[Federal Register Volume 64, Number 194 (Thursday, October 7, 1999)]
[Rules and Regulations]
[Pages 54543-54559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-25977]


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NUCLEAR REGULATORY COMMISSION

10 CFR Part 20

RIN 3150-AF81


Respiratory Protection and Controls to Restrict Internal 
Exposures

AGENCY: Nuclear Regulatory Commission.

ACTION: Final rule.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its 
regulations regarding the use of respiratory protection and other 
controls to restrict intake of radioactive material. The amendments 
make these regulations more consistent with the philosophy of 
controlling the sum of internal and external radiation exposure, 
reflect current guidance on respiratory protection from the American 
National Standards Institute (ANSI), are consistent with recently 
effective revisions to Occupational Safety and Health Administration 
(OSHA's) respiratory protection rule, and make NRC requirements for 
radiological protection less prescriptive while reducing unnecessary 
regulatory burden without reducing worker protection. The amendments 
provide greater assurance that worker dose will be maintained as low as 
is reasonably achievable (ALARA) and that recent technological advances 
in respiratory protection equipment and procedures are reflected in NRC 
regulations and clearly approved for use by licensees.

EFFECTIVE DATE: February 4, 2000.

FOR FURTHER INFORMATION CONTACT: Alan K. Roecklein, Office of Nuclear 
Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 
20555-0001, telephone (301) 415-3883; email [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The NRC published a major revision of 10 CFR Part 20, ``Standards 
for Protection Against Radiation,'' on May 21, 1991 (56 FR 23360). 
Although the NRC was aware that certain provisions of Subpart H and 
Appendix A to Part 20 were out of date and did not reflect new 
technology in respiratory devices and procedures, the NRC made minimal 
changes in the May 21, 1991 final rule. The NRC was aware that an ANSI 
standard was being prepared that was expected to provide state-of-the-
art guidance on acceptable respiratory protection devices and 
procedures. Therefore, the NRC decided to address further revisions to 
Subpart H and Appendix A to Part 20 when the ANSI guidance was 
complete.
    In response to public comments on the proposed 10 CFR Part 20, the 
NRC made several changes to Subpart H in the May 21, 1991, final rule 
to make it consistent with the new philosophy and science underlying 
the new Part 20. The new Subpart H required that the practice of ALARA 
apply to the sum of internal and external dose; addressed correction of 
both high and low initial intake estimates if subsequent, more accurate 
measurements gave different results; and clarified that a respiratory 
protection program consistent with Subpart H is required whenever 
respirators are used to limit intakes of radioactive material.
    After 10 CFR Part 20 was revised, the American National Standards 
Institute approved publication of ANSI Z88.2-1992, ``American National 
Standard for Respiratory Protection''. This document provides an 
authoritative consensus on major elements of an acceptable respiratory 
protection program, including guidance on respirator selection, 
training, fit testing, and assigned protection factors (APF). The NRC 
is amending Subpart H of Part 20 to make the regulations less 
prescriptive without reducing worker protection. This rule is 
consistent with the 1992 ANSI guidance and is consistent with new 
regulations on respiratory protection published by the Occupational 
Safety and Health Administration (OSHA).

II. Analysis of Public Comments and Staff Response

    The proposed rule was published for public comment in the Federal 
Register July 17, 1998 (63 FR 38511). By mid-November seventeen letters 
had been received from the public providing comments on the rule. One 
letter was received from an Agreement State and

[[Page 54544]]

eight letters provided comments on the draft revision to Regulatory 
Guide 8.15.
    This section discusses the comments received, how the NRC staff was 
able to incorporate many of the comments into the final rule, and if 
not, why a comment was not accepted. Numerous suggestions for changes 
were acceptable to the NRC staff consistent with maintaining a 
comprehensive set of regulations for the use of respiratory protection 
against airborne radioactive materials, adequate to assure health and 
safety of workers at NRC-licensed facilities. Every effort was made to 
retain the burden reduction provided by the amendments in the proposed 
rule and to comply with the Commission's intent that regulations be 
risk informed and performance based. Because many commenters addressed 
the same issues, this analysis will address all comments but specific 
commenters will not be identified.
    Several commenters suggested endorsing the regulations on 
respirator use published recently by the Department of Labor, 
Occupational Safety and Health Administration (OSHA), 29 CFR Parts 1910 
and 1926. The proposed NRC regulations were in most respects consistent 
with those adopted by OSHA. Because OSHA's, as well as NRC's, 
regulations on respirator use may be applicable to facilities that have 
both radiological and non-radiological hazards, additional changes have 
been made to the NRC rule to make it even more consistent with OSHA 
requirements. However, the suggestion to rely entirely on the published 
OSHA rules is not possible for the following reasons.
    The Atomic Energy Act (AEA) gives the NRC the statutory 
responsibility to protect public health and safety, which includes 
worker radiological health and safety, in the use of source, byproduct, 
and special nuclear materials. The Occupational Safety and Health Act 
(OSH) Act provides that for working conditions where another Federal 
agency exercises statutory authority to protect worker health and 
safety, the OSH Act is inapplicable. Therefore in implementing its 
statutory authority, the NRC preempts the application of the OSH Act 
for those working conditions involving radioactive materials.
    In 1988, the NRC and OSHA signed a Memorandum of Understanding 
(MOU) to make jurisdictional responsibilities at NRC licensed 
facilities clear. Three areas of interest are intended to be regulated 
by the NRC. These are:

--Radiation risk produced by radioactive materials.
--Chemical risk produced by radioactive materials.
--Plant conditions that affect the safety of radioactive materials and 
thus present an increased radiation risk to workers.

    The NRC cannot meet its responsibility to protect worker and public 
radiological safety in these areas without a comprehensive body of 
regulations to guide inspection and enforcement of essential safety 
issues specifically addressing radiological hazards.
    In addition, the NRC regulation includes the Assigned Protection 
Factors (APFs) recommended by the American National Standards Institute 
(ANSI) with some modifications. Because, in radiological applications, 
using APFs to generate an estimate of intake of radioactive materials 
is an acceptable method to demonstrate compliance with NRC dose limits, 
APFs must be included in the regulation. However, OSHA rules do not 
specify APFs because this section of the OSHA rules is still under 
development.
    The NRC regulations include dose limitation for radiation exposure 
with the concept of keeping total dose As Low As Is Reasonably 
Achievable (ALARA). OSHA does not address radiation hazards and does 
not include the ALARA concept.
    Finally NRC requirements do make it clear that if an NRC licensee 
is using respiratory protection to protect workers against non-
radiological hazards, the OSHA requirements apply. If the NRC has 
jurisdiction and is responsible for inspection, the MOU specifies that 
NRC will inform the licensee and OSHA if the NRC observes an unsafe 
condition relative to non-radiological hazards. For all of these 
reasons, NRC believes it must have respiratory protection regulations 
in place, rather than adopt on OSHA regulations.
    Several commenters suggested endorsing ANSI guidance in the 
regulations such as ANSI Z88.2-1992, ``American National Standard for 
Respiratory Protection.'' The ANSI standards are viewed by the NRC 
staff as comprehensive guidelines that if implemented would contribute 
to an acceptable program. The NRC staff participated in development of 
the standards. However, the ANSI standard does not specifically address 
radiological protection. In addition, the ANSI recommendations for 
general respirator usage are too prescriptive to be incorporated as 
regulatory requirements given the Commission's intent to promulgate 
risk-informed and performance-based rules.
    With changes to the proposed rule discussed here, 10 CFR Part 20, 
Subpart H will be consistent in almost all respects with ANSI guidance. 
The final Regulatory Guide 8.15, ``Acceptable Programs for Respiratory 
Protection'', will endorse, with some minor exceptions, ANSI Z88.2, 
1992, as providing useful guidance for implementing an acceptable 
respiratory protection program. This is considered by the NRC to be 
consistent with the National Technology Transfer and Advancement Act of 
1995.
    Several commenters objected to the NRC proposed change that fit 
tests could be performed every three years, instead of annually, with 
supervisory attention to any physiological changes that might suggest 
more frequent tests. The commenters observed that the NRC proposal was 
inconsistent with ANSI guidance and the OSHA requirement for annual fit 
testing. The OSHA requirement for annual fit testing is based on 
several research studies that showed significant numbers of workers 
failing to maintain an acceptable level of fit after only 1 year. The 
NRC staff agrees and has retained the requirement for annual fit 
testing in the final rule.
    Several commenters suggested that disposable respirators (filtering 
facepieces or dust masks) without elastomeric sealing surfaces and 
adjustable straps, should have an APF equal to 10 listed in Appendix A 
to be consistent with ANSI. The final rule does not assign an APF to 
``filtering facepieces'' that are not equipped with elastomeric face 
seals and at least two adjustable straps, unless the licensee can 
demonstrate a fit factor of at least 100 by use of a quantitative or 
qualitative, and validated or evaluated fit testing protocol. If the 
device can be fit tested to demonstrate a fit factor of at least 100 
then an APF of 10 may be used. Although stated differently, this is 
essentially the condition that ANSI would require of disposables. The 
NRC rule has the benefit of calling attention to the possibility that 
some devices, such as dust masks, may not retain good fit under 
conditions of use in the work place. This provision also permits the 
use of dust masks and other disposables, if requested by a worker, 
without the requirement to perform medical exams or fit tests. Fit 
testing is only required if an APF is assigned, or if credit is taken 
for use of the device in estimating intake or dose, suggesting that the 
intent is to limit intake of radioactive material.
    Three respirator types operating in demand or in demand, 
recirculating mode were given APFs of 5 in the proposed rule. This was 
in an effort to discourage their use by mistake in high concentration 
areas. ANSI gives these devices APFs equal to 100. Consistent

[[Page 54545]]

