Employers, however, are encouraged to

exceed these minimum criteria if, by

doing so, employee protection and

operating efficiency are enhanced.

The final provision for recharging air

and oxygen cylinders for SCBAs in

paragraph (h)(3)(iii) is unchanged from

proposed paragraph (h)(3)(i)(C).

Although no commenters disagreed

with this provision as proposed, a few

commenters (Exs. 54–6, 54–220) asked

OSHA to clarify the requirement that

SCBA equipment be maintained in a

fully charged state and recharged when

the pressure falls to 90% or less of the

manufacturer’s recommended pressure

level. By way of example, OSHA notes

that if the manufacturer states that the

cylinder is fully charged at 100 psi, the

cylinder must be recharged when the

pressure falls to 90 psi (i.e., 90% of the

fully charged level). The 90 percent

level was selected to ensure that

sufficient air remains in the cylinder to

allow emergency responders to perform

their required duties in a contaminated

or oxygen-deficient atmosphere and still

have sufficient air available to escape

from these conditions. The 90 percent

level, and the requirement that

cylinders be recharged once the

pressure falls below 90 percent, was

also recommended by the American

Industrial Hygiene Association (Ex. 54–

208).

In two separate submissions to the

record (Exs. 54–121 and 54–135),

Consolidated Engineering Services

asked what type of training is required

for employees who inspect respirators

used for emergency response. OSHA

notes that, under final paragraph (k), the

specifics of an appropriate training

program are left to the discretion of the

employer. Regarding respirators for

emergency use, final paragraph

(k)(1)(iii) requires that employees be

trained in how to use the respirator

effectively in emergency situations,

while final paragraph (k)(1)(iv) requires

training on how to inspect the

respirator. As these paragraphs make

clear, OSHA requires the employer to

develop appropriate training programs

for employees who inspect emergency

respirators.

As part of the inspection process for

respirators that are maintained for use

in emergencies, paragraph (h)(3)(iv) of

the final standard requires certification

of the inspection. Documentation of

certification includes the date of

inspection, the name or signature of the

inspector, the findings of the inspection,

any required remedial action, and a

serial number or other means of

identifying the inspected respirator.

This information must be tagged to the

respirator or its storage compartment, or

otherwise stored in the form of

inspection reports (i.e., paper or

electronic), and be maintained until

replaced following a subsequent

certification.

This requirement was included in the

proposal, and several comments

addressed it. Dow Chemical (Ex. 54–

278) stated that it supports the proposed

requirement. The American Petroleum

Institute (Ex. 54–330) recommended

that OSHA require ‘‘identification of the

person that made the inspection’’ in lieu

of a signature. However, OSHA believes

that the inspector’s name or signature is

a clear and precise identification, and

therefore has retained this requirement

in the final rule as proposed.

The final provision of paragraph (h)

deals with respirator repairs and

adjustments. Final paragraph (h)(4)

provides that respirators that fail
1252 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

inspections, or are otherwise defective,

are to be removed from service and

discarded, repaired, or adjusted

according to the specified procedures.

In addition, the employer shall ensure

that repairs or adjustments to respirators

are made only by persons appropriately

trained to do so, and that they use only

the respirator manufacturer’s NIOSHapproved parts that are designed for the

particular respirator. The repairs also

must be made in accordance with the

manufacturer’s recommendations and

specifications. Because components

such as reducing and admission valves,

regulators, and alarms are complex and

essential to the safe functioning of the

respirator, they are required to be

adjusted and repaired only by the

manufacturer or a technician trained by

the manufacturer.

Several comments were submitted to

the record regarding this particular

provision. Consolidated Engineering

Services (Exs. 54–121 and 54–135) and

the Florida Department of Labor and

Employment Security (Ex. 54–79) asked

what type of training is required for

employees who repair and adjust

respirators. Motorola (Ex. 54–187) also

addressed this point, but added that

specialized training for most respirator

repair work was not necessary, and that

the training program required by the

standard should provide employees

with sufficient expertise to perform the

necessary repair work, or at least to

recognize when repair is beyond their

ability. Another commenter (Ex. 54–

293) asserted that, depending on the

manufacturer’s recommendation, a

trained person may or may not be

necessary to make repairs; for example,

no training is required to replace a

broken respirator strap.

In response to these concerns, OSHA

does not believe that it is necessary or

appropriate to specify in detail in the

final rule the type of training that is

required to qualify a person to repair

and adjust respirators. However,

because of the important health-related

functions of respirators, the person

making the repair needs to be properly

trained. OSHA expects that such repair

will often be performed by the

manufacturer, particularly if special

expertise is required. Where this is not

the case, the employer must ensure that

the employee or person repairing the

respirator has the skills necessary to

conduct the appropriate repair and

adjustment functions. The use of the

term ‘‘appropriately trained’’ refers to an

individual who has received training

from the respirator manufacturer or

otherwise has demonstrated that he/she

has the skills to return the respirator to

its original state of effectiveness.

The AFL–CIO (Ex. 54–428) and

Service Employees International Union

(SEIU) (Ex. 54–455) recommended that

OSHA require employers to tag as ‘‘out

of service’’ those respirators that fail

inspections. OSHA agrees that some

means must be available for ensuring

that only properly functioning

respirators are introduced into the

workplace. However, OSHA believes

that the decision on how to handle

respirators that fail inspection is most

appropriately addressed in the

employer’s respirator protection

program, as required under final

paragraph (c). Specifically, final

paragraph (c)(1)(v) would allow such

procedures to be tailored to satisfy the

needs of a particular workplace.

The SEIU (Ex. 54–455) recommended

that OSHA require employers to keep an

adequate supply of cartridges and other

routine replacement parts in stock and

readily accessible to employees so that

they can replace needed parts. OSHA

does not believe it is necessary to

specify that employers must maintain

an adequate number of spare parts.

Final paragraph (h)(4) requires that

defective respirators be removed from

service unless they are repaired or

adjusted, and an employer who does not

keep on hand sufficient parts to allow

respirators to be repaired will need to

remove those respirators from service

until suitable repairs can be made.

Thus, an employer who does not

maintain an adequate inventory of parts

will either need to keep extra respirators

on hand or cease operations that require

respirator use until parts can be

obtained or installed.

Paragraph (i)—Breathing Air Quality

and Use

This paragraph of the respiratory

protection standard requires that

breathing air for atmosphere-supplying

respirators be of high purity, meet

quality levels for content, and not

exceed certain contaminant levels and

moisture requirements. The paragraph

sets performance standards for the

operation and maintenance of breathing

air compressors and cylinders,

establishes methods for ensuring

breathing air quality, and sets

requirements for the quality of

purchased breathing air.

Paragraph (i)(1) of the final standard

applies to atmosphere-supplying

respirators that are being used to protect

employees, and requires that breathing

air supplied to these respirators be of

high purity. This same requirement for

breathing air quality was included in

proposed paragraph (i)(1). Both the prior

and final rules refer to a number of

standard references that establish

parameters for breathing air quality. For

example, under (i)(1)(i), the final rule

requires the employer to ensure that

oxygen used for breathing purposes

meets the requirements of the United

States Pharmacopoeia (USP) for medical

or breathing oxygen. This provision is

the same as the requirement in OSHA’s

prior respiratory protection standard at

paragraph (d)(1). The ANSI Z88.2–1992

respirator standard, in Clause 10.5.1,

also requires that air be of high purity

and that oxygen meet the USP

requirements. Inclusion of this

requirement in the final rule was

strongly supported by the AFL-CIO (Ex.

54–428), which stated that the employer

must ensure that ‘‘compressed air,

compressed oxygen, liquid air, and

liquid oxygen used for respiration is of

high purity and in accordance with the

specifications listed in [proposed

paragraph] (i)(1).’’

Under paragraph (i)(1)(ii) of the final

standard, breathing air must meet at

least the requirements for Type I—Grade

D breathing air, as described in the

ANSI/CGA G–7.1–1989 standard, which

is the latest revision of that reference

standard and the one currently used by

OSHA when determining breathing air

quality. Final paragraph (i)(1)(ii)

identifies the specifications for the

contents of Grade D breathing air:

oxygen content (volume/volume) of 19.5

to 23.5 percent; hydrocarbon

(condensed) concentration of five

milligrams or less per cubic meter of air;

carbon monoxide level of 10 ppm or

less; carbon dioxide level of 1,000 ppm

or less; and a lack of noticeable odor.

The OSHA respiratory protection

standard adopted in 1971 referenced the

then-current CGA G–7.1–1966 breathing

air quality standard. In 1973, and again

in 1989, the CGA, in conjunction with

ANSI, revised the G–7.1 standard. The

Grade D specification was changed as

part of the 1989 ANSI revision, at which

time the carbon monoxide level was

reduced from 20 ppm to 10 ppm. The

OSHA Directorate of Compliance

Programs subsequently issued letters of

interpretation in 1991 and 1992 that

required employers to use the updated

Grade D specifications for breathing air

quality.

The proposal requested comments on

whether acceptable respirator breathing

air quality should continue to meet the

specifications for Grade D breathing air

described in the ANSI/CGA G 7.1–1989

standard. Commenters supported

inclusion of a requirement for use of the

1989 Grade D breathing air values in the

final rule (Exs. 54–141, 54–189, 54–267,

54–286, 54–408, 54-443). For example,

the Tennessee Valley Authority (Ex. 54–

189) and Norfolk Southern (Ex. 54-267)
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1253

supported the Grade D breathing air

requirement, stating that, in their

experience, the Grade D air they have

been using is fully adequate and safe,

and that OSHA should not adopt more

stringent requirements across the board.

Modern Safety Techniques, Inc. (Ex.

54–141) supported maintaining the

Grade D breathing air quality

requirement but recommended that the

OSHA rule not specify the year of the

ANSI/CGA standard, because, for

example, employers were confused

when the CGA revised the ANSI/CGA

G–7.1 standard in 1989 and the OSHA

standard referred to an earlier version of

that standard. However, the regulations

governing the incorporation of

documents by reference (1 CFR 51)

require that the revision date of

incorporated references be specified

when they are included in any new or

revised standard. Where incorporated

references are used in final paragraph

(i), therefore, the latest revision dates for

these references have been used.

The Los Alamos National Laboratory

(LANL) (Ex. 36–52) recommended that

Grade E air rather than Grade D air be

used since most air that passes the

Grade D requirements will also pass

Grade E requirements. The Grade E

specifications narrow the range of

permitted oxygen content from 19.5–

23.5 percent to 20 to 22 percent oxygen

and lower the allowable carbon dioxide

level from 1000 ppm to 500 ppm. LANL

gave no specific safety or health reason

for OSHA to adopt this more stringent

recommendation. The Service

Employees International Union (Ex. 54–

455), however, points out that Grade E

air of reliable quality may be difficult

for employers to obtain. In addition,

OSHA is not aware of any problems that

have occurred as a result of breathing

Grade D air, and believes that the Grade

D specifications will fully protect

employees who use atmospheresupplying respirators. Therefore, OSHA

is not convinced a higher grade of air is

required, and the final rule specifies

Grade D air.

OSHA has been informed that NIOSH

has been working with the National

Aeronautics and Space Administration

(NASA) on a new ‘‘liquid air SCBA’’

that may be submitted for NIOSH

certification in the future. In its revision

of the 42 CFR 84 respirator certification

standard, NIOSH incorporated the CGA

Commodity Specification for Air in the

CGA’s G–7.1–1966 standard to maintain

the quality verification category for

Type II liquid compressed air, which

had been removed from the updated

ANSI/CGA G–7.1–1989 standard.

NIOSH included this specification

because a liquid compressed air quality

category is needed for future evaluations

of atmosphere-supplying respirators that

use liquefied compressed air. NIOSH

continues to recommend the use of the

ANSI/CGA G–7.1–1989 standard for

breathing air quality for currently issued

respirator certifications.

Under paragraph (i)(2) of the final

standard, employers are prohibited from

using compressed oxygen in

atmosphere-supplying respirators,

including open-circuit SCBAs, that have

previously used compressed air. This

prohibition was proposed in the NPRM,

and is intended to prevent the fires and

explosions that could result if high

pressure oxygen comes into contact

with oil or grease that has been

introduced to the respirator or the air

lines during compressed air operations.

Comments to the record (Exs. 10, 54–

165, 54–208, 54–218) support this

provision. Additionally, the prohibition

is consistent with Clause 10.5.2 of the

ANSI Z88.2–1992 standard.

Proposed paragraph (i)(3) would have

prohibited the use of oxygen with

supplied air respirators. This provision

was intended to avoid the possibility of

fires and explosions that can result

when oxygen is used in high

concentrations. However, some

respiratory equipment is specifically

designed to avoid fire and explosion

hazards when used with oxygen in

concentrations greater than 23.5%.

Therefore, paragraph (i)(3) of the final

standard specifies that oxygen in

concentrations greater than 23.5% is to

be used only with equipment designed

specifically for oxygen service or

distribution. Several commenters

pointed out the need to specify a

maximum oxygen concentration (Exs.

54–165, 54–208, 54–218, 54–219).

Clause 10.5.2 of the ANSI Z88.2–1992

standard (Ex. 81) also states, ‘‘Oxygen

concentrations greater than 23.5% shall

be used only in equipment designed for

oxygen service or distribution.’’ OSHA

agrees with the recommendations made

by the AIHA (Ex. 54–208), 3M (Ex. 54–

218), and Monsanto (Ex. 54–219) that

the final rule adopt the maximum

oxygen concentration language from the

ANSI standard, and the final rule

reflects this recommendation.

Final paragraph (i)(4) requires that

breathing air for respirators provided

from cylinders or air compressors meet

certain minimum standards. Under final

paragraph (i)(4)(i), cylinders must be

tested and maintained as prescribed in

the Shipping Container Specification

Regulations of the Department of

Transportation (DOT) (49 CFR parts 173

and 178); these DOT regulations are also

required for NIOSH respirator

certification. The DOT regulations in

parts 173 and 178 cover the

construction, maintenance, and testing

of these compressed air cylinders, and

are necessary to prevent the explosions

that can result if high pressure breathing

air cylinders rupture. The proposal

referenced only 49 CFR part 178, but the

AIHA (Ex. 54–208) recommended that

the DOT requirements found in 49 CFR

part 173 also be specified in the final

rule because they apply to breathing air

cylinders. Final paragraph (i)(4)(i)

therefore includes a reference to part

173 in addition to part 178.

Paragraph (i)(4)(ii) of the final

standard includes a provision requiring

employers to ensure that cylinders of

purchased breathing air are

accompanied by a certificate from the

supplier stating that the air meets the

requirements for Type 1-Grade D

breathing air contained in paragraph

(i)(1)(ii) of the final standard. Employers

must obtain a certificate of analysis of

purchased breathing air from the

supplier to ensure that its content and

quality meet the requirements for Grade

D breathing air. This will allow the

employer to have assurance that the

purchased breathing air being used by

employees is safe. The proposal did not

include a requirement for the

certification of the quality of purchased

breathing air. There was, however,

support in the record (Exs. 54–234, 54–

266, 54–273, 54–330, 54–408) for adding

this requirement. For example, the

American Petroleum Institute (Ex. 54–

330) and Duquesne Light Company (Ex.

54–408) recommended that additional

guidance, similar to that in ANSI Z88.2–

1992, be provided to ensure the quality

of purchased breathing air. Exxon (Ex.

54–266) stated that OSHA should not

allow the direct blending of compressed

nitrogen and oxygen gases by the

employer to produce Grade D air, citing

the ‘‘extreme consequences of having

too little oxygen in a cylinder.’’ Exxon

further recommended that 100% of the

cylinders be tested for oxygen content

for all nitrogen/oxygen mixed cylinders

(Ex. 54–266). The requirement that the

employer obtain a certificate of analysis

of purchased breathing air means that

every cylinder will have been analyzed

for oxygen content by the supplier and,

therefore, the situation feared by Exxon

will not arise.

Final paragraph (i)(4)(iii) requires that

the moisture content of compressed air

in air cylinders not exceed a dew point

of ¥50° F (¥45.6° C) at one atmosphere

of pressure. This requirement will

prevent respirator valves from freezing,

which can occur when excess moisture

accumulates on the valves. This

provision has been revised from the

proposed requirement to be consistent
1254 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

with the latest versions of the standard

references for moisture content of

compressed breathing air, the ANSI

Z88.2–1992 and ANSI/CGA G–7.1–1989

standards. Consistency between the

required value and the standard

references will avoid confusion in

measuring moisture content and,

consequently, will enhance employee

protection. This dew point value, as the

AIHA (Ex. 54–208) recommended, has

been taken from the ANSI/CGA G–7.1–

1989 specifications for Grade D air and

replaces the 27 ml/m3 value for

moisture content specified in the

proposal.

Final paragraph (i)(5)(i) requires that

compressors that supply breathing air

are to be constructed and situated so

that contaminated air cannot enter the

air supply system. This provision from

the prior standard is retained and also

reflects the intent of the proposed

requirement. The purity of the air

entering the compressor intake is a

major factor in the purity of air

delivered to the respirator user. The

location of the intake is most important,

and must be in an uncontaminated area

where exhaust gases from nearby

vehicles, the internal combustion motor

that is powering the compressor itself (if

applicable), or other exhaust gases being

ventilated from the plant will not be

picked up by the compressor air intake.

Contaminated air or exhaust gases from

internal combustion engines that are

taken into the compressor are major

hazards to the purity of breathing air

from compressors, and these hazards

occur with all compressors, not just oillubricated ones. Respirator users have

died or been injured when the air intake

was not properly located to avoid

contaminants. Final paragraph (i)(5)(i),

therefore, requires that air intakes for all

compressors be located in a way that

avoids entry of any contaminated air

into the compressor.

Support for this requirement can be

found in the Distler air compressor

study (Ex. 32–1). This study

recommended that engine exhaust gases

should be piped upward or downwind

from the compressor air intake,

particularly where exhaust gases are not

reliably dispersed, such as in partially

enclosed spaces or in turbulent wind

areas. The compressor exhaust piping

used in the Distler study had to be

repositioned several times to find a

location where the exhaust gases would

not be picked up by the compressor air

intake. All of these findings reinforce

the importance of locating the

compressor’s air intake in an area that

ensures that only high-quality air can be

taken in. No comments were received

on the proposed requirement for the

location of compressor air intakes.

Final paragraph (i)(5)(ii) has been

slightly modified from proposed

requirement (i)(4)(ii) to require that the

moisture content of compressed air be

minimized so that the dew point at one

atmosphere of pressure is 10 degrees

Fahrenheit (5.56 degrees Celsius) below

the ambient temperature to prevent

water freezing in valves and

connections of the air supply system.

Such freezing can block air lines,

fittings, and pressure regulators. This

final requirement is similar to the

parallel provision of the previous

standard, which required that breathing

air meet the requirements of CGA G–

7.1–1966. Two commenters (Exs. 54–

208, 54–218) pointed out that the

proposal specified a dew point of 10

degrees Celsius instead of the 10 degrees

Fahrenheit specified in the ANSI/CGA

G–7.1–1989 standard. The value in final

paragraph (i)(5)(ii) has been revised to

match the 10° F provision in the G–7.1–

1989 standard for Grade D air, with an

equivalent value of 5.56°C added to

comply with a Federal government

requirement (P.L. 100–418 and E.O.

12770) that scientific and technical

measures are expressed as metric units.

Paragraph (d)(2)(ii) of the prior

standard required air compressors to

have a receiver of sufficient capacity to

permit the respirator user to escape from

a hazardous atmosphere in the event of

compressor failure. However, under

paragraph (d)(2) of the final standard,

the only respirators that can now be

used in IDLH atmospheres are either

SCBAs or supplied-air respirators with

an auxiliary self-contained air supply

for escape. Consequently, a requirement

for an air receiver to permit escape from

IDLH atmospheres is no longer needed

in the final rule. Also, the prior

respiratory protection standard, in

paragraph (d)(2)(ii), required

compressors to have alarms to indicate

compressor failure and overheating; this

requirement was part of the same

provision that specified that a receiver

for escape from a contaminated

atmosphere in the event of compressor

failure be available. This alarm

requirement was deleted from the

proposal and is not part of the final

standard. An alarm to indicate

compressor failure or overheating is

unnecessary in non-IDLH atmospheres

since, as OSHA stated in the proposal,

the respirator user can readily exit the

hazardous area if the respirator fails.

The deletion from the final standard

of the prior standard’s requirement for

compressors to be equipped with

receivers if they were to be used in

hazardous atmospheres will clarify an

enforcement issue that has arisen in

connection with ambient air movers.

Ambient air movers have been

developed to provide air to supplied-air

respirators. These units are small

electric compressors that are not oillubricated and have no air receiver.

Such compressors are used in non-IDLH

atmospheres. The use of ambient air

movers has been allowed under an

existing OSHA compliance directive

even though such devices do not have

the air receiver required for air

compressors by the prior respiratory

protection standard. However, the final

standard removes the air receiver

requirement for compressors, and

ambient air movers will therefore be

treated like any other air compressor

used in non-IDLH atmospheres.

Under final paragraph (i)(5)(iii),

compressors must be equipped with

suitable in-line air-purifying sorbent

beds and filters to further assure

breathing air purity. The Associated

Builders and Contractors, Inc. (Ex. 54–

309) recommended that the

corresponding provision in the proposal

be revised to add the requirement that

employers change air-purifying sorbent

bed and filters in accordance with the

manufacturer’s instructions. Also,

clause 10.5.4.2 of the ANSI Z88.2–1992

standard recommends that maintenance

and replacement or refurbishment of the

air-purifying and filter media be

performed periodically by trained

personnel and in accordance with the

manufacturer’s recommendations and

instructions. OSHA agrees with the

Associated Builders and Contractors

that sorbent beds and filters must be

maintained properly, and has added

language to paragraph (i)(5)(iii) that is

similar to that in ANSI Z88.2–1992, and

requires sorbent beds and filters to be

maintained and replaced or refurbished

periodically in accordance with the

manufacturer’s recommendations. The

Associated Builders and Contractors

also recommended that sorbent bed and

filter changes be documented, that such

documentation be retained for one year,

and that it be made available to OSHA

on request. However, OSHA is not

generally requiring that records of

respirator maintenance performed under

this standard be kept and does not

believe such a requirement is necessary

here. Instead, OSHA is requiring in

paragraph (i)(5)(iv) that a tag containing

the most recent date of sorbent bed

replacement or refurbishing, along with

the signature of the person performing

the change, be kept at the compressor.

This tagging requirement is also

consistent with OSHA’s efforts, as

required by the Paperwork Reduction
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1255

Act of 1995, to reduce paperwork to the

extent consistent with employee safety

and health.

Paragraphs (I)(6) and (i)(7) address the

control of carbon monoxide levels in

breathing air. Paragraph (i)(6) requires

that, for compressors that are not oil

lubricated, the CO levels in the

breathing air may not exceed 10ppm.

Paragraph (i)(7) requires monitoring of

CO levels for oil lubricated compressors.

OSHA stated in the NPRM that one

method to prevent contaminated air

from reaching the breathing air supply

was to require carbon monoxide filters

with continuous alarms for all breathing

air compressors. The agency requested

comments on the use of carbon

monoxide alarms, high-temperature

alarms, and shutoff devices in the

workplace (59 FR 58926). A number of

comments were received that addressed

the issue of carbon monoxide monitors

and alarms.

Modern Safety Techniques, Inc.

(MST) (Ex. 54–141) noted that in many

workplaces it may be impossible or cost

prohibitive to relocate the air intake to

an area that would reduce the likelihood

of carbon monoxide entering the system.

In these cases, MST recommended

continuous monitoring as the only

method that would ensure breathing air

quality. MST stated that the use of a

carbon monoxide alarm or measuring

device is necessary to tell whether

carbon monoxide purifiers (e.g.,

Hopcalite filters) are functioning

properly. MST stated, ‘‘Unless

continuous monitoring is being

conducted on the breathing air supply,

‘‘frequent’’ monitoring, or proper

placement of the breathing air supply,

only assures that the requirements are

met at that particular instance in time.’’

[Emphasis in original.] Eugene Satrun,

an industrial hygienist who runs a

respirator program in Illinois (Ex. 54–

261), supported the need for continuous

carbon monoxide monitors, noting that

automatic compressors can be operated

with a vehicle running nearby and may

consequently pull significant levels of

carbon monoxide into the intake.

Several commenters were opposed to

OSHA adopting a requirement for

continuous carbon monoxide

monitoring and alarms (Exs. 54–234,

54–250, 54–408). They stated that the

requirements for sorbent bed filtration,

proper air inlet location, and Grade D

air quality, confirmed by periodic

sampling, would be sufficient to control

the carbon monoxide hazard. Kodak (Ex.

54–265) stated that it has assessed the

purity of compressed air for breathing

use over a period of 18 years at its

plants, collecting and analyzing more

than 1200 samples, and that no

incidents of carbon monoxide

production involving oil-lubricated

compressors have been reported. Carbon

monoxide production, Kodak stated, is

best prevented by adequate procedures,

awareness, and certification. Kodak did

not provide specific procedures for

determining air system compliance, nor

further clarification of what is meant by

awareness or certification. The

Duquesne Light Company (Ex. 54–408)

stated that continuous monitoring was

unnecessary, and that requiring

filtration or purification of the air

supply, proper location of the air intake,

and Grade D air purity should be

sufficient to ensure a safe breathing air

supply. Meridian Oil (Ex. 54–206)

opposed continuous monitors because

these devices can generate false alarms.

Other commenters proposed

alternatives to continuous monitoring.

Niagara Mohawk Power (Ex. 54–177), in

comments opposing carbon monoxide

alarms, stated that carbon monoxide

filters with color-change indicators are

an appropriate method to monitor

carbon monoxide. Monsanto (Ex. 54–

219) stated that OSHA should not

require all compressors to have carbon

monoxide filters and alarms. Monsanto

stated that high-temperature alarms or

automatic compressor shut downs

would only be needed when there was

a reasonable possibility of carbon

monoxide production in the compressor

due to equipment problems. TU Electric

(Ex. 54–250) stated that carbon

monoxide filters or continuous

monitoring alarms should not be

required for all breathing air

compressors, but that regular testing of

breathing air prior to use, and testing in

specific locations on a regular basis

during compressor use, should be

required. This commenter also

recommended against a requirement for

carbon monoxide filters or monitors for

oil-free compressors.

Other commenters (Exs. 54–206, 54–

234, 54–250) supported testing ambient

air near the intake on a regular basis, but

did not recommend a testing frequency.

General guidance for periodic sampling

of air quality for compressors is

specified in Clause 10.5.4.3 and Table 4

of the ANSI Z88.2–1992 standard. The

ANSI procedure was recommended by

several commenters (Exs. 54–234, 54–

250, 54–263, 54–273, 54–363). ANSI

Z88.2–1992 recommends acceptance

testing prior to initial use and

representative sampling at distribution

supply points on a periodic basis to

ensure ‘‘a continued high-quality air

supply.’’ Norfolk Southern (Ex. 54–267)

stated that OSHA should not require the

use of carbon monoxide filters with

compressor-supplied air, and that the

employer should have the option of

using a carbon monoxide detector. This

commenter stated also that installing a

carbon monoxide filter is not reasonable

for those systems that already have a

carbon monoxide detector and hightemperature alarm. St. Lawrence Gas

(Ex. 54–402) commented that carbon

monoxide alarms should not be required

and noted that it has found the use of

carbon monoxide-to-carbon dioxide

converters (with color-change

indicators) sufficient for detecting the

presence of carbon monoxide. ORC (Ex.

54–424) stated that carbon monoxide

alarms or high-temperature alarms are

not needed for all compressors. ORC

recommended that adequate procedures,

awareness, and certification for

installation are the best means to ensure

that contaminated air does not enter the

compressor. This language is similar to

that used by Kodak (Ex. 54–265), and,

like Kodak, ORC (Ex. 54–424) did not

provide any elaboration of the phrase

‘‘adequate procedures, awareness, and

certification for installation.’’

A carbon monoxide monitor with an

alarm can be used to continuously

measure the breathing air and warn

respirator users when carbon monoxide

levels exceed the 10 ppm limit set for

Grade D breathing air. However, these

alarms need to be properly maintained

to function effectively. MST (Ex. 54–

141) stated that the electrochemical type

of sensors used today are specific for

carbon monoxide, are relatively stable

during temperature and humidity

changes, and are accurate enough to

meet the CGA G–7.1–1989

requirements. These sensors have

replaced the older metal oxide sensors

that had problems with false alarms.

However, the electrochemical sensors

must be calibrated periodically (usually

on a monthly basis) to perform

accurately. The Service Employees

International Union (Ex. 54–455) also

recommended that the final standard

address regular replacement of alarm

sensors and filter media.

Carbon monoxide filters with colorchange indicators are used to convert

carbon monoxide in breathing air to

carbon dioxide, which is less likely to

pose a hazard to the respirator user. The

source of the carbon monoxide can be

from contamination of the intake air or

from carbon monoxide generated by the

compressor. However, the color change

in the indicator results from moisture in

the breathing air that is trapped in the

filter element. The color-change

indicator, therefore, does not indicate

the presence of carbon monoxide, but

instead signals only the presence of

moisture, which can render the sorbent

filters ineffective. Consequently, the
1256 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

color-change indicator cannot be used

directly to detect carbon monoxide. In

addition, these carbon monoxide filters,

like carbon monoxide alarms, need

periodic maintenance to ensure their

continued effectiveness.

In summary, strong arguments favor a

requirement for continuous carbon

monoxide monitoring of compressorgenerated breathing air. This is the case

because preventing carbon monoxide

contamination by locating the air intake

for compressors in an area that is free of

carbon monoxide contamination is

difficult in many cases and impossible

in others. Automatic compressors with

poorly located air intakes may operate

when a running vehicle is in the

immediate area, thereby contaminating

the air supply with carbon monoxide

from the vehicle’s exhaust. In addition,

older compressors, which may still be

operational after hundreds, if not

thousands of operating hours, may

allow increased oil blow-by due to

piston ring and cylinder wear, which

increases the possibility of carbon

monoxide contamination.

The most convincing evidence against

a requirement for continuous carbon

monoxide monitoring comes from the

18-year collection of sampling results

taken by Kodak (Ex. 54–265). OSHA

notes, however, that Kodak’s results are

likely to be due to the company’s careful

observance of operating procedures,

such as procedures ensuring the proper

location of air intakes and regular and

thorough maintenance and repair of all

compressors. OSHA notes that Clause

10.5.4.3 of the ANSI Z88.2–1992

standard calls for periodic, rather than

continuous, sampling of breathing air

from the air supply.

The arguments for and against carbon

monoxide alarms are less well defined

than the case for carbon monoxide

monitoring devices. Several commenters

specifically recommended the use of

carbon monoxide alarms whenever

compressed air is being used as

breathing air (Exs. 54–337, 54–428, 54–

455). The AFL–CIO (Ex. 54–428)

recommended the use of carbon

monoxide alarms or monitors on all air

supply systems that service respirators

with Grade D breathing air. Both of

these recommendations would assure an

air supply uncontaminated by carbon

monoxide. The proponents of carbon

monoxide alarms (Exs. 54–141, 54–261,

54–337, 54–428, 54–455) state that they

are needed to alert personnel that

equipment is malfunctioning; the Exxon

Company (Ex. 54–266) stated that

gasoline- and diesel-powered

compressors should be required to have

carbon monoxide alarms to detect

exhaust gases that enter the air supply,

as well as compressor failure and hightemperature alarms; other commenters

(Exs. 54–337, 54–428) would require the

use of carbon monoxide alarms to

prevent accidental carbon monoxide

contamination whenever compressed air

is being used as breathing air.

The opponents (Exs. 54–177, 54–206,

54–219, 54–234, 54–250, 54–265, 54–

402) of carbon monoxide alarms cite the

availability of alternate equipment and

procedures that they claim are as

effective as alarms in protecting the

purity of breathing air. Examples of

these alternatives are filters with colorchange indicators, carbon monoxide-tocarbon dioxide converters, oil-free

compressors, proper air intake

placement, certification of air

compressor systems, and periodic

monitoring (Exs. 54–177, 54–206, 54–

219, 54–250, 54–265, 54–330, 54–402,

54–408, 54–424).

OSHA believes that it is essential for

the employer to ensure that excessive

carbon monoxide is not in the

compressed breathing air supplied to

respirators. Final paragraphs (i)(6) and

(i)(7), therefore, require that the

employer prevent carbon monoxide

levels in the breathing air from

exceeding 10 ppm. For compressors that

are not oil-lubricated, this requirement

can be met by several different methods,

including the use of continuous carbon

monoxide alarms, carbon monoxide

filters, proper air intake location in an

area free of contaminants, frequent

monitoring of air quality, or the use of

high-temperature alarms and automatic

shutoff devices, as appropriate. No

single method will be appropriate in all

situations, and several methods may

need to be combined, e.g., the use of

carbon monoxide alarms with carbon

monoxide filters where conditions are

such that a reliable carbon monoxidefree area for compressor air intakes

cannot be found. As the comments to

the record show, there was no

agreement on the most appropriate

method for ensuring that carbon

monoxide would not contaminate the

breathing air coming from compressors.

OSHA has decided that a performancebased requirement ensuring that carbon

monoxide does not contaminate

breathing air will give employers

flexibility in selecting the method(s)

most appropriate for conditions in their

workplace.

Oil-lubricated compressors can

produce carbon monoxide if the oil

enters the combustion chamber and is

ignited. This can be a particularly severe

problem in older compressors whose

piston rings and cylinders are worn.

Final paragraph (i)(7) requires that such

compressors have a high-temperature or

carbon monoxide alarm, or both. If only

a high-temperature alarm is used, the air

from the oil-lubricated compressor must

be monitored at intervals sufficient to

prevent carbon monoxide in the

breathing air from exceeding 10 ppm.

The latter requirement ensures that

carbon monoxide that enters a poorly

located compressor air intake, as well as

carbon monoxide generated by the

compressor itself, is detected.

Final paragraph (i)(7) is similar to a

provision in the previous standard. In

the NPRM, OSHA proposed to delete

the requirement from the previous

respirator standard that oil-lubricated

compressors be equipped with carbon

monoxide alarms and high-temperature

shutoff devices. However, a number of

commenters (Exs. 54–144, 54–219, 54–

266) stated that precautions against

excessive carbon monoxide were

needed when oil-lubricated compressors

were used. Modern Safety Techniques

(Ex. 54–144) stated that oil-lubricated

compressors used by industry to supply

breathing air often have hundreds of

hours of use, allowing greater oil blowby and therefore greater potential for

carbon monoxide production, was

reported in the Distler study. That study

found that properly functioning air

compressors are unlikely to reach

temperatures at which carbon monoxide

production occurs. Exxon (Ex. 54–266)

encouraged OSHA to include a

requirement for in-line carbon

monoxide alarms for diesel- or gasolinepowered compressors, since its

experience indicates that the use of

these compressors increases the risk of

carbon monoxide contamination from

the compressor’s exhaust. Monsanto

(Ex. 54–219) stated that hightemperature alarms or automatic

compressor shutoffs would be needed

when there was a reasonable possibility

of carbon monoxide production in the

compressor due to equipment problems.

The Service Employees International

Union (Ex. 54–455) argued that the

requirements specifying Grade D

breathing air purity and location of the

compressor air intake in an

uncontaminated atmosphere were not

sufficient to ensure that carbon

monoxide is not entrained in the

system.

An incident of carbon monoxide

production by an oil-lubricated

compressor was described in a MSHA

Accident Investigation Report issued in

January 1985 (Ex. 38–12). An oil-cooled,

diesel-powered, two-stage, rotary air

compressor overheated during a

sandblasting operation at a limestone

quarry. The air compressor thermobypass valve, which should have

directed the oil through a cooling
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1257

radiator once the oil had reached a

temperature of 185°F, failed, which

allowed the temperature of the cooling

oil to rise above its flashpoint of 420°F.

The oil ignited, producing carbon

monoxide. The compressor was

equipped with a high-temperature

shutoff switch set for 235°F, but it had

been disconnected for at least 30 days

prior to the incident. The compressor

was not equipped with a carbon

monoxide filter or alarm. The

sandblaster collapsed from carbon

monoxide poisoning. Monsanto (Ex. 54–

219) stated that this incident resulted

from a failure to follow the provision in

the previous standard requiring that oillubricated compressors have a

functional high-temperature or carbon

monoxide alarm, or both. OSHA

believes that this incident, as well as the

comments described above, supports

carrying the previous standard’s

requirement forward in the final rule.

Final paragraph (i)(8) requires that air

line couplings be incompatible with

outlets for non-respirable worksite air or

other gas systems to prevent the

inadvertent provision of nonrespirable

gases to airline respirators. Breathing air

couplings, therefore, are to be made

incompatible with outlets from

nonrespirable plant air and other gas

systems. This requirement is similar to

the provision in paragraph (d)(3) of the

previous respiratory protection standard

and proposed paragraph (i)(5) of the

NPRM. Martin Marietta (Ex. 54–410)

stated that there have been documented

cases in which cross-connections have

introduced hazardous contaminants into

breathing air lines. To avoid this

problem, Martin Marietta recommended

that OSHA add a provision to the final

standard that prohibits connecting

breathing air lines to any nonrespirable

gas source or process. Consistent with

this recommendation, OSHA has added

a sentence to paragraph (i)(8) requiring

that no asphyxiating substance be

introduced into breathing air lines. This

requirement will cover not only the

contamination of the breathing air

system from cross-connections, but will

also cover other potential contaminating

conditions, e.g., using nitrogen to blow

out worksite air lines where the

worksite air source is also used for

breathing air.

The final standard also requires that

the employer prevent utility oxygen,

i.e., oxygen supplied to meet other

manufacturing needs, from entering the

respirator air supply system. As

discussed above, the standard permits

oxygen to be used in respirators

designed for oxygen service. The final

standard prohibits the introduction of

utility oxygen into breathing air systems

that supply respirators that are not

designed for oxygen service; this

provision is needed to prevent the fires

and explosions that could result if highpressure oxygen comes into contact

with oil or grease that has been

introduced to the respirator or the air

lines during compressed air operations.

Final rule paragraph (i)(9) requires

employers to use breathing gas

containers marked in accordance with

the NIOSH respirator certification

standard at 42 CFR part 84. This

requirement differs from proposed

paragraph (i)(6), which listed several

additional standards for breathing gas

containers. These additional standards

have been incorporated into 42 CFR part

84, making reference to them in the final

rule unnecessary.

