[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.
---------------------------------------------------------------------------

    \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:
---------------------------------------------------------------------------

    \1\ HHS will determine the final class definition(s) for each 
petition (see Sec. 83.16).
---------------------------------------------------------------------------

    (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.]
------------------------------------------------------------------------
 
------------------------------------------------------------------------
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.



Sec. 84.178  Head harnesses; minimum requirements.

    (a) All facepieces shall be equipped with 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) Facepiece head harnesses, except those employed on single-use 
respirators, shall be adjustable and replaceable.
    (c) Mouthpieces shall be equipped, where applicable, with adjustable 
and replaceable harnesses, designed and constructed to hold the 
mouthpiece in place.



Sec. 84.179  Non-powered air-purifying particulate respirators; filter 

identification.

    (a) The respirator manufacturer, as part of the application for 
certification, shall specify the filter series and the filter efficiency 
level (i.e., ``N95'', ``R95, ``P95'', ``N99, ``R99'', ``P99'', ``N100'', 
``R100'', or ``P100'') for which certification is being sought.
    (b) Filters shall be prominently labeled as follows:
    (1) N100 filters shall be labeled ``N100 Particulate Filter (99.97% 
filter efficiency level)'' and shall be a color other than magenta.
    (2) R100 filters shall be labeled ``R100 Particulate Filter (99.97% 
filter efficiency level)'' and shall be a color other than magenta.
    (3) P100 filters shall be labeled ``P100 Particulate Filter (99.97% 
filter efficiency level)'' and shall be color coded magenta.
    (4) N99 filters shall be labeled ``N99 Particulate Filter (99% 
filter efficiency level)'' and shall be a color other than magenta.
    (5) R99 filters shall be labeled ``R99 Particulate Filter (99% 
filter efficiency level)'' and shall be a color other than magenta.
    (6) P99 filters shall be labeled ``P99 Particulate Filter (99% 
filter efficiency level)'' and shall be a color other than magenta.
    (7) N95 filters shall be labeled as ``N95 Particulate Filter (95% 
filter efficiency level)'' and shall be a color other than magenta.
    (8) R95 filters shall be labeled as ``R95 Particulate Filter (95% 
filter efficiency level)'' and shall be a color other than magenta.
    (9) P95 filters shall be labeled as ``P95 Particulate Filter (95% 
filter efficiency level)'' and shall be a color other than magenta.



Sec. 84.180  Airflow resistance tests.

    (a) Resistance to airflow will be measured in the facepiece, 
mouthpiece, hood, or helmet of a particulate respirator (complete 
respirator) mounted on a test fixture with air flowing at continuous 
rate of 85 2 liters per minute, before each test 
conducted in accordance with Sec. 84.182.
    (b) The resistances for particulate respirators upon initial 
inhalation shall not exceed 35 mm water column height pressure and upon 
initial exhalation shall not exceed 25 mm water column height pressure.



Sec. 84.181  Non-powered air-purifying particulate filter efficiency level 

determination.

    (a) Twenty filters of each non-powered air-purifying particulate 
respirator model shall be tested for filter efficiency against:
    (1) A solid sodium chloride particulate aerosol as per this section, 
if N-series certification is requested by the applicant.
    (2) A dioctyl phthalate or equivalent liquid particulate aerosol as 
per this section, if R-series or P-series certification is requested by 
the applicant.
    (b) Filters including holders and gaskets; when separable, shall be 
tested for filter efficiency level, as mounted on a test fixture in the 
manner as used on the respirator.
    (c) Prior to filter efficiency testing of 20 N-series filters, the 
20 to be tested shall be taken out of their packaging and placed in an 
environment of 85 5 percent relative humidity at 
38 2.5 [deg]C for 25 1 
hours. Following the pre-conditioning, filters shall be sealed in a gas-
tight container and tested within 10 hours.