with ANSI and in response to public comment, the NRC staff has changed 
these APFs to 100.
    It was suggested that Appendix A could be put into Regulatory Guide 
8.15 so that changes could be made more easily as ANSI revised APFs. 
This suggestion is not accepted by the NRC staff because APFs may be 
used to generate estimates of dose of record from the intake of 
radioactive material and as such should be regulatory requirements. 
Regulatory Guides provide descriptions of acceptable programs, are 
guidance only, and cannot be enforced unless a licensee commits to use 
specific regulatory guides in its license. Although many materials 
licensees and some nuclear power plant licensees do commit to use 
specific regulatory guidance, thus making the guidance enforceable, it 
is not required that all licensees incorporate regulatory guides.
    In addition, APFs, as established by ANSI, are considered to be the 
maximum allowable measure of protection associated with each respirator 
type and mode of operation. These measures are used to select a 
licensee's inventory of available respiratory protection devices as 
well as to select respirators for a particular job. The NRC believes it 
is important to worker safety that APFs not be flexible as they might 
be if they were contained only in regulatory guidance.
    During the information collection phase of this rulemaking, the NRC 
staff was advised by several licensees that they would hesitate to use 
a device unless it were specifically ``permitted'' in the NRC 
regulations. Appendix A is needed in the regulation to specify those 
respiratory devices that are permitted to be used in an NRC licensed 
facility. For example, quarter facepieces although approved by NIOSH 
and ANSI, are not permitted for use in NRC licensed facilities. On the 
other hand, air-supplied suits, that are not tested or certified by 
NIOSH or listed in ANSI, are in Appendix A to Part 20 thus permitting 
their use by licensees.
    Several commenters suggested that the NRC terms and definitions 
should be consistent with those used by OSHA. The NRC staff agrees. 
Several OSHA terms and definitions have been added to 10 CFR Part 20 in 
this final rule and several proposed NRC definitions have been amended 
to be more consistent with OSHA terms.
    A commenter observed that Sec. 20.1703(c)(3) requires that 
respirators be tested for operability prior to each use but that such 
tests (user seal checks) are not quantitative and there is no 
requirement to document the check. It was suggested that this 
requirement be deleted. The NRC staff does not intend that user seal 
checks (fit checks) be quantitative nor that they be documented. User 
seal checks have been required by the NRC since 1979 and are well known 
to the industry. Licensee training programs describe the procedures and 
the procedures are subject to periodic licensee and NRC audits. The 
need to perform a user seal check (fit check) prior to each use is 
considered an essential safety procedure, consistent with industry 
practice and ANSI guidance. This requirement is retained.
    A commenter stated that Sec. 20.1703(c)(2) requires the use of 
bioassays during respirator use in order to evaluate actual intakes and 
that for certain radionuclides, such as W- and Y-class forms of thorium 
and Y-class forms of uranium, bioassay techniques are relatively 
insensitive. The NRC staff observes that Sec. 20.1204, ``Determination 
of internal exposure,'' permits the use of air sampling, bioassays or 
combinations of these measurements to assess dose from the intake of 
radioactive materials. The final Sec. 20.1703(c)(2) states that a 
licensee shall implement and maintain a respiratory protection program 
that includes surveys and bioassays, as necessary, to evaluate actual 
intakes. The intent of this provision is to identify elements required 
to be addressed in the program description. This section does not 
replace Sec. 20.1204 which permits methods other than bioassay to be 
used to determine dose from intake.
    A commenter observed that under the proposed rule, if a licensee 
determined that a work situation did not require the use of respirators 
but a worker requested one, then a respiratory protection program would 
be required to be in effect. This is true for any respirator that has 
been assigned an APF in Appendix A. However, the rule now recognizes 
the use of disposable filtering facepieces (dust masks) without an APF. 
If no credit is to be taken for their use then program elements such as 
a medical exam and fit test are not required. Other program elements 
such as minimal training on limitations of the devices and correct 
methods of use are required.
    A comment was made that the final rule should establish the extent 
to which emergency planning efforts must incorporate the programmatic 
requirement of 10 CFR 20.1703. 10 CFR Part 20 does not directly address 
emergency situations but provides programmatic requirements for normal 
operations. However, Sec. 20.1001 notes that ``* * * nothing in this 
part shall be construed as limiting actions that may be necessary to 
protect health and safety.'' This suggests that in the event of an 
emergency, such as a major release or spill of radioactive material, 
conditions would need to be assessed and the need for respiratory 
protection determined. Licensees should determine whether or not an 
emergency situation could reasonably be expected to arise that would 
require the establishment of a respiratory protection program, and how 
extensive that program would need to be. For nuclear power plants, 
Sec. 50.47 (b)(8) requires ``adequate * * * equipment to support the 
emergency response.'' This includes respiratory protection equipment 
that would be needed in an emergency and a program for its use.
    In NUREG-6204, Question and Answers Based on Revised 10 CFR Part 
20, a question was posed as to whether the requirements of 10 CFR 
20.1703 apply to respiratory protection equipment that is to be used 
only in emergencies. The NRC staff position is that if the equipment is 
to be used to limit intakes of radioactive material, this requirement 
applies. Also, footnote i to the new Appendix A makes it clear that 
full facepiece, Self-Contained-Breathing-Apparatus (SCBA) operating in 
pressure demand, or positive pressure recirculating mode may be used as 
an emergency device in unknown concentrations for protection against 
inhalation hazards. If a licensee determined that there was sufficient 
likelihood of an emergency situation, including significant airborne 
radioactive material, to justify the maintenance of emergency use SCBA, 
then a program would be necessary to assure the safe use of the 
equipment should it be needed. The NRC staff believes that any 
respiratory protection program that meets Part 20 requirements should 
provide a good basis for respirator use in emergency situations. 
Further guidance is provided in Regulatory Guide 8.15.
    A commenter stated that Sec. 20.1703(b) requires application to the 
Commission for approval to use respiratory devices not tested or 
certified by NIOSH. It was suggested that this application would not be 
necessary if the respirator were used in a situation where no 
protection factor was needed. The program elements described in 
Sec. 20.1703 come into effect ``* * * if the licensee assigns or 
permits the use of respiratory protection equipment to limit the intake 
of radioactive material.'' The NRC clarified the statement of 
considerations to help define ``limit intake.'' In effect, if a 
licensee determines that respiratory protection is not required to 
limit intake of radioactive material and a respirator

[[Page 54546]]

is used for some other reason, then the Sec. 20.1703 conditions are not 
applicable. However, in this case, other regulations would govern the 
use of respirators. For example, if a worker requests a respirator that 
will not be used to limit intakes of radioactive material, then OSHA or 
State requirements would come into play. For example, OSHA requirements 
for the voluntary use of disposable filtering facepieces (dust masks) 
would be little more than brief instruction on the limitations of the 
device and correct methods of use. NRC, as well as OSHA requirements 
for the use of tight-fitting, half or full-facepiece respirators are 
more extensive, including medical evaluation.
    A suggestion was made that Sec. 20.1703(d) should include 
instructing a worker that a respirator could be removed in any 
situation where the user judges that his or her health is at risk due 
to physical or psychological stress caused by use of the respirator. 
The NRC staff believes the present language in this section and 
guidance in Reg. Guide 8.15, is adequate to assure that a worker knows 
when and how to secure relief from respirator-induced stress.
    A commenter requested that provisions be added to allow the use of 
combination full facepiece, pressure demand, supplied air respirators 
with auxiliary self-contained air supply for use during emergency entry 
into an unassessed environment. The NRC staff intends that Appendix A 
Section III, Combination Respirators, include any devices or 
combinations of devices as approved by NIOSH in 42 CFR Part 84.70. 
Regulatory Guide 8.15 provides further guidance on the use of 
combination respirators. The NRC staff does not believe that any change 
is needed in the regulation to permit (and continue to allow) the use 
of these approved devices.
    A commenter questioned the statement in footnote e of Appendix A 
that ``* * * no distinction is made * * * between elastomeric half-
masks with replaceable cartridges and those designed with the filter 
medium as an integral part of the face piece (e.g., disposable or 
reusable disposable).'' The commenter observed that there is no 
assurance that a filtering facepiece would provide the same degree of 
protection as a respirator equipped with an elastomeric facepiece. The 
NRC staff agrees with this statement and has assigned a protection 
factor of 10 only to devices having elastomeric face sealing properties 
and two or more adjustable straps. Filtering facepieces not having 
these design features are the first entry in Appendix A and are not 
given an APF.
    A commenter observed that proposed footnote e would permit the use 
of filtering facepiece respirators (dust masks) without medical 
screening or fit testing. The footnote also provides that if a licensee 
can demonstrate a fit factor of at least 100 using an acceptable fit 
test protocol, then an APF of 10 can be used. At question is whether 
the medical screening becomes necessary if the device qualifies for an 
APF. The waiver of medical screening in the new footnote d is based on 
the fact that these devices do not impose physiological stress because 
they are light weight, do not have a tight seal, and do not contribute 
significantly to breathing resistance. The use of these devices, such 
as dust masks, is likely to occur in response to a worker's request for 
a respirator when the licensee has determined that a respirator is not 
needed. Under these circumstances, the least burdensome design 
available should be used. If a filtering facepiece device passes a fit 
test, and is to be used to limit intake, and an APF greater than 1 is 
used to estimate intake, then a full program is required including 
medical screening. This requirement is consistent with the recent OSHA 
regulations.
    A suggestion was made that Appendix A could be clearer with more 
explanatory text in the table, fewer footnotes, and terminology that 
tracks OSHA. The NRC staff has revised Appendix A to some extent, by 
spelling out modes of operation and adopting OSHA terminology whenever 
possible.
    A suggestion was made that Appendix A would be less complicated if 
there was only one column of APF values. The NRC staff agrees and the 
APF column for air purifying respirators is now labeled Particulate, 
and the columns of APFs for atmosphere supplying respirators and 
combination respirators are now labeled Particulate, Gases, and Vapors.
    A commenter observed that footnote a should reference OSHA 
regulations in addition to 29 CFR 1910. The NRC staff agrees and 
footnote a in the final rule references Department of Labor 
regulations. The revised Regulatory Guide 8.15 discusses OSHA 
regulations and guidance in more detail.
    A commenter observed that the NRC-proposed filter efficiency 
requirements specified in proposed footnote c do not take into account 
the observation that filter performance is far better in the field than 
under NIOSH certification testing conditions. The NIOSH tests are 
conducted at extreme conditions such as high flow rates, the challenge 
aerosol is selected to be the most penetrating particle size, and long 
test durations are used. Under field conditions most filters perform at 
nearly 100 percent efficiency.
    Also it is not necessarily most protective to select a high 
efficiency filter because that results in a higher pressure drop across 
the filter which could increase breathing resistance and lead to a 
greater possibility of leakage around the seal as well as increased 
worker stress. The NRC staff agrees with this comment and final 
footnote b is changed to specify 95 percent efficiency filters for APFs 
less than 100, 99 percent efficiency filters for APFs equal to 100, and 
99.97 percent efficiency for APFs greater than 100.
    A commenter suggested that some language in proposed footnote d be 
clarified and that the last sentence could be covered in the text of 
the rule. The NRC staff has revised the first sentence in final 
footnote f to read, ``The assigned protection factors for gases and 
vapors are not applicable to radioactive contaminants that present an 
absorption or submersion hazard.'' The last sentence in proposed 
footnote d made it clear that some sorbent cartridges have been proven 
to be effective against airborne gases and vapors and, after NRC staff 
review and approval on a case-by-case basis, the NRC will continue to 
permit their use. This provision clearly modifies information in 
Appendix A. The NRC staff believes it should remain in the footnotes. 
With the restructuring of Appendix A, this information is found in new 
footnotes c and f. More detailed discussion of the criteria for 
approval of sorbent cartridges against gases and vapors has been added 
to Regulatory Guide 8.15.
    A commentor suggested deleting proposed footnote e because the 
initial statement to the effect that filtering facepieces may be used 
without medical screening or fit testing applies to all tight fitting 
respirators. That is not the case. Fit testing and medical screening 
are required for any respirator that is assigned a protection factor 
(APF). Only disposable, filtering facepieces without elastomeric 
sealing surface and adjustable straps that do not have an APF can be 
used without medical screening. If the devices are fit tested in order 
to use an APF, then medical screening would also be required.
    This commentor suggested that the caution in the proposed footnote 
e to the effect that it is difficult to perform positive or negative 
pressure user seal checks on filtering facepiece respirators is not 
based on technical information. The statement is based on cumulative 
experience in the industry and inspection by the NRC staff of a large 
number of filtering facepiece respirators that do not have elastomeric 
sealing