Paragraph (j)—Identification of Filters,

Cartridges, and Canisters

The final rule provides that the

employer only use filter cartridges and

canisters that are labeled and color

coded with the NIOSH approval label

and that the label not be removed or

made illegible. This is similar to the

parallel requirement in the proposal,

which was supported by commenters

(Exs. 54–361, 54–428, 54–455). OSHA

has modified the proposed language in

certain respects to add compliance

flexibility while retaining the original

objective, i.e., assurance that these

elements meet NIOSH’s stringent

requirements. These comments and

modifications are discussed below.

OSHA proposed to eliminate from the

previous respiratory protection standard

the language in paragraphs (g)(1) to

(g)(6), which described labeling

requirements, and Table I–1, which

listed color codes assigned to canisters

and cartridges. These requirements were

adopted from the original national

consensus standard (i.e., ANSI K13.1,

‘‘Standard for Identification of AirPurifying Respirator Canisters and

Cartridges’’) adopted by OSHA in 1971.

In place of these requirements, proposed

paragraph (j)(1) would have required

employers to ensure that all filters,

cartridges, and canisters bear a NIOSH

approval label before being placed into

service.

Proposed paragraph (j)(2) specified

that the label not be removed, obscured,

or defaced while the filter, cartridge, or

canister was in service to ensure that the

label provided information to the

employee about the protection being

afforded by the respirator. In the final

standard, OSHA has combined

proposed paragraphs (j)(1) and (j)(2) into

a single paragraph (j). The changes from

the previous standard recognize that

employers who use respirators should

be able to rely on labeling and color

coding by respirator manufacturers for

assurance that the respirators meet

NIOSH requirements.

This position is consistent with that

taken by many commenters, who noted

that the labeling and color coding of

filters are the responsibility of the

respirator manufacturer (Exs. 54–208,

54–218, 54–219, 54–278, 54–289) and

are required by NIOSH for certification.

OSHA agrees that color coding and the

attachment of NIOSH approval labels to

respirators are the responsibility of the

manufacturer. However, it is still the

employer’s responsibility to use only

components bearing a NIOSH approval

label, and to ensure that the NIOSH

approval labels are not removed from

the filters, cartridges, and canisters that

are used in the workplace and remain

legible.

The NIOSH label serves several

purposes. It ensures selection of

appropriate filters for the contaminants

encountered in the workplace and

permits the employee using the

respirator to check and confirm that the

respirator has the appropriate filters

before the respirator is used. David Lee,

a CIH, CSP, and respirator consultant

(Ex. 54–304), commented that, once a

filter selection is made and the

respirator is donned, the label becomes

meaningless. However, the employee is

not the only one who uses the color

coding and label. Color coding and

labeling also allow fellow employees,

supervisors, and the respirator program

administrator to readily determine that

the appropriate filters are being used by

the employee. Cartridges that are

appropriate for one operation may be

inappropriate for another, and color

coding and labeling allow respirator

users with inappropriate filters to be

identified in the workplace and

potential respiratory hazards to be

avoided.

Proposed paragraph (j)(2) required

that the NIOSH approval label not be

‘‘removed, obscured or defaced’’ while

respirators are being used. 3M (Ex. 54–

218) and Monsanto (Ex. 54–219) urged

OSHA to add the word ‘‘intentionally’’

before ‘‘removed, obscured or defaced,’’

since they believe that an employer

would be in violation of this provision

if, for example, a label is covered with

paint overspray during use. Monsanto

also stated that some OSHA substancespecific standards require that cartridges

be dated by the employee to indicate

when they were first put into service

and that some employers could use this

dating method to control cartridge use

even when not required by OSHA.

Accordingly, Monsanto urged OSHA to

add the phrase ‘‘except if it is to record
1258 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

initial use information’’ to paragraph

(j)(2) to clarify that adding a date to the

NIOSH label is allowed and will not be

regarded as defacing the label. David

Lee (Ex. 54–304) was concerned that

dirt, dust, and debris can easily obscure

the label once the respirator is in use

and that employees would be required

by the proposed provision to leave the

area to clean the label to make it legible.

Dow (Ex. 54–278) stated that, because of

the small size of the label on some

cartridges, the employer cannot date the

cartridges without obscuring some of

the information on the label. To resolve

this problem, Dow suggested that the

words ‘‘pertinent information’’ be added

before ‘‘obscured.’’

OSHA has not added the term

‘‘intentional’’ to final paragraph (j)

because it would be difficult, if not

impossible, to determine if the removal

or obscuring of a NIOSH label was

accidental or intentional. Also, the final

provision does not include an

exemption for documenting the initial

use date on cartridge and canister labels,

since OSHA already permits this

practice. OSHA’s experience indicates

that the initial use date can easily be

added to a filter, cartridge, or canister

without obscuring the label, and this

procedure has not proven to be a

problem in the substance-specific

standards that require such dating. The

term ‘‘pertinent information’’ has not

been included in final paragraph (j)

because OSHA believes that all of the

information on the NIOSH approval

label is pertinent. The degree of

cleanliness required of the label while

the respirator is in service should not be

an issue because the label only needs to

be legible and reasonably clean to

provide the required information. Any

dust, dirt, paint overspray, or other

substance that completely obscures the

label would also affect respirator

cleanliness and the service life of the

filter, resulting in replacement of the

filter with new filters that have

unobscured labels, as required by

paragraph (g).

In summary, final paragraph (j)

combines into a single provision the

proposed requirements that employers

ensure that the manufacturer’s NIOSH

approval label is on the cartridge, filter,

or canister, and that employers maintain

the labels in legible condition while the

cartridge, filter, or canister is in service.

As with the proposed paragraphs, this

provision is a performance-based

requirement that permits employers to

adopt whatever procedures are

appropriate to ensure that the label

remains on the filter and is not

removed, defaced, or obscured during

respirator use.

Paragraph (k)—Training and

Information

Paragraphs (k)(1)–(3) of the final

standard require employers to provide

effective training for employees required

by the employer to wear respirators.

Employees must be trained sufficiently

to be able to demonstrate a knowledge

of why the respirator is necessary; how

improper fit, usage, or maintenance can

compromise the protective effect of the

respirator; the limitations and

capabilities of the selected respirator;

how to deal with emergency situations

involving the use of respirators or with

respirator malfunction; how to inspect,

don and remove, and check the seal of

the respirator; procedures for

maintenance and storage of the

respirator; the medical symptoms and

signs that may limit or prevent the

effective use of respirators; and the

general requirements of this standard.

Paragraph (k)(4) allows for the

‘‘portability’’ of previous respirator

training, and paragraph (k)(5) specifies

the requirement for at least annual

retraining. Also, as discussed earlier

under the Summary and Explanation for

paragraph (c), Respiratory Protection

Program, final paragraph (k)(6) requires

employers to provide the basic advisory

information presented in Appendix D of

this section to employees who

voluntarily use respirators in their

workplace.

The final standard requires that

training be understandable and be given

to the employee prior to using a

respirator in the workplace, and

annually thereafter. Additionally, if the

employer has reason to believe that any

employee who has already been trained

does not have sufficient understanding

and skill to use the respirator, the

employer must retrain the employee in

those areas in which his or her

knowledge or skill is deficient.

Retraining is also required when

changes in the workplace or in the type

of respirator used render previous

training obsolete.

Section 1910.134(e)(5) of the previous

standard required training in the

selection, use, and maintenance of

respirators and required respirator

wearers to be provided an opportunity

to handle the respirator, have it fitted

properly, test its facepiece seal, and

wear it in normal air for a familiarity

period. The final training paragraph

retains many of these provisions.

However, the format of the final training

provisions is different, and specific

provisions for annual training and

retraining are included in the final

standard. Although the previous

standard’s requirement for a familiarity

period has not specifically been

retained, the final standard requires the

respirator wearer to be trained

sufficiently to demonstrate the ability to

use the respirator properly, which may

or may not necessitate wearing the

respirator in normal air ‘‘for a long

familiarity period.’’

The record shows widespread

agreement that employee training is a

critical part of a successful respiratory

protection program and is essential for

correct respirator use (Exs. 15–13, 15–

18, 15–19, 15–22, 15–30, 15–33, 15–41,

15–45, 15–50, 15–53, 15–54, 15–67, 15–

79, 54–5, 54–68, 54–91, 54–92, 54–165,

54–172, 54–208, 54–219, 54–278, 54–

361, 54–387, 54–428, 54–455, Tr. 186,

387, 595, 1011, 1063, 1083, 1103, 1226).

For example, James Johnson of the

Lawrence Livermore National

Laboratory testified:

The training element of the respiratory

protection program is one of the most

important elements to assure the respirator is

properly used and is performing as intended

* * *. This is the only time that the worker

has a chance to interact with a trained

professional who can properly instruct that

person on the correct use of the respirator,

the employee can see what is right, what

doesn’t work, and can understand this item

that is given to him to wear throughout a year

to help protect his health * * * (Tr. 186)

Dan Faulkner of the United Steelworkers of

America concurred, commenting that:

Training must be seen as a critical

component of respiratory protection. This is

an area that is grossly ignored under the

current regulation * * *. The very first step

in the education process must be to empower

workers to identify the hazardous substances

involved and at what levels they are exposed.

In order for the workers to have confidence

that his/her respirator is providing the

necessary protection from the hostile work

environment they must have a thorough

knowledge of this entire process. Once this

is understood, the worker can make an

informed decision on what type of respirator

to wear. (Tr. 1062)

ASARCO, Inc. (ASARCO) agrees about

the importance of training and reports

that its company Respiratory Protection

Program Manual states: ‘‘For the safe

use of any respirator, it is essential that

the user be properly instructed in the

respirator’s purpose, selection, fitting,

use, and limitations’ (Ex. 163).

OSHA agrees with the many

commenters who urged OSHA to

mandate a program that is performance

oriented and can be presented

informally (Exs. 15–13, 15–18, 15–22,

15–30, 15–41, 15–47, 15–62, 15–73, 15–

75, 54–213, 54–265, 54–275, 54–455).

The final standard does not specify how

the training is to be performed nor the

format to be used by the employer. As

suggested by commenters (Ex. 15–53,

Tr. 837, Tr. 1087), the employer can use
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1259

whatever training method is effective for

the particular worksite, provided that

the method addresses the required

topics. Employers can use prepared

materials such as audio-visual and slide

presentations, formal classroom

instruction, informal discussions during

safety meetings, training programs

developed or conducted by unions or

outside sources such as respirator

manufacturers, or a combination of

these methods.

As in the proposal, several categories

of training information must be

addressed in the final rule. The final

provisions have been simplified since

the proposal, but the information to be

covered is essentially the same as that

proposed.

Paragraph (k)(1) requires the employer

to ensure that before the employee uses

the respirator in the workplace, the

employee demonstrates that he/she has

learned the information communicated

under the training program. The

employer can comply with this

provision by reviewing with the

employee, either in writing or orally, the

informational part of the training

program and by reviewing the

employee’s hands-on use of respirators.

OSHA’s personal protective

equipment standard (§ 1910.132(f)(2))

also requires that employees

demonstrate effectiveness in using PPE

before workplace use. When that

standard was adopted in 1994, OSHA

stated that ‘‘in order for training to be

successful, clear and measurable

objectives must be set, and employees

must demonstrate that the training

objectives have been reached by

showing that they understand the

information provided and that they can

use the PPE properly’’ (59 FR 16339).

This reasoning applies equally to

respiratory protection. In the NPRM for

the respiratory protection standard

(proposed paragraph (k)(1)(iii)), OSHA

proposed a similar requirement, which

stated that the training itself was to

include ‘‘sufficient practice to enable

the employee to become * * * effective

in performing tasks [relating to

inspection, donning and removal,

checking the fit and seals, and in

wearing the respirator.]’’

The final standard’s requirement that

employees ‘‘demonstrate’’ competence

in using respiratory equipment is

supported by the recommendation of

commenters that the PPE standard’s

similar requirement replace the less

direct provision in the respiratory

protection proposal (Exs. 54–213, 54–

319). OSHA’s enforcement of the PPE

standard has reinforced the Agency’s

belief that training effectiveness must be

evaluated by demonstrating how well

employees use equipment on-the-job.

OSHA believes that adopting a

provision in the respirator standard that

is worded similarly to the

corresponding requirement in the PPE

standard will promote compliance with

both standards and uniformity of

interpretations and enforcement actions.

Moreover, measuring the adequacy of

training by evaluating the employee’s

knowledge gained from the training is

consistent with the performance

orientation of the final standard and

with the absence of specific hourly

training requirements in the final

standard.

The first category of information to be

included in the training program,

specified in final paragraph (k)(1)(i), is

a discussion of why the use of the

respirator is necessary. Proposed

paragraph (k)(1)(i) specifically set forth

that this discussion was to include

information on the nature, extent, and

effects of the respiratory hazards to

which the employee may be exposed

while using the respirator. The language

of final paragraph (k)(1)(i) has been

simplified; OSHA believes that training

in why the respirator is necessary will

include information on the nature,

extent, and effects of the respiratory

hazards. For example, such training

would address the identification of the

hazardous chemicals involved, the

extent of employee exposures to those

chemicals, and the potential health

effects of such exposure. Much of this

information will be available on the

Material Safety Data Sheets that

chemical manufacturers provide to

employers under the Hazard

Communication standard (29 CFR

1910.1200). Employee training on the

health effects of hazardous chemicals is

also required under the Hazard

Communication standard, and the same

training could help satisfy this

respirator training requirement. Many

commenters agreed that hazard

information is an essential element of

training (Exs. 15–10, 15–14, 15–18, 15–

19, 15–27A, 15–41, 15–46, 15–53, 15–

62, 15–73, 54–5, 54–68, 54–91, 54–165,

54–172, 54–208, 54–278, 54–361, 54–

428, 54–455).

Information regarding the

consequences of improper fit, usage or

maintenance on respirator effectiveness

must also be provided to employees

under final paragraph (k)(1)(i). Improper

attention to any of these program

elements would obviously defeat the

effectiveness of the respirator.

Employees must understand that proper

fit, usage and maintenance of respirators

is critical to ensure that they can

perform their protective function.

Under final paragraph (k)(1)(ii),

employers are to explain the limitations

and capabilities of the respirator

selected for employee use. A discussion

of the limitations and capabilities of the

respirator must address how the

respirator operates. This training would

include, for example, an explanation of

how the respirator provides protection

by either filtering the air, absorbing the

vapor or gas, or providing clean air from

an uncontaminated source. Where

appropriate, it also should include

limitations on the use of the equipment,

such as prohibitions against using an

air-purifying respirator in IDLH

atmospheres and an explanation of why

such a respirator should not be used in

such situations.

Paragraph (k)(1)(iii) requires that

employees be provided with

information on respirator use in

emergency situations, including those in

which the respirator malfunctions. This

training requirement was included in

proposed paragraph (k)(1)(v).

Respirators malfunction on occasion,

work routines change, and emergency

situations occur that require a different

respirator. The training program must

discuss these possibilities and the

procedures the employer has

established to deal with them.

Commenters concurred that

comprehensive training is necessary

where respirators are to be used in IDLH

situations, including oxygen-deficient

atmospheres, such as those that occur in

firefighting, rescue operations and

confined area entry (Exs. 15–18, 15–19,

15–26, 15–31, 15–33, 15–37, 15–41, 15–

48, 15–50, 15–54, 15–55, 15–56, 15–59,

15–70).

The employee should be able to

thoroughly understand the operation of

the respirator as a result of this training

and demonstrate the ability to properly

use the respirator selected. Numerous

commenters supported the elements in

the training program provided for under

final paragraphs (k)(1) (ii) and (iii) (Exs.

61–3, 15–14, 15–18, 15–27A, 15–41, 15–

46, 15–53, 15–62, 15–73, 54–5, 54–68,

54–91, 54–172, 54–208, 54–361, 54–428,

54–455). For example, Michael P.

Rehfeld, Safety Officer, Westminster

Fire Department, stated that:

In section (k) of the NPRM dealing with

training, I strongly believe OSHA should put

the strongest emphasis. It has been my

experience that the stronger the employer

training program the less likely that an

employee would become injured or dies from

a respiratory protection failure. OSHA has

historically put a strong emphasis on training

(1910.120, 1910.1200, 1910.138, 1910.146).

The same emphasis should appear in this

rule (Ex. 54–68).
1260 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

Final paragraph (k)(1)(iv) requires the

employer to provide specific instruction

on how respirators are inspected,

donned, removed, positive/negative

pressure checked, and worn. Although

the employer is required to ensure that

respirator inspections are performed,

employees using the equipment may

frequently be responsible for inspecting

the respirators assigned to them. In this

case it is necessary that respirator users

have this process explained and

demonstrated to them so that they are

capable of recognizing any problems

that may diminish the protective

capability of the respirator. The training

must include the steps employees are to

follow if they discover any problems

during inspection, such as to whom

problems should be reported and where

replacement equipment can be obtained

if needed. If, however, the employer

routinely has extensive inspections

done by separate personnel, individual

respirator wearers are not required to be

trained in how to perform full

inspections. Training only in those parts

of the inspection process that may be

their responsibility would be sufficient.

The training under this paragraph

must also include the procedures for

donning and removing the respirator,

checking the fit and seals, and using the

respirator. Respirator fit in the

workplace must be as close as possible

to the fit obtained during fit testing;

therefore, employees must know how to

follow procedures that will improve fit

in the workplace. The fit testing

procedures can also help in training

employees. For example, employers can

use quantitative fit testing procedures to

demonstrate to employees the dramatic

improvement in measured fit when the

respirator is adjusted properly (See the

discussion above of paragraph (f) and

Ex. 15–44, Tr. 1083).

Final paragraph (k)(1)(iv) requires

training in how to check the respirator

seal. Appendix B–1 describes methods

for checking the seal of positive and

negative pressure facepieces. Employees

must be trained in the methods set forth

in Appendix B–1 or in alternative

methods that are equally effective. The

training requirements set forth in

paragraph (k)(1)(iv) were widely

supported in the record (Exs. 15–10, 15–

14, 15–22, 15–27A, 15–41, 15–46, 15–

50, 15–62, 15–73, 54–5, 54–68, 54–91,

54–165, 54–172, 54–208, 54–219, 54–

278, 54–361, 54–428, 54–455).

Final paragraph (k)(1)(v), like

proposed paragraph (k)(1)(iv), requires

the employer to explain the procedures

for maintenance and storage of

respirators. The extent of training

required under this provision may vary

according to workplace conditions. In

some cases, where employees are

responsible for performing some or all

respirator maintenance and for storing

respirators while not in use, detailed

training in maintenance and storage

procedures may be necessary. In other

facilities where specific personnel or

central repair facilities are assigned to

perform these activities, employees may

need only to be informed of the

maintenance and storage procedures

without having to learn significant

technical maintenance information. The

importance of providing some

knowledge to all employees regarding

maintenance and storage of respirators

was recognized by a number of

commenters. Those commenters stated

that employees must be able to identify

respirator deficiencies that can result

from improper maintenance and storage

of respirators so that they will not use

improperly functioning respirators (Exs.

61–3, 61–8, 15–10, 15–14, 15–27A, 15–

41, 15–46, 15–50, 15–62, Tr. 1063).

Final paragraph (k)(1)(vi) requires that

employees be instructed in ways to

recognize the medical signs and

symptoms that may limit or prevent the

effective use of respirators. This

provision was not included in the

proposed standard. However, the

Agency agrees with the AFL–CIO (Ex.

54–428) that employee knowledge of

this information is important to ensure

implementation of a successful

respirator program. An employee’s

knowledge of the medical problems that

may preclude the employee from using

some types of respirators or from

wearing a respirator under certain

workplace conditions helps assure that

the employee receives the protection

intended by the standard. Examples of

medical conditions and signs and

symptoms that may affect an employee’s

ability to use a respirator are provided

in mandatory Appendix C of the final

standard. Training in these signs and

symptoms need not be medically

sophisticated or burdensome.

Employees must be provided only with

medical information sufficient for them

to recognize the signs or symptoms of

medical conditions (e.g., shortness of

breath, dizziness) that may affect their

use of respirators. This information will

also enable employees to understand the

purpose of the medical assessment

procedures required under paragraph (e)

of the final standard, will improve the

ability of employees to recognize and

report medical signs and symptoms, and

will give them the knowledge they need

to initiate the follow-up medical

evaluations required under paragraph

(e) of this section, if necessary.

Final paragraph (k)(1)(vii) requires the

employer to inform employees of the

general requirements of this section.

OSHA agrees with Organization

Resources Counselors (Ex. 54–424) that

‘‘general requirements’’ better describes

the substantive purpose of this

provision than did the word ‘‘contents,’’

which was used in proposed paragraph

(k)(1)(vi). OSHA believes it is necessary

to ensure that employees know, in

general, the employer’s obligations

under the standard with respect to

employee protection. This discussion

need not focus on the details of the

standard’s provisions but could, for

example, simply inform employees that

employers are obligated to develop a

written program, properly select

respirators, evaluate respirator use,

correct deficiencies in respirator use,

conduct medical evaluations, provide

for the maintenance, storage, and

cleaning of respirators, and retain and

provide access to specific records.

Proposed paragraph (k)(1)(vi) would

have required that employees be

provided with information on the

written respiratory protection program,

as well as the location and availability

of the written program and the standard.

These elements are omitted from final

paragraph (k)(1)(vii) because they are

addressed in other provisions of the

final standard. For example, employee

access to the standard and written

program is required under final

paragraph (m)(4), and employee

knowledge about the written respirator

program will be imparted to employees

under the training required by final

paragraph (k)(1), which specifies the

elements to be included in the written

respirator program.

All of the training elements are

important. They are presented in

performance language to give the

employer flexibility to adapt the

training to specific workplace

conditions and to the respirators used.

Unless the training information is

presented in a way that employees can

understand, the training will not be

effective. Therefore, final paragraph

(k)(2) requires that training be

conducted in a way that is

understandable to employees.

Employers should develop training

programs based upon their employees’

educational level and language

background. This will ensure that all

employees will receive training that will

enable them to maximize the

effectiveness of the respirators they use.

Inclusion of a provision addressing

training comprehension was supported

in the record (Tr. 166) and is consistent

with similar requirements in other

recent OSHA rulemakings (Cadmium,

29 CFR 1910.1027; Bloodborne
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1261

pathogens, 29 CFR 1910.1030;

Formaldehyde, 29 CFR 1910.1048).

Final paragraph (k)(3) requires the

employer to provide training before the

employee uses a respirator in the

workplace. This provision was included

under proposed paragraph (k)(2) and

was widely supported by rulemaking

participants (Tr. 1011, Tr. 1986; Exs.

54–91, 54–165, 54–196, 54–234, 54–267,

54–278, 54–298, 54–319, 54–334, 54–

361, 54–387, 54–428, 54–455). No

comments opposing this requirement

were received.

Final paragraph (k)(4) provides that

an employer who can demonstrate that

a new employee has received training

within the last 12 months that

addressed the elements specified in

paragraph (k)(1)(i) through (vii) is not

required to repeat such training

provided that, as required by paragraph

(k)(1), the employee can demonstrate

knowledge of the element(s). Employers

availing themselves of this provision

must, however, provide subsequent

training no later than 12 months from

the date of the previous training, as

required by final paragraph (k)(4).

An employee who has been trained in

the use of respirators who moves to

another job that involves the use of

respirators may not need to take all of

the initial training prescribed in

paragraph (k)(4). Prior training in the

topics required by the standard may

remain relevant in the new work setting.

Thus, OSHA is permitting limited

‘‘portability’’ of training, as noted in the

standard. Training in the elements listed

in paragraph (k)(1) that has been

provided in the past 12 months by a

previous employer may be taken into

account by the new employer when

evaluating the training needs of that

new employee.

The employer must demonstrate that

the employee has received the prior

training and retained the necessary

knowledge before the prior training can

be accepted as meeting the requirements

of paragraph (k). Discussions with the

employee and with the previous

employer may be used to determine

whether the previous training has been

sufficient to enable the employee to

wear, use, and care for the respirator

successfully. If the employer cannot

demonstrate that the new employee has

been trained in the required elements of

the program, and understands these

elements, the new employer is obligated

to train the employee. In cases where

training in some elements is lacking or

inadequate, the employer is required by

paragraph (k)(4) to provide training in

those elements.

Final paragraph (k)(5) requires

retraining annually and when certain

situations occur. The requirement for

annual training was strongly supported

by management, labor, and other

rulemaking participants as being

necessary to ensure the continuing

effectiveness of the respirator program

(Exs. 15–10, 15–18, 15–19, 15–20, 15–

37, 15–44, 15–47, 15–48, 15–50, 15–54,

15–55, 15–71, 54–91, 54–157, 54–165,

54–173, 54–208, 54–222, 54–245, 54–

265, 54–292, 54–319, 54–332, 54–361,

54–363, 54–387, 54–424, 54–427, 54–

428, 54–442, 54–455, 122, 166; Tr. 187,

443, 547, 614, 1011, 1022, 1226, 1768).

For example, the Railway Labor

Executive Association testified:

The training requirements as proposed

should be mandated on an annual basis . . .

Such a training schedule will assure

continuous familiarization with the

equipment and will serve to negate the

inevitable effects of complacency on the part

of both the employer and the employee. (Tr.

443)

Exxon stated that ‘‘Annual training is

good so the employee will feel

comfortable with the respirator they will

be using in the future’’ (Tr. 547). James

Johnson of Lawrence Livermore

National Laboratory testified that annual

training is ‘‘. . . necessary to ensure a

reasonable amount of recall and

performance . . . ‘‘ (Tr. 187). Eastman

Chemical Company (Ex. 54–245)

commented that ‘‘Eastman supports

[the] annual training requirement . . .

our Company believes this is necessary

to adequately train employees.’’

ASARCO and U.S. Steel require that

their employees who wear respirators

undergo annual training, and ASARCO

states in its Respiratory Protection

Manual that:

All respirator wearing employees shall be

given annual training on routine respirator

use. . . . Applicable individuals will also be

thoroughly instructed and trained annually

in the use of respiratory protection and

necessary procedures for non-routine or

emergency situations. (Ex. 163)

The Respirator Protection Program

training manual for U.S. Steel,

submitted by AISI, requires that: ‘‘Each

respirator wearer should be retrained at

least annually. Where necessary, more

frequent training should be performed.

The required use of respirators should

be specified in routine training aids

such as Safe Job Procedures.’’ (Ex. 142)

A number of commenters

recommended that training should be

required less frequently than annually

(Exs. 15–41, 54–316, 54–324) or should

be required only in response to a change

in the respirator program (Exs. 54–168,

54–172, 54–178, 54–187, 54–213, 54–

234, 54–267, 54–273, 54–275, 54–278,

54–297, 54–307, 54–316, 54–324, 54–

334, 54–352, 54–389, 54–408, 54–434).

Other commenters recommended more

frequent (than annual) training for

employees required to use SCBAs, or for

employees who may be required to use

respirators in emergency situations (Exs.

54–210, 54–290, 54–363, 54–410, 54–

424).

OSHA believes that annual training is

necessary and appropriate to ensure that

employees know about the respiratory

protection program and that they

cooperate and actively participate in the

program. Further, as specifically noted

by several witnesses at the hearing,

annual training is necessary so that

employees will be confident when using

respirators (Tr. 547, Tr. 595). Annual

training will also eliminate

complacency on the part of both the

employer and employees with respect to

respirator use (Tr. 443), and annual

training will ensure a reasonable

amount of recall and performance on

the part of the respirator user (Tr. 187).

In addition, periodic training provides

an opportunity for the employee to

interact with trained professionals who

can provide instruction and

understanding in the correct use of the

respirator (Tr. 186), which will serve to

overcome employee resistance to proper

respirator use (Tr. 1021). OSHA also

believes that employee interaction with

respirator instructors on at least an

annual basis will reinforce employee

knowledge about the correct use of

respirators and other pertinent elements

of the respiratory protection program.

Commenters requesting that training

be required less frequently than

annually provided no substantive data

demonstrating that training every two

years, for example, would be sufficient

for respirator users to retain information

critical to the successful use of

respirators on a continuing basis (Exs.

54–316, 54–324). Less frequent periodic

training would tend to diminish

employee attention to proper respirator

use and may result in a long period of

poor respirator practice before problems

are identified and corrected. OSHA

notes that both the ANSI Z88.2–1980

and Z88.2–1992 respiratory protection

standards provide for annual retraining.

Further, annual periodic training of

workers with respect to the use of

respirators is required in other OSHA

standards (i.e., 29 CFR 1910.1001,

Asbestos; 29 CFR 1910.1017, Vinyl

chloride; 29 CFR 1910.1018, Arsenic; 29

CFR 1910.1025, Lead; 29 CFR

1910.1029, Coke oven emissions; 29

CFR 1910.1043, Cotton dust; 29 CFR

1910.1044, Dibromochloropropane

(DBCP); 29 CFR 1910.1045,

Acrylonitrile; 29 CFR 1910.1047,

Ethylene oxide; and 29 CFR 1910.1048,

Formaldehyde). In addition, OSHA’s
1262 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

compliance experience has

demonstrated that inadequate respirator

training is a common problem (Ex. 33–

5), and is often associated with

respirator program deficiencies that

could lead to employee exposures to

workplace contaminants. Adherence to

annual training will minimize respirator

misuse. Thus, the Agency’s experience

under other rulemakings, as well as its

compliance experience with the

previous respiratory protection

standard, serve, in part, as the basis for

concluding that annual training for

respirator users under this final

standard is reasonable and appropriate.

As noted above, a number of

commenters argued that training should

be required only to inform employees

about changes in the respirator program.

This view suggests that regular, periodic

training in the use of respirators is not

necessary to ensure the success of a

respirator program. However, as

discussed above, evidence provided by

management, labor, and other

participants in this and other

rulemaking records demonstrates the

importance of reinforcing an employee’s

knowledge with respect to the use of

respirators on a regular basis to ensure

the successful use of respirators.

Accordingly, the final standard in

paragraph (k)(5) includes the

requirement for annual training for

respirator users. This provision ensures

the successful implementation of the

respiratory protection program by

keeping employees thoroughly and

accurately informed on a regular basis

regarding the current status of the

program.

Several commenters recommended

that training be provided more

frequently than annually to users of

SCBAs and to employees who are

required to use respirators during

emergency situations (Exs. 54–210, 54–

290, 54–363, 54–410, 54–424). OSHA

agrees that retraining more frequently

than annually may be appropriate for

some users of SCBAs and emergency

responders. This concern is addressed

in final paragraph (k)(5), which

contemplates such additional training in

circumstances in which the employer

has reason to believe that a previously

trained employee does not have the

understanding and skill required to use

the respirator properly on a continuing

basis. Although this provision is

performance oriented, it requires that

more frequent (than annual) periodic

training be provided if necessary (e.g.,

because of the complexity of the

respirator or exposure conditions). If

respirator users must be trained more

frequently than annually to retain the

knowledge necessary to ensure proper

use of the respirator, then the employer

must provide the additional training.

Final paragraphs (k)(5)(i)–(iii) require

additional training when changes in the

workplace (process change, increase in

exposure, new hazards) or in the type of

respirator used by the employee render

previous training obsolete, when the

employee has not retained the requisite

understanding or skill to use the

respirator properly, or when any other

situation arises in which retraining

appears necessary. These provisions

recognize circumstances that require

supplemental training in addition to full

annual training. For example, retraining

with respect to the nature of the hazard

may be necessary because of an increase

in the workplace level of a hazardous

substance. Retraining would also be

required when an employee does not

sufficiently understand any program

element (Ex. 54–387). OSHA believes

that the regulatory burden imposed on

employers by final paragraph (k)(5) will

be minimal because this paragraph only

requires element-specific retraining on

an as-needed basis to supplement

annual training.

Final paragraph (k)(6) provides very

basic protection for employees who use

respirators voluntarily. As discussed, in

connection with paragraph (c)(2), such

employees are only covered by those

provisions of this standard that are

necessary to ensure that respirator use

does not present a health hazard to

these employees. Respirator use can

create health and safety problems. For

example, an employee who has chronic

obstructive lung disease and who is

given a negative pressure air-purifying

respirator to wear may be at risk of

hypertension, overexertion, and

dizziness. Employees who voluntarily

use some types of respirators (e.g., airpurifying respirators) are potentially

exposed to the hazards associated with

respirator use. Consequently, in

paragraph (k)(6), OSHA requires

employers to provide employees who

voluntarily use some types of respirators

(e.g., air purifying respirators) with the

informational material in Appendix D

so that the employee will be familiar

with basic respirator use procedures.

Paragraph (l)—Program Evaluation

Paragraph (l) requires employers to

perform evaluations to determine

whether the respiratory protection

program is functioning effectively.

Problems with protection, irritation,

breathing resistance, comfort, and other

respirator-related factors occasionally

arise in most respiratory protection

programs. Although it is not possible to

eliminate all problems associated with

respirator use, the employer must

eliminate as many problems as possible

to improve respiratory protection and

encourage employee acceptance and

safe use of respirators. Eliminating

problems is accomplished most

effectively when the respiratory

protection program is evaluated

thoroughly and revised as necessary.

Although the previous respiratory

protection standard requires that the

employer perform regular checks of the

effectiveness of the respiratory

protection program, it provided little

guidance regarding how these

evaluations are to be done. The final

rule, like the proposal, describes the

required program evaluation with

greater specificity than OSHA’s

previous respiratory protection standard

did.

Final paragraph (c) of the respirator

standard requires the employer to

establish a written respiratory

protection program. The program must

include procedures for evaluating the

effectiveness of the respirator program

and must designate a program

administrator who is to monitor

conditions in the workplace on a regular

basis to ensure that the provisions of the

written respiratory protection program

are being properly implemented. Final

paragraph (l) specifies certain steps the

employer must take as part of his/her

regular evaluation of the respiratory

protection program.

Paragraph (l) requires the employer to

consult employees who use respirators

to ascertain whether they perceive any

problems with the equipment and to

obtain their views on program

effectiveness. This assessment must

evaluate such factors as difficulty

breathing or fatigue during respirator

use, whether the respirator interferes

with hearing and vision,

communication, or job performance or

restricts movement, whether the

respirator causes discomfort, and

whether the employee has confidence in

the respirator’s effectiveness. The

employer must correct any problems

that are revealed by the evaluation.

The record supports the need to

review and evaluate workplace

respirator use to ensure the continuous

effectiveness of the respirator program

(Exs. 54–91, 54–153, 54–181, 54–213,

54–219, 54–234, 54–244, 54–252, 54–

263, 54–265, 54–54–286, 54–297, 54–

330, 54–352, 54–387, 54–424, 54–428,

54–455, Tr. 387, 1012, 1714, 1733,

1998). Based on the record, however,

the final program evaluation provisions

were modified, as discussed below,

from those proposed.

Final paragraph (l)(1) requires the

employer to conduct regular evaluations

of the workplace to ensure that the
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1263

provisions of the written program are

being properly implemented for all

employees required to use respirators,

and to ensure the continued

effectiveness of the program. Proposed

paragraph (l)(1) required the employer

to review the written respiratory

protection program at least annually and

to conduct frequent random inspections

of the workplace to ensure that the

provisions of the program are being

properly implemented for all

employees. The review of the written

program was to include an assessment

of each written program element

specified under proposed paragraph

(c)(1) of the standard.

The final standard under paragraph (l)

has deleted the proposed provisions for

annual written program review of each

element and ‘‘frequent random’’

workplace evaluations in favor of more

performance-oriented requirements.

Although a number of commenters

supported annual written program

review (Exs. 54–91, 54–153, 54–181, 54–

213, 54–244, 54–265, 54–361, 54–387,

54–424, 54–428), others asserted that

program review was necessary but

should only be required on an asneeded, rather than annual, basis as

necessitated by workplace or user

conditions or characteristics (Exs. 54–

177, 54–234, 54–263, 54–286, 54–297,

54–330, 54–352, 54–402, Tr. 1733). The

Chemical Manufacturers Association

(CMA) (Ex. 54–263), for example, stated:

For simple programs such as a single air

purifying respirator in use with a single

contaminant, assessments might be necessary

once every 3–5 years. For programs with

numerous hazards that change repeatedly

such as batch processes, reviews may be

needed more frequently.

The CMA (Ex. 54–263) and Mobil

Corporation (Ex. 54–234) support

adoption of the ANSI Z88.2 (1992)

recommendation that reads ‘‘The

program shall be periodically audited to

ensure that it is implemented and

reflects the written procedures.’’

Consumer Power (Ex. 54–297) argued

that program review and revision

should be required ‘‘as necessary to

reflect changes in respirator used,

training, fit test methods, and storage or

maintenance of the respirator in use at

the facility.’’

OSHA agrees with commenters that a

more performance-oriented approach

with respect to written program review

is appropriate in lieu of an annual

requirement. The Agency believes that

the final standard will ensure the

maintenance of an up-to-date written

respirator program without imposing an

arbitrary review schedule. Final

paragraph (c)(1) states, in part, that the

program shall be updated as necessary

to reflect changes in workplace

conditions and respirator use. This

provision requires employers to review

the written program and to revise, as

necessary, the written program elements

specified in paragraph (c)(1) when

workplace conditions affecting the use

of respirators change.

Accordingly, the final standard does

not contain the proposed requirement

for an annual written program review

but instead requires program review and

revision as necessary based on

workplace changes. Evaluation

frequency to ensure the continued

effectiveness of the program is to be

based on program complexity and on

factors such as the nature and extent of

workplace hazards, types of respirators

in use, variability of workplace

processes and operations, number of

respirator users, and worker experience

in the use of respirators. In other words,

the employer must audit respirator use

in the workplace with sufficient

frequency to ensure that continuous,

successful implementation of all written

respirator program elements prescribed

under paragraph (c) is being achieved.

As noted previously, the proposed

requirement for ‘‘frequent random’’

workplace evaluations has been deleted

in favor of a requirement for evaluations

conducted on an as-necessary basis.

OSHA agrees with commenters’

assertions that the meaning of the term

‘‘frequent random’’ was unclear (Exs.

54–181, 54–334), especially with respect

to conditions of infrequent or brief

respirator use (Exs. 54–166, 54–177). In

such instances, the commenters

indicated that evaluations would have

to be scheduled based on when

respirators are used. The Agency

believes that the final standard’s

evaluation procedures incorporate a

flexible and reasonable approach that

will meet the needs of different

workplaces while ensuring continued,

effective implementation of the

respirator program. OSHA emphasizes

that the change in language in the final

standard is not intended to deemphasize

the importance of conducting

evaluations.