[[Page 538]]

    (d) When the filters do not have separable holders and gaskets, the 
exhalation valves shall be blocked so as to ensure that leakage, if 
present, is not included in the filter efficiency level evaluation.
    (e) For non-powered air-purifying particulate respirators with a 
single filter, filters shall be tested at a continuous airflow rate of 
85 4 liters per minute. Where filters are to be 
used in pairs, the test-aerosol airflow rate shall be 42.5 2 liters per minute through each filter.
    (f) Filter efficiency test aerosols. (1) When testing N-series 
filters, a sodium chloride or equivalent solid aerosol at 25 5 [deg]C and relative humidity of 30 10 percent that has been neutralized to the Boltzmann 
equilibrium state shall be used. Each filter shall be challenged with a 
concentration not exceeding 200 mg/m\3\.
    (2) When testing R-series and P-series filters, a neat cold-
nebulized dioctyl phthalate (DOP) or equivalent aerosol at 25 5 [deg]C that has been neutralized to the Boltzmann 
equilibrium state shall be used. Each filter shall be challenged with a 
concentration not exceeding 200 mg/m\3\.
    (3) The test shall continue until minimum efficiency is achieved or 
until an aerosol mass of at least 200 5 mg has 
contacted the filter. For P-series filters, if the filter efficiency is 
decreasing when the 200 5 mg challenge point is 
reached, the test shall be continued until there is no further decrease 
in efficiency.
    (g) The sodium chloride test aerosol shall have a particle size 
distribution with count median diameter of 0.075 0.020 micrometer and a standard geometric deviation not 
exceeding 1.86 at the specified test conditions as determined with a 
scanning mobility particle sizer or equivalent. The DOP aerosol shall 
have a particle size distribution with count median diameter of 0.185 
0.020 micrometer and a standard geometric 
deviation not exceeding 1.60 at the specified test conditions as 
determined with a scanning mobility particle sizer or equivalent.
    (h) The efficiency of the filter shall be monitored and recorded 
throughout the test period by a suitable forward-light-scattering 
photometer or equivalent instrumentation.
    (i) The minimum efficiency for each of the 20 filters shall be 
determined and recorded and be equal to or greater than the filter 
efficiency criterion listed for each level as follows:

P100, R100 and N100: Efficiency =99.97%
P99, R99 and N99: Efficiency =99%
P95, R95 and N95: Efficiency =95%



Sec. 84.182  Exhalation valve leakage test; minimum requirements.

    (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.



                Subpart L_Chemical Cartridge Respirators



Sec. 84.190  Chemical cartridge respirators: description.

    (a) Chemical cartridge respirators including all completely 
assembled respirators which are designed for use as respiratory 
protection during entry into or escape from atmospheres not immediately 
dangerous to life and health, are described according to the specific 
gases or vapors against which they are designed to provide respiratory 
protection, as follows:

------------------------------------------------------------------------
                                                            Maximum use
                                                          concentration,
        Type of chemical cartridge respirator \1\            parts per
                                                              million
------------------------------------------------------------------------
Ammonia.................................................            300
Chlorine................................................             10
Hydrogen chloride.......................................             50
Methyl amine............................................            100
Organic vapor...........................................      \2\ 1,000
Sulfur dioxide..........................................             50
Vinyl chloride..........................................             10
------------------------------------------------------------------------
\1\ Not for use against gases or vapors with poor warning properties
  (except where MSHA or Occupational Safety and Health Administration
  standards may permit such use for a specific gas or vapor) or those
  which generate high heats of reaction with sorbent material in the
  cartridge.
\2\ Maximum use concentrations are lower for organic vapors which
  produce atmospheres immediately hazardous to life or health at
  concentrations equal to or lower than this concentration.

    (b) Chemical cartridge respirators for respiratory protection 
against gases or vapors, which are not specifically listed with their 
maximum use concentration, may be approved if the applicant

[[Page 539]]

submits a request for such approval, in writing, to the Institute. The 
Institute shall consider each such application and accept or reject the 
application after a review of the effects on the wearer's health and 
safety and in the light of any field experience in use of chemical 
cartridge respirators as protection against such hazards.



Sec. 84.191  Chemical cartridge respirators; required components.

    (a) Each chemical cartridge respirator described in Sec. 84.190 
shall, where its design requires, contain the following component parts:
    (1) Facepiece, mouthpiece, and noseclip, hood, or helmet;
    (2) Cartridge;
    (3) Cartridge with filter;
    (4) Harness;
    (5) Breathing tube; and
    (6) Attached blower.
    (b) The components of each chemical cartridge respirator shall meet 
the minimum construction requirements set forth in subpart G of this 
part.



Sec. 84.192  Cartridges in parallel; resistance requirements.