[[Page 54547]]

surfaces and adjustable straps. In most cases, it was very difficult 
for highly experienced respirator users to effectively perform a user 
seal check on filtering facepiece respirators in the negative or 
positive pressure mode.
    A commentor proposed deleting the last sentence in the final 
footnote i that warns against using SCBA in pressure demand or 
recirculating positive pressure modes if any outward leakage of 
breathing gas is perceived. This is an important warning for use of 
these devices in emergencies or unassessed situations because leakage 
could significantly reduce the expected duration of the air supply and 
thus stay time. Premature exhaustion of the air supply could result in 
serious injury or death of a worker in an Immediately Dangerous to Life 
and Health (IDLH) area. This warning appropriately modifies the 
assigned protection factor for this type of device.
    A commentor suggested several revisions to the NRC proposed 
definitions. Based on several comments the NRC staff has decided to use 
OSHA definitions for consistency and the OSHA definitions are 
consistent with the suggestions made by this commentor.
    A commentor questioned the use of the words ``as necessary'' in 
Sec. 20.1703 (c)(2). The intent of the words ``as necessary'' is that 
surveys or bioassays should be included in the program only if a 
licensee believes that these methods would be needed to determine 
intake. For example, if air sampling during all procedures indicates 
that no radioactive material is ever released into the air, then 
evaluation of actual intakes using bioassay would not be necessary. 
Section 20.1204, Determination of internal exposure, states that for 
purposes of determining dose the licensee shall measure concentrations, 
do bioassay, whole body count, or combinations of these measurements. 
The purpose of Sec. 20.1703(c)(2) is to identify elements of an 
acceptable program that may need to be included in the program, not to 
require performance of bioassay if it is not needed.
    A commentor observed that the proposed Sec. 20.1701 stated that 
``The licensee shall use, to the extent practicable, process or other 
engineering controls (e.g. containment, decontamination, or 
ventilation) to control the concentration of radioactive material in 
air. The word ``practicable'' is used in place of ``practical'' as 
found in the current regulations. The NRC staff agrees with this 
comment to the effect that ``practicable'' would require any action 
that was ``possible,'' whereas ``practical'' specifies action that 
would be ``useful''. The word ``practical'' is consistent with 
``reasonable'' as found in ALARA, As Low as Is Reasonably Achievable, 
and the final rule has been changed to retain the word ``practical.''
    A commentor observed that the proposed definition of ``fit factor'' 
is a quantitative measure of the fit of a respirator to an individual. 
The proposed definition of ``fit test'' is a test, quantitative or 
qualitative to evaluate the fit of a respirator and to determine the 
fit factor. The commentor states that a qualitative fit test cannot 
yield a quantitative fit factor. In fact, approved qualitative fit test 
protocols are considered by NIOSH, OSHA, and ANSI to imply minimum 
quantitative fit factors, usually limited to 100.
    However, because the NRC has decided to adopt the OSHA definitions, 
the final rule defines fit factor as ``* * *a quantitative estimate of 
the fit of a particular respirator to a specific individual, and 
typically estimates the ratio of the concentration of substance in 
ambient air to its concentration inside the respirator when worn.'' 
This definition permits use of a challenge medium whose concentration 
at ambient temperature and pressure can be estimated (C1) 
and if not detected by the test subject, a maximum concentration inside 
the mask can be assumed, (C2). The estimated fit factor 
would then be the ratio C1/C2. These qualitative 
fit factors are permitted to be used to determine fit factor, and Reg. 
Guide 8.15 will provide more detailed guidance on the use of approved 
protocols.
    A commentor suggested that the listing of irritant smoke (hydrogen 
chloride) as an acceptable challenge agent in a user seal check (fit 
check), be removed. There is evidence of health risks associated with 
exposure to this chemical agent, not only to the worker but also to the 
person performing the test. The NRC staff has decided to keep this 
option as one of the acceptable user seal checks along with positive 
and negative pressure check and isoamyl acetate, because both OSHA and 
ANSI list it. However, the final version of Reg. Guide 8.15 will 
include a caution regarding excessive exposure to this agent as well as 
some suggestions for performing user seal checks with irritant smoke so 
as to minimize exposure.
    This commentor pointed out that deleting the words ``* * * or had 
certification extended'' from Sec. 20.1703(a) and Sec. 20.1703(b), is 
appropriate but that users should be advised that any particulate 
respirators certified under 30 CFR Part 11 remain certified. The new 
certification regulations are at 42 CFR Part 84. The NRC staff agrees, 
and the statement of considerations includes a note to this effect, and 
Reg. Guide 8.15 discusses certification in more detail.
    The commentor questioned the wording in Sec. 20.1703(c)(3) that 
would exempt respirators with no APFs from user seal checks for tight 
fitting respirators and functional or operability checks for others 
such as atmosphere supplied suits. The NRC staff agrees that if a 
device is capable of being fit checked or operability checked then 
these checks should be performed each time the device is used whether 
or not a APF is used. The words ``* * *with APFs* * *'' are removed 
from Sec. 20.1703(c)(3).
    It was observed that Sec. 20.1703(c)(6) does not specify that fit 
testing measures face seal rather than equipment operation and 
therefore must always be performed with the facepiece operating in the 
negative pressure mode. This provision has been changed to be 
consistent with ANSI. Also, the proposed requirement to fit test any 
tight-fitting, positive pressure, continuous flow and pressure demand 
devices to a fit factor  100 is inconsistent with the OSHA 
specification of 500. This difference could result in workers using 
different masks depending on whether the respirator was used for 
protection against radiological or non-radiological hazards. It was 
further stated that a fit factor of 100 may be too low for full-face 
tight-fitting masks because it in fact would represent a relatively 
poor fit. The NRC staff believes that the OSHA recommended fit factor 
of 500 is not difficult to achieve and provides an additional increment 
of safety. The final rule reflects this change.
    A commentor observed that Appendix A lists a positive pressure (PP) 
operational mode for some air purifying respirator types. This 
designation refers to ``powered air purifying respirators (PAPR)'' and 
should be so designated. The NRC staff agrees and has made this change.
    A commentor suggested the use of ``intake'' or ``dose from internal 
radioactive material,'' instead of ``internal exposures,'' because 
there is some confusion regarding the meaning of that term. The NRC 
staff has reviewed the final rule and, whenever appropriate, more 
precise terminology has been used as suggested.
    A commenter references question number 91 in NUREG/CR-6204, 
Questions and Answers Based on Revised 10 CFR Part 20, in which the NRC 
staff stated that the requirements in 10 CFR 20.1703(a) must be met to 
use

[[Page 54548]]

respiratory protection whether or not credit is taken for the device. 
This statement was made before the NRC staff recognized the utility of 
permitting the use of disposable filtering facepieces (dust-masks) not 
equipped with elastomeric sealing surfaces and adjustable straps. The 
NRC continues to require compliance with Sec. 20.1703(a) if respiratory 
protection is used. However, dust masks and other similar devices can 
be used, probably on request of a worker, without fit testing or 
medical screening. These half-face, light-weight devices do not present 
any significant physiological stresses and are to be used in situations 
that do not require limiting intake. Therefore, these devices can be 
removed at any time they become stressful without any harm to the user. 
Minimal training on the limitations and proper use of the devices would 
be required.
    The commentor observed that the proposed rule would require fit 
factors that are ten times the APF for the specific negative-pressure 
air-purifying device, but that the rule does not specify how this fit 
testing can be accomplished. The NRC staff notes that guidance on fit 
testing, both quantitative and qualitative protocols, is found in Reg. 
Guide 8.15.
    A commentor states that the term ``adequate communication'' in 
Sec. 20.1703(e) may be difficult to demonstrate due to the limited 
communications options available with some respiratory devices and that 
``adequate'' is subject to interpretation. The NRC staff agrees and 
intends that this requirement be determined by licensee judgement. 
Adequate, or ``sufficient for a specific requirement,'' is discussed in 
Reg. Guide 8.15, and guidance as to what constitutes adequate 
communication is provided. This is not a new requirement and the NRC 
staff is not aware of licensees having difficulty with its 
implementation.
    The commentor questioned the requirement in Sec. 20.1703(f) for 
``direct'' communication between the standby rescue person and the 
worker because it might be necessary for the standby person to be in a 
high radiation area or otherwise be exposed to radiation or 
physiological stress. The NRC staff agrees and has changed this section 
to require the standby rescue person to ``maintain continuous 
communication'' with the workers. Acceptable communication methods are 
identified as, visual, voice, signal line, telephone, radio, or other 
suitable means.
    The commentor stated that proposed Sec. 20.1703(h) regarding 
materials or substances that might interfere with the seal of a 
respirator did not adequately reflect the discussion in the statement 
of considerations, and that, because the fit test proves the ability to 
properly maintain a seal, this restriction is not needed. The NRC staff 
observes that a fit test is not performed every time that a worker uses 
a respirator. A user seal check might work with some obstruction in the 
seal area but then break down in the work situation. To better reflect 
the scope and intent of this provision and to be consistent with OSHA, 
the NRC staff has added the underlined words as follows: (h) No 
objects, materials, or substances, such as facial hair, or any other 
conditions that interfere with the face--facepiece seal or valve 
function, that are under the control of the respirator wearer, are 
present.* * *
    A commentor suggested elimination of the planned revision of NUREG-
0041, ``Manual of Respiratory Protection Against Airborne Radioactive 
Material,'' because the document contains information that is found 
elsewhere and is redundant. The NRC staff agrees that it would not be 
useful to repeat information that is found elsewhere and one reason for 
updating and revising the NUREG is to eliminate and avoid redundancy. 
The document will be a technical source for NRC licensees setting up or 
operating respiratory protection programs that will include many 
references to ANSI, NIOSH, and other documents that describe acceptable 
programs. Only procedures unique to protection against airborne 
radioactive material will be addressed in detail if no other sources 
are available.
    The commentor observed that waiving the medical screening 
requirement for the use of single-use disposable respirators is 
inconsistent with OSHA. In fact, OSHA waives the medical screening 
requirement for any voluntary use of filtering facepiece respirators. 
The assumption is that if a licensee determines that a respirator is 
not needed (meets ALARA considerations) but a worker requests one, then 
the least intrusive device should be used, such as a disposable, 
filtering facepiece with no APF that would be unlikely to expose the 
worker to physiological stress. The NRC position is consistent with 
that of OSHA.
    Several commentors questioned the use of 15 percent loss of worker 
efficiency when using a respirator as a recommended, upper bound 
default value if a licensee is not able to justify a higher value. An 
EPRI study, for example, showed that loss of worker efficiency did not 
exceed 7 percent. Other measurements resulted in findings of 25 percent 
loss of efficiency under conditions requiring respiratory protection. 
With this range, a recommended default value of not more than 15 
percent, as specified in Reg. Guide 8.15 seems reasonable. The guide 
provides suggestions for determining an efficiency loss factor that 
would be job and site specific.
    A commentor questioned the need to apply to the Commission for the 
use of an APF greater than 1 for sorbent cartridges as protection 
against airborne radioactive gases and vapors (e.g., radioiodine). The 
commentor stated that the NRC should specify the same APF listed for 
particulate filters for radioactive gases or vapors with good warning 
properties. The NRC staff is aware that most radionuclides (e.g., 
airborne radioiodines) have poor to no warning properties. For this 
reason, the NRC staff intends to continue requiring a specific case 
approval process with some demonstration of effectiveness before 
approval for use.
    A commentor suggested permitting ``a licensed health care 
professional,'' in addition to a physician, to determine that a person 
is medically fit to use a respirator, as is done by OSHA. The 
established NRC position, as described further in Reg. Guide 8.15, 
continues to be that a licensed health care professional can administer 
a medical exam, but the program must be designed by, and be under the 
supervision of a physician. The NRC staff is aware that serious injury 
and death can occur if a person with certain medical conditions is 
permitted to use a respirator.
    In May of 1991 the Commission published a major revision to 10 CFR 
Part 20 that required a licensee to implement and maintain a 
respiratory protection program that includes * * * Determination by a 
physician* * * that the individual user is physically able to use the 
respiratory protection equipment.'' In the statement of considerations 
for that final rule, the Commission noted ``* * *the decision on the 
physical ability of an individual to wear a respirator is a subjective 
judgement that in the Commission's opinion, requires the decisionmaker 
to have a medical degree.'' In 1995 the Commission reaffirmed this 
position in a rulemaking that revised the required frequency of medical 
examination. However, the statement of considerations for that 
rulemaking stated ``* * *The NRC staff believes that physicians need 
not administer each test personally, but that the physician may 
designate someone such as an office nurse to certify medical fitness as 
long as it is clear that the physician is ultimately responsible for

