[Federal Register Volume 64, Number 194 (Thursday, October 7, 1999)]
[Rules and Regulations]
[Pages 54543-54559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-25977]
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NUCLEAR REGULATORY COMMISSION
10 CFR Part 20
RIN 3150-AF81
Respiratory Protection and Controls to Restrict Internal
Exposures
AGENCY: Nuclear Regulatory Commission.
ACTION: Final rule.
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SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its
regulations regarding the use of respiratory protection and other
controls to restrict intake of radioactive material. The amendments
make these regulations more consistent with the philosophy of
controlling the sum of internal and external radiation exposure,
reflect current guidance on respiratory protection from the American
National Standards Institute (ANSI), are consistent with recently
effective revisions to Occupational Safety and Health Administration
(OSHA's) respiratory protection rule, and make NRC requirements for
radiological protection less prescriptive while reducing unnecessary
regulatory burden without reducing worker protection. The amendments
provide greater assurance that worker dose will be maintained as low as
is reasonably achievable (ALARA) and that recent technological advances
in respiratory protection equipment and procedures are reflected in NRC
regulations and clearly approved for use by licensees.
EFFECTIVE DATE: February 4, 2000.
FOR FURTHER INFORMATION CONTACT: Alan K. Roecklein, Office of Nuclear
Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC
20555-0001, telephone (301) 415-3883; email [email protected]
SUPPLEMENTARY INFORMATION:
I. Background
The NRC published a major revision of 10 CFR Part 20, ``Standards
for Protection Against Radiation,'' on May 21, 1991 (56 FR 23360).
Although the NRC was aware that certain provisions of Subpart H and
Appendix A to Part 20 were out of date and did not reflect new
technology in respiratory devices and procedures, the NRC made minimal
changes in the May 21, 1991 final rule. The NRC was aware that an ANSI
standard was being prepared that was expected to provide state-of-the-
art guidance on acceptable respiratory protection devices and
procedures. Therefore, the NRC decided to address further revisions to
Subpart H and Appendix A to Part 20 when the ANSI guidance was
complete.
In response to public comments on the proposed 10 CFR Part 20, the
NRC made several changes to Subpart H in the May 21, 1991, final rule
to make it consistent with the new philosophy and science underlying
the new Part 20. The new Subpart H required that the practice of ALARA
apply to the sum of internal and external dose; addressed correction of
both high and low initial intake estimates if subsequent, more accurate
measurements gave different results; and clarified that a respiratory
protection program consistent with Subpart H is required whenever
respirators are used to limit intakes of radioactive material.
After 10 CFR Part 20 was revised, the American National Standards
Institute approved publication of ANSI Z88.2-1992, ``American National
Standard for Respiratory Protection''. This document provides an
authoritative consensus on major elements of an acceptable respiratory
protection program, including guidance on respirator selection,
training, fit testing, and assigned protection factors (APF). The NRC
is amending Subpart H of Part 20 to make the regulations less
prescriptive without reducing worker protection. This rule is
consistent with the 1992 ANSI guidance and is consistent with new
regulations on respiratory protection published by the Occupational
Safety and Health Administration (OSHA).
II. Analysis of Public Comments and Staff Response
The proposed rule was published for public comment in the Federal
Register July 17, 1998 (63 FR 38511). By mid-November seventeen letters
had been received from the public providing comments on the rule. One
letter was received from an Agreement State and
[[Page 54544]]
eight letters provided comments on the draft revision to Regulatory
Guide 8.15.
This section discusses the comments received, how the NRC staff was
able to incorporate many of the comments into the final rule, and if
not, why a comment was not accepted. Numerous suggestions for changes
were acceptable to the NRC staff consistent with maintaining a
comprehensive set of regulations for the use of respiratory protection
against airborne radioactive materials, adequate to assure health and
safety of workers at NRC-licensed facilities. Every effort was made to
retain the burden reduction provided by the amendments in the proposed
rule and to comply with the Commission's intent that regulations be
risk informed and performance based. Because many commenters addressed
the same issues, this analysis will address all comments but specific
commenters will not be identified.
Several commenters suggested endorsing the regulations on
respirator use published recently by the Department of Labor,
Occupational Safety and Health Administration (OSHA), 29 CFR Parts 1910
and 1926. The proposed NRC regulations were in most respects consistent
with those adopted by OSHA. Because OSHA's, as well as NRC's,
regulations on respirator use may be applicable to facilities that have
both radiological and non-radiological hazards, additional changes have
been made to the NRC rule to make it even more consistent with OSHA
requirements. However, the suggestion to rely entirely on the published
OSHA rules is not possible for the following reasons.
The Atomic Energy Act (AEA) gives the NRC the statutory
responsibility to protect public health and safety, which includes
worker radiological health and safety, in the use of source, byproduct,
and special nuclear materials. The Occupational Safety and Health Act
(OSH) Act provides that for working conditions where another Federal
agency exercises statutory authority to protect worker health and
safety, the OSH Act is inapplicable. Therefore in implementing its
statutory authority, the NRC preempts the application of the OSH Act
for those working conditions involving radioactive materials.
In 1988, the NRC and OSHA signed a Memorandum of Understanding
(MOU) to make jurisdictional responsibilities at NRC licensed
facilities clear. Three areas of interest are intended to be regulated
by the NRC. These are:
--Radiation risk produced by radioactive materials.
--Chemical risk produced by radioactive materials.
--Plant conditions that affect the safety of radioactive materials and
thus present an increased radiation risk to workers.
The NRC cannot meet its responsibility to protect worker and public
radiological safety in these areas without a comprehensive body of
regulations to guide inspection and enforcement of essential safety
issues specifically addressing radiological hazards.
In addition, the NRC regulation includes the Assigned Protection
Factors (APFs) recommended by the American National Standards Institute
(ANSI) with some modifications. Because, in radiological applications,
using APFs to generate an estimate of intake of radioactive materials
is an acceptable method to demonstrate compliance with NRC dose limits,
APFs must be included in the regulation. However, OSHA rules do not
specify APFs because this section of the OSHA rules is still under
development.
The NRC regulations include dose limitation for radiation exposure
with the concept of keeping total dose As Low As Is Reasonably
Achievable (ALARA). OSHA does not address radiation hazards and does
not include the ALARA concept.
Finally NRC requirements do make it clear that if an NRC licensee
is using respiratory protection to protect workers against non-
radiological hazards, the OSHA requirements apply. If the NRC has
jurisdiction and is responsible for inspection, the MOU specifies that
NRC will inform the licensee and OSHA if the NRC observes an unsafe
condition relative to non-radiological hazards. For all of these
reasons, NRC believes it must have respiratory protection regulations
in place, rather than adopt on OSHA regulations.
Several commenters suggested endorsing ANSI guidance in the
regulations such as ANSI Z88.2-1992, ``American National Standard for
Respiratory Protection.'' The ANSI standards are viewed by the NRC
staff as comprehensive guidelines that if implemented would contribute
to an acceptable program. The NRC staff participated in development of
the standards. However, the ANSI standard does not specifically address
radiological protection. In addition, the ANSI recommendations for
general respirator usage are too prescriptive to be incorporated as
regulatory requirements given the Commission's intent to promulgate
risk-informed and performance-based rules.
With changes to the proposed rule discussed here, 10 CFR Part 20,
Subpart H will be consistent in almost all respects with ANSI guidance.
The final Regulatory Guide 8.15, ``Acceptable Programs for Respiratory
Protection'', will endorse, with some minor exceptions, ANSI Z88.2,
1992, as providing useful guidance for implementing an acceptable
respiratory protection program. This is considered by the NRC to be
consistent with the National Technology Transfer and Advancement Act of
1995.
Several commenters objected to the NRC proposed change that fit
tests could be performed every three years, instead of annually, with
supervisory attention to any physiological changes that might suggest
more frequent tests. The commenters observed that the NRC proposal was
inconsistent with ANSI guidance and the OSHA requirement for annual fit
testing. The OSHA requirement for annual fit testing is based on
several research studies that showed significant numbers of workers
failing to maintain an acceptable level of fit after only 1 year. The
NRC staff agrees and has retained the requirement for annual fit
testing in the final rule.
Several commenters suggested that disposable respirators (filtering
facepieces or dust masks) without elastomeric sealing surfaces and
adjustable straps, should have an APF equal to 10 listed in Appendix A
to be consistent with ANSI. The final rule does not assign an APF to
``filtering facepieces'' that are not equipped with elastomeric face
seals and at least two adjustable straps, unless the licensee can
demonstrate a fit factor of at least 100 by use of a quantitative or
qualitative, and validated or evaluated fit testing protocol. If the
device can be fit tested to demonstrate a fit factor of at least 100
then an APF of 10 may be used. Although stated differently, this is
essentially the condition that ANSI would require of disposables. The
NRC rule has the benefit of calling attention to the possibility that
some devices, such as dust masks, may not retain good fit under
conditions of use in the work place. This provision also permits the
use of dust masks and other disposables, if requested by a worker,
without the requirement to perform medical exams or fit tests. Fit
testing is only required if an APF is assigned, or if credit is taken
for use of the device in estimating intake or dose, suggesting that the
intent is to limit intake of radioactive material.
Three respirator types operating in demand or in demand,
recirculating mode were given APFs of 5 in the proposed rule. This was
in an effort to discourage their use by mistake in high concentration
areas. ANSI gives these devices APFs equal to 100. Consistent
[[Page 54545]]
with ANSI and in response to public comment, the NRC staff has changed
these APFs to 100.
It was suggested that Appendix A could be put into Regulatory Guide
8.15 so that changes could be made more easily as ANSI revised APFs.
This suggestion is not accepted by the NRC staff because APFs may be
used to generate estimates of dose of record from the intake of
radioactive material and as such should be regulatory requirements.
Regulatory Guides provide descriptions of acceptable programs, are
guidance only, and cannot be enforced unless a licensee commits to use
specific regulatory guides in its license. Although many materials
licensees and some nuclear power plant licensees do commit to use
specific regulatory guidance, thus making the guidance enforceable, it
is not required that all licensees incorporate regulatory guides.
In addition, APFs, as established by ANSI, are considered to be the
maximum allowable measure of protection associated with each respirator
type and mode of operation. These measures are used to select a
licensee's inventory of available respiratory protection devices as
well as to select respirators for a particular job. The NRC believes it
is important to worker safety that APFs not be flexible as they might
be if they were contained only in regulatory guidance.
During the information collection phase of this rulemaking, the NRC
staff was advised by several licensees that they would hesitate to use
a device unless it were specifically ``permitted'' in the NRC
regulations. Appendix A is needed in the regulation to specify those
respiratory devices that are permitted to be used in an NRC licensed
facility. For example, quarter facepieces although approved by NIOSH
and ANSI, are not permitted for use in NRC licensed facilities. On the
other hand, air-supplied suits, that are not tested or certified by
NIOSH or listed in ANSI, are in Appendix A to Part 20 thus permitting
their use by licensees.
Several commenters suggested that the NRC terms and definitions
should be consistent with those used by OSHA. The NRC staff agrees.
Several OSHA terms and definitions have been added to 10 CFR Part 20 in
this final rule and several proposed NRC definitions have been amended
to be more consistent with OSHA terms.
A commenter observed that Sec. 20.1703(c)(3) requires that
respirators be tested for operability prior to each use but that such
tests (user seal checks) are not quantitative and there is no
requirement to document the check. It was suggested that this
requirement be deleted. The NRC staff does not intend that user seal
checks (fit checks) be quantitative nor that they be documented. User
seal checks have been required by the NRC since 1979 and are well known
to the industry. Licensee training programs describe the procedures and
the procedures are subject to periodic licensee and NRC audits. The
need to perform a user seal check (fit check) prior to each use is
considered an essential safety procedure, consistent with industry
practice and ANSI guidance. This requirement is retained.
