[Title 42 CFR G]
[Code of Federal Regulations (annual edition) - October 1, 2008 Edition]
[Title 42 - PUBLIC HEALTH]
[Chapter I - PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN]
[Subchapter G - OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED]
[From the U.S. Government Printing Office]
42PUBLIC HEALTH12008-10-012008-10-01falseOCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATEDGSUBCHAPTER GPUBLIC HEALTHPUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN
SUBCHAPTER G_OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED
ACTIVITIES
PART 80_ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES--Table of Contents
Subparts A-C [Reserved]
Subpart D_Tuition Fees for Direct Training
Sec.
80.41 Applicability.
80.42 Definitions.
80.43 Tuition fees.
80.44 Schedule of fees.
80.45 Procedure for payment.
80.46 Refunds.
Subparts A-C [Reserved]
Subpart D_Tuition Fees for Direct Training
Authority: Sec. 501, 65 Stat. 290; 31 U.S.C. 483a.
Source: 38 FR 16645, June 25, 1973, unless otherwise noted.
Subparts A-C [Reserved]
Sec. 80.41 Applicability.
The provisions of this subpart set forth the policies of the
National Institute for Occupational Safety and Health with respect to
its charging fees for direct training in occupational safety or health.
Sec. 80.42 Definitions.
Any term not defined herein shall have the same meaning as given it
in the act. As used in this subpart:
(a) Act means the Occupational Safety and Health Act of 1970 (29
U.S.C. 651 et seq.).
(b) Direct training means all technical training courses conducted
directly by NIOSH for personnel of State and local governmental
agencies, other Federal agencies, private industries, universities, and
other non-NIOSH agencies and organizations.
(c) NIOSH or Institute means the National Institute for Occupational
Safety and Health.
(d) Registration Office means the Direct Training Registration
Office, NIOSH, 1014 Broadway, Cincinnati, OH 45202.
Sec. 80.43 Tuition fees.
In accordance with the provisions of the subpart, the National
Institute for Occupational Safety and Health will charge fees for all
students attending NIOSH direct training courses which commence on or
after July 1, 1973.
Sec. 80.44 Schedule of fees.
(a) Tuition fees will be computed on the basis of the cost to the
Government for the Institute's participation in the course, as
determined by the Director of the Institute.
(b) Total tuition charges for each course will be set forth in the
course announcement.
Sec. 80.45 Procedure for payment.
(a) Applications for direct training courses shall be completed and
submitted to the registration office in accordance with the instructions
issued by that office.
(b) Federal agency personnel shall, upon notification of their
acceptance, submit a letter identifying the agency and office to be
billed, the agency order number, and any code numbers or other
information necessary for billing purposes.
(c) All other applicants shall, upon notification of their
acceptance by NIOSH, submit a check payable to the National Institute
for Occupational Safety and Health in the amount indicated by the course
announcement prior to the commencement of the training course.
Sec. 80.46 Refunds.
An applicant may withdraw his application and receive full
reimbursement of the fee provided that written notification to the
registration office is mailed no later than 10 days before the
commencement of the course for which registration has been submitted.
[[Page 464]]
PART 81_GUIDELINES FOR DETERMINING PROBABILITY OF CAUSATION UNDER THE ENERGY
EMPLOYEES OCCUPATIONAL ILLNESS COMPENSATION PROGRAM ACT OF 2000--Table of
Contents
Subpart A_Introduction
Sec.
81.0 Background.
81.1 Purpose and Authority.
81.2 Provisions of EEOICPA concerning this part.
Subpart B_Definitions
81.4 Definition of terms used in this part.
Subpart C_Data Required To Estimate Probability of Causation
81.5 Use of personal and medical information
81.6 Use of radiation dose information.
Subpart D_Requirements for Risk Models Used To Estimate Probability of
Causation
81.10 Use of cancer risk assessment models in NIOSH-IREP.
81.11 Use of uncertainty analysis in NIOSH-IREP.
81.12 Procedure for updating NIOSH-IREP.
Subpart E_Guidelines To Estimate Probability of Causation
81.20 Required use of NIOSH-IREP.
81.21 Cancers requiring the use of NIOSH-IREP.
81.22 General guidelines for use of NIOSH-IREP.
81.23 Guidelines for cancers for which primary site is unknown.
81.24 Guidelines for leukemia.
81.25 Guidelines for claims involving two or more primary cancers.
81.30 Non-radiogenic cancers.
Appendix A to Part 81--Glossary of ICD-9 codes and their cancer
descriptions.
Authority: 42 U.S.C. 7384n(c); E.O. 13179, 65 FR 77487, 3 CFR, 2000
Comp., p. 321.
Source: 67 FR 22309, May 2, 2002, unless otherwise noted.
Subpart A_Introduction
Sec. 81.0 Background.
The Energy Employees Occupational Illness Compensation Program Act
(EEOICPA), 42 U.S.C. 7384-7385 [1994, supp. 2001], provides for the
payment of compensation benefits to covered employees and, where
applicable, survivors of such employees, of the United States Department
of Energy, its predecessor agencies and certain of its contractors and
subcontractors. Among the types of illnesses for which compensation may
be provided are cancers. There are two categories of covered employees
with cancer under EEOICPA for whom compensation may be provided. The
regulations that follow under this part apply only to the category of
employees described under paragraph (a) of this section.
(a) One category is employees with cancer for whom probability of
causation must be estimated or determined, as required under 20 CFR
30.115.
(b) The second category is members of the Special Exposure Cohort
seeking compensation for a specified cancer, as defined under EEOICPA.
The U.S. Department of Labor (DOL) which has primary authority for
implementing EEOICPA, has promulgated regulations at 20 CFR 30.210 et
seq. that identify current members of the Special Exposure Cohort and
requirements for compensation. Pursuant to section 7384(q) of EEOICPA,
the Secretary of HHS is authorized to add additional classes of
employees to the Special Exposure Cohort.
Sec. 81.1 Purpose and Authority.
(a) The purpose of this regulation is to establish guidelines DOL
will apply to adjudicate cancer claims for covered employees seeking
compensation for cancer, other than as members of the Special Exposure
Cohort seeking compensation for a specified cancer. To award a claim,
DOL must first determine that it is at least as likely as not that the
cancer of the employee was caused by radiation doses incurred by the
employee in the performance of duty. These guidelines provide the
procedures DOL must apply and identify the information DOL will use.
(b) Section 7384(n)(b) of EEOICPA requires the President to
promulgate these guidelines. Executive Order 13179 assigned
responsibility for promulgating these guidelines to the Secretary of
HHS.
[[Page 465]]
Sec. 81.2 Provisions of EEOICPA concerning this part.
EEOICPA imposes several general requirements concerning the
development of these guidelines. It requires that the guidelines produce
a determination as to whether it is at least as likely as not (a 50% or
greater probability) that the cancer of the covered employee was related
to radiation doses incurred by the employee in the performance of duty.
It requires the guidelines be based on the radiation dose received by
the employee, incorporating the methods of dose reconstruction to be
established by HHS. It requires determinations be based on the upper 99
percent confidence interval (credibility limit) of the probability of
causation in the RadioEpidemiological tables published under section
7(b) of the Orphan Drug Act (42 U.S.C. 241 note), as such tables may be
updated. EEOICPA also requires HHS consider the type of cancer, past
health-related activities, the risk of developing a radiation-related
cancer from workplace exposure, and other relevant factors. Finally, it
is important to note EEOICPA does not include a requirement limiting the
types of cancers to be considered radiogenic for these guidelines.
Subpart B_Definitions
Sec. 81.4 Definition of terms used in this part.
(a) Covered employee, for purposes of this part, means an individual
who is or was an employee of DOE, a DOE contractor or subcontractor, or
an atomic weapons employer, and for whom DOL has requested HHS to
perform a dose reconstruction.
(b) Dose and dose rate effectiveness factor (DDREF) means a factor
applied to a risk model to modify the dose-risk relationship estimated
by the model to account for the level of the dose and the rate at which
the dose is incurred. As used in IREP, a DDREF value of greater than one
implies that chronic or low doses are less carcinogenic per unit of dose
than acute or higher doses.
(c) Dose-response relationship means a mathematical expression of
the way that the risk of a biological effect (for example, cancer)
changes with increased exposure to a potential health hazard (for
example, ionizing radiation).
(d) EEOICPA means the Energy Employees Occupational Illness
Compensation Program Act of 2000, 42 U.S.C. Sec. Sec. 7384-7385 [1994,
supp. 2001].
(e) Equivalent dose means the absorbed dose in a tissue or organ
multiplied by a radiation weighting factor to account for differences in
the effectiveness of the radiation in inducing cancer.
(f) External dose means the portion of the equivalent dose that is
received from radiation sources outside of the body.
(g) Interactive RadioEpidemiological Program (IREP) means a computer
software program that uses information on the dose-response
relationship, and specific factors such as a claimant's radiation
exposure, gender, age at diagnosis, and age at exposure to calculate the
probability of causation for a given pattern and level of radiation
exposure.
(h) Internal dose means the portion of the equivalent dose that is
received from radioactive materials taken into the body.
(i) Inverse dose rate effect means a phenomenon in which the
protraction of an exposure to a potential health hazard leads to greater
biological effect per unit of dose than the delivery of the same total
amount in a single dose. An inverse dose rate effect implies that the
dose and dose rate effectiveness factor (DDREF) is less than one for
chronic or low doses.
(j) Linear energy transfer (LET) means the average amount of energy
transferred to surrounding body tissues per unit of distance the
radiation travels through body tissues (track length). Low LET radiation
is typified by gamma and x rays, which have high penetrating
capabilities through various tissues, but transfer a relatively small
amount of energy to surrounding tissue per unit of track length. High
LET radiation includes alpha particles and neutrons, which have weaker
penetrating capability but transfer a larger amount of energy per unit
of track length.
(k) NIOSH means the National Institute for Occupational Safety and
Health, Centers for Disease Control and
[[Page 466]]
Prevention, United States Department of Health and Human Services.
(l) Non-radiogenic cancer means a type of cancer that HHS has found
not to be caused by radiation, for the purposes of this regulation.
(m) Primary cancer means a cancer defined by the original body site
at which the cancer was incurred, prior to any spread (metastasis) to
other sites in the body.
(n) Probability of causation means the probability or likelihood
that a cancer was caused by radiation exposure incurred by a covered
employee in the performance of duty. In statistical terms, it is the
cancer risk attributable to radiation exposure divided by the sum of the
baseline cancer risk (the risk to the general population) plus the
cancer risk attributable to the radiation exposure.
(o) RadioEpidemiological Tables means tables that allow computation
of the probability of causation for various cancers associated with a
defined exposure to radiation, after accounting for factors such as age
at exposure, age at diagnosis, and time since exposure.
(p) Relative biological effectiveness (RBE) means a factor applied
to a risk model to account for differences between the amount of cancer
effect produced by different forms of radiation. For purposes of
EEOICPA, the RBE is considered equivalent to the radiation weighting
factor.
(q) Risk model means a mathematical model used under EEOICPA to
estimate a specific probability of causation using information on
radiation dose, cancer type, and personal data (e.g., gender, smoking
history).
(r) Secondary site means a body site to which a primary cancer has
spread (metastasized).
(s) Specified cancer is a term defined in Sec. 7384(l)(17) of
EEOICPA and 20 CFR 30.5(dd) that specifies types of cancer that,
pursuant to 20 CFR part 30, may qualify a member of the Special Exposure
Cohort for compensation. It includes leukemia (other than chronic
lymphocytic leukemia), multiple myeloma, non-Hodgkin's lymphoma, renal
cancers, and cancers of the lung (other than carcinoma in situ diagnosed
at autopsy), thyroid, male breast, female breast, esophagus, stomach,
pharynx, small intestine, pancreas, bile ducts, gall bladder, salivary
gland, urinary bladder, brain, colon, ovary, liver (not associated with
cirrhosis or hepatitis B), and bone.
(t) Uncertainty is a term used in this rule to describe the lack of
precision of a given estimate, the extent of which depends upon the
amount and quality of the evidence or data available.
(u) Uncertainty distribution is a statistical term meaning a range
of discrete or continuous values arrayed around a central estimate,
where each value is assigned a probability of being correct.
(v) Upper 99 percent confidence interval is a term used in EEOICPA
to mean credibility limit, the probability of causation estimate
determined at the 99th percentile of the range of uncertainty around the
central estimate of probability of causation.
Subpart C_Data Required To Estimate Probability of Causation
Sec. 81.5 Use of personal and medical information.
Determining probability of causation may require the use of the
following personal and medical information provided to DOL by claimants
under DOL regulations 20 CFR part 30:
(a) Year of birth
(b) Cancer diagnosis (by ICD-9 code) for primary and secondary
cancers
(c) Date of cancer diagnosis
(d) Gender
(e) Race/ethnicity (if the claim is for skin cancer or a secondary
cancer for which skin cancer is a likely primary cancer)
(f) Smoking history (if the claim is for lung cancer or a secondary
cancer for which lung cancer is a likely primary cancer)
Sec. 81.6 Use of radiation dose information.
Determining probability of causation will require the use of
radiation dose information provided to DOL by the National Institute for
Occupational Safety and Health (NIOSH) under HHS regulations 42 CFR part
82. This information will include annual dose estimates for each year in
which a dose was incurred, together with uncertainty distributions
associated with
[[Page 467]]
each dose estimate. Dose estimates will be distinguished by type of
radiation (low linear energy transfer (LET), protons, neutrons, alpha,
low-energy x-ray) and by dose rate (acute or chronic) for external and
internal radiation dose.
Subpart D_Requirements for Risk Models Used To Estimate Probability of
Causation
Sec. 81.10 Use of cancer risk assessment models in NIOSH IREP.
(a) The risk models used to estimate probability of causation for
covered employees under EEOICPA will be based on risk models updated
from the 1985 NIH Radioepidemiological Tables. These 1985 tables were
developed from analyses of cancer mortality risk among the Japanese
atomic bomb survivor cohort. The National Cancer Institute (NCI) and
Centers for Disease Control and Prevention (CDC) are updating the
tables, replacing them with a sophisticated analytic software program.
This program, the Interactive RadioEpidemiological Program (IREP)\1\,
models the dose-response relationship between ionizing radiation and 33
cancers using morbidity data from the same Japanese atomic bomb survivor
cohort. In the case of thyroid cancer, radiation risk models are based
on a pooled analysis of several international cohorts\1a\.
---------------------------------------------------------------------------
\1\ NIOSH-IREP is available for public review on the NIOSH homepage
at: www.cdc.gov/niosh/ocas/ocasirep/html.
\1a\ Ron E, Lubin JH, Shore RE, et al. ``Thyroid cancer after
exposure to external radiation: a pooled analysis of seven studies.''
Radiat. Res. 141:259-277, 1995.
---------------------------------------------------------------------------
(b) NIOSH will change the risk models in IREP, as needed, to reflect
the radiation exposure and disease experiences of employees covered
under EEOICPA, which differ from the experiences of the Japanese atomic
bomb survivor cohort. Changes will be incorporated in a version of IREP
named NIOSH-IREP, specifically designed for adjudication of claims under
EEOICPA. Possible changes in IREP risk models include the following:
(1) Addition of risk models to IREP, as needed, for claims under
EEOICPA (e.g., malignant melanoma and other skin cancers)
(2) Modification of IREP risk models to incorporate radiation
exposures unique to employees covered by EEOICPA (e.g., radon and low
energy x rays from employer-required medical screening programs,
adjustment of relative biological effectiveness distributions based on
neutron energy).
(3) Modification of IREP risk models to incorporate new
understanding of radiation-related cancer effects relevant to employees
covered by EEOICPA (e.g., incorporation of inverse dose-rate
relationship between high LET radiation exposures and cancer; adjustment
of the low-dose effect reduction factor for acute exposures).
(4) Modification of IREP risk models to incorporate new
understanding of the potential interaction between cancer risk
associated with occupational exposures to chemical carcinogens and
radiation-related cancer effects.
(5) Modification of IREP risk models to incorporate temporal, race
and ethnicity-related differences in the frequency of certain cancers
occurring generally among the U.S. population.
(6) Modifications of IREP to facilitate improved evaluation of the
uncertainty distribution for the probability of causation for claims
based on two or more primary cancers.
Sec. 81.11 Use of uncertainty analysis in NIOSH-IREP.
(a) EEOICPA requires use of the uncertainty associated with the
probability of causation calculation, specifically requiring the use of
the upper 99% confidence interval (credibility limit) estimate of the
probability of causation estimate. As described in the NCI document, \2\
uncertainty from several sources is incorporated into the probability of
causation calculation performed by NIOSH-IREP. These sources include
uncertainties in estimating: radiation dose incurred by the covered
employee; the radiation dose-cancer relationship (statistical
uncertainty in the specific cancer risk
[[Page 468]]
model); the extrapolation of risk (risk transfer) from the Japanese to
the U.S. population; differences in the amount of cancer effect caused
by different radiation types (relative biological effectiveness or RBE);
the relationship between the rate at which a radiation dose is incurred
and the level of cancer risk produced (dose and dose rate effectiveness
factor or DDREF); and, the role of non-radiation risk factors (such as
smoking history).
---------------------------------------------------------------------------
\2\ Draft Report of the NCI-CDC Working Group to Revise the 1985 NIH
Radioepidemiological Tables, May 31, 2000, p. 17-18, p. 22-23.
---------------------------------------------------------------------------
(b) NIOSH-IREP will operate according to the same general protocol
as IREP for the analysis of uncertainty. It will address the same
possible sources of uncertainty affecting probability of causation
estimates, and in most cases will apply the same assumptions
incorporated in IREP risk models. Different procedures and assumptions
will be incorporated into NIOSH-IREP as needed, according to the
criteria outlined under Sec. 81.10.
Sec. 81.12 Procedure to update NIOSH-IREP.
(a) NIOSH may periodically revise NIOSH-IREP to add, modify, or
replace cancer risk models, improve the modeling of uncertainty, and
improve the functionality and user-interface of NIOSH-IREP.
(b) Revisions to NIOSH-IREP may be recommended by the following
sources:
(1) NIOSH,
(2) The Advisory Board on Radiation and Worker Health,
(3) Independent reviews of NIOSH-IREP or elements thereof by
scientific organizations (e.g., National Academy of Sciences),
(4) DOL,
(5) Public comment.
(c) NIOSH will submit substantive changes to NIOSH-IREP (changes
that would substantially affect estimates of probability of causation
calculated using NIOSH-IREP, including the addition of new cancer risk
models) to the Advisory Board on Radiation and Worker Health for review.
NIOSH will obtain such review and address any recommendations of the
review before completing and implementing the change.
(d) NIOSH will inform the public of proposed changes provided to the
Advisory Board for review. HHS will provide instructions for obtaining
relevant materials and providing public comment in the notice announcing
the Advisory Board meeting, published in the Federal Register.
(e) NIOSH will publish periodically a notice in the Federal Register
informing the public of proposed substantive changes to NIOSH-IREP
currently under development, the status of the proposed changes, and the
expected completion dates.
(f) NIOSH will notify DOL and publish a notice in the Federal
Register notifying the public of the completion and implementation of
substantive changes to NIOSH-IREP. In the notice, NIOSH will explain the
effect of the change on estimates of probability of causation and will
summarize and address relevant comments received by NIOSH.
(g) NIOSH may take into account other factors and employ other
procedures than those specified in this section, if circumstances arise
that require NIOSH to implement a change more immediately than the
procedures in this section allow.
Subpart E_Guidelines To Estimate Probability of Causation
Sec. 81.20 Required use of NIOSH-IREP.
(a) NIOSH-IREP is an interactive software program for estimating
probability of causation for covered employees seeking compensation for
cancer under EEOICPA, other than as members of the Special Exposure
Cohort seeking compensation for a specified cancer.
(b) DOL is required to use NIOSH-IREP to estimate probability of
causation for all cancers, as identified under Sec. Sec. 81.21 and
81.23.
Sec. 81.21 Cancers requiring the use of NIOSH-IREP.
(a) DOL will calculate probability of causation for all cancers,
except chronic lymphocytic leukemia as provided under Sec. 81.30, using
NIOSH-IREP.
(b) Carcinoma in situ (ICD-9 codes 230-234), neoplasms of uncertain
behavior (ICD-9 codes 235-238), and neoplasms of unspecified nature
(ICD-9 code 239) are assumed to be malignant,
[[Page 469]]
for purposes of estimating probability of causation.
(c) All secondary and unspecified cancers of the lymph node (ICD-9
code 196) shall be considered secondary cancers (cancers resulting from
metastasis of cancer from a primary site). For claims identifying
cancers of the lymph node, Table 1 in Sec. 81.23 provides guidance for
assigning a primary site and calculating probability of causation using
NIOSH-IREP.
Sec. 81.22 General guidelines for use of NIOSH-IREP.
DOL will use procedures specified in the NIOSH-IREP Operating Guide
to calculate probability of causation estimates under EEOICPA. The guide
provides current, step-by-step instructions for the operation of IREP.
The procedures include entering personal, diagnostic, and exposure data;
setting/confirming appropriate values for variables used in
calculations; conducting the calculation; and, obtaining, evaluating,
and reporting results.
Sec. 81.23 Guidelines for cancers for which primary site is unknown.
(a) In claims for which the primary cancer site cannot be
determined, but a site of metastasis is known, DOL will calculate
probability of causation estimates for various likely primary sites.
Table 1, below, indicates the primary cancer site(s) DOL will use in
NIOSH-IREP when the primary cancer site is unknown.
Table 1
Primary cancers (ICD-9 codes \3\) for which probability of causation
is to be calculated, if only a secondary cancer site is known. ``M''
indicates cancer site should be used for males only, and ``F'' indicates
the cancer site should be used for females only. A glossary of cancer
descriptions for each ICD-9 code is provided in Appendix A to this part.
---------------------------------------------------------------------------
\3\ The International Classification of Diseases Clinical
Modification (9th Revision) Volume I&II. [1991] Department of Health and
Human Services Publication No. (PHS) 91-1260, U.S. Government Printing
Office, Washington D.C.
------------------------------------------------------------------------
Secondary cancer (ICD-9 code) ICD-9 code of likely primary cancers
------------------------------------------------------------------------
Lymph nodes of head, face and 141, 142 (M), 146 (M), 149 (F), 161 (M),
neck (196.0). 162, 172, 173, 174 (F), 193 (F).
Intrathoracic lymph nodes 150 (M), 162, 174 (F).
(196.1).
Intra-abdominal lymph nodes 150 (M), 151 (M), 153, 157 (F), 162, 174
(196.2). (F), 180 (F), 185 (M), 189, 202 (F).
Lymph nodes of axilla and 162, 172, 174 (F).
upper limb (196.3).
Inguinal and lower limb lymph 154 (M), 162, 172, 173 (F), 187 (M).
nodes (196.5).
Intrapelvic lymph nodes 153 (M), 154 (F), 162 (M), 180 (F), 182
(196.6). (F), 185 (M), 188.
Lymph nodes of multiple sites 150 (M), 151 (M), 153 (M), 162, 174 (F).
(196.8).
Lymph nodes, site unspecified 150 (M), 151, 153, 162, 172, 174 (F), 185
(196.9). (M).
Lung (197.0)................. 153, 162, 172 (M), 174 (F), 185 (M), 188
(M), 189.
Mediastinum (197.1).......... 150 (M), 162, 174 (F).
Pleura (197.2)............... 150 (M), 153 (M), 162, 174 (F), 183 (F),
185 (M), 189 (M).
Other respiratory organs 150, 153 (M), 161, 162, 173 (M), 174 (F),
(197.3). 185 (M), 193 (F).
Small intestine, including 152, 153, 157, 162, 171, 172 (M), 174
duodenum (197.4). (F), 183 (F), 189 (M).
Large intestine and rectum 153, 154, 162, 174 (F), 183 (F), 185 (M).
(197.5).
Retroperitoneum and 151, 153, 154 (M), 157, 162 (M), 171, 174
peritoneum (197.6). (F), 182 (F), 183 (F).
Liver, specified as secondary 151 (M), 153, 154 (M), 157, 162, 174 (F).
(197.7).
Other digestive organs 150 (M), 151, 153, 157, 162, 174 (F), 185
(197.8). (M).
Kidney (198.0)............... 153, 162, 174 (F), 180 (F), 185 (M), 188,
189, 202 (F).
Other urinary organs (198.1). 153, 174 (F), 180 (F), 183 (F), 185 (M),
188, 189 (F).
Skin (198.2)................. 153, 162, 171 (M), 172, 173 (M), 174 (F),
189 (M).
Brain and spinal cord (198.3) 162, 172 (M), 174 (F).
Other parts of nervous system 162, 172 (M), 174 (F), 185 (M), 202.
(198.4).
Bone and bone marrow (198.5). 162, 174 (F), 185 (M).
Ovary (198.6)................ 153 (F), 174 (F), 183 (F).
Suprarenal gland (198.7)..... 153 (F), 162, 174 (F).
Other specified sites (198.8) 153, 162, 172 (M), 174 (F), 183 (F), 185
(M), 188 (M).
------------------------------------------------------------------------
[[Page 470]]
(b) DOL will select the site producing the highest estimate for
probability of causation to adjudicate the claim.
Sec. 81.24 Guidelines for leukemia.
(a) For claims involving leukemia, DOL will calculate one or more
probability of causation estimates from up to three of the four
alternate leukemia risk models included in NIOSH-IREP, as specified in
the NIOSH-IREP Operating Guide. These include: ``Leukemia, all types
except CLL'' (IDC-9 codes: 204-208, except 204.1), ``acute lymphocytic
leukemia'' (ICD-9 code: 204.0), and ``acute myelogenous leukemia'' (ICD-
9 code: 205.0).
(b) For leukemia claims in which DOL calculates multiple probability
of causation estimates, as specified in the NIOSH-IREP Operating Guide,
the probability of causation estimate DOL assigns to the claim will be
based on the leukemia risk model producing the highest estimate for
probability of causation.
Sec. 81.25 Guidelines for claims including two or more primary cancers.
For claims including two or more primary cancers, DOL will use
NIOSH-IREP to calculate the estimated probability of causation for each
cancer individually. Then DOL will perform the following calculation
using the probability of causation estimates produced by NIOSH-IREP:
Equation 1
Calculate: 1-[{1-PC1{time} x {1-PC2{time} x. . .
x {1-PCn{time} ] = PCtotal,
where PC1 is the probability of causation for one of the
primary cancers identified in the claim, PC2 is the
probability of causation for a second primary cancer identified in the
claim, and PCn is the probability of causation for the nth
primary cancer identified in the claim. PCtotal is the
probability that at least one of the primary cancers (cancers 1 through
``n'') was caused by the radiation dose estimated for the claim when
Equation 1 is evaluated based on the joint distribution of
PC1, . . ., PCn.\4\ DOL will use the probability
of causation value calculated for PCtotal to adjudicate the
claim.
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\4\ Evaluating Equation 1 based on the individual upper 99th
percentiles of PC1, . . ., PCn approximates the
upper 99th percentile of PCtotal whenever PC1, . .
., PCn are highly related, e.g., when a common dose-
reconstruction is the only non-negligible source of uncertainty in the
individual PCi's. However, this approximation can
overestimate it if other sources of uncertainty contribute independently
to the PC1, . . ., PCn, whereas treating the joint
distribution as fully independent could substantially underestimate the
upper 99th percentile of PCtotal whenever the individual
PCi's are positively correlated.
[67 FR 22309, May 2, 2002; 67 FR 62096, Oct. 3, 2002]
Sec. 81.30 Non-radiogenic cancers.
The following cancers are considered non-radiogenic for the purposes
of EEOICPA and this part. DOL will assign a probability of causation of
zero to the following cancers:
(a) Chronic lymphocytic leukemia (ICD-9 code: 204.1)
(b) [Reserved]
Sec. Appendix A to Part 81--Glossary of ICD-9 Codes and Their Cancer
Descriptions \1\
------------------------------------------------------------------------
ICD-9 code Cancer description
------------------------------------------------------------------------
140....................................... Malignant neoplasm of lip.
141....................................... Malignant neoplasm of
tongue.
142....................................... Malignant neoplasm of major
salivary glands.
143....................................... Malignant neoplasm of gum.
144....................................... Malignant neoplasm of floor
of mouth.
145....................................... Malignant neoplasm of other
and unspecified parts of
mouth.
146....................................... Malignant neoplasm of
oropharynx.
147....................................... Malignant neoplasm of
nasopharynx.
148....................................... Malignant neoplasm of
hypopharynx.
149....................................... Malignant neoplasm of other
and ill-defined sites
within the lip, oral
cavity, and pharynx.
150....................................... Malignant neoplasm of
esophagus.
151....................................... Malignant neoplasm of
stomach.
152....................................... Malignant neoplasm of small
intestine, including
duodenum.
153....................................... Malignant neoplasm of colon.
[[Page 471]]
154....................................... Malignant neoplasm of
rectum, rectosigmoid
junction, and anus.
155....................................... Malignant neoplasm of liver
and intrahepatic bile
ducts.
156....................................... Malignant neoplasm of gall
bladder and extrahepatic
bile ducts.
157....................................... Malignant neoplasm of
pancreas.
158....................................... Malignant neoplasm of
retroperitoneum and
peritoneum.
159....................................... Malignant neoplasm of other
and ill-defined sites
within the digestive organs
and peritoneum.
160....................................... Malignant neoplasm of nasal
cavities, middle ear, and
accessory sinuses.
161....................................... Malignant neoplasm of
larynx.
162....................................... Malignant neoplasm of
trachea, bronchus and lung.
163....................................... Malignant neoplasm of
pleura.
164....................................... Malignant neoplasm of
thymus, heart, and
mediastinum.
165....................................... Malignant neoplasm of other
and ill-defined sites
within the respiratory
system and intrathoracic
organs.
170....................................... Malignant neoplasm of bone
and articular cartilage.
171....................................... Malignant neoplasm of
connective and other soft
tissue.
172....................................... Malignant melanoma of skin.
173....................................... Other malignant neoplasms of
skin.
174....................................... Malignant neoplasm of female
breast.
175....................................... Malignant neoplasm of male
breast.
179....................................... Malignant neoplasm of
uterus, part unspecified.
180....................................... Malignant neoplasm of cervix
uteri.
181....................................... Malignant neoplasm of
placenta.
182....................................... Malignant neoplasm of body
of uterus.