    Where two or more cartridges are used in parallel, their resistance 
to airflow shall be essentially equal.



Sec. 84.193  Cartridges; color and markings; requirements.

    The color and markings of all 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.



Sec. 84.194  Filters used with chemical cartridges; location; replacement.

    (a) Particulate matter filters used in conjunction with a chemical 
cartridge shall be located on the inlet side of the cartridge.
    (b) Filters shall be incorporated in or firmly attached to the 
cartridge and each filter assembly shall, where applicable, be designed 
to permit its easy removal from and replacement on the cartridge.



Sec. 84.195  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. 84.196  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. 84.197  Respirator containers; minimum requirements.

    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.

[[Page 540]]



Sec. 84.198  Half-mask facepieces, full facepieces, mouthpieces, 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) 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.
    (c) Mouthpieces shall be equipped with noseclips which are securely 
attached to the mouthpiece or respirator and provide an airtight fit.
    (d) Full facepieces shall provide for optional use of corrective 
spectacles or lenses which shall not reduce the respiratory protective 
qualities of the respirator.
    (e) Facepieces, hoods, and helmets shall be designed to prevent 
eyepiece fogging.



Sec. 84.199  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. 84.200  Inhalation and exhalation valves; minimum requirements.

    (a) Inhalation and exhalation valves shall be provided where 
necessary and protected against distortion.
    (b) Inhalation valves shall be designed and constructed to prevent 
excessive exhaled air from entering cartridges or adversely affecting 
canisters.
    (c) Exhalation valves shall be--
    (1) Protected against damage and external influence; and
    (2) Designed and constructed to prevent inward leakage of 
contaminated air.



Sec. 84.201  Head harnesses; minimum requirements.

    (a)(1) Facepieces for chemical cartridge respirators other than 
single-use vinyl chloride 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.
    (2) Facepieces for single-use vinyl chloride respirators shall be 
equipped with adjustable 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 an 
adjustable and replaceable harness designed and constructed to hold the 
mouthpiece in place.



Sec. 84.202  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 and shall not exceed 80 
dBA.



Sec. 84.203  Breathing resistance test; minimum requirements.

    (a) Resistance to airflow will be measured in the facepiece, 
mouthpiece, hood, or helmet of a chemical cartridge respirator mounted 
on a test fixture with air flowing at a continuous rate of 85 liters per 
minute, both before and after each test conducted in accordance with 
Sec. Sec. 84.206 through 84.207.
    (b) The maximum allowable resistance requirements for chemical 
cartridge respirators are as follows:

                           Maximum Resistance
                    [Millimeter water column height]
------------------------------------------------------------------------
                                          Inhalation
    Type of chemical-cartridge    --------------------------  Exhalation
            respirator               Initial      Final\1\
------------------------------------------------------------------------
Other than single-use vinyl
 chloride respirators:
    For gases, vapors, or gases             40           45           20
     and vapors..................

[[Page 541]]

 
    For gases, vapors, or gases             50           70           20
     and vapors, and particulates
Single-use respirator with
 valves:
    For vinyl chloride...........           20           25           20
    For vinyl chloride and                  30           45            2
     particulates................
Single-use respirator without
 valves:
    For vinyl chloride...........           15           20        (\2\)
    For vinyl chloride and                  25           40        (\2\)
     particulates................
------------------------------------------------------------------------
\1\ Measured at end of service life specified in Table 11 of this
  subpart.
\2\ Same as inhalation.



Sec. 84.204  Exhalation valve leakage test; minimum requirements.

    (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. 84.205  Facepiece test; minimum requirements.

    (a) The complete chemical cartridge respirator 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 
respirator together with the approximate measurement of faces they are 
designed to fit, the Institute will provide test subjects to suit such 
facial measurements.
    (c) Any chemical cartridge respirator part which must be removed to 
perform the facepiece or mouthpiece fit test shall be replaceable 
without special tools and without disturbing facepiece or mouthpiece 
fit.
    (d) The facepiece or mouthpiece fit test using the positive or 
negative pressure recommended by the applicant and described in his 
instructions will be used before each test.
    (e)(1) Each wearer will enter a chamber containing 100 p.p.m. 
isoamyl acetate vapor for half-mask facepieces, and 1,000 p.p.m. for 
full facepieces, mouthpieces, hoods, and helmets.
    (2) The facepiece or mouthpiece may be adjusted, if necessary, in 
the test chamber before starting the test.
    (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
    (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 vapor 
during the test.



