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[Federal Register Volume 63, Number 137 (Friday, July 17, 1998)]
[Proposed Rules]
[Pages 38511-38521]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19086]

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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: Proposed rule.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is proposing to amend 
its regulations regarding the use of respiratory protection and other 
controls to restrict internal exposure to radioactive material. The 
proposed amendments are intended to 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), and 
make the requirements less prescriptive without reducing worker 
protection. The proposed amendments would provide greater assurance 
that worker exposures 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 are thus clearly approved for use by licensees.

DATES: Submit comments by September 30, 1998. Comments received after 
this date will be considered if it is practical to do so, but the 
Commission is able to assure consideration only for comments received 
on or before this date.

ADDRESSES: Send comments to: Secretary, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, Attention: Rulemakings and 
Adjudications Staff.
    The NRC staff specifically requests comment on whether the 
technical aspects of the rule should be addressed through alternative 
approaches other than the proposed rule, such as a simple

[[Page 38512]]

performance-based rule with a Regulatory Guide endorsing ANSI standards 
to permit a more rapid regulatory response by the NRC to future 
technical developments and changes in industry consensus standards.
    In addition to comments on this proposed rule, the NRC staff 
requests specific comments and suggestions regarding the content and 
scope of a planned revision of NUREG-0041, ``Manual of Respiratory 
Protection Against Airborne Radioactive Materials.''
    Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland 
between 7:30 am and 4:15 pm Federal workdays.
    You may also provide comments via the NRC's interactive rulemaking 
web site through the NRC home page (http://www.nrc.gov). This site 
provides the availability to upload comments as files (any format), if 
your web browser supports that function. For information about the 
interactive rulemaking site, contact Ms. Carol Gallagher, (301) 415-
5905; e-mail [email protected]
    Certain documents related to this rulemaking, including comments 
received and the environmental assessment and finding of no significant 
impact, and NUREG-0041, may be examined at the NRC Public Document 
Room, 2120 L Street NW. (Lower Level), Washington, DC. These same 
documents also may be viewed and downloaded electronically via the 
interactive rulemaking website established by NRC for this rulemaking.
    Single copies of the environmental assessment and finding of no 
significant impact and the regulatory analysis may be obtained from 
Antoinette Walker, Office of Nuclear Reactor Regulation, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555, telephone: (301) 415-1282.
    Single copies of the draft revision of Regulatory Guide 8.15, 
``Acceptable Programs for Respiratory Protection,'' which is related to 
this rulemaking, may be obtained by writing to: U.S. Nuclear Regulatory 
Commission, Printing and Graphics Branch, Washington, DC 20555-0001; or 
by fax at (301) 415-5272.

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

    A major revision of 10 CFR Part 20, ``Standards for Protection 
Against Radiation,'' was published 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, minimal changes were 
made because an ANSI standard was being prepared that was expected to 
provide state-of-the-art guidance on acceptable respiratory protection 
devices and procedures. 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, 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, permitted correction of both 
high and low initial intake estimates if subsequent, more accurate 
bioassay 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, ANSI Z88.2-1992, ``American 
National Standard for Respiratory Protection'' was approved for 
publication by the American National Standards Institute. 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). Consistent with the publication of ANSI Z88.2-1992 the NRC is 
proposing these changes to Subpart H of Part 20 to make the regulations 
less prescriptive without reducing worker protection.

II. Summary of the Proposed Changes

    The Commission is proposing to amend Sec. 20.1003, Secs. 20.1701 
through 20.1704 in Subpart H, ``Respiratory Protection and Controls to 
Restrict Internal Exposure in Restricted Areas,'' of 10 CFR Part 20, 
and Appendix A to Part 20, ``Protection Factors for Respirators''.
    In Sec. 20.1003, Definitions, definitions are proposed for Assigned 
protection factor (APF), Disposable respirator, Fit check, Fit factor 
and Fit test. These added definitions are needed to add clarity to the 
proposed regulations at Secs. 20.1701 through Secs. 20.1705.
    In Sec. 20.1701, Use of process or other engineering controls, the 
word ``decontamination'' would be added to the list of examples of 
process or engineering controls that should be considered for 
controlling the concentration of radioactive material in air. The 
intent is to encourage licensees to 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 exposure instead of using 
respirators.
    Section 20.1702 would be revised by adding a footnote (2) to 
Sec. 20.1702(c) to clarify that if a licensee performs an ALARA 
analysis to determine whether or not respirators should be used, safety 
factors other than radiological may be taken into account. A reduction 
in the TEDE for a worker is not reasonably achievable if an attendant 
increase in the workers' industrial health and safety risk would exceed 
the benefit obtained by the reduction in the radiation risk. Regulatory 
Guide 8.15 (DG-8022) and NUREG-0041 will address in more detail how 
factors such as heat, discomfort, reduced vision, etc., associated with 
respirator use, might reduce efficiency or increase stress thereby 
increasing external dose or health risk. Considerable licensee judgment 
is necessary in determining an appropriate level of respiratory 
protection in many cases.
    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, it is the use of the respiratory protection device to limit 
intake of radioactive material and associated physiological stresses 
that would activate the requirements of Sec. 20.1703. Thus Sec. 20.1703 
can be viewed as defining the minimum respiratory protection program 
expected of any licensee who assigns or permits the use of respirators.
    In Sec. 20.1703(a), the phrase ``pursuant to Sec. 20.1702'' would 
be deleted. 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 air are already 
below values that define an airborne radioactivity area. This is not 
the case and the proposed Sec. 20.1703 should make it clear that, if a 
licensee uses respiratory protection equipment