[[Page 54549]]

the fitness determination. Likewise the NRC staff believes that the 
physician should be involved in the supervision of the fitness program, 
the review of overall results and individuals cases that fall outside 
certain physician determined parameters, and supervision of personnel 
performing the tests.''
    This position is in agreement with ANSI recommendations as stated 
in ANSI--Z88.6 1984. Regulatory Guide 8.15, Rev. 1, ``Acceptable 
Programs for Respiratory Protection states that, ``The medical 
evaluation program should be carried out by the physician, or by a 
certified, medically trained individual such as a registered nurse 
(RN), licensed practical nurse (LPN), emergency medical technician 
(EMT), or someone who, in the judgement of the licensee's physician, 
has adequate experience, education, training, and judgement to 
administer the screening program.'' This is consistent with OSHA's 
regulations that permit a ``licensed health care professional'' to 
administer the fitness screening program.
    A commentor observed that ANSI Z88.2-1992, does not include APFs 
for SCBA used in the pressure-demand or positive pressure recirculating 
modes, because some workplace simulation tests showed that up to 5 
percent of workers don't achieve protection factors that high. ANSI 
instead suggests that APFs up to 10,000 should be used only for 
emergency planning purposes. Footnote a to Appendix A in the NRC 
regulation makes it clear that the APFs apply only to airborne 
radiological hazards and not when chemical or other respiratory hazards 
exist.
    A commentor suggested deletion of irritant smoke and isoamyl 
acetate as example of a user seal check because these are not checks 
that a user can perform without assistance. The NRC staff agrees but 
does not preclude the use of assistance in performing a user seal 
check. It is common for a technician to perform user seal checks on a 
work crew preparing for entry to a job site requiring respirators. If 
no assistance is available then clearly positive or negative pressure 
checks would be the available options.
    It was suggested that more guidance be provided on functional check 
or testing for operability. The NRC staff agrees and Reg. Guide 8.15 
will be expanded to provide more guidance on accepted techniques.
    It was suggested that more specificity regarding actual procedures 
be put in the rule or the Reg. Guide and that requirements for 
addressing non-routine and emergency use of respirators should be 
added. The NRC staff does not agree because respiratory programs should 
be site and work specific and the intent of revising the rule was to 
make it more performance based. Considerable guidance on acceptable 
methods exists and is referenced in Reg. Guide 8.15 or NUREG-0041.
    A commentor said that NRC should require use of the OSHA medical 
check questionnaire, or its equivalent. The NRC staff agrees that the 
OSHA questionnaire is an acceptable way, along with appropriate medical 
oversight, to medically screen workers to use respirators safely, but 
that other methods are also acceptable. In the interest of maintaining 
a performance-based rule, the NRC will rely on review of a licensee's/
physician's judgement regarding the best way to qualify workers. The 
OSHA questionnaire is referenced in Reg. Guide 8.15 for guidance.
    It was suggested that provisions for vision, communication, and low 
temperature protection be made at no cost to the employee. The NRC 
staff believes that this issue is outside the scope of 10 CFR Part 20 
and should be addressed between workers and licensee management.
    A commentor suggested adding a definition for ``Immediately 
Dangerous to Life or Health,'' IDLH. Subpart H of 10 CFR Part 20 
provides program requirements for respiratory protection against 
airborne radioactive material. It would be extremely rare for airborne 
concentrations of radioactive material to reach IDLH levels. IDLH 
refers to industrial and toxic chemical hazards that NRC licensees must 
be alert to in compliance with OSHA regulations. It would be 
inappropriate for NRC to suggest that airborne radiological condition 
would require a definition of IDLH. OSHA defines IDLH as ``* * * an 
atmosphere that poses an immediate threat to life, would cause 
irreversible adverse health effects, or would impair an individuals' 
ability to escape from a dangerous atmosphere.''
    It was suggested that Sec. 20.1703(f) state that a sufficient 
number of standby rescue persons must be immediately available to 
provide effective emergency rescue. The NRC staff agrees and these 
words have been added.
    A commentor observed that the APFs specified by NRC in Appendix A 
are not in complete agreement with those recommended by ANSI. The 
difference for disposable filtering facepieces (dust masks) has been 
discussed. Any other differences between the ANSI recommended APFs and 
those specified by the NRC in the proposed rule have been eliminated in 
this final rule in the interest of providing greater consistency with 
ANSI recommendations.
    Eight comment letters were received regarding the draft Reg. Guide 
8.15. All of the suggested changes derived from comments made on 
proposed Subpart H of 10 CFR Part 20. Reg. Guide 8.15 has been revised 
based on this analysis of comments submitted on the proposed rule and 
the changes that have been made to the rule as discussed in this 
section.

III. Summary of Changes

    This final rule amends Sec. 20.1003, ``Definitions'', Secs. 20.1701 
through 20.1704, adds Sec. 20.1705, and amends Appendix A to Part 20.
    In Sec. 20.1003, the NRC is adding definitions for Air-purifying 
respirator, Assigned protection factor (APF), Atmosphere-supplying 
respirator, Demand respirator, Disposable respirator, Filtering 
facepiece (dust mask), Fit factor, Fit test, Helmet, Hood, Loose-
fitting facepiece, Negative pressure respirator, Positive pressure 
respirator, Powered air-purifying respirator (PAPR), Pressure demand 
respirator, Qualitative fit test (QLFT), Quantitative fit test (QNFT), 
Self-contained breathing apparatus (SCBA), Supplied-air respirator 
(SAR) or airline respirator, Tight-fitting facepiece and User seal 
check. These added definitions clarify the new regulations at 
Secs. 20.1701 through 20.1705.
    In Sec. 20.1701, the word ``decontamination'' is added to the list 
of examples of process or engineering controls that licensees should 
consider for controlling the concentration of radioactive material in 
air. The NRC intends that licensees consider decontamination, 
consistent with maintaining total effective dose equivalent (TEDE) 
ALARA, to reduce resuspension of radioactive material in the work place 
as a means of controlling internal dose instead of using respirators.
    Section 20.1702 is revised to clarify that if a licensee performs 
an ALARA analysis to determine whether or not respirators should be 
used, the licensee may consider safety factors other than radiological. 
A reduction in the TEDE for a worker is not reasonably achievable if, 
in the licensees' judgement, an attendant increase in the worker's 
industrial health and safety risk would exceed the benefit obtained by 
the reduction in the radiation risk. Regulatory Guide 8.15, 
``Acceptable Programs For Respiratory Protection,'' and NUREG-0041, 
``Manual of Respiratory Protection Against Airborne Radioactive 
Material'' address how factors such as heat, discomfort, reduced 
vision, etc., associated with respirator use, might reduce efficiency

[[Page 54550]]

or increase stress thereby increasing dose from external sources or 
health risk. The NRC expects that licensees will exercise judgment in 
determining how nonradiological factors apply to selecting an 
appropriate level of respiratory protection. In the proposed rule this 
amendment would have been accomplished by adding a footnote to 
paragraph (c). The NRC has instead restructured the section to add 
similar language to a new subparagraph Sec. 20.1702(b) in the text of 
the rule to facilitate clarification of this important provision.
    Section 20.1703 states the requirements for licensees who use 
respiratory protection equipment to limit intake of radioactive 
material. The use of a respirator is, by definition, intended to limit 
intakes of airborne radioactive materials, unless the device is clearly 
and exclusively used for protection against non-radiological airborne 
hazards. Whether or not credit is taken for the device in estimating 
doses, use of the respiratory protection device to limit intake of 
radioactive material and associated physiological stresses to the user 
activates the requirements of Sec. 20.1703. Thus Sec. 20.1703 defines 
the minimum respiratory protection program expected of any licensee who 
assigns or permits the use of respirators to limit intake.
    The term ``limit intake of radioactive material'' is not 
specifically defined in this rule. The licensee must determine whether 
the use of a respirator for protection against non-radiological 
airborne hazards or at the request of a worker also limits the intake 
of radioactive material. If so a Sec. 20.1703 program is required. An 
acceptable approach is for the licensee to evaluate the existing or 
potential airborne concentrations of radioactive material (from routine 
operations, likely operational occurances, and credible emergency 
conditions) and determine whether a Part 20, Subpart H respiratory 
program would have been required by the concentration of radioactive 
material. If the analysis shows that respiratory protection would not 
have been required in order to limit intake of radioactive material, 
then compliance with Subpart H would not be required. Respirators used 
for the express purpose of protection against non-radiological hazards, 
and that only incidentally limit the intake of radioactive materials 
that may be present in the air, are not considered to fall under the 
``limit intake'' category. Such respirator use is not regulated by 
Subpart H provisions.
    However, respiratory protection that is used to protect against 
non-radiological hazards or at the request of a worker invokes OSHA 
program requirements. The programmatic requirements prescribed by OSHA 
are commensurate with the degree of hazard present, ranging from a 
program more prescriptive than Subpart H to brief instruction on safety 
issues in the case of the voluntary use of ``dust masks.'' Under a 
Memorandum of Understanding between the NRC and OSHA, the NRC 
inspection staff is obligated to notify the licensee and OSHA if 
industrial safety problems are observed.
    In Sec. 20.1703(a), the phrase ``pursuant to Sec. 20.1702'' is 
removed. This language has been misinterpreted to mean that an approved 
respiratory protection program is not needed if respirators are used 
when concentrations of radioactive material in the air are already 
below values that define an airborne radioactivity area. Section 
20.1703 now makes it clear that, if a licensee uses respiratory 
protection equipment ``to limit intakes,'' the provisions of 
Sec. 20.1703 are the minimum applicable requirements.
    In final Sec. 20.1703(a), licensees are permitted to use only 
respirators that have been tested and certified by NIOSH. The words 
``or had certification extended'' are removed because all existing 
extensions have expired and no new extensions will be granted except 
for classes of respirators certified under 42 CFR Part 84.

    Note: The respiratory certification regulations at 42 CFR Part 
84 replaced those previously at 30 CFR Part 11 for air purifying 
respirators. Devices formerly certified under 30 CFR Part 11 remain 
certified but newer devices certified under 42 CFR Part 84 have 
demonstrated improved performance.

    In final Sec. 20.1703(b), licensees are permitted to apply for 
authorization to use equipment that has not been tested or certified by 
NIOSH. The words ``and has not had certification extended by NIOSH/
MSHA'' have been removed because all existing extensions have expired 
and no new extensions will be granted except for classes of respirators 
certified under 42 CFR Part 84. The words ``to the NRC'' are added to 
make it clear that applications for authorized use of respiratory 
equipment must be submitted to the Commission.
    In new Sec. 20.1703(c), paragraphs (c)(1) through (5) are retained 
as presently codified with the exception of some minor editing. 
Paragraph (c)(4) is reworded to improve clarity, reorder priorities, 
and bring together in one paragraph all of the elements of the required 
written procedures. Paragraph (c)(5) is revised to clarify that the 
worker's medical evaluation for using non-face sealing respirators 
occurs before first field use, not before first fitting (as required 
for tight fitting respirators) because fit testing is not needed for 
these types.
    A new Sec. 20.1703(c)(6) is added to require fit testing before 
first field use of tight-fitting, face sealing respirators and 
periodically after the first use. This change clarifies when and how 
often fit testing is required. The NRC requires that the licensee 
specify a frequency of retest in the procedures, that may not exceed 1 
year (see HPPOS-219 for NRC staff position on testing intervals). The 
proposed rule would have extended the retest period up to three (3) 
years. However, public comment and the NRC's intent to be consistent 
with OSHA requirements, convinced the NRC staff to retain annual fit 
testing. (See Analysis of Public Comment).
    The new Sec. 20.1703(c)(6) also codifies existing NRC staff 
guidance and ANSI recommendations regarding the test ``fit factors'' 
that must be achieved in order to use the APFs. Specifically, fit 
testing with ``fit factors''  10 times the APF is required 
for tight fitting, negative pressure devices. A fit factor  
500 is required for all tight fitting face pieces used with positive 
pressure, continuous flow, and pressure-demand devices. ANSI 
recommended a fit factor of 100 for these devices but OSHA selected 500 
to provide an additional safety margin. The NRC staff agrees with the 
OSHA position and in the interest of consistency is specifying 500. 
This provision is intended to maintain a sufficient margin of safety to 
accommodate the greater difficulty in maintaining a good ``fit'' under 
field and work conditions as compared to fit test environments. It is 
important to note that all tightfitting facepieces are to be fit tested 
in the negative pressure mode regardless of the mode in which they will 
be used.
    Current Sec. 20.1703(a)(4), which required licensees to issue a 
written policy statement, is removed because the NRC believes that it 
is not needed. All of the elements that were required to be in the 
policy statement are already found in Part 20 and in the requirement 
for licensees to have and implement written procedures (see 
Sec. 20.1703(c)(4)).
    The requirements of Sec. 20.1703(a)(6) have been moved to 
Sec. 20.1703(e), clarified and expanded to emphasize the existing 
requirements that provisions be made for vision correction, adequate 
communications, and low-temperature work environments. A licensee is 
required to account for the effects of restricted vision and 
communication limitations as well as the effects of adverse 
environmental conditions on the equipment and the wearer. The NRC