183....................................... Malignant neoplasm of ovary
and other uterine adnexa.
184....................................... Malignant neoplasm of other
and unspecified female
genital organs.
185....................................... Malignant neoplasm of
prostate.
186....................................... Malignant neoplasm of
testis.
187....................................... Malignant neoplasm of penis
and other male genital
organs.
188....................................... Malignant neoplasm of
urinary bladder.
189....................................... Malignant neoplasm of kidney
and other unspecified
urinary organs.
190....................................... Malignant neoplasm of eye.
191....................................... Malignant neoplasm of brain.
192....................................... Malignant neoplasm of other
and unspecified parts of
nervous system.
193....................................... Malignant neoplasm of
thyroid gland.
194....................................... Malignant neoplasm of other
endocrine glands and
related structures.
195....................................... Malignant neoplasm of other
and ill-defined sites.
196....................................... Secondary and unspecified
malignant neoplasm of the
lymph nodes.
197....................................... Secondary malignant neoplasm
of the respiratory and
digestive organs.
198....................................... Secondary malignant neoplasm
of other tissue and organs.
199....................................... Malignant neoplasm without
specification of site.
200....................................... Lymphosarcoma and
reticulosarcoma.
201....................................... Hodgkin's disease.
202....................................... Other malignant neoplasms of
lymphoid and histiocytic
tissue.
203....................................... Multiple myeloma and other
immunoproliferative
neoplasms.
204....................................... Lymphoid leukemia
205....................................... Myeloid leukemia.
206....................................... Monocytic leukemia.
207....................................... Other specified leukemia.
208....................................... Leukemia of unspecified cell
type.
------------------------------------------------------------------------
\1\ The International Classification of Diseases Clinical Modification
(9th Revision) Volume I&II. [1991] Department of Health and Human
Services Publication No. (PHS) 91-1260, U.S. Government Printing
Office, Washington, D.C.
PART 82_METHODS FOR CONDUCTING DOSE RECONSTRUCTION UNDER THE ENERGY EMPLOYEES
OCCUPATIONAL ILLNESS COMPENSATION PROGRAM ACT OF 2000--Table of Contents
Subpart A_Introduction
Sec.
82.0 Background Information on this part.
82.1 What is the purpose of this part?
82.2 What are the basics of dose reconstruction?
82.3 What are the requirements for dose reconstruction under EEOICPA?
82.4 How will DOL use the results of the NIOSH dose reconstructions?
Subpart B_Definitions
82.5 Definition of terms used in this part.
Subpart C_Dose Reconstruction Process
82.10 Overview of the dose reconstruction process.
82.11 For which claims under EEOICPA will NIOSH conduct a dose
reconstruction?
82.12 Will it be possible to conduct dose reconstructions for all
claims?
[[Page 472]]
82.13 What sources of information may be used for dose reconstructions?
82.14 What types of information could be used in dose reconstructions?
82.15 How will NIOSH evaluate the completeness and adequacy of
individual monitoring data?
82.16 How will NIOSH add to monitoring data to remedy limitations of
individual monitoring and missed dose?
82.17 What types of information could be used to supplement or
substitute for individual monitoring data?
82.18 How will NIOSH calculate internal dose to the primary cancer
site(s)?
82.19 How will NIOSH address uncertainty about dose levels?
Subpart D_Reporting and Review of Dose Reconstruction Results
82.25 When will NIOSH report dose reconstruction results, and to whom?
82.26 How will NIOSH report dose reconstruction results?
82.27 How can claimants obtain reviews of their NIOSH dose
reconstruction results by NIOSH?
82.28 Who can review NIOSH dose reconstruction files on individual
claimants?
Subpart E_Updating Scientific Elements Underlying Dose Reconstructions
82.30 How will NIOSH inform the public of any plans to change scientific
elements underlying the dose reconstruction process to
maintain methods reasonably current with scientific progress?
82.31 How can the public recommend changes to scientific elements
underlying the dose reconstruction process?
82.32 How will NIOSH make changes in scientific elements underlying the
dose reconstruction process, based on scientific progress?
82.33 How will NIOSH inform the public of changes to the scientific
elements underlying the dose reconstruction process?
Authority: 42 U.S.C. 7384n(d) and (e); E.O. 13179, 65 FR 77487, 3
CFR, 2000 Comp., p. 321.
Source: 67 FR 22330, May 2, 2002, unless otherwise noted.
Subpart A_Introduction
Sec. 82.0 Background information on this part.
The Energy Employees Occupational Illness Compensation Program Act
(EEOICPA), 42 U.S.C. 7384-7385 [1994, supp. 2001], provides for the
payment of compensation benefits to covered employees and, where
applicable, survivors of such employees, of the United States Department
of Energy (``DOE''), its predecessor agencies and certain of its
contractors and subcontractors. Among the types of illnesses for which
compensation may be provided are cancers. There are two categories of
covered employees with cancer under EEOICPA for whom compensation may be
provided. The regulations that follow under this part apply only to the
category of employees described under paragraph (a) of this section.
(a) One category is employees with cancer for whom a dose
reconstruction must be conducted, as required under 20 CFR 30.115.
(b) The second category is members of the Special Exposure Cohort
seeking compensation for a specified cancer, as defined under EEOICPA.
The U.S. Department of Labor (DOL) which has primary authority for
implementing EEOICPA, has promulgated regulations at 20 CFR 30.210 and
30.213 that identify current members of the Special Exposure Cohort and
requirements for compensation. Pursuant to section 3626 of EEOICPA, the
Secretary of HHS is authorized to add additional classes of employees to
the Special Exposure Cohort.
Sec. 82.1 What is the purpose of this part?
The purpose of this part is to provide methods for determining a
reasonable estimate of the radiation dose received by a covered employee
with cancer under EEOICPA, through the completion of a dose
reconstruction. These methods will be applied by the National Institute
for Occupational Safety and Health (NIOSH) in a dose reconstruction
program serving claimants under EEOICPA, as identified under Sec. 82.0.
Sec. 82.2 What are the basics of dose reconstruction?
The basic principle of dose reconstruction is to characterize the
radiation environments to which workers were exposed and to then place
each worker in time and space within this exposure environment. Then
methods are applied to translate exposure to radiation into quantified
radiation doses at the specific organs or tissues relevant to the types
of cancer occurring
[[Page 473]]
among the workers. A hierarchy of methods is used in a dose
reconstruction, depending on the nature of the exposure conditions and
the type, quality, and completeness of data available to characterize
the environment.
(a) If found to be complete and adequate, individual worker
monitoring data, such as dosimeter readings and bioassay sample results,
are given the highest priority in assessing exposure. These monitoring
data are interpreted using additional data characterizing the workplace
radiation exposures. If radiation exposures in the workplace environment
cannot be fully characterized based on available data, default values
based on reasonable and scientific assumptions may be used as
substitutes. For dose reconstructions conducted in occupational illness
compensation programs, this practice may include use of assumptions that
represent the worst case conditions. For example, if the solubility
classification of an inhaled material can not be determined, the dose
reconstruction would use the classification that results in the largest
dose to the organ or tissue relevant to the cancer and that is possible
given existing knowledge of the material and process.
(b) If individual monitoring data are not available or adequate,
dose reconstructions may use monitoring results for groups of workers
with comparable activities and relationships to the radiation
environment. Alternatively, workplace area monitoring data may be used
to estimate the dose. As with individual worker monitoring data,
workplace exposure characteristics are used in combination with
workplace monitoring data to estimate dose.
(c) If neither adequate worker nor workplace monitoring data are
available, the dose reconstruction may rely substantially on process
description information to analytically develop an exposure model. For
internal exposures, this model includes such factors as the quantity and
composition of the radioactive substance (the source term), the chemical
form, particle size distribution, the level of containment, and the
likelihood of dispersion.
Sec. 82.3 What Are the Requirements for Dose Reconstruction Under EEOICPA?
(a) Dose reconstructions are to be conducted for the following
covered employees with cancer seeking compensation under EEOICPA: An
employee who was not monitored for exposure to radiation at DOE or
Atomic Weapons Employer (AWE) facilities; an employee who was monitored
inadequately for exposure to radiation at such facilities; or an
employee whose records of exposure to radiation at such facility are
missing or incomplete. Technical limitations of radiation monitoring
technology and procedures will require HHS to evaluate each employee's
recorded dose. In most, if not all cases, monitoring limitations will
result in possibly undetected or unrecorded doses, which are estimated
using commonly practiced dose reconstruction methods and would have to
be added to the dose record.
(b) Section 7384(n)(e) of EEOICPA requires the reporting of
radiation dose information resulting from dose reconstructions to the
covered employees for whom claims are being adjudicated. DOE is
specifically charged with this responsibility but the Department of
Health and Human Services (HHS), which will be producing the dose
reconstruction information, will report its findings directly to the
claimant, as well as to DOL and DOE. HHS will also make available to
researchers and the general public information on the assumptions,
methodology, and data used in estimating radiation doses, as required by
EEOICPA.
Sec. 82.4 How Will DOL Use the Results of the NIOSH Dose Reconstructions?
Under 42 CFR part 81, DOL will apply dose reconstruction results
together with information on cancer diagnosis and other personal
information provided to DOL by the claimant to calculate an estimated
probability of causation. This estimate is the probability that the
cancer of the covered employee was caused by radiation exposure at a
covered facility of DOE or an Atomic Weapons Employer (AWE).
[[Page 474]]
Subpart B_Definitions
Sec. 82.5 Definition of terms used in this part.
(a) Atomic weapons employer (AWE) means any entity, other than the
United States, that:
(1) processed or produced, for use by the United States, material
that emitted radiation and was used in the production of an atomic
weapon, excluding uranium mining and milling; and,
(2) is designated by the Secretary of Energy as an atomic weapons
employer for purposes of EEOICPA.
(b) Bioassay means the determination of the kinds, quantities, or
concentrations, and in some cases, locations of radioactive material in
the human body, whether by direct measurement or by analysis, and
evaluation of radioactive material excreted or eliminated by the body.
(c) Claimant means the individual who has filed with the Department
of Labor for compensation under EEOICPA.
(d) Covered employee means, for the purposes of this part, an
individual who is or was an employee of DOE, a DOE contractor or
subcontractor, or an atomic weapons employer, and for whom DOL has
requested HHS to perform a dose reconstruction.
(e) Covered facility means any building, structure, or premises,
including the grounds upon which such building, structure, or premise is
located:
(1) In which operations are, or have been, conducted by, or on
behalf of, the DOE (except for buildings, structures, premises, grounds,
or operations covered by Executive Order 12344, dated February 1, 1982,
pertaining to the Naval Nuclear Propulsion Program); and,
(2) With regard to which the DOE has or had:
(i) A proprietary interest; or,
(ii) Entered into a contract with an entity to provide management
and operation, management and integration, environmental remediation
services, construction, or maintenance services; or
(3) A facility owned by an entity designated by the Secretary of
Energy as an atomic weapons employer for purposes of EEOICPA that is or
was used to process or produce, for use by the United States, material
that emitted radiation and was used in the production of an atomic
weapon, excluding uranium mining or milling.
(f) DOE means the U.S. Department of Energy, and includes
predecessor agencies of DOE, including the Manhattan Engineering
District.
(g) DOL means the U.S. Department of Labor.
(h) EEOICPA means the Energy Employees Occupational Illness
Compensation Program Act of 2000, 42 U.S.C. 7384-7385 [1994, supp.
2001].
(i) Equivalent dose is the absorbed dose in a tissue multiplied by a
radiation weighting factor to account for differences in the
effectiveness of the radiation in inducing cancer.
(j) External dose means that portion of the equivalent dose that is
received from radiation sources outside of the body.
(k) Internal dose means that portion of the equivalent dose that is
received from radioactive materials taken into the body.
(l) NIOSH means the National Institute for Occupational Safety and
Health, Centers for Disease Control and Prevention, U.S. Department of
Health and Human Services.
(m) Primary cancer means a cancer defined by the original body site
at which the cancer was incurred, prior to any spread (metastasis)
resulting in tumors at other sites in the body.
(n) Probability of causation means the probability or likelihood
that a cancer was caused by radiation exposure incurred by a covered
employee in the performance of duty. In statistical terms, it is the
cancer risk attributable to radiation exposure divided by the sum of the
baseline cancer risk (the risk to the general population) plus the
cancer risk attributable to the radiation exposure. This concept is
further explained under 42 CFR part 81, which provides guidelines by
which DOL will determine probability of causation under EEOICPA.
(o) Radiation means ionizing radiation, including alpha particles,
beta particles, gamma rays, x rays, neutrons, protons and other
particles capable of producing ions in the body. For purposes of this
rule, radiation does
[[Page 475]]
not include sources of non-ionizing radiation such as radio-frequency
radiation, microwaves, visible light, and infrared or ultraviolet light
radiation.
(p) Specified cancer is a term defined in Section 3621(17) of
EEOICPA and 20 CFR 30.5(dd) that specifies types of cancer that,
pursuant to 20 CFR part 30, may qualify a member of the Special Exposure
Cohort for compensation. It includes leukemia (other than chronic
lymphocytic leukemia), multiple myeloma, non-Hodgkin's lymphoma, and
cancers of the lung (other than carcinoma in situ diagnosed at autopsy),
thyroid, male breast, female breast, esophagus, stomach, pharynx, small
intestine, pancreas, bile ducts, gall bladder, salivary gland, urinary
bladder, brain, colon, ovary, liver (not associated with cirrhosis or
hepatitis), and bone. Pursuant to section 2403 of Public Law 107-20,
this definition will include renal cancer effective October 1, 2001.
(q) Uncertainty distribution is a statistical term meaning a range
of discrete or continuous values arrayed around a central estimate,
where each value is assigned a probability of being correct.
(r) Worst-case assumption is a term used to describe a type of
assumption used in certain instances for certain dose reconstructions
conducted under this rule. It assigns the highest reasonably possible
value, based on reliable science, documented experience, and relevant
data, to a radiation dose of a covered employee.
Subpart C_Dose Reconstruction Process
Sec. 82.10 Overview of the dose reconstruction process.
(a) Upon receipt of a claims package from the Department of Labor,
as provided under 20 CFR part 30, NIOSH will request from DOE records on
radiation dose monitoring and radiation exposures associated with the
employment history of the covered employee. Additionally, NIOSH may
compile data, and information from NIOSH records that may contribute to
the dose reconstruction. For each dose reconstruction, NIOSH will
include records relevant to internal and external exposures to ionizing
radiation, including exposures from medical screening x rays that were
required as a condition of employment.
(b) NIOSH will evaluate the initial radiation exposure record
compiled to: Reconcile the exposure record with the reported employment
history, as necessary; complete preliminary calculations of dose, based
upon this initial record, and prepare to consult with the claimant. Any
discrepancies in the employment history information will be reconciled
with the assistance of DOE, as necessary.
(c) NIOSH will interview the claimant. The interview may be
conducted in one or more sessions. The purpose of the interview is to:
(1) Explain the dose reconstruction process;
(2) Confirm elements of the employment history transmitted to NIOSH
by DOL;
(3) Identify any relevant information on employment history that may
have been omitted;
(4) Confirm or supplement monitoring information included in the
initial radiation exposure record;
(5) Develop detailed information on work tasks, production
processes, radiologic protection and monitoring practices, and incidents
that may have resulted in undocumented radiation exposures, as
necessary;
(6) Identify co-workers and other witnesses with information
relevant to the radiation exposures of the covered worker to supplement
or confirm information on work experiences, as necessary.
(d) NIOSH will provide a report to the claimant summarizing the
findings of the interview, titled: ``NIOSH Claimant Interview under
EEOICPA.'' The report will also notify the claimant of the opportunity
to contact NIOSH if necessary, by a specified date, to make any written
corrections or additions to information provided by the claimant during
the interview process.
(e) Information provided by the claimant will be accepted and used
for dose reconstruction, providing it is reasonable, supported by
substantial evidence, and is not refuted by other evidence. In assessing
whether the information provided by the claimant is
[[Page 476]]
supported by substantial evidence, NIOSH will consider:
(1) Consistency of the information with other information in the
possession of NIOSH, from radiation safety programs, research, medical
screening programs, labor union documents, worksite investigations, dose
reconstructions conducted by NIOSH under EEOICPA, or other reports
relating to the circumstances at issue;
(2) Consistency of the information with medical records provided by
the claimant;
(3) Consistency of the information with practices or exposures
demonstrated by the dose reconstruction record developed for the
claimant; and,
(4) Confirmation of information by co-workers or other witnesses.
(f) NIOSH will seek to confirm information provided by the claimant
through review of available records and records requested from DOE.
(g) As necessary, NIOSH will request additional records from DOE to
characterize processes and tasks potentially involving radiation
exposure for which dose and exposure monitoring data is incomplete or
insufficient for dose reconstruction.
(h) NIOSH will review the adequacy of monitoring data and
completeness of records provided by DOE. NIOSH will request
certification from DOE that record searches requested by NIOSH have been
completed.
(i) As necessary, NIOSH will characterize the internal and external
exposure environments for parameters known to influence the dose. For
internal exposures, examples of these parameters include the mode of
intake, the composition of the source term (i.e., the radionuclide type
and quantity), the particle size distribution and the absorption type.
When it is not possible to characterize these parameters, NIOSH may use
default values, when they can be established reasonably, fairly, and
based on relevant science. For external exposures, the radiation type
(gamma, x-ray, neutron, beta, or other charged particle) and radiation
energy spectrum will be evaluated. When possible, the effect of non-
uniformity and geometry of the radiation exposure will be assessed.
(j) For individual monitoring records that are incomplete, NIOSH may
assign doses using techniques discussed in Sec. 82.16. Once the
resulting data set is complete, NIOSH will construct an occupational
exposure matrix, using the general hierarchical approach discussed in
Sec. 82.2. This matrix will contain the estimated annual equivalent
dose(s) to the relevant organ(s) or tissue(s), for the period from the
initial date of potential exposure at a covered facility until the date
the cancer was diagnosed. The equivalent dose(s) will be calculated
using the current, standard radiation weighting factors from the
International Commission on Radiological Protection. \1\
---------------------------------------------------------------------------
\1\ The current weighting factors of the International Commission on
Radiological Protection are provided in ICRP 60: ``1990 Recommendations
of the International Commission on Radiological Protection.'' Ann. ICRP
21 (1-3):6.
---------------------------------------------------------------------------
(k) At any point during steps of dose reconstruction described in
paragraphs (f) through (j) of this section, NIOSH may determine that
sufficient research and analysis has been conducted to complete the dose
reconstruction. Research and analysis will be determined sufficient if
one of the following three conditions is met:
(1) From acquired experience, it is evident the estimated cumulative
dose is sufficient to qualify the claimant for compensation (i.e., the
dose produces a probability of causation of 50% or greater);
(2) Dose is determined using worst-case assumptions related to
radiation exposure and intake, to substitute for further research and
analyses; or,
(3) Research and analysis indicated under steps described in
paragraphs (f)-(j) of this section have been completed. Worst-case
assumptions will be employed under condition 2 to limit further research
and analysis only for claims for which it is evident that further
research and analysis will not produce a compensable level of radiation
dose (a dose producing a probability of causation of 50% or greater),
because using worst-case assumptions it can be determined that the
employee could not have incurred a compensable level of radiation dose.
For all claims in which worst-case assumptions are
[[Page 477]]
employed under condition 2, the reasoning that resulted in the
determination to limit further research and analysis will be clearly
described in the draft of the dose reconstruction results reported to
the claimant under Sec. 82.25 and in the dose reconstruction results
reported to the claimant under Sec. 82.26.
(l) After providing the claimant with a copy of a draft of the dose
reconstruction report to be provided to DOL, NIOSH will conduct a
closing interview with the claimant to review the dose reconstruction
results and the basis upon which the results were calculated. This will
be the final opportunity during the dose reconstruction process for the
claimant to provide additional relevant information that may affect the
dose reconstruction. The closing interview may require multiple
sessions, if the claimant requires time to obtain and provide additional
information, and to allow NIOSH time to integrate the new information
into a new draft of the dose reconstruction report. NIOSH will determine
whether to grant requests for time to provide additional information,
based on whether the requests are reasonable and the claimant is
actively seeking the information specified.
(m) Subject to any additional information provided by the claimant
and revision of the draft dose reconstruction report under Sec.
82.10(l), the claimant is required to return form OCAS-1 to NIOSH,
certifying that the claimant has completed providing information and
that the record for dose reconstruction should be closed. Upon receipt
of the form, NIOSH will forward a final dose reconstruction report to
DOL, DOE, and to the claimant.
(n) NIOSH will not forward the dose reconstruction report to DOL for
adjudication without receipt of form OCAS-1 signed by the claimant or a
representative of the claimant authorized pursuant to 20 CFR 30.600. If
the claimant or the authorized representative of the claimant fails to
sign and return form OCAS-1 within 60 days, or 60 days following the
claimant's final provision of additional information and receipt of a
revised draft dose reconstruction report under Sec. 82.10 (l),
whichever occurs last, after notifying the claimant or the authorized
representative, NIOSH may administratively close the dose reconstruction
and notify DOL of this action. Upon receiving this notification by
NIOSH, DOL may administratively close the claim.
(o) Once actions under Sec. 82.10 (m) are completed, the record for
dose reconstruction shall be closed unless reopened at the request of
DOL under 20 CFR part 30.
Sec. 82.11 For which claims under EEOICPA will NIOSH conduct a dose
reconstruction?
NIOSH will conduct a dose reconstruction for each claim determined
by DOL to be a claim for a covered employee with cancer under DOL
regulations at 20 CFR 30.210(b), subject to the limitation and exception
noted in Sec. 82.12. Claims for covered employees who are members of
the Special Exposure Cohort seeking compensation for a specified cancer,
as determined by DOL under 20 CFR 30.210(a), do not require and will not
receive a dose reconstruction under this rule.
Sec. 82.12 Will it be possible to conduct dose reconstructions for all
claims?
It is uncertain whether adequate information of the types outlined
under Sec. 82.14 will be available to complete a dose reconstruction
for every claim eligible under Sec. 82.11.
(a) NIOSH will notify in writing any claimants for whom a dose
reconstruction cannot be completed once that determination is made, as
well as in the closing interview provided for under Sec. 82.10(l).
(b) Notification will describe the basis for finding a dose
reconstruction cannot be completed, including the following:
(1) A summary of the information obtained from DOE and other
sources; and, (2) a summary of necessary information found to be
unavailable from DOE and other sources.
(c) NIOSH will notify DOL and DOE when it is unable to complete a
dose reconstruction for the claimant. This will result in DOL producing
a recommended decision to deny the claim, since DOL cannot determine
probability of causation without a dose estimate produced by NIOSH under
this rule.
[[Page 478]]
(d) A claimant for whom a dose reconstruction cannot be completed,
as indicated under this section, may have recourse to seek compensation
under provisions of the Special Exposure Cohort (see 20 CFR part 30).
Pursuant to section 7384q of EEOICPA, the Secretary of HHS is authorized
to add classes of employees to the Special Exposure Cohort. NIOSH will
provide the claimant with any information and forms that HHS provides to
classes of employees seeking to petition to be added to the Special
Exposure Cohort.
Sec. 82.13 What sources of information may be used for dose reconstructions?
NIOSH will use the following sources of information for dose
reconstructions, as necessary:
(a) DOE and its contractors, including Atomic Weapons Employers and
the former worker medical screening program;
(b) NIOSH and other records from health research on DOE worker
populations;
(c) Interviews and records provided by claimants;
(d) Co-workers of covered employees, or others with information
relevant to the covered employee's exposure, that the claimant
identified during the initial interview with NIOSH;
(e) Labor union records from unions representing employees at
covered facilities of DOE or AWEs; and,
(f) Any other relevant information.
Sec. 82.14 What types of information could be used in dose reconstructions?
NIOSH will obtain the types of information described in this section
for dose reconstructions, as necessary and available:
(a) Subject and employment information, including:
(1) Gender;
(2) Date of birth; and,
(3) DOE and/or AWE employment history, including: job title held by
year, and work location(s): including site names(s), building
numbers(s), technical area(s), and duration of relevant employment or
tasks.
(b) Worker monitoring data, including:
(1) External dosimetry data, including external dosimeter readings
(film badge, TLD, neutron dosimeters); and,
(2) Pocket ionization chamber data.
(c) Internal dosimetry data, including:
(1) Urinalysis results;
(2) Fecal sample results;
(3) In Vivo measurement results;
(4) Incident investigation reports;
(5) Breath radon and/or thoron results;
(6) Nasal smear results;
(7) External contamination measurements; and
(8) Other measurement results applicable to internal dosimetry.
(d) Monitoring program data, including:
(1) Analytical methods used for bioassay analyses;
(2) Performance characteristics of dosimeters for different
radiation types;
(3) Historical detection limits for bioassay samples and dosimeter
badges;
(4) Bioassay sample and dosimeter collection/exchange frequencies;
(5) Documentation of record keeping practices used to record data
and/or administratively assign dose; and,
(6) Other information to characterize the monitoring program
procedures and evaluate monitoring results.
(e) Workplace monitoring data, including:
(1) Surface contamination surveys;
(2) General area air sampling results;
(3) Breathing zone air sampling results;
(4) Radon and/or thoron monitoring results;
(5) Area radiation survey measurements (beta, gamma and neutron);
and,
(6) Fixed location dosimeter results (beta, gamma and neutron); and,
(7) Other workplace monitoring results.
(f) Workplace characterization data, including:
(1) Information on the external exposure environment, including:
radiation type (gamma, x-ray, proton, neutron, beta, other charged
particle); radiation energy spectrum; uniformity of exposure (whole body
vs partial body exposure); irradiation geometry;
(2) Information on work-required medical screening x rays; and,
[[Page 479]]
(3) Other information useful for characterizing workplace radiation
exposures.
(g) Information characterizing internal exposures, including:
(1) Radionuclide(s) and associated chemical forms;
(2) Results of particle size distribution studies;
(3) Respiratory protection practices; and
(4) Other information useful for characterizing internal exposures.
(h) Process descriptions for each work location, including:
(1) General description of the process;
(2) Characterization of the source term (i.e., the radionuclide and
its quantity);
(3) Extent of encapsulation;
(4) Methods of containment;
(5) Other information to assess potential for irradiation by source
or airborne dispersion radioactive material.
Sec. 82.15 How will NIOSH evaluate the completeness and adequacy of
individual monitoring data?
(a) NIOSH will evaluate the completeness and adequacy of an
individual's monitoring data provided by DOE through one or more
possible measures including, but not limited to:
(1) Comparisons with information provided by claimants, co-workers,
and other witnesses;
(2) Comparisons with available information on area monitoring,
production processes, and radiologic protection programs;
(3) Comparisons with information documented in the records of unions
representing covered employees;
(4) Comparisons with data available on co-workers; and
(5) Reviews of DOE contractor record systems.
(b) NIOSH will evaluate the instruments and procedures used to
collect individual monitoring data to determine whether they adequately
characterized the radiation environments in which the covered employee
worked, (adequately for the purpose of dose reconstruction,) based on
present-day scientific understanding. For external dosimeter
measurements, this includes an evaluation of the dosimeter response to
the radiation types (gamma, x-ray, neutron, beta, or other charged
particle) and the associated energy spectrum. For internal exposure, the
methods used to analyze bioassay samples will be reviewed to determine
their ability to detect the radionuclides present in the work
environment. An analysis of the monitoring or exchange frequencies for
the monitoring programs will also be conducted to determine the
potential for undetected dose.
Sec. 82.16 How will NIOSH add to monitoring data to remedy limitations of
individual monitoring and missed dose?
(a) For external dosimeter results that are incomplete due to
historical record keeping practices, NIOSH will use commonly practiced
techniques, such as those described in the NIOSH Research Issues
Workshop, \2\ to estimate the missing component of dose and to add this
to the total dose estimate. For monitoring periods where external
dosimetry data are missing from the records, NIOSH will estimate a
claimant's dose based on interpolation, using available monitoring
results from other time periods close to the period in question, or
based on monitoring data on other workers engaged in similar tasks.
---------------------------------------------------------------------------
\2\ NIOSH [1995]. NIOSH research issues workshop: epidemiologic use
of nondetectable values in radiation exposure measurements. Cincinnati,
OH: U.S. Department of Health and Human Services, Public Health Service,
Centers for Disease Control and Prevention, National Institute for
Occupational Safety and Health, DHHS (NIOSH) Publication No. 224647
(NTIS--PB 95189601).
---------------------------------------------------------------------------
(b) NIOSH will review historical bioassay sample detection limits
and monitoring frequencies to determine, when possible, the minimum
detectable dose for routine internal dose monitoring programs. This
``missed dose'' will establish the upper limit of internal dose that a
worker could have received for periods when bioassay sample analysis
results were below the detection limit. Using ICRP biokinetic models,
NIOSH will estimate the internal dose and include an associated
uncertainty distribution.
[[Page 480]]
Sec. 82.17 What types of information could be used to supplement or
substitute for individual monitoring data?
Three types of information could be used:
(a) Monitoring data from co-workers, if NIOSH determines they had a
common relationship to the radiation environment; or,
(b) A quantitative characterization of the radiation environment in
which the covered employee worked, based on an analysis of historical
workplace monitoring information such as area dosimeter readings,
general area radiation and radioactive contamination survey results, air
sampling data; or,
(c) A quantitative characterization of the radiation environment in
which the employee worked, based on analysis of data describing
processes involving radioactive materials, the source materials,
occupational tasks and locations, and radiation safety practices.
Sec. 82.18 How will NIOSH calculate internal dose to the primary cancer
site(s)?
(a) The calculation of dose from ingested, inhaled or absorbed
radioactivity involves the determination of the types and quantities of
radionuclides that entered the body. NIOSH will use the results of all
available bioassay monitoring information as appropriate, based on
assessment of the technical characteristics of the monitoring program.
If bioassay monitoring data are unavailable or inadequate, the dose
reconstruction will rely on the results of air sampling measurements,
radiation sources, work processes and practices, and incidents involving
radiation contamination, as necessary.