[[Page 38513]]

``to limit intakes,'' the provisions of Sec. 20.1703 apply as a 
minimum.
    In Sec. 20.1703(a)(1), (proposed Sec. 20.1703(a)), licensees are 
permitted to use only respirators that have been tested and certified 
``or had certification extended'' by NIOSH. The words ``or had 
certification extended'' would be deleted because all these extensions 
have expired and no new extensions will be granted.
    In Sec. 20.1703(a)(2), (proposed Sec. 20.1703(b)), licensees are 
permitted to apply for authorization to use equipment that has not been 
tested or certified by NIOSH and ``has not had certification extended 
by NIOSH/MSHA.'' The words ``has not had certification extended by 
NIOSH/MSHA'' would be deleted because all these extensions have expired 
and no new extensions will be granted. The words ``to the NRC'' are 
added to make it clear that applications for authorized use of 
respiratory equipment are to be submitted to the Commission.
    In Sec. 20.1703(a)(3), (proposed Sec. 20.1703(c)), paragraphs 
(c)(1) through (5) are retained as presently codified with the 
exception of some minor editing and that paragraph (c)(4) would be 
reworded to improve clarity, reorder priorities, and bring together in 
one paragraph all of the elements of the required written procedures. 
Paragraph (c)(5) would be revised to clarify that the worker's medical 
evaluation for using non-face sealing respirators occurs prior to first 
field use rather than prior to first fitting (as required for tight 
fitting respirators) because fit testing is not needed for these types.
    A new Sec. 20.1703(c)(6) would be added to require fit testing 
prior to first field use of tight fitting, face sealing respirators and 
periodically thereafter. This proposed change would clarify when and 
how often fit testing is required. The licensee would specify a 
frequency of retest in the procedures, not to exceed 3 years. This 
differs from the ANSI recommendation of annual fit testing. The NRC 
believes that if a licensee is alert to physiological changes that 
might affect an individual's ability to wear a respirator safely, 
annual fit testing is an excessive burden. A requirement to wear 
properly fitted respirators is currently in the footnotes to Appendix A 
to Part 20 and would be moved to the body of the rule. Several general 
programmatic requirements currently found in footnotes to Appendix A to 
Part 20 would be moved to the text of the rule where they more 
appropriately belong and to ensure that they are not overlooked by 
licensees.
    The new Sec. 20.1703(c)(6) would also codify existing NRC staff 
guidance and ANSI recommendations regarding the test ``fit factors'' 
that must be achieved in order to use the APFs and the frequency of fit 
testing. Specifically, fit testing with ``fit factors'' 10 
times the APF would be required for negative pressure devices. A fit 
factor 100 would be required for all tight fitting face 
pieces used with positive pressure, continuous flow, and pressure-
demand devices. 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.
    The proposed Sec. 20.1703(c)(6) would also require retesting at a 
frequency not to exceed 3 years. Guidance in the proposed revision of 
Regulatory Guide 8.15 (DG-8022) on the frequency of fit testing 
suggests a retest period not to exceed 3 years. Currently, most 
licensees perform annual fit testing. The proposed 3-year retesting 
does not agree with the ANSI recommendation for annual retesting. The 
NRC believes that a 3-year interval between fit tests is adequate to 
protect workers under normal circumstances, given adequate surveillance 
of workers for physiological changes. Regulatory Guide 8.15 discusses 
what constitutes an adequate surveillance program, including being 
alert to circumstances such as significant weight loss or gain, facial 
changes, etc., that would suggest more frequent fit testing. Transient 
workers might require more frequent retesting because continuous 
monitoring for physiological changes is impracticable.
    The current Sec. 20.1703(a)(4), which lists requirements for 
licensees to issue a written policy statement, would be deleted because 
the NRC believes that this policy statement is not needed. This change 
is proposed because all of the elements 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 proposed 
Sec. 20.1703(c)(4)).
    Section 20.1703(a)(6) would become Sec. 20.1703(e) and would be 
clarified and expanded to emphasize the existing requirements that 
provisions be made for vision correction, adequate communications, and 
low-temperature work environments. In order to comply with these 
requirements, a licensee would need to take into account 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 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 would be 
added to the proposed Sec. 20.1703(e). For example, 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 face piece 
respirator is another problem that can be caused by low temperature.
    The reference to skin protection currently found in 
Sec. 20.1703(a)(6) would be deleted in the proposed Sec. 20.1703(e). 
The NRC does not consider skin protection 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 for example in 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 facelets instead of respirators or decontamination should be 
considered. Facial contamination may result in a less significant dose 
than that received as a result of respirator use or prior 
decontamination of the area.
    A new Sec. 20.1703(f) would be added to bring a requirement for 
standby rescue persons, currently found in a footnote in Appendix A to 
Part 20, into the rule. This new paragraph would retain a requirement 
for the presence of standby rescue persons 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 unassisted. Standby rescue workers would 
also need to be in direct communication with such workers, be equipped 
with appropriate protective clothing and devices, and be immediately 
available to provide needed assistance in the event that the air supply 
fails. Without continuous air supply, unconsciousness can occur within 
seconds.
    A new Sec. 20.1703(g) would move a requirement from a footnote in 
Appendix A to Part 20, into the rule. This section would specify the 
minimum quality of supplied breathing air, as defined by the Compressed 
Gas Association (CGA) in their publication G-7.1, ``Commodity 
Specification for