[[Page 54551]]

considers the inability of the respirator wearer to read postings, 
operate equipment and/or instrumentation, or properly identify hazards 
to be an unacceptable degradation of personnel safety.
    A requirement for licensees to consider low-temperature work 
environments when selecting respiratory protection devices is added in 
Sec. 20.1703(e). The NRC believes that this requirement is needed 
because the moisture from exhaled air when temperatures are below 
freezing could cause the exhalation valve on negative pressure 
respirators to freeze in the open position. The open valve would 
provide a pathway for unfiltered air into the respirator inlet covering 
without the user being aware of the malfunction. Lens fogging that 
reduces vision in a full facepiece respirator is another problem that 
can be caused by low temperature.
    The reference to skin protection in Sec. 20.1703(a)(6) has been 
removed. The NRC does not consider skin protection to be an appropriate 
reason for the use of respirators (with the exception of air supplied 
suits). Limitation of skin dose is currently dealt with elsewhere in 
the regulations (Sec. 20.1201(a)(2)(ii), skin dose limit). It may be 
inconsistent with ALARA to use tight fitting respirators solely to 
prevent facial contamination. Other protective measures such as the use 
of faceshields instead of respirators, or decontamination should be 
considered.
    A new Sec. 20.1703(f) is added to include a requirement for standby 
rescue persons in the regulatory text. This requirement was previously 
contained in a footnote in Appendix A to Part 20. This provision 
retains a requirement for standby rescue persons to be present whenever 
one-piece atmosphere-supplying suits, or any other combination of 
supplied air respirator device and protective equipment are used that 
are difficult for the wearer to take off without assistance. Standby 
rescue persons would also need to be in continuous communication with 
the workers, be equipped with appropriate protective clothing and 
devices, and be immediately available to provide needed assistance if 
the air supply fails. Without continuous air supply, unconsciousness 
can occur within seconds to minutes.
    A new Sec. 20.1703(g) moves a requirement from a footnote in 
Appendix A to Part 20, into regulatory text. This paragraph specifies 
the minimum quality of supplied breathing air, as defined by the 
Compressed Gas Association (CGA) in their publication G-7.1, 
``Commodity Specification for Air,'' 1997, that must be provided 
whenever atmosphere-supplying respirators are used. This change which 
recognizes the CGA recommendations for air quality, was initiated by 
NIOSH and endorsed by ANSI. The quantity of air supplied, as a function 
of air pressure or flow rate, would be specified in the NIOSH approval 
certificate for each particular device and is not addressed in the 
rule.
    A new Sec. 20.1703(h) is added to clarify and move a requirement 
from the footnotes of Appendix A into regulatory text. This provision 
prohibits the use of respirators whenever any objects, materials, or 
substances such as facial hair, or any other conditions interfere with 
the seal of the respirator. The intent of this provision is to prevent 
the presence of facial hair, cosmetics, spectacle earpieces, surgeons 
caps, and other things from interfering with the respirator seal, 
exhalation valves, and/or proper operation of the respirator.
    Section 20.1703(b)(1) discussed the selection of respiratory 
protection equipment so that protection factors are adequate to reduce 
intake. This paragraph permitted selection of less protective devices 
if that would result in optimizing TEDE. The NRC staff believes that 
this requirement is redundant with the requirement to be ALARA. These 
recommendations are removed from the regulation and are now discussed 
in revised Regulatory Guide 8.15.
    The remainder of Sec. 20.1703(b)(1) has been moved to 
Sec. 20.1703(i) and incorporates the new ANSI terminology for 
``assigned protection factor''. This paragraph retains the provisions 
for changing intake estimates if later, more accurate measurements show 
that intake was greater or less than initially estimated.
    Section 20.1703(b)(2), specifying procedures for applying to the 
NRC to use higher APFs, has been moved to Sec. 20.1705.
    Section 20.1703(c) is removed because it requires licensees to use 
only respiratory protection equipment that has been specifically 
certified or had certification extended for emergency use by NIOSH, as 
emergency devices. Because only equipment approved by NIOSH or NRC can 
be used in the respiratory protection program pursuant to 
Sec. 20.1703(a) and (b), this provision is redundant. The revisions of 
Regulatory Guide 8.15 and NUREG-0041 discuss acceptable types of 
emergency and escape equipment.
    Section 20.1703(d) is removed. This provision required a licensee 
to notify the director of the appropriate NRC Regional Office in 
writing at least 30 days before the date that respiratory protection 
equipment is first used so that the NRC staff could review the licensee 
program. Licensees who possess radioactive material in a form that 
requires a respiratory protection program are expected to submit a 
program description during the license application, amendment, or 
renewal processes. Their programs would be reviewed during this 
process. A 30-day notification requirement imposes a needless 
administrative burden on licensees with no increase in worker health 
and safety. This change is considered to be a burden reduction.
    Section 20.1704(a) is revised to clarify that the Commission will 
use ALARA considerations in any additional restrictions imposed by the 
Commission on the use of respiratory protection equipment for the 
purpose of limiting exposures of individuals to airborne radioactive 
materials.
    Appendix A to Part 20--``Assigned Protection Factors for 
Respirators,'' is modified extensively. In general, new devices are 
recognized, APFs are revised to be consistent with current ANSI 
guidance and technical knowledge, and the footnotes to Appendix A are 
moved, deleted, revised, or adjusted so that only those necessary to 
explain the table remain. Footnotes that are instructive or that 
facilitate implementation of the rule are being moved to Regulatory 
Guide 8.15. Several footnotes are considered to be redundant in that 
they reiterate NIOSH certification criteria to be discussed in NUREG-
0041 and are removed. Generic regulatory requirements, previously 
contained in footnotes in Appendix A, have been moved to the text of 
Part 20.
    The column headed ``Tested and Certified Equipment'' is removed 
from the table. The references to Titles 30 and 42 of the CFR currently 
found in this column apply primarily to respirator manufacturers and 
are not very useful to NRC licensees. Instruction on how to determine 
if a respirator is NIOSH approved are provided in the revision to 
NUREG-0041.
    The column headed Gases and Vapors is deleted, and the APFs for Air 
Purifying respirators are designated ``particulate only,'' while APFs 
for Atmosphere Supplying and Combination Respirators are designated for 
``particulate, gases and vapors''. This change simplifies Appendix A.
    Footnote a to Appendix A is removed because it is redundant with 
air sampling requirements and requirements for estimating possible 
airborne concentration addressed in Sec. 20.1703(c)(1) and 
Sec. 20.1703(i).

[[Page 54552]]

    Footnote b, which permits the use of devices only when nothing 
interferes with the seal of a face piece, has been moved to the text of 
the rule at Sec. 20.1703(h).
    Footnote c, proposed footnote b, which defines the symbols for 
modes of operation, is removed as a result of public comment and 
operating modes are spelled out in Appendix A.
    Footnote d.1 is removed because the essential information regarding 
the meaning and use of APF is in Sec. 20.1703(i). Further guidance 
regarding the application and limitation of APFs is provided in the 
revisions of Regulatory Guide 8.15 and NUREG-0041.
    Footnote d.2(a) stated that APFs are only applicable for trained 
individuals who are properly fitted and for properly maintained 
respirators. This footnote is redundant because adequate provisions for 
training, fit-testing, and equipment maintenance are found in the final 
rule (Sec. 20.1703(c)(4)).
    Footnote d.2(b) stated that APFs are applicable for air-purifying 
respirators only when high-efficiency particulate filters are used in 
atmospheres not deficient in oxygen and not containing radioactive gas 
or vapor respiratory hazards. This statement is revised and included in 
footnote b to say that if using a respirator with an APF less than 100, 
a filter with a minimum efficiency of 95 percent must be used. Air 
purifying respirators with APF=100 must use a filter with an efficiency 
rating of at least 99 percent. Respirators with APF>100 must use 
filters with at least 99.97 percent efficiency. Further guidance is 
provided in Regulatory Guide 8.15 and NUREG-0041. The definitions of 
filter types and efficiencies are discussed in the revisions of 
Regulatory Guide 8.15 and NUREG-0041.
    Footnote d.2(c) stated that APFs cannot be used for sorbents 
against radioactive gases and/or vapors (e.g., radioiodine). This is no 
longer an absolute prohibition. A provision is made in footnote c for 
licensees to apply to the Commission for the use of an APF greater than 
1 for sorbent cartridges.
    Footnote d.2(d) restated part of the NIOSH approval criteria for 
air quality for supplied air respirators and self-contained breathing 
apparatus. This requirement is changed to reflect the fact that air 
quality standards derive from ANSI's recognition of the Compressed Gas 
Association guidance, and is moved to the text of the rule 
(Sec. 20.1703(g)). Air quality is discussed further in Regulatory Guide 
8.15 and NUREG-0041.
    Footnote e made it clear that the APFs for atmosphere-supplying 
respirators and self-contained breathing apparatus are not applicable 
in the case of contaminants that present a skin absorption or 
submersion hazard. This statement is retained in footnote f in Appendix 
A to Part 20. However, the current exception provided for tritium oxide 
requires correction in that the effective protection factor cannot 
exceed 3, rather than 2 as previously stated. This correction is made 
to footnote f of Appendix A. This basis for this change is discussed 
further in revised NUREG-0041.
    Footnote f stated that canisters and cartridges for air purifying 
respirators will not be used beyond service-life limitations. This 
observation restates a NIOSH approval criterion and is more appropriate 
to guidance than to the regulations. This footnote is removed. Service 
life limitations are addressed in Regulatory Guide 8.15 and NUREG-0041.
    Footnote g addressed four issues. The first limits the use of half-
mask facepiece air purifying respirators to ``under-chin'' types only. 
This limitation is retained in footnote e to the new Appendix A to Part 
20. The only type of facepiece eliminated by this requirement is the 
so-called ``quarter-mask'' which seals over the bridge of the nose, 
around the cheeks and between the point of the chin and the lower lip. 
These devices can exhibit erratic face-sealing characteristics, 
especially when the wearer talks or moves his/her mouth.
    The second issue precluded this type of respirator if ambient 
airborne concentrations can reach instantaneous values greater than 10 
times the pertinent values in Table 1, Column 3 of Appendix B to Part 
20. Because respirator assignment is now based on TEDE, ALARA, and 
other considerations, this part of footnote g is removed from the new 
footnote e.
    The third issue precluded the use of this type of respirator for 
protection against plutonium or other high-toxicity materials. Half-
mask respirators, if properly fitted, maintained, and worn, provide 
adequate protection if used within the limitations stated in the NIOSH 
approval and in the rule. The NRC finds no technical or scientific 
basis for continuing this prohibition in view of current knowledge and 
it is removed.
    Finally this footnote required that this type mask be checked for 
fit (user seal check) before each use. This provision is removed 
because Sec. 20.1703(c)(3) requires a user to perform a user seal check 
(e.g., negative pressure check, positive pressure check, irritant smoke 
check) each time a respirator is used.
    Footnote h provided several conditions on air-flow rates necessary 
to operate supplied air hoods effectively. Because all of these 
requirements are elements of the NIOSH approval criteria, they are 
redundant and are removed. These NIOSH requirements are discussed 
further in the revision to NUREG-0041.
    Footnote i specified that appropriate protection factors be 
determined for atmosphere-supplying suits based on design and 
permeability to the contaminant under conditions of use. Conditions for 
the use of these devices are retained in footnote g to the revision of 
Appendix A. Guidance on the use of these devices and on determining 
appropriate protection factors is included in the revision to 
Regulatory Guide 8.15. Footnote i also required that a standby rescue 
person equipped with a respirator or other apparatus appropriate for 
the potential hazards, and communications equipment be present whenever 
supplied-air suits are used. This requirement is moved to the text of 
the rule (Sec. 20.1703(f)).
    Footnote j stated that NIOSH approval schedules are not available 
for atmosphere-supplying suits. This information and criteria for use 
of atmosphere supplying suits is addressed in footnote g to Appendix A. 
Note that an APF is not listed for these devices. Licensees may apply 
to the Commission for the use of higher APFs in accordance with 
Sec. 20.1703(b).
    Footnote k permitted the full facepiece self-contained breathing 
apparatus (SCBA), when operating in the pressure-demand mode, to be 
used as an emergency device in unknown concentrations. This provision 
is retained in footnote i to Appendix A, and full facepiece SCBA 
operating in positive pressure, recirculating mode is added.
    Footnote l required quantitative fit testing with a leakage less 
than 0.02 percent for the use of full facepiece, positive pressure, 
recirculating mode SCBA. This requirement is removed from the footnotes 
and fit test criteria consistent with ANSI guidance are inserted at 
Sec. 20.1703(c)(6). Fit testing is addressed in the revision to 
Regulatory Guide 8.15.
    Footnote l also stated that perceptible outward leakage of 
breathing gas from this or any positive pressure SCBA whether open 
circuit or closed circuit is unacceptable, because service life will be 
reduced substantially. This provision is retained in footnote i to 
Appendix A.
    Footnote l also required that special training in the use of this 
type of