Final paragraph (l)(2) requires the

employer to consult regularly with

employees who wear respirators to

obtain their views on the effectiveness

of the program and to correct any

problems that are identified. This

assessment must determine if the

respirators are properly fitted. It must

also evaluate whether employees are

able to wear the respirators without

interfering with effective workplace

performance, whether respirators are

correctly selected for the hazards

encountered, whether respirators are

being worn when necessary, and

whether respirators are being

maintained properly. Many commenters

(Exs. 54–91, 54–153, 54–181, 54–213,

54–265, 54–361, 54–387, 54–424, 54–

488) supported the proposed

requirement for the employer

periodically to consult with employees.

This requirement is essentially

unchanged from the proposed

provision. Some commenters (Exs. 54–

187, 54–278) argued that the employer’s

obligations to consult with employees

should be limited to those employees

required by OSHA to wear respirators.

However, as explained in detail in the

Summary and Explanation for

paragraphs (a) and (c), OSHA believes

that all employees who are required to

wear respirators should be covered by

the program, regardless of whether their

respirator use is required by OSHA or

their employer.

Thus, final paragraph (l)(2) requires

the employer to consult with employees

who wear respirators when auditing the

effectiveness of the respirator program.

As discussed above in connection with

paragraph (c), OSHA has consistently

required employers who provide their

employees with respirators to ensure

that those respirators do not pose a

health hazard (e.g., do not increase the

work-of-breathing in a way that

threatens health, do not impair vision or

hearing). In general, assessments

conducted to comply with paragraph (l)

will involve a technical evaluation of

whether respirators are being used

properly. If respirators are not being

used properly, the employer is required

to correct any problems found during

the assessment. The areas to be

reevaluated include whether the

respirator program is providing

employees with properly fitting

respirators and whether the appropriate

respirators are being selected, used, and

maintained properly.

Proposed paragraph (l)(2)(i), which

would have required the employer to

assess whether the program was

‘‘preventing the occurrence of illness,’’

has been deleted from the final rule.

Commenters noted that the individual

performing the program evaluation

under this paragraph is not likely to be

a health care professional with

sufficient expertise to identify illnesses

caused by improper respirator use, other

than skin/eye irritation, which can

readily be observed by the program

administrator, supervisor, employer, or

employee. Commenters argued that

medical determinations and evaluations

are part of the review of an employee’s

medical status required by paragraph (e)

of this section (Exs. 54–187, 54–237).

OSHA agrees and, accordingly, has
1264 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

omitted this proposed requirement from

final paragraph (l)(2). However,

identification of respirator-related

medical conditions, such as skin

irritation, would properly be part of the

program evaluation. Employees

identified during the evaluation as

having skin irritation can either be

referred to the PLHCP or be advised by

the program administrator about the

need to leave the respirator use area as

necessary to wash the face and

facepiece, as permitted by paragraph (g).

It should be noted that final paragraph

(e)(7)(iii) requires medical evaluation if

observations made during the program

evaluation indicate that such evaluation

is necessary.

Paragraph (m)—Recordkeeping

The final standard requires the

employer to establish and retain written

information regarding medical

evaluations, fit testing, and the

respirator program. The final provisions

addressing these records differ in some

respects from the proposed

requirements. In the proposed rule,

paragraph (c) contained recordkeeping

provisions for the written respiratory

program, paragraph (m) required

retention of medical evaluation records,

and fit testing records were required to

be maintained under Appendix A. In

the final rule, however, all

recordkeeping requirements have been

consolidated in paragraph (m), in

response to those commenters who

suggested that placing all recordkeeping

provisions in one paragraph will

improve understanding of the rule’s

recordkeeping obligations (Exs. 54–267,

54–286).

Paragraph (m)(1) of the final standard

requires the employer to retain a

medical evaluation record for each

employee subject to medical evaluation

under final paragraph (e). Such records

are to be kept and made available as

required by 29 CFR 1910.1020, OSHA’s

Access to Employee Exposure and

Medical Records rule. The record is to

include the result of the medical

questionnaire and, if applicable, a copy

of the PLHCP’s written opinion and

recommendations, including the results

of relevant medical examinations and

tests. It is standard medical practice to

make and retain written records of

medical examinations and evaluations.

Retention of such records will enable

PLHCPs in subsequent evaluations to

determine whether the employee’s

health has deteriorated, and will enable

employees to obtain copies for their

personal physician or other licensed

health care professional to review as

necessary.

Although the format of final

paragraph (m)(1) has been simplified

from that of the proposed rule, the

substance of the medical evaluation

records to be retained is similar. Several

proposed paragraphs referred

specifically to provisions in 29 CFR

1910.1020 that address the

maintenance, availability, and transfer

of the medical evaluation records. As

recommended by several commenters,

however, only one reference to 29 CFR

1910.1020 is needed for this purpose,

and the final respiratory protection rule

has been revised accordingly (Exs. 54–

220, 54-350, 54–362, 54–455, Tr. 1054).

Final paragraph (m)(2) addresses the

retention of respirator fit-testing records.

The provisions of this paragraph remain

basically unchanged from the

requirements of Appendix A, section II.

12 of the proposal. The records

specified in final paragraphs

(m)(2)(i)(A)—(E) consist of the name or

identification of the person tested; the

type of fit test performed (QLFT,

QNFT—irritant smoke, saccharin, etc.);

the make, model, and size of the

respirator fitted; the date of the fit test;

pass/fail results if a QLFT is used; or the

fit factor and strip chart recording or

other record of the test results if

quantitative fit testing was performed.

Under final paragraph (m)(2)(ii), the

fit test record must be maintained until

the next fit test is administered. If the

employee’s use of a respirator is

discontinued (e.g., because of a change

of duties or successful implementation

of engineering controls), fit test records

need not be retained for the employee.

Fit test records must be maintained to

determine whether annual fit testing has

been done, and whether the employee

who was tested passed the QLFT or

passed the QNFT with a fit factor that

was appropriate for the type of

respirator being used. OSHA agrees with

commenters (Exs. 36–6, 36–17, 36–34,

36–46, 54–165, 54–210) who stated that

fit testing records must be maintained to

ensure that all respirator users have

received a fit test, the respirator selected

by fit testing is being used, and retesting

is being performed annually.

Some commenters argued that the

employer should only be required to

certify that fit testing has been

completed, and that retaining the other

proposed information would provide

little additional benefit (Exs. 54–222,

54–310). OSHA disagrees with this

position. The Agency believes it is

essential that fit test records identify the

respirator and employee being fit tested.

As noted in the preceding paragraph,

other commenters stated that the

information in this record would be the

only means of determining whether the

appropriate respirator was being used

by the employee. OSHA believes that

the effectiveness of the respiratory

protection program will be substantially

improved if these records are kept.

Similar recordkeeping requirements are

found in many OSHA standards: 29 CFR

1910.1027, Cadmium; 29 CFR

1910.1028, Benzene; 29 CFR 1910.1048,

Formaldehyde; 29 CFR 1910.1050,

Methylenedianiline.

Final paragraph (m)(3) specifically

requires employers to maintain a

written copy of the current respiratory

protection program prescribed by final

paragraph (c). As discussed under

paragraph (c), a written program is

necessary to assure the appropriate use

of respirators and the on-going

effectiveness of the program.

Final paragraph (m)(4) provides that

written materials required to be

maintained under final paragraph (m)

must be made available, upon request,

to employees and to the Assistant

Secretary for examination and copying.

This final paragraph replaces, but is

consistent with, the record availability

requirement of proposed paragraph

(m)(2). Employee access to these records

is necessary to ensure that employees

can assess and verify information

describing their exposure to respiratory

hazards in the workplace and the

effectiveness of the respirator program

in protecting them from those hazards.

Access to these records by the Assistant

Secretary or his or her designees is

necessary to allow OSHA to monitor

compliance with the standard and its

effectiveness.

The access provisions in final

paragraph (m)(4) are consistent with

provisions found in other OSHA

standards: 29 CFR 1910.1001, Asbestos;

29 CFR 1910.1027, Cadmium; 29 CFR

1910.1028, Benzene; 29 CFR 1910.1047,

Ethylene Oxide; 29 CFR 1910.1048,

Formaldehyde; and 20 CFR 1910.1050,

Methylenedianiline.

Paragraph (n)—Dates

The final Respiratory Protection

standard will become effective on April

8, 1998. For most requirements of the

standard, however, compliance need not

be achieved until the start-up dates

specified in paragraph (n) of the final

rule. Unless a different start-up date is

specified for a particular requirement,

compliance must be achieved by the

effective date.

The proposal would have required

compliance with all provisions of the

standard 90 days after publication of the

final standard in the Federal Register.

The Air Conditioning Contractors of

America (Ex. 54–248) stated that a 90-

day compliance period should be
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1265

sufficient if OSHA plans to disseminate

information to employers in a ‘‘userfriendly’’ format, but that additional

time would be required if industry

organizations had to analyze and

distribute information on the final

standard by themselves. Several

commenters recommended a 6–12

month effective date for implementing

the final standard (Exs. 54–248, 54–271,

54–283, 54–293, 54–309). The U.S.

Enrichment Corporation (Ex. 54–283)

wanted the standard phased in over a

12-month period to allow additional

time for the employer to obtain

respiratory protection equipment from

manufacturers and to perform fit testing.

The American Subcontractors

Association (Ex. 54–293) stated that

small contractors rely on their

organization and others for education

and training regarding new standards,

and that a 90-day period is too short a

period for transition to a new program.

They specifically mentioned training,

updating written programs, changing

written standard operating procedures

(SOPs), and medical examinations as

provisions in the standard that may be

difficult to comply with in a short time

period. The Associated Building

Contractors (Ex. 54–309) also wanted

the final standard to be phased in over

12 months to allow for revising written

SOPs and programs, training, and

medical evaluation of respirator users.

Exxon (Ex. 54–266) and the American

Petroleum Institute (Ex. 54–330) stated

that employers could not fit test every

employee within the specified 90-day

effective date and recommended that

employees be fit tested within one year

of the effective date of the standard.

Based on many of these comments,

OSHA concludes that additional time is

required for employers to comply with

certain provisions of the final standard.

The Agency has therefore included

extended start-up dates for some of the

program elements. OSHA does intend,

however, to disseminate information on

this standard in a ‘‘user friendly’’

format.

Within 150 days of the effective date

of the standard, employers must

determine whether respirator use is

required under paragraph (a). This

period will afford employers sufficient

time to become familiar with the final

standard and to evaluate whether

respirator use is required in their

workplaces.

Employers must comply with all the

remaining requirements of the respirator

standard no later than 180 days after the

effective date of the standard. OSHA

concludes that with the start-up dates

provided, all employers will have

adequate time to comply. Paragraph

(n)(3) states that if there is an

administrative or judicial delay of the

standard, the respiratory protection

provisions of the previous standards

(i.e., 29 CFR 1910.134 and 29 CFR

1926.103) will remain in effect and will

be enforced until the issues have been

resolved. Many employers already have

an established respiratory protection

program that includes specific program

elements (e.g., fit testing, annual

training, medical evaluations of

respirator users, and program

evaluation) that comply with the

requirements of the Agency’s prior

respirator standards. Program elements

that were implemented to meet the prior

respirator standards’ requirements may

also meet the requirements of this final

respiratory protection standard.

Paragraph (n)(4) states that if, in the 12

month period preceding the effective

date of the revised standard, the

employer has conducted annual

respirator training, fit testing, respirator

program evaluation, or medical

evaluations, the employer may use the

results of these activities to comply with

the corresponding provisions of this

section, provided that these activities

were conducted in a manner that meets

the requirements of the revised

standard. For example, if the employer

has an existing fit testing program in

place on the effective date of the final

standard, the employer may continue

that fit testing program if it meets the fit

testing requirements of the final

standard. In such cases, employees

would be retested within one year of

their last fit test date. Employers,

therefore, can incorporate annual fit

testing, training, and program

evaluation into their existing respiratory

protection programs if the appropriate

program elements comply with the

provisions of the final standard. This

approach should help reduce the impact

of the final rule on employers with

effective existing respirator programs.

Paragraph (o)—Appendices

The final paragraph of the standard

identifies four appendices that

supplement the requirements specified

in the regulatory text. Appendices A (Fit

Testing Procedures), B–1 (User Seal

Check Procedures), B–2 (Cleaning

Procedures), and C (Medical

Questionnaire) are mandatory, and

contain requirements for performing fit

testing, user seal checks, cleaning, and

medical evaluations that supplement

the regulatory requirements in

paragraphs (e), (f), (g), and (h) of the

final standard.

Appendix D (Information for

Employees Using Respirators When Not

Required Under The Standard) is

nonmandatory.

The four appendices are discussed in

detail under the Summary and

Explanation sections of the

corresponding paragraphs of the final

standard: Appendix A in paragraph (f),

‘‘Fit Testing’’; Appendix B–1 in

paragraph (g), ‘‘Use of respirators’’;

Appendix B–2 in paragraph (h),

‘‘Maintenance and care of respirators’’;

Appendix C in paragraph (e), ‘‘Medical

evaluation’’; Appendix D in paragraph

(c), ‘‘Written program’’ and paragraph

(a), ‘‘Permissible practice.’’

Paragraph (p)—Revisions to Specific

OSHA Standards

A number of OSHA standards

regulating exposure to toxic substance

and harmful physical agents incorporate

certain provisions of 29 CFR 1910.134.

OSHA proposed to revise these

provisions to simplify compliance for

employers by consolidating many of the

Agency’s respirator requirements,

removing inconsistencies, and deleting

duplicative requirements. The purpose

of revising the respirator-related

provisions of OSHA’s existing standards

was to conform these standards, to the

extent possible, to each other and to

revised 29 CFR 1910.134 in general.

These standards will be improved by

this process, because they will now refer

to the revised respiratory protection

standard, which is based on current

respirator use and technology. For

example, revising the respiratorapproval references in these standards

from MSHA/NIOSH, Bureau of Mines,

and ANSI Z88.2–1969 to the recently

published NIOSH regulation at 42 CFR

Part 84 updates these respiratory

protection provisions. The Agency

concludes, therefore, that updating

these standards is consistent with the

proposed goal of bringing uniformity to

OSHA’s respiratory protection

requirements. OSHA believes that

regulatory consistency will improve

compliance with the respiratory

protection provisions, reduce the

compliance burden on the regulated

community, and, consequently, enhance

the protection provided to employees

who use respirators. OSHA’s review of

the rulemaking record shows that no

commenters objected to updating the

provisions of these standards to conform

with the requirements of revised 29 CFR

1910.134.

The Agency also notes that revised 29

CFR 1910.134 is intended to serve as a

‘‘building block’’ standard with respect

to future standards that may contain

respiratory protection requirements. To

the extent possible, therefore, future

standards that regulate respirator use in
1266 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

controlling employee exposure to toxic

substances and harmful physical agents

will refer to provisions of the final

respiratory protection standard at 29

CFR 1910.134 instead of containing

their own respirator requirements.

(However, these standards will continue

to have any respirator requirements,

e.g., canister/cartridge change

schedules, that are specific to the

substance or agent being regulated.)

In developing the final revision,

OSHA also revised the wording and/or

location of some paragraphs to improve

the comprehensibility and uniformity of

the requirements; however, the

substantive requirements of the

standards addressing respirators have

not been revised. Additionally, the

tables in the substance-specific

standards specifying parameters for

respirator selection have not been

republished because these tables will

remain unchanged and, thus, will

continue to be part of the substancespecific standards until resolution of the

reserved portions of this final standard.

OSHA found that the existing

substance-specific standards were

especially in need of revision. Except

for a limited number of respirator

provisions unique to each substancespecific standard, the remaining

regulatory text on respirators now reads

virtually the same for each of these

standards. For example, all provisions

addressing respirator use, selection, and

fit testing were deleted from the

substance-specific standards, making

these standards consistent with the final

respiratory protection standard with

respect to these requirements. The

Agency believes that revisions to 29

CFR 1910.134 are sufficiently

comprehensive to allow deletion of

those provisions in the substancespecific standards that duplicated

provisions of revised 29 CFR 1910.134.

A provision was retained only when it

addressed conditions (for example,

medical evaluation) that were unique

and/or integral to the substance-specific

standard. The Agency concludes,

therefore, that deletion of duplicative

provisions from the substance-specific

standards will reduce confusion among

members of the regulated community

and decrease the burden of compliance.

It will thereby enhance compliance with

the respiratory protection requirements

and, consequently, improve the

protection afforded to employees who

use respirators to control exposure to

the toxic substances and harmful

physical agents regulated by these

standards. The proposed revisions to the

substance-specific standards were

widely supported by rulemaking

participants (Exs. 54–187, 54–208, 54–

219, 54–220, 54–233, 54–234, 54–261,

54–263, 54–266, 54–267, 54–273, 54–

283, 54–289, 54–327, 54–333, 54–363,

54–424.)

In general, for the substance-specific

standards, the incorporated provisions

of revised 29 CFR 1910.134 cover the

following requirements: definitions

(paragraph (b)); respiratory protection

program (paragraph (c)); selection of

respirators (paragraph (d)); fit testing

(paragraph (f)); use of respirators

(paragraph (g)); maintenance and care of

respirators (paragraph (h)); breathing air

quality and use (paragraph (i));

identification of filters, cartridges, and

canisters (paragraph (j)); training and

information (paragraph (k)); program

evaluation (paragraph (l)); and

recordkeeping (paragraph (m)). Each of

these requirements was addressed by

paragraphs (b), (c), (d), (e), and (f) of the

prior respiratory protection standard.

OSHA did not propose to conform the

respirator provisions of its Cadmium,

Benzene, Formaldehyde, 1,3-Butadiene,

and Methylene chloride standards with

the corresponding requirements of

revised 29 CFR 1910.134. Rulemaking

participants recommended that the

respirator provisions of the existing

Cadmium, Benzene, and Formaldehyde

standards be revised to conform with

those provisions of 29 CFR 1910.134 to

improve regulatory consistency and

uniformity (Exs. 54–194, 54–195, 54–

208, 54–218, 54–275, 54–294, 54–337,

54–350, 54–387, 54–434). In view of

these comments, the Agency assumes

that a consensus exists among the

regulated community to bring these

standards (as well as the 1,3-Butadiene

and Methylene chloride standards,

which were issued after the close of the

comment period for the respirator

rulemaking) into conformity with the

revised respiratory protection standard.

Accordingly, these standards have been

revised in the same manner as the other

substance-specific standards for which

OSHA proposed revisions.

In revising the fit-testing provisions

(paragraph (f)) of the substance-specific

standards, the frequency of respirator fit

testing was revised from semiannually

to annually for the Asbestos (29 CFR

1910.1001 and 1926.1101), Arsenic (29

CFR 1910.1018), Lead (29 CFR

1910.1025 and 1926.62) and

Acrylonitrile (29 CFR 1910.1045)

standards. The Agency believes that this

revision will not diminish the

effectiveness of respiratory protection

provided by these standards. OSHA’s

experience in recent rulemakings

(Cadmium, 1992; Methylenedianiline,

1992; Formaldehyde, 1992; Methylene

chloride, 1997) has led the Agency to

conclude that annual respirator fit

testing, which is provided for in the

recent standards, protects employees

appropriately, and that semi-annual fit

testing is not necessary for employee

protection. The basis for adopting a

semiannual fit-testing requirement is

not discussed in the preambles to any of

the standards that contain that

requirement. For example, there is no

discussion in the preambles of those

standards that semiannual fit testing

was adopted because of the toxic

properties of the regulated substances or

the particular characteristics of the

respirators to be used.

Recent rulemakings, including

proposed revisions to the respiratory

protection standard, have provided the

Agency with much more scientific and

experiential information on fit testing

than was available when the affected

standards were adopted. A number of

commenters in the current rulemaking

asserted that provisions for semiannual

fit testing in the existing Asbestos,

Arsenic, Lead, and Acrylonitrile

standards should be revised to conform

to the annual fit testing requirements of

the recently-adopted standards (Exs. 54–

5, 54–179, 54–186, 54–208, 54–218, 54–

219, 54–222, 54–242, 54–289, 54–326,

54–330, 54–348, 54–410, 54–424, 54–

439, 54–443.) The Agency, therefore,

concludes that it is reasonable and

appropriate, for the purpose of

regulatory consistency and uniformity,

to require only annual respirator fit

testing in its substance-specific

standards.

While the proposal did not

incorporate revised paragraph (m)

(recordkeeping) into the existing

substance-specific standards, OSHA

incorporated this paragraph in the final

rulemaking in the belief that such

action: (1) Will make recordkeeping

requirements consistent and uniform for

employers who use respirators to

control employee exposures to the

airborne contaminants regulated by the

substance-specific standards; (2) will

reduce the regulatory burden on

employers because they are currently

required under 29 CFR 1910.1020 to

maintain exposure and medical records;

and, (3) it is a prevailing business and

industrial-hygiene practice to retain fittesting records to demonstrate that

protection was provided to exposed

employees.

For the 13 carcinogens addressed by

existing 29 CFR 1910.1003 (the ‘‘13

Carcinogens standard’’), the provision

requiring employers to ensure that

employees use respirators ‘‘in

accordance with 29 CFR 1910.134’’ was

amended to require compliance with

paragraphs (b), (c), (d) (except (d)(1)

(iii), (iv), and (d)(3)), and (e)–(m) of the
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1267

final standard. While the proposal did

not incorporate revised paragraph (e)

(medical evaluation) into the 13

Carcinogens standard, OSHA did so in

the final rulemaking because such

incorporation is consistent with the

requirements of existing 29 CFR

1910.134, conforms to accepted industry

practice, and improves comprehension

of, and compliance with, the respiratory

protection requirements of the 13

Carcinogens standard.

Unlike 29 CFR 1910.1003, each of the

existing substance-specific OSHA

standards includes unique medicalevaluation requirements for employees

who use respirators. OSHA believes that

the medical-evaluation requirements for

respirator use established under its

existing substance-specific standards

provide a high degree of medical

protection to employees who are

required to use respirators to control

their exposures to the airborne

substances regulated by the substancespecific standards. In addition, the

medical-evaluation requirements for

respirator use in the substance-specific

standards are part of a comprehensive,

integrated medical-surveillance program

designed to evaluate employees for

conditions and risks associated with

exposure to the regulated substances;

consequently, OSHA believes that any

revision to the frequency or content of

medical evaluations for respirator use

would unnecessarily disrupt ongoing

medical-surveillance programs and,

therefore, jeopardize the health of

employees who must use respirators to

prevent exposure to hazardous

workplace substances.

Paragraph (d)(1)(iii) of the revised

respiratory protection standard, which

requires employers to estimate exposure

levels in selecting appropriate

respirators, has not been incorporated

into OSHA’s substance-specific

standards in the final rulemaking. The

existing substance-specific standards,

except the 13 Carcinogens standard,

already include exposure assessment

provisions that are more specific than

the general exposure-assessment

requirement in the final respiratory

protection standard. With respect to the

13 Carcinogens standard, no PELs or

other exposure criteria are specified in

that standard that would be relevant to

respirator selection. In the 13

Carcinogens standard, exposure

estimates for the substances regulated

by the standard are not necessary for

respirator selection because appropriate

respirators have been identified for

specific work activities that occur

during employee exposure to each of the

13 carcinogenic substances.

OSHA excepted substance-specific

standards that already contain

requirements for cartridge- and canisterchange schedules (Vinyl chloride,

Benzene, Acrylonitrile, Formaldehyde,

and 1,3-Butadiene) from paragraphs

(d)(3)(iii)(B) (1) and (2) of the revised

respiratory protection standard, which

also addresses change schedules, to

preclude regulatory conflict. The

Agency finds that information obtained

during the rulemakings for these

substance-specific standards resulted in

the development of change schedules

that were especially tailored to the

chemistry of the specific substance,

documented the exposure conditions

requiring these schedules, and

determined the types of respirators

required for employee protection.

Consequently, the Agency concludes

that the change schedules adopted

during these rulemakings must not be

replaced by the generic change-schedule

requirements of revised 29 CFR

1910.134.

As proposed, the Agency also

removed a number of appendices from

the substance-specific standards that

addressed fit-testing requirements,

replacing them with references to

Appendix A of revised 29 CFR

1910.134. In this regard, the Agency

proposed to update Section IV of

Appendix B of 29 CFR 1910.1025 (the

Lead standard) by citing Appendix A of

29 CFR 1910.134 as the reference for fittesting procedures; the proposed

revision has been made in the final

rulemaking. While not proposed, the

Agency revised the same information in

Appendix B of 29 CFR 1926.62 (the

Lead standard for Construction),

removed the sixth paragraph from

Section IV of Appendix B of 29 CFR

1910.1025 and 1926.62 as being

outdated, and revised references for

respirator approval in Section IV of

Appendix B of 29 CFR 1910.1025,

Section IV of Appendix A to 29 CFR

1910.1045 (the Acrylonitrile standard),

Section IV of Appendix A to 29 CFR

1910.1047 (the Ethylene Oxide

standard), Section III of Appendix A to

29 CFR 1910.1050 (the 4, 4’-

Methylenedianiline standard), and

Section IV of Appendix B to 29 CFR

1926.62, Lead in Construction. The

Agency believes that these revisions

will conform the affected standards with

the provisions of the revised respiratory

protection standard; the resulting

consistency will, therefore, reduce

confusion and ease compliance.

The following provisions, addressing

fit-testing, respirator selection, and

respirator use, have been deleted from

OSHA’s substance-specific standards

because they duplicate requirements

specified in revised 29 CFR 1910.134:

(1) Fit Testing

This requirement is specified in

paragraph (f) of the revised respiratory

protection standard, allowing for the

removal of the following paragraphs:

(a) 29 CFR 1910.1001 Asbestos.

(g)(4) and Appendix C

(b) 29 CFR 1910.1018 Inorganic arsenic.

(h)(3) (i), (ii), and (iii)

(c) 29 CFR 1910.1025 Lead.

(f)(3) (i) and (ii), and Appendix D;

Section IV of Appendix B revised in

part

(d) 29 CFR 1910.1027 Cadmium.

(g)(4) and Appendix C

(e) 29 CFR 1910.1028 Benzene.

(g)(5) and Appendix E

(f) 29 CFR 1910.1045 Acrylonitrile.

(h)(3)(iii)

(g) 1910.1048 Formaldehyde.

(g)(3)(ii) and Appendix E

(h) 29 CFR 1910.1050

Methylenedianiline.

(h)(5) and Appendix E

(i) 29 CFR 1910.1051 1,3-Butadiene.

(h)(5) and Appendix E

(j) 29 CFR 1910.1052 Methylene

chloride.

(g)(7)

(k) 29 CFR 1926.60 Methylenedianiline.

(i)(5) and Appendix E

(l) 29 CFR 1926.62 Lead.

(f)(3) (i) and (ii), and Appendix D;

Section IV of Appendix B revised in

part

(m) 29 CFR 1926.1101 Asbestos.

(h)(4) and Appendix C

(n) 29 CFR 1926.1127 Cadmium.

(g)(4) and Appendix C

(2) Respirator-Approval Requirements

that Reference MSHA or NIOSH 30 CFR

Part 11

The requirement to select respirators

approved by NIOSH in 42 CFR part 84

is specified in paragraph (d)(1)(ii) of the

revised respiratory protection standard.

This requirement updates the existing

respirator-approval requirement in the

substance-specific standards to select

respirators approved by MSHA or

NIOSH under 30 CFR part 11, allowing

for removal of the following paragraphs:

(a) 29 CFR 1910.1001 Asbestos.

(g)(2)(i) [part]

(b) 29 CFR 1910.1017 Vinyl chloride.

(g)(2)

(c) 29 CFR 1910.1018 Inorganic arsenic.

(h)(2)(iii)

(d) 29 CFR 1910.1025 Lead.

(f)(2)(iii); Section IV of Appendix B

revised in part

(e) 29 CFR 1910.1027 Cadmium.

(g)(2)(i) [part]

(f) 29 CFR 1910.1028 Benzene
1268 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

(g)(2)(ii)

(g) 29 CFR 1910.1029 Coke oven

emissions.

(g)(2)(iii)

(h) 29 CFR 1910.1044 1,2-Dibromo-3-

chloropropane.

(h)(2)(ii)

(i) 29 CFR 1910.1045 Acrylonitrile.

(h)(2)(ii); Section IV of Appendix A

revised in part

(j) 29 CFR 1910.1047 Ethylene oxide.

(g)(2)(ii); Section IV of Appendix A

revised in part

(k) 29 CFR 1910.1048 Formaldehyde.

(g)(2)(i) [part]

(l) 29 CFR 1910.1050

Methylenedianiline.

(h)(2)(ii); Section III of Appendix A

revised in part

(m) 29 CFR 1910.1051 1,3-Butadiene.

(h)(2)(ii) [part]

(n) 29 CFR 1910.1052 Methylene

chloride.

(g)(3) [part]

(o) 29 CFR 1926.60

Methylenedianiline.

(i)(2)(ii)

(p) 29 CFR 1926.62 Lead.

(f)(2)(iii); Section IV of Appendix B

revised in part

(q) 29 CFR 1926.1101 Asbestos.

(h)(2)(ii)

(r) 29 CFR 1926.1127 Cadmium.

(g)(2)(i) [part]

(3) Respirator Use

Paragraph (g) of the revised

respiratory protection standard

addresses, in part, facepiece seal

protection (paragraph (g)(1)), and

employees leaving the work area to

wash their faces and respirator

facepieces (paragraph (g)(2)(ii)(A)) and

to change filter elements (paragraph

(g)(2)(ii) (B) and (C)), allowing removal

of the following paragraphs:

(a) 29 CFR 1910.1001 Asbestos.

(g)(3) (ii) and (iii)

(b) 29 CFR 1910.1018 Inorganic

arsenic.

(h)(4) (ii) and (iii)

(c) 29 CFR 1910.1025 Lead.

(f)(4) (ii) and (iii)

(d) 29 CFR 1910.1027 Cadmium.

(g)(3) (ii) and (iii)

(e) 29 CFR 1910.1028 Benzene.

(g)(4)(iii)

(f) 29 CFR 1910.1029 Coke oven

emissions.

(g)(4)

(g) 29 CFR 1910.1043 Cotton dust.

(f)(4)

(h) 29 CFR 1910.1044 1,2-Dibromo-3-

chloropropane.

(h)(3)(ii)

(i) 29 CFR 1910.1045 Acrylonitrile.

(h)(3)(iv)

(j) 29 CFR 1910.1048 Formaldehyde.

(g)(3)(v)

(k) 29 CFR 1910.1050

Methylenedianiline.

(h)(4)(ii)

(l) 29 CFR 1910.1051 1,3-Butadiene.

(h)(4)(v)

(m) 29 CFR 1910.1052 Methylene

chloride.

(g)(5)

(n) 29 CFR 1926.60

Methylenedianiline. (i)(4)(ii)

(o) 29 CFR 1926.62 Lead.

(f)(4) (ii) and (iii)

(p) 1926.1101 Asbestos.

(h)(3) (ii) and (iii)

(q) 29 CFR 19126.1127 Cadmium.

(g)(3) (ii) and (iii)

The full text, after deletions and

revisions, of the paragraphs dealing

with respirators that remain in each of

OSHA’s existing substance specific

standards has been published in Section

XI of this preamble.

The provisions of the respiratory

protection standard found in 29 CFR

part 1926 (Construction), specifically 29

CFR 1926.103, are now identical to the

new 29 CFR 1910.134. Following its

policy of not repeating identical health

provisions in order to reduce paperwork

burden and to avoid regulatory

confusion, OSHA is deleting the

duplicate text in 29 CFR 1926.103 and

cross-referencing the text in 29 CFR

1910.134. To implement this action, the

title of this section remains, but a Note

is added to read: ‘‘Note: The

requirements applicable to construction

work under this section are identical to

those set forth at 29 CFR 1910.134 of

this chapter.’’ For the convenience of

the Construction industry, OSHA makes

available an indexed manual that

includes the full text of all regulations

applicable to construction, including

OSHA’s respirator requirements.

OSHA is also revising or removing a

number of provisions in addition to

safety and health standards, other than

the substance-specific standards, that

duplicate provisions now found in the

revised respiratory protection standard.

These standards and their revisions

include:

(1) 29 CFR 1910.94 Ventilation.

(a)(1)(i)—Removed the phrase

‘‘continuous flow’’ from the definition

of abrasive-blasting respirator consistent

with the proposed requirement to select

respirators in accordance with 29 CFR

1910.134.

(a)(5)(i)—Revised the reference from

‘‘30 CFR part 11’’ to ‘‘42 CFR Part 84.’’

(a)(5)(iii)—Provided the reference ‘‘42

CFR Part 84.’’

(a)(5)(iv)—Revised the reference from

‘‘§ 1910.134 (a) and (b)’’ to ‘‘§ 1910.134.’’

(a)(6)—Revised the air-requirement

reference for abrasive-blasting

respirators from ‘‘ANSI Z9.2–1960’’ to

‘‘29 CFR 1910.134(i).’’

(c)(6)(iii)(a)—Revised the reference

from ‘‘MSHA/NIOSH/ANSI Z–88.2–

1969’’ to ‘‘NIOSH under 42 CFR Part

84.’’

(d)(9)(vi)—Revised the reference from

‘‘MSHA/NIOSH’’ to ‘‘NIOSH under 42

CFR Part 84.’’

(2) 29 CFR 1910.111 Storage and

handling of anhydrous ammonia.

(a)(2)(x)—Revised the reference from

‘‘MSHA’’ to ‘‘the National Institute for

Occupational Safety and Health

(NIOSH) under 42 CFR Part 84.’’

(b)(10)(ii)—Revised the reference from

‘‘Bureau of Mines’’ to ‘‘NIOSH under 42

CFR Part 84.’’

(3) 29 CFR 1910.156 Fire brigades.

(f)(1)(i) and (v)—Revised the reference

from ‘‘MSHA/NIOSH’’ to ‘‘NIOSH under

42 CFR Part 84.’’

(4) 29 CFR 1910.252 General

requirements.

(c)(4)(ii) and (iii), (c)(7)(iii), (c)(9)(i),

and (c)(10)—Revised the references from

‘‘MSHA/NIOSH’’ to ‘‘National Institute

for Occupational Safety and Health

(NIOSH) under 42 CFR Part 84’’ and

‘‘NIOSH under 42 CFR Part 84.’’

(5) 29 CFR 1910.261 Pulp, paper,

and paperboard mills.

(b)(2) and (g)(10—Revised the

reference from ‘‘ANSI Z88.2–1969’’ to

‘‘29 CFR 1910.134.’’

(h)(2)(iii) and (iv)—Revised the

reference from ‘‘ANSI Z–88.2–1969 and

K–13.1–1967’’ to ‘‘29 CFR 1910.134.’’

(6) 29 CFR 1926.57 Ventilation.

(f)(1)(ii)—Removed the phrase

‘‘continuous flow’’ from the definition

of abrasive-blasting respirator consistent

with the proposed requirement to select

respirators in accordance with 29 CFR

1910.134.

(f)(5)(i)—Revised the reference from

‘‘30 CFR Part 11’’ to ‘‘42 CFR Part 84.’’

(f)(5)(iii)—Provided the reference ‘‘42

CFR Part 84.’’

(f)(6)—Revised the air-requirement

reference for abrasive-blasting

respirators from ‘‘ANSI Z9.2–1960’’ to

‘‘29 CFR 1910.134(i).’’

(h)(6)(iii)(A)—Revised the reference

from ‘‘MSHA/NIOSH/ANSI Z–88.2–

1969’’ to ‘‘NIOSH under 42 CFR Part

84.’’

(i)(9)(vi)—Revised the reference from

‘‘MSHA/NIOSH’’ to ‘‘NIOSH under 42

CFR Part 84.’’

(7) 29 CFR 1926.103 Respiratory

protection.

Removed paragraphs (a) through (i)

and replaced them with a note to read

as follows:

Note: The requirements applicable to

construction work under this section are

identical to those set forth at § 1910.134 of

this chapter.
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1269

(8) 29 CFR 1926.800 Underground

construction.

(g)(2)—Revised the reference from

‘‘MSHA/NIOSH’’ to ‘‘the National

Institute for Occupational Safety and

Health under 42 CFR Part 84,’’ and from

‘‘§ 1926.103 (b) and (c)’’ to ‘‘29 CFR

1926.103.’’

Appendices

The four appendices are discussed in

detail under the Summary and

Explanation sections for the following

paragraphs of the final standard:

Appendix A in paragraph (f), ‘‘Fit

Testing’’; Appendix B–1 in paragraph

(g), ‘‘Use of respirators’’; Appendix B–2

in paragraph (h), ‘‘Maintenance and care

of respirators’; Appendix C in paragraph

(e), ‘‘Medical evaluation’’; Appendix D

in paragraphs (c), ‘‘Written program’’

and paragraph (a), ‘‘Permissible

practice.’’

VIII. Authority and Signature

This document was prepared under

the direction of Charles N. Jeffress,

Assistant Secretary of Labor for

Occupational Safety and Health, U.S.

Department of Labor, 200 Constitution

Avenue, NW., Washington, DC 20210.

Pursuant to 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); Sec. 107 of the Contract Work

Hours and Safety Standards Act (the

Construction Safety Act) (40 U.S.C.

333); Sec. 41, the Longshore and Harbor

Worker’s Compensation Act (33 U.S.C.

941); Secretary of Labor’s Order Nos.

12–71 (36 FR 8754), 8–76 (41 FR 25059),

9–83 (48 FR 35736), 1–90 (55 FR 9033),

or 6–96 (62 FR 111), as applicable; and

29 CFR part 1911; 29 CFR parts 1910

and 1926 are amended as set forth

below.

List of Subjects in 29 CFR Parts 1910

and 1926

Health, Occupational safety and

health, Reporting and recordkeeping

requirements.

Signed at Washington, DC, this 15th day of

December, 1997.

Charles N. Jeffress,

Assistant Secretary of Labor for Occupational

Safety and Health.

IX. Amended Standards

Part 1910 of Title 29 of the Code of

Federal Regulations is hearby amended

as follows:

PART 1910—[AMENDED]

Subpart G—[Amended]

1. The authority citation for Subpart

G of Part 1910 is revised to read as

follows:

Authority: Secs. 4, 6, and 8 of the

Occupational Safety and Health Act of 1970

(29 U.S.C. 653, 655, 657); Secretary of Labor’s

Orders 12–71 (36 FR 8754), 8–76 (41 FR

25059), 9-83 (48 FR 35736), 1–90 (55 FR

9033), or 6–96 (62 FR 111), as applicable; and

29 CFR part 1911.

2. Section 1910.94 is amended by

revising paragraphs (a)(1)(ii), (a)(5)(i),

(a)(5)(iii) introductory text, (a)(5)(iv),

(a)(6), (c)(6)(iii)(a), and (d)(9)(vi) as

follows:

§ 1910.94 Ventilation.