[[Page 38514]]

Air,'' 1989 (ANSI-CGA G-7.1, 1989), that must be provided whenever 
atmosphere-supplying respirators are used. This change to recognizing 
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 
proposed rule.
    A new Sec. 20.1703(h) is added to clarify and move a requirement 
from the footnotes of Appendix A to Part 20, into the rule. This 
section prohibits the use of respirators whenever any material or 
substance might 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 and/or proper operation of the respirator.
    Currently, Sec. 20.1703(b)(1) discusses selection of respiratory 
protection equipment so that protection factors are adequate to reduce 
intake. This paragraph permits selection of less protective devices if 
that would result in optimizing TEDE. The NRC believes that this 
requirement is redundant with the requirement to be ALARA. These 
recommendations are being removed and will be discussed in the revised 
Regulatory Guide 8.15.
    The remainder of Sec. 20.1703(b)(1) would become Sec. 20.1703(i) 
and be revised to incorporate the new ANSI terminology for ``assigned 
protection factor'' and to retain the provision for changing intake 
estimates if later, more accurate bioassay measurements show that 
exposure was greater or less than initially estimated.
    Current Sec. 20.1703(b)(2), specifying procedures for applying to 
the NRC to use higher APFs, is renumbered as Sec. 20.1705.
    Current Sec. 20.1703(c) would be removed because it requires 
licensees to use as emergency devices only respiratory protection 
equipment that has been specifically certified or had certification 
extended for emergency use by NIOSH. This approval category no longer 
exists. Acceptable types of emergency and escape equipment will be 
discussed in the revisions of Regulatory Guide 8.15 and NUREG-0041. 
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 considered redundant.
    Current Sec. 20.1703(d) would be deleted. This section currently 
requires a licensee to notify in writing the director of the 
appropriate NRC Regional Office at least 30 days before the date that 
respiratory protection equipment is first used under the provisions of 
either current Sec. 20.1703(a) or (b). All licensees who possess 
radioactive material in a form that requires a respiratory protection 
program are identified 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 proposed change is considered to be a burden 
reduction.
    Section 20.1704(a) would be revised to clarify that ALARA 
considerations are included in any restrictions imposed by the 
Commission in addition to those found in Secs. 20.1702, 20.1703, and 
Appendix A to Part 20 on the use of respiratory protection equipment 
for the purpose of limiting exposures of individuals to airborne 
radioactive materials.
    Appendix A to Part 20--``Protection Factors (PF) for Respirators,'' 
would be 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 would be 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 would be 
removed. Generic regulatory requirements, previously contained in 
footnotes in Appendix A to Part 20 would be moved to the codified text 
of Part 20.
    The column headed ``Tested and Certified Equipment,'' would be 
deleted. 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 will be provided in the revision to NUREG-
0041.
    Current footnote a to Appendix A to Part 20 would be deleted 
because it is considered to be redundant with air sampling requirements 
and requirements for estimating possible airborne concentration 
addressed in the proposed rule at Sec. 20.1703(c)(1) and 
Sec. 20.1703(i).
    Current footnote b, which permits the use of devices only when 
nothing interferes with the seal of a face piece, would be moved to the 
codified text at Sec. 20.1703(h).
    Current footnote c, which defines the symbols for modes of 
operation would be revised to fit the new list of respiratory devices 
in Appendix A to Part 20 consistent with ANSI Z88.2-1992 and become 
footnote b.
    Current footnote d.1 would be removed because the essential 
information regarding the meaning and use of APF is found in the 
proposed rule at Sec. 20.1703(i). Further guidance regarding the 
application and limitation of APFs would be provided in the revisions 
of Regulatory Guide 8.15 and NUREG-0041.
    Current footnote d.2(a) states that APFs are only applicable for 
trained individuals who are properly fitted and for properly maintained 
respirators. This footnote is redundant with the current and proposed 
Sec. 20.1703 and would be removed. Adequate provisions for training, 
fit-testing, and equipment maintenance are found in the proposed rule 
at Sec. 20.1703(c)(4).
    Current footnote d.2(b) states 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 would be 
revised in proposed footnote c to say that if using a respirator with 
an APF greater than 100, a filter with a minimum efficiency of 99.97 
percent must be used. Further guidance will be provided in Regulatory 
Guide 8.15 and NUREG-0041. The definitions of filter types and 
efficiencies will be discussed in the revisions of Regulatory Guide 
8.15 and NUREG-0041.
    Current footnote d.2(c) states 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 would be made in 
the new proposed footnote d for licensees to apply to the Commission 
for the use of an APF greater than 1 for sorbent cartridges.
    Current footnote d.2(d) restates part of the NIOSH approval 
criteria for air quality for supplied air respirators and self-
contained breathing apparatus. This requirement would be changed to 
reflect the fact that air quality standards derive from ANSI's 
recognition of the Compressed Gas Association guidance, and moved to 
the rule at Sec. 20.1703(g). Air quality is discussed further in 
Regulatory Guide 8.15 and NUREG-0041.
    The current footnote e makes it clear that the APFs for atmosphere-
supplying respirators and self-contained breathing