(b) NIOSH will calculate the dose to the organ or tissue of concern
using the appropriate current metabolic models published by ICRP. Using
data available to NIOSH, the models will be based on exposure conditions
representative of the work environment. When NIOSH cannot establish
exposure conditions with sufficient specificity, the dose calculation
will assume exposure conditions that maximize the dose to the organ
under consideration. When the cancer covered by a claim is in a tissue
not covered by existing ICRP models, NIOSH will use the ICRP model that
best approximates the model needed, while giving the benefit of the
doubt to the claimant. For internal exposures, NIOSH will select the
highest dose estimate from among the modeled organs or tissues that do
not concentrate the radionuclide.
(c) Internal doses will be calculated for each year of exposure from
the date of initial exposure to the date of cancer diagnosis.
Sec. 82.19 How will NIOSH address uncertainty about dose levels?
The estimate of each annual dose will be characterized with a
probability distribution that accounts for the uncertainty of the
estimate. This information will be used by DOL in the calculation of
probability of causation, under HHS guidelines for calculating
probability of causation estimates at 42 CFR 81. In this way, claimants
will receive the benefit of the doubt in cases in which the actual dose
may have exceeded the best estimate calculated by NIOSH.
Subpart D_Reporting and Review of Dose Reconstruction Results
Sec. 82.25 When will NIOSH report dose reconstruction results, and to whom?
NIOSH will report dose reconstruction results to DOL and to the
claimant, as provided for under Sec. 82.10. Draft results will be
reported to the claimant upon tentative completion of the dose
reconstruction. Final results will be reported to the claimant, DOL and
DOE after NIOSH receives certification from the claimant that the
claimant has completed providing information to NIOSH for the dose
reconstruction (Form OCAS-1).
Sec. 82.26 How will NIOSH report dose reconstruction results?
(a) NIOSH will provide dose reconstruction results to the claimant,
DOL, and DOE in a report: ``NIOSH Report of Dose Reconstruction under
EEOICPA.'' The report itself will not provide information on probability
of causation, which DOL must calculate to determine a recommended
decision on the claim.
[[Page 481]]
(b) The report will include the following information, as relevant:
(1) Annual dose estimates (or a fraction thereof) related to covered
employment for each year from the date of initial radiation exposure at
a covered facility to the date of cancer diagnosis;
(2) Separate dose estimates for acute and chronic exposures,
different types of ionizing radiation, and internal and external doses,
providing internal dose information only for the organ or tissue
relevant to the primary cancer site(s) established in the claim;
(3) Uncertainty distributions associated with each dose estimated,
as necessary;
(4) Explanation of each type of dose estimate included in terms of
its relevance for estimating probability of causation;
(5) Identification of any information provided by the claimant
relevant to dose estimation that NIOSH decided to omit from the basis
for dose reconstruction, justification for the decision, and if
possible, a quantitative estimate of the effect of the omission on the
dose reconstruction results; and
(6) A summary and explanation of information and methods applied to
produce the dose reconstruction estimates, including any factual
findings and the evidence upon which those findings are based.
(c) As provided under Sec. 82.10(l), NIOSH staff will conduct a
closing interview with claimants to explain the dose reconstruction
report.
Sec. 82.27 How can claimants obtain reviews of their NIOSH dose
reconstruction results by NIOSH?
(a) Claimants can seek reviews of their dose reconstruction through
the processes established by DOL under 20 CFR 30. DOL will request NIOSH
to review dose reconstructions under the following conditions, as
provided under 20 CFR 30.318:
(1) DOL may determine that factual findings of the dose
reconstruction do not appear to be supported by substantial evidence;
or,
(2) Although the methodology established by HHS under this Part is
binding on DOL, DOL may determine that arguments concerning the
application of this methodology should be considered by NIOSH.
(b) NIOSH may review completed dose reconstructions on its own
initiative and with the assistance of DOL to identify denied claims when
either of the following circumstances arise:
(1) NIOSH obtains records or information on radiation exposures of
DOE or AWE employees that could substantially increase the level of
radiation doses estimated in the completed dose reconstructions; or
(2) NIOSH changes a scientific element underlying dose
reconstructions according to the provisions of Subpart E of this rule
and the change could substantially increase the level of radiation doses
estimated in the completed dose reconstructions.
(c) When NIOSH completes the review of a dose reconstruction, NIOSH
will provide a report describing the basis for the review, the methods
employed in the review, and the review findings to the claimant, DOL,
and DOE.
Sec. 82.28 Who can review NIOSH dose reconstruction files on individual
claimants?
(a) Claimants and DOL will be provided individual dose
reconstruction files, upon request. Claimants should note, however, that
a complete summary of the data and methods used in a dose reconstruction
will be included in the ``NIOSH Report of Dose Reconstruction under
EEOICPA''.
(b) Researchers and the public will be provided limited access to
NIOSH dose reconstruction files, subject to provisions and restrictions
of the Privacy Act for the protection of confidential information on
individuals.
[[Page 482]]
Subpart E_Updating the Scientific Elements Underlying Dose
Reconstructions
Sec. 82.30 How will NIOSH inform the public of any plans to change scientific
elements underlying the dose reconstruction process to maintain methods
reasonably current with scientific progress?
Periodically, NIOSH will publish a notice in the Federal Register
notifying the public of plans to change scientific elements underlying
the dose reconstruction process under EEOICPA to reflect scientific
progress. Notice will include a summary of the planned changes and the
expected completion date for such changes.
Sec. 82.31 How can the public recommend changes to scientific elements
underlying the dose reconstruction process?
(a) At any time, the public can submit written recommendations to
NIOSH for changes to scientific elements underlying the dose
reconstruction process, based on relevant new research findings and
technological advances. NIOSH will provide these recommendations to the
Advisory Board on Radiation and Worker Health to be addressed at a
public meeting of the Advisory Board, with notification provided to the
source of the recommendations. Recommendations should be addressed to:
Director, Office of Compensation Analysis and Support, National
Institute for Occupational Safety and Health, 4676 Columbia Parkway, MS-
R45, Cincinnati, Ohio 45226.
(b) The public can also submit recommendations by e-mail.
Instructions will be provided on the NIOSH Internet homepage at
www.cdc.gov/niosh/ocas.
Sec. 82.32 How will NIOSH make changes in scientific elements underlying the
dose reconstruction process, based on scientific progress?
NIOSH will present proposed changes to the Advisory Board on
Radiation and Worker Health prior to implementation. These proposed
changes will be summarized in a notice published in the Federal
Register. The public will have the opportunity to comment on proposed
changes at the meeting of the Advisory Board and/or in written comments
submitted for this purpose. NIOSH will fully consider the comments of
the Advisory Board and of the public before deciding upon any changes.
Sec. 82.33 How will NIOSH inform the public of changes to the scientific
elements underlying the dose reconstruction process?
(a) NIOSH will publish a notice in the Federal Register informing
the public of changes and the rationale for the changes. This notice
will also provide a summary of the recommendations and comments received
from the Advisory Board and the public, as well as responses to the
comments.
(b) NIOSH may take into account other factors and employ other
procedures than those specified in this subpart, if circumstances arise
that require NIOSH to implement a change more immediately than the
procedures in this subpart allow.
PART 83_PROCEDURES FOR DESIGNATING CLASSES OF EMPLOYEES AS MEMBERS OF THE
SPECIAL EXPOSURE COHORT UNDER THE ENERGY EMPLOYEES OCCUPATIONAL ILLNESS
COMPENSATION PROGRAM ACT OF 2000--Table of Contents
Subpart A_Introduction
Sec.
83.0 Background information on the procedures in this part.
83.1 What is the purpose of the procedures in this part?
83.2 How will DOL use the designations established under the procedures
in this part?
Subpart B_Definitions
83.5 Definitions of terms used in the procedures in this part.
Subpart C_Procedures for Adding Classes of Employees to the Cohort
83.6 Overview of the procedures in this part.
83.7 Who can submit a petition on behalf of a class of employees?
83.8 How is a petition submitted?
83.9 What information must a petition include?
83.10 If a petition satisfies all relevant requirements under Sec.
83.9, does this mean the class will be added to the Cohort?
[[Page 483]]
83.11 What happens to petition submissions that do not satisfy all
relevant requirements under Sec. Sec. 83.7 through 83.9?
83.12 How will NIOSH notify petitioners, the Board, and the public of
petitions that have been selected for evaluation?
83.13 How will NIOSH evaluate petitions, other than petitions by
claimants covered under Sec. 83.14?
83.14 How will NIOSH evaluate a petition by a claimant whose dose
reconstruction NIOSH could not complete under 42 CFR Part 82?
83.15 How will the Board consider and advise the Secretary on a
petition?
83.16 How will the Secretary decide the outcome of a petition?
83.17 How will the Secretary report a final decision to add a class of
employees to the Cohort and any action of Congress concerning
the effect of the final decision?
83.18 How can petitioners obtain an administrative review of a final
decision by the Secretary?
83.19 How can the Secretary cancel or modify a final decision to add a
class of employees to the Cohort?
Authority: 42 U.S.C. 7384q; E.O. 13179, 65 FR 77487, 3 CFR, 2000
Comp., p. 321.
Source: At 69 FR 30780, May 28, 2004, unless otherwise noted.
Subpart A_Introduction
Sec. 83.0 Background information on the procedures in this part.
The Energy Employees Occupational Illness Compensation Program Act,
as amended (``EEOICPA'' or ``the Act''), 42 U.S.C. 7384-7385, provides
for the payment of compensation benefits to covered employees and, where
applicable, survivors of such employees, of DOE, its predecessor
agencies and certain of its contractors and subcontractors. Among the
types of illnesses for which compensation may be provided are cancers.
There are two methods set forth in the statute for claimants to
establish that a cancer incurred by a covered worker is compensable
under EEOICPA. The first is to establish that the cancer is at least as
likely as not related to covered employment at a DOE or Atomic Weapons
Employer (``AWE'') facility pursuant to guidelines issued by the
Department of Health and Human Services (``HHS''), which are found at 42
CFR part 81. The second method to establish that a cancer incurred by a
covered worker is compensable under EEOICPA is to establish that the
worker is a member of the Special Exposure Cohort (``the Cohort'') and
suffered a specified cancer after beginning employment at a DOE facility
or AWE facility. In Section 3621(14) of EEOICPA (42 U.S.C. 7384l(14))
Congress included certain classes of employees in the Cohort. Section
3626 of the Act (42 U.S.C. 7384q) authorizes the addition to the Cohort
of other classes of employees. This authority has been delegated to the
Secretary of HHS by Executive Order 13179.
Sec. 83.1 What is the purpose of the procedures in this part?
EEOICPA authorizes the President to add classes of employees to the
Cohort, while providing Congress with the opportunity to review and
expedite or reverse these decisions. The President delegated his
authority to the Secretary of HHS. This part specifies the procedures by
which HHS will determine whether to add new classes of employees from
DOE and AWE facilities to the Cohort. HHS will consider adding new
classes of employees in response to petitions by, or on behalf of, such
classes of employees. The procedures specify requirements for petitions
and for their consideration. These requirements are intended to ensure
that petitions are submitted by authorized parties, are justified, and
receive uniform, fair, scientific consideration. The procedures are also
designed to give petitioners and interested parties opportunity for
appropriate involvement in the process, and to ensure that the process
is timely and consistent with requirements specified in EEOICPA. The
procedures are not intended to provide a second opportunity to qualify a
claim for compensation, once HHS has completed the dose reconstruction
and DOL has determined that the cancer subject to the claim was not ``at
least as likely as not'' caused by the estimated radiation doses. DOL
has established procedures separate from those covered by this part,
under 20 CFR part 30, for cancer claimants who want to contest the
factual determinations or how NIOSH conducted their dose
reconstructions.
[[Page 484]]
Sec. 83.2 How will DOL use the designations established under the procedures
in this part?
DOL will adjudicate compensation claims for members of classes of
employees added to the Cohort according to the same general procedures
that apply to the statutorily defined classes of employees in the
Cohort. Specifically, DOL will determine whether the claim is for a
qualified member of the Cohort with a specified cancer, pursuant to the
procedures set forth in 20 CFR part 30.
Subpart B_Definitions
Sec. 83.5 Definitions of terms used in the procedures in this part.
(a) Advisory Board on Radiation and Worker Health (``the Board'') is
a federal advisory committee established under EEOICPA and appointed by
the President to advise HHS in implementing its responsibilities under
EEOICPA.
(b) Atomic Weapons Employer (``AWE'') is a statutory term of EEOICPA
which means any entity, other than the United States, that:
(1) Processed or produced, for use by the United States, material
that emitted radiation and was used in the production of an atomic
weapon, excluding uranium mining and milling: and,
(2) Is designated by the Secretary of Energy as an atomic weapons
employer for purposes of EEOICPA.
(c) Computation of Time Periods: In this Rule, all prescribed or
allowed time periods will be counted as calendar days from the business
day of receipt by the submitter(s), the petitioner(s), NIOSH, or HHS.
Receipt by NIOSH, the submitter(s) or petitioner(s) will be either the
business day of actual receipt or three (3) business days after initial
proof of mailing, whichever time period is shorter. Business days are
defined as Monday through Friday, 8 a.m. to 4:30 p.m. est and ``legal
holiday'' will be used as defined by the FED. R. CIV. P. 6(a).
(d) Class of employees means, for the purposes of this part, a group
of employees who work or worked at the same DOE facility or AWE
facility, and for whom the availability of information and recorded data
on radiation exposures is comparable with respect to the informational
needs of dose reconstructions conducted under 42 CFR part 82.
(e) HHS is the U.S. Department of Health and Human Services.
(f) DOE is the U.S. Department of Energy, which includes predecessor
agencies of DOE, including the Manhattan Engineering District.
(g) DOL is the U.S. Department of Labor.
(h) Employee, for the purposes of these procedures, means a person
who is or was, for the purposes of EEOICPA, an employee of DOE, a DOE
contractor or subcontractor, or an Atomic Weapons Employer.
(i) NIOSH is the National Institute for Occupational Safety and
Health, Centers for Disease Control and Prevention, U.S. Department of
Health and Human Services.
(j) OCAS is the Office of Compensation Analysis and Support,
National Institute for Occupational Safety and Health, Centers for
Disease Control and Prevention, U.S. Department of Health and Human
Services.
(k) Petitioner means an individual or organization that submits a
petition on behalf of a class of employees and qualifies as a petitioner
under Sec. 83.7. A single petition shall only include up to three
petitioners.
(l) Radiation means ionizing radiation, including alpha particles,
beta particles, gamma rays, x rays, neutrons, protons and other
particles capable of producing ions in the body. For the purposes of the
proposed procedures, radiation does not include sources of non-ionizing
radiation such as radio-frequency radiation, microwaves, visible light,
and infrared or ultraviolet light radiation.
(m) Secretary is the Secretary of Health and Human Services.
(n) Specified cancer, as is defined in Section 3621(17) of EEOICPA
(42 U.S.C. 7384l(17)) and the DOL regulation implementing EEOICPA (20
CFR 30.5(dd)), means:
(1) Leukemia (other than chronic lymphocytic leukemia) provided that
onset of the disease was at least two years after initial occupational
exposure;
[[Page 485]]
(2) Lung cancer (other than in situ lung cancer that is discovered
during or after a post-mortem exam);
(3) Bone cancer;
(4) Renal cancers;
(5) The following diseases, provided onset was at least 5 years
after first exposure:
(i) Multiple myeloma;
(ii) Lymphomas (other than Hodgkin's disease);
(iii) Primary cancer of the:
(A) Thyroid;
(B) Male or female breast;
(C) Esophagus;
(D) Stomach;
(E) Pharynx;
(F) Small intestine;
(G) Pancreas;
(H) Bile ducts;
(I) Gall bladder;
(J) Salivary gland;
(K) Urinary bladder;
(L) Brain;
(M) Colon;
(N) Ovary;
(O) Liver (except if cirrhosis or hepatitis B is indicated).
(6) The specified diseases designated in this section mean the
physiological condition or conditions that are recognized by the
National Cancer Institute under those names or nomenclature, or under
any previously accepted or commonly used names or nomenclature.
(o) Survivor means a surviving spouse, child, parent, grandchild and
grandparent of a deceased covered employee as defined in EEOICPA.
[69 FR 30780, May 28, 2004, as amended at 70 FR 75952, Dec. 22, 2005; 72
FR 37459, July, 10, 2007]
Subpart C_Procedures for Adding Classes of Employees to the Cohort
Sec. 83.6 Overview of the procedures in this part.
The procedures in this part specify who may petition to add a class
of employees to the Cohort, the requirements for such a petition, how a
petition will be selected for evaluation by NIOSH and for the advice of
the Board, and the process NIOSH, the Board, and the Secretary will use
to consider a petition, leading to the Secretary's final determination
to accept or deny adding a class to the Cohort. The rule provides for
petitions in two distinct circumstances. One circumstance is when NIOSH
has attempted to conduct a dose reconstruction for a cancer claimant,
under 42 CFR part 82, and finds that the dose reconstruction cannot be
completed, because there is insufficient information to estimate the
radiation doses of the claimant with sufficient accuracy. The second
circumstance includes all other possibilities. For example, a petition
may be submitted representing a class of employees whose members have
yet to file claims under EEOICPA, or even have yet to be diagnosed with
cancer. As required by EEOICPA (42 U.S.C. 7384l(14)(c)(ii)), the
procedures in this part include formal notice to Congress of any
decision by the Secretary to add a class to the Cohort, and the
opportunity for Congress to expedite or change the outcome of the
decision within 180 days.
Sec. 83.7 Who can submit a petition on behalf of a class of employees?
A petitioner or petitioners for a petition must be one or more, up
to a maximum of three, of the following:
(a) One or more DOE, DOE contractor or subcontractor, or AWE
employees, who would be included in the proposed class of employees, or
their survivors; or
(b) One or more labor organizations representing or formerly having
represented DOE, DOE contractor or subcontractor, or AWE employees, who
would be included in the proposed class of employees; or
(c) One or more individuals or entities authorized in writing by one
or more DOE, DOE contractor or subcontractor, or AWE employees, who
would be included in the proposed class of employees, or their
survivors.
Sec. 83.8 How is a petition submitted?
The petitioner(s) must send a petition in writing to NIOSH. A
petition must provide identifying and contact information on the
petitioner(s) and information to justify the petition, as specified
under Sec. 83.9. Detailed instructions for preparing and submitting a
petition, including an optional petition form, are available from NIOSH
through direct request (1-800-35-
[[Page 486]]
NIOSH) or on the Internet at www.cdc.gov/niosh/ocas.
Sec. 83.9 What information must a petition include?
(a) All petitions must provide identifying and contact information
on the petitioner(s). The information required to justify a petition
differs, depending on the basis of the petition. If the petition is by a
claimant in response to a finding by NIOSH that the dose reconstruction
for the claimant cannot be completed, then the petition must provide
only the justification specified under paragraph (b) of this section.
All other petitions must provide only the information specified under
paragraph (c) of this section. The informational requirements for
petitions are also summarized in Table 1 at the end of this section.
(b) The petition must notify NIOSH that the claimant is petitioning
on the basis that NIOSH found, under 42 CFR 82.12, that the dose
reconstruction for the claimant could not be completed due to
insufficient records and information.
(c) The petition must include the following:
(1) A proposed class definition \1\ specifying:
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\1\ HHS will determine the final class definition(s) for each
petition (see Sec. 83.16).
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(i) The DOE facility or AWE facility \2\ at which the class worked;
---------------------------------------------------------------------------
\2\ Depending on the factual circumstances present, a facility that
meets the definition of an AWE facility or DOE facility covered under
EEOICPA (42 U.S.C. 7384l(5) and (12)) could, among other possibilities,
constitute a single building or structure, including the grounds upon
which it is located, or a site encompassing numerous buildings or
structures, including the grounds upon which it is located.
---------------------------------------------------------------------------
(ii) The location or locations at the facility covered by the
petition (e.g., building, technical area);
(iii) The job titles and/or job duties of the class members;
(iv) The period of employment relevant to the petition;
(v) Identification of any exposure incident that was unmonitored,
unrecorded, or inadequately monitored or recorded, if such incident
comprises the basis of the petition; and
(2) A description of the petitioner's (petitioners'') basis for
believing records and information available are inadequate to estimate
the radiation doses incurred by members of the proposed class of
employees with sufficient accuracy. This description must include one of
the following elements:
(i) Documentation or statements provided by affidavit indicating
that radiation exposures and doses to members of the proposed class were
not monitored, either through personal or area monitoring; or
(ii) Documentation or statements provided by affidavit indicating
that radiation monitoring records for members of the proposed class have
been lost, falsified, or destroyed; or
(iii) A report from a health physicist or other individual with
expertise in dose reconstruction documenting the limitations of existing
DOE or AWE records on radiation exposures at the facility, as relevant
to the petition. This report should specify the basis for believing
these documented limitations might prevent the completion of dose
reconstructions for members of the class under 42 CFR part 82 and
related NIOSH technical implementation guidelines; or
(iv) A scientific or technical report, published or issued by a
government agency of the Executive Branch of government or the General
Accounting Office, the Nuclear Regulatory Commission, or the Defense
Nuclear Facilities Safety Board, or published in a peer-reviewed
journal, that identifies dosimetry and related information that are
unavailable (due to either a lack of monitoring or the destruction or
loss of records) for estimating the radiation doses of employees covered
by the petition.
(3) If the petition is based on an exposure incident as described
under paragraph (c)(1)(v) of this section, the petitioner(s) might be
required to provide evidence that the incident occurred, but only if
NIOSH is unable to obtain records or confirmation of the occurrence of
such an incident from sources independent of the petitioner(s). Such
evidence would not be required at the time the petition is submitted and
the
[[Page 487]]
petitioner(s) would be directly informed of the need for this
supplemental information. In such cases, either of the following may
qualify as evidence:
(i) Medical evidence that one or more members of the class may have
incurred a high level radiation dose from the incident, such as a
depressed white blood cell count associated with radiation exposure or
the application of chelation therapy; or
(ii) NIOSH will consider evidence provided by affidavit from one or
more employees who witnessed the incident. If the petitioner cannot
provide such affidavits because such employees are deceased, prevented
by reasons of poor health or impairment, or cannot be identified or
located, then the requirement for evidence provided by affidavit can be
met by providing such an affidavit from one or more individuals who did
not witness the incident, provided the individual was directly informed
by one or more employees who witnessed the incident.\3\
---------------------------------------------------------------------------
\3\ An affidavit may be from a petitioner but HHS does not require
that an affidavit be from a petitioner.
---------------------------------------------------------------------------
(4) The provision of any evidence under this section or other
provisions of this part, including one or more affidavits, would not, in
and of itself, be sufficient to confirm the facts presented by that
evidence. NIOSH will consider the adequacy and credibility of any
evidence provided.
(5) If, under Sec. 83.15(a), NIOSH has already issued a Federal
Register notice scheduling a Board meeting to consider a petition
concerning a class of employees, then any petitions for such a class of
employees submitted following this notice must, under paragraph (c)(2)
of this section, present substantially new information that has not
already been considered by NIOSH. For this purpose, NIOSH would find
that information has been already considered by NIOSH if it were
included in the petition(s) that were already considered by NIOSH or if
it were addressed either in the report(s) by NIOSH evaluating such a
petition or petitions under Sec. 83.13(c) or in a proposed decision by
NIOSH responding to such a petition or petitions under Sec. 83.16(a).
Table 1 for Sec. 83.9: Summary of Informational Requirements for All
Petitions
[Petitioner(s) must submit identifying and contact information and
either A. or B. of this table.]
------------------------------------------------------------------------
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A. The claimant's authorization of the B. (1) A proposed class
petition, based on NIOSH having found definition identifying: (i)
it could not complete a dose Facility, (ii) relevant
reconstrucitn for the claimant locations at the facility;
submitting the petition; or. (iii) job titles/duties, (iv)
period of employment, and if
relevant, (v) exposure
incident.
(2) The basis for infeasibility
of dose reconstruction;
either: (i) lack of
monitoring; or (ii)
destruction, falsification, or
loss of records; or (iii)
expert report; or (iv)
scientific or technical
report.
------------------------------------------------------------------------
Sec. 83.10 If a petition satisfies all relevant requirements under Sec. 83.9,
does this mean the class will be added to the Cohort?
Satisfying the informational requirements for a petition does not
mean the class will be added to the Cohort. It means the petition will
receive a full evaluation by NIOSH, the Board, and HHS, as described
under Sec. Sec. 83.13 through 83.16. The role of the petitioner(s) is
to identify classes of employees that should be considered for addition
to the Cohort.
[[Page 488]]
Sec. 83.11 What happens to petitions that do not satisfy all relevant
requirements under Sec. Sec. 83.7 through 83.9?
(a) NIOSH will notify the petitioner(s) of any requirement that is
not met by the petition, assist the petitioner(s) with guidance in
developing relevant information, and provide 30 calendar days for the
petitioner(s) to revise the petition accordingly.
(b) After 30 calendar days from the date of notification under
paragraph (a) of this section, NIOSH will notify any petitioner(s) whose
petition remains unsatisfactory of the proposed finding of NIOSH that
the petition fails to meet the specified requirements and the basis for
this finding.
(c) A petitioner may request in writing a review of a proposed
finding within 30 calendar days of notification under paragraph (b) of
this section. Petitioners must specify why the proposed finding should
be reversed, based on the petition requirements and on the information
that the petitioners had already submitted. The request may not include
any new information or documentation that was not included in the
completed petition. If the petitioner obtains new information within
this 30-day period, the petitioner should provide it to NIOSH. NIOSH
will consider this new information as a revision of the petition under
paragraph (a) of this section.
(d) Three HHS personnel, appointed by the Director of NIOSH, who
were not involved in developing the proposed finding will complete
reviews within 30 work days of the request for such a review. The
Director of NIOSH will consider the results of the review and then make
a final decision as to whether the petition satisfies the requirements
for a petition.
(e) Proposed findings established by NIOSH under paragraph (b) of
this section will become final decisions in 31 calendar days if not
reviewed under paragraph (d) of this section.
(f) Based on new information, NIOSH may, at its discretion,
reconsider a decision that a petition does not satisfy the requirements
for a petition.
(g) A petitioner whose petition has been found not to satisfy the
requirements for a petition under either paragraph (d) or (e) of this
section may submit to NIOSH a new petition for the identical class of
employees at any time thereafter on the basis of new information not
provided to NIOSH in the original petition. In such a case, the
petitioner is required to fully re-address all the requirements of
Sec. Sec. 83.7-83.9 in the petition.
[70 FR 75952, Dec. 22, 2005, as amended at 72 FR 37459, July 10, 2007]
Sec. 83.12 How will NIOSH notify petitioners, the Board, and the public of
petitions that have been selected for evaluation?
(a) NIOSH will notify the petitioner(s) in writing that it has
selected the petition for evaluation. NIOSH will also provide the
petitioner(s) with information on the steps of the evaluation and other
processes required pursuant to these procedures.
(b) NIOSH will combine separate petitions and evaluate them as a
single petition if, at this or at any point in the evaluation process
under Sec. Sec. 83.13 and 83.14, NIOSH finds such petitions represent
the same class of employees.
(c) NIOSH will present petitions selected for evaluation to the
Board with plans specific to evaluating each petition. Each evaluation
plan will include the following elements:
(1) An initial proposed definition for the class being evaluated,
subject to revision as warranted by the evaluation conducted under Sec.
83.13 or Sec. 83.14; and
(2) A list of activities for evaluating the radiation exposure
potential of the class and the adequacy of existing records and
information needed to conduct dose reconstructions for all class members
under 42 CFR part 82.
(d) NIOSH may initiate work to evaluate a petition immediately,
prior to presenting the petition and evaluation plan to the Board.
(e) NIOSH will publish a notice in the Federal Register notifying
the public of its decision to evaluate a petition.
Sec. 83.13 How will NIOSH evaluate petitions, other than petitions by
claimants covered under Sec. 83.14?
(a) NIOSH will collect information on the types and levels of
radiation exposures that potential members of the class may have
incurred, as specified
[[Page 489]]
under 42 CFR 83.14, from the following potential sources, as necessary:
(1) The petition or petitions submitted on behalf of the class;
(2) DOE and AWE facility records and information;
(3) Potential members of the class and their survivors;
(4) Labor organizations who represent or represented employees at
the facility during the relevant period of employment;
(5) Managers, radiation safety officials, and other witnesses
present during the relevant period of employment at the DOE facility or
AWE facility;
(6) NIOSH records from epidemiological research on DOE populations
and records from dose reconstructions conducted under 42 CFR part 82;
(7) Records from research, dose reconstructions, medical screening
programs, and other related activities conducted to evaluate the health
and/or radiation exposures of DOE employees, DOE contractor or
subcontractor employees, and/or AWE employees; and
(8) Other sources.
(b) The Director of OCAS may determine that records and/or
information requested from DOE, an AWE, or another source to evaluate a
petition is not, or will not be, available on a timely basis. Such a
determination will be treated, for the purposes of the petition
evaluation, as equivalent to a finding that the records and/or
information requested are not available.
(1) Before the Director of OCAS makes such a determination, the
source(s) potentially in possession of such records and/or information
will be allowed a reasonable amount of time, as determined by the
Director of OCAS, to provide the records and/or information.
(2) Such a determination may take into account the types and
quantity of records and/or information requested from the source, as
well as any other factors that might be relevant to the judgment under
paragraph (b)(1) of this this section of the amount of time that is
reasonable to provide the records and/or information, which would be
decided on a case-by-case basis by the Director of OCAS.
(c) NIOSH will evaluate records and information collected to make
the following determinations:
(1) Is it feasible to estimate the level of radiation doses of
individual members of the class with sufficient accuracy? (i) Radiation
doses can be estimated with sufficient accuracy if NIOSH has established
that it has access to sufficient information to estimate the maximum
radiation dose, for every type of cancer for which radiation doses are
reconstructed, that could have been incurred in plausible circumstances
by any member of the class, or if NIOSH has established that it has
access to sufficient information to estimate the radiation doses of
members of the class more precisely than an estimate of the maximum
radiation dose. NIOSH must also determine that it has information
regarding monitoring, source, source term, or process from the site
where the employees worked to serve as the basis for a dose
reconstruction. This basis requirement does not limit NIOSH to using
only or primarily information from the site where the employee worked,
but a dose reconstruction must, as a starting point, be based on some
information from the site where the employee worked.