Sec. 84.206  Particulate tests; respirators with filters; minimum 

requirements; general.

    (a) Three respirators with cartridges containing, or having attached 
to them, filters for protection against particulates will be tested in 
accordance with the provisions of Sec. 84.207.
    (b) In addition to the test requirements set forth in paragraph (a) 
of this section, three such respirators will be tested, as appropriate, 
in accordance with the provisions of Sec. Sec. 84.179 through 84.183; 
however, the maximum allowable resistance of complete particulate, and 
gas, vapor, or gas and vapor chemical cartridge respirators shall not 
exceed the maximum allowable limits set forth in Sec. 84.203.



Sec. 84.207  Bench tests; gas and vapor tests; minimum requirements; general.

    (a) Bench tests will be made on an apparatus that allows the test 
atmosphere at 50 5 percent relative humidity and 
room temperature, approximately 25 [deg]C, to enter the cartridges 
continuously at predetermined concentrations and rates of flow, and that

[[Page 542]]

has means for determining the test life of the cartridges.
    (b) Where two cartridges are used in parallel on a chemical 
cartridge respirator, the bench test will be performed with the 
cartridges arranged in parallel, and the test requirements will apply to 
the combination rather than to the individual cartridges.
    (c) Three cartridges or pairs of cartridges will be removed from 
containers and tested as received from the applicant.
    (d) Two air purifying cartridges or pairs of cartridges will be 
equilibrated at room temperature by passing 25 percent relative humidity 
air through them at the flow rate of 25 liters per minute (l.p.m.) for 6 
hours.
    (e) Two air purifying cartridges or pairs of cartridges will be 
equilibrated by passing 85 percent relative humidity air through them at 
the flow rate of 25 l.p.m.
    (f) All cartridges will be resealed, kept in an upright position, at 
room temperatures, and tested within 18 hours.
    (g) Cartridges will be tested and shall meet the minimum 
requirements set forth in Table 11 of this subpart.



                   Sec. Tables to Subpart L of Part 84

                                                                 Tables 9-10 [Reserved]
                                                    Table 11--Cartridge Bench Tests and Requirements
                                                               [42 CFR part 84, subpart L]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                           Test atmosphere
                                                               --------------------------------------   Flowrate    Number of   Penetration    Minimum
              Cartridge                     Test condition                             Concentration    (l.p.m.)      tests         \1\        life \2\
                                                                     Gas or vapor         (p.p.m.)                                (p.p.m.)      (min.)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ammonia..............................  As received............  NH3                            1000            64            3           50           50
Ammonia..............................  Equilibrated...........  NH3                            1000            32            4           50           50
Chlorine.............................  As received............  Cl2                             500            64            3            5           35
Chlorine.............................  Equilibrated...........  Cl2                             500            32            4            5           35
Hydrogen chloride....................  As received............  HCl                             500            64            3            5           50
Hydrogen chloride....................  Equilibrated...........  HCl                             500            32            4            5           50
Methylamine..........................  As received............  CH3 NH2                        1000            64            3           10           25
Methylamine..........................  Equilibrated...........  CH3 NH2                        1000            32            4           10           25
Organic vapors.......................  As received............  CCl4                           1000            64            3            5           50
Organic vapors.......................  Equilibrated...........  CCl4                           1000            32            4            5           50
Sulfur dioxide.......................  As received............  SO2                             500            64            3            5           30
Sulfur dioxide.......................  Equilibrated...........  SO2                             500            32            4            5           30
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Minimum life will be determined at the indicated penetration.
\2\ Where a respirator is designed for respiratory protection against more than one type of gas or vapor, as for use in ammonia and in chlorine, the
  minimum life shall be one-half that shown for each type of gas or vapor. Where a respirator is designed for respiratory protection against more than
  one gas of a type, as for use in chlorine and sulfur dioxide, the stated minimal life shall apply.

Subpart M [Reserved]



                    Subpart N_Special Use Respirators



Sec. 84.250  Vinyl chloride respirators; description.