[[Page 38515]]

apparatus are not applicable in the case of contaminants that present a 
skin absorption or submersion hazard. This statement would be retained 
in footnote d in the proposed 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 
stated. This correction would be made in footnote d of the proposed 
Appendix A to Part 20. A discussion of the basis for this change will 
be found in revised NUREG-0041.
    Current footnote f observes 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 would be 
deleted. Service life limitations are addressed in Regulatory Guide 
8.15 and NUREG-0041.
    The current footnote g addresses four issues. The first limits the 
use of half-mask face piece air purifying respirators to ``under-chin'' 
types only. This limitation would be retained as footnote (f) to the 
proposed new Appendix A to Part 20. The only type of face piece 
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 exhibit erratic 
face-sealing characteristics, especially when the wearer talks or moves 
his/her mouth.
    The second issue precludes this type of respirator if ambient 
airborne concentrations can reach instantaneous values greater than 10 
times the pertinent values in Table 1, Column 1 of Appendix B to Part 
20. Because respirator assignment is now based on TEDE, ALARA, and 
other consideration, this part of current footnote g would be deleted 
from the proposed footnote f.
    The third issue precludes 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 
proposes to remove it.
    Finally this footnote requires that this type mask be tested for 
fit (user seal check) before each use. This provision would be removed 
because the proposed Sec. 20.1703(c)(3) would require a user to perform 
a fit check (e.g., negative pressure check, positive pressure check, 
irritant smoke check) each time a respirator is used.
    Current footnote h provides 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 would be removed. However, these NIOSH requirements 
will be discussed in the revision to NUREG-0041.
    Current footnote I specifies 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 proposed 
revision of Appendix A to Part 20. Guidance on the use of these devices 
would be included in the revision to Regulatory Guide 8.15. Current 
footnote I also requires 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 would be deleted from the footnotes to Appendix 
A to Part 20 and moved to the body of the rule at Sec. 20.1703(f).
    Current footnote j states that NIOSH approval schedules are not 
available for atmosphere-supplying suits. This information and criteria 
for use of atmosphere supplying suits would be addressed in footnote g 
to the proposed Appendix A to Part 20. Note that an APF is not listed 
for these devices. Licensees would be permitted to apply to the 
Commission for the use of higher APFs in accordance with 
Sec. 20.1703(b).
    Current footnote k permits the full face piece self-contained 
breathing apparatus (SCBA), when operating in the pressure-demand mode, 
to be used as an emergency device in unknown concentrations. This 
provision would be retained in footnote I to the proposed Appendix A to 
Part 20 and full face piece SCBA operating in positive pressure, 
recirculating mode is added.
    Current footnote l requires quantitative fit testing with a leakage 
less than 0.02 percent for the use of full face piece, positive 
pressure, recirculating mode SCBA. This requirement would be removed 
from the rule to be consistent with ANSI guidance and addressed in the 
revision to Regulatory Guide 8.15.
    Current footnote l also states 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 would be retained in footnote I 
to the proposed Appendix A to Part 20.
    Current footnote l also requires that special training in the use 
of this type of 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 would be removed.
    Note 1 to the current Appendix A to Part 20 discusses conditions 
under which the protection factors in the appendix may be used, warns 
against assuming that listed devices are effective against chemical or 
respiratory hazards other than radiological hazards, and states the 
need to take into account applicable approvals of the U.S. Bureau of 
Mines/NIOSH when selecting respirators for nonradiological hazards. 
Note 1 would be retained as footnote (a) to the proposed Appendix A to 
Part 20 and would be revised to reference Department of Labor (DOL) 
regulations at 29 CFR 1910. The NRC believes that these conditions are 
essential to the safe use of APFs and that the DOL regulations are also 
applicable whenever other than radiological respiratory hazards are 
present.
    Note 2 to the current Appendix A to Part 20 warns 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 would be retained as the second paragraph of footnote 
a to the proposed Appendix A to Part 20.
    In the title of Appendix A to Part 20, and throughout the proposed 
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 face piece 
disposable respirators, disposables that do not have seal enhancing 
elastomeric components and are not equipped with two or more adjustable 
suspension straps would be permitted for use but would not have an APF 
assigned (i.e., no credit may be taken for their use). The NRC believes 
that without these components 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 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