(a) * * *

(1) * * *

(ii) Abrasive-blasting respirator. A

respirator constructed so that it covers

the wearer’s head, neck, and shoulders

to protect the wearer from rebounding

abrasive.

* * * * *

(5) Personal protective equipment. (i)

Employers must use only respirators

approved by the National Institute for

Occupational Safety and Health

(NIOSH) under 42 CFR part 84 to

protect employees from dusts produced

during abrasive-blasting operations.

* * * * *

(iii) Properly fitted particulate-filter

respirators, commonly referred to as

dust-filter respirators, may be used for

short, intermittent, or occasional dust

exposures such as cleanup, dumping of

dust collectors, or unloading shipments

of sand at a receiving point when it is

not feasible to control the dust by

enclosure, exhaust ventilation, or other

means. The respirators used must be

approved by NIOSH under 42 CFR part

84 for protection against the specific

type of dust encountered.

* * * * *

(iv) For employees who use

respirators required by this section, the

employer must implement a respiratory

protection program in accordance with

29 CFR 1910.134.

* * * * *

(6) Air supply and air compressors.

Air for abrasive-blasting respirators

must be free of harmful quantities of

dusts, mists, or noxious gases, and must

meet the requirements for supplied-air

quality and use specified in 29 CFR

1910.134(i).

* * * * *

(c) * * *

(6) * * *

(iii) (a) When an operator is in a booth

downstream from the object being

sprayed, an air-supplied respirator or

other type of respirator must be used by

employees that has been approved by

NIOSH under 42 CFR part 84 for the

material being sprayed.

* * * * *

(d) * * *

(9) * * *

(vi) During the emergencies specified

in paragraph (d)(11)(v) of this section, if

employees must be in areas where the

concentrations of air contaminants are

greater than the limits set by paragraph

(d)(2)(iii) of this section or the oxygen

concentration is less than 19.5 percent,

they must use respirators that reduce

their exposure to a level below these

limits or that provide adequate oxygen.

Such respirators must also be provided

in marked, quickly-accessible storage

compartments built for this purpose

when the possibility exists that

hazardous concentrations of air

contaminants could be released

accidentally. The respirators must be

approved by the NIOSH under 42 CFR

part 84, selected by a competent

industrial hygienist or other technicallyqualified source, and used in

accordance with 29 CFR 1910.134.

* * * * *

Subpart H—[Amended]

3. The authority citation for subpart H

of part 1910 is revised to read as

follows:

Authority: Secs. 4, 6, and 8 of the

Occupational Safety and Health Act of 1970

(29 U.S.C. 653, 655, 657); Secretary of Labor’s

Orders 12–71 (36 FR 8754), 8–76 (41 FR

25059), 9-83 (48 FR 35736), 1–90 (55 FR

9033), or 6–96 (62 FR 111), as applicable; and

29 CFR part 1911.

4. Section 1910.111 is amended by

revising paragraphs (a)(2)(x) and

(b)(10)(ii) as follows:

§ 1910.111 Storage and handling of

anhydrous ammonia.

(a) * * *

(2) * * *

(x) Gas masks. Gas masks must be

approved by the National Institute for

Occupational Safety and Health

(NIOSH) under 42 CFR part 84 for use

with anhydrous ammonia.

* * * * *

(b) * * *

(10) * * *

(ii) Stationary storage installations

must have at least two suitable gas

masks in readily-accessible locations.

Full-face masks with ammonia canisters

that have been approved by NIOSH

under 42 CFR part 84 are suitable for

emergency action involving most

anhydrous ammonia leaks, particularly

leaks that occur outdoors. For

respiratory protection in concentrated

ammonia atmospheres, a self-contained

breathing apparatus is required.

* * * * *
1270 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

Subpart I—[Amended]

5. The authority citation for Subpart

I of Part 1910 is revised to read as

follows:

Authority: Sections 4, 6, and 8,

Occupational Safety and Health Act of 1970

(29 U.S.C. 653, 655, 657); Secretary of Labor’s

Order No. 12–71 (36 FR 8754), 8–76 (41 FR

25059), 9–83 (48 FR 35736), 1–90 (55 FR

9033), or 6–96 (62 FR 111), as applicable.

Sections 1910.132, 1910.134, and 1910.138

also issued under 29 CFR part 1911.

Sections 1910.133, 1910.135, and 1910.136

also issued under 29 CFR part 1911 and 5

U.S.C. 553.

6. Section 1910.134 is redesignated as

§ 1910.139 in subpart I and amended by

revising its title and adding introductory

text to read as follows:

§ 1910.139 Respiratory protection for M.

tuberculosis.

This section applies only to

respiratory protection against M.

tuberculosis and applies in lieu of

§ 1910.134.

* * * * *

7. A new section 1910.134 is added to

read as follows:

§ 1910.134 Respiratory protection.

This section applies to General

Industry (part 1910), Shipyards (part

1915), Marine Terminals (part 1917),

Longshoring (part 1918), and

Construction (part 1926).

(a) Permissible practice. (1) In the

control of those occupational diseases

caused by breathing air contaminated

with harmful dusts, fogs, fumes, mists,

gases, smokes, sprays, or vapors, the

primary objective shall be to prevent

atmospheric contamination. This shall

be accomplished as far as feasible by

accepted engineering control measures

(for example, enclosure or confinement

of the operation, general and local

ventilation, and substitution of less

toxic materials). When effective

engineering controls are not feasible, or

while they are being instituted,

appropriate respirators shall be used

pursuant to this section.

(2) Respirators shall be provided by

the employer when such equipment is

necessary to protect the health of the

employee. The employer shall provide

the respirators which are applicable and

suitable for the purpose intended. The

employer shall be responsible for the

establishment and maintenance of a

respiratory protection program which

shall include the requirements outlined

in paragraph (c) of this section.

(b) Definitions. The following

definitions are important terms used in

the respiratory protection standard in

this section.

Air-purifying respirator means a

respirator with an air-purifying filter,

cartridge, or canister that removes

specific air contaminants by passing

ambient air through the air-purifying

element.

Assigned protection factor (APF)

[Reserved]

Atmosphere-supplying respirator

means a respirator that supplies the

respirator user with breathing air from

a source independent of the ambient

atmosphere, and includes supplied-air

respirators (SARs) and self-contained

breathing apparatus (SCBA) units.

Canister or cartridge means a

container with a filter, sorbent, or

catalyst, or combination of these items,

which removes specific contaminants

from the air passed through the

container.

Demand respirator means an

atmosphere-supplying respirator that

admits breathing air to the facepiece

only when a negative pressure is created

inside the facepiece by inhalation.

Emergency situation means any

occurrence such as, but not limited to,

equipment failure, rupture of

containers, or failure of control

equipment that may or does result in an

uncontrolled significant release of an

airborne contaminant.

Employee exposure means exposure

to a concentration of an airborne

contaminant that would occur if the

employee were not using respiratory

protection.

End-of-service-life indicator (ESLI)

means a system that warns the

respirator user of the approach of the

end of adequate respiratory protection,

for example, that the sorbent is

approaching saturation or is no longer

effective.

Escape-only respirator means a

respirator intended to be used only for

emergency exit.

Filter or air purifying element means

a component used in respirators to

remove solid or liquid aerosols from the

inspired air.

Filtering facepiece (dust mask) means

a negative pressure particulate

respirator with a filter as an integral part

of the facepiece or with the entire

facepiece composed of the filtering

medium.

Fit factor means a quantitative

estimate of the fit of a particular

respirator to a specific individual, and

typically estimates the ratio of the

concentration of a substance in ambient

air to its concentration inside the

respirator when worn.

Fit test means the use of a protocol to

qualitatively or quantitatively evaluate

the fit of a respirator on an individual.

(See also Qualitative fit test QLFT and

Quantitative fit test QNFT.)

Helmet means a rigid respiratory inlet

covering that also provides head

protection against impact and

penetration.

High efficiency particulate air (HEPA)

filter means a filter that is at least

99.97% efficient in removing

monodisperse particles of 0.3

micrometers in diameter. The

equivalent NIOSH 42 CFR 84 particulate

filters are the N100, R100, and P100

filters.

Hood means a respiratory inlet

covering that completely covers the

head and neck and may also cover

portions of the shoulders and torso.

Immediately dangerous to life or

health (IDLH) means an atmosphere that

poses an immediate threat to life, would

cause irreversible adverse health effects,

or would impair an individual’s ability

to escape from a dangerous atmosphere.

Interior structural firefighting means

the physical activity of fire suppression,

rescue or both, inside of buildings or

enclosed structures which are involved

in a fire situation beyond the incipient

stage. (See 29 CFR 1910.155)

Loose-fitting facepiece means a

respiratory inlet covering that is

designed to form a partial seal with the

face.

Maximum use concentration (MUC)

[Reserved].

Negative pressure respirator (tight

fitting) means a respirator in which the

air pressure inside the facepiece is

negative during inhalation with respect

to the ambient air pressure outside the

respirator.

Oxygen deficient atmosphere means

an atmosphere with an oxygen content

below 19.5% by volume.

Physician or other licensed health

care professional (PLHCP) means an

individual whose legally permitted

scope of practice (i.e., license,

registration, or certification) allows him

or her to independently provide, or be

delegated the responsibility to provide,

some or all of the health care services

required by paragraph (e) of this section.

Positive pressure respirator means a

respirator in which the pressure inside

the respiratory inlet covering exceeds

the ambient air pressure outside the

respirator.

Powered air-purifying respirator

(PAPR) means an air-purifying

respirator that uses a blower to force the

ambient air through air-purifying

elements to the inlet covering.

Pressure demand respirator means a

positive pressure atmosphere-supplying

respirator that admits breathing air to

the facepiece when the positive pressure
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1271

is reduced inside the facepiece by

inhalation.

Qualitative fit test (QLFT) means a

pass/fail fit test to assess the adequacy

of respirator fit that relies on the

individual’s response to the test agent.

Quantitative fit test (QNFT) means an

assessment of the adequacy of respirator

fit by numerically measuring the

amount of leakage into the respirator.

Respiratory inlet covering means that

portion of a respirator that forms the

protective barrier between the user’s

respiratory tract and an air-purifying

device or breathing air source, or both.

It may be a facepiece, helmet, hood,

suit, or a mouthpiece respirator with

nose clamp.

Self-contained breathing apparatus

(SCBA) means an atmosphere-supplying

respirator for which the breathing air

source is designed to be carried by the

user.

Service life means the period of time

that a respirator, filter or sorbent, or

other respiratory equipment provides

adequate protection to the wearer.

Supplied-air respirator (SAR) or

airline respirator means an atmospheresupplying respirator for which the

source of breathing air is not designed

to be carried by the user.

This section means this respiratory

protection standard.

Tight-fitting facepiece means a

respiratory inlet covering that forms a

complete seal with the face.

User seal check means an action

conducted by the respirator user to

determine if the respirator is properly

seated to the face.

(c) Respiratory protection program.

This paragraph requires the employer to

develop and implement a written

respiratory protection program with

required worksite-specific procedures

and elements for required respirator use.

The program must be administered by a

suitably trained program administrator.

In addition, certain program elements

may be required for voluntary use to

prevent potential hazards associated

with the use of the respirator. The Small

Entity Compliance Guide contains

criteria for the selection of a program

administrator and a sample program

that meets the requirements of this

paragraph. Copies of the Small Entity

Compliance Guide will be available on

or about April 8, 1998 from the

Occupational Safety and Health

Administration’s Office of Publications,

Room N 3101, 200 Constitution Avenue,

NW, Washington, DC, 20210 (202–219–

4667).

(1) In any workplace where

respirators are necessary to protect the

health of the employee or whenever

respirators are required by the

employer, the employer shall establish

and implement a written respiratory

protection program with worksitespecific procedures. The program shall

be updated as necessary to reflect those

changes in workplace conditions that

affect respirator use. The employer shall

include in the program the following

provisions of this section, as applicable:

(i) Procedures for selecting respirators

for use in the workplace;

(ii) Medical evaluations of employees

required to use respirators;

(iii) Fit testing procedures for tightfitting respirators;

(iv) Procedures for proper use of

respirators in routine and reasonably

foreseeable emergency situations;

(v) Procedures and schedules for

cleaning, disinfecting, storing,

inspecting, repairing, discarding, and

otherwise maintaining respirators;

(vi) Procedures to ensure adequate air

quality, quantity, and flow of breathing

air for atmosphere-supplying

respirators;

(vii) Training of employees in the

respiratory hazards to which they are

potentially exposed during routine and

emergency situations;

(viii) Training of employees in the

proper use of respirators, including

putting on and removing them, any

limitations on their use, and their

maintenance; and

(ix) Procedures for regularly

evaluating the effectiveness of the

program.

(2) Where respirator use is not

required:

(i) An employer may provide

respirators at the request of employees

or permit employees to use their own

respirators, if the employer determines

that such respirator use will not in itself

create a hazard. If the employer

determines that any voluntary respirator

use is permissible, the employer shall

provide the respirator users with the

information contained in Appendix D to

this section (‘‘Information for

Employees Using Respirators When Not

Required Under the Standard’’); and

(ii) In addition, the employer must

establish and implement those elements

of a written respiratory protection

program necessary to ensure that any

employee using a respirator voluntarily

is medically able to use that respirator,

and that the respirator is cleaned,

stored, and maintained so that its use

does not present a health hazard to the

user. Exception: Employers are not

required to include in a written

respiratory protection program those

employees whose only use of respirators

involves the voluntary use of filtering

facepieces (dust masks).

(3) The employer shall designate a

program administrator who is qualified

by appropriate training or experience

that is commensurate with the

complexity of the program to administer

or oversee the respiratory protection

program and conduct the required

evaluations of program effectiveness.

(4) The employer shall provide

respirators, training, and medical

evaluations at no cost to the employee.

(d) Selection of respirators. This

paragraph requires the employer to

evaluate respiratory hazard(s) in the

workplace, identify relevant workplace

and user factors, and base respirator

selection on these factors. The

paragraph also specifies appropriately

protective respirators for use in IDLH

atmospheres, and limits the selection

and use of air-purifying respirators.

(1) General requirements. (i) The

employer shall select and provide an

appropriate respirator based on the

respiratory hazard(s) to which the

worker is exposed and workplace and

user factors that affect respirator

performance and reliability.

(ii) The employer shall select a

NIOSH-certified respirator. The

respirator shall be used in compliance

with the conditions of its certification.

(iii) The employer shall identify and

evaluate the respiratory hazard(s) in the

workplace; this evaluation shall include

a reasonable estimate of employee

exposures to respiratory hazard(s) and

an identification of the contaminant’s

chemical state and physical form.

Where the employer cannot identify or

reasonably estimate the employee

exposure, the employer shall consider

the atmosphere to be IDLH.

(iv) The employer shall select

respirators from a sufficient number of

respirator models and sizes so that the

respirator is acceptable to, and correctly

fits, the user.

(2) Respirators for IDLH atmospheres.

(i) The employer shall provide the

following respirators for employee use

in IDLH atmospheres:

(A) A full facepiece pressure demand

SCBA certified by NIOSH for a

minimum service life of thirty minutes,

or

(B) A combination full facepiece

pressure demand supplied-air respirator

(SAR) with auxiliary self-contained air

supply.

(ii) Respirators provided only for

escape from IDLH atmospheres shall be

NIOSH-certified for escape from the

atmosphere in which they will be used.

(iii) All oxygen-deficient atmospheres

shall be considered IDLH. Exception: If

the employer demonstrates that, under

all foreseeable conditions, the oxygen

concentration can be maintained within
1272 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

the ranges specified in Table II of this

section (i.e., for the altitudes set out in

the table), then any atmospheresupplying respirator may be used.

(3) Respirators for atmospheres that

are not IDLH. (i) The employer shall

provide a respirator that is adequate to

protect the health of the employee and

ensure compliance with all other OSHA

statutory and regulatory requirements,

under routine and reasonably

foreseeable emergency situations.

(A) Assigned Protection Factors

(APFs) [Reserved]

(B) Maximum Use Concentration

(MUC) [Reserved]

(ii) The respirator selected shall be

appropriate for the chemical state and

physical form of the contaminant.

(iii) For protection against gases and

vapors, the employer shall provide:

(A) An atmosphere-supplying

respirator, or

(B) An air-purifying respirator,

provided that:

(1) The respirator is equipped with an

end-of-service-life indicator (ESLI)

certified by NIOSH for the contaminant;

or

(2) If there is no ESLI appropriate for

conditions in the employer’s workplace,

the employer implements a change

schedule for canisters and cartridges

that is based on objective information or

data that will ensure that canisters and

cartridges are changed before the end of

their service life. The employer shall

describe in the respirator program the

information and data relied upon and

the basis for the canister and cartridge

change schedule and the basis for

reliance on the data.

(iv) For protection against

particulates, the employer shall provide:

(A) An atmosphere-supplying

respirator; or

(B) An air-purifying respirator

equipped with a filter certified by

NIOSH under 30 CFR part 11 as a high

efficiency particulate air (HEPA) filter,

or an air-purifying respirator equipped

with a filter certified for particulates by

NIOSH under 42 CFR part 84; or

(C) For contaminants consisting

primarily of particles with mass median

aerodynamic diameters (MMAD) of at

least 2 micrometers, an air-purifying

respirator equipped with any filter

certified for particulates by NIOSH.

TABLE I.—Assigned Protection

Factors [Reserved]

TABLE II

Altitude (ft.)

Oxygen deficient

Atmospheres

(% 02) for

which the

employer

may rely on

atmospheresupplying

respirators

Less than 3,001 ....................... 16.0–19.5

3,001–4,000 ............................. 16.4–19.5

4,001–5,000 ............................. 17.1–19.5

5,001–6,000 ............................. 17.8–19.5

6,001–7,000 ............................. 18.5–19.5

7,001–8,0001 ........................... 19.3–19.5.

1Above 8,000 feet the exception does not

apply. Oxygen-enriched breathing air must be

supplied above 14,000 feet.

(e) Medical evaluation. Using a

respirator may place a physiological

burden on employees that varies with

the type of respirator worn, the job and

workplace conditions in which the

respirator is used, and the medical

status of the employee. Accordingly,

this paragraph specifies the minimum

requirements for medical evaluation

that employers must implement to

determine the employee’s ability to use

a respirator.

(1) General. The employer shall

provide a medical evaluation to

determine the employee’s ability to use

a respirator, before the employee is fit

tested or required to use the respirator

in the workplace. The employer may

discontinue an employee’s medical

evaluations when the employee is no

longer required to use a respirator.

(2) Medical evaluation procedures. (i)

The employer shall identify a physician

or other licensed health care

professional (PLHCP) to perform

medical evaluations using a medical

questionnaire or an initial medical

examination that obtains the same

information as the medical

questionnaire.

(ii) The medical evaluation shall

obtain the information requested by the

questionnaire in Sections 1 and 2, Part

A of Appendix C of this section.

(3) Follow-up medical examination.

(i) The employer shall ensure that a

follow-up medical examination is

provided for an employee who gives a

positive response to any question among

questions 1 through 8 in Section 2, Part

A of Appendix C or whose initial

medical examination demonstrates the

need for a follow-up medical

examination.

(ii) The follow-up medical

examination shall include any medical

tests, consultations, or diagnostic

procedures that the PLHCP deems

necessary to make a final determination.

(4) Administration of the medical

questionnaire and examinations. (i) The

medical questionnaire and examinations

shall be administered confidentially

during the employee’s normal working

hours or at a time and place convenient

to the employee. The medical

questionnaire shall be administered in a

manner that ensures that the employee

understands its content.

(ii) The employer shall provide the

employee with an opportunity to

discuss the questionnaire and

examination results with the PLHCP.

(5) Supplemental information for the

PLHCP. (i) The following information

must be provided to the PLHCP before

the PLHCP makes a recommendation

concerning an employee’s ability to use

a respirator:

(A) The type and weight of the

respirator to be used by the employee;

(B) The duration and frequency of

respirator use (including use for rescue

and escape);

(C) The expected physical work effort;

(D) Additional protective clothing and

equipment to be worn; and

(E) Temperature and humidity

extremes that may be encountered.

(ii) Any supplemental information

provided previously to the PLHCP

regarding an employee need not be

provided for a subsequent medical

evaluation if the information and the

PLHCP remain the same.

(iii) The employer shall provide the

PLHCP with a copy of the written

respiratory protection program and a

copy of this section.

Note to Paragraph (e)(5)(iii): When the

employer replaces a PLHCP, the employer

must ensure that the new PLHCP obtains this

information, either by providing the

documents directly to the PLHCP or having

the documents transferred from the former

PLHCP to the new PLHCP. However, OSHA

does not expect employers to have employees

medically reevaluated solely because a new

PLHCP has been selected.

(6) Medical determination. In

determining the employee’s ability to

use a respirator, the employer shall:

(i) Obtain a written recommendation

regarding the employee’s ability to use

the respirator from the PLHCP. The

recommendation shall provide only the

following information:

(A) Any limitations on respirator use

related to the medical condition of the

employee, or relating to the workplace

conditions in which the respirator will

be used, including whether or not the

employee is medically able to use the

respirator;

(B) The need, if any, for follow-up

medical evaluations; and

(C) A statement that the PLHCP has

provided the employee with a copy of

the PLHCP’s written recommendation.
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1273

(ii) If the respirator is a negative

pressure respirator and the PLHCP finds

a medical condition that may place the

employee’s health at increased risk if

the respirator is used, the employer

shall provide a PAPR if the PLHCP’s

medical evaluation finds that the

employee can use such a respirator; if a

subsequent medical evaluation finds

that the employee is medically able to

use a negative pressure respirator, then

the employer is no longer required to

provide a PAPR.

(7) Additional medical evaluations.

At a minimum, the employer shall

provide additional medical evaluations

that comply with the requirements of

this section if:

(i) An employee reports medical signs

or symptoms that are related to ability

to use a respirator;

(ii) A PLHCP, supervisor, or the

respirator program administrator

informs the employer that an employee

needs to be reevaluated;

(iii) Information from the respiratory

protection program, including

observations made during fit testing and

program evaluation, indicates a need for

employee reevaluation; or

(iv) A change occurs in workplace

conditions (e.g., physical work effort,

protective clothing, temperature) that

may result in a substantial increase in

the physiological burden placed on an

employee.

(f) Fit testing. This paragraph requires

that, before an employee may be

required to use any respirator with a

negative or positive pressure tight-fitting

facepiece, the employee must be fit

tested with the same make, model, style,

and size of respirator that will be used.

This paragraph specifies the kinds of fit

tests allowed, the procedures for

conducting them, and how the results of

the fit tests must be used.

(1) The employer shall ensure that

employees using a tight-fitting facepiece

respirator pass an appropriate

qualitative fit test (QLFT) or quantitative

fit test (QNFT) as stated in this

paragraph.

(2) The employer shall ensure that an

employee using a tight-fitting facepiece

respirator is fit tested prior to initial use

of the respirator, whenever a different

respirator facepiece (size, style, model

or make) is used, and at least annually

thereafter.

(3) The employer shall conduct an

additional fit test whenever the

employee reports, or the employer,

PLHCP, supervisor, or program

administrator makes visual observations

of, changes in the employee’s physical

condition that could affect respirator fit.

Such conditions include, but are not

limited to, facial scarring, dental

changes, cosmetic surgery, or an

obvious change in body weight.

(4) If after passing a QLFT or QNFT,

the employee subsequently notifies the

employer, program administrator,

supervisor, or PLHCP that the fit of the

respirator is unacceptable, the employee

shall be given a reasonable opportunity

to select a different respirator facepiece

and to be retested.

(5) The fit test shall be administered

using an OSHA-accepted QLFT or

QNFT protocol. The OSHA-accepted

QLFT and QNFT protocols and

procedures are contained in Appendix

A of this section.

(6) QLFT may only be used to fit test

negative pressure air-purifying

respirators that must achieve a fit factor

of 100 or less.

(7) If the fit factor, as determined

through an OSHA-accepted QNFT

protocol, is equal to or greater than 100

for tight-fitting half facepieces, or equal

to or greater than 500 for tight-fitting

full facepieces, the QNFT has been

passed with that respirator.

(8) Fit testing of tight-fitting

atmosphere-supplying respirators and

tight-fitting powered air-purifying

respirators shall be accomplished by

performing quantitative or qualitative fit

testing in the negative pressure mode,

regardless of the mode of operation

(negative or positive pressure) that is

used for respiratory protection.

(i) Qualitative fit testing of these

respirators shall be accomplished by

temporarily converting the respirator

user’s actual facepiece into a negative

pressure respirator with appropriate

filters, or by using an identical negative

pressure air-purifying respirator

facepiece with the same sealing surfaces

as a surrogate for the atmospheresupplying or powered air-purifying

respirator facepiece.

(ii) Quantitative fit testing of these

respirators shall be accomplished by

modifying the facepiece to allow

sampling inside the facepiece in the

breathing zone of the user, midway

between the nose and mouth. This

requirement shall be accomplished by

installing a permanent sampling probe

onto a surrogate facepiece, or by using

a sampling adapter designed to

temporarily provide a means of

sampling air from inside the facepiece.

(iii) Any modifications to the

respirator facepiece for fit testing shall

be completely removed, and the

facepiece restored to NIOSH-approved

configuration, before that facepiece can

be used in the workplace.

(g) Use of respirators. This paragraph

requires employers to establish and

implement procedures for the proper

use of respirators. These requirements

include prohibiting conditions that may

result in facepiece seal leakage,

preventing employees from removing

respirators in hazardous environments,

taking actions to ensure continued

effective respirator operation throughout

the work shift, and establishing

procedures for the use of respirators in

IDLH atmospheres or in interior

structural firefighting situations.

(1) Facepiece seal protection. (i) The

employer shall not permit respirators

with tight-fitting facepieces to be worn

by employees who have:

(A) Facial hair that comes between the

sealing surface of the facepiece and the

face or that interferes with valve

function; or

(B) Any condition that interferes with

the face-to-facepiece seal or valve

function.

(ii) If an employee wears corrective

glasses or goggles or other personal

protective equipment, the employer

shall ensure that such equipment is

worn in a manner that does not interfere

with the seal of the facepiece to the face

of the user.

(iii) For all tight-fitting respirators, the

employer shall ensure that employees

perform a user seal check each time they

put on the respirator using the

procedures in Appendix B–1 or

procedures recommended by the

respirator manufacturer that the

employer demonstrates are as effective

as those in Appendix B–1 of this

section.

(2) Continuing respirator

effectiveness. (i) Appropriate

surveillance shall be maintained of

work area conditions and degree of

employee exposure or stress. When

there is a change in work area

conditions or degree of employee

exposure or stress that may affect

respirator effectiveness, the employer

shall reevaluate the continued

effectiveness of the respirator.

(ii) The employer shall ensure that

employees leave the respirator use area:

(A) To wash their faces and respirator

facepieces as necessary to prevent eye or

skin irritation associated with respirator

use; or

(B) If they detect vapor or gas

breakthrough, changes in breathing

resistance, or leakage of the facepiece; or

(C) To replace the respirator or the

filter, cartridge, or canister elements.

(iii) If the employee detects vapor or

gas breakthrough, changes in breathing

resistance, or leakage of the facepiece,

the employer must replace or repair the

respirator before allowing the employee

to return to the work area.

(3) Procedures for IDLH atmospheres.

For all IDLH atmospheres, the employer

shall ensure that:
1274 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

(i) One employee or, when needed,

more than one employee is located

outside the IDLH atmosphere;

(ii) Visual, voice, or signal line

communication is maintained between

the employee(s) in the IDLH atmosphere

and the employee(s) located outside the

IDLH atmosphere;

(iii) The employee(s) located outside

the IDLH atmosphere are trained and

equipped to provide effective

emergency rescue;

(iv) The employer or designee is

notified before the employee(s) located

outside the IDLH atmosphere enter the

IDLH atmosphere to provide emergency

rescue;

(v) The employer or designee

authorized to do so by the employer,

once notified, provides necessary

assistance appropriate to the situation;

(vi) Employee(s) located outside the

IDLH atmospheres are equipped with:

(A) Pressure demand or other positive

pressure SCBAs, or a pressure demand

or other positive pressure supplied-air

respirator with auxiliary SCBA; and

either

(B) Appropriate retrieval equipment

for removing the employee(s) who

enter(s) these hazardous atmospheres

where retrieval equipment would

contribute to the rescue of the

employee(s) and would not increase the

overall risk resulting from entry; or

(C) Equivalent means for rescue where

retrieval equipment is not required

under paragraph (g)(3)(vi)(B).

(4) Procedures for interior structural

firefighting. In addition to the

requirements set forth under paragraph

(g)(3), in interior structural fires, the

employer shall ensure that:

(i) At least two employees enter the

IDLH atmosphere and remain in visual

or voice contact with one another at all

times;

(ii) At least two employees are located

outside the IDLH atmosphere; and

(iii) All employees engaged in interior

structural firefighting use SCBAs.

Note 1 to paragraph (g): One of the two

individuals located outside the IDLH

atmosphere may be assigned to an additional

role, such as incident commander in charge

of the emergency or safety officer, so long as

this individual is able to perform assistance

or rescue activities without jeopardizing the

safety or health of any firefighter working at

the incident.

Note 2 to paragraph (g): Nothing in this

section is meant to preclude firefighters from

performing emergency rescue activities

before an entire team has assembled.

(h) Maintenance and care of

respirators. This paragraph requires the

employer to provide for the cleaning

and disinfecting, storage, inspection,

and repair of respirators used by

employees.

(1) Cleaning and disinfecting. The

employer shall provide each respirator

user with a respirator that is clean,

sanitary, and in good working order.

The employer shall ensure that

respirators are cleaned and disinfected

using the procedures in Appendix B–2

of this section, or procedures

recommended by the respirator

manufacturer, provided that such

procedures are of equivalent

effectiveness. The respirators shall be

cleaned and disinfected at the following

intervals:

(i) Respirators issued for the exclusive

use of an employee shall be cleaned and

disinfected as often as necessary to be

maintained in a sanitary condition;

(ii) Respirators issued to more than

one employee shall be cleaned and

disinfected before being worn by

different individuals;

(iii) Respirators maintained for

emergency use shall be cleaned and

disinfected after each use; and

(iv) Respirators used in fit testing and

training shall be cleaned and disinfected

after each use.

(2) Storage. The employer shall

ensure that respirators are stored as

follows:

(i) All respirators shall be stored to

protect them from damage,

contamination, dust, sunlight, extreme

temperatures, excessive moisture, and

damaging chemicals, and they shall be

packed or stored to prevent deformation

of the facepiece and exhalation valve.

(ii) In addition to the requirements of

paragraph (h)(2)(i) of this section,

emergency respirators shall be:

(A) Kept accessible to the work area;

(B) Stored in compartments or in

covers that are clearly marked as

containing emergency respirators; and

(C) Stored in accordance with any

applicable manufacturer instructions.

(3) Inspection. (i) The employer shall

ensure that respirators are inspected as

follows:

(A) All respirators used in routine

situations shall be inspected before each

use and during cleaning;

(B) All respirators maintained for use

in emergency situations shall be

inspected at least monthly and in

accordance with the manufacturer’s

recommendations, and shall be checked

for proper function before and after each

use; and

(C) Emergency escape-only respirators

shall be inspected before being carried

into the workplace for use.

(ii) The employer shall ensure that

respirator inspections include the

following:

(A) A check of respirator function,

tightness of connections, and the

condition of the various parts including,

but not limited to, the facepiece, head

straps, valves, connecting tube, and

cartridges, canisters or filters; and

(B) A check of elastomeric parts for

pliability and signs of deterioration.

(iii) In addition to the requirements of

paragraphs (h)(3)(i) and (ii) of this

section, self-contained breathing

apparatus shall be inspected monthly.

Air and oxygen cylinders shall be

maintained in a fully charged state and

shall be recharged when the pressure

falls to 90% of the manufacturer’s

recommended pressure level. The

employer shall determine that the

regulator and warning devices function

properly.

(iv) For respirators maintained for

emergency use, the employer shall:

(A) Certify the respirator by

documenting the date the inspection

was performed, the name (or signature)

of the person who made the inspection,

the findings, required remedial action,

and a serial number or other means of

identifying the inspected respirator; and

(B) Provide this information on a tag

or label that is attached to the storage

compartment for the respirator, is kept

with the respirator, or is included in

inspection reports stored as paper or

electronic files. This information shall

be maintained until replaced following

a subsequent certification.

(4) Repairs. The employer shall

ensure that respirators that fail an

inspection or are otherwise found to be

defective are removed from service, and

are discarded or repaired or adjusted in

accordance with the following

procedures:

(i) Repairs or adjustments to

respirators are to be made only by

persons appropriately trained to

perform such operations and shall use

only the respirator manufacturer’s

NIOSH-approved parts designed for the

respirator;

(ii) Repairs shall be made according to

the manufacturer’s recommendations

and specifications for the type and

extent of repairs to be performed; and

(iii) Reducing and admission valves,

regulators, and alarms shall be adjusted

or repaired only by the manufacturer or

a technician trained by the

manufacturer.

(i) Breathing air quality and use. This

paragraph requires the employer to

provide employees using atmospheresupplying respirators (supplied-air and

SCBA) with breathing gases of high

purity.

(1) The employer shall ensure that

compressed air, compressed oxygen,

liquid air, and liquid oxygen used for

respiration accords with the following

specifications:
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1275

(i) Compressed and liquid oxygen

shall meet the United States

Pharmacopoeia requirements for

medical or breathing oxygen; and

(ii) Compressed breathing air shall

meet at least the requirements for Type

1-Grade D breathing air described in

ANSI/Compressed Gas Association

Commodity Specification for Air, G–

7.1–1989, to include:

(A) Oxygen content (v/v) of 19.5–

23.5%;

(B) Hydrocarbon (condensed) content

of 5 milligrams per cubic meter of air or

less;

(C) Carbon monoxide (CO) content of

10 ppm or less;

(D) Carbon dioxide content of 1,000

ppm or less; and

(E) Lack of noticeable odor.

(2) The employer shall ensure that

compressed oxygen is not used in

atmosphere-supplying respirators that

have previously used compressed air.

(3) The employer shall ensure that

oxygen concentrations greater than

23.5% are used only in equipment

designed for oxygen service or

distribution.

(4) The employer shall ensure that

cylinders used to supply breathing air to

respirators meet the following

requirements:

(i) Cylinders are tested and

maintained as prescribed in the

Shipping Container Specification

Regulations of the Department of

Transportation (49 CFR part 173 and

part 178);

(ii) Cylinders of purchased breathing

air have a certificate of analysis from the

supplier that the breathing air meets the

requirements for Type 1—Grade D

breathing air; and

(iii) The moisture content in the

cylinder does not exceed a dew point of

¥50 °F (¥45.6 °C) at 1 atmosphere

pressure.

(5) The employer shall ensure that

compressors used to supply breathing

air to respirators are constructed and

situated so as to:

(i) Prevent entry of contaminated air

into the air-supply system;

(ii) Minimize moisture content so that

the dew point at 1 atmosphere pressure

is 10 degrees F (5.56 °C) below the

ambient temperature;

(iii) Have suitable in-line air-purifying

sorbent beds and filters to further ensure

breathing air quality. Sorbent beds and

filters shall be maintained and replaced

or refurbished periodically following

the manufacturer’s instructions.

(iv) Have a tag containing the most

recent change date and the signature of

the person authorized by the employer

to perform the change. The tag shall be

maintained at the compressor.

(6) For compressors that are not oillubricated, the employer shall ensure

that carbon monoxide levels in the

breathing air do not exceed 10 ppm.

(7) For oil-lubricated compressors, the

employer shall use a high-temperature

or carbon monoxide alarm, or both, to

monitor carbon monoxide levels. If only

high-temperature alarms are used, the

air supply shall be monitored at

intervals sufficient to prevent carbon

monoxide in the breathing air from

exceeding 10 ppm.

(8) The employer shall ensure that

breathing air couplings are incompatible

with outlets for nonrespirable worksite

air or other gas systems. No

asphyxiating substance shall be

introduced into breathing air lines.

(9) The employer shall use breathing

gas containers marked in accordance

with the NIOSH respirator certification

standard, 42 CFR part 84.

(j) Identification of filters, cartridges,

and canisters. The employer shall

ensure that all filters, cartridges and

canisters used in the workplace are

labeled and color coded with the NIOSH

approval label and that the label is not

removed and remains legible.

(k) Training and information. This

paragraph requires the employer to

provide effective training to employees

who are required to use respirators. The

training must be comprehensive,

understandable, and recur annually, and

more often if necessary. This paragraph

also requires the employer to provide

the basic information on respirators in

Appendix D of this section to employees

who wear respirators when not required

by this section or by the employer to do

so.

(1) The employer shall ensure that

each employee can demonstrate

knowledge of at least the following:

(i) Why the respirator is necessary and

how improper fit, usage, or maintenance

can compromise the protective effect of

the respirator;

(ii) What the limitations and

capabilities of the respirator are;

(iii) How to use the respirator

effectively in emergency situations,

including situations in which the

respirator malfunctions;

(iv) How to inspect, put on and

remove, use, and check the seals of the

respirator;

(v) What the procedures are for

maintenance and storage of the

respirator;

(vi) How to recognize medical signs

and symptoms that may limit or prevent

the effective use of respirators; and

(vii) The general requirements of this

section.

(2) The training shall be conducted in

a manner that is understandable to the

employee.

(3) The employer shall provide the

training prior to requiring the employee

to use a respirator in the workplace.

(4) An employer who is able to

demonstrate that a new employee has

received training within the last 12

months that addresses the elements

specified in paragraph (k)(1)(i) through

(vii) is not required to repeat such

training provided that, as required by

paragraph (k)(1), the employee can

demonstrate knowledge of those

element(s). Previous training not

repeated initially by the employer must

be provided no later than 12 months

from the date of the previous training.

(5) Retraining shall be administered

annually, and when the following

situations occur:

(i) Changes in the workplace or the

type of respirator render previous

training obsolete;

(ii) Inadequacies in the employee’s

knowledge or use of the respirator

indicate that the employee has not

retained the requisite understanding or

skill; or

(iii) Any other situation arises in

which retraining appears necessary to

ensure safe respirator use.