[[Page 54553]]

apparatus be provided to the user. The NRC believes that the training 
requirement that would be retained at Sec. 20.1703(c)(4) is adequate to 
assure the training necessary for the use of SCBA devices. This element 
of footnote l is removed.
    Note 1 to Appendix A to Part 20 discussed conditions under which 
the protection factors in the appendix may be used, warned against 
assuming that listed devices are effective against chemical or 
respiratory hazards other than radiological hazards, and stated the 
need to take into account applicable approvals of the U.S. Bureau of 
Mines/NIOSH when selecting respirators for nonradiological hazards. 
Note 1 is retained in footnote a to Appendix A and amended to reference 
Department of Labor (DOL) regulations. The NRC believes that these 
conditions are essential to the safe use of respirators and that the 
DOL regulations also apply when hazards other than radiological 
respiratory hazards are present.
    Note 2 to Appendix A warned that external dose from submersion in 
high concentrations of radioactive material may result in limitations 
on occupancy being governed by external dose limits. This note is 
retained as the second paragraph of footnote a to Appendix A to Part 
20.
    In the title of Appendix A, and throughout the rule, the term 
``assigned protection factor'' (APF) is used to be consistent with the 
new ANSI Z88.2-1992 terminology.
    Although ANSI suggested an APF = 10 for all half-mask filtering 
facepiece disposable respirators, disposables that do not have seal-
enhancing elastomeric components and are not equipped with two or more 
adjustable suspension straps are permitted for use but do not have an 
APF assigned (i.e., no credit may be taken for their use). The NRC 
believes that without these design features it is difficult to maintain 
a seal in the workplace. These devices have little physiological impact 
on the wearer, may be useful in certain situations, and they may 
accommodate workers who request respiratory protection devices as is 
required by OSHA. Medical screening is not required for each individual 
prior to use because the devices impose very little physiological 
stress. In addition, fit testing is not required because an APF is not 
specified (i.e., no credit may be taken for their use). However, all 
other aspects of an acceptable program specified in Sec. 20.1703 are 
required including training of users in the use and limitations of the 
device. The NRC believes that this provision allows the flexible and 
effective use of these devices without imposing conditions that are 
burdensome.
    However, for those licensees who would like to use the ANSI-
recommended APF of 10 for filtering facepiece (dust masks), footnote d 
to Appendix A permits an APF of 10 to be used if the licensee can 
demonstrate a fit factor of at least 100 using a validated or 
evaluated, quantitative or qualitative fit test. This requirement is 
consistent with ANSI recommendations because fit testing is an explicit 
component of the ANSI respirator program. The full Sec. 20.1703 program 
would then be needed including a medical evaluation.
    The half-facepiece respirator continues to be approved with an APF 
= 10, but relatively new variations of this type of device are referred 
to in the industry as ``reusable,'' ``reusable-disposable,'' 
``filtering facepiece'' or ``maintenance-free'' devices. In these 
devices, including those considered to be disposables, the filter 
medium may be an integral part of the facepiece, is at least 95 percent 
efficient, and may not be replaceable. Also, the seal area is enhanced 
by the application of plastic or rubber to the face-to-facepiece seal 
area and the 2 or more suspension straps are adjustable. These devices 
are acceptable to the NRC, are considered half facepieces, may be 
disposable, and are given an APF = 10, consistent with ANSI 
recommendations. Individual workers must achieve a fit factor of at 
least 100 to use the APF of 10.
    The APF for full facepiece air purifying respirators operating in 
the negative pressure mode is increased from 50 to 100. This change is 
consistent with ANSI recommendations based on review of industry test 
results. Appendix A previously listed a protection factor of 50 because 
one design that was tested at Los Alamos in 1975 did not meet the 
protection factor criterion of 100. This device is no longer available.
    A fit factor of 10 times the APF for tight fitting, negative-
pressure air-purifying respirators, which must be obtained as a result 
of required fit testing under Sec. 20.1703(c)(6), is recommended by 
ANSI and is required under the new rule. A person would have to achieve 
a minimum of 1,000 on a fit test in order to use an APF of 100 in the 
field. Requiring a fit factor of 10 times the APF for negative pressure 
devices effectively limits intake and protects against any respirator 
leakage that might occur during workplace activities. A fit factor 
 500 is required for any positive pressure, continuous flow 
and pressure demand device. The proposed rule had stated a fit factor 
of 100. However, public comment suggested this number was too low, and 
OSHA rules also require 500.
    A new category of respirator, the loose-fitting facepiece, positive 
pressure (powered) air purifying type, is included in Appendix A to 
Part 20. An APF of 25 is assigned to this new device in accordance with 
ANSI Z88.2-1992.
    The half facepiece and the full facepiece air-line respirators 
operating in demand mode were listed in the proposed rule with APFs 
unchanged at 5. In order to be consistent with ANSI and with public 
comment, the APFs for these two devices have been changed. The new APF 
for the half facepiece is 10, and the APF for the full facepiece is 
100. The NRC believes that supplied-air respirators operating in the 
demand mode should be used with great care in nuclear applications. 
Because they are very similar in appearance to more highly effective 
devices (continuous flow and pressure-demand supplied air respirators), 
they might mistakenly be used instead of the more protective devices.
    The APFs for half- and full-facepiece air-line respirators 
operating on continuous flow are reduced from 1,000 to 50 and from 
2,000 to 1,000 respectively. The APF for a full facepiece air-line 
respirator operating in pressure-demand mode is reduced from 2,000 to 
1,000. These changes are based on ANSI recommendations and the results 
of field and laboratory experiences indicating that these devices are 
not as effective as originally thought. This change is expected to have 
little impact on licensees because typical workplace concentrations 
encountered are far less than 1000 times the derived air concentrations 
(DACs). However, licensees may apply for higher APFs if needed and 
justified. A half-mask air-line respirator operating in pressure-demand 
mode is added to Appendix A with an APF of 50 based on ANSI 
recommendations. The helmet/hood air-line respirator operating under 
continuous flow is retained with the APF listed as 1,000. Footnote h 
which specified NIOSH certification criteria for flow rates is removed. 
The criteria for air flow rates are part of the NIOSH approval and are 
addressed in the revision to NUREG-0041.
    The new loose-fitting facepiece design is also included as an air-
line respirator operating under continuous flow. This device is 
assigned an APF of 25 in Appendix A consistent with ANSI 
recommendations.
    The air-line atmosphere-supplied suit is not assigned an APF. These 
devices have been used with no APF for many years in radiological 
environments, such as control rod drive removal at boiling

[[Page 54554]]

water reactors. These devices are primarily used as contamination 
control devices, but they are supplied with breathing air. No worker 
safety problems are known to have occurred at nuclear power plants or 
other NRC licensees that would disallow use of these devices. The NRC 
is allowing the use of non-NIOSH-approved suits but wearers are 
required to meet all other respirator program requirements in 
Sec. 20.1703 except the need for a fit test. Licensees have an option 
to apply to the Commission for higher APFs for these devices in 
accordance with Sec. 20.1703(b). Requirements for standby rescue 
persons apply to operations where these devices are used 
(Sec. 20.1703(f)).
    In Appendix A to Part 20, APFs for SCBA devices remain unchanged 
except for those operating in demand or demand recirculating modes. 
APFs for these two devices have been changed from 5 to 100 to be 
consistent with ANSI and in response to public comment. Use of SCBA in 
demand open circuit and demand recirculating mode requires considerable 
caution. The chance of facepiece leakage when operating in the negative 
pressure mode is considerably higher than when operating in a positive 
pressure mode. This is especially critical for devices that could be 
mistakenly used in immediately dangerous to life and health (IDLH) 
areas during emergency situations. Although ANSI lists relatively high 
APFs for these devices, they are not recommended by the NRC for use and 
acceptable alternative devices are readily available. Footnote h 
requires that controls be implemented to assure that these devices are 
not used in IDLH areas.
    A specific statement is added in footnote f, to exclude radioactive 
noble gases from consideration as an inhalation hazard and advising 
that external (submersion) dose considerations should be the basis for 
protective actions. DAC values are listed for each noble gas isotope. 
This has led some licensees to inappropriately base respirator 
assignments in whole or in part on the presence of these gases. The 
requirement for monitoring external dose can be found in 10 CFR 
20.1502.

IV. Issue of Compatibility for Agreement States

    In accordance with the Policy Statement on Adequacy and 
Compatibility of Agreement State Programs published September 3, 1997 
(62 FR 46517) and implementing procedures, the modifications to 
Sec. 20.1701 through Sec. 20.1703 (except 20.1703(c)(4)), have health 
and safety significance and Agreement States should adopt the essential 
objectives of these rule modifications. Therefore, these provisions are 
assigned to the ``Health and Safety (H&S)'' category. The definitions 
(added to Sec. 20.1003), of Air purifying respirator, Atmosphere-
supplying respirator, Assigned Protection Factor (APF), Demand 
respirator, Disposable respirator, Fit factor, Fit test, Filtering 
facepiece (dust mask), Helmet, Hood, Loose-fitting facepiece, Negative 
pressure respirator, Positive pressure respirator, Powered air-
purifying respirator, Pressure demand respirator, Qualitative fit test, 
Quantitative fit test, Self-contained breathing apparatus, Supplied-air 
respirator, Tight-fitting facepiece, and User seal check (fit check), 
because of their precise operational meanings, are designated as 
compatibility category B to help insure effective communication and to 
promote a common understanding for licensees who operate in multiple 
jurisdictions. Therefore, Agreement States should adopt definitions 
that are essentially identical to those of NRC.
    Sec. 20.1703(c)(4) and Sec. 20.1704, which address requirements for 
written procedures, and imposition of additional restrictions on the 
use of respiratory protection, respectively, are designated as 
compatibility category D.
    Appendix A to 10 CFR Part 20, and Sec. 20.1705 which permits 
applying for the use of higher APFs on a case by case basis, are 
designated as compatibility category B. Consistency is required in APFs 
that are established as acceptable in NRC and Agreement State 
regulations to reduce impacts on licensees who may operate in multiple 
jurisdictions.