    Vinyl chloride respirators, including all completely assembled 
respirators which are designed for use as respiratory protection during 
entry into and escape from vinyl chloride atmospheres containing 
adequate oxygen to support life, are described according to their 
construction as follows:
    (a) Front-mounted or back-mounted gas masks;
    (b) Chin-style gas masks;
    (c) Chemical-cartridge respirators;
    (d) Powered air-purifying respirators; and
    (e) Other devices, including combination respirators.

[[Page 543]]



Sec. 84.251  Required components.

    (a) Each vinyl chloride respirator described in Sec. 84.250 shall, 
where its design requires, contain the following component parts:
    (1) Facepiece;
    (2) Canister with end-of-service-life indicator;
    (3) Cartridge with end-of-service-life indicator;
    (4) Harness;
    (5) Attached blower; and
    (6) Breathing tube.
    (b) The components of each vinyl chloride respirator shall meet the 
minimum construction requirements set forth in Subpart G of this part.



Sec. 84.252  Gas masks; requirements and tests.

    (a) Except for the tests prescribed in Sec. 84.126, the minimum 
requirements and performance tests for gas masks, prescribed in Subpart 
I of this part, are applicable to vinyl chloride gas masks.
    (b) The following bench tests are applicable to canisters designed 
for use with gas masks for entry into and escape from vinyl chloride 
atmospheres containing adequate oxygen to support life:
    (1) Four canisters will be equilibrated at 25 5 [deg]C by passing 85 5 percent 
relative humidity air through them at 64 liters per minute for six 
hours.
    (2) The equilibrated canisters will be resealed, kept in an upright 
position at room temperature, and tested according to paragraph (b)(3) 
of this section within 18 hours.
    (3) The canisters equilibrated and stored as described in paragraphs 
(b) (1) and (2) of this section will be tested on an apparatus that 
allows the test atmosphere at 85 5 percent 
relative humidity and 25 5 [deg]C to enter the 
canister continuously at a concentration of 25 ppm vinyl chloride 
monomer at a total flow rate of 64 liters per minute.
    (4) The maximum allowable penetration after six hours of testing 
according to paragraph (b)(3) of this section shall not exceed 1 ppm 
vinyl chloride.
    (c) Where canisters are submitted for testing and approval with a 
service life of more than four hours, the period of time for testing for 
vinyl chloride penetration will be performed at 150% of the service life 
specified in the manufacturer's application. (Example: If a manufacturer 
requests approval of a respirator for six hours use against exposure to 
vinyl chloride, the maximum allowable penetration after nine hours of 
testing shall not exceed 1 ppm vinyl chloride.)



Sec. 84.253  Chemical-cartridge respirators; requirements and tests.

    (a) Except for the tests prescribed in Sec. Sec. 84.206 and 84.207, 
the minimum requirements and performance tests for chemical-cartridge 
respirators prescribed in Subpart L of this part are applicable to 
replaceable-cartridge and single-use vinyl chloride chemical-cartridge 
respirators.
    (b) The following bench tests are applicable to cartridges designed 
for use with chemical-cartridge respirators for entry into and escape 
from vinyl chloride atmospheres containing adequate oxygen to support 
life:
    (1) Where two cartridges are used in parallel on a chemical-
cartridge respirator, the bench test requirements will apply to the 
combination rather than the individual cartridges.
    (2) Four cartridges or pairs of cartridges will be equilibrated at 
25 5 [deg]C by passing 85 5 
percent relative humidity air through them at 25 liters per minute for 
six hours.
    (3) The equilibrated cartridges will be resealed, kept in an upright 
position, at room temperature, and tested according to paragraphs (b)(4) 
and (b)(5) of this section for other than single-use respirators or 
according to paragraphs (b)(6) and (b)(7) of this section for single-use 
respirators within 18 hours.
    (4) The cartridges or pairs of cartridges for other than single-use 
respirators, equilibrated and stored as described in paragraphs (b)(1), 
(b)(2), and (b)(3) of this section, will be tested on an apparatus that 
allows the test atmosphere at 85 5 percent 
relative humidity and 25 5 [deg]C, to enter the 
cartridges or pairs of cartridges continuously at a concentration of 10 
ppm vinyl chloride monomer at a total flowrate of 64 liters per minute.
    (5) The maximum allowable penetration after 90 minutes testing of 
cartridges or pairs of cartridges for other than single-use respirators, 
according