A commenter stated that Sec. 20.1703(c)(2) requires the use of
bioassays during respirator use in order to evaluate actual intakes and
that for certain radionuclides, such as W- and Y-class forms of thorium
and Y-class forms of uranium, bioassay techniques are relatively
insensitive. The NRC staff observes that Sec. 20.1204, ``Determination
of internal exposure,'' permits the use of air sampling, bioassays or
combinations of these measurements to assess dose from the intake of
radioactive materials. The final Sec. 20.1703(c)(2) states that a
licensee shall implement and maintain a respiratory protection program
that includes surveys and bioassays, as necessary, to evaluate actual
intakes. The intent of this provision is to identify elements required
to be addressed in the program description. This section does not
replace Sec. 20.1204 which permits methods other than bioassay to be
used to determine dose from intake.
A commenter observed that under the proposed rule, if a licensee
determined that a work situation did not require the use of respirators
but a worker requested one, then a respiratory protection program would
be required to be in effect. This is true for any respirator that has
been assigned an APF in Appendix A. However, the rule now recognizes
the use of disposable filtering facepieces (dust masks) without an APF.
If no credit is to be taken for their use then program elements such as
a medical exam and fit test are not required. Other program elements
such as minimal training on limitations of the devices and correct
methods of use are required.
A comment was made that the final rule should establish the extent
to which emergency planning efforts must incorporate the programmatic
requirement of 10 CFR 20.1703. 10 CFR Part 20 does not directly address
emergency situations but provides programmatic requirements for normal
operations. However, Sec. 20.1001 notes that ``* * * nothing in this
part shall be construed as limiting actions that may be necessary to
protect health and safety.'' This suggests that in the event of an
emergency, such as a major release or spill of radioactive material,
conditions would need to be assessed and the need for respiratory
protection determined. Licensees should determine whether or not an
emergency situation could reasonably be expected to arise that would
require the establishment of a respiratory protection program, and how
extensive that program would need to be. For nuclear power plants,
Sec. 50.47 (b)(8) requires ``adequate * * * equipment to support the
emergency response.'' This includes respiratory protection equipment
that would be needed in an emergency and a program for its use.
In NUREG-6204, Question and Answers Based on Revised 10 CFR Part
20, a question was posed as to whether the requirements of 10 CFR
20.1703 apply to respiratory protection equipment that is to be used
only in emergencies. The NRC staff position is that if the equipment is
to be used to limit intakes of radioactive material, this requirement
applies. Also, footnote i to the new Appendix A makes it clear that
full facepiece, Self-Contained-Breathing-Apparatus (SCBA) operating in
pressure demand, or positive pressure recirculating mode may be used as
an emergency device in unknown concentrations for protection against
inhalation hazards. If a licensee determined that there was sufficient
likelihood of an emergency situation, including significant airborne
radioactive material, to justify the maintenance of emergency use SCBA,
then a program would be necessary to assure the safe use of the
equipment should it be needed. The NRC staff believes that any
respiratory protection program that meets Part 20 requirements should
provide a good basis for respirator use in emergency situations.
Further guidance is provided in Regulatory Guide 8.15.
A commenter stated that Sec. 20.1703(b) requires application to the
Commission for approval to use respiratory devices not tested or
certified by NIOSH. It was suggested that this application would not be
necessary if the respirator were used in a situation where no
protection factor was needed. The program elements described in
Sec. 20.1703 come into effect ``* * * if the licensee assigns or
permits the use of respiratory protection equipment to limit the intake
of radioactive material.'' The NRC clarified the statement of
considerations to help define ``limit intake.'' In effect, if a
licensee determines that respiratory protection is not required to
limit intake of radioactive material and a respirator
[[Page 54546]]
is used for some other reason, then the Sec. 20.1703 conditions are not
applicable. However, in this case, other regulations would govern the
use of respirators. For example, if a worker requests a respirator that
will not be used to limit intakes of radioactive material, then OSHA or
State requirements would come into play. For example, OSHA requirements
for the voluntary use of disposable filtering facepieces (dust masks)
would be little more than brief instruction on the limitations of the
device and correct methods of use. NRC, as well as OSHA requirements
for the use of tight-fitting, half or full-facepiece respirators are
more extensive, including medical evaluation.
A suggestion was made that Sec. 20.1703(d) should include
instructing a worker that a respirator could be removed in any
situation where the user judges that his or her health is at risk due
to physical or psychological stress caused by use of the respirator.
The NRC staff believes the present language in this section and
guidance in Reg. Guide 8.15, is adequate to assure that a worker knows
when and how to secure relief from respirator-induced stress.
A commenter requested that provisions be added to allow the use of
combination full facepiece, pressure demand, supplied air respirators
with auxiliary self-contained air supply for use during emergency entry
into an unassessed environment. The NRC staff intends that Appendix A
Section III, Combination Respirators, include any devices or
combinations of devices as approved by NIOSH in 42 CFR Part 84.70.
Regulatory Guide 8.15 provides further guidance on the use of
combination respirators. The NRC staff does not believe that any change
is needed in the regulation to permit (and continue to allow) the use
of these approved devices.
A commenter questioned the statement in footnote e of Appendix A
that ``* * * no distinction is made * * * between elastomeric half-
masks with replaceable cartridges and those designed with the filter
medium as an integral part of the face piece (e.g., disposable or
reusable disposable).'' The commenter observed that there is no
assurance that a filtering facepiece would provide the same degree of
protection as a respirator equipped with an elastomeric facepiece. The
NRC staff agrees with this statement and has assigned a protection
factor of 10 only to devices having elastomeric face sealing properties
and two or more adjustable straps. Filtering facepieces not having
these design features are the first entry in Appendix A and are not
given an APF.
A commenter observed that proposed footnote e would permit the use
of filtering facepiece respirators (dust masks) without medical
screening or fit testing. The footnote also provides that if a licensee
can demonstrate a fit factor of at least 100 using an acceptable fit
test protocol, then an APF of 10 can be used. At question is whether
the medical screening becomes necessary if the device qualifies for an
APF. The waiver of medical screening in the new footnote d is based on
the fact that these devices do not impose physiological stress because
they are light weight, do not have a tight seal, and do not contribute
significantly to breathing resistance. The use of these devices, such
as dust masks, is likely to occur in response to a worker's request for
a respirator when the licensee has determined that a respirator is not
needed. Under these circumstances, the least burdensome design
available should be used. If a filtering facepiece device passes a fit
test, and is to be used to limit intake, and an APF greater than 1 is
used to estimate intake, then a full program is required including
medical screening. This requirement is consistent with the recent OSHA
regulations.
A suggestion was made that Appendix A could be clearer with more
explanatory text in the table, fewer footnotes, and terminology that
tracks OSHA. The NRC staff has revised Appendix A to some extent, by
spelling out modes of operation and adopting OSHA terminology whenever
possible.
A suggestion was made that Appendix A would be less complicated if
there was only one column of APF values. The NRC staff agrees and the
APF column for air purifying respirators is now labeled Particulate,
and the columns of APFs for atmosphere supplying respirators and
combination respirators are now labeled Particulate, Gases, and Vapors.
A commenter observed that footnote a should reference OSHA
regulations in addition to 29 CFR 1910. The NRC staff agrees and
footnote a in the final rule references Department of Labor
regulations. The revised Regulatory Guide 8.15 discusses OSHA
regulations and guidance in more detail.
A commenter observed that the NRC-proposed filter efficiency
requirements specified in proposed footnote c do not take into account
the observation that filter performance is far better in the field than
under NIOSH certification testing conditions. The NIOSH tests are
conducted at extreme conditions such as high flow rates, the challenge
aerosol is selected to be the most penetrating particle size, and long
test durations are used. Under field conditions most filters perform at
nearly 100 percent efficiency.
Also it is not necessarily most protective to select a high
efficiency filter because that results in a higher pressure drop across
the filter which could increase breathing resistance and lead to a
greater possibility of leakage around the seal as well as increased
worker stress. The NRC staff agrees with this comment and final
footnote b is changed to specify 95 percent efficiency filters for APFs
less than 100, 99 percent efficiency filters for APFs equal to 100, and
99.97 percent efficiency for APFs greater than 100.
A commenter suggested that some language in proposed footnote d be
clarified and that the last sentence could be covered in the text of
the rule. The NRC staff has revised the first sentence in final
footnote f to read, ``The assigned protection factors for gases and
vapors are not applicable to radioactive contaminants that present an
absorption or submersion hazard.'' The last sentence in proposed
footnote d made it clear that some sorbent cartridges have been proven
to be effective against airborne gases and vapors and, after NRC staff
review and approval on a case-by-case basis, the NRC will continue to
permit their use. This provision clearly modifies information in
Appendix A. The NRC staff believes it should remain in the footnotes.
With the restructuring of Appendix A, this information is found in new
footnotes c and f. More detailed discussion of the criteria for
approval of sorbent cartridges against gases and vapors has been added
to Regulatory Guide 8.15.
A commentor suggested deleting proposed footnote e because the
initial statement to the effect that filtering facepieces may be used
without medical screening or fit testing applies to all tight fitting
respirators. That is not the case. Fit testing and medical screening
are required for any respirator that is assigned a protection factor
(APF). Only disposable, filtering facepieces without elastomeric
sealing surface and adjustable straps that do not have an APF can be
used without medical screening. If the devices are fit tested in order
to use an APF, then medical screening would also be required.
This commentor suggested that the caution in the proposed footnote
e to the effect that it is difficult to perform positive or negative
pressure user seal checks on filtering facepiece respirators is not
based on technical information. The statement is based on cumulative
experience in the industry and inspection by the NRC staff of a large
number of filtering facepiece respirators that do not have elastomeric
sealing
[[Page 54547]]
surfaces and adjustable straps. In most cases, it was very difficult
for highly experienced respirator users to effectively perform a user
seal check on filtering facepiece respirators in the negative or
positive pressure mode.
A commentor proposed deleting the last sentence in the final
footnote i that warns against using SCBA in pressure demand or
recirculating positive pressure modes if any outward leakage of
breathing gas is perceived. This is an important warning for use of
these devices in emergencies or unassessed situations because leakage
could significantly reduce the expected duration of the air supply and
thus stay time. Premature exhaustion of the air supply could result in
serious injury or death of a worker in an Immediately Dangerous to Life
and Health (IDLH) area. This warning appropriately modifies the
assigned protection factor for this type of device.
A commentor suggested several revisions to the NRC proposed
definitions. Based on several comments the NRC staff has decided to use
OSHA definitions for consistency and the OSHA definitions are
consistent with the suggestions made by this commentor.
A commentor questioned the use of the words ``as necessary'' in
Sec. 20.1703 (c)(2). The intent of the words ``as necessary'' is that
surveys or bioassays should be included in the program only if a
licensee believes that these methods would be needed to determine
intake. For example, if air sampling during all procedures indicates
that no radioactive material is ever released into the air, then
evaluation of actual intakes using bioassay would not be necessary.
Section 20.1204, Determination of internal exposure, states that for
purposes of determining dose the licensee shall measure concentrations,
do bioassay, whole body count, or combinations of these measurements.
The purpose of Sec. 20.1703(c)(2) is to identify elements of an
acceptable program that may need to be included in the program, not to
require performance of bioassay if it is not needed.