(6) The basic advisory information on

respirators, as presented in Appendix D

of this section, shall be provided by the

employer in any written or oral format,

to employees who wear respirators

when such use is not required by this

section or by the employer.

(l) Program evaluation. This section

requires the employer to conduct

evaluations of the workplace to ensure

that the written respiratory protection

program is being properly implemented,

and to consult employees to ensure that

they are using the respirators properly.

(1) The employer shall conduct

evaluations of the workplace as

necessary to ensure that the provisions

of the current written program are being

effectively implemented and that it

continues to be effective.

(2) The employer shall regularly

consult employees required to use

respirators to assess the employees’

views on program effectiveness and to

identify any problems. Any problems

that are identified during this

assessment shall be corrected. Factors to

be assessed include, but are not limited

to:

(i) Respirator fit (including the ability

to use the respirator without interfering

with effective workplace performance);

(ii) Appropriate respirator selection

for the hazards to which the employee

is exposed;
1276 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

(iii) Proper respirator use under the

workplace conditions the employee

encounters; and

(iv) Proper respirator maintenance.

(m) Recordkeeping. This section

requires the employer to establish and

retain written information regarding

medical evaluations, fit testing, and the

respirator program. This information

will facilitate employee involvement in

the respirator program, assist the

employer in auditing the adequacy of

the program, and provide a record for

compliance determinations by OSHA.

(1) Medical evaluation. Records of

medical evaluations required by this

section must be retained and made

available in accordance with 29 CFR

1910.1020.

(2) Fit testing. (i) The employer shall

establish a record of the qualitative and

quantitative fit tests administered to an

employee including:

(A) The name or identification of the

employee tested;

(B) Type of fit test performed;

(C) Specific make, model, style, and

size of respirator tested;

(D) Date of test; and

(E) The pass/fail results for QLFTs or

the fit factor and strip chart recording or

other recording of the test results for

QNFTs.

(ii) Fit test records shall be retained

for respirator users until the next fit test

is administered.

(3) A written copy of the current

respirator program shall be retained by

the employer.

(4) Written materials required to be

retained under this paragraph shall be

made available upon request to affected

employees and to the Assistant

Secretary or designee for examination

and copying.

(n) Dates. (1) Effective date. This

section is effective April 8, 1998. The

obligations imposed by this section

commence on the effective date unless

otherwise noted in this paragraph.

Compliance with obligations that do not

commence on the effective date shall

occur no later than the applicable startup date.

(2) Compliance dates. All obligations

of this section commence on the

effective date except as follows:

(i) The determination that respirator

use is required (paragraph (a)) shall be

completed no later than September 8,

1998.

(ii) Compliance with provisions of

this section for all other provisions shall

be completed no later than October 5,

1998.

(3) The provisions of 29 CFR 1910.134

and 29 CFR 1926.103, contained in the

29 CFR parts 1900 to 1910.99 and the

29 CFR part 1926 editions, revised as of

July 1, 1997, are in effect and

enforceable until April 8, 1998, or

during any administrative or judicial

stay of the provisions of this section.

(4) Existing Respiratory Protection

Programs. If, in the 12 month period

preceding April 8, 1998, the employer

has conducted annual respirator

training, fit testing, respirator program

evaluation, or medical evaluations, the

employer may use the results of those

activities to comply with the

corresponding provisions of this

section, providing that these activities

were conducted in a manner that meets

the requirements of this section.

(o) Appendices. (1) Compliance with

Appendix A, Appendix B–1, Appendix

B–2, and Appendix C of this section is

mandatory.

(2) Appendix D of this section is nonmandatory and is not intended to create

any additional obligations not otherwise

imposed or to detract from any existing

obligations.

Appendix A to § 1910.134: Fit Testing

Procedures (Mandatory)

Part I. OSHA-Accepted Fit Test Protocols

A. Fit Testing Procedures—General

Requirements

The employer shall conduct fit testing

using the following procedures. The

requirements in this appendix apply to all

OSHA-accepted fit test methods, both QLFT

and QNFT.

1. The test subject shall be allowed to pick

the most acceptable respirator from a

sufficient number of respirator models and

sizes so that the respirator is acceptable to,

and correctly fits, the user.

2. Prior to the selection process, the test

subject shall be shown how to put on a

respirator, how it should be positioned on

the face, how to set strap tension and how

to determine an acceptable fit. A mirror shall

be available to assist the subject in evaluating

the fit and positioning of the respirator. This

instruction may not constitute the subject’s

formal training on respirator use, because it

is only a review.

3. The test subject shall be informed that

he/she is being asked to select the respirator

that provides the most acceptable fit. Each

respirator represents a different size and

shape, and if fitted and used properly, will

provide adequate protection.

4. The test subject shall be instructed to

hold each chosen facepiece up to the face

and eliminate those that obviously do not

give an acceptable fit.

5. The more acceptable facepieces are

noted in case the one selected proves

unacceptable; the most comfortable mask is

donned and worn at least five minutes to

assess comfort. Assistance in assessing

comfort can be given by discussing the points

in the following item A.6. If the test subject

is not familiar with using a particular

respirator, the test subject shall be directed

to don the mask several times and to adjust

the straps each time to become adept at

setting proper tension on the straps.

6. Assessment of comfort shall include a

review of the following points with the test

subject and allowing the test subject adequate

time to determine the comfort of the

respirator:

(a) Position of the mask on the nose

(b) Room for eye protection

(c) Room to talk

(d) Position of mask on face and cheeks

7. The following criteria shall be used to

help determine the adequacy of the respirator

fit:

(a) Chin properly placed;

(b) Adequate strap tension, not overly

tightened;

(c) Fit across nose bridge;

(d) Respirator of proper size to span

distance from nose to chin;

(e) Tendency of respirator to slip;

(f) Self-observation in mirror to evaluate fit

and respirator position.

8. The test subject shall conduct a user seal

check, either the negative and positive

pressure seal checks described in Appendix

B–1 of this section or those recommended by

the respirator manufacturer which provide

equivalent protection to the procedures in

Appendix B–1. Before conducting the

negative and positive pressure checks, the

subject shall be told to seat the mask on the

face by moving the head from side-to-side

and up and down slowly while taking in a

few slow deep breaths. Another facepiece

shall be selected and retested if the test

subject fails the user seal check tests.

9. The test shall not be conducted if there

is any hair growth between the skin and the

facepiece sealing surface, such as stubble

beard growth, beard, mustache or sideburns

which cross the respirator sealing surface.

Any type of apparel which interferes with a

satisfactory fit shall be altered or removed.

10. If a test subject exhibits difficulty in

breathing during the tests, she or he shall be

referred to a physician or other licensed

health care professional, as appropriate, to

determine whether the test subject can wear

a respirator while performing her or his

duties.

11. If the employee finds the fit of the

respirator unacceptable, the test subject shall

be given the opportunity to select a different

respirator and to be retested.

12. Exercise regimen. Prior to the

commencement of the fit test, the test subject

shall be given a description of the fit test and

the test subject’s responsibilities during the

test procedure. The description of the process

shall include a description of the test

exercises that the subject will be performing.

The respirator to be tested shall be worn for

at least 5 minutes before the start of the fit

test.

13. The fit test shall be performed while

the test subject is wearing any applicable

safety equipment that may be worn during

actual respirator use which could interfere

with respirator fit.

14. Test Exercises. (a) The following test

exercises are to be performed for all fit testing

methods prescribed in this appendix, except

for the CNP method. A separate fit testing

exercise regimen is contained in the CNP

protocol. The test subject shall perform

exercises, in the test environment, in the

following manner:
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1277

(1) Normal breathing. In a normal standing

position, without talking, the subject shall

breathe normally.

(2) Deep breathing. In a normal standing

position, the subject shall breathe slowly and

deeply, taking caution so as not to

hyperventilate.

(3) Turning head side to side. Standing in

place, the subject shall slowly turn his/her

head from side to side between the extreme

positions on each side. The head shall be

held at each extreme momentarily so the

subject can inhale at each side.

(4) Moving head up and down. Standing in

place, the subject shall slowly move his/her

head up and down. The subject shall be

instructed to inhale in the up position (i.e.,

when looking toward the ceiling).

(5) Talking. The subject shall talk out loud

slowly and loud enough so as to be heard

clearly by the test conductor. The subject can

read from a prepared text such as the

Rainbow Passage, count backward from 100,

or recite a memorized poem or song.

Rainbow Passage

When the sunlight strikes raindrops in the

air, they act like a prism and form a rainbow.

The rainbow is a division of white light into

many beautiful colors. These take the shape

of a long round arch, with its path high

above, and its two ends apparently beyond

the horizon. There is, according to legend, a

boiling pot of gold at one end. People look,

but no one ever finds it. When a man looks

for something beyond reach, his friends say

he is looking for the pot of gold at the end

of the rainbow.

(6) Grimace. The test subject shall grimace

by smiling or frowning. (This applies only to

QNFT testing; it is not performed for QLFT)

(7) Bending over. The test subject shall

bend at the waist as if he/she were to touch

his/her toes. Jogging in place shall be

substituted for this exercise in those test

environments such as shroud type QNFT or

QLFT units that do not permit bending over

at the waist.

(8) Normal breathing. Same as exercise (1).

(b) Each test exercise shall be performed

for one minute except for the grimace

exercise which shall be performed for 15

seconds. The test subject shall be questioned

by the test conductor regarding the comfort

of the respirator upon completion of the

protocol. If it has become unacceptable,

another model of respirator shall be tried.

The respirator shall not be adjusted once the

fit test exercises begin. Any adjustment voids

the test, and the fit test must be repeated.

B. Qualitative Fit Test (QLFT) Protocols

1. General

(a) The employer shall ensure that persons

administering QLFT are able to prepare test

solutions, calibrate equipment and perform

tests properly, recognize invalid tests, and

ensure that test equipment is in proper

working order.

(b) The employer shall ensure that QLFT

equipment is kept clean and well maintained

so as to operate within the parameters for

which it was designed.

2. Isoamyl Acetate Protocol

Note: This protocol is not appropriate to

use for the fit testing of particulate

respirators. If used to fit test particulate

respirators, the respirator must be equipped

with an organic vapor filter.

(a) Odor Threshold Screening

Odor threshold screening, performed

without wearing a respirator, is intended to

determine if the individual tested can detect

the odor of isoamyl acetate at low levels.

(1) Three 1 liter glass jars with metal lids

are required.

(2) Odor-free water (e.g., distilled or spring

water) at approximately 25° C (77° F) shall

be used for the solutions.

(3) The isoamyl acetate (IAA) (also known

at isopentyl acetate) stock solution is

prepared by adding 1 ml of pure IAA to 800

ml of odor-free water in a 1 liter jar, closing

the lid and shaking for 30 seconds. A new

solution shall be prepared at least weekly.

(4) The screening test shall be conducted

in a room separate from the room used for

actual fit testing. The two rooms shall be

well-ventilated to prevent the odor of IAA

from becoming evident in the general room

air where testing takes place.

(5) The odor test solution is prepared in a

second jar by placing 0.4 ml of the stock

solution into 500 ml of odor-free water using

a clean dropper or pipette. The solution shall

be shaken for 30 seconds and allowed to

stand for two to three minutes so that the

IAA concentration above the liquid may

reach equilibrium. This solution shall be

used for only one day.

(6) A test blank shall be prepared in a third

jar by adding 500 cc of odor-free water.

(7) The odor test and test blank jar lids

shall be labeled (e.g., 1 and 2) for jar

identification. Labels shall be placed on the

lids so that they can be peeled off

periodically and switched to maintain the

integrity of the test.

(8) The following instruction shall be typed

on a card and placed on the table in front of

the two test jars (i.e., 1 and 2): ‘‘The purpose

of this test is to determine if you can smell

banana oil at a low concentration. The two

bottles in front of you contain water. One of

these bottles also contains a small amount of

banana oil. Be sure the covers are on tight,

then shake each bottle for two seconds.

Unscrew the lid of each bottle, one at a time,

and sniff at the mouth of the bottle. Indicate

to the test conductor which bottle contains

banana oil.’’

(9) The mixtures used in the IAA odor

detection test shall be prepared in an area

separate from where the test is performed, in

order to prevent olfactory fatigue in the

subject.

(10) If the test subject is unable to correctly

identify the jar containing the odor test

solution, the IAA qualitative fit test shall not

be performed.

(11) If the test subject correctly identifies

the jar containing the odor test solution, the

test subject may proceed to respirator

selection and fit testing.

(b) Isoamyl Acetate Fit Test

(1) The fit test chamber shall be a clear 55-

gallon drum liner suspended inverted over a

2-foot diameter frame so that the top of the

chamber is about 6 inches above the test

subject’s head. If no drum liner is available,

a similar chamber shall be constructed using

plastic sheeting. The inside top center of the

chamber shall have a small hook attached.

(2) Each respirator used for the fitting and

fit testing shall be equipped with organic

vapor cartridges or offer protection against

organic vapors.

(3) After selecting, donning, and properly

adjusting a respirator, the test subject shall

wear it to the fit testing room. This room

shall be separate from the room used for odor

threshold screening and respirator selection,

and shall be well-ventilated, as by an exhaust

fan or lab hood, to prevent general room

contamination.

(4) A copy of the test exercises and any

prepared text from which the subject is to

read shall be taped to the inside of the test

chamber.

(5) Upon entering the test chamber, the test

subject shall be given a 6-inch by 5-inch

piece of paper towel, or other porous,

absorbent, single-ply material, folded in half

and wetted with 0.75 ml of pure IAA. The

test subject shall hang the wet towel on the

hook at the top of the chamber. An IAA test

swab or ampule may be substituted for the

IAA wetted paper towel provided it has been

demonstrated that the alternative IAA source

will generate an IAA test atmosphere with a

concentration equivalent to that generated by

the paper towel method.

(6) Allow two minutes for the IAA test

concentration to stabilize before starting the

fit test exercises. This would be an

appropriate time to talk with the test subject;

to explain the fit test, the importance of his/

her cooperation, and the purpose for the test

exercises; or to demonstrate some of the

exercises.

(7) If at any time during the test, the subject

detects the banana-like odor of IAA, the test

is failed. The subject shall quickly exit from

the test chamber and leave the test area to

avoid olfactory fatigue.

(8) If the test is failed, the subject shall

return to the selection room and remove the

respirator. The test subject shall repeat the

odor sensitivity test, select and put on

another respirator, return to the test area and

again begin the fit test procedure described

in (b) (1) through (7) above. The process

continues until a respirator that fits well has

been found. Should the odor sensitivity test

be failed, the subject shall wait at least 5

minutes before retesting. Odor sensitivity

will usually have returned by this time.

(9) If the subject passes the test, the

efficiency of the test procedure shall be

demonstrated by having the subject break the

respirator face seal and take a breath before

exiting the chamber.

(10) When the test subject leaves the

chamber, the subject shall remove the

saturated towel and return it to the person

conducting the test, so that there is no

significant IAA concentration buildup in the

chamber during subsequent tests. The used

towels shall be kept in a self-sealing plastic

bag to keep the test area from being

contaminated.

3. Saccharin Solution Aerosol Protocol

The entire screening and testing procedure

shall be explained to the test subject prior to

the conduct of the screening test.

(a) Taste threshold screening. The

saccharin taste threshold screening,
1278 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

performed without wearing a respirator, is

intended to determine whether the

individual being tested can detect the taste of

saccharin.

(1) During threshold screening as well as

during fit testing, subjects shall wear an

enclosure about the head and shoulders that

is approximately 12 inches in diameter by 14

inches tall with at least the front portion

clear and that allows free movements of the

head when a respirator is worn. An enclosure

substantially similar to the 3M hood

assembly, parts # FT 14 and # FT 15

combined, is adequate.

(2) The test enclosure shall have a 3⁄4-inch

(1.9 cm) hole in front of the test subject’s

nose and mouth area to accommodate the

nebulizer nozzle.

(3) The test subject shall don the test

enclosure. Throughout the threshold

screening test, the test subject shall breathe

through his/her slightly open mouth with

tongue extended. The subject is instructed to

report when he/she detects a sweet taste.

(4) Using a DeVilbiss Model 40 Inhalation

Medication Nebulizer or equivalent, the test

conductor shall spray the threshold check

solution into the enclosure. The nozzle is

directed away from the nose and mouth of

the person. This nebulizer shall be clearly

marked to distinguish it from the fit test

solution nebulizer.

(5) The threshold check solution is

prepared by dissolving 0.83 gram of sodium

saccharin USP in 100 ml of warm water. It

can be prepared by putting 1 ml of the fit test

solution (see (b)(5) below) in 100 ml of

distilled water.

(6) To produce the aerosol, the nebulizer

bulb is firmly squeezed so that it collapses

completely, then released and allowed to

fully expand.

(7) Ten squeezes are repeated rapidly and

then the test subject is asked whether the

saccharin can be tasted. If the test subject

reports tasting the sweet taste during the ten

squeezes, the screening test is completed.

The taste threshold is noted as ten regardless

of the number of squeezes actually

completed.

(8) If the first response is negative, ten

more squeezes are repeated rapidly and the

test subject is again asked whether the

saccharin is tasted. If the test subject reports

tasting the sweet taste during the second ten

squeezes, the screening test is completed.

The taste threshold is noted as twenty

regardless of the number of squeezes actually

completed.

(9) If the second response is negative, ten

more squeezes are repeated rapidly and the

test subject is again asked whether the

saccharin is tasted. If the test subject reports

tasting the sweet taste during the third set of

ten squeezes, the screening test is completed.

The taste threshold is noted as thirty

regardless of the number of squeezes actually

completed.

(10) The test conductor will take note of

the number of squeezes required to solicit a

taste response.

(11) If the saccharin is not tasted after 30

squeezes (step 10), the test subject is unable

to taste saccharin and may not perform the

saccharin fit test.

Note to paragraph 3. (a): If the test subject

eats or drinks something sweet before the

screening test, he/she may be unable to taste

the weak saccharin solution.

(12) If a taste response is elicited, the test

subject shall be asked to take note of the taste

for reference in the fit test.

(13) Correct use of the nebulizer means that

approximately 1 ml of liquid is used at a time

in the nebulizer body.

(14) The nebulizer shall be thoroughly

rinsed in water, shaken dry, and refilled at

least each morning and afternoon or at least

every four hours.

(b) Saccharin solution aerosol fit test

procedure.

(1) The test subject may not eat, drink

(except plain water), smoke, or chew gum for

15 minutes before the test.

(2) The fit test uses the same enclosure

described in 3. (a) above.

(3) The test subject shall don the enclosure

while wearing the respirator selected in

section I. A. of this appendix. The respirator

shall be properly adjusted and equipped with

a particulate filter(s).

(4) A second DeVilbiss Model 40

Inhalation Medication Nebulizer or

equivalent is used to spray the fit test

solution into the enclosure. This nebulizer

shall be clearly marked to distinguish it from

the screening test solution nebulizer.

(5) The fit test solution is prepared by

adding 83 grams of sodium saccharin to 100

ml of warm water.

(6) As before, the test subject shall breathe

through the slightly open mouth with tongue

extended, and report if he/she tastes the

sweet taste of saccharin.

(7) The nebulizer is inserted into the hole

in the front of the enclosure and an initial

concentration of saccharin fit test solution is

sprayed into the enclosure using the same

number of squeezes (either 10, 20 or 30

squeezes) based on the number of squeezes

required to elicit a taste response as noted

during the screening test. A minimum of 10

squeezes is required.

(8) After generating the aerosol, the test

subject shall be instructed to perform the

exercises in section I. A. 14. of this appendix.

(9) Every 30 seconds the aerosol

concentration shall be replenished using one

half the original number of squeezes used

initially (e.g., 5, 10 or 15).

(10) The test subject shall indicate to the

test conductor if at any time during the fit

test the taste of saccharin is detected. If the

test subject does not report tasting the

saccharin, the test is passed.

(11) If the taste of saccharin is detected, the

fit is deemed unsatisfactory and the test is

failed. A different respirator shall be tried

and the entire test procedure is repeated

(taste threshold screening and fit testing).

(12) Since the nebulizer has a tendency to

clog during use, the test operator must make

periodic checks of the nebulizer to ensure

that it is not clogged. If clogging is found at

the end of the test session, the test is invalid.

4. BitrexTM (Denatonium Benzoate) Solution

Aerosol Qualitative Fit Test Protocol

The BitrexTM (Denatonium benzoate)

solution aerosol QLFT protocol uses the

published saccharin test protocol because

that protocol is widely accepted. Bitrex is

routinely used as a taste aversion agent in

household liquids which children should not

be drinking and is endorsed by the American

Medical Association, the National Safety

Council, and the American Association of

Poison Control Centers. The entire screening

and testing procedure shall be explained to

the test subject prior to the conduct of the

screening test.

(a) Taste Threshold Screening.

The Bitrex taste threshold screening,

performed without wearing a respirator, is

intended to determine whether the

individual being tested can detect the taste of

Bitrex.

(1) During threshold screening as well as

during fit testing, subjects shall wear an

enclosure about the head and shoulders that

is approximately 12 inches (30.5 cm) in

diameter by 14 inches (35.6 cm) tall. The

front portion of the enclosure shall be clear

from the respirator and allow free movement

of the head when a respirator is worn. An

enclosure substantially similar to the 3M

hood assembly, parts #14 and #15 combined,

is adequate.

(2) The test enclosure shall have a 3⁄4 inch

(1.9 cm) hole in front of the test subject’s

nose and mouth area to accommodate the

nebulizer nozzle.

(3) The test subject shall don the test

enclosure. Throughout the threshold

screening test, the test subject shall breathe

through his or her slightly open mouth with

tongue extended. The subject is instructed to

report when he/she detects a bitter taste.

(4) Using a DeVilbiss Model 40 Inhalation

Medication Nebulizer or equivalent, the test

conductor shall spray the Threshold Check

Solution into the enclosure. This Nebulizer

shall be clearly marked to distinguish it from

the fit test solution nebulizer.

(5) The Threshold Check Solution is

prepared by adding 13.5 milligrams of Bitrex

to 100 ml of 5% salt (NaCl) solution in

distilled water.

(6) To produce the aerosol, the nebulizer

bulb is firmly squeezed so that the bulb

collapses completely, and is then released

and allowed to fully expand.

(7) An initial ten squeezes are repeated

rapidly and then the test subject is asked

whether the Bitrex can be tasted. If the test

subject reports tasting the bitter taste during

the ten squeezes, the screening test is

completed. The taste threshold is noted as

ten regardless of the number of squeezes

actually completed.

(8) If the first response is negative, ten

more squeezes are repeated rapidly and the

test subject is again asked whether the Bitrex

is tasted. If the test subject reports tasting the

bitter taste during the second ten squeezes,

the screening test is completed. The taste

threshold is noted as twenty regardless of the

number of squeezes actually completed.

(9) If the second response is negative, ten

more squeezes are repeated rapidly and the

test subject is again asked whether the Bitrex

is tasted. If the test subject reports tasting the

bitter taste during the third set of ten

squeezes, the screening test is completed.

The taste threshold is noted as thirty

regardless of the number of squeezes actually

completed.

(10) The test conductor will take note of

the number of squeezes required to solicit a

taste response.
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1279

(11) If the Bitrex is not tasted after 30

squeezes (step 10), the test subject is unable

to taste Bitrex and may not perform the

Bitrex fit test.

(12) If a taste response is elicited, the test

subject shall be asked to take note of the taste

for reference in the fit test.

(13) Correct use of the nebulizer means that

approximately 1 ml of liquid is used at a time

in the nebulizer body.

(14) The nebulizer shall be thoroughly

rinsed in water, shaken to dry, and refilled

at least each morning and afternoon or at

least every four hours.

(b) Bitrex Solution Aerosol Fit Test

Procedure.

(1) The test subject may not eat, drink

(except plain water), smoke, or chew gum for

15 minutes before the test.

(2) The fit test uses the same enclosure as

that described in 4. (a) above.

(3) The test subject shall don the enclosure

while wearing the respirator selected

according to section I. A. of this appendix.

The respirator shall be properly adjusted and

equipped with any type particulate filter(s).

(4) A second DeVilbiss Model 40

Inhalation Medication Nebulizer or

equivalent is used to spray the fit test

solution into the enclosure. This nebulizer

shall be clearly marked to distinguish it from

the screening test solution nebulizer.

(5) The fit test solution is prepared by

adding 337.5 mg of Bitrex to 200 ml of a 5%

salt (NaCl) solution in warm water.

(6) As before, the test subject shall breathe

through his or her slightly open mouth with

tongue extended, and be instructed to report

if he/she tastes the bitter taste of Bitrex..

(7) The nebulizer is inserted into the hole

in the front of the enclosure and an initial

concentration of the fit test solution is

sprayed into the enclosure using the same

number of squeezes (either 10, 20 or 30

squeezes) based on the number of squeezes

required to elicit a taste response as noted

during the screening test.

(8) After generating the aerosol, the test

subject shall be instructed to perform the

exercises in section I. A. 14. of this appendix.

(9) Every 30 seconds the aerosol

concentration shall be replenished using one

half the number of squeezes used initially

(e.g., 5, 10 or 15).

(10) The test subject shall indicate to the

test conductor if at any time during the fit

test the taste of Bitrex is detected. If the test

subject does not report tasting the Bitrex, the

test is passed.

(11) If the taste of Bitrex is detected, the

fit is deemed unsatisfactory and the test is

failed. A different respirator shall be tried

and the entire test procedure is repeated

(taste threshold screening and fit testing).

5. Irritant Smoke (Stannic Chloride) Protocol

This qualitative fit test uses a person’s

response to the irritating chemicals released

in the ‘‘smoke’’ produced by a stannic

chloride ventilation smoke tube to detect

leakage into the respirator.

(a) General Requirements and Precautions

(1) The respirator to be tested shall be

equipped with high efficiency particulate air

(HEPA) or P100 series filter(s).

(2) Only stannic chloride smoke tubes shall

be used for this protocol.

(3) No form of test enclosure or hood for

the test subject shall be used.

(4) The smoke can be irritating to the eyes,

lungs, and nasal passages. The test conductor

shall take precautions to minimize the test

subject’s exposure to irritant smoke.

Sensitivity varies, and certain individuals

may respond to a greater degree to irritant

smoke. Care shall be taken when performing

the sensitivity screening checks that

determine whether the test subject can detect

irritant smoke to use only the minimum

amount of smoke necessary to elicit a

response from the test subject.

(5) The fit test shall be performed in an

area with adequate ventilation to prevent

exposure of the person conducting the fit test

or the build-up of irritant smoke in the

general atmosphere.

(b) Sensitivity Screening Check

The person to be tested must demonstrate

his or her ability to detect a weak

concentration of the irritant smoke.

(1) The test operator shall break both ends

of a ventilation smoke tube containing

stannic chloride, and attach one end of the

smoke tube to a low flow air pump set to

deliver 200 milliliters per minute, or an

aspirator squeeze bulb. The test operator

shall cover the other end of the smoke tube

with a short piece of tubing to prevent

potential injury from the jagged end of the

smoke tube.

(2) The test operator shall advise the test

subject that the smoke can be irritating to the

eyes, lungs, and nasal passages and instruct

the subject to keep his/her eyes closed while

the test is performed.

(3) The test subject shall be allowed to

smell a weak concentration of the irritant

smoke before the respirator is donned to

become familiar with its irritating properties

and to determine if he/she can detect the

irritating properties of the smoke. The test

operator shall carefully direct a small amount

of the irritant smoke in the test subject’s

direction to determine that he/she can detect

it.

(c) Irritant Smoke Fit Test Procedure

(1) The person being fit tested shall don the

respirator without assistance, and perform

the required user seal check(s).

(2) The test subject shall be instructed to

keep his/her eyes closed.

(3) The test operator shall direct the stream

of irritant smoke from the smoke tube toward

the faceseal area of the test subject, using the

low flow pump or the squeeze bulb. The test

operator shall begin at least 12 inches from

the facepiece and move the smoke stream

around the whole perimeter of the mask. The

operator shall gradually make two more

passes around the perimeter of the mask,

moving to within six inches of the respirator.

(4) If the person being tested has not had

an involuntary response and/or detected the

irritant smoke, proceed with the test

exercises.

(5) The exercises identified in section I.A.

14. of this appendix shall be performed by

the test subject while the respirator seal is

being continually challenged by the smoke,

directed around the perimeter of the

respirator at a distance of six inches.

(6) If the person being fit tested reports

detecting the irritant smoke at any time, the

test is failed. The person being retested must

repeat the entire sensitivity check and fit test

procedure.

(7) Each test subject passing the irritant

smoke test without evidence of a response

(involuntary cough, irritation) shall be given

a second sensitivity screening check, with

the smoke from the same smoke tube used

during the fit test, once the respirator has

been removed, to determine whether he/she

still reacts to the smoke. Failure to evoke a

response shall void the fit test.

(8) If a response is produced during this

second sensitivity check, then the fit test is

passed.

C. Quantitative Fit Test (QNFT) Protocols

The following quantitative fit testing

procedures have been demonstrated to be

acceptable: Quantitative fit testing using a

non-hazardous test aerosol (such as corn oil,

polyethylene glycol 400 [PEG 400], di-2-ethyl

hexyl sebacate [DEHS], or sodium chloride)

generated in a test chamber, and employing

instrumentation to quantify the fit of the

respirator; Quantitative fit testing using

ambient aerosol as the test agent and

appropriate instrumentation (condensation

nuclei counter) to quantify the respirator fit;

Quantitative fit testing using controlled

negative pressure and appropriate

instrumentation to measure the volumetric

leak rate of a facepiece to quantify the

respirator fit.

1. General

(a) The employer shall ensure that persons

administering QNFT are able to calibrate

equipment and perform tests properly,

recognize invalid tests, calculate fit factors

properly and ensure that test equipment is in

proper working order.

(b) The employer shall ensure that QNFT

equipment is kept clean, and is maintained

and calibrated according to the

manufacturer’s instructions so as to operate

at the parameters for which it was designed.

2. Generated Aerosol Quantitative Fit Testing

Protocol

(a) Apparatus.

(1) Instrumentation. Aerosol generation,

dilution, and measurement systems using

particulates (corn oil, polyethylene glycol

400 [PEG 400], di-2-ethyl hexyl sebacate

[DEHS] or sodium chloride) as test aerosols

shall be used for quantitative fit testing.

(2) Test chamber. The test chamber shall be

large enough to permit all test subjects to

perform freely all required exercises without

disturbing the test agent concentration or the

measurement apparatus. The test chamber

shall be equipped and constructed so that the

test agent is effectively isolated from the

ambient air, yet uniform in concentration

throughout the chamber.

(3) When testing air-purifying respirators,

the normal filter or cartridge element shall be

replaced with a high efficiency particulate air

(HEPA) or P100 series filter supplied by the

same manufacturer.

(4) The sampling instrument shall be

selected so that a computer record or strip

chart record may be made of the test showing

the rise and fall of the test agent

concentration with each inspiration and

expiration at fit factors of at least 2,000.
1280 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

Integrators or computers that integrate the

amount of test agent penetration leakage into

the respirator for each exercise may be used

provided a record of the readings is made.

(5) The combination of substitute airpurifying elements, test agent and test agent

concentration shall be such that the test

subject is not exposed in excess of an

established exposure limit for the test agent

at any time during the testing process, based

upon the length of the exposure and the

exposure limit duration.

(6) The sampling port on the test specimen

respirator shall be placed and constructed so

that no leakage occurs around the port (e.g.,

where the respirator is probed), a free air

flow is allowed into the sampling line at all

times, and there is no interference with the

fit or performance of the respirator. The inmask sampling device (probe) shall be

designed and used so that the air sample is

drawn from the breathing zone of the test

subject, midway between the nose and mouth

and with the probe extending into the

facepiece cavity at least 1/4 inch.

(7) The test setup shall permit the person

administering the test to observe the test

subject inside the chamber during the test.

(8) The equipment generating the test

atmosphere shall maintain the concentration

of test agent constant to within a 10 percent

variation for the duration of the test.

(9) The time lag (interval between an event

and the recording of the event on the strip

chart or computer or integrator) shall be kept

to a minimum. There shall be a clear

association between the occurrence of an

event and its being recorded.

(10) The sampling line tubing for the test

chamber atmosphere and for the respirator

sampling port shall be of equal diameter and

of the same material. The length of the two

lines shall be equal.

(11) The exhaust flow from the test

chamber shall pass through an appropriate

filter (i.e., high efficiency particulate or P100

series filter) before release.

(12) When sodium chloride aerosol is used,

the relative humidity inside the test chamber

shall not exceed 50 percent.

(13) The limitations of instrument

detection shall be taken into account when

determining the fit factor.

(14) Test respirators shall be maintained in

proper working order and be inspected

regularly for deficiencies such as cracks or

missing valves and gaskets.

(b) Procedural Requirements.

(1) When performing the initial user seal

check using a positive or negative pressure

check, the sampling line shall be crimped

closed in order to avoid air pressure leakage

during either of these pressure checks.

(2) The use of an abbreviated screening

QLFT test is optional. Such a test may be

utilized in order to quickly identify poor

fitting respirators that passed the positive

and/or negative pressure test and reduce the

amount of QNFT time. The use of the CNC

QNFT instrument in the count mode is

another optional method to obtain a quick

estimate of fit and eliminate poor fitting

respirators before going on to perform a full

QNFT.

(3) A reasonably stable test agent

concentration shall be measured in the test

chamber prior to testing. For canopy or

shower curtain types of test units, the

determination of the test agent’s stability may

be established after the test subject has

entered the test environment.

(4) Immediately after the subject enters the

test chamber, the test agent concentration

inside the respirator shall be measured to

ensure that the peak penetration does not

exceed 5 percent for a half mask or 1 percent

for a full facepiece respirator.

(5) A stable test agent concentration shall

be obtained prior to the actual start of testing.

(6) Respirator restraining straps shall not

be over-tightened for testing. The straps shall

be adjusted by the wearer without assistance

from other persons to give a reasonably

comfortable fit typical of normal use. The

respirator shall not be adjusted once the fit

test exercises begin.

(7) The test shall be terminated whenever

any single peak penetration exceeds 5

percent for half masks and 1 percent for full

facepiece respirators. The test subject shall be

refitted and retested.

(8) Calculation of fit factors.

(i) The fit factor shall be determined for the

quantitative fit test by taking the ratio of the

average chamber concentration to the

concentration measured inside the respirator

for each test exercise except the grimace

exercise.

(ii) The average test chamber concentration

shall be calculated as the arithmetic average

of the concentration measured before and

after each test (i.e., 7 exercises) or the

arithmetic average of the concentration

measured before and after each exercise or

the true average measured continuously

during the respirator sample.

(iii) The concentration of the challenge

agent inside the respirator shall be

determined by one of the following methods:

(A) Average peak penetration method

means the method of determining test agent

penetration into the respirator utilizing a

strip chart recorder, integrator, or computer.

The agent penetration is determined by an

average of the peak heights on the graph or

by computer integration, for each exercise

except the grimace exercise. Integrators or

computers that calculate the actual test agent

penetration into the respirator for each

exercise will also be considered to meet the

requirements of the average peak penetration

method.

(B) Maximum peak penetration method

means the method of determining test agent

penetration in the respirator as determined

by strip chart recordings of the test. The

highest peak penetration for a given exercise

is taken to be representative of average

penetration into the respirator for that

exercise.

(C) Integration by calculation of the area

under the individual peak for each exercise

except the grimace exercise. This includes

computerized integration.

(D) The calculation of the overall fit factor

using individual exercise fit factors involves

first converting the exercise fit factors to

penetration values, determining the average,

and then converting that result back to a fit

factor. This procedure is described in the

following equation:

Overall Fit Factor Number of exercises = 1 1 1 1 1 1 1 1 2 3 4 + + + + + + 5 7 8 ff ff ff ff ff ff ff

Where ff1, ff2, ff3, etc. are the fit factors for

exercises 1, 2, 3, etc.

(9) The test subject shall not be permitted

to wear a half mask or quarter facepiece

respirator unless a minimum fit factor of 100

is obtained, or a full facepiece respirator

unless a minimum fit factor of 500 is

obtained.

(10) Filters used for quantitative fit testing

shall be replaced whenever increased

breathing resistance is encountered, or when

the test agent has altered the integrity of the

filter media.

3. Ambient aerosol condensation nuclei

counter (CNC) quantitative fit testing

protocol.

The ambient aerosol condensation nuclei

counter (CNC) quantitative fit testing

(Portacount TM ) protocol quantitatively fit

tests respirators with the use of a probe. The

probed respirator is only used for

quantitative fit tests. A probed respirator has

a special sampling device, installed on the

respirator, that allows the probe to sample

the air from inside the mask. A probed

respirator is required for each make, style,

model, and size that the employer uses and

can be obtained from the respirator

manufacturer or distributor. The CNC

instrument manufacturer, TSI Inc., also

provides probe attachments (TSI sampling

adapters) that permit fit testing in an

employee’s own respirator. A minimum fit

factor pass level of at least 100 is necessary

for a half-mask respirator and a minimum fit

factor pass level of at least 500 is required for

a full facepiece negative pressure respirator.

The entire screening and testing procedure

shall be explained to the test subject prior to

the conduct of the screening test.

(a) Portacount Fit Test Requirements.

(1) Check the respirator to make sure the

respirator is fitted with a high-efficiency

filter and that the sampling probe and line

are properly attached to the facepiece.

(2) Instruct the person to be tested to don

the respirator for five minutes before the fit

test starts. This purges the ambient particles

trapped inside the respirator and permits the

wearer to make certain the respirator is

comfortable. This individual shall already

have been trained on how to wear the

respirator properly.
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1281

(3) Check the following conditions for the

adequacy of the respirator fit: Chin properly

placed; Adequate strap tension, not overly

tightened; Fit across nose bridge; Respirator

of proper size to span distance from nose to

chin; Tendency of the respirator to slip; Selfobservation in a mirror to evaluate fit and

respirator position.

(4) Have the person wearing the respirator

do a user seal check. If leakage is detected,

determine the cause. If leakage is from a

poorly fitting facepiece, try another size of

the same model respirator, or another model

of respirator.

(5) Follow the manufacturer’s instructions

for operating the Portacount and proceed

with the test.

(6) The test subject shall be instructed to

perform the exercises in section I. A. 14. of

this appendix.

(7) After the test exercises, the test subject

shall be questioned by the test conductor

regarding the comfort of the respirator upon

completion of the protocol. If it has become

unacceptable, another model of respirator

shall be tried.

(b) Portacount Test Instrument.