[[Page 38516]]

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 
impracticable. However, for those licensees who would like to use the 
ANSI recommended APF of 10, proposed footnote e to Appendix A to Part 
20 would permit 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 appropriate 
because fit testing is an implicit component of the ANSI approval 
process.
    The half-mask face piece respirator would continue to be approved, 
but relatively new variations are referred to in the industry as 
``reusable,'' ``reusable-disposable,'' ``face-piece-filtering'' or 
``maintenance-free'' devices. In these devices, including those 
considered to be disposables, the filter medium may be an integral part 
of the face piece, is at least 99 percent efficient, and may not be 
replaceable. Also, the seal area is enhanced by the application of 
plastic or rubber to the face-to-face piece seal area and the 2 or more 
suspension straps are adjustable. These devices are acceptable to the 
NRC, are considered half masks, may be disposable, and would be given 
an APF=10, consistent with ANSI recommendations.
    The assigned protection factor for full face piece air purifying 
respirators operating in the negative pressure mode would be increased 
from 50 to 100. This change is consistent with ANSI recommendations and 
industry test results. The current Appendix A to Part 20 lists a 
protection factor of 50 because one design that was tested at Los 
Alamos in 1975 did not meet the PF 100 criterion. This device is no 
longer available.
    A fit factor of 10 times the APF for 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 would 
be required under the proposed rule; that is, 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. Use of a fit factor of 10 times the APF effectively 
limits internal dose and accounts for any respirator leakage that might 
occur during workplace activities. Fit factors of 10 times the APF were 
previously not required for such devices.
    A new category of respirator, the loose-fitting face piece, 
positive pressure (powered) air purifying type, would be included in 
the proposed Appendix A to Part 20. An APF of 25 would be assigned to 
this new device in accordance with ANSI Z88.2-1992.
    The half-mask and the full face piece air-line respirators 
operating in demand mode would be listed with APF unchanged at 5. 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-face piece air-line respirators 
operating on continuous flow would be reduced from 1,000 to 50 and from 
2,000 to 1,000 respectively. The APF for a full face piece air-line 
respirator operating in pressure-demand mode would be reduced from 
2,000 to 1,000. These changes are based on ANSI recommendations and the 
results of field measurements indicating that these devices are not as 
effective as originally thought. This change would 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 would 
be added to Appendix A with an APF of 50 based on ANSI recommendations. 
The helmet/hood air-line respirator operating under continuous flow 
would be retained with the APF listed as 1,000. Current footnote h 
which specifies NIOSH certification criteria for flow rates would be 
removed. The criteria for air flow rates are part of the NIOSH approval 
and would be addressed in the revision to NUREG-0041.
    The new loose fitting face piece design is also included as an air-
line respirator operating under continuous flow. This device would be 
assigned an APF of 25 in the proposed Appendix A to Part 20 consistent 
with ANSI recommendations.
    The air-line atmosphere-supplied suit would not be assigned an APF. 
These devices have been used for many years in radiological 
environments such as control rod drive removal at boiling water 
reactors with no APF. These devices are primarily used as contamination 
control devices, but they are supplied with air that the wearer 
breathes. No 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 would still have 
an option to apply to the Commission for higher APFs in accordance with 
proposed Sec. 20.1703(b). Requirements for standby rescue persons apply 
to these devices (Sec. 20.1703(f)).
    In the proposed Appendix A to Part 20, APFs for SCBA devices would 
remain unchanged. Use of SCBA in demand open circuit and demand 
recirculating mode requires considerable caution. In the NRC's view, 
the performance level and reliability of these devices is questionable. 
The chance of face piece 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 emergency situations. Although ANSI lists 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 immediately dangerous to life and health (IDLH) areas.
    In proposed footnote d, a specific statement would be added to 
exclude radioactive noble gases from consideration as an airborne 
hazard and advising that external (submersion) dose considerations 
should be the basis for protective actions. In the current rule, 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.
    The complete proposed changes to Part 20, Subpart H and Appendix A 
to Part 20 are presented in the codified text section of this document.