V. Finding of No Significant Environmental Impact: Availability

    The NRC has determined under the National Environmental Policy Act 
of 1969, as amended, and the Commission's regulations in Subpart A of 
10 CFR Part 51, that the amendments are not a major Federal action 
significantly affecting the quality of the human environment and 
therefore, an environmental impact statement is not required.
    The amendments make technical and procedural improvements in the 
use of respiratory protection devices to maintain total occupational 
dose as low as is reasonably achievable. None of the impacts associated 
with this rulemaking have any effect on any places or entities outside 
of a licensed site. An effect of this rulemaking is expected to be a 
decrease in the use of respiratory devices and an increase in 
engineering and other controls to reduce airborne contaminants. It is 
expected that there would be no change in radiation dose to any member 
of the public as a result of the revised regulation.
    The determination of this environmental assessment is that there 
will be no significant offsite impact to the public from this action. 
Therefore, in accord with its commitment to complying with Executive 
Order 12898--Federal Actions to Address Environmental Justice in 
Minority Populations and Low-Income Populations, dated February 11, 
1994, in all its actions, the NRC has also determined that there are no 
disproportionate, high, and adverse impacts on minority and low-income 
populations. The NRC uses the following working definition of 
``environmental justice'': the fair treatment and meaningful 
involvement of all people, regardless of race, ethnicity, culture, 
income, or educational level with respect to the development, 
implementation, and enforcement of environmental laws, regulations, and 
policies.
    The NRC requested public comments and the views of the States on 
the environmental assessment for this rule. No comments were received 
that addressed changes to the environmental assessment.
    The environmental assessment is available for inspection at the NRC 
Public Document Room, 2120 L Street, NW. (Lower Level), Washington, DC.

VI. Paperwork Reduction Act Statement

    This final rule decreases the burden on licensees by eliminating 
reporting requirements in Sec. 20.1703(a)(4) and (d). The burden 
reduction for this information collection is estimated to be 250 hours 
annually. Because the burden reduction for this information collection 
is insignificant, compared to the overall burden of 10 CFR Part 20, 
Office of Management and Budget (OMB) clearance is not required. 
Existing requirements were approved by the Office of Management and 
Budget, approval number 3150-0014.

VII. Public Protection Notification

    If a means used to impose an information collection does not 
display a currently valid OMB control number, the NRC may not conduct 
or sponsor, and a person is not required to respond to, the information 
collection.

VIII. Regulatory Analysis

    The NRC has prepared a regulatory analysis for the amendments. The 
analysis examines the benefits and impacts considered by the NRC. The 
regulatory analysis is available for

[[Page 54555]]

inspection at the NRC Public Document Room at 2120 L Street NW. (Lower 
Level), Washington, DC.

IX. Regulatory Flexibility Certification

    As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 
605(b), the NRC certifies that, this rule will not have a significant 
economic impact on a substantial number of small entities. The 
anticipated impact of the changes will not be significant because the 
revised regulation basically represents a continuation of current 
practice. The benefit of the rule is that it provides relief from 
certain reporting and recordkeeping requirements, incorporates several 
ANSI recommendations for improved programmatic procedures, and permits 
the use of new, effective respiratory devices, thus increasing licensee 
flexibility.

X. Backfit Analysis

    Although the NRC staff has concluded that some of the changes being 
made constitute a reduction in burden, the implementation of these and 
other changes will require revisions to licensee procedures 
constituting a backfit under 10 CFR 50.109(a)(1), 72.62(a)(2), and 
76.76(a)(1). However, because the rule incorporates national consensus 
standard (ANSI) recommendations that are worker safety related, the NRC 
staff believes that this rule constitutes a substantial increase in the 
overall protection of public health and safety that is cost justified.
    The Regulatory Analysis that was prepared for this rule concluded 
that the rule would result in a net benefit to industry of about $1.5 
million dollars per year, including the cost of revising procedures. 
The largest savings result from eliminating the need for a written 
policy statement and permitting the use of disposable, filtering 
facepieces instead of more expensive respirators. For most of the other 
changes made in this final rule, the costs of implementing the change 
are equal to the estimated cost savings. The Regulatory Analysis 
further concludes that compared to the practice under the current Part 
20, Subpart H, each change either involves no change in value/impact, 
or represents an improvement in regulatory protection of worker health 
and safety without any significant added costs (i.e., all value), or 
presents the potential for reductions in regulatory burden and/or 
increased operational flexibility with net savings to licensees and the 
NRC.
    Many of the changes only clarify existing requirements (i.e., 
reduce the potential for licensee misunderstandings) or formally adopt 
recommendations of the current ANSI standard Z88.2-1992.
    Section III in this FR Notice, Summary of Changes, summarizes the 
changes to Subpart H of 10 CFR Part 20. The reasons for making these 
changes are also provided. Many of the changes are considered by the 
NRC to constitute a substantial worker safety enhancement in that they 
reflect new consensus technical guidance published by the American 
National Standards Institute (ANSI) on respiratory protection developed 
since 10 CFR Part 20, Subpart H was published. The changes include 
recognizing new respirator designs and types that were not available 20 
years ago, changing the assigned protection factors (APFs) based on new 
data, deleting certain reporting requirements which are considered no 
longer needed for oversight of a mature industry, and numerous 
procedural improvements that have been developed and proven by 
respiratory practitioners.
    Permitting the use of disposable, filtering facepieces, for 
example, accommodates workers who voluntarily use respiratory 
protection when it is not needed. These devices provide some 
respiratory protection, do not impose stress or breathing resistance on 
workers as do more cumbersome designs, and when credit is not being 
taken for their use, do not require medical screening or fit testing.
    Current NRC regulations list APFs that are inconsistent with 
current national consensus standards. APFs are used to select types of 
respirators to provide needed degree of protection, and to estimate the 
intake and internal dose workers might receive. The new, and correct, 
APFs will provide a substantial increase in worker protection.
    Deleting two paperwork requirements that are no longer considered 
useful or needed will permit resources to be redirected to more 
important safety matters.
    Incorporation of the ANSI fit test criteria provides a needed 
safety margin that protects against deteriorating conditions in the 
workplace that affect facepiece seal.
    The rule also leads to greater uniformity of practice in that the 
new requirements are consistent with the general respiratory protection 
regulations published recently by OSHA. NRC licensees are often subject 
to OSHA respiratory protection regulations when the intent is to 
protect workers against non-radiological inhalation hazards. This final 
rule would not require a licensee to maintain two distinct programs, 
and only minor differences exist between the OSHA requirements and this 
final rule.
    In addition the new rules provide greater flexibility in practice 
in that several new devices are now approved for use. Numerous 
prescriptive requirements are deleted because they are redundant or no 
longer needed. The Assigned Protection Factors currently in Appendix A 
of 10 CFR Part 20 are incorrect; some are too conservative and others 
might underprotect the worker. This rule corrects the APFs in the NRC 
regulations according to the national consensus standard 
recommendations of ANSI.
    In conclusion, the Commission believes that for quantitative and 
qualitative reasons, this rule change constitutes a burden reduction 
and a substantial increase in the overall protection of public (worker) 
health and safety that is cost justified.

XI. Small Business Regulatory Enforcement Fairness Act

    In accordance with the Small Business Regulatory Enforcement 
Fairness Act of 1996, the NRC has determined that this action is not a 
major rule and has verified this determination with the Office of 
Information and Regulatory Affairs of OMB.

XII. Voluntary Consensus Standards

    The National Technology Transfer and Advancement Act of 1995, 
Public Law 104-113, requires that Federal agencies use technical 
standards that are developed or adopted by voluntary consensus 
standards bodies unless the use of such a standard is inconsistent with 
applicable law or otherwise impractical. In this final rule the NRC is 
using recommendations from the following voluntary consensus standard, 
``American National Standard for Respiratory Protection,'' (ANSI 
Z88.2), American National Standards Institute, 1992.

List of Subjects in 10 CFR Part 20

    Byproduct material, Licensed material, Nuclear materials, Nuclear 
power plants and reactors, Occupational safety and health, Packaging 
and containers, Penalty, Radiation protection, Reporting and recording 
requirements, Special nuclear material, Source material, Waste 
treatment and disposal.

    For the reasons set out in the preamble and under the authority of 
the Atomic Energy Act of 1954, as amended, the Energy Reorganization 
Act of 1974, as amended, and 5 U.S.C. 552 and 553, the NRC is adopting 
the following amendments to 10 CFR Part 20.

[[Page 54556]]

PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION

    1. The authority citation for Part 20 continues to read as follows:

    Authority: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68 
Stat. 930, 933, 935, 936, 937, 948, 953, 955, as amended (42 U.S.C. 
2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236), secs. 201, as 
amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (U.S.C. 
5841, 5842, 5846).

    2. Section 20.1003 is amended by adding the definitions Air-
purifying respirator, Assigned protection factor (APF), Atmosphere-
supplying respirator, Demand respirator, Disposable respirator, 
Filtering facepiece (dust mask), Fit factor, Fit test, Helmet, Hood, 
Loose-fitting facepiece, Negative pressure respirator, Positive 
pressure respirator, Powered air-purifying respirator (PAPR), Pressure 
demand respirator, Qualitative fit test (QLFT), Quantitative fit test 
(QNFT), Self-contained breathing apparatus (SCBA), Supplied-air 
respirator (SAR) or airline respirator, Tight-fitting facepiece and 
User seal check (fit check) (in alphabetical order) to read as follows:


Sec. 20.1003  Definitions.

* * * * *
    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) means the expected workplace level 
of respiratory protection that would be provided by a properly 
functioning respirator or a class of respirators to properly fitted and 
trained users. Operationally, the inhaled concentration can be 
estimated by dividing the ambient airborne concentration by the APF.
    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.
* * * * *
    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.
* * * * *
    Disposable respirator means a respirator for which maintenance is 
not intended and that is designed to be discarded after excessive 
breathing resistance, sorbent exhaustion, physical damage, or end-of-
service-life renders it unsuitable for use. Examples of this type of 
respirator are a disposable half-mask respirator or a disposable 
escape-only self-contained breathing apparatus (SCBA).
* * * * *
    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, not equipped with elastomeric sealing surfaces and adjustable 
straps.
    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.
* * * * *
    Helmet means a rigid respiratory inlet covering that also provides 
head protection against impact and penetration.
* * * * *
    Hood means a respiratory inlet covering that completely covers the 
head and neck and may also cover portions of the shoulders and torso.
* * * * *
    Loose-fitting facepiece means a respiratory inlet covering that is 
designed to form a partial seal with the face.
* * * * *
    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.
* * * * *
    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 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.
* * * * *
    Self-contained breathing apparatus (SCBA) means an atmosphere-
supplying respirator for which the breathing air source is designed to 
be carried by the user.
* * * * *
    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.
* * * * *
    Tight-fitting facepiece means a respiratory inlet covering that 
forms a complete seal with the face.
* * * * *
    User seal check (fit check) means an action conducted by the 
respirator user to determine if the respirator is properly seated to 
the face. Examples include negative pressure check, positive pressure 
check, irritant smoke check, or isoamyl acetate check.
* * * * *

Subpart H--Respiratory Protection and Controls to Restrict Internal 
Exposure

    3. Section 20.1701 is revised to read as follows:


Sec. 20.1701  Use of process or other engineering controls.

    The licensee shall use, to the extent practical, process or other 
engineering controls (e.g., containment, decontamination, or 
ventilation) to control the concentration of radioactive material in 
air.
    4. Section 20.1702, is revised to read as follows:


Sec. 20.1702  Use of other controls.

    (a) When it is not practical to apply process or other engineering 
controls to control the concentrations of radioactive material in the 
air to values below those that define an airborne radioactivity area, 
the licensee shall, consistent with maintaining the total effective 
dose equivalent ALARA, increase monitoring and limit intakes by one or 
more of the following means--
    (1) Control of access;
    (2) Limitation of exposure times;
    (3) Use of respiratory protection equipment; or
    (4) Other controls.
    (b) If the licensee performs an ALARA analysis to determine whether 
or not respirators should be used, the licensee

[[Page 54557]]

may consider safety factors other than radiological factors. The 
licensee should also consider the impact of respirator use on workers' 
industrial health and safety.
    5. Section 20.1703 is revised to read as follows:


Sec. 20.1703  Use of individual respiratory protection equipment.