(ii) In many circumstances, to establish a positive finding under
paragraph (c)(1)(i) of this section would require, at a minimum, that
NIOSH have access to reliable information on the identity or set of
possible identities and maximum quantity of each radionuclide (the
radioactive source material) to which members of the class were
potentially exposed without adequate protection. Alternatively, if
members of the class were potentially exposed without adequate
protection to unmonitored radiation from radiation generating equipment
(e.g., particle accelerator, industrial x-ray equipment), in many
circumstances, NIOSH would require relevant equipment design and
performance specifications or information on maximum emissions.
(iii) In many circumstances, to establish a positive finding under
paragraph (c)(1)(i) of this section would also require information
describing the process through which the radiation exposures of concern
may have occurred
[[Page 490]]
and the physical environment in which the exposures may have occurred.
(iv) In many circumstances, access to personal dosimetry data and
area monitoring data is not necessary to estimate the maximum radiation
doses that could have been incurred by any member of the class, although
radiation doses can be estimated more precisely with such data.
(2) How should the class be defined, consistent with the findings of
the analysis discussed under paragraph (c)(1) of this section? NIOSH
will define the following characteristics of a class, taking into
account the class definition proposed by the petition and modified as
necessary to reflect the results of the evaluation under paragraph
(c)(1) of this section:
(i) Any of the following employment parameters, as necessary to
identify members included in the class: facility, job titles, duties,
and/or specific work locations at the facility, the relevant time
period, and any additional identifying characteristics of employment;
and
(ii) If applicable, the identification of an exposure incident, when
unmonitored radiation exposure during such an incident comprises the
basis of the petition or the class definition.
(3) Is there a reasonable likelihood that such radiation dose may
have endangered the health of members of the class? If it is not
feasible to estimate with sufficient accuracy radiation doses for
members of the class, as provided under paragraph (c)(1) of this
section, then NIOSH must determine, as required by the statute, that
``there is a reasonable likelihood that such radiation dose may have
endangered the health of members of the class'' (42 U.S.C. 7384q(b)(2)).
(i) For classes of employees that may have been exposed to radiation
during discrete incidents likely to have involved exceptionally high
level exposures, such as nuclear criticality incidents or other events
involving similarly high levels of exposures resulting from the failure
of radiation protection controls, NIOSH will assume for the purposes of
this section that any duration of unprotected exposure could cause a
specified cancer, and hence may have endangered the health of members of
the class. Presence with potential exposure during the discrete
incident, rather than a quantified duration of potential exposure, will
satisfy the health endangerment criterion.
(ii) For health endangerment not established on the basis of a
discrete incident, as described under paragraph (c)(3)(i) of this
section, NIOSH will specify a minimum duration of employment to satisfy
the health endangerment criterion as having been employed for a number
of work days aggregating at least 250 work days within the parameters
established for the class or in combination with work days within the
parameters established for one or more other classes of employees in the
Cohort.
(d) NIOSH will submit a report of its evaluation findings to the
Board and to the petitioner(s). The report will include the following
elements:
(1) An identification of the relevant petitions;
(2) A proposed definition of the class or classes of employees to
which the evaluation applies, and a summary of the basis for this
definition, including, as necessary:
(i) Any justification that may be needed for the inclusion of groups
of employees who were not specified in the original petition(s);
(ii) The identification of any groups of employees who were
identified in the original petition(s) who should constitute a separate
class of employees; or
(iii) The merging of multiple petitions that represent a single
class of employees;
(3) The proposed class definition will address the following
employment parameters:
(i) The DOE facility or the AWE facility that employed the class;
(ii) The job titles and/or job duties and/or work locations of class
members;
(iii) The period of employment within which a class member must have
been employed at the facility under the job titles and/or performing the
job duties and/or working in the locations specified in this class
definition;
(iv) If applicable, identification of an exposure incident, when
potential radiation exposure during such an incident
[[Page 491]]
comprises the basis of the class definition;
(v) If necessary, any other parameters that serve to define the
membership of the class; and
(vi) For a class for which it is not feasible to estimate radiation
doses with sufficient accuracy, a minimum duration of employment within
the parameters of the class for inclusion in the class, as defined under
paragraph (c)(3) of this section;
(4) A summary of the findings concerning the adequacy of existing
records and information for reconstructing doses for individual members
of the class under the methods of 42 CFR part 82 specifying, for each
class defined in the report, whether NIOSH finds that it is feasible to
estimate the radiation doses of members of the class with sufficient
accuracy, and a description of the evaluation methods and information
upon which these findings are based; and
(5) For a class for which it is not feasible to estimate radiation
doses with sufficient accuracy, a summary of the basis for establishing
the duration of employment requirement with respect to health
endangerment.
(e) The NIOSH report under paragraph (d) of this section shall be
completed within 180 calendar days of the receipt of the petition by
NIOSH. The procedure for computing this time period is specified in
Sec. 83.5(c). In addition, the computing of 180 calendar days shall not
include any days during which the petitioner may be revising the
petition to remedy deficiencies identified by NIOSH under Sec. 83.11(a)
or (b), nor shall it include any days during which the petitioner may
request a review of a proposed finding under Sec. 83.11(c) or during
the conduct of such a review under Sec. 83.11(d).
[69 FR 30780, May 28, 2004, as amended at 72 FR 37459, July 10, 2007]
Sec. 83.14 How will NIOSH evaluate a petition by a claimant whose dose
reconstruction NIOSH could not complete under 42 CFR part 82?
(a) NIOSH may establish two classes for evaluation, to permit the
timely adjudication of the existing cancer claim:
(1) A class of employees defined using the research and analyses
already completed in attempting the dose reconstruction for the employee
identified in the claimant's petition; and
(2) A class of co-workers similar to the class defined under
paragraph (a)(1) of this section, to be defined by NIOSH on the basis of
further research and analyses, using the procedures under Sec. 83.13.
(b) NIOSH will determine the health endangerment criteria for adding
the class under paragraph (a)(1) of this section to the Cohort, using
the procedures under Sec. 83.13. NIOSH will report to the Board and to
petitioner(s) the results of this determination, together with its
finding under 42 CFR part 82 that there was insufficient information to
complete the dose reconstruction. HHS will consider this finding under
42 CFR part 82 sufficient, without further consideration, to determine
that it is not feasible to estimate the levels of radiation doses of
individual members of the class with sufficient accuracy.
(c) NIOSH will evaluate the petition as it may concern a class of
co-workers, as described under paragraph (a)(2) of this section,
according to the procedures under Sec. 83.13.
Sec. 83.15 How will the Board consider and advise the Secretary on a
petition?
(a) NIOSH will publish a notice in the Federal Register providing
notice of a Board meeting at which a petition will be considered, and
summarizing the petition to be considered by the Board at the meeting
and the findings of NIOSH from evaluating the petition.
(b) The Board will consider the petition and the NIOSH evaluation
report at the meeting, to which the petitioner(s) will be invited to
present views and information on the petition and the NIOSH evaluation
findings. In considering the petition, both NIOSH and the members of the
Board will take all steps necessary to prevent the disclosure of
information of a personal nature, concerning the petitioners or others,
where disclosure would constitute a clearly unwarranted invasion of
personal privacy.
[[Page 492]]
(c) In considering the petition, the Board may obtain and consider
additional information not addressed in the petition or the initial
NIOSH evaluation report.
(d) NIOSH may decide to further evaluate a petition, upon the
request of the Board. If NIOSH conducts further evaluation, it will
report new findings to the Board and the petitioner(s).
(e) Upon the completion of NIOSH evaluations and deliberations of
the Board concerning a petition, the Board will develop and transmit to
the Secretary a report containing its recommendations. The Board's
report will include the following:
(1) The identification and inclusion of the relevant petition(s);
(2) The definition of the class of employees covered by the
recommendation;
(3) A recommendation as to whether or not the Secretary should
designate the class as an addition to the Cohort;
(4) The relevant criteria under Sec. 83.13(c) and findings and
information upon which the recommendation is based, including NIOSH
evaluation reports, information provided by the petitioners, any other
information considered by the Board, and the deliberations of the Board.
Sec. 83.16 How will the Secretary decide the outcome(s) of a petition?
(a) The Director of NIOSH will propose a decision to add or deny
adding any class or classes of employees to the Cohort, including an
iteration of the relevant criteria, as specified under Sec. 83.13(c),
and a summary of the information and findings on which the proposed
decision is based. This proposed decision will take into consideration
the evaluations of NIOSH and the report and recommendations of the
Board, and may also take into consideration information presented or
submitted to the Board and the deliberations of the Board. In the case
of a petition that NIOSH has determined encompasses more than one class
of employees, the Director of NIOSH will issue a separate proposed
decision for each separate class of employees.
(b) The Secretary will make the final decision to add or deny adding
a class to the Cohort, including the definition of the class, after
considering information and recommendations provided to the Secretary by
the Director of NIOSH and the Board. HHS will transmit a report of the
decision to the petitioner(s), including an iteration of the relevant
criteria, as specified under Sec. 83.13(c), and a summary of the
information and findings on which the decision is based. HHS will also
publish a notice summarizing the decision in the Federal Register.
(c) If, under Sec. 83.15(e), the Board recommends that the
Secretary designate a class covered by the petition as an addition to
the Cohort, and if, under paragraph (b) of Sec. 83.16, the Secretary
decides to deny adding the class, as defined by the Board, to the
Cohort, then the Secretary will submit to Congress a determination that
the statutory criteria specified under 42 U.S.C. 7384q(b)(1) and (2)
have not been met for adding the class to the Cohort. The Secretary will
submit this determination to Congress within 30 calendar days following
receipt by the Secretary of the recommendation of the Board.
[70 FR 75953, Dec. 22, 2005]
Sec. 83.17 How will the Secretary report a final decision to add a class of
employees to the Cohort and any action of Congress concerning the effect of
the final decision?
(a) If the Secretary designates a class of employees to be added to
the Cohort, the Secretary will transmit to Congress a report providing
the designation, the definition of the class of employees covered by the
designation, and the criteria and findings upon which the designation
was based.\4\
---------------------------------------------------------------------------
\4\ See 42 U.S.C. 7384l(14)(C)(ii).
---------------------------------------------------------------------------
(b) If, under Sec. 83.15(e), the Board recommends that the
Secretary designate a class covered by the petition as an addition to
the Cohort, and if, under paragraph (b) of Sec. 83.16, the Secretary
decides to add a class to the Cohort that is inclusive of the class as
defined by the Board, then the Secretary will transmit to Congress the
report specified in paragraph (a) of this section within 30 calendar
days following receipt by the Secretary of the recommendation of the
Board.
[[Page 493]]
(c) A designation of the Secretary will take effect 30 calendar days
after the date on which the report of the Secretary under paragraph (a)
of this section is submitted to Congress, or is deemed to have been
submitted to Congress,\5\ unless Congress takes an action that reverses
or expedites the designation.
---------------------------------------------------------------------------
\5\ Under 42 U.S.C. 7384q(c)(2)(C), if the Secretary does not submit
within 30 days the determination required under paragraph (a) of Sec.
83.17 of this part, then on the following day, ``it shall be deemed''
that the Secretary submitted the report specified under paragraph (b) of
Sec. 83.17 of this part.
---------------------------------------------------------------------------
(d) After either the expiration of the congressional review period
or notification of final congressional action, whichever comes first,
the Secretary will transmit to DOL and to the petitioner(s) a report
providing the definition of the class and one of the following outcomes:
(1) The addition of the class to the Cohort; or
(2) The result of any action by Congress to reverse or expedite the
decision of the Secretary to add the class to the Cohort.
(e) The report specified under paragraph (d) of this section will be
published on the Internet at http://www.cdc.gov/niosh/ocas and in the
Federal Register.
[69 FR 30780, May 28, 2004, as amended at 70 FR 75953, Dec. 22, 2005]
Sec. 83.18 How can petitioners obtain an administrative review of a final
decision by the Secretary?
(a) HHS will allow petitioners to contest only a final decision to
deny adding a class to the Cohort or a health endangerment determination
under Sec. 83.13(c)(3)(ii). Such challenges must be submitted in
writing within 30 calendar days and must include evidence that the final
decision relies on a record of either substantial factual errors or
substantial errors in the implementation of the procedures of this part.
Challenges may not introduce new information or documentation concerning
the petition or the NIOSH or Board evaluation(s) that was not submitted
or presented by the petitioner(s) or others to NIOSH or to the Board
prior to the Board's issuing its recommendations under Sec. 83.15.
(b) A panel of three HHS personnel, independent of NIOSH and
appointed by the Secretary, will conduct an administrative review based
on a challenge submitted under paragraph (a) of this section and provide
recommendations of the panel to the Secretary concerning the merits of
the challenge and the resolution of issues contested by the challenge.
Reviews by the panel will consider, in addition to the views and
information submitted by the petitioner(s) in the challenge, the NIOSH
evaluation report(s), the report containing the recommendations of the
Board issued under Sec. 83.15, and recommendations of the Director of
NIOSH to the Secretary. The reviews may also consider information
presented or submitted to the Board and the deliberations of the Board
prior to the issuance of the recommendations of the Board under Sec.
83.15. The panel shall consider whether HHS substantially complied with
the procedures of this part, the factual accuracy of the information
supporting the final decision, and the principal findings and
recommendations of NIOSH and those of the Board issued under Sec.
83.15.
(c) The Secretary will decide whether or not to revise a final
decision contested by the petitioner(s) under this section after
considering information and recommendations provided to the Secretary by
the Director of NIOSH, the Board, and from the HHS administrative review
conducted under paragraph (b) of this section. HHS will transmit a
report of the decision to the petitioner(s).
(d) If the Secretary decides under paragraph (c) of this section to
change a designation under Sec. 83.17(a) of this part or a
determination under Sec. 83.16(c) of this part, the Secretary will
transmit to Congress a report providing such change to the designation
or determination, including an iteration of the relevant criteria, as
specified under Sec. 83.13(c), and a summary of the information and
findings on which the decision is based. HHS will also publish a notice
summarizing the decision in the Federal Register.
[[Page 494]]
(e) A new designation of the Secretary under this section will take
effect 30 calendar days after the date on which the report of the
Secretary under paragraph (d) of this section is submitted to Congress,
unless Congress takes an action that reverses or expedites the
designation. Such new designations and related congressional actions
will be further reported by the Secretary pursuant to paragraphs (d) and
(e) of Sec. 83.17.
[70 FR 75953, Dec. 22, 2005]
Sec. 83.19 How can the Secretary cancel or modify a final decision to add a
class of employees to the Cohort?
(a) The Secretary can cancel a final decision to add a class to the
Cohort, or can modify a final decision to reduce the scope of a class
added by the Secretary, if HHS obtains records relevant to radiation
exposures of members of the class that enable NIOSH to estimate the
radiation doses incurred by individual members of the class through dose
reconstructions conducted under the requirements of 42 CFR part 82.
(b) Before canceling a final decision to add a class or modifying a
final decision to reduce the scope of a class, the Secretary intends to
follow evaluation procedures that are substantially similar to those
described in this part for adding a class of employees to the Cohort.
The procedures will include the following:
(1) Publication of a notice in the Federal Register informing the
public of the intent of the Secretary to review the final decision on
the basis of new information and describing procedures for this review;
(2) An analysis by NIOSH of the utility of the new information for
conducting dose reconstructions under 42 CFR part 82; the analysis will
be performed consistently with the requirements for analysis of a
petition by NIOSH under Sec. Sec. 83.13(c)(1) and (2), and 83.13(c)(2)
and (3);
(3) A recommendation by the Board to the Secretary as to whether or
not the Secretary should cancel or modify his final decision that added
the class to the Cohort, based upon a review by the Board of the NIOSH
analysis under paragraph (b)(2) of this section and any other relevant
information considered by the Board;
(4) An opportunity for members of the class to contest a proposed
decision to cancel or modify the prior final decision that added the
class to the Cohort, including a reasonable and timely effort by the
Secretary to notify members of the class of this opportunity; and
(5) Publication in the Federal Register of a final decision to
cancel or modify the prior final decision that added the class to the
Cohort.
[69 FR 30780, May 28, 2004. Redesignated at 70 FR 75953, Dec. 22, 2005]
PART 84_APPROVAL OF RESPIRATORY PROTECTIVE DEVICES--Table of Contents
Subpart A_General Provisions
Sec.
84.1 Purpose.
84.2 Definitions.
84.3 Respirators for mine rescue or other emergency use in mines.
Subpart B_Application for Approval
84.10 Application procedures.
84.11 Contents of application.
84.12 Delivery of respirators and components by applicant; requirements.
Subpart C_Fees
84.20 Examination, inspection, and testing of complete respirator
assemblies; fees.
84.21 Examination, inspection, and testing of respirator components or
subassemblies; fees.
84.22 Unlisted fees; additional fees; payment by applicant prior to
approval.
Subpart D_Approval and Disapproval
84.30 Certificates of approval; scope of approval.
84.31 Certificates of approval; contents.
84.32 Notice of disapproval.
84.33 Approval labels and markings; approval of contents; use.
84.34 Revocation of certificates of approval.
84.35 Changes or modifications of approved respirators; issuance of
modification of certificate of approval.
84.36 Delivery of changed or modified approved respirator.
Subpart E_Quality Control
84.40 Quality control plans; filing requirements.
84.41 Quality control plans; contents.
[[Page 495]]
84.42 Proposed quality control plans; approval by the Institute.
84.43 Quality control records; review by the Institute; revocation of
approval.
Subpart F_Classification of Approved Respirators; Scope of Approval;
Atmospheric Hazards; Service Time
84.50 Types of respirators to be approved; scope of approval.
84.51 Entry and escape, or escape only; classification.
84.52 Respiratory hazards; classification.
84.53 Service time; classification.
Subpart G_General Construction and Performance Requirements
84.60 Construction and performance requirements; general.
84.61 General construction requirements.
84.62 Component parts; minimum requirements.
84.63 Test requirements; general.
84.64 Pretesting by applicant; approval of test methods.
84.65 Conduct of examinations, inspections, and tests by the Institute;
assistance by applicant; observers; recorded data; public
demonstrations.
84.66 Withdrawal of applications; refund of fees.
Subpart H_Self-Contained Breathing Apparatus
84.70 Self-contained breathing apparatus; description.
84.71 Self-contained breathing apparatus; required components.
84.72 Breathing tubes; minimum requirements.
84.73 Harnesses; installation and construction; minimum requirements.
84.74 Apparatus containers; minimum requirements.
84.75 Half-mask facepieces, full facepieces, mouthpieces; fit; minimum
requirements.
84.76 Facepieces; eyepieces; minimum requirements.
84.77 Inhalation and exhalation valves; minimum requirements.
84.78 Head harnesses; minimum requirements.
84.79 Breathing gas; minimum requirements.
84.80 Interchangeability of oxygen and air prohibited.
84.81 Compressed breathing gas and liquefied breathing gas containers;
minimum requirements.
84.82 Gas pressure gages; minimum requirements.
84.83 Timers; elapsed time indicators; remaining service life
indicators; minimum requirements.
84.84 Hand-operated valves; minimum requirements.
84.85 Breathing bags; minimum requirements.
84.86 Component parts exposed to oxygen pressures; minimum requirements.
84.87 Compressed gas filters; minimum requirements.
84.88 Breathing bag test.
84.89 Weight requirement.
84.90 Breathing resistance test; inhalation.
84.91 Breathing resistance test; exhalation.
84.92 Exhalation valve leakage test.
84.93 Gas flow test; open-circuit apparatus.
84.94 Gas flow test; closed-circuit apparatus.
84.95 Service time test; open-circuit apparatus.
84.96 Service time test; closed-circuit apparatus.
84.97 Test for carbon dioxide in inspired gas; open- and closed-circuit
apparatus; maximum allowable limits.
84.98 Tests during low temperature operation.
84.99 Man tests; testing conditions; general requirements.
84.100 Man tests 1, 2, 3, and 4; requirements.
84.101 Man test 5; requirements.
84.102 Man test 6; requirements.
84.103 Man tests; performance requirements.
84.104 Gas tightness test; minimum requirements.
Tables to Subpart H of Part 84
Subpart I_Gas Masks
84.110 Gas masks; description.
84.111 Gas masks; required components.
84.112 Canisters and cartridges in parallel; resistance requirements.
84.113 Canisters and cartridges; color and markings; requirements.
84.114 Filters used with canisters and cartridges; location;
replacement.
84.115 Breathing tubes; minimum requirements.
84.116 Harnesses; installation and construction; minimum requirements.
84.117 Gas mask containers; minimum requirements.
84.118 Half-mask facepieces, full facepieces, and mouthpieces; fit;
minimum requirements.
84.119 Facepieces; eyepieces; minimum requirements.
84.120 Inhalation and exhalation valves; minimum requirements.
84.121 Head harnesses; minimum requirements.
84.122 Breathing resistance test; minimum requirements.
84.123 Exhalation valve leakage test.
[[Page 496]]
84.124 Facepiece tests; minimum requirements.
84.125 Particulate tests; canisters containing particulate filters;
minimum requirements.
84.126 Canister bench tests; minimum requirements.
Tables to Subpart I of Part 84
Subpart J_Supplied-Air Respirators
84.130 Supplied-air respirators; description.
84.131 Supplied-air respirators; required components.
84.132 Breathing tubes; minimum requirements.
84.133 Harnesses; installation and construction; minimum requirements.
84.134 Respirator containers; minimum requirements.
84.135 Half-mask facepieces, full facepieces, hoods, and helmets; fit;
minimum requirements.
84.136 Facepieces, hoods, and helmets; eyepieces; minimum requirements.
84.137 Inhalation and exhalation valves; check valves; minimum
requirements.
84.138 Head harnesses; minimum requirements.
84.139 Head and neck protection; supplied-air respirators; minimum
requirements.
84.140 Air velocity and noise levels; hoods and helmets; minimum
requirements.
84.141 Breathing gas; minimum requirements.
84.142 Air supply source; hand-operated or motor driven air blowers;
Type A supplied-air respirators; minimum requirements.
84.143 Terminal fittings or chambers; Type B supplied-air respirators;
minimum requirements.
84.144 Hand-operated blower test; minimum requirements.
84.145 Motor-operated blower test; minimum requirements.
84.146 Method of measuring the power and torque required to operate
blowers.
84.147 Type B supplied-air respirator; minimum requirements.
84.148 Type C supplied-air respirator, continuous-flow class; minimum
requirements.
84.149 Type C supplied-air respirator, demand and pressure demand class;
minimum requirements.
84.150 Air-supply line tests; minimum requirements.
84.151 Harness test; minimum requirements.
84.152 Breathing tube test; minimum requirements.
84.153 Airflow resistance test, Type A and Type AE supplied-air
respirators; minimum requirements.
84.154 Airflow resistance test; Type B and Type BE supplied-air
respirators; minimum requirements.
84.155 Airflow resistance test; Type C supplied-air respirator,
continuous flow class and Type CE supplied-air respirator;
minimum requirements.
84.156 Airflow resistance test; Type C supplied-air respirator, demand
class; minimum requirements.
84.157 Airflow resistance test; Type C supplied-air respirator,
pressure-demand class; minimum requirements.
84.158 Exhalation valve leakage test.
84.159 Man tests for gases and vapors; supplied-air respirators; general
performance requirements.
84.160 Man test for gases and vapors; Type A and Type AE respirators;
test requirements.
84.161 Man tests for gases and vapors; Type B and Type BE respirators;
test requirements.
84.162 Man test for gases and vapors; Type C respirators, continuous-
flow class and Type CE supplied-air respirators; test
requirements.
84.163 Man test for gases and vapors; Type C supplied-air respirators,
demand and pressure-demand classes; test requirements.
Tables to Subpart J of Part 84
Subpart K_Non-Powered Air-Purifying Particulate Respirators
84.170 Non-powered air-purifying particulate respirators; description.
84.171 Non-powered air-purifying particulate respirators; required
components.
84.172 Breathing tubes; minimum requirements.
84.173 Harnesses; installation and construction; minimum requirements.
84.174 Respirator containers; minimum requirements.
84.175 Half-mask facepieces, full facepieces, hoods, helmets, and
mouthpieces; fit; minimum requirements.
84.176 Facepieces, hoods, and helmets; eyepieces; minimum requirements.
84.177 Inhalation and exhalation valves; minimum requirements.
84.178 Head harnesses; minimum requirements.
84.179 Non-powered air-purifying particulate respirators; filter
identification.
84.180 Airflow resistance tests.
84.181 Non-powered air-purifying particulate filter efficiency level
determination.
84.182 Exhalation valve leakage test; minimum requirements.
Subpart L_Chemical Cartridge Respirators
84.190 Chemical cartridge respirators: description.
84.191 Chemical cartridge respirators; required components.
[[Page 497]]
84.192 Cartridges in parallel; resistance requirements.
84.193 Cartridges; color and markings; requirements.
84.194 Filters used with chemical cartridges; location; replacement.
84.195 Breathing tubes; minimum requirements.
84.196 Harnesses; installation and construction; minimum requirements.
84.197 Respirator containers; minimum requirements.
84.198 Half-mask facepieces, full facepieces, mouthpieces, hoods, and
helmets; fit; minimum requirements.
84.199 Facepieces, hoods, and helmets; eyepieces; minimum requirements.
84.200 Inhalation and exhalation valves; minimum requirements.
84.201 Head harnesses; minimum requirements.
84.202 Air velocity and noise levels; hoods and helmets; minimum
requirements.
84.203 Breathing resistance test; minimum requirements.
84.204 Exhalation valve leakage test; minimum requirements.
84.205 Facepiece test; minimum requirements.
84.206 Particulate tests; respirators with filters; minimum
requirements; general.
84.207 Bench tests; gas and vapor tests; minimum requirements; general.
Tables to Subpart L of Part 84
Subpart M [Reserved]
Subpart N_Special Use Respirators
84.250 Vinyl chloride respirators; description.
84.251 Required components.
84.252 Gas masks; requirements and tests.
84.253 Chemical-cartridge respirators; requirements and tests.
84.254 Powered air-purifying respirators; requirements and tests.
84.255 Requirements for end-of-service-life indicator.
84.256 Quality control requirements.
84.257 Labeling requirements.
84.258 Fees.
Subparts O-JJ [Reserved]
Subpart KK_Dust, Fume, and Mist; Pesticide; Paint Spray; Powered Air-
Purifying High Efficiency Respirators and Combination Gas Masks
84.1100 Scope and effective dates.
84.1101 Definitions.
84.1102 Examination, inspection and testing of complete respirator
assemblies; fees.
84.1103 Approval labels and markings; approval of contents; use.
84.1130 Respirators; description.
84.1131 Respirators; required components.
84.1132 Breathing tubes; minimum requirements.
84.1133 Harnesses; installation and construction; minimum requirements.
84.1134 Respirator containers; minimum requirements.
84.1135 Half-mask facepieces, full facepieces, hoods, helmets, and
mouthpieces; fit; minimum requirements.
84.1136 Facepieces, hoods, and helmets; eyepieces; minimum requirements.
84.1137 Inhalation and exhalation valves; minimum requirements.
84.1138 Head harnesses; minimum requirements.
84.1139 Air velocity and noise levels; hoods and helmets; minimum
requirements.
84.1140 Dust, fume, and mist respirators; performance requirements;
general.
84.1141 Isoamyl acetate tightness test; dust, fume, and mist respirators
designed for respiratory protection against fumes of various
metals having an air contamination level not less than 0.05
milligram per cubic meter; minimum requirements.
84.1142 Isoamyl acetate tightness test; respirators designed for
respiratory protection against dusts, fumes, and mists having
an air contamination level less than 0.05 milligram per cubic
meter, or against radionuclides; minimum requirements.
84.1143 Dust, fume, and mist air-purifying filter tests; performance
requirements; general.
84.1144 Silica dust test for dust, fume, and mist respirators; single-
use or reusable filters; minimum requirements.
84.1145 Silica dust test; non-powered single-use dust respirators;
minimum requirements.
84.1146 Lead fume test for dust, fume, and mist respirators; minimum
requirements.
84.1147 Silica mist test for dust, fume, and mist respirators; minimum
requirements.
84.1148 Tests for respirators designed for respiratory protection
against more than one type of dispersoid; minimum
requirements.
84.1149 Airflow resistance tests; all dust, fume, and mist respirators;
minimum requirements.
84.1150 Exhalation valve leakage test; minimum requirements.
84.1151 DOP filter test; respirators designed as respiratory protection
against dusts, fumes, and mists having an air contamination
level less than 0.05 milligram per cubic meter and against
radionuclides; minimum requirements.
84.1152 Silica dust loading test; respirators designed as protection
against dusts, fumes, and mists having an air contamination
level less than 0.05 milligram per
[[Page 498]]
cubic meter and against radionuclides; minimum requirements.
84.1153 Dust, fume, mist, and smoke tests; canister bench tests; gas
mask canisters containing filters; minimum requirements.
84.1154 Canister and cartridge requirements.
84.1155 Filters used with canisters and cartridges; location;
replacement.
84.1156 Pesticide respirators; performance requirements; general.
84.1157 Chemical cartridge respirators with particulate filters;
performance requirements; general.
84.1158 Dust, fume, and mist tests; respirators with filters; minimum
requirements; general.
Tables to Subpart KK of Part 84
Authority: 29 U.S.C. 577a, 651 et seq., and 657(g); 30 U.S.C. 3, 5,
7, 811, 842(h), 844.
Source: 60 FR 30355, June 8, 1995, unless otherwise noted.
Editorial Note: Nomenclature changes to part 84 appear at 69 FR
18803, Apr. 9, 2004.
Subpart A_General Provisions
Sec. 84.1 Purpose.
The purpose of the regulations contained in this part 84 is:
(a) To establish procedures and prescribe requirements which must be
met in filing applications for approval by the National Institute for
Occupational Safety and Health of respirators or changes or
modifications of approved respirators;
(b) To establish a schedule of fees to be charged each applicant for
the inspections, examinations, and testing conducted by the Institute
under the provisions of this part;
(c) To provide for the issuance of certificates of approval or
modifications of certificates of approval for respirators which have met
the applicable construction, performance, and respiratory protection
requirements set forth in this part; and
(d) To specify minimum requirements and to prescribe methods to be
employed by the Institute and by the applicant in conducting
inspections, examinations, and tests to determine the effectiveness of
respirators used during entry into or escape from hazardous atmospheres.
Sec. 84.2 Definitions.
As used in this part--
(a) Applicant means an individual, partnership, company,
corporation, association, or other organization that designs,
manufactures, assembles, or controls the assembly of a respirator and
who seeks to obtain a certificate of approval for such respirator.