(1) The Portacount will automatically stop

and calculate the overall fit factor for the

entire set of exercises. The overall fit factor

is what counts. The Pass or Fail message will

indicate whether or not the test was

successful. If the test was a Pass, the fit test

is over.

(2) Since the pass or fail criterion of the

Portacount is user programmable, the test

operator shall ensure that the pass or fail

criterion meet the requirements for minimum

respirator performance in this Appendix.

(3) A record of the test needs to be kept on

file, assuming the fit test was successful. The

record must contain the test subject’s name;

overall fit factor; make, model, style, and size

of respirator used; and date tested.

4. Controlled negative pressure (CNP)

quantitative fit testing protocol.

The CNP protocol provides an alternative

to aerosol fit test methods. The CNP fit test

method technology is based on exhausting air

from a temporarily sealed respirator

facepiece to generate and then maintain a

constant negative pressure inside the

facepiece. The rate of air exhaust is

controlled so that a constant negative

pressure is maintained in the respirator

during the fit test. The level of pressure is

selected to replicate the mean inspiratory

pressure that causes leakage into the

respirator under normal use conditions. With

pressure held constant, air flow out of the

respirator is equal to air flow into the

respirator. Therefore, measurement of the

exhaust stream that is required to hold the

pressure in the temporarily sealed respirator

constant yields a direct measure of leakage

air flow into the respirator. The CNP fit test

method measures leak rates through the

facepiece as a method for determining the

facepiece fit for negative pressure respirators.

The CNP instrument manufacturer Dynatech

Nevada also provides attachments (sampling

manifolds) that replace the filter cartridges to

permit fit testing in an employee’s own

respirator. To perform the test, the test

subject closes his or her mouth and holds

his/her breath, after which an air pump

removes air from the respirator facepiece at

a pre-selected constant pressure. The

facepiece fit is expressed as the leak rate

through the facepiece, expressed as

milliliters per minute. The quality and

validity of the CNP fit tests are determined

by the degree to which the in-mask pressure

tracks the test pressure during the system

measurement time of approximately five

seconds. Instantaneous feedback in the form

of a real-time pressure trace of the in-mask

pressure is provided and used to determine

test validity and quality. A minimum fit

factor pass level of 100 is necessary for a halfmask respirator and a minimum fit factor of

at least 500 is required for a full facepiece

respirator. The entire screening and testing

procedure shall be explained to the test

subject prior to the conduct of the screening

test.

(a) CNP Fit Test Requirements.

(1) The instrument shall have a nonadjustable test pressure of 15.0 mm water

pressure.

(2) The CNP system defaults selected for

test pressure shall be set at—1.5 mm of water

(-0.58 inches of water) and the modeled

inspiratory flow rate shall be 53.8 liters per

minute for performing fit tests.

(Note: CNP systems have built-in capability

to conduct fit testing that is specific to

unique work rate, mask, and gender

situations that might apply in a specific

workplace. Use of system default values,

which were selected to represent respirator

wear with medium cartridge resistance at a

low-moderate work rate, will allow inter-test

comparison of the respirator fit.)

(3) The individual who conducts the CNP

fit testing shall be thoroughly trained to

perform the test.

(4) The respirator filter or cartridge needs

to be replaced with the CNP test manifold.

The inhalation valve downstream from the

manifold either needs to be temporarily

removed or propped open.

(5) The test subject shall be trained to hold

his or her breath for at least 20 seconds.

(6) The test subject shall don the test

respirator without any assistance from the

individual who conducts the CNP fit test.

(7) The QNFT protocol shall be followed

according to section I. C. 1. of this appendix

with an exception for the CNP test exercises.

(b) CNP Test Exercises.

(1) Normal breathing. In a normal standing

position, without talking, the subject shall

breathe normally for 1 minute. After the

normal breathing exercise, the subject needs

to hold head straight ahead and hold his or

her breath for 10 seconds during the test

measurement.

(2) Deep breathing. In a normal standing

position, the subject shall breathe slowly and

deeply for 1 minute, being careful not to

hyperventilate. After the deep breathing

exercise, the subject shall hold his or her

head straight ahead and hold his or her

breath for 10 seconds during test

measurement.

(3) Turning head side to side. Standing in

place, the subject shall slowly turn his or her

head from side to side between the extreme

positions on each side for 1 minute. The head

shall be held at each extreme momentarily so

the subject can inhale at each side. After the

turning head side to side exercise, the subject

needs to hold head full left and hold his or

her breath for 10 seconds during test

measurement. Next, the subject needs to hold

head full right and hold his or her breath for

10 seconds during test measurement.

(4) Moving head up and down. Standing in

place, the subject shall slowly move his or

her head up and down for 1 minute. The

subject shall be instructed to inhale in the up

position (i.e., when looking toward the

ceiling). After the moving head up and down

exercise, the subject shall hold his or her

head full up and hold his or her breath for

10 seconds during test measurement. Next,

the subject shall hold his or her head full

down and hold his or her breath for 10

seconds during test measurement.

(5) Talking. The subject shall talk out loud

slowly and loud enough so as to be heard

clearly by the test conductor. The subject can

read from a prepared text such as the

Rainbow Passage, count backward from 100,

or recite a memorized poem or song for 1

minute. After the talking exercise, the subject

shall hold his or her head straight ahead and

hold his or her breath for 10 seconds during

the test measurement.

(6) Grimace. The test subject shall grimace

by smiling or frowning for 15 seconds.

(7) Bending Over. The test subject shall

bend at the waist as if he or she were to touch

his or her toes for 1 minute. Jogging in place

shall be substituted for this exercise in those

test environments such as shroud-type QNFT

units that prohibit bending at the waist. After

the bending over exercise, the subject shall

hold his or her head straight ahead and hold

his or her breath for 10 seconds during the

test measurement.

(8) Normal Breathing. The test subject shall

remove and re-don the respirator within a

one-minute period. Then, in a normal

standing position, without talking, the

subject shall breathe normally for 1 minute.

After the normal breathing exercise, the

subject shall hold his or her head straight

ahead and hold his or her breath for 10

seconds during the test measurement. After

the test exercises, the test subject shall be

questioned by the test conductor regarding

the comfort of the respirator upon

completion of the protocol. If it has become

unacceptable, another model of a respirator

shall be tried.

(c) CNP Test Instrument.

(1) The test instrument shall have an

effective audio warning device when the test

subject fails to hold his or her breath during

the test. The test shall be terminated

whenever the test subject failed to hold his

or her breath. The test subject may be refitted

and retested.

(2) A record of the test shall be kept on file,

assuming the fit test was successful. The

record must contain the test subject’s name;

overall fit factor; make, model, style and size

of respirator used; and date tested.

Part II. New Fit Test Protocols

A. Any person may submit to OSHA an

application for approval of a new fit test

protocol. If the application meets the

following criteria, OSHA will initiate a

rulemaking proceeding under section 6(b)(7)

of the OSH Act to determine whether to list
1282 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

the new protocol as an approved protocol in

this Appendix A.

B. The application must include a detailed

description of the proposed new fit test

protocol. This application must be supported

by either:

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 has

tested the protocol and had found it to be

accurate and reliable; or

2. An article that has been published in a

peer-reviewed industrial hygiene journal

describing the protocol and explaining how

test data support the protocol’s accuracy and

reliability.

C. If OSHA determines that additional

information is required before the Agency

commences a rulemaking proceeding under

this section, OSHA will so notify the

applicant and afford the applicant the

opportunity to submit the supplemental

information. Initiation of a rulemaking

proceeding will be deferred until OSHA has

received and evaluated the supplemental

information.

Appendix B–1 to § 1910.134: User Seal

Check Procedures (Mandatory)

The individual who uses a tight-fitting

respirator is to perform a user seal check to

ensure that an adequate seal is achieved each

time the respirator is put on. Either the

positive and negative pressure checks listed

in this appendix, or the respirator

manufacturer’s recommended user seal check

method shall be used. User seal checks are

not substitutes for qualitative or quantitative

fit tests.

I. Facepiece Positive and/or Negative

Pressure Checks

A. Positive pressure check. Close off the

exhalation valve and exhale gently into the

facepiece. The face fit is considered

satisfactory if a slight positive pressure can

be built up inside the facepiece without any

evidence of outward leakage of air at the seal.

For most respirators this method of leak

testing requires the wearer to first remove the

exhalation valve cover before closing off the

exhalation valve and then carefully replacing

it after the test.

B. Negative pressure check. Close off the

inlet opening of the canister or cartridge(s) by

covering with the palm of the hand(s) or by

replacing the filter seal(s), inhale gently so

that the facepiece collapses slightly, and hold

the breath for ten seconds. The design of the

inlet opening of some cartridges cannot be

effectively covered with the palm of the

hand. The test can be performed by covering

the inlet opening of the cartridge with a thin

latex or nitrile glove. If the facepiece remains

in its slightly collapsed condition and no

inward leakage of air is detected, the

tightness of the respirator is considered

satisfactory.

II. Manufacturer’s Recommended User Seal

Check Procedures

The respirator manufacturer’s

recommended procedures for performing a

user seal check may be used instead of the

positive and/or negative pressure check

procedures provided that the employer

demonstrates that the manufacturer’s

procedures are equally effective.

Appendix B–2 to § 1910.134: Respirator

Cleaning Procedures (Mandatory)

These procedures are provided for

employer use when cleaning respirators.

They are general in nature, and the employer

as an alternative may use the cleaning

recommendations provided by the

manufacturer of the respirators used by their

employees, provided such procedures are as

effective as those listed here in Appendix B–

2. Equivalent effectiveness simply means that

the procedures used must accomplish the

objectives set forth in Appendix B–2, i.e.,

must ensure that the respirator is properly

cleaned and disinfected in a manner that

prevents damage to the respirator and does

not cause harm to the user.

I. Procedures for Cleaning Respirators

A. Remove filters, cartridges, or canisters.

Disassemble facepieces by removing speaking

diaphragms, demand and pressure-demand

valve assemblies, hoses, or any components

recommended by the manufacturer. Discard

or repair any defective parts.

B. Wash components in warm (43° C [110°

F] maximum) water with a mild detergent or

with a cleaner recommended by the

manufacturer. A stiff bristle (not wire) brush

may be used to facilitate the removal of dirt.

C. Rinse components thoroughly in clean,

warm (43° C [110° F] maximum), preferably

running water. Drain.

D. When the cleaner used does not contain

a disinfecting agent, respirator components

should be immersed for two minutes in one

of the following:

1. Hypochlorite solution (50 ppm of

chlorine) made by adding approximately one

milliliter of laundry bleach to one liter of

water at 43° C (110° F); or,

2. Aqueous solution of iodine (50 ppm

iodine) made by adding approximately 0.8

milliliters of tincture of iodine (6–8 grams

ammonium and/or potassium iodide/100 cc

of 45% alcohol) to one liter of water at 43°

C (110° F); or,

3. Other commercially available cleansers

of equivalent disinfectant quality when used

as directed, if their use is recommended or

approved by the respirator manufacturer.

E. Rinse components thoroughly in clean,

warm (43° C [110° F] maximum), preferably

running water. Drain. The importance of

thorough rinsing cannot be overemphasized.

Detergents or disinfectants that dry on

facepieces may result in dermatitis. In

addition, some disinfectants may cause

deterioration of rubber or corrosion of metal

parts if not completely removed.

F. Components should be hand-dried with

a clean lint-free cloth or air-dried.

G. Reassemble facepiece, replacing filters,

cartridges, and canisters where necessary.

H. Test the respirator to ensure that all

components work properly.

Appendix C to § 1910.134: OSHA Respirator

Medical Evaluation Questionnaire

(Mandatory)

To the employer: Answers to questions in

Section 1, and to question 9 in Section 2 of

Part A, do not require a medical examination.

To the employee:

Can you read (circle one): Yes/No

Your employer must allow you to answer

this questionnaire during normal working

hours, or at a time and place that is

convenient to you. To maintain your

confidentiality, your employer or supervisor

must not look at or review your answers, and

your employer must tell you how to deliver

or send this questionnaire to the health care

professional who will review it.

Part A. Section 1. (Mandatory) The

following information must be provided by

every employee who has been selected to use

any type of respirator (please print).

1. Today’s date: lllllllllllll

2. Your name: llllllllllllll

3. Your age (to nearest year): lllllll

4. Sex (circle one): Male/Female

5. Your height: lllllft. lllllin.

6. Your weight: llllll lbs.

7. Your job title: lllllllllllll

8. A phone number where you can be

reached by the health care professional

who reviews this questionnaire (include

the Area Code): llllllllll

9. The best time to phone you at this number:

llllllll

10. Has your employer told you how to

contact the health care professional who

will review this questionnaire (circle one):

Yes/No

11. Check the type of respirator you will use

(you can check more than one category):

a. lll N, R, or P disposable respirator

(filter-mask, non-cartridge type only).

b. lll Other type (for example, half- or

full-facepiece type, powered-air

purifying, supplied-air, self-contained

breathing apparatus).

12. Have you worn a respirator (circle one):

Yes/No

If ‘‘yes,’’ what type(s): lllllllll

lllllllllllllllllllll

Part A. Section 2. (Mandatory) Questions 1

through 9 below must be answered by every

employee who has been selected to use any

type of respirator (please circle ‘‘yes’’ or

‘‘no’’).

1. Do you currently smoke tobacco, or have

you smoked tobacco in the last month:

Yes/No

2. Have you ever had any of the following

conditions?

a. Seizures (fits): Yes/No

b. Diabetes (sugar disease): Yes/No

c. Allergic reactions that interfere with

your breathing: Yes/No

d. Claustrophobia (fear of closed-in places):

Yes/No

e. Trouble smelling odors: Yes/No

3. Have you ever had any of the following

pulmonary or lung problems?

a. Asbestosis: Yes/No

b. Asthma: Yes/No
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1283

c. Chronic bronchitis: Yes/No

d. Emphysema: Yes/No

e. Pneumonia: Yes/No

f. Tuberculosis: Yes/No

g. Silicosis: Yes/No

h. Pneumothorax (collapsed lung): Yes/No

i. Lung cancer: Yes/No

j. Broken ribs: Yes/No

k. Any chest injuries or surgeries: Yes/No

l. Any other lung problem that you’ve been

told about: Yes/No

4. Do you currently have any of the following

symptoms of pulmonary or lung illness?

a. Shortness of breath: Yes/No

b. Shortness of breath when walking fast

on level ground or walking up a slight

hill or incline: Yes/No

c. Shortness of breath when walking with

other people at an ordinary pace on level

ground: Yes/No

d. Have to stop for breath when walking at

your own pace on level ground: Yes/No

e. Shortness of breath when washing or

dressing yourself: Yes/No

f. Shortness of breath that interferes with

your job: Yes/No

g. Coughing that produces phlegm (thick

sputum): Yes/No

h. Coughing that wakes you early in the

morning: Yes/No

i. Coughing that occurs mostly when you

are lying down: Yes/No

j. Coughing up blood in the last month:

Yes/No

k. Wheezing: Yes/No

l. Wheezing that interferes with your job:

Yes/No

m. Chest pain when you breathe deeply:

Yes/No

n. Any other symptoms that you think may

be related to lung problems: Yes/No

5. Have you ever had any of the following

cardiovascular or heart problems?

a. Heart attack: Yes/No

b. Stroke: Yes/No

c. Angina: Yes/No

d. Heart failure: Yes/No

e. Swelling in your legs or feet (not caused

by walking): Yes/No

f. Heart arrhythmia (heart beating

irregularly): Yes/No

g. High blood pressure: Yes/No

h. Any other heart problem that you’ve

been told about: Yes/No

6. Have you ever had any of the following

cardiovascular or heart symptoms?

a. Frequent pain or tightness in your chest:

Yes/No

b. Pain or tightness in your chest during

physical activity: Yes/No

c. Pain or tightness in your chest that

interferes with your job: Yes/No

d. In the past two years, have you noticed

your heart skipping or missing a beat:

Yes/No

e. Heartburn or indigestion that is not

related to eating: Yes/No

f. Any other symptoms that you think may

be related to heart or circulation

problems: Yes/No

7. Do you currently take medication for any

of the following problems?

a. Breathing or lung problems: Yes/No

b. Heart trouble: Yes/No

c. Blood pressure: Yes/No

d. Seizures (fits): Yes/No

8. If you’ve used a respirator, have you ever

had any of the following problems? (If

you’ve never used a respirator, check the

following space and go to question 9:)

a. Eye irritation: Yes/No

b. Skin allergies or rashes: Yes/No

c. Anxiety: Yes/No

d. General weakness or fatigue: Yes/No

e. Any other problem that interferes with

your use of a respirator: Yes/No

9. Would you like to talk to the health care

professional who will review this

questionnaire about your answers to this

questionnaire: Yes/No

Questions 10 to 15 below must be

answered by every employee who has been

selected to use either a full-facepiece

respirator or a self-contained breathing

apparatus (SCBA). For employees who have

been selected to use other types of

respirators, answering these questions is

voluntary.

10. Have you ever lost vision in either eye

(temporarily or permanently): Yes/No

11. Do you currently have any of the

following vision problems?

a. Wear contact lenses: Yes/No

b. Wear glasses: Yes/No

c. Color blind: Yes/No

e. Any other eye or vision problem: Yes/

No

12. Have you ever had an injury to your ears,

including a broken ear drum: Yes/No

13. Do you currently have any of the

following hearing problems?

a. Difficulty hearing: Yes/No

b. Wear a hearing aid: Yes/No

c. Any other hearing or ear problem: Yes/

No

14. Have you ever had a back injury: Yes/No

15. Do you currently have any of the

following musculoskeletal problems?

a. Weakness in any of your arms, hands,

legs, or feet: Yes/No

b. Back pain: Yes/No

c. Difficulty fully moving your arms and

legs: Yes/No

d. Pain or stiffness when you lean forward

or backward at the waist: Yes/No

e. Difficulty fully moving your head up or

down: Yes/No

f. Difficulty fully moving your head side to

side: Yes/No

g. Difficulty bending at your knees: Yes/No

h. Difficulty squatting to the ground: Yes/

No

i. Climbing a flight of stairs or a ladder

carrying more than 25 lbs: Yes/No

j. Any other muscle or skeletal problem

that interferes with using a respirator:

Yes/No

Part B Any of the following questions,

and other questions not listed, may be added

to the questionnaire at the discretion of the

health care professional who will review the

questionnaire.

1. In your present job, are you working at

high altitudes (over 5,000 feet) or in a

place that has lower than normal

amounts of oxygen: Yes/No

If ‘‘yes,’’ do you have feelings of dizziness,

shortness of breath, pounding in your

chest, or other symptoms when you’re

working under these conditions: Yes/No

2. At work or at home, have you ever been

exposed to hazardous solvents,

hazardous airborne chemicals (e.g.,

gases, fumes, or dust), or have you come

into skin contact with hazardous

chemicals: Yes/No

If ‘‘yes,’’ name the chemicals if you know

them: llllllllllllllllll

lllllllllllllllllllll

lllllllllllllllllllll

3. Have you ever worked with any of the

materials, or under any of the conditions,

listed below:

a. Asbestos: Yes/No

b. Silica (e.g., in sandblasting): Yes/No

c. Tungsten/cobalt (e.g., grinding or

welding this material): Yes/No

d. Beryllium: Yes/No

e. Aluminum: Yes/No

f. Coal (for example, mining): Yes/No

g. Iron: Yes/No

h. Tin: Yes/No

i. Dusty environments: Yes/No

j. Any other hazardous exposures: Yes/No

If ‘‘yes,’’ describe these exposures: lll

lllllllllllllllllllll

lllllllllllllllllllll

4. List any second jobs or side businesses you

have: llllllllllllllllll

lllllllllllllllllllll

5. List your previous occupations: lllll

lllllllllllllllllllll

6. List your current and previous hobbies: l

lllllllllllllllllllll

7. Have you been in the military services?

Yes/No

If ‘‘yes,’’ were you exposed to biological or

chemical agents (either in training or

combat): Yes/No

8. Have you ever worked on a HAZMAT

team? Yes/No

9. Other than medications for breathing and

lung problems, heart trouble, blood

pressure, and seizures mentioned earlier

in this questionnaire, are you taking any

other medications for any reason

(including over-the-counter

medications): Yes/No

If ‘‘yes,’’ name the medications if you know

them: llllllllllllllllll

10. Will you be using any of the following

items with your respirator(s)?

a. HEPA Filters: Yes/No

b. Canisters (for example, gas masks): Yes/

No

c. Cartridges: Yes/No

11. How often are you expected to use the

respirator(s) (circle ‘‘yes’’ or ‘‘no’’ for all

answers that apply to you)?:

a. Escape only (no rescue): Yes/No

b. Emergency rescue only: Yes/No

c. Less than 5 hours per week: Yes/No

d. Less than 2 hours per day: Yes/No

e. 2 to 4 hours per day: Yes/No
1284 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

f. Over 4 hours per day: Yes/No

12. During the period you are using the

respirator(s), is your work effort:

a. Light (less than 200 kcal per hour): Yes/

No

If ‘‘yes,’’ how long does this period last

during the average

shift:llllllhrs.llllllmins.

Examples of a light work effort are sitting

while writing, typing, drafting, or performing

light assembly work; or standing while

operating a drill press (1–3 lbs.) or

controlling machines.

b. Moderate (200 to 350 kcal per hour):

Yes/No

If ‘‘yes,’’ how long does this period last

during the average

shift:llllllhrs.llllllmins.

Examples of moderate work effort are

sitting while nailing or filing; driving a truck

or bus in urban traffic; standing while

drilling, nailing, performing assembly work,

or transferring a moderate load (about 35 lbs.)

at trunk level; walking on a level surface

about 2 mph or down a 5-degree grade about

3 mph; or pushing a wheelbarrow with a

heavy load (about 100 lbs.) on a level surface.

c. Heavy (above 350 kcal per hour): Yes/

No

If ‘‘yes,’’ how long does this period last

during the average

shift:llllllhrs.llllllmins.

Examples of heavy work are lifting a heavy

load (about 50 lbs.) from the floor to your

waist or shoulder; working on a loading dock;

shoveling; standing while bricklaying or

chipping castings; walking up an 8-degree

grade about 2 mph; climbing stairs with a

heavy load (about 50 lbs.).

13. Will you be wearing protective clothing

and/or equipment (other than the

respirator) when you’re using your

respirator: Yes/No

If ‘‘yes,’’ describe this protective clothing

and/or equipment: llllllllllll

lllllllllllllllllllll

14. Will you be working under hot conditions

(temperature exceeding 77° F): Yes/No

15. Will you be working under humid

conditions: Yes/No

16. Describe the work you’ll be doing while

you’re using your respirator(s):

lllllllllllllllllllll

lllllllllllllllllllll

17. Describe any special or hazardous

conditions you might encounter when

you’re using your respirator(s) (for

example, confined spaces, lifethreatening gases):

lllllllllllllllllllll

lllllllllllllllllllll

18. Provide the following information, if you

know it, for each toxic substance that

you’ll be exposed to when you’re using

your respirator(s):

Name of the first toxic substance: llll

Estimated maximum exposure level per

shift: llllllllllllllllll

Duration of exposure per shift lllll

Name of the second toxic substance: lll

Estimated maximum exposure level per

shift: llllllllllllllllll

Duration of exposure per shift: lllll

Name of the third toxic substance: llll

Estimated maximum exposure level per

shift: llllllllllllllllll

Duration of exposure per shift: lllll

The name of any other toxic substances

that you’ll be exposed to while using

your respirator:

lllllllllllllllllllll

lllllllllllllllllllll

lllllllllllllllllllll

19. Describe any special responsibilities

you’ll have while using your respirator(s)

that may affect the safety and well-being

of others (for example, rescue, security):

lllllllllllllllllllll

Appendix D to § 1910.134 (Non-Mandatory)

Information for Employees Using

Respirators When Not Required Under the

Standard

Respirators are an effective method of

protection against designated hazards when

properly selected and worn. Respirator use is

encouraged, even when exposures are below

the exposure limit, to provide an additional

level of comfort and protection for workers.

However, if a respirator is used improperly

or not kept clean, the respirator itself can

become a hazard to the worker. Sometimes,

workers may wear respirators to avoid

exposures to hazards, even if the amount of

hazardous substance does not exceed the

limits set by OSHA standards. If your

employer provides respirators for your

voluntary use, of if you provide your own

respirator, you need to take certain

precautions to be sure that the respirator

itself does not present a hazard.

You should do the following:

1. Read and heed all instructions provided

by the manufacturer on use, maintenance,

cleaning and care, and warnings regarding

the respirators limitations.

2. Choose respirators certified for use to

protect against the contaminant of concern.

NIOSH, the National Institute for

Occupational Safety and Health of the U.S.

Department of Health and Human Services,

certifies respirators. A label or statement of

certification should appear on the respirator

or respirator packaging. It will tell you what

the respirator is designed for and how much

it will protect you.

3. Do not wear your respirator into

atmospheres containing contaminants for

which your respirator is not designed to

protect against. For example, a respirator

designed to filter dust particles will not

protect you against gases, vapors, or very

small solid particles of fumes or smoke.

4. Keep track of your respirator so that you

do not mistakenly use someone else’s

respirator.

Subpart L—[Amended]

8. The authority citation for Subpart

L of Part 1910 is revised to read as

follows:

Authority: Secs. 4, 6, and 8 of the

Occupational Safety and Health Act of 1970

(29 U.S.C. 653, 655, 657); Secretary of Labor’s

Orders 12–71 (36 FR 8754), 8–76 (41 FR

25059), 9–83 (48 FR 35736), 1–90 (55 FR

9033), or 6–96 (62 FR 111), as applicable.

9. Section 1910.156 is amended by

revising paragraphs (f)(1)(i) and (f)(1)(v)

as follows:

§ 1910.156 Fire brigades.

* * * * *

(f) Respiratory protection. (1) General.

(i) The employer must ensure that

respirators are provided to, and used by,

fire brigade members, and that the

respirators meet the requirements of 29

CFR 1910.134 and this paragraph.

* * * * *

(v) Self-contained breathing

apparatuses must have a minimum

service-life rating of 30 minutes in

accordance with the methods and

requirements specified by NIOSH under

42 CFR part 84, except for escape selfcontained breathing apparatus (ESCBAs)

used only for emergency escape

purposes.

* * * * *

Subpart Q—[Amended]

10. The authority citation for Subpart

Q of Part 1910 is revised to read as

follows:

Authority: Secs. 4, 6, and 8 of the

Occupational Safety and Health Act of 1970

(29 U.S.C. 653, 655, 657); Secretary of Labor’s

Orders 12–71 (36 FR 8754), 8–76 (41 FR

25059), 9–83 (48 FR 35736), 1–90 (55 FR

9033), or 6–96 (62 FR 111), as applicable; and

29 CFR part 1911.

11. Section 1910.252 is amended by

revising paragraphs (c)(4)(ii), (c)(4)(iii),

(c)(7)(iii), (c)(9)(i), and (c)(10) as follows:

§ 1910.252 General requirements.

* * * * *

(c) * * *

(4) * * *

(ii) Airline respirators. In

circumstances for which it is impossible

to provide such ventilation, airline

respirators or hose masks approved for

this purpose by the National Institute

for Occupational Safety and Health

(NIOSH) under 42 CFR part 84 must be

used.

(iii) Self-contained units. In areas

immediately hazardous to life, a fullfacepiece, pressure-demand, selfcontained breathing apparatus or a

combination full-facepiece, pressuredemand supplied-air respirator with an

auxiliary, self-contained air supply

approved by NIOSH under 42 CFR part

84 must be used.

* * * * *

(7) * * *

(iii) Local ventilation. In confined

spaces or indoors, welding or cutting

operations involving metals containing

lead, other than as an impurity, or
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1285

metals coated with lead-bearing

materials, including paint, must be done

using local exhaust ventilation or airline

respirators. Such operations, when done

outdoors, must be done using

respirators approved for this purpose by

NIOSH under 42 CFR part 84. In all

cases, workers in the immediate vicinity

of the cutting operation must be

protected by local exhaust ventilation or

airline respirators.

* * * * *

(9) * * *

(i) General. In confined spaces or

indoors, welding or cutting operations

involving cadmium-bearing or

cadmium-coated base metals must be

done using local exhaust ventilation or

airline respirators unless atmospheric

tests under the most adverse conditions

show that employee exposure is within

the acceptable concentrations specified

by 29 CFR 1910.1000. Such operations,

when done outdoors, must be done

using respirators, such as fume

respirators, approved for this purpose

by NIOSH under 42 CFR part 84.

* * * * *

(10) Mercury. In confined spaces or

indoors, welding or cutting operations

involving metals coated with mercurybearing materials, including paint, must

be done using local exhaust ventilation

or airline respirators unless atmospheric

tests under the most adverse conditions

show that employee exposure is within

the acceptable concentrations specified

by 29 CFR 1910.1000. Such operations,

when done outdoors, must be done

using respirators approved for this

purpose by NIOSH under 42 CFR part

84.

* * * * *

Subpart R—[Amended]

12. The authority citation for Subpart

R of Part 1910 is revised as follows:

Authority: Sections 4, 6, and 8 of the

Occupational Safety and Health Act of 1970

(29 U.S.C. 653, 655, 657); Secretary of Labor’s

Orders 12–71 (36 FR 8754), 8–76 (41 FR

25059), 9–83 (48 FR 35736), 1–90 (55 FR

9033), or 6–96 (62 FR 111), as applicable; and

29 CFR part 11.

Sections 1910.261, 1910.262, 1910.265

through 1910.269, 1910.274, and 1910.275

also issued under 29 CFR part 1911.

13. Section 1910.261 is amended by

revising paragraphs (b)(2), (g)(10),

(h)(2)(iii), and (h)(2)(iv) as follows:

§ 1910.261 Pulp, paper, and paperboard

mills.

* * * * *

(b) * * *

(2) Personal protective clothing and

equipment. Foot protection, shin

guards, hard hats, noise-attenuation

devices, and other personal protective

clothing and equipment must be worn

when the extent of the hazard warrants

their use. Such equipment must be worn

when specifically required by other

paragraphs of this section, and must be

maintained in accordance with

applicable American National Standards

Institute standards. Respirators, goggles,

protective masks, rubber gloves, rubber

boots, and other such equipment must

be cleaned and disinfected before being

used by another employee. Required

eye, head, and ear protection must

conform to American National

Standards Institute standards Z24.22–

1957, Z87.1–1968, and Z89.1–1969.

Respiratory protection must conform to

the requirements of 29 CFR 1910.134.

* * * * *

(g) * * *

(10) Gas masks (digester building).

Gas masks must be available, and they

must furnish adequate protection

against sulfurous acid and chlorine

gases and be inspected and repaired in

accordance with 29 CFR 1910.134.

* * * * *

(h) * * *

(2) * * *

(iii) Gas masks must be provided for

emergency use in accordance with 29

CFR 1910.134.

(iv) For emergency and rescue

operations, the employer must provide

employees with self-contained breathing

apparatuses or supplied-air respirators,

and ensure that employees use these

respirators, in accordance with the

requirements of 29 CFR 1910.134.

* * * * *

Subpart Z—[Amended]

14. The general authority citation for

Subpart Z of 29 CFR Part 1910 is revised

to read as follows:

Authority: Secs. 4, 6, and 8 of the

Occupational Safety and Health Act (29

U.S.C. 653, 655, and 657); Secretary of

Labor’s Orders 12–71 (36 FR 8754), 8–76 (41

FR 25059), 9–83 (48 FR 35736), 1–90 (55 FR

9033), or 6–96 (62 FR 111), as applicable; and

29 CFR Part 1911.

* * * * *

15. Section 1910.1001 is amended by

removing Appendix C and revising

paragraph (g), to read as follows:

§ 1910.1001 Asbestos.

* * * * *

(g) Respiratory protection. (1) General.

For employees who use respirators

required by this section, the employer

must provide respirators that comply

with the requirements of this paragraph.

Respirators must be used during:

(i) Periods necessary to install or

implement feasible engineering and

work-practice controls.

(ii) Work operations, such as

maintenance and repair activities, for

which engineering and work-practice

controls are not feasible.

(iii) Work operations for which

feasible engineering and work-practice

controls are not yet sufficient to reduce

employee exposure to or below the

TWA and/or excursion limit.

(iv) Emergencies.

(2) Respirator program. (i) The

employer must implement a respiratory

protection program in accordance with

29 CFR 1910.134 (b) through (d) (except

(d)(1)(iii)), and (f) through (m).

(ii) The employer must provide a

tight-fitting, powered, air-purifying

respirator instead of any negativepressure respirator specified in Table 1

of this section when an employee

chooses to use this type of respirator

and the respirator provides adequate

protection to the employee.

(iii) No employee must be assigned to

tasks requiring the use of respirators if,

based on their most recent medical

examination, the examining physician

determines that the employee will be

unable to function normally using a

respirator, or that the safety or health of

the employee or other employees will be

impaired by the use of a respirator. Such

employees must be assigned to another

job or given the opportunity to transfer

to a different position, the duties of

which they can perform. If such a

transfer position is available, the

position must be with the same

employer, in the same geographical

area, and with the same seniority,

status, and rate of pay the employee had

just prior to such transfer.

(3) Respirator selection. The employer

must select and provide the appropriate

respirator from Table 1 of this section.

TABLE 1.—RESPIRATORY PROTECTION FOR ASBESTOS FIBERS

Airborne concentration of asbestos or conditions

of use Required respirator

Not in excess of 1 f/cc (10 X PEL) ..................... Half-mask air purifying respirator other than a disposable respirator, equipped with high efficiency filters.
1286 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

TABLE 1.—RESPIRATORY PROTECTION FOR ASBESTOS FIBERS—Continued

Airborne concentration of asbestos or conditions

of use Required respirator

Not in excess of 5 f/cc (50 X PEL) ..................... Full facepiece air-purifying respirator equipped with high efficiency filters.

Not in excess of 10 f/cc (100 X PEL) ................. Any powered air-purifying respirator equipped with high efficiency filters or any supplied air

respirator operated in continuous flow mode.

Not in excess of 100 f/cc (1,000 X PEL) ............ Full facepiece supplied air respirator operated in pressure demand mode.

Greater than 100 f/cc (1,000 X PEL) or unknown concentration.Full facepiece supplied air respirator operated in pressure demand mode, equipped with an

auxiliary positive pressure self-contained breathing apparatus.

NOTE: a. Respirators assigned for high environmental concentrations may be used at lower concentrations, or when required respirator use is

independent of concentration.

b. A high efficiency filter means a filter that is at least 99.97 percent efficient against mono-dispersed particles of 0.3 micrometers in diameter

or larger.

* * * * *

16. Section 1910.1003 is amended by

revising paragraphs (c)(4)(iv) and (d)(1)

as follows:

§ 1910.1003 13 Carcinogens (4-

Nitrobiphenyl, etc.).

* * * * *

(c) * * *

(4) * * *

(iv) Employees engaged in handling

operations involving the carcinogens

addressed by this section must be

provided with, and required to wear and

use, a half-face filter-type respirator for

dusts, mists, and fumes. A respirator

affording higher levels of protection

than this respirator may be substituted.

* * * * *

(d) * * *

(1) Respirator program. The employer

must implement a respiratory protection

program in accordance with 29 CFR

1910.134 (b), (c), (d) (except (d)(1)(iii)

and (iv), and (d)(3)), and (e) through (m).

* * * * *

17. Section 1910.1017 is amended by

revising paragraph (g) to read as follows:

§ 1910.1017 Vinyl chloride.

* * * * *

(g) Respiratory protection. (1) General.

For employees who use respirators

required by this section, the employer

must provide respirators that comply

with the requirements of this paragraph.

(2) Respirator program. The employer

must implement a respiratory protection

program in accordance with 29 CFR

1910.134 (b) through (d) (except

(d)(1)(iii), and (d)(3)(iii)(B)(1) and (2)),

and (f) through (m).

(3) Respirator selection. (i) Respirators

must be selected from the following

table:

Atmospheric concentration of vinyl chloride Required apparatus

(i) Unknown, or above 3,600 p/m ....................... Open-circuit, self-contained breathing apparatus, pressure demand type, with full facepiece.

(ii) Not over 3,600 p/m ........................................ (A) Combination type C supplied air respirator, pressure demand type, with full or half facepiece, and auxiliary self-contained air supply; or

(iii) Not over 1,000 p/m ....................................... (B) Combination type, supplied air respirator continuous flow type, with full or half facepiece,

and auxiliary self-contained air supply. Type C, supplied air respirator, continuous flow type,

with full or half facepiece, helmet or hood.

(iv) Not over 100 p/m .......................................... (A) Combination type C supplied air respirator demand type, with full facepiece, and auxiliary

self-contained air supply; or

(B) Open-circuit self-contained breathing apparatus with full facepiece, in demand mode; or

Type (C) supplied air respirator, demand type, with full facepiece.

(v) Not over 25 p/m ............................................. (A) A powered air-purifying respirator with hood, helmet, full or half facepiece, and a canister

which provides a service life of at least 4 hours for concentrations of vinyl chloride up to 25

p/m, or

(B) Gas mask, front- or back-mounted canister which provides a service life of at least 4 hours

for concentrations of vinyl chloride up to 25 p/m.

(vi) Not over 10 p/m ............................................ (A) Combination type C supplied-air respirator, demand type, with half facepiece, and auxiliary

self-contained air supply; or

(B) Type C supplied-air respirator, demand type, with half facepiece; or

(C) Any chemical cartridge respirator with an organic vapor cartridge which provides a service

life of at least 1 hour for concentrations of vinyl chloride up to 10 p/m.

(ii) When air-purifying respirators are

used:

(A) Air-purifying canisters or

cartridges must be replaced prior to the

expiration of their service life or the end

of the shift in which they are first used,

whichever occurs first.

(B) A continuous-monitoring and

alarm system must be provided when

concentrations of vinyl chloride could

reasonably exceed the allowable

concentrations for the devices in use.

Such a system must be used to alert

employees when vinyl chloride

concentrations exceed the allowable

concentrations for the devices in use.

(iii) Respirators specified for higher

concentrations may be used for lower

concentrations.

* * * * *

18. Section 1910.1018 is amended by

revising paragraph (h) to read as

follows:

§ 1910.1018 Inorganic arsenic.

* * * * *

(h) Respiratory protection. (1)

General. For employees who use

respirators required by this section, the

employer must provide respirators that

comply with the requirements of this

paragraph. Respirators must be used

during:

(i) Periods necessary to install or

implement feasible engineering or workpractice controls.