III. Issue of Compatibility for Agreement States

    In accordance with the new adequacy and compatibility policy and 
implementing procedures approved by the Commission on June 30, 1997, 
the proposed modifications to Secs. 20.1701 through 20.1703, and 
Sec. 20.1705 have health and safety significance and Agreement States 
should adopt the essential objectives of these rule modifications in 
order to maintain an adequate program. Therefore, these provisions are 
assigned to the ``Health and Safety (H&S)'' category. The proposed 
definition of Assigned

[[Page 38517]]

Protection Factor (APF) because of its precise operational meaning, is 
designated as compatibility category C to help insure effective 
communication. Therefore, Agreement States should adopt the essential 
objectives of this provision to avoid conflicts, duplication or gaps. 
The proposed definitions of Disposable respirator, Fit check, Fit 
factor and Fit test, are stated in general terms and are therefore 
designated as compatibility category D, not required for purposes of 
compatibility. Flexibility is also provided to States regarding 
Sec. 20.1704 in how they handle imposition of additional restrictions 
on the use of respiratory protection. Therefore, this provision is 
designated as compatability category D. Comments are specifically 
requested on whether assigning different compatibility categories to 
the proposed new definitions creates any implementation problems or 
inconsistencies.
    Appendix A to 10 CFR Part 20 is designated as compatibility 
category B because assigned protection factors (APFs) provide 
acceptable levels of protection to be afforded by respirators. 
Additionally, although Sec. 20.1705 permits applying for the use of 
higher APFs on a case by case basis, 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.
    These proposed amendments were provided to the Agreement States 
during the NRC staff review process via the use of the NRC rulemaking 
bulletin board and notification to the States of its availability. Two 
comments were received. One suggested assigning compatibility 
categories to the five new definitions, which has been done in this 
proposed rule. A second noted that removal of generic requirements from 
the footnotes to Appendix A greatly improved the rule.

IV. 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 proposed amendments, if adopted, would not be 
a major Federal action significantly affecting the quality of the human 
environment and therefore, an environmental impact statement is not 
required.
    The proposed amendment addresses 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 proposed 
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. Comments on any aspect of the environmental assessment may be 
submitted to the NRC as indicated under the ADDRESSES heading.
    The NRC has sent a copy of the environmental assessment and this 
proposed rule to every State Liaison Officer and requested their 
comments on the environmental assessment.
    The draft environmental assessment is available for inspection at 
the NRC Public Document Room, 2120 L Street, NW. (Lower Level), 
Washington, DC. Single copies of this document are available as 
indicated in the ADDRESSES heading.

V. Paperwork Reduction Act Statement

    This proposed rule contains amendments to reduce the information 
collection requirements contained in 10 CFR Part 20 that are considered 
to be insignificant (250 hours annually), when compared with the 
overall requirements of the CFR Part (210, 205 hours annually). NRC 
does not consider this reduction in the burden to be significant enough 
to trigger the requirements of the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501 et seq.). Existing requirements were approved by the Office 
of Management and Budget, approval number 3150-0014.

Public Protection Notification

    If 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.

VI. Regulatory Analysis

    The NRC has prepared a regulatory analysis for the proposed 
amendment. The analysis examines the benefits and impacts considered by 
the NRC. The regulatory analysis is available for inspection at the NRC 
Public Document Room at 2120 L Street NW. (Lower Level), Washington, 
DC. Single copies are available as indicated under the ADDRESSES 
heading.

VII. Regulatory Flexibility Certification

    As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 
605(b), the NRC certifies that, if adopted, this proposed rule would 
not have a significant economic impact on a substantial number of small 
entities. The anticipated impact of the proposed changes would not be 
significant because the revised regulation basically represents a 
continuation of current practice. The benefit of the proposed rule is 
that it would provide relief from certain reporting and recordkeeping 
requirements, incorporate several ANSI recommendations for improved 
programmatic procedures, and permit the use of new, effective 
respiratory devices, thus increasing licensee flexibility.
    The NRC is seeking public comment on the initial regulatory 
flexibility certification. The NRC is seeking comment particularly from 
small entities as defined under the NRC's size standards 10 CFR 2.810, 
as to how the proposed regulations would affect them and how the 
regulations may be implemented or otherwise modified to impose less 
stringent requirements on small entities while still adequately 
protecting the public health and safety. Any small entity subject to 
this regulation who determines that, because of its size, it is likely 
to bear a disproportionate adverse economic impact should offer 
comments that specifically discuss the following items:
    (a) The licensee's size and how the proposed regulation would 
result in a significant economic burden or whether the resources 
necessary to implement this amendment could be more effectively used in 
other ways to optimize public health and safety, as compared to the 
economic burden on a larger licensee;