(b) Approval means a certificate or formal document issued by the
Institute stating that an individual respirator or combination of
respirators has met the minimum requirements of this part, and that the
applicant is authorized to use and attach an approval label to any
respirator, respirator container, or instruction card for any respirator
manufactured or assembled in conformance with the plans and
specifications upon which the approval was based, as evidence of such
approval.
(c) Approved means conforming to the minimum requirements of this
part.
(d) Auxiliary equipment means a self-contained breathing apparatus,
the use of which is limited in underground mine rescue and recovery
operations to situations where the wearer has ready access to fresh air
and at least one crew equipped with approved self-contained breathing
apparatus of 2 hours or longer rating, is in reserve at a fresh-air
base.
(e) Certification and Quality Assurance Branch means the
Certification and Quality Assurance Branch, Division of Safety Research,
Appalachian Laboratory for Occupational Safety and Health, National
Institute for Occupational Safety and Health, 1095 Willowdale Road,
Morgantown, West Virginia 26505-2888.
(f) Compressed-breathing gas means oxygen or air stored in a
compressed state and supplied to the wearer in gaseous form.
(g) dBA means sound pressure levels in decibels, as measured with
the A-weighted network of a standard sound level meter using slow
response.
(h) Dust means a solid mechanically produced particle with a size
ranging from submicroscopic to macroscopic.
(i) Respirators for entry into and escape from means respiratory
devices providing protection during entry into and escape from hazardous
atmospheres.
[[Page 499]]
(j) Respirators for escape only means respiratory devices providing
protection only during escape from hazardous atmospheres.
(k) A facepiece or mouthpiece is a respirator component designed to
provide a gas-tight or dust-tight fit with the face and may include
headbands, valves, and connections for canisters, cartridges, filters,
or respirable gas source.
(l) Final inspection means that activity carried out on a product
after all manufacturing and assembly operations are completed to insure
completeness and adherence to performance or other specifications,
including satisfactory appearance.
(m) Fume means a solid condensation particle, generally less than 1
micrometer in diameter.
(n) Gas means an aeriform fluid which is in a gaseous state at
ordinary temperature and pressure.
(o) Hazardous atmosphere means:
(1) Any atmosphere containing a toxic or disease producing gas,
vapor, dust, fume, mist, or pesticide, either immediately or not
immediately dangerous to life or health; or
(2) Any oxygen-deficient atmosphere.
(p) A hood or helmet is a respirator component which covers the
wearer's head and neck, or head, neck, and shoulders, and is supplied
with incoming respirable air for the wearer to breathe. It may include a
headharness and connection for a breathing tube.
(q) Immediately dangerous to life or health means conditions that
pose an immediate threat to life or health or conditions that pose an
immediate threat of severe exposure to contaminants, such as radioactive
materials, which are likely to have adverse cumulative or delayed
effects on health.
(r) Incoming inspection means the activity of receiving, examining,
and accepting only those materials and parts whose quality conforms to
specification requirements.
(s) In-process inspection means the control of products at the
source of production and at each step of the manufacturing process, so
that departures from specifications can be corrected before defective
components or materials are assembled into the finished product.
(t) Institute means the National Institute for Occupational Safety
and Health, Department of Health and Human Services.
(u) Liquefied-breathing gas means oxygen or air stored in liquid
form and supplied to the wearer in a gaseous form.
(v) Mist means a liquid condensation particle with a size ranging
from submicroscopic to macroscopic.
(w) MSHA means the Mine Safety and Health Administration, U.S.
Department of Labor.
(x) Not immediately dangerous to life or health means any hazardous
atmosphere which may produce physical discomfort immediately, chronic
poisoning after repeated exposure, or acute adverse physiological
symptoms after prolonged exposure.
(y) Oxygen-deficient atmosphere means an atmosphere which contains
an oxygen partial pressure of less than 148 millimeters of mercury (19.5
percent by volume at sea level).
(z) Powered air-purifying respirator means a device equipped with a
facepiece, hood, or helmet, breathing tube, canister, cartridge, filter,
canister with filter, or cartridge with filter, and a blower.
(aa) Respirator means any device designed to provide the wearer with
respiratory protection against inhalation of a hazardous atmosphere.
(bb) Single-use respirator means a respirator that is entirely
discarded after excessive resistance, sorbent exhaustion, or physical
damage renders it unsuitable for further use.
(cc) Vapor means the gaseous state of a substance that is solid or
liquid at ordinary temperature and pressure.
Sec. 84.3 Respirators for mine rescue or other emergency use in mines.
(a)(1) NIOSH and the Mine Safety and Health Administration (MSHA),
U.S. Department of Labor, shall jointly review and issue certifications
for respirators used for mine emergencies and mine rescue, including any
associated service-life plans, users' manuals and other supporting
documentation.
(2) Each certification for a respirator designed for mine rescue or
other emergency use in mines shall include,
[[Page 500]]
as a condition of approval, any use limitations related to mine safety
and health.
(b) NIOSH and MSHA shall jointly determine appropriate recall and
retrofit remedies for field complaints or identified deficiencies
involving any respirators used in the mining environment.
Subpart B_Application for Approval
Sec. 84.10 Application procedures.
(a) Inspection, examination, and testing leading to the approval of
the types of respirators classified in subpart F of this part shall be
undertaken by the Institute only pursuant to written applications which
meet the minimum requirements set forth in this subpart B.
(b) Applications shall be submitted to the Certification and Quality
Assurance Branch, and shall be accompanied by a check, bank draft, or
money order in the amount specified in subpart C of this part, payable
to the order of the National Institute for Occupational Safety and
Health.
(c) Except as provided in Sec. 84.64, the examination, inspection,
and testing of all respirators shall be conducted by the Certification
and Quality Assurance Branch.
(d) Applicants, manufacturers, or their representatives may visit or
communicate with the Certification and Quality Assurance Branch in order
to discuss the requirements for approval of any respirator or the
proposed designs thereof. No charge shall be made for such consultation
and no written report shall be issued to applicants, manufacturers, or
their representatives by the Institute as a result of such consultation.
(e) Respirators having electrical or electronic components that are
required to be permissible under chapter I of title 30 shall be tested
in accordance with 30 CFR part 18. Applications for approval of such
respirators by MSHA shall be submitted in writing to: MSHA, Approval and
Certification Center, Box 251, Industrial Park Road, Triadelphia, West
Virginia 26059.
Sec. 84.11 Contents of application.
(a) Each application for approval shall contain a complete written
description of the respirator for which approval is requested together
with drawings and specifications (and lists thereof) showing full
details of construction of the respirator and of the materials used.
(b) Drawings shall be titled, numbered, and dated; any revision
dates shall be shown on the drawings, and the purpose of each revision
being sought shall be shown on the drawing or described on an attachment
to the drawing to which it applies.
(c) Each application for approval shall contain a proposed plan for
quality control which meets the minimum requirements set forth in
subpart E of this part.
(d) Each application shall contain a statement that the respirator
has been pretested by the applicant as prescribed in Sec. 84.64, and
shall include the results of such tests.
(e) Each application for approval shall contain a statement that the
respirator and component parts submitted for approval are either
prototypes, or made on regular production tooling, with no operation
included which will not be incorporated in regular production
processing.
(The information collections contained in this section are approved
under OMB control number 0920-0109)
Sec. 84.12 Delivery of respirators and components by applicant; requirements.
(a) Each applicant shall, when an application is filed pursuant to
Sec. 84.10, be advised by the Institute of the total number of
respirators and component parts required for testing.
(b) The applicant shall deliver, at his own expense, the number of
completely assembled respirators and component parts required for
testing, to the Certification and Quality Assurance Branch.
(c) Respirators and component parts submitted for approval must be
made from materials specified in the application.
(d) One completely assembled respirator approved under the
provisions
[[Page 501]]
of this part may be retained by the Institute as a laboratory exhibit,
the remaining respirators may be returned to the applicant at his own
expense, upon written request within 30 days after notice of approval.
If no such request is made, the respirators will be disposed of by the
Institute in such manner as it deems appropriate.
(e) Where a respirator fails to meet the requirements for approval
set forth in this part, all respirators and components delivered in
accordance with this section may be returned to the applicant at his own
expense, upon written request within 30 days after notice of
disapproval. If no such request is made, the respirators will be
disposed of by the Institute in such manner as it deems appropriate.
Subpart C_Fees
Sec. 84.20 Examination, inspection, and testing of complete respirator
assemblies; fees.
Except as provided in Sec. 84.22, the following fees shall be
charged by the Institute for the examination, inspection and testing of
complete respirator assemblies:
Self-contained breathing apparatus:
Entry and escape, 1 hour or more............................. $3,500
Entry and escape, less than 1 hour........................... 2,750
Escape only.................................................. 2,000
Gas masks:
Single hazard................................................ 1,100
Type N....................................................... 4,100
Supplied-air respirators....................................... 750
Particulate respirators........................................ 1,250
Chemical cartridge respirators................................. 1,150
Sec. 84.21 Examination, inspection, and testing of respirator components or
subassemblies; fees.
Except as provided in Sec. 84.22, the following fees shall be
charged by the Institute for the examination, inspection and testing of
the individual respirator components or subassemblies:
Facepieces....................................................... $450
Canisters........................................................ 900
Cartridges....................................................... 600
Filters.......................................................... 650
Hoses............................................................ 250
Blowers.......................................................... 250
Harnesses........................................................ 100
Sec. 84.22 Unlisted fees; additional fees; payment by applicant prior to
approval.
(a) Applications for the examination, inspection and testing of
complete respirator assemblies which are not listed in Sec. 84.20, or
for the examination, inspection, and testing of respirator components or
subassemblies which are not listed in Sec. 84.21, shall be accompanied
by the following deposits:
Complete respirator assembly................................... $1,500
Each individual component or subassembly....................... 500
(b) The Institute reserves the right to conduct any examination,
inspection, or test it deems necessary to determine the quality and
effectiveness of any listed or unlisted respirator assembly or
respirator component or subassembly, and to assess the cost of such
examinations, inspections, or tests against the applicant prior to the
issuance of any approval for such assembly, component, or subassembly.
(c) The fees charged for the examination, inspection, and testing of
unlisted respirator assemblies, unlisted individual respirator
components or subassemblies, and for the additional examination,
inspection, and testing of listed respirator assemblies and components
or subassemblies shall be at the rate of $100 per day for each man-day
required to be expended by the Institute.
(d) Upon completion of all examinations, inspections, and tests of
unlisted respirator assemblies or components, or following the
completion of any additional examination, inspections, or tests of
listed assemblies, or components or subassemblies, including retesting
subsequent to disapproval, the Institute shall advise the applicant in
writing of the total cost assessed and the additional amount, if any,
which must be paid to the Institute as a condition of approval.
(e) In the event the amount assessed by the Institute for unlisted
assemblies, or components or subassemblies is less than the amount of
the deposit submitted in accordance with paragraph (a) of this section,
the Institute shall refund the overpayment upon the issuance of any
approval or notice of disapproval.
[[Page 502]]
Subpart D_Approval and Disapproval
Sec. 84.30 Certificates of approval; scope of approval.
(a) The Institute shall issue certificates of approval pursuant to
the provisions of this subpart only for individual, completely assembled
respirators which have been examined, inspected, and tested, and which
meet the minimum requirements set forth in subparts H through L of this
part, as applicable.
(b) The Institute will not issue certificates of approval for any
respirator component or for any respirator subassembly.
(c) The Institute shall not issue an informal notification of
approval. However, if the application for approval, submitted in
accordance with Sec. 84.11, states that the submitted respirator and
component parts are only prototypes, the Institute will examine,
inspect, and test such respirator and component parts in accordance with
the provisions of this part. If, upon completion of such examinations,
inspections and tests, it is found that the prototype meets the minimum
requirements set forth in this part, the Institute may inform the
applicant, in writing, of the results of the examinations, inspections,
and tests, and may require him to resubmit respirators and component
parts made on regular production tooling, with no operations included
which will not be incorporated in regular production processing, for
further examination, inspection, and testing, prior to issuance of the
certificate of approval.
(d) Applicants required to resubmit respirators and component parts
made on regular production tooling, with no operation included which
will not be incorporated in regular production processing, shall be
charged fees in accordance with subpart C of this part.
Sec. 84.31 Certificates of approval; contents.
(a) The certificate of approval shall contain a classification and a
description of the respirator or combination of respirators for which it
is issued, as provided in this part.
(b) The certificate of approval shall specifically set forth any
restrictions or limitations on the respirator's use in hazardous
atmospheres.
(c) Each certificate of approval shall be accompanied by the
drawings and specifications (and lists thereof) submitted by the
applicant in accordance with Sec. 84.11. These drawings and
specifications shall be referenced in the certificate of approval, and
shall be maintained by the applicant. The drawings and specifications
listed in each certificate of approval shall set forth in detail the
design and construction requirements which shall be met by the applicant
during commercial production of the respirator.
(d) Each certificate of approval shall be accompanied by a
reproduction of the approval label design to be employed by the
applicant with each approved respirator, as provided in Sec. 84.33.
(e) No test data or specific laboratory findings will accompany any
certificate of approval, however, the Institute will release pertinent
test data and specific findings upon written request by the applicant,
or as required by statute or regulation.
(f) Each certificate of approval shall also contain the approved
quality control plan as specified in Sec. 84.42.
Sec. 84.32 Notice of disapproval.
(a) If, upon the completion of the examinations, inspections, and
tests required to be conducted in accordance with the provisions of this
part, it is found that the respirator does not meet the minimum
requirements set forth in this part, the Institute shall issue a written
notice of disapproval to the applicant.
(b) Each notice of disapproval shall be accompanied by all pertinent
data or findings with respect to the defects of the respirator for which
approval was sought with a view to the possible correction of any such
defects.
(c) The Institute shall not disclose, except to the applicant or as
required by statute or regulation, any data, findings, or other
information with respect to any respirator for which a notice of
disapproval is issued.
[[Page 503]]
Sec. 84.33 Approval labels and markings; approval of contents; use.
(a) Full-scale reproductions of approval labels and markings, and a
sketch or description of the method of application and position on the
harness, container, canister, cartridge, filter, or other component,
together with instructions for the use and maintenance of the respirator
shall be submitted to the Institute for approval.
(b) Approval labels shall bear the emblem of the National Institute
for Occupational Safety and Health and the seal of the Department of
Health and Human Services, the applicant's name and address, an approval
number assigned by the Institute and, where appropriate, restrictions or
limitations placed upon the use of the respirator by the Institute. The
approval number assigned by the Institute shall be designated by the
prefix TC and a serial number.
(c) The Institute shall, where necessary, notify the applicant when
additional labels, markings, or instructions will be required.
(d) Approval labels and markings shall only be used by the applicant
to whom they were issued.
(e) Legible reproductions or abbreviated forms of the label approved
by the Institute for use on each respirator shall be attached to or
printed at the following locations:
------------------------------------------------------------------------
Respirator type Label type Location
------------------------------------------------------------------------
Self-contained breathing Entire........... Harness assembly and
apparatus. canister (where
applicable).
Gas mask...................... Entire........... Mask container and
canister.
Supplied air respirator....... ......do......... Respirator container
or instruction card.
Particulate respirator........ ......do......... Respirator container
and filter
container.
Abbreviated...... Filters.
Chemical-cartridge respirator. Entire........... Respirator container,
cartridge container,
and filter
containers (where
applicable).
Abbreviated...... Cartridges and
filters and filter
containers.
------------------------------------------------------------------------
(f) The use of any Institute approval label obligates the applicant
to whom it is issued to maintain or cause to be maintained the approved
quality control sampling schedule and the acceptable quality level for
each characteristic tested, and to assure that it is manufactured
according to the drawings and specifications upon which the certificate
of approval is based.
(g) Each respirator, respirator component, and respirator container
shall, as required by the Institute to assure quality control and proper
use of the respirator, be labeled distinctly to show the name of the
applicant, and the name and letters or numbers by which the respirator
or respirator component is designated for trade purposes, and the lot
number, serial number, or approximate date of manufacture.
Sec. 84.34 Revocation of certificates of approval.
The Institute reserves the right to revoke, for cause, any
certificate of approval issued pursuant to the provisions of this part.
Such causes include, but are not limited to, misuse of approval labels
and markings, misleading advertising, and failure to maintain or cause
to be maintained the quality control requirements of the certificate of
approval.
Sec. 84.35 Changes or modifications of approved respirators; issuance of
modification of certificate of approval.
(a) Each applicant may, if he desires to change any feature of an
approved respirator, request a modification of the original certificate
of approval issued by the Institute for such respirator by filing an
application for such modification in accordance with the provisions of
this section.
(b) Applications shall be submitted as for an original certificate
of approval, with a request for a modification of the existing
certificate to cover any proposed change.
(c) The application shall be accompanied by appropriate drawings and
specifications, and by a proposed quality control plan which meets the
requirements of subpart E of this part.
[[Page 504]]
(d) The application for modification, together with the accompanying
material, shall be examined by the Institute to determine whether
testing will be required.
(e) The Institute shall inform the applicant of the fee required for
any additional testing and the applicant will be charged for the actual
cost of any examination, inspection, or test required, and such fees
shall be submitted in accordance with the provisions of subpart C of
this part.
(f) If the proposed change or modification meets the requirements of
this part, a formal certificate of modification will be issued,
accompanied, where necessary, by a list of new and revised drawings and
specifications covering the change(s) and reproductions of revised
approval labels.
(The information collections contained in this section are approved
under OMB control number 0920-0109)
Sec. 84.36 Delivery of changed or modified approved respirator.
An approved respirator for which a formal certificate of
modification has been issued shall be delivered, with proper markings
and containers, by the applicant to the Certification and Quality
Assurance Branch, as soon as it is commercially produced.
Subpart E_Quality Control
Sec. 84.40 Quality control plans; filing requirements.
As a part of each application for approval or modification of
approval submitted pursuant to this part, each applicant shall file with
the Institute a proposed quality control plan which shall be designed to
assure the quality of respiratory protection provided by the respirator
for which approval is sought.
Sec. 84.41 Quality control plans; contents.
(a) Each quality control plan shall contain provisions for the
management of quality, including:
(1) Requirements for the production of quality data and the use of
quality control records;
(2) Control of engineering drawings, documentations, and changes;
(3) Control and calibration of measuring and test equipment;
(4) Control of purchased material to include incoming inspection;
(5) Lot identification, control of processes, manufacturing,
fabrication, and assembly work conducted in the applicant's plant;
(6) Audit of final inspection of the completed product; and
(7) The organizational structure necessary to carry out these
provisions.
(b) Each provision for incoming and final inspection in the quality
control plan shall include a procedure for the selection of a sample of
respirators and the components thereof for testing, in accordance with
procedures set forth in Military Standard MIL-STD-414, 11 June 1957,
including Change Notice No. 1, ``Sampling Procedures and Tables for
Inspection by Variables for Percent Defective,'' or an approved
equivalent sampling procedure, or an approved combination of sampling
procedures. The procedure of Military Standard MIL-STD-105D, 29 April
1963, ``Sampling Procedures and Tables for Inspection by Attributes,''
is an example of an equivalent sampling procedure. MIL-STD-414 is
incorporated by reference and has been approved by the Director of the
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
Copies may be obtained from DODSSP, Standardization Document Order Desk,
700 Robbins Avenue, Bldg. 4D, Philadelphia, PA 19111-5094. Copies may be
inspected at the NIOSH, Certification and Quality Assurance Branch, 1095
Willowdale Road, Morgantown, WV 26505-2888, or at the National Archives
and Records Administration (NARA). For information on the availability
of this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html. Copies of MIL-STD-105D may be inspected or obtained from
the NIOSH, Certification and Quality Assurance Branch, 1095 Willowdale
Road, Morgantown, WV 26505-2888. Incoming bulk raw material inspection
or verification of specification, and in-process inspection shall be
sufficient to ensure control of product quality through the
manufacturing cycle.
[[Page 505]]
(c) The sampling procedure shall include a list of the
characteristics to be tested by the applicant or his agent.
(d) The characteristics listed in accordance with paragraph (c) of
this section shall be classified according to the potential effect of
such defect and grouped into the following classes:
(1) Critical. A defect that judgment and experience indicate is
likely to result in a condition immediately hazardous to life or health
for individuals using or depending upon the respirator;
(2) Major A. A defect, other than critical, that is likely to result
in failure to the degree that the respirator does not provide any
respiratory protection, or a defect that reduces protection and is not
detectable by the user;
(3) Major B. A defect, other than Major A or critical, that is
likely to result in reduced respiratory protection, and is detectable by
the user; and
(4) Minor. A defect that is not likely to materially reduce the
usability of the respirator for its intended purpose, or a defect that
is a departure from established standards and has little bearing on the
effective use or operation of the respirator.
(e) The quality control inspection test method to be used by the
applicant or his agent for each characteristic required to be tested
shall be described in detail.
(f) Each item manufactured shall be 100 percent inspected for
defects in all critical characteristics and all defective items shall be
rejected.
(g) The Acceptable Quality Level (AQL) for each major or minor
defect so classified by the applicant shall be:
(1) Major A. 1.0 percent;
(2) Major B. 2.5 percent; and
(3) Minor. 4.0 percent.
(h) Except as provided in paragraph (i) of this section, inspection
level IV as described in MIL-STD-414, 11 June 1957, including Change
Notice No.1, ``Sampling Procedures and Tables for Inspection by
Variables for Percent Defective,'' or an equivalent procedure, shall be
used for major and minor characteristics and 100 percent inspection for
critical characteristics. Inspection level II as described in MIL-STD-
105D, 29 April 1963, ``Sampling Procedures and Tables for Inspection by
Attributes,'' is an example of an equivalent procedure.
(i) Subject to the approval of the Institute, where the quality
control plan provisions for raw material, processes, manufacturing, and
fabrication, inspections are adequate to ensure control of finished
article quality, destructive testing of finished articles may be
conducted at a lower level of inspection than that specified in
paragraph (h) of this section.
(The information collections contained in this section are approved
under OMB control number 0920-0109)
Sec. 84.42 Proposed quality control plans; approval by the Institute.
(a) Each proposed quality control plan submitted in accordance with
this subpart shall be reviewed by the Institute to determine its
effectiveness in ensuring the quality of respiratory protection provided
by the respirator for which an approval is sought.
(b) If the Institute determines that the proposed quality control
plan submitted by the applicant will not ensure adequate quality
control, the Institute shall require the applicant to modify the
procedures and testing requirements of the plan prior to approval of the
plan and issuance of any certificate of approval.
(c) Approved quality control plans shall constitute a part of and be
incorporated into any certificate of approval issued by the Institute,
and compliance with such plans by the applicant shall be a condition of
approval.
Sec. 84.43 Quality control records; review by the Institute; revocation of
approval.
(a) The applicant shall keep quality control inspection records
sufficient to carry out the procedures required in MIL-STD-414, 11 June
1957, including Change Notice No. 1, ``Sampling Procedures and Tables
for Inspection by Variables for Percent Defective,'' or an approved
equivalent sampling procedure. MIL-STD-105D, 29 April 1963, ``Sampling
Procedures and Tables for Inspection by Attributes,'' is an example of
an approved equivalent sampling procedure. MIL-STD-414 is incorporated
by reference and has been approved by the Director of the Federal
[[Page 506]]
Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies
may be obtained from DODSSP, Standardization Document Order Desk, 700
Robbins Avenue, Bldg. 4D, Philadelphia, Pa. 19111-5094. Copies may be
inspected at the NIOSH, Certification and Quality Assurance Branch, 1095
Willowdale Road, Morgantown, WV 26505-2888, or at the National Archives
and Records Administration (NARA). For information on the availability
of this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html. Copies of MIL-STD-105D may be inspected or obtained from
the NIOSH, Certification and Quality Assurance Branch, 1095 Willowdale
Road, Morgantown, WV 26505-2888.
(b) The Institute reserves the right to have its representatives
inspect the applicant's quality control test methods, equipment, and
records, and to interview any employee or agent of the applicant in
regard to quality control test methods, equipment, and records.
(c) The Institute reserves the right to revoke, for cause, any
certificate of approval where it is found that the applicant's quality
control test methods, equipment, or records do not ensure effective
quality control over the respirator for which the approval was issued.
(The information collections contained in this section are approved
under OMB control number 0920-0109)
Subpart F_Classification of Approved Respirators; Scope of Approval;
Atmospheric Hazards; Service Time
Sec. 84.50 Types of respirators to be approved; scope of approval.
Approvals shall be issued for the types of respirators which have
been classified pursuant to this subpart F, have been inspected,
examined and tested by the Institute, in accordance with the provisions
of subparts G through L of this part, and have been found to provide
respiratory protection for fixed periods of time against the hazards
specified in such approval.
Sec. 84.51 Entry and escape, or escape only; classification.
Respirators described in subparts H through L of this part shall be
classified for use as follows:
(a) Entry and escape. Respirators designed and approved for use
during entry into a hazardous atmosphere, and for escape from a
hazardous atmosphere; or
(b) Escape only. Respirators designed and approved for use only
during escape from a hazardous atmosphere.
Sec. 84.52 Respiratory hazards; classification.
Respirators described in subparts H through L of this part shall be
classified as approved for use against any or all of the following
respiratory hazards:
(a) Oxygen deficiency;
(b) Gases and vapors; and
(c) Particles, including dusts, fumes and mists.
Sec. 84.53 Service time; classification.
(a) Respirators described in subparts H through L of this part shall
be classified, where applicable, as approved for use during the
following prescribed service times:
(1) Four hours;
(2) Three hours;
(3) Two hours;
(4) One hour;
(5) Forty-five minutes;
(6) Thirty minutes;
(7) Fifteen minutes;
(8) Ten minutes;
(9) Five minutes; or
(10) Three minutes.
(b) Other service times may be prescribed by the Institute.
Subpart G_General Construction and Performance Requirements
Sec. 84.60 Construction and performance requirements; general.
(a) The Institute shall issue approvals for the types of respirators
described in subparts H through L of this part which have met the
minimum requirements set forth for such respirators in this part.
(b) In addition to the types of respirators specified in subparts H
through L of this part, the Institute
[[Page 507]]
shall issue approvals for other respiratory protective devices not
specifically described in this part subject to such additional
requirements as may be imposed in accordance with Sec. 84.63(c).
Sec. 84.61 General construction requirements.
(a) Respirators will not be accepted by the Institute for
examination, inspection and testing unless they are designed on sound
engineering and scientific principles, constructed of suitable materials
and evidence good workmanship.
(b) Respirator components which come into contact with the wearer's
skin shall be made of nonirritating materials.
(c) Components replaced during or after use shall be constructed of
materials which will not be damaged by normal handling.
(d) Mouthpieces, hoods, helmets, and facepieces, except those
employed in single-use respirators, shall be constructed of materials
which will withstand repeated disinfection as recommended by the
applicant in his instructions for use of the device.
Sec. 84.62 Component parts; minimum requirements.
(a) The component parts of each respirator shall be:
(1) Designed, constructed, and fitted to insure against creation of
any hazard to the wearer;
(2) Assembled to permit easy access for inspection and repair of
functional parts; and
(3) Assembled to permit easy access to parts which require periodic
cleaning and disinfecting.
(b) Replacement parts shall be designed and constructed to permit
easy installation and to maintain the effectiveness of the respirator.
Sec. 84.63 Test requirements; general.
(a) Each respirator and respirator component shall when tested by
the applicant and by the Institute, and meet the applicable requirements
set forth in subparts H through L of this part.
(b) Where a combination respirator is assembled from two or more
types of respirators, as described in this part, each of the individual
respirator types which have been combined shall, as applicable, meet the
minimum requirements for such respirators set forth in subparts H
through L of this part, and such combination respirators, except as
specified in Sec. 84.70(b)(2), will be classified by the type of
respirator in the combination which provides the least protection to the
user.
(c) In addition to the minimum requirements set forth in subparts H
through L of this part, the Institute reserves the right to require, as
a further condition of approval, any additional requirements deemed
necessary to establish the quality, effectiveness, and safety of any
respirator used as protection against hazardous atmospheres.
(d) Where it is determined after receipt of an application that
additional requirements will be required for approval, the Institute
will notify the applicant in writing of these additional requirements,
and necessary examinations, inspections, or tests, stating generally the
reasons for such requirements, examinations, inspections, or tests.
Sec. 84.64 Pretesting by applicant; approval of test methods.
(a) Prior to making or filing any application for approval or
modification of approval, the applicant shall conduct, or cause to be
conducted, examinations, inspections, and tests of respirator
performance which are equal to or exceed the severity of those
prescribed in this part.
(b) With the application, the applicant shall provide a statement to
the Institute showing the types and results of the examinations,
inspections, and tests required under paragraph (a) of this section and
state that the respirator meets the minimum requirements of subparts H
through L of this part, as applicable. Complete examination, inspection,
and test data shall be retained on file by the applicant and be
submitted, upon request, to the Institute.
(c) The Institute may, upon written request by the applicant,
provide drawings and descriptions of its test equipment and otherwise
assist the applicant in establishing a test laboratory
[[Page 508]]
or securing the services of a testing agency.
(d) No approval will be issued until the Institute has validated the
applicant's test results.
Sec. 84.65 Conduct of examinations, inspections, and tests by the Institute;
assistance by applicant; observers; recorded data; public demonstrations.
(a) All examinations, inspections, and tests conducted pursuant to
subparts H through L of this part will be under the sole direction and
control of the Institute.
(b) The Institute may, as a condition of approval, require the
assistance of the applicant or agents of the applicant during the
assembly, disassembly, or preparation of any respirator or respirator
component prior to testing or in the operation of such equipment during
testing.
(c) Only Institute personnel, persons assisting the Institute
pursuant to paragraph (b) of this section, and such other persons as are
requested by the Institute or the applicant to be observers, shall be
present during any examination, inspection, or test conducted prior to
the issuance of an approval by the Institute for the equipment under
consideration.
(d) The Institute shall hold as confidential any analyses, drawings,
specifications, or materials submitted by the applicant and shall not
disclose any principles or patentable features of such equipment, except
as required by statute or regulation.
(e) As a condition of each approval issued for any respirator, the
Institute reserves the right, following the issuance of such approval,
to conduct such public tests and demonstrations of the approved
respiratory equipment as is deemed appropriate.
Sec. 84.66 Withdrawal of applications; refund of fees.