[[Page 544]]

to paragraph (b)(4) of this section shall not exceed 1 ppm vinyl 
chloride.
    (6) The single-use respirators, equilibrated and stored as described 
in paragraphs (b)(2) and (b)(3) of this section, will be tested on an 
apparatus that allows a test atmosphere at 85 5 
percent relative humidity and 25 5 [deg]C to be 
cycled through the respirator by a breathing machine at a concentration 
of 10 ppm vinyl chloride monomer at the rate of 24 respirations per 
minute at a minute volume of 40 0.6 liters. Air 
exhaled through the respirator will be 35 2 [deg]C 
with 94 3 percent relative humidity.
    (7) The maximum allowable penetration after 144 minutes testing of 
respirators, according to paragraph (b)(6) of this section, shall not 
exceed 1 ppm vinyl chloride.



Sec. 84.254  Powered air-purifying respirators; requirements and tests.

    (a) Except for the tests prescribed in Sec. 84.207, the minimum 
requirements and performance tests for powered air-purifying respirators 
prescribed in subpart L of this part are applicable to vinyl chloride 
powered air-purifying respirators.
    (b) The following bench tests are applicable to cartridges designed 
for use with powered air-purifying respirators for entry into and escape 
from vinyl chloride atmospheres containing adequate oxygen to support 
life:
    (1) Four cartridges will be equilibrated at 25  [deg]C by passing 85 5 percent 
relative humidity air through them at 115 liters per minute for tight-
fitting facepieces and 170 liters per minute for loose-fitting hoods and 
helmets, for six hours.
    (2) The equilibrated cartridges will be resealed, kept in an upright 
position at room temperature and tested according to paragraph (b)(3) of 
this section within 18 hours.
    (3) The cartridges equilibrated and stored as described in 
paragraphs (b) (1) and (2) of this section will be tested on an 
apparatus that allows the test atmosphere at 85 5 
percent relative humidity and 25 5 [deg]C to enter 
the cartridge continuously at a concentration of 25 ppm vinyl chloride 
monomer at a total flow rate of 115 liters per minute for tight-fitting 
facepieces and 170 liters per minute for loose-fitting hoods and 
helmets.
    (4) The maximum allowable penetration after six hours of testing 
according to paragraph (b)(3) of this section shall not exceed 1 ppm 
vinyl chloride.



Sec. 84.255  Requirements for end-of-service-life indicator.

    (a) Each canister or cartridge submitted for testing and approval in 
accordance with Sec. Sec. 84.252, 84.253, and 84.254 shall be equipped 
with a canister or cartridge end-of-service-life indicator which shows a 
satisfactory indicator change or other obvious warning before 1 ppm 
vinyl chloride penetration occurs. The indicator shall show such change 
or afford such warning at 80 10 percent of the 
total service life to 1 ppm leakage, as determined by continuing each 
test described in Sec. Sec. 84.252(b), 84.253(b), and 84.254(b) until a 
1 ppm leakage of vinyl chloride occurs.
    (b) The applicant shall provide sufficient pretest data to verify 
the performance of the end-of-service-life indicator required in 
paragraph (a) of this section.



Sec. 84.256  Quality control requirements.

    (a) In addition to the construction and performance requirements 
specified in Sec. Sec. 84.251, 84.252, 84.253, 84.254, and 84.255, the 
quality control requirements in paragraphs (b), (c), and (d) of this 
section apply to approval of gas masks, chemical cartridge respirators, 
and powered air-purifying respirators for entry into and escape from 
vinyl chloride atmospheres containing adequate oxygen to support life.
    (b) The respirators submitted for approval as described in paragraph 
(a) of this section shall be accompanied by a complete quality control 
plan meeting the requirements of subpart E of this part.
    (c)(1) The applicant shall specify in the plan that a sufficient 
number of samples will be drawn from each bulk container of sorbent 
material and that where activated carbon is used, the following specific 
tests will be performed:
    (i) Apparent density;
    (ii) Iodine number;
    (iii) Moisture content;

[[Page 545]]

    (iv) Carbon tetrachloride number; and
    (v) Mesh size.
    (2) The tests in paragraph (c)(1) of this section shall be performed 
in a quantity necessary to assure continued satisfactory conformance of 
the canisters and cartridges to the requirements of this subpart.
    (d) Final performance quality control tests on the complete 
canisters and cartridges shall be accomplished using the bench tests and 
procedures prescribed in Sec. Sec. 84.252, 84.253, 84.254, and 84.255.