[[Page 38518]]

    (b) How the proposed regulation could be modified to take into 
account the licensees' differing needs or capabilities;
    (c) The benefits that would accrue, or the detriments that would be 
avoided, if the proposed regulation were modified as suggested by the 
licensee;
    (d) How the proposed regulation, as modified, could more closely 
equalize the impact of NRC regulations or create more equal access to 
the benefits of Federal programs as opposed to providing special 
advantages to any individual or group; and
    (e) How the proposed regulation, as modified, would still 
adequately protect the public health and safety.
    The comments should be sent to the Secretary of the Commission, 
U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. ATTN: 
Rulemakings and Adjudications Staff. Hand deliver comments to 11555 
Rockville Pike, Rockville, Maryland, between 7:30 am and 4:15 pm 
Federal workdays.

VIII. Backfit Analysis

    Although the NRC staff has concluded that some of the changes being 
proposed constitute a reduction in burden, the implementation of these 
and other changes will require revisions to licensee procedures 
constituting a potential backfit under 10 CFR 50.109(a)(1). Under 
Sec. 50.109(a)(2), a backfit analysis is required unless the proposed 
rule meets one of the exceptions listed in Sec. 50.109(a)(4). This 
proposed rule meets the exception at Sec. 50.109(a)(4)(iii) in that it 
is redefining the level of adequate protection as regards the use of 
respirators for radiological protection.
    Section II, Summary of the Proposed Changes, summarizes the 
proposed changes to Subpart H of 10 CFR Part 20. The reasons for making 
these changes are also provided. Many of the proposed changes are 
considered by the NRC to constitute a redefinition of adequate level of 
protection 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.
    In conclusion, the Commission believes that the proposed changes 
constitute a burden reduction with the exception of the need to revise 
procedures to implement the requirements. The proposed changes also 
clearly redefine the level of adequate protection required for workers 
who use respiratory protection and are, therefore, the type of change 
for which a backfit analysis is not required under 
Sec. 50.109(a)(4)(iii).

List of Subjects in 10 CFR Part 20

    Byproduct material, Criminal penalties, Licensed material, Nuclear 
materials, Nuclear power plants and reactors, Occupational safety and 
health, Packaging and containers, 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. 553, the NRC is proposing to 
adopt the following amendments to 10 CFR Part 20.

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 (42 U.S.C. 
5841, 5842, 5846).

    2. Section 20.1003 is amended by adding the definitions Assigned 
protection factor (APF), Disposable respirator, Fit check, Fit factor, 
and Fit test to read as follows:

Sec. 20.1003  Definitions.

* * * * *
    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.
* * * * *
    Disposable respirator means a respirator for which maintenance is 
not intended and that is designed to be discarded after excessive 
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).
* * * * *
    Fit check (user seal check) means a performance check conducted by 
a respirator wearer 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.
    Fit factor means a quantitative measure of the fit of a particular 
respirator to a particular individual.
    Fit test means a test, quantitative or qualitative, to evaluate the 
fit of a respirator on an individual and to determine a fit factor.
* * * * *
    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 practicable, process or other 
engineering controls (e.g., containment, decontamination, or 
ventilation) to control the concentration of radioactive material in 
air.
    4. In Sec. 20.1702, paragraph (c) is revised to add the following 
footnote:

Sec. 20.1702  Use of other controls.

* * * * *
    (c) Use of respiratory protection equipment \2\; or
---------------------------------------------------------------------------

    \2\ If the licensee performs an ALARA analysis to determine 
whether or not respirators should be used, safety factors other than 
radiological may be taken into consideration and the impact of the 
use of respirators on workers industrial health and safety risk 
should be considered.
---------------------------------------------------------------------------

    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).
    (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

[[Page 38519]]