A commentor observed that the proposed Sec. 20.1701 stated that
``The licensee shall use, to the extent practicable, process or other
engineering controls (e.g. containment, decontamination, or
ventilation) to control the concentration of radioactive material in
air. The word ``practicable'' is used in place of ``practical'' as
found in the current regulations. The NRC staff agrees with this
comment to the effect that ``practicable'' would require any action
that was ``possible,'' whereas ``practical'' specifies action that
would be ``useful''. The word ``practical'' is consistent with
``reasonable'' as found in ALARA, As Low as Is Reasonably Achievable,
and the final rule has been changed to retain the word ``practical.''
A commentor observed that the proposed definition of ``fit factor''
is a quantitative measure of the fit of a respirator to an individual.
The proposed definition of ``fit test'' is a test, quantitative or
qualitative to evaluate the fit of a respirator and to determine the
fit factor. The commentor states that a qualitative fit test cannot
yield a quantitative fit factor. In fact, approved qualitative fit test
protocols are considered by NIOSH, OSHA, and ANSI to imply minimum
quantitative fit factors, usually limited to 100.
However, because the NRC has decided to adopt the OSHA definitions,
the final rule defines fit factor as ``* * *a quantitative estimate of
the fit of a particular respirator to a specific individual, and
typically estimates the ratio of the concentration of substance in
ambient air to its concentration inside the respirator when worn.''
This definition permits use of a challenge medium whose concentration
at ambient temperature and pressure can be estimated (C1)
and if not detected by the test subject, a maximum concentration inside
the mask can be assumed, (C2). The estimated fit factor
would then be the ratio C1/C2. These qualitative
fit factors are permitted to be used to determine fit factor, and Reg.
Guide 8.15 will provide more detailed guidance on the use of approved
protocols.
A commentor suggested that the listing of irritant smoke (hydrogen
chloride) as an acceptable challenge agent in a user seal check (fit
check), be removed. There is evidence of health risks associated with
exposure to this chemical agent, not only to the worker but also to the
person performing the test. The NRC staff has decided to keep this
option as one of the acceptable user seal checks along with positive
and negative pressure check and isoamyl acetate, because both OSHA and
ANSI list it. However, the final version of Reg. Guide 8.15 will
include a caution regarding excessive exposure to this agent as well as
some suggestions for performing user seal checks with irritant smoke so
as to minimize exposure.
This commentor pointed out that deleting the words ``* * * or had
certification extended'' from Sec. 20.1703(a) and Sec. 20.1703(b), is
appropriate but that users should be advised that any particulate
respirators certified under 30 CFR Part 11 remain certified. The new
certification regulations are at 42 CFR Part 84. The NRC staff agrees,
and the statement of considerations includes a note to this effect, and
Reg. Guide 8.15 discusses certification in more detail.
The commentor questioned the wording in Sec. 20.1703(c)(3) that
would exempt respirators with no APFs from user seal checks for tight
fitting respirators and functional or operability checks for others
such as atmosphere supplied suits. The NRC staff agrees that if a
device is capable of being fit checked or operability checked then
these checks should be performed each time the device is used whether
or not a APF is used. The words ``* * *with APFs* * *'' are removed
from Sec. 20.1703(c)(3).
It was observed that Sec. 20.1703(c)(6) does not specify that fit
testing measures face seal rather than equipment operation and
therefore must always be performed with the facepiece operating in the
negative pressure mode. This provision has been changed to be
consistent with ANSI. Also, the proposed requirement to fit test any
tight-fitting, positive pressure, continuous flow and pressure demand
devices to a fit factor 100 is inconsistent with the OSHA
specification of 500. This difference could result in workers using
different masks depending on whether the respirator was used for
protection against radiological or non-radiological hazards. It was
further stated that a fit factor of 100 may be too low for full-face
tight-fitting masks because it in fact would represent a relatively
poor fit. The NRC staff believes that the OSHA recommended fit factor
of 500 is not difficult to achieve and provides an additional increment
of safety. The final rule reflects this change.
A commentor observed that Appendix A lists a positive pressure (PP)
operational mode for some air purifying respirator types. This
designation refers to ``powered air purifying respirators (PAPR)'' and
should be so designated. The NRC staff agrees and has made this change.
A commentor suggested the use of ``intake'' or ``dose from internal
radioactive material,'' instead of ``internal exposures,'' because
there is some confusion regarding the meaning of that term. The NRC
staff has reviewed the final rule and, whenever appropriate, more
precise terminology has been used as suggested.
A commenter references question number 91 in NUREG/CR-6204,
Questions and Answers Based on Revised 10 CFR Part 20, in which the NRC
staff stated that the requirements in 10 CFR 20.1703(a) must be met to
use
[[Page 54548]]
respiratory protection whether or not credit is taken for the device.
This statement was made before the NRC staff recognized the utility of
permitting the use of disposable filtering facepieces (dust-masks) not
equipped with elastomeric sealing surfaces and adjustable straps. The
NRC continues to require compliance with Sec. 20.1703(a) if respiratory
protection is used. However, dust masks and other similar devices can
be used, probably on request of a worker, without fit testing or
medical screening. These half-face, light-weight devices do not present
any significant physiological stresses and are to be used in situations
that do not require limiting intake. Therefore, these devices can be
removed at any time they become stressful without any harm to the user.
Minimal training on the limitations and proper use of the devices would
be required.
The commentor observed that the proposed rule would require fit
factors that are ten times the APF for the specific negative-pressure
air-purifying device, but that the rule does not specify how this fit
testing can be accomplished. The NRC staff notes that guidance on fit
testing, both quantitative and qualitative protocols, is found in Reg.
Guide 8.15.
A commentor states that the term ``adequate communication'' in
Sec. 20.1703(e) may be difficult to demonstrate due to the limited
communications options available with some respiratory devices and that
``adequate'' is subject to interpretation. The NRC staff agrees and
intends that this requirement be determined by licensee judgement.
Adequate, or ``sufficient for a specific requirement,'' is discussed in
Reg. Guide 8.15, and guidance as to what constitutes adequate
communication is provided. This is not a new requirement and the NRC
staff is not aware of licensees having difficulty with its
implementation.
The commentor questioned the requirement in Sec. 20.1703(f) for
``direct'' communication between the standby rescue person and the
worker because it might be necessary for the standby person to be in a
high radiation area or otherwise be exposed to radiation or
physiological stress. The NRC staff agrees and has changed this section
to require the standby rescue person to ``maintain continuous
communication'' with the workers. Acceptable communication methods are
identified as, visual, voice, signal line, telephone, radio, or other
suitable means.
The commentor stated that proposed Sec. 20.1703(h) regarding
materials or substances that might interfere with the seal of a
respirator did not adequately reflect the discussion in the statement
of considerations, and that, because the fit test proves the ability to
properly maintain a seal, this restriction is not needed. The NRC staff
observes that a fit test is not performed every time that a worker uses
a respirator. A user seal check might work with some obstruction in the
seal area but then break down in the work situation. To better reflect
the scope and intent of this provision and to be consistent with OSHA,
the NRC staff has added the underlined words as follows: (h) No
objects, materials, or substances, such as facial hair, or any other
conditions that interfere with the face--facepiece seal or valve
function, that are under the control of the respirator wearer, are
present.* * *
A commentor suggested elimination of the planned revision of NUREG-
0041, ``Manual of Respiratory Protection Against Airborne Radioactive
Material,'' because the document contains information that is found
elsewhere and is redundant. The NRC staff agrees that it would not be
useful to repeat information that is found elsewhere and one reason for
updating and revising the NUREG is to eliminate and avoid redundancy.
The document will be a technical source for NRC licensees setting up or
operating respiratory protection programs that will include many
references to ANSI, NIOSH, and other documents that describe acceptable
programs. Only procedures unique to protection against airborne
radioactive material will be addressed in detail if no other sources
are available.
The commentor observed that waiving the medical screening
requirement for the use of single-use disposable respirators is
inconsistent with OSHA. In fact, OSHA waives the medical screening
requirement for any voluntary use of filtering facepiece respirators.
The assumption is that if a licensee determines that a respirator is
not needed (meets ALARA considerations) but a worker requests one, then
the least intrusive device should be used, such as a disposable,
filtering facepiece with no APF that would be unlikely to expose the
worker to physiological stress. The NRC position is consistent with
that of OSHA.
Several commentors questioned the use of 15 percent loss of worker
efficiency when using a respirator as a recommended, upper bound
default value if a licensee is not able to justify a higher value. An
EPRI study, for example, showed that loss of worker efficiency did not
exceed 7 percent. Other measurements resulted in findings of 25 percent
loss of efficiency under conditions requiring respiratory protection.
With this range, a recommended default value of not more than 15
percent, as specified in Reg. Guide 8.15 seems reasonable. The guide
provides suggestions for determining an efficiency loss factor that
would be job and site specific.
A commentor questioned the need to apply to the Commission for the
use of an APF greater than 1 for sorbent cartridges as protection
against airborne radioactive gases and vapors (e.g., radioiodine). The
commentor stated that the NRC should specify the same APF listed for
particulate filters for radioactive gases or vapors with good warning
properties. The NRC staff is aware that most radionuclides (e.g.,
airborne radioiodines) have poor to no warning properties. For this
reason, the NRC staff intends to continue requiring a specific case
approval process with some demonstration of effectiveness before
approval for use.
A commentor suggested permitting ``a licensed health care
professional,'' in addition to a physician, to determine that a person
is medically fit to use a respirator, as is done by OSHA. The
established NRC position, as described further in Reg. Guide 8.15,
continues to be that a licensed health care professional can administer
a medical exam, but the program must be designed by, and be under the
supervision of a physician. The NRC staff is aware that serious injury
and death can occur if a person with certain medical conditions is
permitted to use a respirator.
In May of 1991 the Commission published a major revision to 10 CFR
Part 20 that required a licensee to implement and maintain a
respiratory protection program that includes * * * Determination by a
physician* * * that the individual user is physically able to use the
respiratory protection equipment.'' In the statement of considerations
for that final rule, the Commission noted ``* * *the decision on the
physical ability of an individual to wear a respirator is a subjective
judgement that in the Commission's opinion, requires the decisionmaker
to have a medical degree.'' In 1995 the Commission reaffirmed this
position in a rulemaking that revised the required frequency of medical
examination. However, the statement of considerations for that
rulemaking stated ``* * *The NRC staff believes that physicians need
not administer each test personally, but that the physician may
designate someone such as an office nurse to certify medical fitness as
long as it is clear that the physician is ultimately responsible for
[[Page 54549]]
the fitness determination. Likewise the NRC staff believes that the
physician should be involved in the supervision of the fitness program,
the review of overall results and individuals cases that fall outside
certain physician determined parameters, and supervision of personnel
performing the tests.''
This position is in agreement with ANSI recommendations as stated
in ANSI--Z88.6 1984. Regulatory Guide 8.15, Rev. 1, ``Acceptable
Programs for Respiratory Protection states that, ``The medical
evaluation program should be carried out by the physician, or by a
certified, medically trained individual such as a registered nurse
(RN), licensed practical nurse (LPN), emergency medical technician
(EMT), or someone who, in the judgement of the licensee's physician,
has adequate experience, education, training, and judgement to
administer the screening program.'' This is consistent with OSHA's
regulations that permit a ``licensed health care professional'' to
administer the fitness screening program.
A commentor observed that ANSI Z88.2-1992, does not include APFs
for SCBA used in the pressure-demand or positive pressure recirculating
modes, because some workplace simulation tests showed that up to 5
percent of workers don't achieve protection factors that high. ANSI
instead suggests that APFs up to 10,000 should be used only for
emergency planning purposes. Footnote a to Appendix A in the NRC
regulation makes it clear that the APFs apply only to airborne
radiological hazards and not when chemical or other respiratory hazards
exist.