(ii) Work operations, such as

maintenance and repair activities, for

which the employer establishes that
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1287

engineering and work-practice controls

are not feasible.

(iii) Work operations for which

engineering and work-practice controls

are not yet sufficient to reduce

employee exposures to or below the

permissible exposure limit.

(iv) Emergencies.

(2) Respirator program. (i) The

employer must implement a respiratory

protection program in accordance with

29 CFR 1910.134 (b) through (d) (except

(d)(1)(iii)), and (f) through (m).

(ii) If an employee exhibits breathing

difficulty during fit testing or respirator

use, they must be examined by a

physician trained in pulmonary

medicine to determine whether they can

use a respirator while performing the

required duty.

(3) Respirator selection. (i) The

employer must use Table I of this

section to select the appropriate

respirator or combination of respirators

for inorganic arsenic compounds

without significant vapor pressure, and

Table II of this section to select the

appropriate respirator or combination of

respirators for inorganic arsenic

compounds that have significant vapor

pressure.

(ii) When employee exposures exceed

the permissible exposure limit for

inorganic arsenic and also exceed the

relevant limit for other gases (for

example, sulfur dioxide), an airpurifying respirator provided to the

employee as specified by this section

must have a combination highefficiency filter with an appropriate gas

sorbent. (See footnote in Table 1 of this

section.)

(iii) Employees required to use

respirators may choose, and the

employer must provide, a powered airpurifying respirator if it will provide

proper protection. In addition, the

employer must provide a combination

dust and acid-gas respirator to

employees who are exposed to gases

over the relevant exposure limits.

TABLE I.—RESPIRATORY PROTECTION FOR INORGANIC ARSENIC PARTICULATE EXCEPT FOR THOSE WITH SIGNIFICANT

VAPOR PRESSURE

Concentration of inorganic arsenic (as As) or

condition of use Required respirator

(i) Unknown or greater or lesser than 20,000

μg/m(3) (20 mg/m(3)) or firefighting.

(A) Any full facepiece self-contained breathing apparatus operated in positive pressure mode.

(ii) Not greater than 20,000 μg/m(3) (20 mg/

m(3)).

(A) Supplied air respirator with full facepiece, hood, or helmet or suit and operated in positive

pressure mode.

(iii) Not greater than 10,000 μg/m(3) (10 mg/

m(3)).

(A) Powered air-purifying respirators in all inlet face coverings with high efficiency filters 1.

(B)Half-mask supplied air respirators operated in positive pressure mode.

(iv) Not greater than 500 μg/m(3) ....................... (A) Full facepiece air-purifying respirator equipped with high-efficiency filter 1.

(B) Any full facepiece supplied air respirator.

(C) Any full facepiece self-contained breathing apparatus.

(v) Not greater than 100 μg/m(3) ........................ (A) Half-mask air-purifying respirator equipped with high-efficiency filter 1.

(B) Any half-mask supplied air respirator.

1 High-efficiency filter-99.97 pct efficiency against 0.3 micrometer monodisperse diethyl-hexyl phthalate (DOP) particles.

TABLE II.—RESPIRATORY PROTECTION FOR INORGANIC ARSENICALS (SUCH AS ARSENIC TRICHLORIDE 2 AND ARSENIC

PHOSPHIDE) WITH SIGNIFICANT VAPOR PRESSURE

Concentration of inorganic arsenic (as As) or

condition of use Required respirator

(i) Unknown or greater or lesser than 20,000

μg/m(3) (20 mg/m(3)) or firefighting.

(A) Any full facepiece self-contained breathing apparatus operated in positive pressure mode.

(ii) Not greater than 20,000 μg/m(3) (20 mg/

m(3)).

(A) Supplied air respirator with full facepiece, hood, or helmet or suit and operated in positive

pressure mode.

(iii) Not greater than 10,000 μg/m(3) (10 mg/

m(3)).

(A) Half-mask 2 supplied air respirator operated in positive pressure mode.

(iv) Not greater than 500 μg/m(3) ....................... (A) Front or back mounted gas mask equipped with high-efficiency filter 1 and acid gas canister.

(B) Any full facepiece supplied air respirator.

(C) Any full facepiece self-contained breathing apparatus.

(v) Not greater than 100 μg/m(3) ........................ (A) Half-mask air-purifying respirator equipped with high efficiency filter 1 and acid gas cartridge.

(B) Any half-mask supplied air respirator.

1 High-efficiency filter-99.97 pct efficiency against 0.3 micrometer monodisperse diethyl-hexyl phthalate (DOP) particles.

2 Half-mask respirators shall not be used for protection against arsenic trichloride, as it is rapidly absorbed through the skin.

* * * * *

19. Section 1910.1025 is amended by

revising paragraph (f); revising the

second and fourth paragraphs of Section

IV to Appendix B; removing the sixth

paragraph of Section IV to Appendix B;

and removing Appendix D, as follows:

§ 1910.1025 Lead.

* * * * *

(f) Respiratory protection. (1) General.

For employees who use respirators

required by this section, the employer

must provide respirators that comply

with the requirements of this paragraph.

Respirators must be used during:

(i) Periods necessary to install or

implement engineering or work-practice

controls, except that no employer can

require an employee to use a respirator

longer than 4.4 hours per day.

(ii) Work operations for which

engineering and work-practice controls

are not sufficient to reduce employee

exposures to or below the permissible

exposure limit.

(iii) Periods when an employee

requests a respirator.
1288 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

(2) Respirator program. (i) The

employer must implement a respiratory

protection program in accordance with

29 CFR 1910.134 (b) through (d) (except

(d)(1)(iii)), and (f) through (m).

(ii) If an employee has breathing

difficulty during fit testing or respirator

use, the employer must provide the

employee with a medical examination

in accordance with paragraph (j)(3)(i)(C)

of this section to determine whether or

not the employee can use a respirator

while performing the required duty.

TABLE II.—RESPIRATORY PROTECTION FOR LEAD AEROSOLS

Airborne concentration of lead or condition of

use Required respirator

Not in excess of 0.5 mg/m3 (10X PEL) .............. Half-mask, air-purifying respirator equipped with high efficiency filters.2 3

Not in excess of 2.5 mg/m3 (50X PEL) .............. Full facepiece, air-purifying respirator with high efficiency filters.3

Not in excess of 50 mg/m3 (1000X PEL) ........... (1) Any powered, air-purifying respirator with high efficiency filters3; or (2) Half-mask suppliedair respirator operated in positive-pressure mode.2

Not in excess of 100 mg/m3 (2000XPEL) .......... Supplied-air respirators with full facepiece, hood, helmet, or suit, operated in positive pressure

mode.

Greater than 100 mg/m3, unknown concentration or fire fighting.Full facepiece, self-contained breathing apparatus operated in positive-pressure mode.

1 Respirators specified for high concentrations can be used at lower concentrations of lead.

2Full facepiece is required if the lead aerosols cause eye or skin irritation at the use concentrations.

3A high efficiency particulate filter means 99.97 percent efficient against 0.3 micron size particles.

(3) Respirator selection. (i) The

employer must select the appropriate

respirator or combination of respirators

from Table II of this section.

(ii) The employer must provide a

powered air-purifying respirator instead

of the respirator specified in Table II of

this section when an employee chooses

to use this type of respirator and such

a respirator provides adequate

protection to the employee.

* * * * *

Appendix B to § 1910.1025—Employee

Standard Summary

* * * * *

IV. Respiratory Protection—Paragraph (f)

* * * * *

Your employer is required to select

respirators from the seven types listed in

Table II of the Respiratory Protection section

of the standard (§ 1910.1025(f)). Any

respirator chosen must be approved by the

National Institute for Occupational Safety

and Health (NIOSH) under the provisions of

42 CFR part 84. This respirator selection

table will enable your employer to choose a

type of respirator that will give you a proper

amount of protection based on your airborne

lead exposure. Your employer may select a

type of respirator that provides greater

protection than that required by the standard;

that is, one recommended for a higher

concentration of lead than is present in your

workplace. For example, a powered airpurifying respirator (PAPR) is much more

protective than a typical negative pressure

respirator, and may also be more comfortable

to wear. A PAPR has a filter, cartridge, or

canister to clean the air, and a power source

that continuously blows filtered air into your

breathing zone. Your employer might make a

PAPR available to you to ease the burden of

having to wear a respirator for long periods

of time. The standard provides that you can

obtain a PAPR upon request.

* * * * *

Your employer must ensure that your

respirator facepiece fits properly. Proper fit of

a respirator facepiece is critical to your

protection from airborne lead. Obtaining a

proper fit on each employee may require

your employer to make available several

different types of respirator masks. To ensure

that your respirator fits properly and that

facepiece leakage is minimal, your employer

must give you either a qualitative or

quantitative fit test as specified in Appendix

A of the Respiratory Protection standard

located at 29 CFR 1910.134.

* * * * *

20. Section 1910.1027 is amended by

removing and reserving Appendix C and

revising paragraph (g) to read as follows:

§ 1910.1027 Cadmium.

* * * * *

(g) Respiratory protection. (1) General.

For employees who use respirators

required by this section, the employer

must provide respirators that comply

with the requirements of this paragraph.

Respirators must be used during:

(i) Periods necessary to install or

implement feasible engineering and

work-practice controls when employee

exposure levels exceed the PEL.

(ii) Maintenance and repair activities,

and brief or intermittent operations, for

which employee exposures exceed the

PEL and engineering and work-practice

controls are not feasible or are not

required.

(iii) Activities in regulated areas

specified in paragraph (e) of this

section.

(iv) Work operations for which the

employer has implemented all feasible

engineering and work-practice controls

and such controls are not sufficient to

reduce employee exposures to or below

the PEL.

(v) Work operations for which an

employee is exposed to cadmium at or

above the action level, and the

employee requests a respirator.

(vi) Work operations for which an

employee is exposed to cadmium above

the PEL and engineering controls are not

required by paragraph (f)(1)(ii) of this

section.

(vii) Emergencies.

(2) Respirator program. (i) The

employer must implement a respiratory

protection program in accordance with

29 CFR 1910.134 (b) through (d) (except

(d)(1)(iii)), and (f) through (m).

(ii) No employees must use a

respirator if, based on their most recent

medical examination, the examining

physician determines that they will be

unable to continue to function normally

while using a respirator. If the physician

determines that the employee must be

limited in, or removed from, their

current job because of their inability to

use a respirator, the limitation or

removal must be in accordance with

paragraphs (l) (11) and (12) of this

section.

(iii) If an employee has breathing

difficulty during fit testing or respirator

use, the employer must provide the

employee with a medical examination

in accordance with paragraph (l)(6)(ii) of

this section to determine if the

employee can use a respirator while

performing the required duties.

(3) Respirator selection. (i) The

employer must select the appropriate

respirator from Table 2 of this section.
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1289

TABLE 2.—RESPIRATORY PROTECTION FOR CADMIUM

Airborne concentration or condition of use a Required respirator type b

10 X or less ......................................................... A half mask, air-purifying equipped with a HEPAc filter.d

25 X or less ......................................................... A powered air-purifying respirator (‘‘PAPR’’) with a loose-fitting hood or helmet equipped with

a HEPA filter, or a supplied-air respirator with a loose-fitting hood or helmet facepiece operated in the continuous flow mode.

50 X or less ......................................................... A full facepiece air-purifying respirator equipped with a HEPA filter, or a powered air-purifying

respirator with a tight-fitting half mask equipped with a HEPA filter, or a supplied-air respirator with a tight-fitting half mask operated in the continuous flow mode.

250 X or less ....................................................... A powered air-purifying respirator with a tight fitting full facepiece equipped with a HEPA filter,

or a supplied-air respirator with a tight-fitting full facepiece operated in the continuous flow

mode.

1000 X or less ..................................................... A supplied air respirator with half mask or full facepiece operated in the pressure demand or

other positive pressure mode.

>1000 X or unknown concentrations .................. A self-contained breathing apparatus with a full facepiece operated in the pressure demand or

other positive pressure mode, or a supplied-air respirator with a full facepiece operated in

the pressure demand or other positive pressure mode and equipped with an auxiliary escape type self-contained breathing apparatus operated in the pressure demand mode.

Fire fighting ......................................................... A self-contained breathing apparatus with full facepiece operated in the pressure demand or

other positive pressure mode.

a Concentrations expressed as multiple of the PEL.

b Respirators assigned for higher environmental concentrations may be used at lower exposure levels. Quantitative fit testing is required for all

tight-fitting air purifying respirators where airborne concentration of cadmium exceeds 10 times the TWA PEL (10 X 5 ug/m(3) = 50 ug/m(3)). A

full facepiece respirator is required when eye irritation is experienced. c HEPA means High-efficiency Particulate Air.

dFit testing, qualitative or quantitative, is required.

SOURCE: Respiratory Decision Logic, NIOSH, 1987.

(ii) The employer must provide an

employee with a powered air-purifying

respirator instead of a negative-pressure

respirator when an employee who is

entitled to a respirator chooses to use

this type of respirator and such a

respirator provides adequate protection

to the employee.

* * * * *

21. Section 1910.1028 is amended by

removing Appendix E and revising

paragraph (g) to read as follows:

§ 1910.1028 Benzene.

* * * * *

(g) Respiratory protection. (1) General.

For employees who use respirators

required by this section, the employer

must provide respirators that comply

with the requirements of this paragraph.

Respirators must be used during:

(i) Periods necessary to install or

implement feasible engineering and

work-practice controls.

(ii) Work operations for which the

employer establishes that compliance

with either the TWA or STEL through

the use of engineering and workpractice controls is not feasible; for

example, some maintenance and repair

activities, vessel cleaning, or other

operations for which engineering and

work-practice controls are infeasible

because exposures are intermittent and

limited in duration.

(iii) Work operations for which

feasible engineering and work-practice

controls are not yet sufficient, or are not

required under paragraph (f)(1)(iii) of

this section, to reduce employee

exposure to or below the PELs.

(iv) Emergencies.

(2) Respirator program. (i) The

employer must implement a respiratory

protection program in accordance with

29 CFR 1910.134 (b) through (d) (except

(d)(1)(iii), (d)(3)(iii)(b)(1), and (2)), and

(f) through (m).

(ii) For air-purifying respirators, the

employer must replace the air-purifying

element at the expiration of its service

life or at the beginning of each shift in

which such elements are used,

whichever comes first.

(iii) If NIOSH approves an airpurifying element with an end-ofservice-life indicator for benzene, such

an element may be used until the

indicator shows no further useful life.

(3) Respirator selection. (i) The

employer must select the appropriate

respirator from Table 1 of this section.

(ii) Any employee who cannot use a

negative-pressure respirator must be

allowed to use a respirator with less

breathing resistance, such as a powered

air-purifying respirator or supplied-air

respirator.

TABLE 1.—RESPIRATORY PROTECTION FOR BENZENE

Airborne concentration of benzene or condition

of use Respirator type

(a) Less than or equal to 10 ppm ....................... (1) Half-mask air-purifying respirator with organic vapor cartridge.

(b) Less than or equal to 50 ppm ....................... (1) Full facepiece respirator with organic vapor cartridges.

(1) Full facepiece gas mask with chin style canister.1

(c) Less than or equal to 100 ppm ..................... (1) Full facepiece powered air-purifying respirator with organic vapor canister.1

(d) Less than or equal to 1,000 ppm .................. (1) Supplied air respirator with full facepiece in positive-pressure mode.

(e) Greater than 1,000 ppm or unknown concentration.(1) Self-contained breathing apparatus with full facepiece in positive pressure mode.

(2) Full facepiece positive-pressure supplied-air respirator with auxiliary self-contained air supply.

(f) Escape ............................................................ (1) Any organic vapor gas mask; or

(2) Any self-contained breathing apparatus with full facepiece.
1290 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

TABLE 1.—RESPIRATORY PROTECTION FOR BENZENE—Continued

Airborne concentration of benzene or condition

of use Respirator type

(g) Firefighting ..................................................... (1) Full facepiece self-contained breathing apparatus in positive pressure mode.

1 Canisters must have a minimum service life of four (4) hours when tested at 150 ppm benzene, at a flow rate of 64 LPM, 25 deg. C, and

85% relative humidity for non-powered air purifying respirators. The flow rate shall be 115 LPM and 170 LPM respectively for tight fitting and

loose fitting powered air-purifying respirators.

* * * * *

22. Section 1910.1029 is amended by

revising paragraph (g) to read as follows:

§ 1910.1029 Coke oven emissions.

* * * * *

(g) Respiratory protection. (1) General.

For employees who use respirators

required by this section, the employer

must provide respirators that comply

with the requirements of this paragraph.

Compliance with the permissible

exposure limit may not be achieved by

the use of respirators except during:

(i) Periods necessary to install or

implement feasible engineering and

work-practice controls.

(ii) Work operations, such as

maintenance and repair activity, for

which engineering and work-practice

controls are technologically not feasible.

(iii) Work operations for which

feasible engineering and work-practice

controls are not yet sufficient to reduce

employee exposure to or below the

permissible exposure limit.

(iv) Emergencies.

(2) Respirator program. The employer

must implement a respiratory protection

program in accordance with 29 CFR

1910.134 (b) through (d) (except

(d)(1)(iii)), and (f) through (m).

(3) Respirator selection. The employer

must select appropriate respirators or

combination of respirators from Table I

of this section.

TABLE I.—RESPIRATORY PROTECTION FOR COKE OVEN EMISSIONS

Airborne concentration of coke oven emissions Required respirator

(a) Any concentration .......................................... (1) A Type C supplied air respirator operated in pressure demand or other positive pressure or

continuous flow mode; or

(2) A powered air-purifying particulate filter respirator for dust and mist or

(3) A powered air-purifying particulate filter respirator or combination chemical cartridge and

particulate filter respirator for coke oven emissions.

(b) Concentrations not greater than 1500 ug/m 3 (1) Any particulate filter respirator for dust and mist except single-use respirator; or

(2) Any particulate filter respirator or combination chemical cartridge and particulate filter respirator for coke oven emissions; or

(3) Any respirator listed in paragraph (g)(3)(a) of this section.

* * * * *

23. Section 1910.1043 is amended by

revising paragraph (f) to read as follows:

§ 1910.1043 Cotton dust.

* * * * *

(f) Respiratory protection. (1) General.

For employees who are required to use

respirators by this section, the employer

must provide respirators that comply

with the requirements of this paragraph.

Respirators must be used during:

(i) Periods necessary to install or

implement feasible engineering and

work-practice controls.

(ii) Maintenance and repair activities

for which engineering and workpractice controls are not feasible.

(iii) Work operations for which

feasible engineering and work-practice

controls are not yet sufficient to reduce

employee exposure to or below the

permissible exposure limits.

(iv) Work operations specified under

paragraph (g)(1) of this section.

(v) Periods for which an employee

requests a respirator.

(2) Respirator program. (i) The

employer must implement a respiratory

protection program in accordance with

29 CFR 1910.134 (b) through (d) (except

(d)(1)(iii)), and (f) through (m).

(ii) Whenever a physician determines

that an employee who works in an area

in which the cotton-dust concentration

exceeds the PEL is unable to use a

respirator, including a powered airpurifying respirator, the employee must

be given the opportunity to transfer to

an available position, or to a position

that becomes available later, that has a

cotton-dust concentration at or below

the PEL. The employer must ensure that

such employees retain their current

wage rate or other benefits as a result of

the transfer.

(3) Respirator selection. (i) The

employer must select the appropriate

respirator from Table I of this section.

TABLE I

Cotton dust concentration Required respirator

Not greater than:

(a) 5 × the applicable permissible exposure

limit (PEL).

A disposable respirator with a particulate filter.

(b) 10 × the applicable PEL ......................... A quarter or half-mask respirator, other than a disposable respirator, equipped with particulate

filters.

(c) 100 × the applicable PEL ....................... A full facepiece respirator equipped with high-efficiency particulate filters.

(d) Greater than 100 × the applicable PEL A powered air-purifying respirator equipped with high-efficiency particulate filters.

Notes:

1. A disposable respirator means the filter element is an inseparable part of the respirator.

2. Any respirators permitted at higher environmental concentrations can be used at lower concentrations.
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1291

3. Self-contained breathing apparatus are not required respirators but are permitted respirators.

4. Supplied air respirators are not required but are permitted under the following conditions: Cotton dust concentration not greater than 10X

the PEL—Any supplied air respirator; not greater than 100X the PEL—Any supplied air respirator with full facepiece, helmet or hood; greater

than 100X the PEL—A supplied air respirator operated in positive pressure mode.

(ii) Whenever respirators are required

by this section for cotton-dust

concentrations that do not exceed the

applicable permissible exposure limit

by a multiple of 100 (100 X), the

employer must, when requested by an

employee, provide a powered airpurifying respirator with a highefficiency particulate filter instead of

the respirator specified in paragraphs

(a), (b), or (c) of Table I of this section.

* * * * *

24. Section 1910.1044 is amended by

revising paragraph (h) to read as

follows:

§ 1910.1044 1,2-Dibromo-3-chloropropane.

* * * * *

(h) Respiratory protection. (1)

General. For employees who are

required to use respirators by this

section, the employer must provide

respirators that comply with the

requirements of this paragraph.

Respirators must be used during:

(i) Periods necessary to install or

implement feasible engineering and

work-practice controls.

(ii) Maintenance and repair activities

for which engineering and workpractice controls are not feasible.

(iii) Work operations for which

feasible engineering and work-practice

controls are not yet sufficient to reduce

employee exposure to or below the

permissible exposure limit.

(iv) Emergencies.

(2) Respirator program. The employer

must implement a respiratory protection

program in accordance with 29 CFR

1910.134 (b) through (d) (except

(d)(1)(iii)), and (f) through (m).

(3) Respirator selection. The employer

must select the appropriate respirator

from Table 1 of this section.

TABLE 1.—RESPIRATORY PROTECTION FOR DBCP

Airborne concentration of DBCP or condition of

use Respirator type

(a) Less than or equal to 10 ppb ........................ (1) Any supplied-air respirator; or (2) any self-contained breathing apparatus.

(b) Less than or equal to 50 ppb ........................ (1) Any supplied-air respirator with full facepiece, helmet, or hood; or (2) any self-contained

breathing apparatus with full facepiece.

(c) Less than or equal to 1,000 ppb ................... (1) A Type C supplied-air respirator operated in pressure-demand or other positive pressure or

continuous flow mode.

(d) Less than or equal to 2,000 ppb ................... (1) A Type C supplied-air respirator with full facepiece operated in pressure-demand or other

positive pressure mode, or with full facepiece, helmet, or hood operated in continuous flow

mode.

(e) Greater than 2,000 ppb or entry and escape

from unknown concentrations.

(1) A combination respirator which includes a Type C supplied-air respirator with full facepiece

operated in pressure-demand or other positive pressure or continuous flow mode and an

auxiliary self-contained breathing apparatus operated in pressure-demand or positive pressure mode; or (2) a self-contained breathing apparatus with full facepiece operated in pressure-demand or other positive pressure mode.

(f) Firefighting ...................................................... (1) A self-contained breathing apparatus with full facepiece operated in pressure-demand or

other positive pressure mode.

* * * * *

25. Section 1910.1045 is amended by

revising paragraph (h) and the first

paragraph of Section IV to Appendix A

to read as follows:

§ 1910.1045 Acrylonitrile.

* * * * *

(h) Respiratory protection. (1)

General. For employees who use

respirators required by this section, the

employer must provide respirators that

comply with the requirements of this

paragraph. Respirators must be used

during:

(i) Periods necessary to install or

implement feasible engineering and

work-practice controls.

(ii) Work operations, such as

maintenance and repair activities or

reactor cleaning, for which the employer

establishes that engineering and workpractice controls are not feasible.

(iii) Work operations for which

feasible engineering and work-practice

controls are not yet sufficient to reduce

employee exposure to or below the

permissible exposure limits.

(iv) Emergencies.

(2) Respirator program. (i) The

employer must implement a respiratory

protection program in accordance with

29 CFR 1910.134 (b) through (d) (except

(d)(1)(iii), (d)(3)(iii)(b)(1), and (2)), and

(f) through (m).

(ii) If air-purifying respirators

(chemical-cartridge or chemical-canister

types) are used:

(A) The air-purifying canister or

cartridge must be replaced prior to the

expiration of its service life or at the

completion of each shift, whichever

occurs first.

(B) A label must be attached to the

cartridge or canister to indicate the date

and time at which it is first installed on

the respirator.

(3) Respirator selection. The employer

must select the appropriate respirator

from Table I of this section.

TABLE I.—RESPIRATORY PROTECTION FOR ACRYLONITRILE (AN)

Concentration of AN or condition of use Respirator type

(a) Less than or equal to 20 ppm ....................... (1) Chemical cartridge respirator with organic vapor cartridge(s) and half-mask facepiece; or

(2) Supplied air respirator with half-mask facepiece.

(b) Less than or equal to 100 ppm or maximum

use concentration (MUC) of cartridges or canisters, whichever is lower.

(1) Full facepiece respirator with (A) organic vapor cartridges, (B) organic vapor gas mask

chin-style, or (C) organic vapor gas mask canister, front-or back-mounted;
1292 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

TABLE I.—RESPIRATORY PROTECTION FOR ACRYLONITRILE (AN)—Continued

Concentration of AN or condition of use Respirator type

(2) Supplied air respirator with full facepiece; or

(3) Self-contained breathing apparatus with full facepiece.

(c) Less than or equal to 4,000 ppm .................. (1) Supplied air respirator operated in the positive pressure mode with full facepiece, helmet,

suit, or hood.

(d) Greater than 4,000 ppm or unknown concentration.(1) Supplied air and auxiliary self-contained breathing apparatus with full facepiece in positive

pressure mode; or

(2) Self-contained breathing apparatus with full facepiece in positive pressure mode.

(e) Firefighting ..................................................... Self-contained breathing apparatus with full facepiece in positive pressure mode.

(f) Escape ............................................................ (1) Any organic vapor respirator, or

(2) Any self-contained breathing apparatus.

* * * * *

Appendix A to § 1910.1045—Substance

Safety Data Sheet for Acrylonitrile

* * * * *

IV. Respirators and Protective Clothing

A. Respirators. You may be required to

wear a respirator for nonroutine activities, in

emergencies, while your employer is in the

process of reducing acrylonitrile exposures

through engineering controls, and in areas

where engineering controls are not feasible.

If respirators are worn, they must have a label

issued by the National Institute for

Occupational Safety and Health under the

provisions of 42 CFR part 84 stating that the

respirators have been approved for use with

organic vapors. For effective protection,

respirators must fit your face and head

snugly. Respirators must not be loosened or

removed in work situations where their use

is required.

* * * * *

26. Section 1910.1047 is amended by

removing table 1 following paragraph

(h)(2) and revising paragraph (g) and the

first paragraph of Section IV to

Appendix A to read as follows:

§ 1910.1047 Ethylene oxide.

* * * * *

(g) Respiratory protection and

personal protective equipment. (1)

General. For employees who use

respirators required by this section, the

employer must provide respirators that

comply with the requirements of this

paragraph. Respirators must be used

during:

(i) Periods necessary to install or

implement feasible engineering and

work-practice controls.

(ii) Work operations, such as

maintenance and repair activities and

vessel cleaning, for which engineering

and work-practice controls are not

feasible.

(iii) Work operations for which

feasible engineering and work-practice

controls are not yet sufficient to reduce

employee exposure to or below the

TWA.

(iv) Emergencies.

(2) Respirator program. The employer

must implement a respiratory protection

program in accordance with 29 CFR

1910.134 (b) through (d) (except

(d)(1)(iii)), and (f) through (m).

(3) Respirator selection. The employer

must select the appropriate respirator

from Table 1 of this section.

TABLE 1.—MINIMUM REQUIREMENTS FOR RESPIRATORY PROTECTION FOR AIRBORNE ETO

Condition of use or concentration of airborne

EtO (ppm) Minimum required respirator

Equal to or less than 50 ..................................... (a) Full facepiece respirator with EtO approved canister, front-or back-mounted.

Equal to or less than 2,000 ................................ (a) Positive-pressure supplied air respirator, equipped with full facepiece, hood, or helmet, or

(b) Continuous-flow supplied air respirator (positive pressure) equipped with hood, helmet or

suit.

Concentration above 2,000 or unknown concentration (such as in emergencies).(a) Positive-pressure self-contained breathing apparatus (SCBA), equipped with full facepiece,

or

(b) Positive-pressure full facepiece supplied air respirator equipped with an auxiliary positivepressure self-contained breathing apparatus.

Firefighting .......................................................... (a) Positive pressure self-contained breathing apparatus equipped with full facepiece.

Escape ................................................................ (a) Any respirator described above.

Note. Respirators approved for use in higher concentrations are permitted to be used in lower concentrations.

(4) Protective clothing and equipment.

When employees could have eye or skin

contact with EtO or EtO solutions, the

employer must select and provide, at no

cost to the employee, appropriate

protective clothing or other equipment

in accordance with 29 CFR 1910.132

and 1910.133 to protect any area of the

employee’s body that may come in

contact with the EtO or EtO solution,

and must ensure that the employee

wears the protective clothing and

equipment provided.

* * * * *

Appendix A to § 1910.1047—Substance

Safety Data Sheet for Ethylene Oxide (Nonmandatory)

* * * * *

IV. Respirators and Protective Clothing

A. Respirators. You may be required to

wear a respirator for nonroutine activities, in

emergencies, while your employer is in the

process of reducing EtO exposures through

engineering controls, and in areas where

engineering controls are not feasible. As of

the effective date of this standard, only airsupplied, positive-pressure, full-facepiece

respirators are approved for protection

against EtO. If air-purifying respirators are

worn in the future, they must have a label

issued by the National Institute for

Occupational Safety and Health under the

provisions of 42 CFR part 84 stating that the

respirators have been approved for use with

ethylene oxide. For effective protection,

respirators must fit your face and head

snugly. Respirators must not be loosened or

removed in work situations where their use

is required.

* * * * *

27. Section 1910.1048 is amended by

removing Appendix E and revising

paragraph (g) to read as follows:
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1293

§ 1910.1048 Formaldehyde.

* * * * *

(g) Respiratory protection. (1) General.

For employees who use respirators

required by this section, the employer

must provide respirators that comply

with the requirements of this paragraph.

Respirators must be used during:

(i) Periods necessary to install or

implement feasible engineering and

work-practice controls.

(ii) Work operations, such as

maintenance and repair activities or

vessel cleaning, for which the employer

establishes that engineering and workpractice controls are not feasible.

(iii) Work operations for which

feasible engineering and work-practice

controls are not yet sufficient to reduce

employee exposure to or below the

PELs.

(iv) Emergencies.

(2) Respirator program. (i) The

employer must implement a respiratory

protection program in accordance with

29 CFR 1910.134 (b) through (d) (except

(d)(1)(iii), (d)(3)(iii)(b)(1), and (2)), and

(f) through (m).

(ii) If air-purifying chemical-cartridge

respirators are used, the employer must:

(A) Replace the cartridge after three

(3) hours of use or at the end of the

workshift, whichever occurs first, unless

the cartridge contains a NIOSHapproved end-of-service-life indicator

(ESLI) to show when breakthrough

occurs.

(B) Unless the canister contains a

NIOSH-approved ESLI to show when

breakthrough occurs, replace canisters

used in atmospheres up to 7.5 ppm

(10xPEL) every four (4) hours and

industrial-sized canisters used in

atmospheres up to 75 ppm (100xPEL)

every two (2) hours, or at the end of the

workshift, whichever occurs first.

(3) Respirator selection. (i) The

employer must select appropriate

respirators from Table 1 in this section.

TABLE 1.—MINIMUM REQUIREMENTS FOR RESPIRATORY PROTECTION AGAINST FORMALDEHYDE

Condition of use or formaldehyde concentration

(ppm) Minimum respirator required 1

Up to 7.5 ppm. (10 x PEL) ................................. Full facepiece with cartridges or canisters specifically approved for protection against formaldehyde.2

Up to 75 ppm. (100 x PEL) ................................ Full-face mask with chin style or chest or back mounted type, with industrial size canister specifically approved for protection against formaldehyde. Type C supplied air respirator, demand type, or continuous flow type, with full facepiece, hood, or helmet.

Above 75 ppm or unknown. (emergencies).

(100 x PEL).

Self-contained breathing apparatus (SCBA) with positive pressure full facepiece. Combination

supplied-air, full facepiece positive pressure respirator with auxiliary self-contained air supply.

Firefighting .......................................................... SCBA with positive pressure in full face-piece.

Escape ................................................................ SCBA in demand or pressure demand mode. Full-face mask with chin style or front or back

mounted type industrial size canister specifically approved for protection against formaldehyde.

1 Respirators specified for use at higher concentrations may be used at lower concentrations.

2A half-mask respirator with cartridges specifically approved for protection against formaldehyde can be substituted for the full facepiece respirator providing that effective gas-proof goggles are provided and used in combination with the half-mask respirator.

(ii) The employer must provide a

powered air-purifying respirator

adequate to protect against

formaldehyde exposure to any employee

who has difficulty using a negativepressure respirator.

* * * * *

28. Section 1910.1050 is amended by

revising paragraph (h) and the first

paragraph of Section III to Appendix A

to read as follows:

§ 1910.1050 Methylenedianiline.

* * * * *

(h) Respiratory protection. (1)

General. For employees who use

respirators required by this section, the

employer must provide respirators that

comply with the requirements of this

paragraph. Respirators must be used

during:

(i) Periods necessary to install or

implement feasible engineering and

work-practice controls.

(ii) Work operations for which the

employer establishes that engineering

and work-practice controls are not

feasible.

(iii) Work operations for which

feasible engineering and work-practice

controls are not yet sufficient to reduce

employee exposure to or below the PEL.

(iv) Emergencies.

(2) Respirator program. The employer

must implement a respiratory protection

program in accordance with 29 CFR

1910.134 (b) through (d) (except

(d)(1)(iii)), and (f) through (m).

(3) Respirator selection. (i) The

employer must select, and ensure that

employees use, the appropriate

respirator from Table 1 in this section.

TABLE 1.—RESPIRATORY PROTECTION FOR MDA

Airborne concentration of MDA or condition of

use Respirator type

a. Less than or equal to 10 × PEL ..................... (1) Half-Mask Respirator with HEPA1 Cartridge.2

b. Less than or equal to 50 × PEL ..................... (1) Full facepiece Respirator with HEPA1 Cartridge or Canister.2

c. Less than or equal to 1000 × PEL ................. (1) Full facepiece powered air-purifying respirator with HEPA1 cartridges.2

d. Greater than 1000 × PEL or unknown concentrations.(1) Self-contained breathing apparatus with full facepiece in positive pressure mode.

(2) Full facepiece positive pressure demand supplied-air respirator with auxiliary self-contained

air supply.

e. Escape ............................................................ (1) Any full facepiece air-purifying respirator with HEPA1 cartridges; 2

(2) Any positive pressure or continuous flow self-contained breathing apparatus with full facepiece or hood.

f. Firefighting ....................................................... (1) Full facepiece self-contained breathing apparatus in positive pressure demand mode.

Note: Respirators assigned for higher environmental concentrations may be used at lower concentrations.
1294 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

1 High Efficiency Particulate in Air filter (HEPA) means a filter that is at least 99.97 percent efficient against mono-dispersed particles of 0.3 micrometers or larger. 2 Combination HEPA/Organic Vapor Cartridges shall be used whenever MDA in liquid form or a process requiring heat is used.

(ii) Any employee who cannot use a

negative-pressure respirator must be

given the option of using a positivepressure respirator, or a supplied-air

respirator operated in the continuousflow or pressure-demand mode.

* * * * *

Appendix A to § 1910.1050—Substance

Safety Data Sheet for 4,4’–

Methylenedianiline

* * * * *

III. Protective Clothing and Equipment

A. Respirators. Respirators are required for

those operations in which engineering

controls or work-practice controls are not

adequate or feasible to reduce exposure to the

permissible limit. If respirators are worn,

they must have a label issued by the National

Institute for Occupational Safety and Health

under the provisions of 42 CFR part 84

stating that the respirators have been

approved for this purpose, and cartridges and

canisters must be replaced in accordance

with the requirements of 29 CFR 1910.134. If

you experience difficulty breathing while

wearing a respirator, you can request a

positive-pressure respirator from your

employer. You must be thoroughly trained to

use the assigned respirator, and the training

must be provided by your employer.

* * * * *

29. Section 1910.1051 is amended by

removing and reserving Appendix E and

revising paragraph (h) to read as

follows:

§ 1910.1051 1,3–Butadiene.

* * * * *

(h) Respiratory protection. (1)

General. For employees who use

respirators required by this section, the

employer must provide respirators that

comply with the requirements of this

paragraph. Respirators must be used

during:

(i) Periods necessary to install or

implement feasible engineering and

work-practice controls.

(ii) Non-routine work operations that

are performed infrequently and for

which employee exposures are limited

in duration.

(iii) Work operations for which

feasible engineering and work-practice

controls are not yet sufficient to reduce

employee exposures to or below the

PELs.

(iv) Emergencies.

(2) Respirator program. (i) The

employer must implement a respiratory

protection program in accordance with

29 CFR 1910.134 (b) through (d) (except

(d)(1)(iii), (d)(3)(iii)(B)(1), and (2)), and

(f) through (m).

(ii) If air-purifying respirators are

used, the employer must replace the airpurifying filter elements according to

the replacement schedule set for the

class of respirators listed in Table 1 of

this section, and at the beginning of

each work shift.

(iii) Instead of using the replacement

schedule listed in Table 1 of this

section, the employer may replace

cartridges or canisters at 90% of their

expiration service life, provided the

employer:

(A) Demonstrates that employees will

be adequately protected by this

procedure.

(B) Uses BD breakthrough data for this

purpose that have been derived from

tests conducted under worst-case

conditions of humidity, temperature,

and air-flow rate through the filter

element, and the employer also

describes the data supporting the

cartridge-or canister-change schedule, as

well as the basis for using the data in

the employer’s respirator program.

(iv) A label must be attached to each

filter element to indicate the date and

time it is first installed on the respirator.

(v) If NIOSH approves an end-ofservice-life indicator (ESLI) for an airpurifying filter element, the element

may be used until the ESLI shows no

further useful service life or until the

element is replaced at the beginning of

the next work shift, whichever occurs

first.

(vi) Regardless of the air-purifying

element used, if an employee detects the

odor of BD, the employer must replace

the air-purifying element immediately.

(3) Respirator selection. (i) The

employer must select appropriate

respirators from Table 1 of this section.