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 exposures;
    (2) Surveys and bioassays, as necessary, to evaluate actual 
intakes;
    (3) Testing of respirators with APFs for operability (fit check for 
face sealing devices and functional check for others) immediately prior 
to each use;
    (4) Written procedures regarding monitoring, including air sampling 
and bioassays; training of respirator users; fit testing; respirator 
selection; breathing air quality; inventory and control; storage, 
issuance, maintenance, repair, testing, and quality assurance of 
respiratory protection equipment; recordkeeping; and limitations on 
periods of respirator use and relief from respirator use;
    (5) Determination by a physician before the initial fitting of face 
sealing respirators, before the first field use of non-face sealing 
respirators, and either every 12 months thereafter, or periodically at 
a frequency determined by a physician, that the individual user is 
medically fit to use the respiratory protection equipment;
    (6) Fit testing, with fit factor 10 times the APF for 
negative pressure devices, and a fit factor 100 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 3 years.
    (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 use equipment, within limitations for type 
and mode of use and shall make provision for vision correction, 
adequate communication, low temperature work environments, and the 
concurrent use of other safety or radiological protection 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 be in direct communication with the workers and must 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 available to 
effectively assist all users of this type of equipment.
    (g) Whenever atmosphere-supplying respirators are used, they must 
be supplied with respirable air of grade D quality or better as defined 
by the Compressed Gas Association and endorsed by ANSI, in publication 
G-7.1, ``Commodity Specification for Air,'' 1989, (ANSI-CGA G-7.1, 
1989).
    (h) No material or substance, the presence or absence of which is 
under the control of the respirator wearer, may be present between the 
skin of the wearer's face and the sealing surface of a tight-fitting 
respirator facepiece.
    (i) In estimating the exposure of individuals to 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 exposure is later 
found to be greater than estimated, the corrected value must be used. 
If the exposure is later found to be less than estimated, 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 those in 
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 exposures of individuals to 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 read 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 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 protection factors                   
                                              ------------------------------------------------------------------
                 Description                                                                         Gases and  
                                                            Modes b                Particulate c     vapors d   
----------------------------------------------------------------------------------------------------------------
I. AIR PURIFYING RESPIRATORS:                                                                                   
    Single-use disposable e..................  NP                                            (e)                
    Facepiece, half mask f...................  NP                                             10                
    Facepiece, full..........................  NP                                            100                
    Facepiece, half mask.....................  PP                                             50                
    Facepiece, full..........................  PP                                           1000                
    Helmet/hood..............................  PP                                           1000                
    Facepiece, loose-fitting.................  PP                                             25                
II. ATMOSPHERE SUPPLYING RESPIRATORS:                                                                           

[[Page 38520]]

                                                                                                                
    1. Air-line respirator                                                                                      
        Facepiece, half mask.................  D                                               5               5
        Facepiece, half mask.................  CF                                             50              50
        Facepiece, half mask.................  PD                                             50              50
        Facepiece, full......................  D                                               5               5
        Facepiece, full......................  CF                                           1000           1,000
        Facepiece, full......................  PD                                           1000           1,000
        Helmet/hood..........................  CF                                           1000           1,000
        Facepiece, loose-fitting.............  CF                                             25              25
        Suit.................................  CF                                            (g)             (g)
    2. Self-contained breathing                                                                                 
        Apparatus (SCBA).....................                                                                   
        Facepiece, full......................  D                                            h 50            h 50
        Facepiece, full......................  PD                                       i 10,000        i 10,000
        Facepiece, full......................  RD                                           h 50            h 50
        Facepiece, full......................  RP                                       i 10,000        i 10,000
III. COMBINATION RESPIRATORS:                                                                                   
    Any combination of air-purifying and                                                                        
     atmosphere-supply respirators                                                                              
(1) Assigned protection factor for type and                                                                     
 mode of operation as listed 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 contained in 29 CFR 1910.                                                                         
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. The mode symbols are defined as follows:                                                                     
NP = negative pressure (air-purifying respirator)                                                               
PP = positive pressure (air-purifying respirator)                                                               
CF = continuous flow (supplied-air respirator)                                                                  
D = demand (supplied-air respirator)                                                                            
PD = pressure-demand (open circuit, supplied-air respirator)                                                    
RD = demand, recirculating (closed circuit SCBA)                                                                
RP = positive pressure, recirculating (closed circuit SCBA).                                                    
c. Air purifying respirators with APF  100 must be equipped with particulate filters that are at     
  least 99 percent efficient. Air purifying respirators with APF  100 must be equipped with          
  particulate filters that are at least 99.97 percent efficient.                                                
d. Excluding 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. The licensee may apply to
  the Commission for the use of an APF greater than 1 for sorbent cartridges as protection against airborne     
  radioactive gasses and vapors (e.g., radioiodine).                                                            
e. 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 fit 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.                                                                                        
f. 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 99 percent efficient and all other requirements of this part are    
  met.                                                                                                          
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 and 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 38521]]

    Dated at Rockville, Maryland this 13th day of July 1998.

    For the Nuclear Regulatory Commission.
John C. Hoyle,
Secretary of the Commission.
[FR Doc. 98-19086 Filed 7-16-98; 8:45 am]
BILLING CODE 7590-01-P
```