A commentor suggested deletion of irritant smoke and isoamyl
acetate as example of a user seal check because these are not checks
that a user can perform without assistance. The NRC staff agrees but
does not preclude the use of assistance in performing a user seal
check. It is common for a technician to perform user seal checks on a
work crew preparing for entry to a job site requiring respirators. If
no assistance is available then clearly positive or negative pressure
checks would be the available options.
It was suggested that more guidance be provided on functional check
or testing for operability. The NRC staff agrees and Reg. Guide 8.15
will be expanded to provide more guidance on accepted techniques.
It was suggested that more specificity regarding actual procedures
be put in the rule or the Reg. Guide and that requirements for
addressing non-routine and emergency use of respirators should be
added. The NRC staff does not agree because respiratory programs should
be site and work specific and the intent of revising the rule was to
make it more performance based. Considerable guidance on acceptable
methods exists and is referenced in Reg. Guide 8.15 or NUREG-0041.
A commentor said that NRC should require use of the OSHA medical
check questionnaire, or its equivalent. The NRC staff agrees that the
OSHA questionnaire is an acceptable way, along with appropriate medical
oversight, to medically screen workers to use respirators safely, but
that other methods are also acceptable. In the interest of maintaining
a performance-based rule, the NRC will rely on review of a licensee's/
physician's judgement regarding the best way to qualify workers. The
OSHA questionnaire is referenced in Reg. Guide 8.15 for guidance.
It was suggested that provisions for vision, communication, and low
temperature protection be made at no cost to the employee. The NRC
staff believes that this issue is outside the scope of 10 CFR Part 20
and should be addressed between workers and licensee management.
A commentor suggested adding a definition for ``Immediately
Dangerous to Life or Health,'' IDLH. Subpart H of 10 CFR Part 20
provides program requirements for respiratory protection against
airborne radioactive material. It would be extremely rare for airborne
concentrations of radioactive material to reach IDLH levels. IDLH
refers to industrial and toxic chemical hazards that NRC licensees must
be alert to in compliance with OSHA regulations. It would be
inappropriate for NRC to suggest that airborne radiological condition
would require a definition of IDLH. OSHA defines IDLH as ``* * * an
atmosphere that poses an immediate threat to life, would cause
irreversible adverse health effects, or would impair an individuals'
ability to escape from a dangerous atmosphere.''
It was suggested that Sec. 20.1703(f) state that a sufficient
number of standby rescue persons must be immediately available to
provide effective emergency rescue. The NRC staff agrees and these
words have been added.
A commentor observed that the APFs specified by NRC in Appendix A
are not in complete agreement with those recommended by ANSI. The
difference for disposable filtering facepieces (dust masks) has been
discussed. Any other differences between the ANSI recommended APFs and
those specified by the NRC in the proposed rule have been eliminated in
this final rule in the interest of providing greater consistency with
ANSI recommendations.
Eight comment letters were received regarding the draft Reg. Guide
8.15. All of the suggested changes derived from comments made on
proposed Subpart H of 10 CFR Part 20. Reg. Guide 8.15 has been revised
based on this analysis of comments submitted on the proposed rule and
the changes that have been made to the rule as discussed in this
section.
III. Summary of Changes
This final rule amends Sec. 20.1003, ``Definitions'', Secs. 20.1701
through 20.1704, adds Sec. 20.1705, and amends Appendix A to Part 20.
In Sec. 20.1003, the NRC is adding definitions for Air-purifying
respirator, Assigned protection factor (APF), Atmosphere-supplying
respirator, Demand respirator, Disposable respirator, Filtering
facepiece (dust mask), Fit factor, Fit test, Helmet, Hood, Loose-
fitting facepiece, Negative pressure respirator, Positive pressure
respirator, Powered air-purifying respirator (PAPR), Pressure demand
respirator, Qualitative fit test (QLFT), Quantitative fit test (QNFT),
Self-contained breathing apparatus (SCBA), Supplied-air respirator
(SAR) or airline respirator, Tight-fitting facepiece and User seal
check. These added definitions clarify the new regulations at
Secs. 20.1701 through 20.1705.
In Sec. 20.1701, the word ``decontamination'' is added to the list
of examples of process or engineering controls that licensees should
consider for controlling the concentration of radioactive material in
air. The NRC intends that licensees consider decontamination,
consistent with maintaining total effective dose equivalent (TEDE)
ALARA, to reduce resuspension of radioactive material in the work place
as a means of controlling internal dose instead of using respirators.
Section 20.1702 is revised to clarify that if a licensee performs
an ALARA analysis to determine whether or not respirators should be
used, the licensee may consider safety factors other than radiological.
A reduction in the TEDE for a worker is not reasonably achievable if,
in the licensees' judgement, an attendant increase in the worker's
industrial health and safety risk would exceed the benefit obtained by
the reduction in the radiation risk. Regulatory Guide 8.15,
``Acceptable Programs For Respiratory Protection,'' and NUREG-0041,
``Manual of Respiratory Protection Against Airborne Radioactive
Material'' address how factors such as heat, discomfort, reduced
vision, etc., associated with respirator use, might reduce efficiency
[[Page 54550]]
or increase stress thereby increasing dose from external sources or
health risk. The NRC expects that licensees will exercise judgment in
determining how nonradiological factors apply to selecting an
appropriate level of respiratory protection. In the proposed rule this
amendment would have been accomplished by adding a footnote to
paragraph (c). The NRC has instead restructured the section to add
similar language to a new subparagraph Sec. 20.1702(b) in the text of
the rule to facilitate clarification of this important provision.
Section 20.1703 states the requirements for licensees who use
respiratory protection equipment to limit intake of radioactive
material. The use of a respirator is, by definition, intended to limit
intakes of airborne radioactive materials, unless the device is clearly
and exclusively used for protection against non-radiological airborne
hazards. Whether or not credit is taken for the device in estimating
doses, use of the respiratory protection device to limit intake of
radioactive material and associated physiological stresses to the user
activates the requirements of Sec. 20.1703. Thus Sec. 20.1703 defines
the minimum respiratory protection program expected of any licensee who
assigns or permits the use of respirators to limit intake.
The term ``limit intake of radioactive material'' is not
specifically defined in this rule. The licensee must determine whether
the use of a respirator for protection against non-radiological
airborne hazards or at the request of a worker also limits the intake
of radioactive material. If so a Sec. 20.1703 program is required. An
acceptable approach is for the licensee to evaluate the existing or
potential airborne concentrations of radioactive material (from routine
operations, likely operational occurances, and credible emergency
conditions) and determine whether a Part 20, Subpart H respiratory
program would have been required by the concentration of radioactive
material. If the analysis shows that respiratory protection would not
have been required in order to limit intake of radioactive material,
then compliance with Subpart H would not be required. Respirators used
for the express purpose of protection against non-radiological hazards,
and that only incidentally limit the intake of radioactive materials
that may be present in the air, are not considered to fall under the
``limit intake'' category. Such respirator use is not regulated by
Subpart H provisions.
However, respiratory protection that is used to protect against
non-radiological hazards or at the request of a worker invokes OSHA
program requirements. The programmatic requirements prescribed by OSHA
are commensurate with the degree of hazard present, ranging from a
program more prescriptive than Subpart H to brief instruction on safety
issues in the case of the voluntary use of ``dust masks.'' Under a
Memorandum of Understanding between the NRC and OSHA, the NRC
inspection staff is obligated to notify the licensee and OSHA if
industrial safety problems are observed.
In Sec. 20.1703(a), the phrase ``pursuant to Sec. 20.1702'' is
removed. This language has been misinterpreted to mean that an approved
respiratory protection program is not needed if respirators are used
when concentrations of radioactive material in the air are already
below values that define an airborne radioactivity area. Section
20.1703 now makes it clear that, if a licensee uses respiratory
protection equipment ``to limit intakes,'' the provisions of
Sec. 20.1703 are the minimum applicable requirements.
In final Sec. 20.1703(a), licensees are permitted to use only
respirators that have been tested and certified by NIOSH. The words
``or had certification extended'' are removed because all existing
extensions have expired and no new extensions will be granted except
for classes of respirators certified under 42 CFR Part 84.
Note: The respiratory certification regulations at 42 CFR Part
84 replaced those previously at 30 CFR Part 11 for air purifying
respirators. Devices formerly certified under 30 CFR Part 11 remain
certified but newer devices certified under 42 CFR Part 84 have
demonstrated improved performance.
In final Sec. 20.1703(b), licensees are permitted to apply for
authorization to use equipment that has not been tested or certified by
NIOSH. The words ``and has not had certification extended by NIOSH/
MSHA'' have been removed because all existing extensions have expired
and no new extensions will be granted except for classes of respirators
certified under 42 CFR Part 84. The words ``to the NRC'' are added to
make it clear that applications for authorized use of respiratory
equipment must be submitted to the Commission.
In new Sec. 20.1703(c), paragraphs (c)(1) through (5) are retained
as presently codified with the exception of some minor editing.
Paragraph (c)(4) is reworded to improve clarity, reorder priorities,
and bring together in one paragraph all of the elements of the required
written procedures. Paragraph (c)(5) is revised to clarify that the
worker's medical evaluation for using non-face sealing respirators
occurs before first field use, not before first fitting (as required
for tight fitting respirators) because fit testing is not needed for
these types.
A new Sec. 20.1703(c)(6) is added to require fit testing before
first field use of tight-fitting, face sealing respirators and
periodically after the first use. This change clarifies when and how
often fit testing is required. The NRC requires that the licensee
specify a frequency of retest in the procedures, that may not exceed 1
year (see HPPOS-219 for NRC staff position on testing intervals). The
proposed rule would have extended the retest period up to three (3)
years. However, public comment and the NRC's intent to be consistent
with OSHA requirements, convinced the NRC staff to retain annual fit
testing. (See Analysis of Public Comment).
The new Sec. 20.1703(c)(6) also codifies existing NRC staff
guidance and ANSI recommendations regarding the test ``fit factors''
that must be achieved in order to use the APFs. Specifically, fit
testing with ``fit factors'' 10 times the APF is required
for tight fitting, negative pressure devices. A fit factor
500 is required for all tight fitting face pieces used with positive
pressure, continuous flow, and pressure-demand devices. ANSI
recommended a fit factor of 100 for these devices but OSHA selected 500
to provide an additional safety margin. The NRC staff agrees with the
OSHA position and in the interest of consistency is specifying 500.
This provision is intended to maintain a sufficient margin of safety to
accommodate the greater difficulty in maintaining a good ``fit'' under
field and work conditions as compared to fit test environments. It is
important to note that all tightfitting facepieces are to be fit tested
in the negative pressure mode regardless of the mode in which they will
be used.
Current Sec. 20.1703(a)(4), which required licensees to issue a
written policy statement, is removed because the NRC believes that it
is not needed. All of the elements that were required to be in the
policy statement are already found in Part 20 and in the requirement
for licensees to have and implement written procedures (see
Sec. 20.1703(c)(4)).
The requirements of Sec. 20.1703(a)(6) have been moved to
Sec. 20.1703(e), clarified and expanded to emphasize the existing
requirements that provisions be made for vision correction, adequate
communications, and low-temperature work environments. A licensee is
required to account for the effects of restricted vision and
communication limitations as well as the effects of adverse
environmental conditions on the equipment and the wearer. The NRC
[[Page 54551]]
considers the inability of the respirator wearer to read postings,
operate equipment and/or instrumentation, or properly identify hazards
to be an unacceptable degradation of personnel safety.