(a) Any applicant may, upon a written request submitted to the
Institute, withdraw any application for approval of any respirator.
(b) Upon receipt of a written request for the withdrawal of an
application, the Institute shall determine the total man-days expended
and the amount due for services already performed during the course of
any examinations, inspections, or tests conducted pursuant to such
application. The total amount due shall be determined in accordance with
the provisions of Sec. 84.22 and assessed against the fees submitted by
the applicant. If the total amount assessed is less than the fees
submitted, the Institute shall refund the balance together with a
statement of the charges made for services rendered.
Subpart H_Self-Contained Breathing Apparatus
Sec. 84.70 Self-contained breathing apparatus; description.
(a) Self-contained breathing apparatus, including all completely
assembled, portable, self-contained devices designed for use as
respiratory protection during entry into and escape from or escape only
from hazardous atmospheres, are described as follows:
(1) Closed-circuit apparatus. An apparatus of the type in which the
exhalation is rebreathed by the wearer after the carbon dioxide has been
effectively removed and a suitable oxygen concentration restored from
sources composed of:
(i) Compressed oxygen; or
(ii) Chemical oxygen; or
(iii) Liquid-oxygen.
(2) Open-circuit apparatus. An apparatus of the following types from
which exhalation is vented to the atmosphere and not rebreathed:
(i) Demand-type apparatus. An apparatus in which the pressure inside
the facepiece in relation to the immediate environment is positive
during exhalation and negative during inhalation; or
(ii) Pressure-demand-type apparatus. An apparatus in which the
pressure inside the facepiece in relation to the immediate environment
is positive during both inhalation and exhalation.
(b) The following respirators may be classified as designed and
approved for use during emergency entry into a hazardous atmosphere:
(1) A combination respirator which includes a self-contained
breathing apparatus; and
(2) A Type ``C'' or Type ``CE'' supplied air respirator, where--
(i) The self-contained breathing apparatus is classified for 3-, 5-,
or 10-
[[Page 509]]
minute service time and the air line supply is used during entry; or
(ii) The self-contained breathing apparatus is classified for 15
minutes or longer service time and not more than 20 percent of the rated
capacity of the air supply is used during entry.
(c) Self-contained breathing apparatus classified for less than 1
hour service time will not be approved for use during underground mine
rescue and recovery operations except as auxiliary equipment.
(d) Self-contained breathing apparatus classified for less than 30
minutes' service time will not be approved for use as auxiliary
equipment during underground mine rescue and recovery operations.
Sec. 84.71 Self-contained breathing apparatus; required components.
(a) Each self-contained breathing apparatus described in Sec. 84.70
shall, where its design requires, contain the following component parts:
(1) Facepiece or mouthpiece, and noseclip;
(2) Respirable breathing gas container;
(3) Supply of respirable breathing gas;
(4) Gas pressure or liquid level gages;
(5) Timer;
(6) Remaining service life indicator or warning device;
(7) Hand-operated valves;
(8) Breathing bag;
(9) Safety relief valve or safety relief system; and
(10) Harness.
(b) The components of each self-contained breathing apparatus shall
meet the minimum construction requirements set forth in subpart G of
this part.
Sec. 84.72 Breathing tubes; minimum requirements.
Flexible breathing tubes used in conjunction with breathing
apparatus shall be designed and constructed to prevent:
(a) Restriction of free head movement;
(b) Disturbance of the fit of facepieces and mouthpieces;
(c) Interference with the wearer's activities; and
(d) Shutoff of airflow due to kinking, or from chin or arm pressure.
Sec. 84.73 Harnesses; installation and construction; minimum requirements.
(a) Each apparatus shall, where necessary, be equipped with a
suitable harness designed and constructed to hold the components of the
apparatus in position against the wearer's body.
(b) Harnesses shall be designed and constructed to permit easy
removal and replacement of apparatus parts and, where applicable,
provide for holding a full facepiece in the ready position when not in
use.
Sec. 84.74 Apparatus containers; minimum requirements.
(a) Apparatus may be equipped with a substantial, durable container
bearing markings which show the applicant's name, the type and
commercial designation of the respirator it contains, and all
appropriate approval labels.
(b) Containers supplied by the applicant for carrying or storing
self-contained breathing apparatus will be inspected, examined, and
tested as components of the respirator for which approval is sought.
(c) Containers for self-contained breathing apparatus shall be
designed and constructed to permit easy removal of the apparatus.
Sec. 84.75 Half-mask facepieces, full facepieces, mouthpieces; fit; minimum
requirements.
(a) Half-mask facepieces and full facepieces shall be designed and
constructed to fit persons with various facial shapes and sizes, either:
(1) By providing more than one facepiece size; or
(2) By providing one facepiece size which will fit varying facial
shapes and sizes.
(b) Full facepieces shall provide for the optional use of corrective
spectacles or lenses which shall not reduce the respiratory protective
qualities of the apparatus.
(c) Apparatus with mouthpieces shall be equipped with noseclips
which are securely attached to the mouthpiece or apparatus and provide
an airtight seal.
[[Page 510]]
(d) Facepieces shall be designed to prevent eyepiece, spectacle, and
lens fogging.
Sec. 84.76 Facepieces; eyepieces; minimum requirements.
(a) Facepieces shall be designed and constructed to provide adequate
vision which is not distorted by the eyepiece.
(b) All eyepieces shall be designed and constructed to be impact and
penetration resistant. Federal Specification, Mask, Air Line: and
Respirator, Air Filtering, Industrial, GGG-M-125d, October 11, 1965 with
interim amendment-1, July 30, 1969, is an example of an appropriate
standard for determining impact and penetration resistance. Copies of
GGG-M-125d may be obtained from the NIOSH, Certification and Quality
Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888.
Sec. 84.77 Inhalation and exhalation valves; minimum requirements.
(a) Inhalation and exhalation valves shall be provided where
necessary and protected against damage and distortion.
(b) Exhalation valves shall be--
(1) Protected against external influence; and
(2) Designed and constructed to prevent inward leakage of
contaminated air.
Sec. 84.78 Head harnesses; minimum requirements.
(a) Facepieces shall be equipped with adjustable and replaceable
head harnesses designed and constructed to provide adequate tension
during suspension and an even distribution of pressure over the entire
area in contact with the face.
(b) Mouthpieces shall be equipped, where applicable, with adjustable
and replaceable harnesses designed and constructed to hold the
mouthpiece in place.
Sec. 84.79 Breathing gas; minimum requirements.
(a) Breathing gas used to supply apparatus shall be respirable and
contain no less than 19.5 (dry atmosphere) volume percent of oxygen.
(b) Oxygen, including liquid oxygen, shall contain not less than
99.0 percent, by volume, of pure O2, not more than 0.03%, by
volume, carbon dioxide, and not more than 0.001%, by volume, carbon
monoxide. Methods for making these determinations can be found in the
U.S. Pharmacopeia National Formulary. Containers used for oxygen must
not be treated with any toxic, sleep-inducing, narcosis-producing, or
respiratory tract irritating compounds.
(c) Compressed, gaseous breathing air shall meet the applicable
minimum grade requirements for Type I gaseous air set forth in the
Compressed Gas Association Commodity Specification for Air, G-7.1, 1966
(Grade D or higher quality). G-7.1 is incorporated by reference and has
been approved by the Director of the Federal Register in accordance with
5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from American
National Standards Institute, Inc., 1430 Broadway, New York, NY 10018.
Copies may be inspected at the NIOSH, Certification and Quality
Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888, or at
the National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call 202-741-6030, or go
to: http://www.archives.gov/federal--register/code--of--federal--
regulations/ibr--locations.html.
(d) Compressed, liquefied breathing air shall meet the applicable
minimum grade requirements for Type II liquid air set forth in the
Compressed Gas Association Commodity Specification for Air, G-7.1, 1966
(Grade B or higher quality). G-7.1 is incorporated by reference and has
been approved by the Director of the Federal Register in accordance with
5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from American
National Standards Institute, Inc., 1430 Broadway, New York, NY 10018.
Copies may be inspected at the NIOSH, Certification and Quality
Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888, or at
the National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call 202-741-6030, or go
to: http://www.archives.gov/federal--register/
[[Page 511]]
code--of--federal--regulations/ibr--locations.html.
Sec. 84.80 Interchangeability of oxygen and air prohibited.
Approvals shall not be issued by the Institute for any apparatus,
combination of respirator assemblies, or any apparatus or respirator
component which is designed or constructed to permit the interchangeable
use of oxygen and air.
Sec. 84.81 Compressed breathing gas and liquefied breathing gas containers;
minimum requirements.
(a) Compressed breathing gas and liquefied breathing gas containers
shall meet the minimum requirements of the Department of Transportation
for interstate shipment of such containers when fully charged.
(b) Such containers shall be permanently and legibly marked to
identify their contents, e.g., compressed breathing air, compressed
breathing oxygen, liquefied breathing air, or liquefied breathing
oxygen.
(c) Containers normally removed from apparatus for refilling shall
be equipped with a dial indicating gage which shows the pressure in the
container.
(d) Compressed breathing gas contained valves or a separate charging
system or adapter provided with each apparatus shall be equipped with
outlet threads specified for the service by the American Standards
Association, Compressed Gas Cylinder Valve Outlet and Inlet Connections,
B57.1-1965. B57.1-1965 is incorporated by reference and has been
approved by the Director of the Federal Register in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from American
National Standards Institute, Inc., 1430 Broadway, New York, NY Copies
may be inspected at the NIOSH, Certification and Quality Assurance
Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888, or at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, call 202-741-6030, or go to:
http://www.archives.gov/federal--register/code--of--federal--
regulations/ibr--locations.html.
Sec. 84.82 Gas pressure gages; minimum requirements.
(a) Gas pressure gages employed on compressed breathing gas
containers shall be calibrated in pounds per square inch.
(b) Liquid-level gages shall be calibrated in fractions of total
container capacity, or in units of liquid volume.
(c) Gas pressure gages other than those specified in paragraphs (a)
and (b) of this section shall be calibrated in:
(1) Pounds per square inch; or
(2) In fractions of total container capacity; or
(3) Both in pounds per square inch and fractions of total container
capacity.
(d)(1) Dial-indicating gages shall be reliable to within 5 percent of full scale when tested both up and down the
scale at each of 5 equal intervals.
(2) The full-scale graduation of dial-indicating gages shall not
exceed 150 percent of the maximum rated cylinder pressures specified for
the container in applicable Department of Transportation specifications
or permits.
(e)(1) Stem-type gages shall be readable by sight and by touch and
shall have a stem travel distance of not less than one-fourth inch
between each graduation.
(2) A minimum of five graduations shall be engraved on the stem of
each gage and these graduations shall include readings for empty, one-
quarter, one-half, three-quarters, and full.
(3) Stem gage readings shall not vary from true readings by more
than one-sixteenth inch per inch of stem travel.
(f) The loss of gas through a broken gage or severed gage connection
shall not exceed 70 liters per minute when the cylinder pressure is
6,900 kN/m.\2\ (1,000 pounds per square inch gage) or when the liquid
level is at one-half.
(g) Where gages are connected to the apparatus through a gage line,
the gage and line shall be capable of being isolated from the apparatus
except where the failure of the gage or line would not impair the
performance or service life of the apparatus.
(h) Oxygen pressure gages shall have the words ``Oxygen'' and ``Use
No Oil'' marked prominently on the gage.
[[Page 512]]
(i)(1) Apparatus using compressed breathing gas, except apparatus
classified for escape only, shall be equipped with gages visible to the
wearer which indicate the remaining gas content in the container.
(2) Apparatus using liquefied breathing gas, except apparatus
classified for escape only, shall be equipped with gages visible to the
wearer which indicate the remaining liquid content in the container;
however, where the liquid content cannot be rapidly vented, and the
service time of the device begins immediately after filling, a timer
shall be provided in place of a visible gage.
Sec. 84.83 Timers; elapsed time indicators; remaining service life
indicators; minimum requirements.
(a) Elapsed time indicators shall be provided for apparatus with a
chemical oxygen source, except:
(1) Apparatus used for escape only; or
(2) Liquefied breathing gas apparatus equipped with gages visible to
the wearer which indicate the remaining liquid content in the container.
(b) The timer or other indicator shall be accurately calibrated in
minutes of remaining service life.
(c) Timers shall be readable by sight and by touch during use by the
wearer.
(d) Timers shall be equipped with automatically preset alarms which
will warn the wearer for a period of 7 seconds or more after the preset
time has elapsed.
(e) Remaining service-life indicators or warning devices shall be
provided in addition to a pressure gage on compressed gas self-contained
breathing apparatus, except apparatus used for escape only, and shall
operate automatically without preadjustment by the wearer.
(f) Each remaining service-life indicator or warning device shall
give an alarm when the remaining service life of the apparatus is
reduced within a range of 20 to 25 percent of its rated service time.
Sec. 84.84 Hand-operated valves; minimum requirements.
(a) Hand-operated valves shall be designed and constructed to
prevent removal of the stem from the valve body during normal usage to
insure against a sudden release of the full pressure of the container
when the valve is opened.
(b) Valves shall be designed or positioned to prevent accidental
opening and closing, and damage from external forces.
(c) Valves operated during use of the apparatus shall be installed
in locations where they can be readily adjusted by the wearer.
(d) Main-line valves, designed and constructed to conserve gas in
the event of a regulator or demand valve failure, shall be provided in
addition to gas container valves, except when such failure will not
affect performance.
(e) Hand-operated bypass systems designed and constructed to permit
the wearer to breathe and to conserve his gas supply in the event of a
regulator or demand valve failure, shall be provided where necessary.
(f) Valves installed on apparatus shall be clearly distinguishable
from one another by sight and touch.
(g) The bypass system valve control shall be colored red.
(h) A main-line or bypass valve or system will not be required on
apparatus for escape only.
(i) Safety relief valves or systems, designed and constructed to
release excess pressure in the breathing circuit, shall be provided on
closed-circuit apparatus, and shall meet the following requirements:
(1) The relief valve or system shall operate automatically when the
pressure in the breathing circuit on the inhalation side of the
breathing bag reaches 13 mm. (one-half inch) water-column height of
pressure above the minimum pressure required to fill the breathing bag,
within the breathing resistance requirements for the apparatus.
(2) The relief valve or system shall be designed to prevent external
atmospheres from entering the breathing circuit.
(3) The relief valve or system shall be designed to permit manual
overriding for test purposes and in the event of a failure in the valve
or system.
[[Page 513]]
Sec. 84.85 Breathing bags; minimum requirements.
(a) Breathing bags shall have sufficient volume to prevent gas waste
during exhalation and to provide an adequate reserve for inhalation.
(b) Breathing bags shall be constructed of materials which are
flexible and resistant to gasoline vapors.
(c) Breathing bags shall be installed in a location which will
protect them from damage or collapse by external forces, except on
apparatus classified for escape only.
Sec. 84.86 Component parts exposed to oxygen pressures; minimum requirements.
Each applicant shall certify that the materials employed in the
construction of component parts exposed to oxygen pressures above
atmospheric pressure are safe and compatible for their intended use.
Sec. 84.87 Compressed gas filters; minimum requirements.
All self-contained breathing apparatus using compressed gas shall
have a filter downstream of the gas source to effectively remove
particles from the gas stream.
Sec. 84.88 Breathing bag test.
(a) Breathing bags will be tested in an air atmosphere saturated
with gasoline vapor at room temperature (24-30 [deg]C./75-85 [deg]F.)
for a continuous period of twice the rated time of the apparatus (except
for apparatus for escape only where the test period shall be the rated
time of the apparatus).
(b) The bag will be operated during this test by a breathing machine
with 24 respirations per minute and a minute-volume of 40 liters.
(c) A breathing machine cam with a work rate of 622 kp.-m./min. will
be used. The dimensions of a suitable breathing machine cam are
available from the Institute upon request.
(d) The air within the bag(s) shall not contain more than 100 parts
per million of gasoline vapor at the end of the test.
Sec. 84.89 Weight requirement.
(a) The completely assembled and fully charged apparatus shall not
weigh more than 16 kg. (35 pounds); however, where the weight decreases
by more than 25 percent of its initial charge weight during its rated
service life, the maximum allowable weight of a completely assembled and
fully charged apparatus shall be 18 kg. (40 pounds).
(b) Where an apparatus employs equipment which contributes
materially to the wearer's comfort, e.g., a cooling system, the
completely assembled and fully charged apparatus shall not weigh more
than 18 kg. (40 pounds) regardless of the decrease in weight during use.
Sec. 84.90 Breathing resistance test; inhalation.
(a) Resistance to inhalation airflow will be measured in the
facepiece or mouthpiece while the apparatus is operated by a breathing
machine as described in Sec. 84.88.
(b) The inhalation resistance of open-circuit apparatus shall not
exceed 32 mm. (1.25 inch) water-column height (at a flow rate of 120
liters per minute).
(c) The inhalation resistance of closed-circuit apparatus shall not
exceed the difference between exhalation resistance (Sec. 84.91(e)) and
10 cm. (4 inches) water-column height.
Sec. 84.91 Breathing resistance test; exhalation.
(a) Resistance to exhalation airflow will be measured in the
facepiece or mouthpiece of open-circuit apparatus with air flowing at a
continuous rate of 85 liters per minute.
(b) The exhalation resistance of demand apparatus shall not exceed
25 mm. (1 inch) water-column height.
(c) The exhalation resistance of pressure-demand apparatus shall not
exceed the static pressure in the facepiece by more than 51 mm. (2
inches) water-column height.
(d) The static pressure (at zero flow) in the facepiece shall not
exceed 38 mm. (1.5 inches) water-column height.
(e) Resistance to exhalation airflow will be measured in the
facepiece or mouthpiece of closed-circuit apparatus with a breathing
machine as described in Sec. 84.88, and the exhalation resistance shall
not exceed 51 mm. (2 inches) water-column height.
[[Page 514]]
Sec. 84.92 Exhalation valve leakage test.
(a) Dry exhalation valves and valve seats will be subjected to a
suction of 25 mm. (1 inch) water-column height while in a normal
operating position.
(b) Leakage between the valve and the valve seat shall not exceed 30
milliliters per minute.
Sec. 84.93 Gas flow test; open-circuit apparatus.
(a) A static-flow test will be performed on all open-circuit
apparatus.
(b) The flow from the apparatus shall be greater than 200 liters per
minute when the pressure in the facepiece of demand-apparatus is lowered
by 51 mm. (2 inches) water-column height when full container pressure is
applied.
(c) Where pressure demand apparatus are tested, the flow will be
measured at zero gage pressure in the facepiece.
(d) Where apparatus with compressed-breathing-gas containers are
tested, the flow test shall also be made with 3,450 kN/m.\2\ (500
p.s.i.g.) container pressure applied.
Sec. 84.94 Gas flow test; closed-circuit apparatus.
(a) Where oxygen is supplied by a constant-flow device only, the
rate of flow shall be at least 3 liters per minute for the entire rated
service time of the apparatus.
(b) Where constant flow is used in conjunction with demand flow, the
constant flow shall be greater than 1.5 liters per minute for the entire
rated service time.
(c) All demand-flow devices shall provide at least 30 liters of
oxygen per minute when in the fully open position.
Sec. 84.95 Service time test; open-circuit apparatus.
(a) Service time will be measured with a breathing machine as
described in Sec. 84.88.
(b) The open-circuit apparatus will be classified according to the
length of time it supplies air or oxygen to the breathing machine.
(c) The service time obtained on this test will be used to classify
the open-circuit apparatus in accordance with Sec. 84.53.
Sec. 84.96 Service time test; closed-circuit apparatus.
(a) The closed-circuit apparatus will be classified according to the
length of time it supplies adequate breathing gas to the wearer during
man test No. 4 described in Table 4 of this subpart.
(b) The service time obtained on man test No. 4 will be used to
classify the closed-circuit apparatus in accordance with Sec. 84.53.
Sec. 84.97 Test for carbon dioxide in inspired gas; open- and closed-circuit apparatus; maximum allowable limits.
(a) Open-circuit apparatus. (1) The concentration of carbon dioxide
in inspired gas in open-circuit apparatus will be measured at the mouth
while the apparatus mounted on a dummy head is operated by a breathing
machine. An acceptable method for measuring the concentration of carbon
dioxide is described in Bureau of Mines Report of Investigations 6865, A
Machine-Test Method for Measuring Carbon Dioxide in the Inspired Air of
Self-Contained Breathing Apparatus, 1966. Copies of Report of
Investigations 6865 may be inspected or obtained from the NIOSH,
Certification and Quality Assurance Branch, 1095 Willowdale Road,
Morgantown, WV. 26505-2888.
(2) The breathing rate will be 14.5 respirations per minute with a
minute-volume of 10.5 liters.
(3) A sedentary breathing machine cam will be used.
(4) The apparatus will be tested at a temperature of 27 2 [deg]C. (80 5 [deg]F.).
(5) A concentration of 5 percent carbon dioxide in air will be
exhaled into the facepiece.
(b) Closed-circuit apparatus. The concentration of carbon dioxide in
inspired gas in closed-circuit apparatus will be measured at the mouth
while the parts of the apparatus contributing to dead-air space are
mounted on a dummy head and operated by the breathing machine as in
paragraphs (a) (1) through (5) of this section.
(c) During the testing required by paragraphs (a) and (b) of this
section, the concentration of carbon dioxide in inspired gas at the
mouth will be continuously recorded, and the maximum
[[Page 515]]
average concentration during the inhalation portion of the breathing
cycle shall not exceed the following limits:
------------------------------------------------------------------------
Maximum allowable
average concentration
Where the service time is of carbon dioxide in
inspired air percent by
volume
------------------------------------------------------------------------
Not more than 30 minutes....................... 2.5
1 hour......................................... 2.0
2 hours........................................ 1.5
3 hours........................................ 1.0
4 hours........................................ 1.0
------------------------------------------------------------------------
(d) In addition to the test requirements for closed-circuit
apparatus set forth in paragraph (b) of this section, gas samples will
be taken during the course of the man tests described in Tables 1, 2, 3,
and 4 of this subpart. These gas samples will be taken from the closed-
circuit apparatus at a point downstream of the carbon dioxide sorbent,
and they shall not contain more than 0.5 percent carbon dioxide at any
time, except on apparatus for escape only, using a mouthpiece only, the
sample shall not contain more than 1.5 percent carbon dioxide at any
time.
Sec. 84.98 Tests during low temperature operation.
(a) The applicant shall specify the minimum temperature for safe
operation and two persons will perform the tests described in paragraphs
(c) and (d) of this section, wearing the apparatus according to
applicant's directions. At the specified temperature, the apparatus
shall meet all the requirements described in paragraph (e) of this
section.
(b) The apparatus will be precooled at the specified minimum
temperature for 4 hours.
(c) The apparatus will be worn in the low temperature chamber for 30
minutes, or for the service time of the apparatus, whichever is less.
(d) During the test period, alternate 1-minute periods of exercise
and rest will be required with the exercise periods consisting of
stepping onto and off a box 21.5 cm. (8\1/2\ inches) high at a rate of
30 cycles per minute.
(e)(1) The apparatus shall function satisfactorily at the specified
minimum temperature on duplicate tests.
(2) The wearer shall have sufficient unobscured vision to perform
the work.
(3) The wearer shall not experience undue discomfort because of
airflow restriction or other physical or chemical changes in the
operation of the apparatus.
(f) Auxiliary low-temperature parts which are commercially available
to the user may be used on the apparatus to meet the requirements
described in paragraph (e) of this section.
Sec. 84.99 Man tests; testing conditions; general requirements.
(a) The man tests described in Tables 1, 2, 3, and 4 of this subpart
represent the workload performed in the mining, mineral, or allied
industries by a person wearing the apparatus tested.
(b) The apparatus tested will be worn by Institute personnel trained
in the use of self-contained breathing apparatus, and the wearer will,
before participating in these tests, pass a physical examination
conducted by a qualified physician.
(c) All man tests will be conducted by the Institute.
(d) The apparatus will be examined before each man test to ensure
that it is in proper working order.
(e) Breathing resistance will be measured within the facepiece or
mouthpiece and the wearer's pulse and respiration rate will be recorded
during each 2 minute sample period prescribed in tests 1, 2, 3, and 4.
(f) Man tests 1, 2, 3, 4, 5, and 6 will be conducted in duplicate.
(g) If man tests are not completed through no fault of the
apparatus, the test will be repeated.
Sec. 84.100 Man tests 1, 2, 3, and 4; requirements.
Man tests 1, 2, 3, and 4, set forth in Tables 1, 2, 3, and 4 of this
subpart, respectively, prescribe the duration and sequence of specific
activities. These tests will be conducted to--
(a) Familiarize the wearer with the apparatus during use;
(b) Provide for a gradual increase in activity;
(c) Evaluate the apparatus under different types of work and
physical orientation; and
(d) Provide information on the operating and breathing
characteristics of the apparatus during actual use.
[[Page 516]]
Sec. 84.101 Man test 5; requirements.
(a) Test 5 will be conducted to determine the maximum length of time
the apparatus will supply the respiratory needs of the wearer while he
is sitting at rest.
(b) The wearer will manipulate the devices controlling the supply of
breathing gas to the advantage of the apparatus.
(c) Samples of inspiration from within the apparatus facepiece or
mouthpiece shall be taken once every 15 minutes, and shall meet the
minimum requirement for oxygen specified in Sec. 84.79(a), and the
maximum allowable average concentration of carbon dioxide specified in
Sec. 84.97(c).
(d) One sample of inspiration will be taken in the case of 3-, 5-,
and 10-minute apparatus.
Sec. 84.102 Man test 6; requirements.
(a) Man test 6 will be conducted with respect to liquefied breathing
gas apparatus only.
(b) This test will be conducted to evaluate operation of the
apparatus in other than vertical positions.
(c) The wearer will lie face downward for one-fourth the service
life of the apparatus with a full charge of liquefied breathing gas, and
then a one-quarter full charge of liquefied breathing gas.
(d) The test will be repeated with the wearer lying on each side and
on his back.
(e) The oxygen content of the gas supplied to the wearer by the
apparatus will be continuously measured.
Sec. 84.103 Man tests; performance requirements.
(a) The apparatus shall satisfy the respiratory requirements of the
wearer for the classified service time.
(b) Fogging of the eyepiece shall not obscure the wearer's vision,
and the wearer shall not experience undue discomfort because of fit or
other characteristics of the apparatus.
(c) When the ambient temperature during testing is 24 6 [deg]C. (75 10 [deg]F.), the
maximum temperature of inspired air recorded during man tests shall not
exceed the following, after correction for deviation from 24 [deg]C. (75
[deg]F.):
------------------------------------------------------------------------
Where percent Maximum permissible
relative temperature of inspired
Where service life of humidity of air shall not exceed--
apparatus is-- inspired air -------------------------
is-- [deg]F. [deg]C.
------------------------------------------------------------------------
\1/4\ hour or less............ 0-100 135 57
\1/4\ hour to \3/4\ hour...... 0-50 125 52
50-100 \1\ 110 \1\ 43
1 to 2 hours.................. 0-50 115 46
50-100 \1\105 \1\41
3 hours....................... 0-50 110 43
50-100 \1\100 \1\ 38
4 hours....................... 0-50 105 41
50-100 \1\ 95 \1\ 35
------------------------------------------------------------------------
\1\ Where percent relative humidity is 50-100 and apparatus is designed
for escape only, these maximum permissible temperatures will be
increased by 5 [deg]C (10 [deg]F).
Sec. 84.104 Gas tightness test; minimum requirements.
(a) Each apparatus will be tested for tightness by persons wearing
it in an atmosphere of 1,000 p.p.m. isoamyl acetate.
(b) Six persons will each wear the apparatus in the test
concentrations specified in paragraph (a) of this section for 2 minutes
and none shall detect the odor or taste of the test vapor.
[[Page 517]]
Sec. Tables to Subpart H of Part 84
Table 1--Duration and Sequence of Specific Activities for Test 1, in Minutes
[42 CFR part 84, subpart H]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Service time--
---------------------------------------------------------------------------------------------------------
Activity 3 5 10 15 30 45
minutes minutes minutes minutes minutes minutes 1 hour 2, 3, and 4 hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sampling and readings......................... ........ ........ ........ 2 2 2 2 Perform 1 hour test 2, 3, or 4
times respectively.
Walks at 4.8 km. (3 miles) per hour........... 3 5 3 4 8 12 18
Sampling and readings......................... ........ ........ 2 2 2 2 2
Walks at 4.8 km. (3 miles) per hour........... ........ ........ 3 5 8 12 18
Sampling and readings......................... ........ ........ 2 2 2 2 2 ..................................
Walks at 4.8 km. (3 miles) per hour........... ........ ........ ........ ........ 6 13 16
Sampling and readings......................... ........ ........ ........ ........ 2 2 2 ..................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 2--Duration and Sequence of Specific Activities For Test 2, in Minutes
[42 CFR part 84, subpart H]
----------------------------------------------------------------------------------------------------------------
Service time--
-----------------------------------------------------------------------------------
Activity 2, 3 and
3 5 10 15 30 45 1 hour 4 hours
minutes minutes minutes minutes minutes minutes \1\
----------------------------------------------------------------------------------------------------------------
Sampling and readings....... ....... ....... ......... 2 2 2 2 2
Walks at 4.8 km. (3 miles) ....... ....... 1 1 3 4 6 10.
per hour...................
Carries 23 kg. (50 pound) ....... ....... 1 time in 1 time in 2 times 3 times 4 times 5 times
weight over overcast....... 2 minutes 2 minutes in 4 in 6 in 8 in 10
minutes minutes minutes minutes.
Walks at 4.8 km. (3 miles) ....... ....... ......... 1 3 3 3 5.
per hour...................
Climbs vertical treadmill 1 1 1 1 1 1 1 1.
\2\ (or equivalent)........
Walks at 4.8 km. (3 miles) ....... 1 1 ......... ......... 2 3 5
per hour...................
Climbs vertical treadmill ....... 1 ......... ......... ......... 1 1 1.
(or equivalent)............
Sampling and readings....... ....... ....... ......... ......... 2 2 2 2.
Walks at 4.8 km. (3 miles) ....... ....... ......... 2 2 3 5 11.
per hour...................
Climbs vertical treadmill ....... ....... ......... 1 1 1 1 1.
(or equivalent)............