TABLE 1.—MINIMUM REQUIREMENTS FOR RESPIRATORY PROTECTION FOR AIRBORNE BD

Concentration of airborne BD (ppm) or condition

of use Minimum required respirator

Less than or equal to 5 ppm (5 times PEL) ....... (a) Air-purifying half mask or full facepiece respirator equipped with approved BD or organic

vapor cartridges or canisters. Cartridges or canisters shall be replaced every 4 hours.

Less than or equal to 10 ppm (10 times PEL) ... (a) Air-purifying half mask or full facepiece respirator equipped with approved BD or organic

vapor cartridges or canisters. Cartridges or canisters shall be replaced every 3 hours.

Less than or equal to 25 ppm (25 times PEL) ... (a) Air-purifying full facepiece respirator equipped with approved BD or organic vapor cartridges or canisters. Cartridges or canisters shall be replaced every 2 hours.

(b) Any powered air-purifying respirator equipped with approved BD or organic vapor cartridges. PAPR cartridges shall be replaced every 2 hours.

(c) Continuous flow supplied air respirator equipped with a hood or helmet.

Less than or equal to 50 ppm (50 times PEL) ... (a) Air-purifying full facepiece respirator equipped with approved BD or organic vapor cartridges or canisters. Cartridges or canisters shall be replaced every (1) hour.

(b) Powered air-purifying respirator equipped with a tight-fitting facepiece and an approved BD

or organic vapor cartridges. PAPR cartridges shall be replaced every (1) hour.

Less than or equal to 1,000 ppm (1,000 times

PEL).

(a) Supplied air respirator equipped with a half mask of full facepiece and operated in a pressure demand or other positive pressure mode.

Greater than 1000 ppm unknown concentration,

or firefighting.

(a) Self-contained breathing apparatus equipped with a full facepiece and operated in a pressure demand or other positive pressure mode.

(b) Any supplied air respirator equipped with a full facepiece and operated in a pressure demand or other positive pressure mode in combination with an auxiliary self-contained

breathing apparatus operated in a pressure demand or other positive pressure mode.

Escape from IDLH conditions ............................. (a) Any positive pressure self-contained breathing apparatus with an appropriate service life.
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1295

TABLE 1.—MINIMUM REQUIREMENTS FOR RESPIRATORY PROTECTION FOR AIRBORNE BD—Continued

Concentration of airborne BD (ppm) or condition

of use Minimum required respirator

(b) A air-purifying full facepiece respirator equipped with a front or back mounted BD or organic vapor canister.

NOTES: Respirators approved for use in higher concentrations are permitted to be used in lower concentrations. Full facepiece is required

when eye irritation is anticipated.

(ii) Air-purifying respirators must

have filter elements approved by NIOSH

for organic vapors or BD.

(iii) When an employee whose job

requires the use of a respirator cannot

use a negative-pressure respirator, the

employer must provide the employee

with a respirator that has less breathing

resistance than the negative-pressure

respirator, such as a powered airpurifying respirator or supplied-air

respirator, when the employee is able to

use it and if it provides the employee

adequate protection.

* * * * *

30. Section 1910.1052 is amended by

revising paragraph (g) to read as follows:

§ 1910.1052 Methylene chloride.

* * * * *

(g) Respiratory protection. (1) General.

For employees who use respirators

required by this section, the employer

must provide respirators that comply

with the requirements of this paragraph.

Respirators must be used during:

(i) Periods when an employee’s

exposure to MC exceeds the 8-hour

TWA, PEL, or STEL (for example, when

an employee is using MC in a regulated

area).

(ii) Periods necessary to install or

implement feasible engineering and

work-practice controls.

(iii) A few work operations, such as

some maintenance operations and repair

activities, for which the employer

demonstrates that engineering and

work-practice controls are infeasible.

(iv) Work operations for which

feasible engineering and work-practice

controls are not sufficient to reduce

employee exposures to or below the

PELs.

(v) Emergencies.

(2) Respirator program. (i) The

employer must implement a respiratory

protection program in accordance with

29 CFR 1910.134 (b) through (m) (except

(d)(1)(iii)).

(ii) Employers who provide

employees with gas masks with organicvapor canisters for the purpose of

emergency escape must replace the

canisters after any emergency use and

before the gas masks are returned to

service.

(3) Respirator selection. The employer

must select appropriate atmospheresupplying respirators from Table 2 of

this section.

TABLE 2.—MINIMUM REQUIREMENTS FOR RESPIRATORY PROTECTION FOR AIRBORNE METHYLENE CHLORIDE

Methylene chloride airborne concentration

(ppm) or condition of use Minimum respirator required 1

Up to 625 ppm (25 X PEL) ................................. (1) Continuous flow supplied-air respirator, hood or helmet.

Up to 1250 ppm (50 X 8–TWA PEL) .................. (1) Full facepiece supplied-air respirator operated in negative pressure (demand) mode.

(2) Full facepiece self-contained breathing apparatus (SCBA) operated in negative pressure

(demand) mode.

Up to 5000 ppm (200 X 8–TWA PEL) ................ (1) Continuous flow supplied-air respirator, full facepiece.

(2) Pressure demand supplied-air respirator, full facepiece.

(3) Positive pressure full facepiece SCBA.

Unknown concentration, or above 5000 ppm

(Greater than 200 X 8–TWA PEL).

(1) Positive pressure full facepiece SCBA.

(2) Full facepiece pressure demand supplied-air respirator with an auxiliary self-contained air

supply.

Fire fighting ......................................................... Positive pressure full facepiece SCBA.

Emergency escape ............................................. (1) Any continuous flow or pressure demand SCBA.

(2) Gas mask with organic vapor canister.

1 Respirators assigned for higher airborne concentrations may be used at lower concentrations.

(4) Medical evaluation. Before having

an employee use a supplied-air

respirator in the negative-pressure

mode, or a gas mask with an organicvapor canister for emergency escape, the

employer must:

(i) Have a physician or other licensed

health-care professional (PLHCP)

evaluate the employee’s ability to use

such respiratory protection.

(ii) Ensure that the PLHCP provides

their findings in a written opinion to the

employee and the employer.

* * * * *

PART 1926—[AMENDED]

Subpart D—[Amended]

31. The authority citation for Subpart

D of Part 1926 is revised to read as

follows:

Authority: Sec. 107, Contract Work Hours

and Safety Standards Act (Construction

Safety Act) (40 U.S.C. 333); secs. 4, 6, and 8

of the Occupational Safety and Health Act of

1970 (29 U.S.C. 653, 655, 657); Secretary of

Labor’s Orders 12–71 (36 FR 8754), 8–76 (41

FR 25059), 9–83 (48 FR 35736), 1–90 (55 FR

9033), or 6–96 (62 FR 111), as applicable; and

29 CFR Part 11.

Secs. 1926.58, 1926.59, 1926.60, and

1926.65 of 29 CFR, also issued under 5 U.S.C.

553, and 29 CFR Part 1911.

Sec. 1926.62 of 29 CFR, also issued under

sec. 1031 of the Housing and Community

Development Act of 1992 (42 U.S.C. 4853).

Sec. 1926.65 of 29 CFR, also issued under

sec. 126 of the Superfund Amendments and

Reauthorization Act of 1986, as amended (29

U.S.C. 655 note), and 5 U.S.C. 553.

32. Section 1926.57 is amended by

revising paragraphs (f)(1)(ii), (f)(5)(i) and

(iii), (f)(6), (h)(6)(iii)(A), and (i)(9)(vi) to

read as follows:

§ 1926.57 Ventilation.

* * * * *
1296 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

(f) * * *

(1) * * *

(ii) Abrasive-blasting respirator. A

respirator constructed so that it covers

the wearer’s head, neck, and shoulders

to protect the wearer from rebounding

abrasive.

* * * * *

(5) Personal protective equipment. (i)

Employers must use only respirators

approved by NIOSH under 42 CFR part

84 for protecting employees from dusts

produced during abrasive-blasting

operations.

* * * * *

(iii) Properly fitted particulate-filter

respirators, commonly referred to as

dust-filter respirators, may be used for

short, intermittent, or occasional dust

exposures such as cleanup, dumping of

dust collectors, or unloading shipments

of sand at a receiving point when it is

not feasible to control the dust by

enclosure, exhaust ventilation, or other

means. The respirators used must be

approved by NIOSH under 42 CFR part

84 for protection against the specific

type of dust encountered.

* * * * *

(6) Air supply and air compressors.

Air for abrasive-blasting respirators

must be free of harmful quantities of

dusts, mists, or noxious gases, and must

meet the requirements for supplied-air

quality and use specified in 29 CFR

1910.134(i).

* * * * *

(h) * * *

(6) * * *

(iii)(A) When an operator is in a booth

downstream of the object being sprayed,

an air-supplied respirator or other type

of respirator approved by NIOSH under

42 CFR Part 84 for the material being

sprayed should be used by the operator.

* * * * *

(i) * * *

(9) * * *

(vi) When, during the emergencies

specified in paragraph (i)(11)(v) of this

section, employees must be in areas

where concentrations of air

contaminants are greater than the limits

set by paragraph (i)(2)(iii) of this section

or oxygen concentrations are less than

19.5 percent, they must use respirators

that reduce their exposure to a level

below these limits or that provide

adequate oxygen. Such respirators must

also be provided in marked, quicklyaccessible storage compartments built

for this purpose when the possibility

exists of accidental release of hazardous

concentrations of air contaminants.

Respirators must be approved by NIOSH

under 42 CFR part 84, selected by a

competent industrial hygienist or other

technically-qualified source, and used

in accordance with 29 CFR 1926.103.

* * * * *

33. Section 1926.60 is amended by

removing Appendix E and revising

paragraph (i) to read as follows:

§ 1926.60 Methylenedianiline.

* * * * *

(i) Respiratory protection. (1) General.

For employees who use respirators

required by this section, the employer

must provide respirators that comply

with the requirements of this paragraph.

Respirators must be used during:

(i) Periods necessary to install or

implement feasible engineering and

work-practice controls.

(ii) Work operations, such as

maintenance and repair activities and

spray-application processes, for which

engineering and work-practice controls

are not feasible.

(iii) Work operations for which

feasible engineering and work-practice

controls are not yet sufficient to reduce

employee exposure to or below the

PELs.

(iv) Emergencies.

(2) Respirator program. The employer

must implement a respiratory protection

program in accordance with 29 CFR

1910.134 (b) through (d) (except

(d)(1)(iii), and (f) through (m).

(3) Respirator selection. (i) The

employer must select the appropriate

respirator from Table 1 of this section.

TABLE 1.—RESPIRATORY PROTECTION FOR MDA

Airborne concentration of MDA or condition of

use Respirator type

a. Less than or equal to 10 × PEL ..................... (1) Half-Mask Respirator with HEPA1 Cartridge.2

b. Less than or equal to 50 × PEL ..................... (1) Full facepiece Respirator with HEPA1 Cartridge or Canister.2

c. Less than or equal to 1000 × PEL ................. (1) Full facepiece powered air-purifying respirator with HEPA1 cartridge.2

d. Greater than 1000 × PEL or unknown concentration.(1) Self-contained breathing apparatus with full facepiece in positive pressure mode.

(2) Full facepiece positive pressure demand supplied-air respirator with auxiliary self-contained

air supply.

e. Escape ............................................................ (1) Any full facepiece air-purifying respirator with HEPA1 cartridges.2

(2) Any positive pressure or continuous flow self-contained breathing apparatus with full facepiece or hood.

f. Firefighting ....................................................... (1) Full facepiece self-contained breathing apparatus in positive pressure demand mode.

NOTE: Respirators assigned for higher environmental concentrations may be used at lower concentrations. 1 High Efficiency Particulate in Air filter (HEPA) means a filter that is at least 99.97 percent efficient against mono-dispersed particles of 0.3 micrometers or larger. 2 Combination HEPA/Organic Vapor Cartridges shall be used whenever MDA in liquid form or a process requiring heat is used.

(ii) An employee who cannot use a

negative-pressure respirator must be

given the option of using a positivepressure respirator, or a supplied-air

respirator operated in the continuousflow or pressure-demand mode.

* * * * *

34. Section 1926.62 is amended by

revising paragraph (f); revising the

second and fourth paragraphs of Section

IV to Appendix B; removing the sixth

paragraph of Section IV to Appendix B;

and removing Appendix D, as follows:

§ 1926.62 Lead.

* * * * *

(f) Respiratory protection. (1) General.

For employees who use respirators

required by this section, the employer

must provide respirators that comply

with the requirements of this paragraph.

Respirators must be used during:

(i) Periods when an employee’s

exposure to lead exceeds the PEL.

(ii) Work operations for which

engineering and work-practice controls

are not sufficient to reduce employee

exposures to or below the PEL.

(iii) Periods when an employee

requests a respirator.

(iv) Periods when respirators are

required to provide interim protection

of employees while they perform the
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1297

operations specified in paragraph (d)(2)

of this section.

(2) Respirator program. (i) The

employer must implement a respiratory

protection program in accordance with

29 CFR 1910.134 (b) through (d) (except

(d)(1)(iii)), and (f) through (m).

(ii) If an employee has breathing

difficulty during fit testing or respirator

use, the employer must provide the

employee with a medical examination

in accordance with paragraph (j)(3)(i)(B)

of this section to determine whether or

not the employee can use a respirator

while performing the required duty.

(3) Respirator selection. (i) The

employer must select the appropriate

respirator or combination of respirators

from Table I of this section.

(ii) The employer must provide a

powered air-purifying respirator when

an employee chooses to use such a

respirator and it will provide adequate

protection to the employee.

TABLE 1.—RESPIRATORY PROTECTION FOR LEAD AEROSOLS

Airborne concentration of lead or condition of

use Required respirator 1

Not in excess of 500 ug/m3 ................................ 1⁄2 mask air purifying respirator with high efficiency filters.2 3

1⁄2 mask supplied air respirator operated in demand (negative pressure) mode.

Not in excess of 1,250 ug/m3 ............................. Loose fitting hood or helmet powered air purifying respirator with high efficiency filters.3

Hood or helmet supplied air respirator operated in a continuous-flow mode—e.g., type CE abrasive blasting respirators operated in a continuous-flow mode.

Not in excess of 2,500 ug/m3 ............................. Full facepiece air purifying respirator with high efficiency filters.3

Tight fitting powered air purifying respirator with high efficiency filters.3

Full facepiece supplied air respirator operated in demand mode.

1⁄2 mask or full facepiece supplied air respirator operated in a continuous-flow mode.

Full facepiece self-contained breathing apparatus (SCBA) operated in demand mode.

Not in excess of 50,000 ug/m3 ........................... 1⁄2 mask supplied air respirator operated in pressure demand or other positive-pressure mode.

Not in excess of 100,000 ug/m3 ......................... Full facepiece supplied air respirator operated in pressure demand or other positive-pressure

mode—e.g., type CE abrasive blasting respirators operated in a positive-pressure mode.

Greater than 100,000 ug/m3 unknown concentration, or fire fighting.Full facepiece SCBA operated in pressure demand or other positive-pressure mode.

1 Respirators specified for higher concentrations can be used at lower concentrations of lead.

2Full facepiece is required if the lead aerosols cause eye or skin irritation at the use concentrations.

3A high efficiency particulate filter (HEPA) means a filter that is a 99.97 percent efficient against particles of 0.3 micron size or larger.

* * * * *

Appendix B to § 1926.62—Employee

Standard Summary

* * * * *

IV. Respiratory Protection—Paragraph (f)

* * * * *

Your employer is required to select

respirators from the types listed in Table

I of the Respiratory Protection section of

the standard (§ 1926.62 (f)). Any

respirator chosen must be approved by

the National Institute for Occupational

Safety and Health (NIOSH) under the

provisions of 42 CFR part 84. This

respirator selection table will enable

your employer to choose a type of

respirator that will give you a proper

amount of protection based on your

airborne lead exposure. Your employer

may select a type of respirator that

provides greater protection than that

required by the standard; that is, one

recommended for a higher

concentration of lead than is present in

your workplace. For example, a

powered air-purifying respirator (PAPR)

is much more protective than a typical

negative pressure respirator, and may

also be more comfortable to wear. A

PAPR has a filter, cartridge, or canister

to clean the air, and a power source that

continuously blows filtered air into your

breathing zone. Your employer might

make a PAPR available to you to ease

the burden of having to wear a

respirator for long periods of time. The

standard provides that you can obtain a

PAPR upon request.

* * * * *

Your employer must ensure that your

respirator facepiece fits properly. Proper fit of

a respirator facepiece is critical to your

protection from airborne lead. Obtaining a

proper fit on each employee may require

your employer to make available several

different types of respirator masks. To ensure

that your respirator fits properly and that

facepiece leakage is minimal, your employer

must give you either a qualitative or

quantitative fit test as specified in Appendix

A of the Respiratory Protection standard

located at 29 CFR 1910.134.

* * * * *

Subpart E—[Amended]

35. The authority citation for Subpart

E of Part 1926 is revised to read as

follows:

Authority: Sec. 107, Contract Work Hours

and Safety Standards Act (Construction

Safety Act) (40 U.S.C. 333); secs. 4, 6, and 8

of the Occupational Safety and Health Act of

1970 (29 U.S.C. 653, 655, 657); Secretary of

Labor’s Orders 12–71 (36 FR 8754), 8–76 (41

FR 25059), 9–83 (48 FR 35736), 1–90 (55 FR

9033), or 6–96 (62 FR 111), as applicable; and

29 CFR part 11.

36. Section 1926.103 is revised to read

as follows:

§ 1926.103 Respiratory protection.

Note: The requirements applicable to

construction work under this section are

identical to those set forth at 29 CFR

1910.134 of this chapter.

Subpart S—[Amended]

37. The authority citation for Subpart

S of Part 1926 is revised to read as

follows:

Authority: Sec. 107, Contract Work Hours

and Safety Standards Act (40 U.S.C. 333);

secs. 4, 6, and 8 of the Occupational Safety

and Health Act of 1970 (29 U.S.C. 653, 655,

657); Secretary of Labor’s Orders 12–71 (36

FR 8754), 8–76 (41 FR 25059), 9–83 (48 FR

35736), 1–90 (55 FR 9033), or 6–96 (62 FR

111), as applicable.

38. Section 1926.800 is amended by

revising paragraph (g)(2) as follows:

§ 1926.800 Underground construction.

* * * * *

(g) * * *

(2) Self-rescuers. The employer must

provide self-rescuers approved by the

National Institute for Occupational

Safety and Health under 42 CFR part 84.

The respirators must be immediately

available to all employees at work

stations in underground areas where

employees might be trapped by smoke

or gas. The selection, issuance, use, and

care of respirators must be in

accordance with 29 CFR 1926.103.

* * * * *
1298 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

Subpart Z—[Amended]

39. The authority citation for Subpart

Z of Part 1926 is revised to read as

follows:

Authority: Secs. 4, 6, and 8 of the

Occupational Safety and Health Act of 1970

(29 U.S.C. 653, 655, 657); Secretary of Labor’s

Orders 12–71 (36 FR 8754), 8–76 (41 FR

25059), 9–83 (48 FR 35736), 1–90 (55 FR

9033), or 6–96 (62 FR 111), as applicable; and

29 CFR part 11.

Section 1926.1102 of 29 CFR not issued

under 29 U.S.C. 655 or 29 CFR part 1911;

also issued under 5 U.S.C. 553.

40. Section 1926.1101 is amended by

removing and reserving Appendix C and

revising paragraph (h) to read as

follows:

§ 1926.1101 Asbestos.

* * * * *

(h) Respiratory protection. (1)

General. For employees who use

respirators required by this section, the

employer must provide respirators that

comply with the requirements of this

paragraph. Respirators must be used

during:

(i) Class I asbestos work.

(ii) Class II asbestos work when ACM

is not removed in a substantially intact

state.

(iii) Class II and III asbestos work that

is not performed using wet methods,

except for removal of ACM from sloped

roofs when a negative-exposure

assessment has been conducted and

ACM is removed in an intact state.

(iv) Class II and III asbestos work for

which a negative-exposure assessment

has not been conducted.

(v) Class III asbestos work when TSI

or surfacing ACM or PACM is being

disturbed.

(vi) Class IV asbestos work performed

within regulated areas where employees

who are performing other work are

required to use respirators.

(vii) Work operations covered by this

section for which employees are

exposed above the TWA or excursion

limit.

(viii) Emergencies.

(2) Respirator program. (i) The

employer must implement a respiratory

protection program in accordance with

29 CFR 1910.134 (b) through (d) (except

(d)(1)(iii)), and (f) through (m).

(ii) No employee shall be assigned to

asbestos work that requires respirator

use if, based on their most recent

medical examination, the examining

physician determines that the employee

will be unable to function normally

while using a respirator, or that the

safety or health of the employee or other

employees will be impaired by the

employee’s respirator use. Such

employees must be assigned to another

job or given the opportunity to transfer

to a different position that they can

perform. If such a transfer position is

available, it must be with the same

employer, in the same geographical

area, and with the same seniority,

status, rate of pay, and other job benefits

the employee had just prior to such

transfer.

(3) Respirator selection. (i) The

employer must select the appropriate

respirator from Table 1 of this section.

TABLE 1.—RESPIRATORY PROTECTION FOR ASBESTOS FIBERS

Airborne concentrations of asbestos or conditions of use Required respirator

Not in excess of 1 f/cc (10 X PEL), or otherwise

as required independent of exposure pursuant to paragraph (h)(2)(iv) of this section.

Half-mask air purifying respirator other than a disposable respirator, equipped with high efficiency filters.

Not in excess of 5 f/cc (50 X PEL) ..................... Full facepiece air-purifying respirator equipped with high efficiency filters.

Not in excess of 10 f/cc (100 X PEL) ................. Any powered air-purifying respirator equipped with high efficiency filter or any supplied air respirator operated in continuous flow mode.

Not in excess of 100 f/cc (1,000 X PEL) or unknown concentration.Full facepiece supplied air respirator operated in pressure demand mode.

Greater than 100 f/cc (1,000 X PEL) or unknown concentration.Full facepiece supplied air respirator operated in pressure demand mode, equipped with an

auxiliary positive pressure self-contained breathing apparatus.

NOTE: a. Respirators assigned for high environmental concentrations may be used at lower concentrations, or when required respirator use is

independent of concentration.

b. A high efficiency filter means a filter that is at least 99.97 percent efficient against mono-dispersed particles of 0.3 micrometers in diameters

in diameter or larger.

(ii) The employer must provide an

employee with a tight-fitting, powered

air-purifying respirator instead of a

negative-pressure respirator from Table

1 when the employee chooses to use

this type of respirator and such a

respirator will provide adequate

protection to the employee.

(iii) The employer must provide a

half-mask air-purifying respirator, other

than a disposable respirator, that is

equipped with high-efficiency filters

when the employee performs:

(A) Class II and III asbestos work and

a negative-exposure assessment has not

been conducted by the employer.

(B) Class III asbestos work when TSI

or surfacing ACM or PACM is being

disturbed.

(iv) The employer must provide

employees with a full-facepiece

supplied-air respirator operated in the

pressure-demand mode and equipped

with an auxiliary, positive-pressure selfcontained breathing apparatus when the

employees are in a regulated area where

Class I work is being performed and the

employer has not conducted a negativeexposure assessment.

* * * * *

41. Section 1926.1127 is amended by

removing and reserving Appendix C and

revising paragraph (g) to read as follows:

§ 1926.1127 Cadmium.

* * * * *

(g) Respirator protection. (1) General.

For employees who use respirators

required by this section, the employer

must provide respirators that comply

with the requirements of this paragraph.

Respirators must be used during:

(i) Periods necessary to install or

implement feasible engineering and

work-practice controls when employee

exposures exceed the PEL.

(ii) Maintenance and repair activities,

and brief or intermittent work

operations, for which employee

exposures exceed the PEL and

engineering and work-practice controls

are not feasible or are not required.

(iii) Work operations in the regulated

areas specified in paragraph (e) of this

section.

(iv) Work operations for which the

employer has implemented all feasible

engineering and work-practice controls,

and such controls are not sufficient to

reduce employee exposures to or below

the PEL.
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations 1299

(v) Work operations for which an

employee, who is exposed to cadmium

at or above the action level, requests a

respirator.

(vi) Work operations for which

engineering controls are not required by

paragraph (f)(1)(ii) of this section to

reduce employee exposures that exceed

the PEL.

(vii) Emergencies.

(2) Respirator program. (i) The

employer must implement a respiratory

protection program in accordance with

29 CFR 1910.134 (b) through (d) (except

(d)(1)(iii)), and (f) through (m).

(ii) If an employee exhibits breathing

difficulty during fit testing or respirator

use, the employer must provide the

employee with a medical examination

in accordance with paragraph (l)(6)(ii) of

this section to determine if the

employee can use a respirator while

performing the required duties.

(iii) No employee must use a

respirator when, based on their most

recent medical examination, the

examining physician determines that

the employee will be unable to continue

to function normally while using a

respirator. If the physician determines

the employee must be limited in, or

removed from, their current job because

of the employee’s inability to use a

respirator, the job limitation or removal

must be conducted in accordance with

paragraphs (l) (11) and (12) of this

section.

(3) Respirator selection. (i) The

employer must select the appropriate

respirator from Table 1 of this section.

TABLE 1.—RESPIRATORY PROTECTION FOR CADMIUM

Airborne concentration or condition of

use a Required respirator type b

10 X or less ............................................... A half mask, air-purifying equipped with a HEPAc filter.d

25 X or less ............................................... A powered air-purifying respirator (‘‘PAPR’’) with a loose-fitting hood or helmet equipped with a

HEPA filter, or a supplied-air respirator with a loose-fitting hood or helmet facepiece operated in

the continuous flow mode.

50 X or less ............................................... A full facepiece air-purifying respirator equipped with a HEPA filter, or a powered air-purifying respirator with a tight-fitting half mask equipped with a HEPA filter, or a supplied-air respirator with a

tight-fitting half mask operated in the continuous flow mode.

250 X or less ............................................. A powered air-purifying respirator with a tight fitting full facepiece equipped with a HEPA filter, or a

supplied-air respirator with a tight-fitting full facepiece operated in the continuous flow mode.

1000 X or less ........................................... A supplied air respirator with half mask or full facepiece operated in the pressure demand or other

positive pressure mode.

>1000 X or unknown concentrations ........ A self-contained breathing apparatus with a full facepiece operated in the pressure demand or other

positive pressure mode, or a supplied-air respirator with a full facepiece operated in the pressure

demand or other positive pressure mode and equipped with an auxiliary escape type self-contained breathing apparatus operated in the pressure demand mode.

Firefighting ................................................. A self-contained breathing apparatus with full facepiece operated in the pressure demand or other

positive pressure mode.

a Concentrations expressed as multiple of the PEL.

b Respirators assigned for higher environmental concentrations may be used at lower exposure levels. Quantitative fit testing is required for all

tight-fitting air purifying respirators where airborne concentration of cadmium exceeds 10 times the TWA PEL (10 X 5 ug/m(3) = 50 ug/m(3)). A

full facepiece respirator is required when eye irritation is experienced. c HEPA means High-efficiency Particulate Air.

dFit testing, qualitative or quantitative, is required.

SOURCE: Respiratory Decision Logic, NIOSH, 1987.

(ii) The employer must provide a

powered air-purifying respirator instead

of a negative-pressure respirator when

an employee entitled to a respirator

chooses to use this type of respirator

and such a respirator will provide

adequate protection to the employee.

* * * * *

Note: The following table will not appear

in the Code of Federal Regulations.

REDESIGNATION TABLE FOR ACTIONS

ON SPECIFIC STANDARDS

Old section New section

1910.94:

(a)(1)(ii) .................. Revised.

(a)(5)(i) ................... Revised.

(a)(5)(iii) ................. Revised.

(a)(5)(iv) ................. Revised.

(a)(6) ...................... Revised.

(c)(6)(iii)(a) ............. Revised.

(d)(9)(vi) ................. Revised.

1910.111:

(a)(2)(x) .................. Revised.

(b)(10)(ii) ................ Revised.

REDESIGNATION TABLE FOR ACTIONS

ON SPECIFIC STANDARDS—Continued

Old section New section

1910.156:

(f)(1)(i) .................... Revised.

(f)(1)(v) ................... Revised.

1910.252:

(c)(4)(ii) .................. Revised.

(c)(4)(iii) ................. Revised.

(c)(7)(iii) ................. Revised.

(c)(9)(i) ................... Revised.

(c)(10) .................... Revised.

1910.261:

(b)(2) ...................... Revised.

(g)(10) .................... Revised.

(h)(2)(iii) ................. Revised.

(h)(2)(iv) ................. Revised.

1910.1001:

(g)(1) ...................... Revised.

(g)(2)(i) ................... Revised; (g)(3).

(g)(2)(ii) .................. Revised; (g)(2)(ii).

(g)(3)(i) ................... Revised; (g)(2)(i).

(g)(3)(ii) .................. Removed.

(g)(3)(iii) ................. Removed.

(g)(3)(iv) ................. Revised; (g)(2)(iii).

(g)(4) ...................... Removed.

REDESIGNATION TABLE FOR ACTIONS

ON SPECIFIC STANDARDS—Continued

Old section New section

Appendix C ............ Removed.

1910.1003:

(c)(4)(iv) ................. Revised.

(d)(1) [Reserved] ... Revised.

1910.1017:

(g)(1) ...................... Revised.

(g)(2) ...................... Removed.

(g)(3) ...................... Revised; (g)(2).

(g)(4) ...................... Revised; (g)(3)(i).

(g)(5) ...................... Removed.

(g)(6) (i) and (ii) ..... Revised; (g)(3)(ii).

(g)(7) ...................... Revised; (g)(3)(iii).

1910.1018:

(h)(1) ...................... Revised.

(h)(2)(i) ................... Revised; (h)(3)(i).

(h)(2)(ii) .................. Revised; (h)(3)(ii).

(h)(2)(iii) ................. Removed.

(h)(3)(i), (ii), and

(iii).

Removed.

(h)(3)(iv) ................. Revised; (h)(2)(ii).

(h)(4)(i) ................... Revised; (h)(2)(i).

(h)(4) (ii) and (iii) ... Removed.

(h)(5) (i) and (ii) ..... Removed.
1300 Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules and Regulations

REDESIGNATION TABLE FOR ACTIONS

ON SPECIFIC STANDARDS—Continued

Old section New section

(h)(5)(iii) ................. Revised; (h)(4)(iii).

1910.1025:

(f)(1) and (f)(1)(i) ... Revised.

(f)(2)(i) .................... Revised; (f)(3)(i).

(f)(2)(ii) ................... Revised; (f)(3)(ii).

(f)(2)(iii) .................. Removed.

(f)(3)(i) and (ii) ....... Removed.

(f)(3)(iii) .................. Revised; (f)(2)(ii).

(f)(4)(i) .................... Revised; (f)(2)(i).

(f)(4) (ii) and (iii) .... Removed.

Appendix B, Section IV.Revised second and

fourth paragraphs;

removed sixth paragraph.

Appendix D ............ Removed.

1910.1027:

(g)(1) ...................... Revised.

(g)(2)(i) ................... Revised; (f)(3)(i).

(g)(2)(ii) .................. Revised; (f)(3)(ii).

(g)(3)(i) ................... Revised; (f)(2)(i).

(g)(3) (ii) and (iii) ... Removed.

(g)(3)(iv) ................. Revised; (g)(2)(iii).

(g)(3)(v) .................. Revised; (g)(2)(ii).

(g)(4) ...................... Removed.

Appendix C ............... Removed.

1910.1028:

(g)(1) ...................... Revised.

(g)(2)(i) ................... Revised; (g)(3)(i).

(g)(2)(ii) .................. Removed.

(g)(2)(iii) ................. Revised; (g)(3)(ii).

(g)(3) ...................... Revised; (g)(2).

(g)(4)(i) ................... Revised; (g)(2)(ii).

(g)(4)(ii) .................. Revised; (g)(2)(iii).

(g)(4)(iii) ................. Removed.

(g)(5) ...................... Removed.

Appendix E ............ Removed.

1910.1029:

(g)(1)(i) ................... Revised.

(g)(1)(ii) .................. Removed.

(g)(2)(i) ................... Revised; (g)(3).

(g)(2)(ii) and (iii) ..... Removed.

(g)(3) ...................... Revised; (g)(2).

(g)(4) ...................... Removed.

1910.1043:

(f)(1) ....................... Revised.

(f)(2)(i) .................... Revised; (f)(3)(i).

(f)(2)(ii) ................... Removed.

(f)(2)(iii) .................. Revised; (f)(3)(ii).

(f)(2)(iv) .................. Revised; (f)(2)(ii).

(f)(3) ....................... Revised; (f)(2)(i).

(f)(4) ....................... Removed.

1910.1044:

(h)(1) ...................... Revised.

(h)(2)(i) ................... Revised; (h)(3).

(h)(2)(ii) .................. Removed.

(h)(3)(i) ................... Revised; (h)(3).

(h)(3)(ii) .................. Removed.

1910.1045:

(h)(1) ...................... Revised.

(h)(2)(i) ................... Revised; (h)(3).

(h)(2)(ii) .................. Removed.

REDESIGNATION TABLE FOR ACTIONS

ON SPECIFIC STANDARDS—Continued

Old section New section

(h)(3)(i) ................... Revised; (h)(2)(i).

(h)(3)(ii) .................. Revised; (h)(2)(ii).

(h)(3)(iii) ................. Removed.

(h)(3)(iv) ................. Removed.

Appendix A, Section IV.Revised first paragraph.

1910.1047:

(g)(1) ...................... Revised.

(g)(2)(i) ................... Revised; (g)(3).

(g)(2)(ii) .................. Removed.

(g)(3) ...................... Revised; (g)(2).

(g)(4) ...................... Revised; (g)(4).

Appendix A, Section IV.Revised first paragraph.

1910.1048:

(g)(1) ...................... Revised.

(g)(2)(i) ................... Revised; (g)(3)(i).

(g)(2)(ii) .................. Revised; (g)(3)(ii).

(g)(3)(i) ................... Revised; (g)(2)(i).

(g)(3)(ii) .................. Removed.

(g)(3)(iii) ................. Revised; (g)(2)(ii)(A).

(g)(3)(iv) ................. Revised; (g)(2)(ii)(B).

(g)(3)(v) .................. Removed.

Appendix E ............ Removed.

1910.1050:

(h)(1) ...................... Revised.

(h)(2)(i) ................... Revised; (h)(3)(i).

(h)(2)(ii) .................. Removed.

(h)(2)(iii) ................. Revised; (h)(3)(ii).

(h)(3) ...................... Revised; (h)(2).

(h)(4) ...................... Removed.

(h)(5) ...................... Removed.

Appendix A, Section III.Revised first paragraph.

Appendix E ............ Removed.

1910.1051:

(h)(1) ...................... Revised.

(h)(2)(i) ................... Revised; (h)(3)(i).

(h)(2)(ii) .................. Revised; (h)(3)(ii).

(h)(2)(iii) ................. Revised; (h)(3)(iii).

(h)(3) ...................... Revised; (h)(2)(i).

(h)(4)(i) ................... Revised; (h)(2)(ii).

(h)(4)(ii) .................. Revised; (h)(2)(iii).

(h)(4)(iii) ................. Revised; (h)(2) (iv)

and (vi).

(h)(4)(iv) ................. Revised; (h)(2) (vi)

and (vi).

(h)(4)(v) .................. Removed.

(h)(5) ...................... Removed.

Appendix E ............ Removed.

1910.1052:

(g)(1) ...................... Revised.

(g)(2) ...................... Revised; (g)(4).

(g)(3) ...................... Revised; (g)(3).

(g)(4) ...................... Revised; (g)(2)(i).

(g)(5) ...................... Removed.

(g)(6) ...................... Revised; (g)(2)(ii).

(g)(7) ...................... Removed.

1926.57:

(f)(1)(ii) ................... Revised.

(f)(5)(i) .................... Revised.

REDESIGNATION TABLE FOR ACTIONS

ON SPECIFIC STANDARDS—Continued

Old section New section

(f)(5)(iii) .................. Revised.

(f)(6) ....................... Revised.

(f)(6)(i), (ii), and (iii) Removed.

(h)(6)(iii)(A) ............ Revised.

(i)(9)(vi) .................. Revised.

1926.60:

(i)(1) ....................... Revised.

(i)(2)(i) .................... Revised; (i)(3)(i).

(i)(2)(ii) ................... Removed.

(i)(2)(iii) .................. Revised; (i)(3)(ii).

(i)(3) ....................... Revised; (i)(2).

(i)(4) ....................... Removed.

(i)(5) ....................... Removed.

Appendix E ............ Removed.

1926.62:

(f)(1) ....................... Revised.

(f)(2)(i) .................... Revised; (f)(3)(i).

(f)(2)(ii) ................... Revised; (f)(3)(ii).

(f)(2)(iii) .................. Removed.

(f)(3)(i) .................... Removed.

(f)(3)(ii) ................... Removed.

(f)(3)(iii) .................. Revised; (f)(2)(ii).

(f)(4)(i) .................... Revised; (f)(2)(i).

(f)(4) (ii) and (iii) .... Removed.

Appendix B, Section IV.Revised second and

fourth paragraphs;

removed sixth paragraph.

Appendix D ............ Removed.

1926.103:

All ........................... Revised to a single

provision.

1926.800:

(g)(2) ...................... Revised.

1926.1101:

(h)(1) ...................... Revised.

(h)(2)(i) ................... Revised; (h)(3)(i).

(h)(2)(ii) .................. Removed.

(h)(2)(iii) ................. Revised; (h)(3)(ii).

(h)(2)(iv) ................. Revised; (h)(3)(iii).

(h)(2)(v) .................. Revised; (h)(3)(iv).

(h)(3)(i) ................... Revised; (h)(2)(i).

(h)(3)(ii) .................. Removed.

(h)(3)(iii) ................. Removed.

(h)(3)(iv) ................. Revised; (h)(2)(ii).

(h)(4) ...................... Removed.

Appendix C ............ Removed.

1926.1127:

(g)(1) ...................... Revised.

(g)(2)(i) ................... Revised; (g)(3)(i).

(g)(2)(ii) .................. Revised; (g)(3)(ii).

(g)(3)(i) ................... Revised; (g)(2)(i).

(g)(3)(ii) and (iii) ..... Removed.

(g)(3)(iv) ................. Revised; (g)(2)(ii).

(g)(3)(v) .................. Revised; (g)(2)(iii).

(g)(4) ...................... Removed.

Appendix C ............ Removed.

[FR Doc. 97–33843 Filed 12–31–97; 8:45 am]

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