A requirement for licensees to consider low-temperature work
environments when selecting respiratory protection devices is added in
Sec. 20.1703(e). The NRC believes that this requirement is needed
because the moisture from exhaled air when temperatures are below
freezing could cause the exhalation valve on negative pressure
respirators to freeze in the open position. The open valve would
provide a pathway for unfiltered air into the respirator inlet covering
without the user being aware of the malfunction. Lens fogging that
reduces vision in a full facepiece respirator is another problem that
can be caused by low temperature.
The reference to skin protection in Sec. 20.1703(a)(6) has been
removed. The NRC does not consider skin protection to be an appropriate
reason for the use of respirators (with the exception of air supplied
suits). Limitation of skin dose is currently dealt with elsewhere in
the regulations (Sec. 20.1201(a)(2)(ii), skin dose limit). It may be
inconsistent with ALARA to use tight fitting respirators solely to
prevent facial contamination. Other protective measures such as the use
of faceshields instead of respirators, or decontamination should be
considered.
A new Sec. 20.1703(f) is added to include a requirement for standby
rescue persons in the regulatory text. This requirement was previously
contained in a footnote in Appendix A to Part 20. This provision
retains a requirement for standby rescue persons to be present whenever
one-piece atmosphere-supplying suits, or any other combination of
supplied air respirator device and protective equipment are used that
are difficult for the wearer to take off without assistance. Standby
rescue persons would also need to be in continuous communication with
the workers, be equipped with appropriate protective clothing and
devices, and be immediately available to provide needed assistance if
the air supply fails. Without continuous air supply, unconsciousness
can occur within seconds to minutes.
A new Sec. 20.1703(g) moves a requirement from a footnote in
Appendix A to Part 20, into regulatory text. This paragraph specifies
the minimum quality of supplied breathing air, as defined by the
Compressed Gas Association (CGA) in their publication G-7.1,
``Commodity Specification for Air,'' 1997, that must be provided
whenever atmosphere-supplying respirators are used. This change which
recognizes the CGA recommendations for air quality, was initiated by
NIOSH and endorsed by ANSI. The quantity of air supplied, as a function
of air pressure or flow rate, would be specified in the NIOSH approval
certificate for each particular device and is not addressed in the
rule.
A new Sec. 20.1703(h) is added to clarify and move a requirement
from the footnotes of Appendix A into regulatory text. This provision
prohibits the use of respirators whenever any objects, materials, or
substances such as facial hair, or any other conditions interfere with
the seal of the respirator. The intent of this provision is to prevent
the presence of facial hair, cosmetics, spectacle earpieces, surgeons
caps, and other things from interfering with the respirator seal,
exhalation valves, and/or proper operation of the respirator.
Section 20.1703(b)(1) discussed the selection of respiratory
protection equipment so that protection factors are adequate to reduce
intake. This paragraph permitted selection of less protective devices
if that would result in optimizing TEDE. The NRC staff believes that
this requirement is redundant with the requirement to be ALARA. These
recommendations are removed from the regulation and are now discussed
in revised Regulatory Guide 8.15.
The remainder of Sec. 20.1703(b)(1) has been moved to
Sec. 20.1703(i) and incorporates the new ANSI terminology for
``assigned protection factor''. This paragraph retains the provisions
for changing intake estimates if later, more accurate measurements show
that intake was greater or less than initially estimated.
Section 20.1703(b)(2), specifying procedures for applying to the
NRC to use higher APFs, has been moved to Sec. 20.1705.
Section 20.1703(c) is removed because it requires licensees to use
only respiratory protection equipment that has been specifically
certified or had certification extended for emergency use by NIOSH, as
emergency devices. Because only equipment approved by NIOSH or NRC can
be used in the respiratory protection program pursuant to
Sec. 20.1703(a) and (b), this provision is redundant. The revisions of
Regulatory Guide 8.15 and NUREG-0041 discuss acceptable types of
emergency and escape equipment.
Section 20.1703(d) is removed. This provision required a licensee
to notify the director of the appropriate NRC Regional Office in
writing at least 30 days before the date that respiratory protection
equipment is first used so that the NRC staff could review the licensee
program. Licensees who possess radioactive material in a form that
requires a respiratory protection program are expected to submit a
program description during the license application, amendment, or
renewal processes. Their programs would be reviewed during this
process. A 30-day notification requirement imposes a needless
administrative burden on licensees with no increase in worker health
and safety. This change is considered to be a burden reduction.
Section 20.1704(a) is revised to clarify that the Commission will
use ALARA considerations in any additional restrictions imposed by the
Commission on the use of respiratory protection equipment for the
purpose of limiting exposures of individuals to airborne radioactive
materials.
Appendix A to Part 20--``Assigned Protection Factors for
Respirators,'' is modified extensively. In general, new devices are
recognized, APFs are revised to be consistent with current ANSI
guidance and technical knowledge, and the footnotes to Appendix A are
moved, deleted, revised, or adjusted so that only those necessary to
explain the table remain. Footnotes that are instructive or that
facilitate implementation of the rule are being moved to Regulatory
Guide 8.15. Several footnotes are considered to be redundant in that
they reiterate NIOSH certification criteria to be discussed in NUREG-
0041 and are removed. Generic regulatory requirements, previously
contained in footnotes in Appendix A, have been moved to the text of
Part 20.
The column headed ``Tested and Certified Equipment'' is removed
from the table. The references to Titles 30 and 42 of the CFR currently
found in this column apply primarily to respirator manufacturers and
are not very useful to NRC licensees. Instruction on how to determine
if a respirator is NIOSH approved are provided in the revision to
NUREG-0041.
The column headed Gases and Vapors is deleted, and the APFs for Air
Purifying respirators are designated ``particulate only,'' while APFs
for Atmosphere Supplying and Combination Respirators are designated for
``particulate, gases and vapors''. This change simplifies Appendix A.
Footnote a to Appendix A is removed because it is redundant with
air sampling requirements and requirements for estimating possible
airborne concentration addressed in Sec. 20.1703(c)(1) and
Sec. 20.1703(i).
[[Page 54552]]
Footnote b, which permits the use of devices only when nothing
interferes with the seal of a face piece, has been moved to the text of
the rule at Sec. 20.1703(h).
Footnote c, proposed footnote b, which defines the symbols for
modes of operation, is removed as a result of public comment and
operating modes are spelled out in Appendix A.
Footnote d.1 is removed because the essential information regarding
the meaning and use of APF is in Sec. 20.1703(i). Further guidance
regarding the application and limitation of APFs is provided in the
revisions of Regulatory Guide 8.15 and NUREG-0041.
Footnote d.2(a) stated that APFs are only applicable for trained
individuals who are properly fitted and for properly maintained
respirators. This footnote is redundant because adequate provisions for
training, fit-testing, and equipment maintenance are found in the final
rule (Sec. 20.1703(c)(4)).
Footnote d.2(b) stated that APFs are applicable for air-purifying
respirators only when high-efficiency particulate filters are used in
atmospheres not deficient in oxygen and not containing radioactive gas
or vapor respiratory hazards. This statement is revised and included in
footnote b to say that if using a respirator with an APF less than 100,
a filter with a minimum efficiency of 95 percent must be used. Air
purifying respirators with APF=100 must use a filter with an efficiency
rating of at least 99 percent. Respirators with APF>100 must use
filters with at least 99.97 percent efficiency. Further guidance is
provided in Regulatory Guide 8.15 and NUREG-0041. The definitions of
filter types and efficiencies are discussed in the revisions of
Regulatory Guide 8.15 and NUREG-0041.
Footnote d.2(c) stated that APFs cannot be used for sorbents
against radioactive gases and/or vapors (e.g., radioiodine). This is no
longer an absolute prohibition. A provision is made in footnote c for
licensees to apply to the Commission for the use of an APF greater than
1 for sorbent cartridges.
Footnote d.2(d) restated part of the NIOSH approval criteria for
air quality for supplied air respirators and self-contained breathing
apparatus. This requirement is changed to reflect the fact that air
quality standards derive from ANSI's recognition of the Compressed Gas
Association guidance, and is moved to the text of the rule
(Sec. 20.1703(g)). Air quality is discussed further in Regulatory Guide
8.15 and NUREG-0041.
Footnote e made it clear that the APFs for atmosphere-supplying
respirators and self-contained breathing apparatus are not applicable
in the case of contaminants that present a skin absorption or
submersion hazard. This statement is retained in footnote f in Appendix
A to Part 20. However, the current exception provided for tritium oxide
requires correction in that the effective protection factor cannot
exceed 3, rather than 2 as previously stated. This correction is made
to footnote f of Appendix A. This basis for this change is discussed
further in revised NUREG-0041.
Footnote f stated that canisters and cartridges for air purifying
respirators will not be used beyond service-life limitations. This
observation restates a NIOSH approval criterion and is more appropriate
to guidance than to the regulations. This footnote is removed. Service
life limitations are addressed in Regulatory Guide 8.15 and NUREG-0041.
Footnote g addressed four issues. The first limits the use of half-
mask facepiece air purifying respirators to ``under-chin'' types only.
This limitation is retained in footnote e to the new Appendix A to Part
20. The only type of facepiece eliminated by this requirement is the
so-called ``quarter-mask'' which seals over the bridge of the nose,
around the cheeks and between the point of the chin and the lower lip.
These devices can exhibit erratic face-sealing characteristics,
especially when the wearer talks or moves his/her mouth.
The second issue precluded this type of respirator if ambient
airborne concentrations can reach instantaneous values greater than 10
times the pertinent values in Table 1, Column 3 of Appendix B to Part
20. Because respirator assignment is now based on TEDE, ALARA, and
other considerations, this part of footnote g is removed from the new
footnote e.
The third issue precluded the use of this type of respirator for
protection against plutonium or other high-toxicity materials. Half-
mask respirators, if properly fitted, maintained, and worn, provide
adequate protection if used within the limitations stated in the NIOSH
approval and in the rule. The NRC finds no technical or scientific
basis for continuing this prohibition in view of current knowledge and
it is removed.
Finally this footnote required that this type mask be checked for
fit (user seal check) before each use. This provision is removed
because Sec. 20.1703(c)(3) requires a user to perform a user seal check
(e.g., negative pressure check, positive pressure check, irritant smoke
check) each time a respirator is used.
Footnote h provided several conditions on air-flow rates necessary
to operate supplied air hoods effectively. Because all of these
requirements are elements of the NIOSH approval criteria, they are
redundant and are removed. These NIOSH requirements are discussed
further in the revision to NUREG-0041.
Footnote i specified that appropriate protection factors be
determined for atmosphere-supplying suits based on design and
permeability to the contaminant under conditions of use. Conditions for
the use of these devices are retained in footnote g to the revision of
Appendix A. Guidance on the use of these devices and on determining
appropriate protection factors is included in the revision to
Regulatory Guide 8.15. Footnote i also required that a standby rescue
person equipped with a respirator or other apparatus appropriate for
the potential hazards, and communications equipment be present whenever
supplied-air suits are used. This requirement is moved to the text of
the rule (Sec. 20.1703(f)).
Footnote j stated that NIOSH approval schedules are not available
for atmosphere-supplying suits. This information and criteria for use
of atmosphere supplying suits is addressed in footnote g to Appendix A.
Note that an APF is not listed for these devices. Licensees may apply
to the Commission for the use of higher APFs in accordance with
Sec. 20.1703(b).
Footnote k permitted the full facepiece self-contained breathing
apparatus (SCBA), when operating in the pressure-demand mode, to be
used as an emergency device in unknown concentrations. This provision
is retained in footnote i to Appendix A, and full facepiece SCBA
operating in positive pressure, recirculating mode is added.