Carries 23 kg. (50 pound) ....... ....... ......... 1 time in 3 times 4 times 5 times 5 times
weight over overcast....... 2 minutes in 6 in 8 in 10 in 10
minutes minutes minutes minutes.
Sampling and readings....... ....... ....... 2 ......... ......... 2 2 2.
Walks at 4.8 km. (3 miles) ....... ....... ......... 1 3 3 3 .........
per hour...................
Climbs vertical treadmill ....... ....... 1 1 1 1 1 Then
(or equivalent)............ repeat
above
activitie
s once.
Walks at 4.8 km. (3 miles) ....... ....... 2 ......... ......... 2 3
per hour...................
Climbs vertical treadmill ....... ....... ......... ......... ......... 1 1 .........
(or equivalent)............
Carries 20 kg. (45 pound) 1 ....... ......... ......... ......... ......... 2 .........
weight and walks at 4.8 km.
(3 miles) per hour.........
Walks at 4.8 km. (3 miles) 1 2 ......... ......... ......... 1 4 .........
per hour...................
[[Page 518]]
Sampling and readings....... ....... ....... ......... 2 2 2 2 .........
----------------------------------------------------------------------------------------------------------------
\1\ Total test time for Test 2 for 2-hour, 3-hour, and 4-hour apparatus is 2 hours.
\2\ Treadmill shall be inclined 15[deg] from vertical and operated at a speed of 1 foot per second.
Table 3--Duration and Sequence of Specific Activities For Test 3, in Minutes
[42 CFR part 84, subpart H]
----------------------------------------------------------------------------------------------------------------
Service time--
-------------------------------------------------------------------------------
Activity 2, 3 and
3 5 10 15 30 45 1 hour 4 hours
minutes minutes minutes minutes minutes minutes \1\
----------------------------------------------------------------------------------------------------------------
Sampling and readings........... ........ ........ ........ 2 2 2 2 (\2\)
Walks at 4.8 km. (3 miles) per ........ ........ 1 1 2 2 3 ........
hour...........................
Runs at 9.7 km. (6 miles) per 1 1 1 1 1 1 1 ........
hour...........................
Pulls 20 kg. (45 pound) weight ........ 15 times ........ 30 times 30 times 30 times 60 times ........
to 5 feet...................... in 1 in 2 in 2 in 2 in 6
minute minutes minutes minutes minutes
Lies on side.................... 1/2 1 1 2 3 4 5 ........
Lies on back.................... 1/2 1 1 2 2 3 3 ........
Crawls on hands and knees....... 1 1 1 2 2 2 2 ........
Sampling and readings........... ........ ........ 2 ........ 2 2 2 ........
Runs at 9.7 km. (6 miles) per ........ ........ ........ 1 1 1 1 ........
hour...........................
Walks at 4.8 km. (3 miles) per ........ ........ ........ ........ 2 8 10 ........
hour...........................
Pulls 20 kg. (45 pound) weight ........ ........ 30 times ........ 60 times 60 times 60 times ........
to 5 feet...................... in 2 in 6 in 6 in 6
minutes minutes minutes minutes
Sampling and readings........... ........ ........ ........ 2 ........ 2 2 ........
Walks at 4.8 km. (3 miles) per ........ ........ 1 ........ 3 4 10 ........
hour...........................
Lies on side.................... ........ ........ ........ ........ ........ 2 4 ........
Lies on back.................... ........ ........ ........ ........ ........ 2 1 ........
Sampling and readings........... ........ ........ ........ ........ 2 2 2 ........
----------------------------------------------------------------------------------------------------------------
\1\ Total test time for Test 3 for 2-hour, 3-hour, and 4-hour apparatus is 2 hours.
\2\ Perform test No. 3 for 1 hr. apparatus; then perform test No. 1 for 1 hour apparatus.
Table 4--Duration and Sequence of Specific Activities for Test 4, in Minutes
[42 CFR part 84, subpart H]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Service time--
---------------------------------------------------------------------------------------------------
Activity 3 5 10 15 30 45
minutes minutes minutes minutes minutes minutes 1 hour 2 hours 3 hours 4 hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sampling and readings............................... ........ ........ ........ 2 2 2 2 (\2\) (\3\) (\4\)
Walks at 4.8 km. (3 miles) per hour................. ........ ........ ........ 1 2 2 2 ........ ........ ........
Climbs vertical treadmill \1\ (or equivalent)....... 1 1 1 1 1 1 1 ........ ........ ........
Walks at 4.8 km. (3 miles) per hour................. ........ 1 1 1 2 2 2 ........ ........ ........
Pulls 20 kg. (45 pound) weight to 5 feet............ ........ 30 times 30 times 30 times 60 times 60 times 60 times ........ ........ ........
in 2 in 2 in 2 in 5 in 5 in 5
minutes minutes minutes minutes minutes minutes
Walks at 4.8 km. (3 miles) per hour................. ........ ........ 1 1 1 2 3 ........ ........ ........
[[Page 519]]
Carries 23 kg. (50 pound) weight over overcast...... ........ ........ ........ 1 time 1 time 2 times 4 times ........ ........ ........
in 1 in 1 in 3 in 8
minute minute minutes minutes
Sampling and readings............................... ........ ........ 2 ........ 2 2 2 ........ ........ ........
Walks at 4.8 km. (3 miles) per hour................. ........ ........ ........ 1 3 3 4 ........ ........ ........
Runs at 9.7 km. (6 miles) per hour.................. ........ 1 1 1 1 1 1 ........ ........ ........
Carries 23 kg. (50 pound) weight over overcast...... ........ ........ 1 time 1 time 2 times 4 times 6 times ........ ........ ........
in 1 in 1 in 3 in 6 in 9
minute minute minutes minutes minutes
Pulls 20 kg (45 pound) weight to 5 feet............. 15 times ........ ........ 15 times 60 times 30 times 36 times ........ ........ ........
in 1 in 1 in 5 in 2 in 3
minute minute minutes minutes minutes
Sampling and readings............................... ........ ........ ........ 2 2 2 2 ........ ........ ........
Walks at 4.8 km. (3 miles) per hour................. 1 ........ 1 ........ ........ 2 6 ........ ........
Pulls 20 kg. (45 pound) weight to 5 feet............ ........ ........ ........ ........ ........ 60 times 60 times ........ ........ ........
in 5 in 5
minutes minutes
Carries 20 kg. (45 pound) weight and walks at 4.8 ........ ........ ........ ........ ........ 3 3 ........ ........ ........
km. (3 miles) per hour.............................
Sampling and readings............................... ........ ........ ........ ........ ........ 2 2 ........ ........ ........
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Treadmill shall be inclined 15[deg] from vertical and operated at a speed of 30 cm. (1 foot) per second.
\2\ Perform test No. 1 for 30-minute apparatus; then perform test No. 4 for 1-hour apparatus; then perform test No. 1 for 30-minute apparatus.
\3\ Perform test No. 1 for 1-hour apparatus; then perform test No. 4 for 1-hour apparatus; then perform test No. 1 for 1-hour apparatus.
\4\ Perform test No. 1 for 1-hour apparatus; then perform test No. 4 for 1-hour apparatus; then perform test No. 1 for 1-hour apparatus twice (i.e., two
one-hour tests).
Subpart I_Gas Masks
Sec. 84.110 Gas masks; description.
(a) Gas masks including all completely assembled air purifying masks
designed for use as respiratory protection during entry into atmospheres
not immediately dangerous to life or health or escape only from
hazardous atmospheres containing adequate oxygen to support life are
described as follows:
(1) Front-mounted or back-mounted gas mask. A gas mask which
consists of a full facepiece, a breathing tube, a canister at the front
or back, a canister harness, and associated connections.
(2) Chin-style gas mask. A gas mask which consists of a full
facepiece, a canister which is usually attached to the facepiece, and
associated connections.
[[Page 520]]
(3) Escape gas mask. A gas mask designed for use during escape only
from hazardous atmospheres which consists of a facepiece or mouthpiece,
a canister, and associated connections.
(b) Gas masks shall be further described according to the types of
gases or vapors against which they are designed to provide respiratory
protection, as follows:
------------------------------------------------------------------------
Type of front-mounted or back-mounted gas mask:
Acid gas \1,2,3\
Ammonia
Carbon monoxide
Organic Vapor \1,2,3\
Other gas(es) and vapor(s) \1,2,3\
Combination of two or more of the above gases and vapors. \1,2,3\
Combination of acid gas, ammonia, carbon monoxide, and organic vapors.
\1,2,3\
Type of chin-style gas mask:
Acid gas \1,2,3\
Ammonia
Carbon monoxide
Organic vapor \1,2,3\
Other gas(es) and vapor \1,2,3\
Combination of two or more of the above gases and vapors. \1,2,3\
Type of escape gas mask:
Acid gas \1,2,3,4\
Ammonia \4\
Carbon monoxide
Organic vapor \1,2,3,4\
Other gas(s) and vapor(s) \1,2,3,4\
Combination of two or more of the above gases and vapors. \1,2,3,4\
------------------------------------------------------------------------
\1\ Approval may be for acid gases or organic vapors as a class or for
specific acid gases or organic vapors.
\2\ Not for use against gases or vapors with poor warning properties
(except where MSHA or Occupational Safety and Health Administration
standards permit such use for a specific gas or vapor), or those which
generate high heats or reaction with sorbent materials in the
canister.
\3\ Use of the gas mask may be limited by factors such as lower
explosive limit, toxicological effects, and facepiece fit. Limitations
on gas mask service life and sorbent capacity limitations shall be
specified by the applicant in instructions for selection, use and
maintenance of the gas mask.
\4\ Eye protection may be required in certain concentrations of gases
and vapors.
(c) Gas masks for respiratory protection against gases and vapors
other than those specified in paragraph (b) of this section, may be
approved upon submittal of an application in writing for approval to the
Certification and Quality Assurance Branch listing the gas or vapor and
suggested maximum use concentration for the specific type of gas mask.
The Institute will consider the application and accept or reject it on
the basis of effect on the wearer's health and safety and any field
experience in use of gas masks for such exposures. If the application is
accepted, the Institute will test such masks in accordance with the
requirements of this subpart.
Sec. 84.111 Gas masks; required components.
(a) Each gas mask described in Sec. 84.110 shall, where its design
requires, contain the following component parts:
(1) Facepiece or mouthpiece and noseclip;
(2) Canister or cartridge;
(3) Canister harness;
(4) External check valve; and
(5) Breathing tube.
(b) The components of each gas mask shall meet the minimum
construction requirements set forth in subpart G of this part.
Sec. 84.112 Canisters and cartridges in parallel; resistance requirements.
Where two or more canisters or cartridges are used in parallel,
their resistance to airflow shall be essentially equal.
Sec. 84.113 Canisters and cartridges; color and markings; requirements.
The color and markings of all canisters and cartridges or labels
shall conform with the requirements of the American National Standards
Institute, American National Standard for Identification of Air-
Purifying Respirator Canisters and Cartridges, ANSI K13.1-1973. ANSI
K13.1 is incorporated by reference and has been approved by the Director
of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies may be obtained from American National Standards
Institute, Inc., 1430 Broadway, New York, NY 10018. Copies may be
inspected at the NIOSH, Certification and Quality Assurance Branch, 1095
Willowdale Road, Morgantown, WV 26505-2888, or at the National Archives
and Records Administration (NARA). For information on the availability
of this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html.
[[Page 521]]
Sec. 84.114 Filters used with canisters and cartridges; location;
replacement.
(a) Particulate matter filters used in conjunction with a canister
or cartridge shall be located on the inlet side of the canister or
cartridge.
(b) Filters shall be incorporated in or firmly attached to the
canister or cartridge and each filter assembly shall, where applicable,
be designed to permit its easy removal from and replacement in the
canister or cartridge.
Sec. 84.115 Breathing tubes; minimum requirements.
Flexible breathing tubes used in conjunction with gas masks shall be
designed and constructed to prevent:
(a) Restriction of free head movement;
(b) Disturbance of the fit of facepieces or mouthpieces;
(c) Interference with the wearer's activities; and
(d) Shutoff of airflow due to kinking, or from chin or arm pressure.
Sec. 84.116 Harnesses; installation and construction; minimum requirements.
(a) Each gas mask shall, where necessary, be equipped with a
suitable harness designed and constructed to hold the components of the
gas mask in position against the wearer's body.
(b) Harnesses shall be designed and constructed to permit easy
removal and replacement of gas mask parts, and where applicable, provide
for holding a full facepiece in the ready position when not in use.
Sec. 84.117 Gas mask containers; minimum requirements.
(a) Gas masks shall be equipped with a substantial, durable
container bearing markings which show the applicant's name, the type and
commercial designation of mask it contains and all appropriate approval
labels.
(b) Containers for gas masks shall be designed and constructed to
permit easy removal of the mask.
Sec. 84.118 Half-mask facepieces, full facepieces, and mouthpieces; fit;
minimum requirements.
(a) Half-mask facepieces and full facepieces shall be designed and
constructed to fit persons with various facial shapes and sizes either:
(1) By providing more than one facepiece size; or
(2) By providing one facepiece size which will fit varying facial
shapes and sizes.
(b) Full facepieces shall provide for optional use of corrective
spectacles or lenses, which shall not reduce the respiratory protective
qualities of the gas mask.
(c) Half-mask facepieces shall not interfere with the fit of common
industrial safety spectacles, as determined by the Institute's facepiece
tests in Sec. 84.124.
(d) Gas masks with mouthpieces shall be equipped with noseclips
which are securely attached to the mouthpiece or gas mask and provide an
airtight seal.
(e) Facepieces shall be designed to prevent eyepiece fogging.
Sec. 84.119 Facepieces; eyepieces; minimum requirements.
(a) Full facepieces shall be designed and constructed to provide
adequate vision which is not distorted by the eye.
(b) All eyepieces shall be designed and constructed to be impact and
penetration resistant. Federal Specification, Mask, Air Line: and
Respirator, Air Filtering, Industrial, GGG-M-125d, October 11, 1965 with
interim amendment-1, July 30, 1969, is an example of an appropriate
standard for determining impact and penetration resistance. Copies of
GGG-M-125d may be obtained from the NIOSH, Certification and Quality
Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888.
Sec. 84.120 Inhalation and exhalation valves; minimum requirements.
(a) Inhalation and exhalation valves shall be provided where
necessary and protected against damage and distortion.
[[Page 522]]
(b) Inhalation valves shall be designed and constructed to prevent
excessive exhaled air from adversely affecting cartridges, canisters,
and filters.
(c) Exhalation valves shall be protected against external influence,
and designed and constructed to prevent inward leakage of contaminated
air.
Sec. 84.121 Head harnesses; minimum requirements.
(a) Facepieces shall be equipped with adjustable and replaceable
head harnesses, designed and constructed to provide adequate tension
during use and an even distribution of pressure over the entire area in
contact with the face.
(b) Mouthpieces shall be equipped, where applicable, with adjustable
and replaceable harnesses designed and constructed to hold the
mouthpiece in place.
Sec. 84.122 Breathing resistance test; minimum requirements.
(a) Resistance to airflow will be measured in the facepiece or
mouthpiece of a gas mask mounted on a breathing machine both before and
after each test conducted in accordance with Sec. Sec. 84.124, 84.125,
and 84.126, with air flowing at a continuous rate of 85 liters per
minute.
(b) The maximum allowable resistance requirements for gas masks are
as follows:
Maximum Resistance
[mm. water-column height]
------------------------------------------------------------------------
Inhalation
Type of gas mask -------------------------- Exhalation
Initial Final \1\
------------------------------------------------------------------------
Front-mounted or back-mounted 60 75 20
(without particulate filter)....
Front-mounted or back-mounted 70 85 20
(with approved particulate
filter).........................
Chin-style (without particulate 40 55 20
filter).........................
Chin-style (with approved 65 80 20
particulate filter).............
Escape (without particulate 60 75 20
filter).........................
Escape (with approved particulate 70 85 20
filter).........................
------------------------------------------------------------------------
\1\ Measured at end of the service life specified in Tables 5, 6, and 7
of this subpart.
Sec. 84.123 Exhalation valve leakage test.
(a) Dry exhalation valves and valve seats will be subjected to a
suction of 25 mm. water-column height while in a normal operating
position.
(b) Leakage between the valve and valve seat shall not exceed 30
milliliters per minute.
Sec. 84.124 Facepiece tests; minimum requirements.
(a) The complete gas mask will be fitted to the faces of persons
having varying facial shapes and sizes.
(b) Where the applicant specifies a facepiece size or sizes for the
gas mask, together with the approximate measurements of faces they are
designed to fit, the Institute will insure that test subjects suit such
facial measurements.
(c) Any gas mask parts which must be removed to perform the
facepiece or mouthpiece fit test shall be replaceable without special
tools and without disturbing the facepiece or mouthpiece fit.
(d) The facepiece or mouthpiece fit test, using positive or negative
pressure recommended by the applicant and described in his instructions
will be used before each test specified in paragraph (e) of this
section, and in Sec. 84.125.
(e)(1) Each wearer will enter a chamber containing 100 p.p.m.
isoamyl acetate vapor for a half-mask facepiece and 1,000 p.p.m. isoamyl
acetate vapor for a full facepiece or mouthpiece.
(2) The facepiece or mouthpiece may be adjusted, if necessary, in
the test chamber before starting the tests.
(3) Each wearer will remain in the chamber for 8 minutes while
performing the following activities:
(i) Two minutes, nodding and turning head;
(ii) Two minutes, calisthenic arm movements;
(iii) Two minutes, running in place; and
[[Page 523]]
(iv) Two minutes, pumping with a tire pump into a 28 liter (1 cubic
foot) container.
(4) Each wearer shall not detect the odor of isoamyl acetate during
the test.
Sec. 84.125 Particulate tests; canisters containing particulate filters;
minimum requirements.
Gas mask canisters containing filters for protection against
particulates (e.g. dusts, fumes, mists, and smokes) in combination with
gases, vapors, or gases and vapors, shall also comply with the
requirements as prescribed in Sec. Sec. 84.170 through 84.183, except
for the airflow resistance test of Sec. 84.181.
Sec. 84.126 Canister bench tests; minimum requirements.
(a)(1) Bench tests, except for carbon monoxide tests, will be made
on an apparatus that allows the test atmosphere at 50 5 percent relative humidity and room temperature (25
2.5 [deg]C.) to enter the canister continuously at
concentrations and rates of flow specified in Tables 5, 6, and 7 of this
subpart.
(2) Three canisters will be removed from containers and tested as
received from the applicant.
(3) Two canisters, other than those described in paragraph (a)(2) of
this section, will be equilibrated at room temperature by passing 25
percent relative humidity air through them at 64 liters per minute for 6
hours.
(4) Two canisters, other than those described in paragraphs (a) (2)
and (3) of this section, will be equilibrated at room temperature by
passing 85 percent relative humidity air through them at 64 liters per
minute for 6 hours.
(5) The equilibrated canisters will be resealed, kept in an upright
position at room temperature, and tested within 18 hours.
(b) Front-mounted and back-mounted gas mask canisters will be tested
and shall meet the minimum requirements set forth in Table 5 of this
subpart.
(c)(1) Front-mounted, and back-mounted, and chin-style canisters
designated as providing respiratory protection against gases, ammonia,
organic vapors, carbon monoxide and particulate contaminants shall have
a window or other indicator to warn the gas mask wearer when the
canister will no longer satisfactorily remove carbon monoxide from the
inhaled air.
(2) Other types of front- and back-mounted canisters may also be
equipped with a window or other indicator to warn of imminent leakage of
other gases or vapors.
(3) The window indicator canisters will be tested as regular
canisters, but shall show a satisfactory indicator change or other
warning before the allowable canister penetration has occurred.
(d) Chin-style gas mask canisters shall meet the minimum
requirements set forth in Table 6 of this subpart.
(e) Escape gas mask canisters shall meet the minimum requirements
set forth in Table 7 of this subpart.
Sec. Tables to Subpart I of Part 84
Table 5--Canister Bench Tests and Requirements for Front-Mounted and Back-Mounted Gas Mask Canisters
[42 CFR part 84, subpart I]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Test atmosphere
---------------------------------------------------- Maximum Minimum
Flow rate Number of allowable service
Canister type Test condition Concentration (liters tests penetratin life
Gas or vapor (parts per per (parts per (minutes)
million) minute) million) \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acid gas................................ As received SO2 20,000 64 3 5 12
Equilibrated Cl2 20,000 64 3 5 12
........................ SO2 20,000 32 4 5 12
........................ Cl2 20,000 32 4 5 12
Organic vapor........................... As received CCl4 20,000 64 3 5 12
Equilibrated CCl4 20,000 32 4 5 12
Ammonia................................. As received NH3 30,000 64 3 50 12
Equilibrated NH3 30,000 32 4 50 12
Carbon monoxide......................... As received CO 20,000 \4\ 64 2 (\3\) 60
[[Page 524]]
Equilibrated CO 5,000 \2\ 32 3 (\3\) 60
........................ CO 3,000 \2\ 32 3 (\3\) 60
Combination of 2 or 3 of above types \5\
Combination of all above types \6\
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Minimum life will be determined at the indicated penetration.
\2\ Relative humidity of test atmosphere will be 95 3pct; temperature of test atmosphere will be 25 2.5
[deg]C.
\3\ Maximum allowable CO penetration will be 385 cm \3\ during the minimum life. The penetration shall not exceed 500 p/m during this time.
\4\ Relative humidity of test atmosphere will be 95 3pct; temperature of test atmosphere entering the test fixture will be 0 2.5 [deg]C-0 [deg]C.
\5\ Test conditions and requirements will be applicable as shown in this table.
\6\ Test conditions and requirements will be applicable as shown in this table, except the minimum service lives for acid gas, organic vapor, and
ammonia will be 6 min instead of 12 min.
Table 6--Canister Bench Tests and Requirements for Chin-Style Gas Mask Canisters
[42 CFR part 84, subpart I]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Test atmosphere
------------------------------------------------- Maximum Minimum
Flow rate Number of allowable service
Canister type Test condition Concentration (liters tests penetration life
Gas or vapor (parts per per (parts per (minutes)
million) minute) million) \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acid gas............................. As received Equilibrated SO2 50,000 64 3 5 12
............................. Cl2 5,000 64 3 5 12
............................. SO2 5,000 32 4 5 12
............................. Cl2 5,000 32 4 5 12
Organic vapor........................ As received Equilibrated CCl4 5,000 64 3 5 12
............................. CCl4 5,000 32 4 5 12
Ammonia.............................. As received Equilibrated NH3 5,000 64 3 50 12
As received Equilibrated NH3 5,000 32 4 50 12
Carbon monoxide...................... As received CO 20,000 \2\ 64 2 (\3\) 60
............................. CO 5,000 \4\ 32 3 (\3\) 60
............................. CO 3,000 \2\ 32 3 (\3\) 60
Combination of 2 or 3 of above types
\5\
Combination of all above types \6\
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Minimum life will be determined at the indicated penetration.
\2\ Relative humidity of test atmosphere will be 95 3pct; temperature of test atmosphere will be 25 2.5
[deg] C.
\3\ Maximum allowable CO penetration will be 385 cm \3\ during the minimum life. The penetration shall not exceed 500 p/m during this time.
\4\ Relative humidity of test atmosphere will be 95 3pct; temperature of test atmosphere entering the test fixture will be 0 2.5 [deg]C-0[deg] C.
\5\ Test conditions and requirements will be applicable as shown in this table.
\6\ Test conditions and requirements will be applicable as shown in this table, except the minimum service lives for acid gas, organic vapor, and
ammonia will be 6 min instead of 12 min.
Table 7--Canister Bench Tests and Requirements for Escape Gas Mask Canisters
[42 CFR part 84, subpart I]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Test atmosphere
------------------------------------------------- Maximum Minimum
Flow rate Number of allowable service
Canister type Test condition Concentration (liters tests penetration life
Gas or vapor (parts per per (parts per (minutes)
million) minute) million) \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acid gas............................. As received.................. SO2 5,000 64 3 5 12
Equilibrated................. Cl2 5,000 64 3 5 12
SO2 5,000 32 4 5 12
Cl2 5,000 32 4 5 12
[[Page 525]]
Organic vapor........................ As received.................. CCl4 5,000 64 3 5 12
Equilibrated................. CCl4 5,000 32 4 5 12
Ammonia.............................. As received.................. NH3 5,000 64 3 50 12
Equilibrated................. NH3 5,000 32 4 50 12
Carbon monoxide...................... As received.................. CO 10,000 \2\ 32 2 (\3\) \4\ 60
CO 5,000 \5\ 32 3 (\3\) 60
CO 3,000 \2\ 32 3 (\3\) 60
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Minimum life will be determined at the indicated penetration.
\2\ Relative humidity of test atmosphere will be 95 3 pct; temperature of test atmosphere will be 25 2.5
[deg]C.
\3\ Maximum allowable CO penetration will be 385 cm \3\ during the minimum life. The penetration shall not exceed 500 p/m during this time.
\4\ If effluent temperature exceeds 100[deg] C during this test, the escape gas mask shall be equipped with an effective heat exchanger.
\5\ Relative humidity of test atmosphere will be 95 3 pct; temperature of test atmosphere entering the test fixture will be 0
2.5 [deg]C-0 [deg]C.
Subpart J_Supplied-Air Respirators
Sec. 84.130 Supplied-air respirators; description.
Supplied-air respirators, including all completely assembled
respirators designed for use as respiratory protection during entry into
and escape from atmospheres not immediately dangerous to life or health
are described as follows:
(a) Type ``A'' supplied-air respirators. A hose mask respirator, for
entry into and escape from atmospheres not immediately dangerous to life
or health, which consists of a motor-driven or hand-operated blower that
permits the free entrance of air when the blower is not operating, a
strong large-diameter hose having a low resistance to airflow, a harness
to which the hose and the life-line are attached and a tight-fitting
facepiece.
(b) Type ``AE'' supplied-air respirators. A Type ``A'' supplied-air
respirator equipped with additional devices designed to protect the
wearer's head and neck against impact and abrasion from rebounding
abrasive material, and with shielding material such as plastic, glass,
woven wire, sheet metal, or other suitable material to protect the
window(s) of facepieces, hoods, and helmets which do not unduly
interfere with the wearer's vision and permit easy access to the
external surface of such window(s) for cleaning.
(c) Type ``B'' supplied-air respirators. A hose mask respirator, for
entry into and escape from atmospheres not immediately dangerous to life
or health, which consists of a strong large-diameter hose with low
resistance to airflow through which the user draws inspired air by means
of his lungs alone, a harness to which the hose is attached, and a
tight-fitting facepiece.
(d) Type ``BE'' supplied-air respirators. A type ``B'' supplied-air
respirator equipped with additional devices designed to protect the
wearer's head and neck against impact and abrasion from rebounding
abrasive material, and with shielding material such as plastic, glass,
woven wire, sheet metal, or other suitable material to protect the
window(s) of facepieces, hoods, and helmets which do not unduly
interfere with the wearer's vision and permit easy access to the
external surface of such window(s) for cleaning.
(e) Type ``C'' supplied-air respirators. An airline respirator, for
entry into and escape from atmospheres not immediately dangerous to life
or health, which consists of a source of respirable breathing air, a
hose, a detachable coupling, a control valve, orifice, a demand valve or
pressure demand valve, an arrangement for attaching the hose to the
wearer, and a facepiece, hood, or helmet.
[[Page 526]]
(f) Type ``CE'' supplied-air respirators. A type ``C'' supplied-air
respirator equipped with additional devices designed to protect the
wearer's head and neck against impact and abrasion from rebounding
abrasive material, and with shielding material such as plastic, glass,
woven wire, sheet metal, or other suitable material to protect the
window(s) of facepieces, hoods, and helmets which do not unduly
interfere with the wearer's vision and permit easy access to the
external surface of such window(s) for cleaning.
Sec. 84.131 Supplied-air respirators; required components.
(a) Each supplied-air respirator described in Sec. 84.130 shall,
where its design requires, contain the following component parts:
(1) Facepiece, hood, or helmet;
(2) Air supply valve, orifice, or demand or pressure-demand
regulator;
(3) Hand operated or motor driven air blower;
(4) Air supply hose;
(5) Detachable couplings;
(6) Flexible breathing tube; and
(7) Respirator harness.
(b) The component parts of each supplied-air respirator shall meet
the minimum construction requirements set forth in subpart G of this
part.
Sec. 84.132 Breathing tubes; minimum requirements.
Flexible breathing tubes used in conjunction with supplied-air
respirators shall be designed and constructed to prevent:
(a) Restriction of free head movement;
(b) Disturbance of the fit of facepieces, mouthpieces, hoods, or
helmets;
(c) Interference with the wearer's activities; and
(d) Shutoff of airflow due to kinking, or from chin or arm pressure.
Sec. 84.133 Harnesses; installation and construction; minimum requirements.
(a) Each supplied-air respirator shall, where necessary, be equipped
with a suitable harness designed and constructed to hold the components
of the respirator in position against the wearer's body.
(b) Harnesses shall be designed and constructed to permit easy
removal and replacement of respirator parts, and where applicable,
provide for holding a full facepiece in the ready position when not in
use.
Sec. 84.134 Respirator containers; minimum requirements.
Supplied-air respirators shall be equipped with a substantial,
durable container bearing markings which show the applicant's name, the
type and commercial designation of the respirator it contains, and all
appropriate approval labels.
Sec. 84.135 Half-mask facepieces, full facepieces, hoods, and helmets; fit; minimum requirements.
(a) Half-mask facepieces and full facepieces shall be designed and
constructed to fit persons with various facial shapes and sizes either:
(1) By providing more than one facepiece size; or
(2) By providing one facepiece size which will fit varying facial
shapes and sizes.
(b) Full facepieces shall provide for optional use of corrective
spectacles or lenses, which shall not reduce the respiratory protective
qualities of the respirator.
(c) Hoods and helmets shall be designed and constructed to fit
persons with various head sizes, provide for the optional use of
corrective spectacles or lenses, and insure against any restriction of
movement by the wearer.
(d) Facepieces, hoods, and helmets shall be designed to prevent
eyepiece fogging.
Sec. 84.136 Facepieces, hoods, and helmets; eyepieces; minimum requirements.
(a) Facepieces, hoods, and helmets shall be designed and constructed
to provide adequate vision which is not distorted by the eyepiece.