    If the licensee assigns or permits the use of respiratory 
protection equipment to limit the intake of radioactive material,
    (a) The licensee shall use only respiratory protection equipment 
that is tested and certified by the National Institute for Occupational 
Safety and Health (NIOSH) except as otherwise noted in this part.
    (b) If the licensee wishes to use equipment that has not been 
tested or certified by NIOSH, or for which there is no schedule for 
testing or certification, the licensee shall submit an application to 
the NRC for authorized use of this equipment except as provided in this 
part. The application must include evidence that the material and 
performance characteristics of the equipment are capable of providing 
the proposed degree of protection under anticipated conditions of use. 
This must be demonstrated either by licensee testing or on the basis of 
reliable test information.
    (c) The licensee shall implement and maintain a respiratory 
protection program that includes:
    (1) Air sampling sufficient to identify the potential hazard, 
permit proper equipment selection, and estimate doses;
    (2) Surveys and bioassays, as necessary, to evaluate actual 
intakes;
    (3) Testing of respirators for operability (user seal check for 
face sealing devices and functional check for others) immediately prior 
to each use;
    (4) Written procedures regarding--
    (i) Monitoring, including air sampling and bioassays;
    (ii) Supervision and training of respirator users;
    (iii) Fit testing;
    (iv) Respirator selection;
    (v) Breathing air quality;
    (vi) Inventory and control;
    (vii) Storage, issuance, maintenance, repair, testing, and quality 
assurance of respiratory protection equipment;
    (viii) Recordkeeping; and
    (ix) Limitations on periods of respirator use and relief from 
respirator use;
    (5) Determination by a physician that the individual user is 
medically fit to use respiratory protection equipment; before
    (i) The initial fitting of a face sealing respirator;
    (ii) Before the first field use of non-face sealing respirators, 
and
    (iii) Either every 12 months thereafter, or periodically at a 
frequency determined by a physician.
    (6) Fit testing, with fit factor  10 times the APF for 
negative pressure devices, and a fit factor  500 for any 
positive pressure, continuous flow, and pressure-demand devices, before 
the first field use of tight fitting, face-sealing respirators and 
periodically thereafter at a frequency not to exceed 1 year. Fit 
testing must be performed with the facepiece operating in the negative 
pressure mode.
    (d) The licensee shall advise each respirator user that the user 
may leave the area at any time for relief from respirator use in the 
event of equipment malfunction, physical or psychological distress, 
procedural or communication failure, significant deterioration of 
operating conditions, or any other conditions that might require such 
relief.
    (e) The licensee shall also consider limitations appropriate to the 
type and mode of use. When selecting respiratory devices the licensee 
shall provide for vision correction, adequate communication, low 
temperature work environments, and the concurrent use of other safety 
or radiological protection equipment. The licensee shall use equipment 
in such a way as not to interfere with the proper operation of the 
respirator.
    (f) Standby rescue persons are required whenever one-piece 
atmosphere-supplying suits, or any combination of supplied air 
respiratory protection device and personnel protective equipment are 
used from which an unaided individual would have difficulty extricating 
himself or herself. The standby persons must be equipped with 
respiratory protection devices or other apparatus appropriate for the 
potential hazards. The standby rescue persons shall observe or 
otherwise maintain continuous communication with the workers (visual, 
voice, signal line, telephone, radio, or other suitable means), and be 
immediately available to assist them in case of a failure of the air 
supply or for any other reason that requires relief from distress. A 
sufficient number of standby rescue persons must be immediately 
available to assist all users of this type of equipment and to provide 
effective emergency rescue if needed.
    (g) Atmosphere-supplying respirators must be supplied with 
respirable air of grade D quality or better as defined by the 
Compressed Gas Association in publication G-7.1, ``Commodity 
Specification for Air,'' 1997 and included in the regulations of the 
Occupational Safety and Health Administration (29 CFR 
1910.134(i)(1)(ii)(A) through (E). Grade D quality air criteria 
include--
    (1) Oxygen content (v/v) of 19.5-23.5%;
    (2) Hydrocarbon (condensed) content of 5 milligrams per cubic meter 
of air or less;
    (3) Carbon monoxide (CO) content of 10 ppm or less;
    (4) Carbon dioxide content of 1,000 ppm or less; and
    (5) Lack of noticable odor.
    (h) The licensee shall ensure that no objects, materials or 
substances, such as facial hair, or any conditions that interfere with 
the face--facepiece seal or valve function, and that are under the 
control of the respirator wearer, are present between the skin of the 
wearer's face and the sealing surface of a tight-fitting respirator 
facepiece.
    (i) In estimating the dose to individuals from intake of airborne 
radioactive materials, the concentration of radioactive material in the 
air that is inhaled when respirators are worn is initially assumed to 
be the ambient concentration in air without respiratory protection, 
divided by the assigned protection factor. If the dose is later found 
to be greater than the estimated dose, the corrected value must be 
used. If the dose is later found to be less than the estimated dose, 
the corrected value may be used.
    6. Section 20.1704 is revised to read as follows:


Sec. 20.1704  Further restrictions on the use of respiratory protection 
equipment.

    The Commission may impose restrictions in addition to the 
provisions of Secs. 20.1702, 20.1703, and Appendix A to Part 20, in 
order to:
    (a) Ensure that the respiratory protection program of the licensee 
is adequate to limit doses to individuals from intakes of airborne 
radioactive materials consistent with maintaining total effective dose 
equivalent ALARA; and
    (b) Limit the extent to which a licensee may use respiratory 
protection equipment instead of process or other engineering controls.
    7. Section 20.1705 is added to subpart H as follows:


Sec. 20.1705  Application for use of higher assigned protection 
factors.

    The licensee shall obtain authorization from the Commission before 
using assigned protection factors in excess of those specified in 
Appendix

[[Page 54558]]

A to Part 20. The Commission may authorize a licensee to use higher 
assigned protection factors on receipt of an application that--
    (a) Describes the situation for which a need exists for higher 
protection factors; and
    (b) Demonstrates that the respiratory protection equipment provides 
these higher protection factors under the proposed conditions of use.
    8. Appendix A to Part 20 is revised to read as follows:

  Appendix A to Part 20.--Assigned Protection Factors for Respirators a
------------------------------------------------------------------------
                                                               Assigned
                                        Operating mode        Protection
                                                               Factors
------------------------------------------------------------------------
I. Air Purifying Respirators
 [Particulate b only] c:
    Filtering facepiece            Negative Pressure.......          (d)
     disposabled.
    Facepiece, half e............  Negative Pressure.......           10
    Facepiece, full..............  Negative Pressure.......          100
    Facepiece, half..............  Powered air-purifying              50
                                    respirators.
    Facepiece, full..............  Powered air-purifying            1000
                                    respirators.
    Helmet/hood..................  Powered air-purifying            1000
                                    respirators.
    Facepiece, loose-fitting.....  Powered air-purifying              25
                                    respirators.
II. Atmosphere supplying
 respirators [particulate, gases
 and vapors f]:
    1. Air-line respirator:
        Facepiece, half..........  Demand..................           10
        Facepiece, half..........  Continuous Flow.........           50
        Facepiece, half..........  Pressure Demand.........           50
        Facepiece, full..........  Demand..................          100
        Facepiece, full..........  Continuous Flow.........         1000
        Facepiece, full..........  Pressure Demand.........         1000
        Helmet/hood..............  Continuous Flow.........         1000
        Facepiece, loose-fitting.  Continuous Flow.........           25
        Suit.....................  Continuous Flow.........          (g)
    2. Self-contained breathing
     Apparatus (SCBA):
        Facepiece, full..........  Demand..................        i 100
        Facepiece, full..........  Pressure Demand.........     i 10,000
        Facepiece, full..........  Demand, Recirculating...        i 100
        Facepiece, full..........  Positive Pressure            i 10,000
                                    Recirculating.
III. Combination Respirators:
    Any combination of air-          Assigned protection factor for type
     purifying and atmosphere-         and mode of operation as listed
     supplying respirators.                        above.
------------------------------------------------------------------------
a These assigned protection factors apply only in a respiratory
  protection program that meets the requirements of this Part. They are
  applicable only to airborne radiological hazards and may not be
  appropriate to circumstances when chemical or other respiratory
  hazards exist instead of, or in addition to, radioactive hazards.
  Selection and use of respirators for such circumstances must also
  comply with Department of Labor regulations.
 Radioactive contaminants for which the concentration values in Table 1,
  Column 3 of Appendix B to Part 20 are based on internal dose due to
  inhalation may, in addition, present external exposure hazards at
  higher concentrations. Under these circumstances, limitations on
  occupancy may have to be governed by external dose limits.
b Air purifying respirators with APF <100 must be equipped with
  particulate filters that are at least 95 percent efficient. Air
  purifying respirators with APF = 100 must be equipped with particulate
  filters that are at least 99 percent efficient. Air purifying
  respirators with APFs >100 must be equipped with particulate filters
  that are at least 99.97 percent efficient.
c The licensee may apply to the Commission for the use of an APF greater
  than 1 for sorbent cartridges as protection against airborne
  radioactive gases and vapors (e.g., radioiodine).
d Licensees may permit individuals to use this type of respirator who
  have not been medically screened or fit tested on the device provided
  that no credit be taken for their use in estimating intake or dose. It
  is also recognized that it is difficult to perform an effective
  positive or negative pressure pre-use user seal check on this type of
  device. All other respiratory protection program requirements listed
  in Sec.  20.1703 apply. An assigned protection factor has not been
  assigned for these devices. However, an APF equal to 10 may be used if
  the licensee can demonstrate a fit factor of at least 100 by use of a
  validated or evaluated, qualitative or quantitative fit test.
e Under-chin type only. No distinction is made in this Appendix between
  elastomeric half-masks with replaceable cartridges and those designed
  with the filter medium as an integral part of the facepiece (e.g.,
  disposable or reusable disposable). Both types are acceptable so long
  as the seal area of the latter contains some substantial type of seal-
  enhancing material such as rubber or plastic, the two or more
  suspension straps are adjustable, the filter medium is at least 95
  percent efficient and all other requirements of this Part are met.
f The assigned protection factors for gases and vapors are not
  applicable to radioactive contaminants that present an absorption or
  submersion hazard. For tritium oxide vapor, approximately one-third of
  the intake occurs by absorption through the skin so that an overall
  protection factor of 3 is appropriate when atmosphere-supplying
  respirators are used to protect against tritium oxide. Exposure to
  radioactive noble gases is not considered a significant respiratory
  hazard, and protective actions for these contaminants should be based
  on external (submersion) dose considerations.
g No NIOSH approval schedule is currently available for atmosphere
  supplying suits. This equipment may be used in an acceptable
  respiratory protection program as long as all the other minimum
  program requirements, with the exception of fit testing, are met
  (i.e., Sec.  20.1703).
h The licensee should implement institutional controls to assure that
  these devices are not used in areas immediately dangerous to life or
  health (IDLH).
i This type of respirator may be used as an emergency device in unknown
  concentrations for protection against inhalation hazards. External
  radiation hazards and other limitations to permitted exposure such as
  skin absorption shall be taken into account in these circumstances.
  This device may not be used by any individual who experiences
  perceptible outward leakage of breathing gas while wearing the device.


[[Page 54559]]

    Dated at Rockville, Maryland this 30th day of September, 1999.

    For the Nuclear Regulatory Commission.
Andrew L. Bates,
Acting Secretary of the Commission.
[FR Doc. 99-25977 Filed 10-6-99; 8:45 am]
BILLING CODE 7590-01-P