Footnote l required quantitative fit testing with a leakage less
than 0.02 percent for the use of full facepiece, positive pressure,
recirculating mode SCBA. This requirement is removed from the footnotes
and fit test criteria consistent with ANSI guidance are inserted at
Sec. 20.1703(c)(6). Fit testing is addressed in the revision to
Regulatory Guide 8.15.
Footnote l also stated that perceptible outward leakage of
breathing gas from this or any positive pressure SCBA whether open
circuit or closed circuit is unacceptable, because service life will be
reduced substantially. This provision is retained in footnote i to
Appendix A.
Footnote l also required that special training in the use of this
type of
[[Page 54553]]
apparatus be provided to the user. The NRC believes that the training
requirement that would be retained at Sec. 20.1703(c)(4) is adequate to
assure the training necessary for the use of SCBA devices. This element
of footnote l is removed.
Note 1 to Appendix A to Part 20 discussed conditions under which
the protection factors in the appendix may be used, warned against
assuming that listed devices are effective against chemical or
respiratory hazards other than radiological hazards, and stated the
need to take into account applicable approvals of the U.S. Bureau of
Mines/NIOSH when selecting respirators for nonradiological hazards.
Note 1 is retained in footnote a to Appendix A and amended to reference
Department of Labor (DOL) regulations. The NRC believes that these
conditions are essential to the safe use of respirators and that the
DOL regulations also apply when hazards other than radiological
respiratory hazards are present.
Note 2 to Appendix A warned that external dose from submersion in
high concentrations of radioactive material may result in limitations
on occupancy being governed by external dose limits. This note is
retained as the second paragraph of footnote a to Appendix A to Part
20.
In the title of Appendix A, and throughout the rule, the term
``assigned protection factor'' (APF) is used to be consistent with the
new ANSI Z88.2-1992 terminology.
Although ANSI suggested an APF = 10 for all half-mask filtering
facepiece disposable respirators, disposables that do not have seal-
enhancing elastomeric components and are not equipped with two or more
adjustable suspension straps are permitted for use but do not have an
APF assigned (i.e., no credit may be taken for their use). The NRC
believes that without these design features it is difficult to maintain
a seal in the workplace. These devices have little physiological impact
on the wearer, may be useful in certain situations, and they may
accommodate workers who request respiratory protection devices as is
required by OSHA. Medical screening is not required for each individual
prior to use because the devices impose very little physiological
stress. In addition, fit testing is not required because an APF is not
specified (i.e., no credit may be taken for their use). However, all
other aspects of an acceptable program specified in Sec. 20.1703 are
required including training of users in the use and limitations of the
device. The NRC believes that this provision allows the flexible and
effective use of these devices without imposing conditions that are
burdensome.
However, for those licensees who would like to use the ANSI-
recommended APF of 10 for filtering facepiece (dust masks), footnote d
to Appendix A permits an APF of 10 to be used if the licensee can
demonstrate a fit factor of at least 100 using a validated or
evaluated, quantitative or qualitative fit test. This requirement is
consistent with ANSI recommendations because fit testing is an explicit
component of the ANSI respirator program. The full Sec. 20.1703 program
would then be needed including a medical evaluation.
The half-facepiece respirator continues to be approved with an APF
= 10, but relatively new variations of this type of device are referred
to in the industry as ``reusable,'' ``reusable-disposable,''
``filtering facepiece'' or ``maintenance-free'' devices. In these
devices, including those considered to be disposables, the filter
medium may be an integral part of the facepiece, is at least 95 percent
efficient, and may not be replaceable. Also, the seal area is enhanced
by the application of plastic or rubber to the face-to-facepiece seal
area and the 2 or more suspension straps are adjustable. These devices
are acceptable to the NRC, are considered half facepieces, may be
disposable, and are given an APF = 10, consistent with ANSI
recommendations. Individual workers must achieve a fit factor of at
least 100 to use the APF of 10.
The APF for full facepiece air purifying respirators operating in
the negative pressure mode is increased from 50 to 100. This change is
consistent with ANSI recommendations based on review of industry test
results. Appendix A previously listed a protection factor of 50 because
one design that was tested at Los Alamos in 1975 did not meet the
protection factor criterion of 100. This device is no longer available.
A fit factor of 10 times the APF for tight fitting, negative-
pressure air-purifying respirators, which must be obtained as a result
of required fit testing under Sec. 20.1703(c)(6), is recommended by
ANSI and is required under the new rule. A person would have to achieve
a minimum of 1,000 on a fit test in order to use an APF of 100 in the
field. Requiring a fit factor of 10 times the APF for negative pressure
devices effectively limits intake and protects against any respirator
leakage that might occur during workplace activities. A fit factor
500 is required for any positive pressure, continuous flow
and pressure demand device. The proposed rule had stated a fit factor
of 100. However, public comment suggested this number was too low, and
OSHA rules also require 500.
A new category of respirator, the loose-fitting facepiece, positive
pressure (powered) air purifying type, is included in Appendix A to
Part 20. An APF of 25 is assigned to this new device in accordance with
ANSI Z88.2-1992.
The half facepiece and the full facepiece air-line respirators
operating in demand mode were listed in the proposed rule with APFs
unchanged at 5. In order to be consistent with ANSI and with public
comment, the APFs for these two devices have been changed. The new APF
for the half facepiece is 10, and the APF for the full facepiece is
100. The NRC believes that supplied-air respirators operating in the
demand mode should be used with great care in nuclear applications.
Because they are very similar in appearance to more highly effective
devices (continuous flow and pressure-demand supplied air respirators),
they might mistakenly be used instead of the more protective devices.
The APFs for half- and full-facepiece air-line respirators
operating on continuous flow are reduced from 1,000 to 50 and from
2,000 to 1,000 respectively. The APF for a full facepiece air-line
respirator operating in pressure-demand mode is reduced from 2,000 to
1,000. These changes are based on ANSI recommendations and the results
of field and laboratory experiences indicating that these devices are
not as effective as originally thought. This change is expected to have
little impact on licensees because typical workplace concentrations
encountered are far less than 1000 times the derived air concentrations
(DACs). However, licensees may apply for higher APFs if needed and
justified. A half-mask air-line respirator operating in pressure-demand
mode is added to Appendix A with an APF of 50 based on ANSI
recommendations. The helmet/hood air-line respirator operating under
continuous flow is retained with the APF listed as 1,000. Footnote h
which specified NIOSH certification criteria for flow rates is removed.
The criteria for air flow rates are part of the NIOSH approval and are
addressed in the revision to NUREG-0041.
The new loose-fitting facepiece design is also included as an air-
line respirator operating under continuous flow. This device is
assigned an APF of 25 in Appendix A consistent with ANSI
recommendations.
The air-line atmosphere-supplied suit is not assigned an APF. These
devices have been used with no APF for many years in radiological
environments, such as control rod drive removal at boiling
[[Page 54554]]
water reactors. These devices are primarily used as contamination
control devices, but they are supplied with breathing air. No worker
safety problems are known to have occurred at nuclear power plants or
other NRC licensees that would disallow use of these devices. The NRC
is allowing the use of non-NIOSH-approved suits but wearers are
required to meet all other respirator program requirements in
Sec. 20.1703 except the need for a fit test. Licensees have an option
to apply to the Commission for higher APFs for these devices in
accordance with Sec. 20.1703(b). Requirements for standby rescue
persons apply to operations where these devices are used
(Sec. 20.1703(f)).
In Appendix A to Part 20, APFs for SCBA devices remain unchanged
except for those operating in demand or demand recirculating modes.
APFs for these two devices have been changed from 5 to 100 to be
consistent with ANSI and in response to public comment. Use of SCBA in
demand open circuit and demand recirculating mode requires considerable
caution. The chance of facepiece leakage when operating in the negative
pressure mode is considerably higher than when operating in a positive
pressure mode. This is especially critical for devices that could be
mistakenly used in immediately dangerous to life and health (IDLH)
areas during emergency situations. Although ANSI lists relatively high
APFs for these devices, they are not recommended by the NRC for use and
acceptable alternative devices are readily available. Footnote h
requires that controls be implemented to assure that these devices are
not used in IDLH areas.
A specific statement is added in footnote f, to exclude radioactive
noble gases from consideration as an inhalation hazard and advising
that external (submersion) dose considerations should be the basis for
protective actions. DAC values are listed for each noble gas isotope.
This has led some licensees to inappropriately base respirator
assignments in whole or in part on the presence of these gases. The
requirement for monitoring external dose can be found in 10 CFR
20.1502.
IV. Issue of Compatibility for Agreement States
In accordance with the Policy Statement on Adequacy and
Compatibility of Agreement State Programs published September 3, 1997
(62 FR 46517) and implementing procedures, the modifications to
Sec. 20.1701 through Sec. 20.1703 (except 20.1703(c)(4)), have health
and safety significance and Agreement States should adopt the essential
objectives of these rule modifications. Therefore, these provisions are
assigned to the ``Health and Safety (H&S)'' category. The definitions
(added to Sec. 20.1003), of Air purifying respirator, Atmosphere-
supplying respirator, Assigned Protection Factor (APF), Demand
respirator, Disposable respirator, Fit factor, Fit test, Filtering
facepiece (dust mask), Helmet, Hood, Loose-fitting facepiece, Negative
pressure respirator, Positive pressure respirator, Powered air-
purifying respirator, Pressure demand respirator, Qualitative fit test,
Quantitative fit test, Self-contained breathing apparatus, Supplied-air
respirator, Tight-fitting facepiece, and User seal check (fit check),
because of their precise operational meanings, are designated as
compatibility category B to help insure effective communication and to
promote a common understanding for licensees who operate in multiple
jurisdictions. Therefore, Agreement States should adopt definitions
that are essentially identical to those of NRC.
Sec. 20.1703(c)(4) and Sec. 20.1704, which address requirements for
written procedures, and imposition of additional restrictions on the
use of respiratory protection, respectively, are designated as
compatibility category D.
Appendix A to 10 CFR Part 20, and Sec. 20.1705 which permits
applying for the use of higher APFs on a case by case basis, are
designated as compatibility category B. Consistency is required in APFs
that are established as acceptable in NRC and Agreement State
regulations to reduce impacts on licensees who may operate in multiple
jurisdictions.
V. Finding of No Significant Environmental Impact: Availability
The NRC has determined under the National Environmental Policy Act
of 1969, as amended, and the Commission's regulations in Subpart A of
10 CFR Part 51, that the amendments are not a major Federal action
significantly affecting the quality of the human environment and
therefore, an environmental impact statement is not required.
The amendments make technical and procedural improvements in the
use of respiratory protection devices to maintain total occupational
dose as low as is reasonably achievable. None of the impacts associated
with this rulemaking have any effect on any places or entities outside
of a licensed site. An effect of this rulemaking is expected to be a
decrease in the use of respiratory devices and an increase in
engineering and other controls to reduce airborne contaminants. It is
expected that there would be no change in radiation dose to any member
of the public as a result of the revised regulation.
The determination of this environmental assessment is that there
will be no significant offsite impact to the public from this action.
Therefore, in accord with its commitment to complying with Executive
Order 12898--Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations, dated February 11,
1994, in all its actions, the NRC has also determined that there are no
disproportionate, high, and adverse impacts on minority and low-income
populations. The NRC uses the following working definition of
``environmental justice'': the fair treatment and meaningful
involvement of all people, regardless of race, ethnicity, culture,
income, or educational level with respect to the development,
implementation, and enforcement of environmental laws, regulations, and
policies.
The NRC requested public comments and the views of the States on
the environmental assessment for this rule. No comments were received
that addressed changes to the environmental assessment.
The environmental assessment is available for inspection at the NRC
Public Document Room, 2120 L Street, NW. (Lower Level), Washington, DC.