(b) All eyepieces except those on Types B, BE, C, and CE supplied-
air respirators shall be designed and constructed to be impact and
penetration resistant. Federal Specification, Mask, Air Line: and
Respirator, Air Filtering,
[[Page 527]]
Industrial, GGG-M-125d, October 11, 1965 with interim amendment-1, July
30, 1969, is an example of an appropriate standard for determining
impact and penetration resistance. Copies of GGG-M-125d may be obtained
from the NIOSH, Certification and Quality Assurance Branch, 1095
Willowdale Road, Morgantown, WV 26505-2888.
(c)(1) The eyepieces of AE, BE, and CE type supplied-air respirators
shall be shielded by plastic, glass, woven wire, sheet metal, or other
suitable material which does not interfere with the vision of the
wearer.
(2) Shields shall be mounted and attached to the facepiece to
provide easy access to the external surface of the eyepiece for
cleaning.
Sec. 84.137 Inhalation and exhalation valves; check valves; minimum
requirements.
(a) Inhalation and exhalation valves shall be provided where
necessary and protected against distortion.
(b) Exhalation valves shall be:
(1) Protected against damage and external influence; and
(2) Designed and constructed to prevent inward leakage of
contaminated air.
(c) Check valves designed and constructed to allow airflow toward
the facepiece only shall be provided in the connections to the facepiece
or in the hose fitting near the facepiece of all Type A, AE, B, and BE
supplied-air respirators.
Sec. 84.138 Head harnesses; minimum requirements.
Facepieces shall be equipped with adjustable and replaceable head
harnesses which are designed and constructed to provide adequate tension
during use, and an even distribution of pressure over the entire area in
contact with the face.
Sec. 84.139 Head and neck protection; supplied-air respirators; minimum
requirements.
Type AE, BE, and CE supplied-air respirators shall be designed and
constructed to provide protection against impact and abrasion from
rebounding abrasive materials to the wearer's head and neck.
Sec. 84.140 Air velocity and noise levels; hoods and helmets; minimum
requirements.
Noise levels generated by the respirator will be measured inside the
hood or helmet at maximum airflow obtainable within pressure and hose
length requirements and shall not exceed 80 dBA.
Sec. 84.141 Breathing gas; minimum requirements.
(a) Breathing gas used to supply supplied-air respirators shall be
respirable breathing air and contain no less than 19.5 volume-percent of
oxygen.
(b) Compressed, gaseous breathing air shall meet the applicable
minimum grade requirements for Type I gaseous air set forth in the
Compressed Gas Association Commodity Specification for Air, G-7.1, 1966
(Grade D or higher quality). G-7.1 is incorporated by reference and has
been approved by the Director of the Federal Register in accordance with
5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from American
National Standards Institute, Inc., 1430 Broadway, New York, NY 10018.
Copies may be inspected at the NIOSH, Certification and Quality
Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888, or at
the National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call 202-741-6030, or go
to: http://www.archives.gov/federal--register/code--of--federal--
regulations/ibr--locations.html.
(c) Compressed, liquefied breathing air shall meet the applicable
minimum grade requirements for Type II liquid air set forth in the
Compressed Gas Association Commodity Specification for Air, G-7.1, 1966
(Grade B or higher quality). G-7.1 is incorporated by reference and has
been approved by the Director of the Federal Register in accordance with
5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from American
National Standards Institute, Inc., 1430 Broadway, New York, NY 10018.
Copies may be inspected at the NIOSH, Certification and Quality
Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888, or at
the National Archives and Records Administration
[[Page 528]]
(NARA). For information on the availability of this material at NARA,
call 202-741-6030, or go to: http://www.archives.gov/federal--register/
code--of--federal--regulations/ibr--locations.html.
Sec. 84.142 Air supply source; hand-operated or motor driven air blowers;
Type A supplied-air respirators; minimum requirements.
(a) Blowers shall be designed and constructed to deliver an adequate
amount of air to the wearer with either direction of rotation, unless
constructed to permit rotation in one direction only, and to permit the
free entrance of air to the hose when the blower is not operated.
(b) No multiple systems, whereby more than one user is supplied by
one blower, will be approved, unless each hose line is connected
directly to a manifold at the blower.
Sec. 84.143 Terminal fittings or chambers; Type B supplied-air respirators;
minimum requirements.
(a) Blowers or connections to air supplies providing positive
pressures shall not be approved for use on Type B supplied-air
respirators.
(b) Terminal fittings or chambers employed in Type B supplied-air
respirators, shall be:
(1) Installed in the inlet of the hose.
(2) Designed and constructed to provide for the drawing of air
through corrosion resistant material arranged so as to be capable of
removing material larger than 0.149 mm. in diameter (149 micrometers,
100-mesh, U.S. Standard sieve).
(3) Installed to provide a means for fastening or anchoring the
fitting or chamber in a fixed position in a zone of respirable air.
Sec. 84.144 Hand-operated blower test; minimum requirements.
(a) Hand-operated blowers shall be tested by attaching them to a
mechanical drive and operating them 6 to 8 hours daily for a period of
100 hours at a speed necessary to deliver 50 liters of air per minute
through each completely assembled respirator. Each respirator shall be
equipped with the maximum length of hose with which the device is to be
approved and the hose shall be connected to each blower or manifold
outlet designed for hose connections.
(b) The crank speed of the hand-operated blower shall not exceed 50
revolutions per minute in order to deliver the required 50 liters of air
per minute to each facepiece.
(c) The power required to deliver 50 liters of air per minute to
each wearer through the maximum length of hose shall not exceed one-
fiftieth horsepower, and the torque shall not exceed a force of 2.3 kg.
(5 pounds) on a 20 cm. (8-inch) crank, as defined in Sec. 84.146.
(d) The blower shall operate throughout the period without failure
or indication of excessive wear of bearings or other working parts.
Sec. 84.145 Motor-operated blower test; minimum requirements.
(a) Motor-operated blowers shall be tested by operating them at
their specified running speed 6 to 8 hours daily for a period of 100
hours when assembled with the kind and maximum length of hose for which
the device is to be approved and when connected to each blower or
manifold outlet designed for hose connections.
(b) The connection between the motor and the blower shall be so
constructed that the motor may be disengaged from the blower when the
blower is operated by hand.
(c) The blower shall operate throughout the period without failure
or indication of excessive wear of bearings or other working parts.
(d) Where a blower, which is ordinarily motor driven, is operated by
hand, the power required to deliver 50 liters of air per minute to each
wearer through the maximum length of hose shall not exceed one-fiftieth
horsepower, and the torque shall not exceed a force of 2.3 kg. (5
pounds) on a 20 cm. (8-inch) crank, as defined in Sec. 84.146.
(e) Where the respirator is assembled with the facepiece and 15 m.
(50 feet) of the hose for which it is to be approved, and when connected
to one outlet with all other outlets closed and operated at a speed not
exceeding 50 revolutions of the crank per minute, the amount of air
delivered into the respiratory-inlet covering shall not exceed 150
liters per minute.
[[Page 529]]
Sec. 84.146 Method of measuring the power and torque required to operate
blowers.
As shown in Figure 1 of this section, the blower crank is replaced
by a wooden drum, a (13 cm. (5 inches) in diameter is convenient). This
drum is wound with about 12 m. (40 feet) of No. 2 picture cord, b. A
weight, c, of sufficient mass to rotate the blower at the desired speed
is suspended from this wire cord. A mark is made on the cord about 3 to
4.5 m. (10 to 15 feet) from the weight, c. Another mark is placed at a
measured distance (6-9 m./20-30 feet is convenient) from the first.
These are used to facilitate timing. To determine the torque or
horsepower required to operate the blower, the drum is started in
rotation manually at or slightly above the speed at which the power
measurement is to be made. The blower is then permitted to assume
constant speed, and then as the first mark on the wire leaves the drum,
a stopwatch is started. The watch is stopped when the second mark leaves
the drum. From these data the foot-pounds per minute and the torque may
be calculated.
Figure 1--Apparatus for measuring power required to operate blower. (42
CFR part 84, subpart J, Sec. 84.146)
[GRAPHIC] [TIFF OMITTED] TC01FE91.050
Sec. 84.147 Type B supplied-air respirator; minimum requirements.
No Type B supplied-air respirator shall be approved for use with a
blower or with connection to an air supply device at positive pressures.
Sec. 84.148 Type C supplied-air respirator, continuous flow class; minimum
requirements.
(a) Respirators tested under this section shall be approved only
when they
[[Page 530]]
supply respirable air at the pressures and quantities required.
(b) The pressure at the inlet of the hose connection shall not
exceed 863 kN/m.\2\ (125 pounds per square inch gage).
(c) Where the pressure at any point in the supply system exceeds 863
kN/m.\2\ (125 pounds per square inch gage), the respirator shall be
equipped with a pressure-release mechanism that will prevent the
pressure at the hose connection from exceeding 863 kN/m.\2\ (125 pounds
per square inch gage) under any conditions.
Sec. 84.149 Type C supplied-air respirator, demand and pressure demand class;
minimum requirements.
(a) Respirators tested under this section shall be approved only
when used to supply respirable air at the pressures and quantities
required.
(b) The manufacturer shall specify the range of air pressure at the
point of attachment of the air-supply hose to the air-supply system, and
the range of hose length for the respirator. For example, he might
specify that the respirator be used with compressed air at pressures
ranging from 280-550 kN/m.\2\ (40 to 80 pounds per square inch) with
from 6 to 76 m. (15 to 250 feet) of air-supply hose.
(c) The specified air pressure at the point of attachment of the
hose to the air-supply system shall not exceed 863 kN/m.\2\ (125 pounds
per square inch gage).
(d)(1) Where the pressure in the air-supply system exceeds 863 kN/
m.\2\ (125 pounds per square inch gage), the respirator shall be
equipped with a pressure-release mechanism that will prevent the
pressure at the point of attachment of the hose to the air-supply system
from exceeding 863 kN/m.\2\ (125 pounds per square inch gage).
(2) The pressure-release mechanism shall be set to operate at a
pressure not more than 20 percent above the manufacturer's highest
specified pressure. For example, if the highest specified pressure is
863 kN/m.\2\ (125 pounds per square inch), the pressure-release
mechanism would be set to operate at a maximum of 1,035 kN/m.\2\ (150
pounds per square inch).
Sec. 84.150 Air-supply line tests; minimum requirements.
Air supply lines employed on Type A, Type B, and Type C supplied-air
respirators shall meet the minimum test requirements set forth in Table
8 of this subpart.
Sec. 84.151 Harness test; minimum requirements.
(a)(1) Shoulder straps employed on Type A supplied-air respirators
shall be tested for strength of material, joints, and seams and must
separately withstand a pull of 113 kg. (250 pounds) for 30 minutes
without failure.
(2) Belts, rings, and attachments for life lines must withstand a
pull of 136 kg. (300 pounds) for 30 minutes without failure.
(3) The hose shall be firmly attached to the harness so as to
withstand a pull of 113 kg. (250 pounds) for 30 minutes without
separating, and the hose attachments shall be arranged so that the pull
or drag of the hose behind an advancing wearer does not disarrange the
harness or exert pull upon the facepiece.
(4) The arrangement and suitability of all harness accessories and
fittings will be considered.
(b)(1) The harness employed on Type B supplied-air respirators shall
not be uncomfortable, disturbing, or interfere with the movements of the
wearer.
(2) The harness shall be easily adjustable to various sizes.
(3) The hose shall be attached to the harness in a manner that will
withstand a pull of 45 kg. (100 pounds) for 30 minutes without
separating or showing signs of failure.
(4) The design of the harness and attachment of the line shall
permit dragging the maximum length of hose considered for approval over
a concrete floor without disarranging the harness or exerting a pull on
the facepiece.
(5) The arrangement and suitability of all harness accessories and
fittings will be considered.
(c) The harness employed on Type C respirators shall be similar to
that required on the Type B respirator, or, it may consist of a simple
arrangement for attaching the hose to a part of the wearer's clothing in
a practical manner
[[Page 531]]
that prevents a pull equivalent to dragging the maximum length of the
hose over a concrete floor from exerting pull upon the respiratory-inlet
covering.
(d) Where supplied-air respirators have a rigid or partly rigid head
covering, a suitable harness shall be required to assist in holding this
covering in place.
Sec. 84.152 Breathing tube test; minimum requirements.
(a)(1) Type A and Type B supplied-air respirators shall employ one
or two flexible breathing tubes of the nonkinking type which extend from
the facepiece to a connecting hose coupling attached to the belt or
harness.
(2) The breathing tubes employed shall permit free head movement,
insure against closing off by kinking or by chin or arm pressure, and
they shall not create a pull that will loosen the facepiece or disturb
the wearer.
(b) Breathing tubes employed on Type C supplied-air respirators of
the continuous flow class shall meet the minimum requirements set forth
in paragraph (a) of this section, however, an extension of the
connecting hose may be employed in lieu of the breathing tubes required.
(c)(1) A flexible, nonkinking type breathing tube shall:
(i) Be employed on Type C supplied-air respirators of the demand and
pressure-demand class; and
(ii) Extend from the facepiece to the demand or pressure-demand
valve, except where the valve is attached directly to the facepiece.
(2) The breathing tube shall permit free head movement, insure
against closing off by kinking or by chin or arm pressure, and shall not
create a pull that will loosen the facepiece or disturb the wearer.
Sec. 84.153 Airflow resistance test, Type A and Type AE supplied-air
respirators; minimum requirements.
(a) Airflow resistance will be determined when the respirator is
completely assembled with the respiratory-inlet covering, the air-supply
device, and the maximum length of air-supply hose coiled for one-half
its length in loops 1.5 to 2.1 m. (5 to 7 feet) in diameter.
(b) The inhalation resistance, drawn at the rate of 85 liters (3
cubic feet) per minute when the blower is not operating or under any
practical condition of blower operation shall not exceed the following
amounts:
------------------------------------------------------------------------
Maximum length of hose for which Maximum resistance, water column
respirator is approved height
------------------------------------------------------------------------
Feet Meters Inches Millimeters
------------------------------------------------------------------------
75 23 1.5 38
150 46 2.5 64
250 76 3.5 89
300 91 4.0 102
------------------------------------------------------------------------
(c) The exhalation resistance shall not exceed 25 mm. (1 inch) of
water-column height at a flow rate of 85 liters (3 cubic feet) per
minute when the blower is not operating or under any practical condition
of blower operation.
Sec. 84.154 Airflow resistance test; Type B and Type BE supplied-air
respirators; minimum requirements.
(a) Airflow resistance shall be determined when the respirator is
completely assembled with the respiratory-inlet covering and the hose in
the maximum length to be considered for approval, coiled in loops 1.5 to
2.1 m. (5 to 7 feet) in diameter.
(b) Airflow resistance shall not exceed 38 mm. (1.5 inches) of
water-column height to air drawn at the flow rate of 85 liters (3 cubic
feet) per minute.
(c) The exhalation resistance shall not exceed 25 mm. (1 inch) of
water-column height at this flow rate.
Sec. 84.155 Airflow resistance test; Type C supplied-air respirator,
continuous flow class and Type CE supplied-air respirator; minimum
requirements.
The resistance to air flowing from the respirator shall not exceed
25 mm. (1 inch) of water-column height when the air flow into the
respiratory-inlet covering is 115 liters (4 cubic feet) per minute.
Sec. 84.156 Airflow resistance test; Type C supplied-air respirator, demand
class; minimum requirements.
(a) Inhalation resistance shall not exceed 50 millimeters (2 inches)
of water at an air flow of 115 liters (4 cubic feet) per minute.
[[Page 532]]
(b) The exhalation resistance to a flow of air at a rate of 85
liters (3 cubic feet) per minute shall not exceed 25 millimeters (1
inch) of water.
Sec. 84.157 Airflow resistance test; Type C supplied-air respirator,
pressure-demand class; minimum requirements.
(a) The static pressure in the facepiece shall not exceed 38 mm.
(1.5 inches) of water-column height.
(b) The pressure in the facepiece shall not fall below atmospheric
at inhalation airflows less than 115 liters (4 cubic feet) per minute.
(c) The exhalation resistance to a flow of air at a rate of 85
liters (3 cubic feet) per minute shall not exceed the static pressure in
the facepiece by more than 51 mm. (2 inches) of water-column height.
Sec. 84.158 Exhalation valve leakage test.
(a) Dry exhalation valves and valve seats will be subjected to a
suction of 25 mm. water-column height while in a normal operating
position.
(b) Leakage between the valve and valve seat shall not exceed 30
milliliters per minute.
Sec. 84.159 Man tests for gases and vapors; supplied-air respirators; general
performance requirements.
(a) Wearers will enter a chamber containing a gas or vapor as
prescribed in Sec. Sec. 84.160, 84.161, 84.162, and 84.163.
(b) Each wearer will spend 10 minutes in work to provide
observations on freedom of the device from leakage. The freedom and
comfort allowed the wearer will also be considered.
(c) Time during the test period will be divided as follows:
(1) Five minutes. Walking, turning head, dipping chin; and
(2) Five minutes. Pumping air with a tire pump into a 28-liter (1
cubic foot) container, or equivalent work.
(d) No odor of the test gas or vapor shall be detected by the wearer
in the air breathed during any such test, and the wearer shall not be
subjected to any undue discomfort or encumbrance because of the fit, air
delivery, or other features of the respirator during the testing period.
Sec. 84.160 Man test for gases and vapors; Type A and Type AE respirators;
test requirements.
(a) The completely assembled respirator will be worn in a chamber
containing 0.1 0.025 percent isoamyl acetate
vapor, and the blower, the intake of the hose, and not more than 25
percent of the hose length will be located in isoamyl acetate-free air.
(b) The man in the isoamyl acetate atmosphere will draw his inspired
air through the hose, connections, and all parts of the air device by
means of his lungs alone (blower not operating).
(c) The 10-minute work test will be repeated with the blower in
operation at any practical speed up to 50 revolutions of the crank per
minute.
Sec. 84.161 Man test for gases and vapors; Type B and Type BE respirators;
test requirements.
(a) The completely assembled respirator will be worn in a chamber
containing 0.1 0.025 percent isoamyl acetate
vapor, and the intake of the hose, and not more than 25 percent of the
hose length will be located in isoamyl acetate-free air.
(b) The man in the isoamyl acetate atmosphere will draw his inspired
air through the hose and connections by means of his lungs alone.
Sec. 84.162 Man test for gases and vapors; Type C respirators, continuous-
flow class and Type CE supplied-air respirators; test requirements.
(a) The completely assembled respirator will be worn in a chamber
containing 0.1 0.025 percent isoamyl acetate
vapor, the intake of the hose will be connected to a suitable source of
respirable air, and not more than 25 percent of the hose length will be
located in isoamyl acetate-free air.
(b) The minimum flow of air required to maintain a positive pressure
in the respiratory-inlet covering throughout the entire breathing cycle
will be supplied to the wearer, provided however, that airflow shall not
be less than 115 liters per minute for tight-fitting and not less than
170 liters per minute for loose-fitting respiratory inlet-coverings.
[[Page 533]]
(c) The test will be repeated with the maximum rate of flow
attainable within specified operating pressures.
Sec. 84.163 Man test for gases and vapors; Type C supplied-air respirators,
demand and pressure-demand classes; test requirements.
(a) The completely assembled respirator will be worn in a chamber
containing 0.1 0.025 percent isoamyl acetate
vapor, the intake of the hose will be connected to a suitable source of
respirable air, and not more than 25 percent of the hose length will be
located in isoamyl acetate-free air.
(b) The test will be conducted at the minimum pressure with the
maximum hose length and will be repeated at the maximum pressure with
the minimum hose length.
Sec. Table to Subpart J of Part 84
Table 8--Air-Supply-Line Requirements and Tests
[42 CFR part 84, subpart J]
----------------------------------------------------------------------------------------------------------------
Requirements for the air-supply lines of the indicated type of supplied-air
respirators
Specific requirements ----------------------------------------------------------------------------
Type A Type B Type C
----------------------------------------------------------------------------------------------------------------
Length of hose..................... Maximum of 91 m. (300 Maximum of 23 m. (75 Maximum of 91 m. (300 feet)
feet), in multiples feet) in multiples of in multiples of 7.6 m. (25
of 7.6 m. (25 feet). 7.6 m. (25 feet). feet). It will be
permissible for the
applicant to supply hose
of the approved type of
shorter length than 7.6 m.
(25 feet) provided it
meets the requirements of
the part.
Air flow........................... None.................. None.................. The air-supply hose with
air regulating valve or
orifice shall permit a
flow of not less than 115
liters (4 cubic feet) per
minute to tight-fitting
and 170 liters (6 cubic
feet) per minute to loose-
fitting respiratory-inlet
coverings through the
maximum length of hose for
which approval is granted
and at the minimum
specified air-supply
pressure. The maximum flow
shall not exceed 425
liters (15 cubic feet) per
minute at the maximum
specified air-supply
pressure with the minimum
length of hose for which
approval is granted.
Air flow........................... ......do.............. ......do.............. The air-supply hose,
detachable coupling, and
demand valve of the demand
class or pressure-demand
valve of the pressure-
demand class for Type C
supplied-air respirators,
demand and pressure-demand
classes, shall be capable
of delivering respirable
air at a rate of not less
than 115 liters (4 cubic
feet) per minute to the
respiratory-inlet covering
at an inhalation
resistance not exceeding
50 millimeters (2 inches)
of water-column height
measured in the
respiratory-inlet covering
with any combination of
air-supply pressure and
length of hose within the
applicant's specified
range of pressure and hose
length. The air-flow rate
and resistance to
inhalation shall be
measured while the demand
or pressure-demand valve
is actuated 20 times per
minute by a source of
intermittent suction. The
maximum rate of flow to
the respiratory-inlet
covering shall not exceed
425 liters (15 cubic feet)
per minute under the
specified operating
conditions.
[[Page 534]]
Air-regulating valve............... ......do.............. ......do.............. If an air-regulating valve
is provided, it shall be
so designed that it will
remain at a specific
adjustment, which will not
be affected by the
ordinary movement of the
wearer. The valve must be
so constructed that the
air supply with the
maximum length of hose and
at the minimum specified
air-supply pressure will
not be less than 115
liters (4 cubic feet) of
air per minute to tight-
fitting and 170 liters (6
cubic feet) of air per
minute of loose-fitting
respiratory inlet
coverings for any
adjustment of the valve.
If a demand or pressure-
demand valve replaces the
air-regulating valve, it
shall be connected to the
air-supply at the maximum
air pressure for which
approval is sought by
means of the minimum
length of air-supply hose
for which approval is
sought. The outlet of the
demand or pressure-demand
valve shall be connected
to a source of
intermittent suction so
that the demand or
pressure-demand valve is
actuated approximately 20
times per minute for a
total of 100,000
inhalations. To expedite
this test, the rate of
actuation may be increased
if mutually agreeable to
the applicant and NIOSH.
During this test the valve
shall function without
failure and without
excessive wear of the
moving parts. The demand
or pressure-demand valve
shall not be damaged in
any way when subjected at
the outlet to a pressure
or suction of 25 cm. (10
inches) of water gage for
2 minutes.
Noncollapsibility.................. The hose shall not Same as Type A........ None.
collapse or exhibit
permanent deformation
when a force of 90
kg. (200 pounds) is
applied for 5 minutes
between 2 planes 7.6
cm. (3 inches) wide
on opposite sides of
the hose.
Nonkinkability..................... None.................. None.................. A 7.6 m. (25 foot) section
of the hose will be placed
on a horizontal-plane
surface and shaped into a
one-loop coil with one end
of the hose connected to
an airflow meter and the
other end of the hose
supplied with air at the
minimum specified supply
pressure. The connection
shall be in the plane of
the loop. The other end of
the hose will be pulled
tangentially to the loop
and in the plane of the
loop until the hose
straightens. To meet the
requirements of this test
the loop shall maintain a
uniform near-circular
shape and ultimately
unfold as a spiral,
without any localized
deformation that decreases
the flow of air to less
than 90 percent of the
flow when the hose is
tested while remaining in
a straight line.
Strength of hose and couplings..... Hose and couplings Same as Type A........ Hose and couplings shall
shall not separate or not exhibit any separation
fail when tested with or failure when tested
a pull of 113 kg. with a pull of 45 kg. (100
(250 pounds) for 5 pounds) for 5 minutes and
minutes. when tested by subjecting
them to an internal air
pressure of 2 times the
maximum respirator-supply
pressure that is specified
by the applicant or at 173
kN/m. 2 (25 pounds per
square inch) gage,
whichever is higher.
[[Page 535]]
Tightness.......................... No air leakage shall None.................. Leakage of air exceeding 50
occur when the hose cc. per minute at each
and couplings are coupling shall not be
joined and the permitted when the hose
joint(s) are immersed and couplings are joined
in water and and are immersed in water,
subjected to an with air flowing through
internal air pressure the respirator under a
of 35 kN/m. 2 (5 pressure of 173 kN/m. 2
pounds per square (25 pounds per square
inch) gage. inch) gage applied to the
inlet end of the air-
supply hose, or at twice
the maximum respirator-
supply pressure that is
specified by the
applicant, whichever is
higher.
Permeation of hose by gasoline..... The permeation of the Same as for Type A.... Same as for Type A, except
hose by gasoline will the test period shall be 1
be tested by hour.
immersing 7.6 m. (25
feet) of hose and one
coupling in gasoline,
with air flowing
through the hose at
the rate of 8 liters
per minute for 6
hours. The air from
the hose shall not
contain more than
0.01 percent by
volume of gasoline
vapor at the end of
the test.
Detachable coupling................ None.................. None.................. A hand-operated detachable
coupling by which the
wearer can readily attach
or detach the connecting
hose shall be provided at
a convenient location.
This coupling shall be
durable, remain connected
under all conditions of
normal respirator use, and
meet the prescribed tests
for strength and tightness
of hose and couplings.
----------------------------------------------------------------------------------------------------------------
Subpart K_Non-Powered Air-Purifying Particulate Respirators
Sec. 84.170 Non-powered air-purifying particulate respirators; description.
(a) Non-powered air-purifying particulate respirators utilize the
wearer's negative inhalation pressure to draw the ambient air through
the air-purifying filter elements (filters) to remove particulates from
the ambient air. They are designed for use as respiratory protection
against atmospheres with particulate contaminants (e.g., dusts, fumes,
mists) that are not immediately dangerous to life or health and that
contain adequate oxygen to support life.
(b) Non-powered air-purifying particulate respirators are classified
into three series, N-, R-, and P-series. The N-series filters are
restricted to use in those workplaces free of oil aerosols. The R- and
P-series filters are intended for removal of any particulate that
includes oil-based liquid particulates.
(c) Non-powered air-purifying particulate respirators are classified
according to the efficiency level of the filter(s) as tested according
to the requirements of this part.
(1) N100, R100, and P100 filters shall demonstrate a minimum
efficiency level of 99.97 percent.
(2) N99, R99, and P99 filters shall demonstrate a minimum efficiency
level of 99 percent.
(3) N95, R95, and P95 filters shall demonstrate a minimum efficiency
level of 95 percent.
Sec. 84.171 Non-powered air-purifying particulate respirators; required
components.
(a) Each non-powered air-purifying particulate respirator described
in Sec. 84.170 shall, where its design requires, contain the following
component parts:
[[Page 536]]
(1) Facepiece, mouthpiece with noseclip, hood, or helmet;
(2) Filter unit;
(3) Harness;
(4) Attached blower; and
(5) Breathing tube.
(b) The components of each non-powered air-purifying particulate
respirator shall meet the minimum construction requirements set forth in
subpart G of this part.
Sec. 84.172 Breathing tubes; minimum requirements.
Flexible breathing tubes used in conjunction with respirators shall
be designed and constructed to prevent:
(a) Restriction of free head movement;
(b) Disturbance of the fit of facepieces, mouthpieces, hoods, or
helmets;
(c) Interference with the wearer's activities; and
(d) Shutoff of airflow due to kinking, or from chin or arm pressure.
Sec. 84.173 Harnesses; installation and construction; minimum requirements.
(a) Each respirator shall, where necessary, be equipped with a
suitable harness designed and constructed to hold the components of the
respirator in position against the wearer's body.
(b) Harnesses shall be designed and constructed to permit easy
removal and replacement of respirator parts, and, where applicable,
provide for holding a full facepiece in the ready position when not in
use.
Sec. 84.174 Respirator containers; minimum requirements.
(a) Except as provided in paragraph (b) of this section each
respirator shall be equipped with a substantial, durable container
bearing markings which show the applicant's name, the type of respirator
it contains, and all appropriate approval labels.
(b) Containers for single-use respirators may provide for storage of
more than one respirator, however, such containers shall be designed and
constructed to prevent contamination of respirators which are not
removed, and to prevent damage to respirators during transit.
Sec. 84.175 Half-mask facepieces, full facepieces, hoods, helmets, and
mouthpieces; fit; minimum requirements.
(a) Half-mask facepieces and full facepieces shall be designed and
constructed to fit persons with various facial shapes and sizes either:
(1) By providing more than one facepiece size; or
(2) By providing one facepiece size which will fit varying facial
shapes and sizes.
(b) Full facepieces shall provide for optional use of corrective
spectacles or lenses, which shall not reduce the respiratory protective
qualities of the respirator.
(c) Hoods and helmets shall be designed and constructed to fit
persons with various head sizes, provide for the optional use of
corrective spectacles or lenses, and insure against any restriction of
movement by the wearer.
(d) Mouthpieces shall be equipped with noseclips which are securely
attached to the mouthpiece or respirator and provide an airtight seal.
(e) Facepieces, hoods, and helmets shall be designed to prevent
eyepiece fogging.
(f) Half-mask facepieces shall not interfere with the fit of common
industrial safety corrective spectacles.
Sec. 84.176 Facepieces, hoods, and helmets; eyepieces; minimum requirements.
Facepieces, hoods, and helmets shall be designed and constructed to
provide adequate vision which is not distorted by the eyepieces.
Sec. 84.177 Inhalation and exhalation valves; minimum requirements.
(a) Inhalation and exhalation valves shall be protected against
distortion.
(b) Inhalation valves shall be designed and constructed and provided
where necessary to prevent excessive exhaled air from adversely
affecting filters, except where filters are specifically designed to
resist moisture.
(c) Exhalation valves shall be:
(1) Provided where necessary;
(2) Protected against damage and external influence; and
[[Page 537]]
(3) Designed and constructed to prevent inward leakage of
contaminated air.