[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