VI. Paperwork Reduction Act Statement
This final rule decreases the burden on licensees by eliminating
reporting requirements in Sec. 20.1703(a)(4) and (d). The burden
reduction for this information collection is estimated to be 250 hours
annually. Because the burden reduction for this information collection
is insignificant, compared to the overall burden of 10 CFR Part 20,
Office of Management and Budget (OMB) clearance is not required.
Existing requirements were approved by the Office of Management and
Budget, approval number 3150-0014.
VII. Public Protection Notification
If a means used to impose an information collection does not
display a currently valid OMB control number, the NRC may not conduct
or sponsor, and a person is not required to respond to, the information
collection.
VIII. Regulatory Analysis
The NRC has prepared a regulatory analysis for the amendments. The
analysis examines the benefits and impacts considered by the NRC. The
regulatory analysis is available for
[[Page 54555]]
inspection at the NRC Public Document Room at 2120 L Street NW. (Lower
Level), Washington, DC.
IX. Regulatory Flexibility Certification
As required by the Regulatory Flexibility Act of 1980, 5 U.S.C.
605(b), the NRC certifies that, this rule will not have a significant
economic impact on a substantial number of small entities. The
anticipated impact of the changes will not be significant because the
revised regulation basically represents a continuation of current
practice. The benefit of the rule is that it provides relief from
certain reporting and recordkeeping requirements, incorporates several
ANSI recommendations for improved programmatic procedures, and permits
the use of new, effective respiratory devices, thus increasing licensee
flexibility.
X. Backfit Analysis
Although the NRC staff has concluded that some of the changes being
made constitute a reduction in burden, the implementation of these and
other changes will require revisions to licensee procedures
constituting a backfit under 10 CFR 50.109(a)(1), 72.62(a)(2), and
76.76(a)(1). However, because the rule incorporates national consensus
standard (ANSI) recommendations that are worker safety related, the NRC
staff believes that this rule constitutes a substantial increase in the
overall protection of public health and safety that is cost justified.
The Regulatory Analysis that was prepared for this rule concluded
that the rule would result in a net benefit to industry of about $1.5
million dollars per year, including the cost of revising procedures.
The largest savings result from eliminating the need for a written
policy statement and permitting the use of disposable, filtering
facepieces instead of more expensive respirators. For most of the other
changes made in this final rule, the costs of implementing the change
are equal to the estimated cost savings. The Regulatory Analysis
further concludes that compared to the practice under the current Part
20, Subpart H, each change either involves no change in value/impact,
or represents an improvement in regulatory protection of worker health
and safety without any significant added costs (i.e., all value), or
presents the potential for reductions in regulatory burden and/or
increased operational flexibility with net savings to licensees and the
NRC.
Many of the changes only clarify existing requirements (i.e.,
reduce the potential for licensee misunderstandings) or formally adopt
recommendations of the current ANSI standard Z88.2-1992.
Section III in this FR Notice, Summary of Changes, summarizes the
changes to Subpart H of 10 CFR Part 20. The reasons for making these
changes are also provided. Many of the changes are considered by the
NRC to constitute a substantial worker safety enhancement in that they
reflect new consensus technical guidance published by the American
National Standards Institute (ANSI) on respiratory protection developed
since 10 CFR Part 20, Subpart H was published. The changes include
recognizing new respirator designs and types that were not available 20
years ago, changing the assigned protection factors (APFs) based on new
data, deleting certain reporting requirements which are considered no
longer needed for oversight of a mature industry, and numerous
procedural improvements that have been developed and proven by
respiratory practitioners.
Permitting the use of disposable, filtering facepieces, for
example, accommodates workers who voluntarily use respiratory
protection when it is not needed. These devices provide some
respiratory protection, do not impose stress or breathing resistance on
workers as do more cumbersome designs, and when credit is not being
taken for their use, do not require medical screening or fit testing.
Current NRC regulations list APFs that are inconsistent with
current national consensus standards. APFs are used to select types of
respirators to provide needed degree of protection, and to estimate the
intake and internal dose workers might receive. The new, and correct,
APFs will provide a substantial increase in worker protection.
Deleting two paperwork requirements that are no longer considered
useful or needed will permit resources to be redirected to more
important safety matters.
Incorporation of the ANSI fit test criteria provides a needed
safety margin that protects against deteriorating conditions in the
workplace that affect facepiece seal.
The rule also leads to greater uniformity of practice in that the
new requirements are consistent with the general respiratory protection
regulations published recently by OSHA. NRC licensees are often subject
to OSHA respiratory protection regulations when the intent is to
protect workers against non-radiological inhalation hazards. This final
rule would not require a licensee to maintain two distinct programs,
and only minor differences exist between the OSHA requirements and this
final rule.
In addition the new rules provide greater flexibility in practice
in that several new devices are now approved for use. Numerous
prescriptive requirements are deleted because they are redundant or no
longer needed. The Assigned Protection Factors currently in Appendix A
of 10 CFR Part 20 are incorrect; some are too conservative and others
might underprotect the worker. This rule corrects the APFs in the NRC
regulations according to the national consensus standard
recommendations of ANSI.
In conclusion, the Commission believes that for quantitative and
qualitative reasons, this rule change constitutes a burden reduction
and a substantial increase in the overall protection of public (worker)
health and safety that is cost justified.
XI. Small Business Regulatory Enforcement Fairness Act
In accordance with the Small Business Regulatory Enforcement
Fairness Act of 1996, the NRC has determined that this action is not a
major rule and has verified this determination with the Office of
Information and Regulatory Affairs of OMB.
XII. Voluntary Consensus Standards
The National Technology Transfer and Advancement Act of 1995,
Public Law 104-113, requires that Federal agencies use technical
standards that are developed or adopted by voluntary consensus
standards bodies unless the use of such a standard is inconsistent with
applicable law or otherwise impractical. In this final rule the NRC is
using recommendations from the following voluntary consensus standard,
``American National Standard for Respiratory Protection,'' (ANSI
Z88.2), American National Standards Institute, 1992.
List of Subjects in 10 CFR Part 20
Byproduct material, Licensed material, Nuclear materials, Nuclear
power plants and reactors, Occupational safety and health, Packaging
and containers, Penalty, Radiation protection, Reporting and recording
requirements, Special nuclear material, Source material, Waste
treatment and disposal.
For the reasons set out in the preamble and under the authority of
the Atomic Energy Act of 1954, as amended, the Energy Reorganization
Act of 1974, as amended, and 5 U.S.C. 552 and 553, the NRC is adopting
the following amendments to 10 CFR Part 20.
[[Page 54556]]
PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION
1. The authority citation for Part 20 continues to read as follows:
Authority: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68
Stat. 930, 933, 935, 936, 937, 948, 953, 955, as amended (42 U.S.C.
2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236), secs. 201, as
amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (U.S.C.
5841, 5842, 5846).
2. Section 20.1003 is amended by adding the definitions Air-
purifying respirator, Assigned protection factor (APF), Atmosphere-
supplying respirator, Demand respirator, Disposable respirator,
Filtering facepiece (dust mask), Fit factor, Fit test, Helmet, Hood,
Loose-fitting facepiece, Negative pressure respirator, Positive
pressure respirator, Powered air-purifying respirator (PAPR), Pressure
demand respirator, Qualitative fit test (QLFT), Quantitative fit test
(QNFT), Self-contained breathing apparatus (SCBA), Supplied-air
respirator (SAR) or airline respirator, Tight-fitting facepiece and
User seal check (fit check) (in alphabetical order) to read as follows:
Sec. 20.1003 Definitions.
* * * * *
Air-purifying respirator means a respirator with an air-purifying
filter, cartridge, or canister that removes specific air contaminants
by passing ambient air through the air-purifying element.
* * * * *
Assigned protection factor (APF) means the expected workplace level
of respiratory protection that would be provided by a properly
functioning respirator or a class of respirators to properly fitted and
trained users. Operationally, the inhaled concentration can be
estimated by dividing the ambient airborne concentration by the APF.
Atmosphere-supplying respirator means a respirator that supplies
the respirator user with breathing air from a source independent of the
ambient atmosphere, and includes supplied-air respirators (SARs) and
self-contained breathing apparatus (SCBA) units.
* * * * *
Demand respirator means an atmosphere-supplying respirator that
admits breathing air to the facepiece only when a negative pressure is
created inside the facepiece by inhalation.
* * * * *
Disposable respirator means a respirator for which maintenance is
not intended and that is designed to be discarded after excessive
breathing resistance, sorbent exhaustion, physical damage, or end-of-
service-life renders it unsuitable for use. Examples of this type of
respirator are a disposable half-mask respirator or a disposable
escape-only self-contained breathing apparatus (SCBA).
* * * * *
Filtering facepiece (dust mask) means a negative pressure
particulate respirator with a filter as an integral part of the
facepiece or with the entire facepiece composed of the filtering
medium, not equipped with elastomeric sealing surfaces and adjustable
straps.
Fit factor means a quantitative estimate of the fit of a particular
respirator to a specific individual, and typically estimates the ratio
of the concentration of a substance in ambient air to its concentration
inside the respirator when worn.
Fit test means the use of a protocol to qualitatively or
quantitatively evaluate the fit of a respirator on an individual.
* * * * *
Helmet means a rigid respiratory inlet covering that also provides
head protection against impact and penetration.
* * * * *
Hood means a respiratory inlet covering that completely covers the
head and neck and may also cover portions of the shoulders and torso.
* * * * *
Loose-fitting facepiece means a respiratory inlet covering that is
designed to form a partial seal with the face.
* * * * *
Negative pressure respirator (tight fitting) means a respirator in
which the air pressure inside the facepiece is negative during
inhalation with respect to the ambient air pressure outside the
respirator.
* * * * *
Positive pressure respirator means a respirator in which the
pressure inside the respiratory inlet covering exceeds the ambient air
pressure outside the respirator.
Powered air-purifying respirator (PAPR) means an air-purifying
respirator that uses a blower to force the ambient air through air-
purifying elements to the inlet covering.
Pressure demand respirator means a positive pressure atmosphere-
supplying respirator that admits breathing air to the facepiece when
the positive pressure is reduced inside the facepiece by inhalation.
* * * * *
Qualitative fit test (QLFT) means a pass/fail fit test to assess
the adequacy of respirator fit that relies on the individual's response
to the test agent.
* * * * *
Quantitative fit test (QNFT) means an assessment of the adequacy of
respirator fit by numerically measuring the amount of leakage into the
respirator.
* * * * *
Self-contained breathing apparatus (SCBA) means an atmosphere-
supplying respirator for which the breathing air source is designed to
be carried by the user.
* * * * *
Supplied-air respirator (SAR) or airline respirator means an
atmosphere-supplying respirator for which the source of breathing air
is not designed to be carried by the user.
* * * * *
Tight-fitting facepiece means a respiratory inlet covering that
forms a complete seal with the face.
* * * * *
User seal check (fit check) means an action conducted by the
respirator user to determine if the respirator is properly seated to
the face. Examples include negative pressure check, positive pressure
check, irritant smoke check, or isoamyl acetate check.
* * * * *
Subpart H--Respiratory Protection and Controls to Restrict Internal
Exposure
3. Section 20.1701 is revised to read as follows:
Sec. 20.1701 Use of process or other engineering controls.
The licensee shall use, to the extent practical, process or other
engineering controls (e.g., containment, decontamination, or
ventilation) to control the concentration of radioactive material in
air.
4. Section 20.1702, is revised to read as follows:
Sec. 20.1702 Use of other controls.
(a) When it is not practical to apply process or other engineering
controls to control the concentrations of radioactive material in the
air to values below those that define an airborne radioactivity area,
the licensee shall, consistent with maintaining the total effective
dose equivalent ALARA, increase monitoring and limit intakes by one or
more of the following means--
(1) Control of access;
(2) Limitation of exposure times;
(3) Use of respiratory protection equipment; or
(4) Other controls.
(b) If the licensee performs an ALARA analysis to determine whether
or not respirators should be used, the licensee
[[Page 54557]]
may consider safety factors other than radiological factors. The
licensee should also consider the impact of respirator use on workers'
industrial health and safety.
5. Section 20.1703 is revised to read as follows:
Sec. 20.1703 Use of individual respiratory protection equipment.
If the licensee assigns or permits the use of respiratory
protection equipment to limit the intake of radioactive material,
(a) The licensee shall use only respiratory protection equipment
that is tested and certified by the National Institute for Occupational
Safety and Health (NIOSH) except as otherwise noted in this part.
(b) If the licensee wishes to use equipment that has not been
tested or certified by NIOSH, or for which there is no schedule for
testing or certification, the licensee shall submit an application to
the NRC for authorized use of this equipment except as provided in this
part. The application must include evidence that the material and
performance characteristics of the equipment are capable of providing
the proposed degree of protection under anticipated conditions of use.
This must be demonstrated either by licensee testing or on the basis of
reliable test information.
(c) The licensee shall implement and maintain a respiratory
protection program that includes:
(1) Air sampling sufficient to identify the potential hazard,
permit proper equipment selection, and estimate doses;
(2) Surveys and bioassays, as necessary, to evaluate actual
intakes;
(3) Testing of respirators for operability (user seal check for
face sealing devices and functional check for others) immediately prior
to each use;
(4) Written procedures regarding--
(i) Monitoring, including air sampling and bioassays;
(ii) Supervision and training of respirator users;
(iii) Fit testing;
(iv) Respirator selection;
(v) Breathing air quality;
(vi) Inventory and control;
(vii) Storage, issuance, maintenance, repair, testing, and quality
assurance of respiratory protection equipment;
(viii) Recordkeeping; and
(ix) Limitations on periods of respirator use and relief from
respirator use;
(5) Determination by a physician that the individual user is
medically fit to use respiratory protection equipment; before
(i) The initial fitting of a face sealing respirator;
(ii) Before the first field use of non-face sealing respirators,
and
(iii) Either every 12 months thereafter, or periodically at a
frequency determined by a physician.
(6) Fit testing, with fit factor 10 times the APF for
negative pressure devices, and a fit factor 500 for any
positive pressure, continuous flow, and pressure-demand devices, before
the first field use of tight fitting, face-sealing respirators and
periodically thereafter at a frequency not to exceed 1 year. Fit
testing must be performed with the facepiece operating in the negative
pressure mode.
(d) The licensee shall advise each respirator user that the user
may leave the area at any time for relief from respirator use in the
event of equipment malfunction, physical or psychological distress,
procedural or communication failure, significant deterioration of
operating conditions, or any other conditions that might require such
relief.
(e) The licensee shall also consider limitations appropriate to the
type and mode of use. When selecting respiratory devices the licensee
shall provide for vision correction, adequate communication, low
temperature work environments, and the concurrent use of other safety
or radiological protection equipment. The licensee shall use equipment
in such a way as not to interfere with the proper operation of the
respirator.
(f) Standby rescue persons are required whenever one-piece
atmosphere-supplying suits, or any combination of supplied air
respiratory protection device and personnel protective equipment are
used from which an unaided individual would have difficulty extricating
himself or herself. The standby persons must be equipped with
respiratory protection devices or other apparatus appropriate for the
potential hazards. The standby rescue persons shall observe or
otherwise maintain continuous communication with the workers (visual,
voice, signal line, telephone, radio, or other suitable means), and be
immediately available to assist them in case of a failure of the air
supply or for any other reason that requires relief from distress. A
sufficient number of standby rescue persons must be immediately
available to assist all users of this type of equipment and to provide
effective emergency rescue if needed.
(g) Atmosphere-supplying respirators must be supplied with
respirable air of grade D quality or better as defined by the
Compressed Gas Association in publication G-7.1, ``Commodity
Specification for Air,'' 1997 and included in the regulations of the
Occupational Safety and Health Administration (29 CFR
1910.134(i)(1)(ii)(A) through (E). Grade D quality air criteria
include--
(1) Oxygen content (v/v) of 19.5-23.5%;
(2) Hydrocarbon (condensed) content of 5 milligrams per cubic meter
of air or less;
(3) Carbon monoxide (CO) content of 10 ppm or less;
(4) Carbon dioxide content of 1,000 ppm or less; and
(5) Lack of noticable odor.
(h) The licensee shall ensure that no objects, materials or
substances, such as facial hair, or any conditions that interfere with
the face--facepiece seal or valve function, and that are under the
control of the respirator wearer, are present between the skin of the
wearer's face and the sealing surface of a tight-fitting respirator
facepiece.
(i) In estimating the dose to individuals from intake of airborne
radioactive materials, the concentration of radioactive material in the
air that is inhaled when respirators are worn is initially assumed to
be the ambient concentration in air without respiratory protection,
divided by the assigned protection factor. If the dose is later found
to be greater than the estimated dose, the corrected value must be
used. If the dose is later found to be less than the estimated dose,
the corrected value may be used.
6. Section 20.1704 is revised to read as follows:
Sec. 20.1704 Further restrictions on the use of respiratory protection
equipment.
The Commission may impose restrictions in addition to the
provisions of Secs. 20.1702, 20.1703, and Appendix A to Part 20, in
order to:
(a) Ensure that the respiratory protection program of the licensee
is adequate to limit doses to individuals from intakes of airborne
radioactive materials consistent with maintaining total effective dose
equivalent ALARA; and
(b) Limit the extent to which a licensee may use respiratory
protection equipment instead of process or other engineering controls.
7. Section 20.1705 is added to subpart H as follows:
Sec. 20.1705 Application for use of higher assigned protection
factors.
The licensee shall obtain authorization from the Commission before
using assigned protection factors in excess of those specified in
Appendix
[[Page 54558]]
A to Part 20. The Commission may authorize a licensee to use higher
assigned protection factors on receipt of an application that--
(a) Describes the situation for which a need exists for higher
protection factors; and
(b) Demonstrates that the respiratory protection equipment provides
these higher protection factors under the proposed conditions of use.
8. Appendix A to Part 20 is revised to read as follows:
Appendix A to Part 20.--Assigned Protection Factors for Respirators a
------------------------------------------------------------------------
Assigned
Operating mode Protection
Factors
------------------------------------------------------------------------
I. Air Purifying Respirators
[Particulate b only] c:
Filtering facepiece Negative Pressure....... (d)
disposabled.
Facepiece, half e............ Negative Pressure....... 10
Facepiece, full.............. Negative Pressure....... 100
Facepiece, half.............. Powered air-purifying 50
respirators.
Facepiece, full.............. Powered air-purifying 1000
respirators.
Helmet/hood.................. Powered air-purifying 1000
respirators.
Facepiece, loose-fitting..... Powered air-purifying 25
respirators.
II. Atmosphere supplying
respirators [particulate, gases
and vapors f]:
1. Air-line respirator:
Facepiece, half.......... Demand.................. 10
Facepiece, half.......... Continuous Flow......... 50
Facepiece, half.......... Pressure Demand......... 50
Facepiece, full.......... Demand.................. 100
Facepiece, full.......... Continuous Flow......... 1000
Facepiece, full.......... Pressure Demand......... 1000
Helmet/hood.............. Continuous Flow......... 1000
Facepiece, loose-fitting. Continuous Flow......... 25
Suit..................... Continuous Flow......... (g)
2. Self-contained breathing
Apparatus (SCBA):
Facepiece, full.......... Demand.................. i 100
Facepiece, full.......... Pressure Demand......... i 10,000
Facepiece, full.......... Demand, Recirculating... i 100
Facepiece, full.......... Positive Pressure i 10,000
Recirculating.
III. Combination Respirators:
Any combination of air- Assigned protection factor for type
purifying and atmosphere- and mode of operation as listed
supplying respirators. above.
------------------------------------------------------------------------
a These assigned protection factors apply only in a respiratory
protection program that meets the requirements of this Part. They are
applicable only to airborne radiological hazards and may not be
appropriate to circumstances when chemical or other respiratory
hazards exist instead of, or in addition to, radioactive hazards.
Selection and use of respirators for such circumstances must also
comply with Department of Labor regulations.
Radioactive contaminants for which the concentration values in Table 1,
Column 3 of Appendix B to Part 20 are based on internal dose due to
inhalation may, in addition, present external exposure hazards at
higher concentrations. Under these circumstances, limitations on
occupancy may have to be governed by external dose limits.
b Air purifying respirators with APF <100 must="" be="" equipped="" with="" particulate="" filters="" that="" are="" at="" least="" 95="" percent="" efficient.="" air="" purifying="" respirators="" with="" apf="100" must="" be="" equipped="" with="" particulate="" filters="" that="" are="" at="" least="" 99="" percent="" efficient.="" air="" purifying="" respirators="" with="" apfs="">100 must be equipped with particulate filters
that are at least 99.97 percent efficient.
c The licensee may apply to the Commission for the use of an APF greater
than 1 for sorbent cartridges as protection against airborne
radioactive gases and vapors (e.g., radioiodine).
d Licensees may permit individuals to use this type of respirator who
have not been medically screened or fit tested on the device provided
that no credit be taken for their use in estimating intake or dose. It
is also recognized that it is difficult to perform an effective
positive or negative pressure pre-use user seal check on this type of
device. All other respiratory protection program requirements listed
in Sec. 20.1703 apply. An assigned protection factor has not been
assigned for these devices. However, an APF equal to 10 may be used if
the licensee can demonstrate a fit factor of at least 100 by use of a
validated or evaluated, qualitative or quantitative fit test.
e Under-chin type only. No distinction is made in this Appendix between
elastomeric half-masks with replaceable cartridges and those designed
with the filter medium as an integral part of the facepiece (e.g.,
disposable or reusable disposable). Both types are acceptable so long
as the seal area of the latter contains some substantial type of seal-
enhancing material such as rubber or plastic, the two or more
suspension straps are adjustable, the filter medium is at least 95
percent efficient and all other requirements of this Part are met.
f The assigned protection factors for gases and vapors are not
applicable to radioactive contaminants that present an absorption or
submersion hazard. For tritium oxide vapor, approximately one-third of
the intake occurs by absorption through the skin so that an overall
protection factor of 3 is appropriate when atmosphere-supplying
respirators are used to protect against tritium oxide. Exposure to
radioactive noble gases is not considered a significant respiratory
hazard, and protective actions for these contaminants should be based
on external (submersion) dose considerations.
g No NIOSH approval schedule is currently available for atmosphere
supplying suits. This equipment may be used in an acceptable
respiratory protection program as long as all the other minimum
program requirements, with the exception of fit testing, are met
(i.e., Sec. 20.1703).
h The licensee should implement institutional controls to assure that
these devices are not used in areas immediately dangerous to life or
health (IDLH).
i This type of respirator may be used as an emergency device in unknown
concentrations for protection against inhalation hazards. External
radiation hazards and other limitations to permitted exposure such as
skin absorption shall be taken into account in these circumstances.
This device may not be used by any individual who experiences
perceptible outward leakage of breathing gas while wearing the device.
[[Page 54559]]
Dated at Rockville, Maryland this 30th day of September, 1999.
For the Nuclear Regulatory Commission.
Andrew L. Bates,
Acting Secretary of the Commission.
[FR Doc. 99-25977 Filed 10-6-99; 8:45 am]
BILLING CODE 7590-01-P