Sec. 84.257  Labeling requirements.

    (a) A warning shall be placed on the label of each gas mask, 
chemical-cartridge respirator, and powered air-purifying respirator, and 
on the label of each canister and cartridge, alerting the wearer to the 
need for a fitting test in accordance with the manufacturer's facepiece 
fitting instructions, providing service life information, providing 
specific instructions for disposal, and advising that the wearer may 
communicate to NIOSH any difficulties that may be experienced in the 
design and performance of any gas mask, chemical-cartridge respirator, 
or powered air-purifying respirator approved under the requirements of 
this subpart. The service lives of respirators meeting the test 
requirements of this subpart shall be specified as follows:

Chemical-cartridge respirator....................................1 hour.
Gas mask........................................................4 hours.
Powered air-purifying respirator................................4 hours.

    (b) Where the service life of a respirator is approved for more than 
four hours, the service life for which the respirator has been approved 
will be specified.



Sec. 84.258  Fees.

    The following fees shall be charged for the examination, inspection, 
and testing of complete assemblies and components of respirators 
described in Sec. Sec. 84.250 and 84.251:

Complete gas mask.................................................$1,100
Complete chemical-cartridge respirator.............................1,150
Complete powered air-purifying respirator..........................1,500
Canister or cartridge only...........................................750

Subparts O-JJ [Reserved]



  Subpart KK_Dust, Fume, and Mist; Pesticide; Paint Spray; Powered Air-

     Purifying High Efficiency Respirators and Combination Gas Masks



Sec. 84.1100  Scope and effective dates.

    The purpose of this subpart KK is to establish procedures and 
requirements for issuing extensions of approval of particulate 
respirators certified prior to July 10, 1995 under the provisions of 30 
CFR part 11 (See 30 CFR part 11 edition, as revised July 1, 1994.), new 
approvals and extensions of approval of particulate respirators for 
applications that are in NIOSH receipt on July 10, 1995, and approval of 
powered air-purifying respirators.
    (a) Air-purifying respirators with particulate filters approved 
under the provisions of this subpart after July 10, 1995 will have a 30 
CFR part 11 approval label.
    (b) Only changes or modifications of non-powered air-purifying 
respirators with particulate filters approved under the provisions of 
subparts I, K, L, or M of 30 CFR part 11 or paragraph (a) of this 
section and deemed necessary by NIOSH to ensure the health and safety of 
the wearer will be approved until July 10, 1998 and will have a 30 CFR 
part 11 approval label.
    (c) Only changes or modifications of powered air-purifying 
respirators with particulate filters approved under the provisions of 
subparts I, K, L, or M of 30 CFR part 11 or paragraph (a) of this 
section and deemed necessary by NIOSH to ensure the health and safety of 
the wearer will be approved under this subpart until July 10, 1998 and 
will have a 30 CFR part 11 label.
    (d) Approval of powered air-purifying respirators will be issued 
under this subpart. Particulate filters for powered air-purifying 
respirators approved under the provisions of this subpart shall be only 
high-efficiency (HEPA) as described in Sec. 84.1130(a)(4) and will 
carry a 42 CFR part 84 approval label. In addition, changes or 
modifications of powered HEPA air-purifying respirators approved under 
the provisions of this subpart KK will be approved

[[Page 546]]

under this subpart and will have a 42 CFR part 84 approval label.



Sec. 84.1101  Definitions.

    As used in this subpart
    (a) Air Contamination Level means the standards of contaminant 
levels prescribed by the Secretary of Labor in accordance with the 
provisions of the Occupational Safety and Health Act of 1970 (Pub. L. 
91-596; 84 Stat. 1590).
    (b) DOP means a homogenous liquid aerosol, having a particle 
diameter of 0.3 micrometer, which is generated by vaporization and 
condensation of dioctyl phthalate.
    (c) Pesticide means:
    (1) Any substance or mixture of substances (including solvents and 
impurities) intended to prevent, destroy, repel, or mitigate any insect, 
rodent, nematode, fungus, weed, or other form of plant or animal life or 
virus; and
    (2) Any substance or mixture of substances (including solvents and 
impurities) intended for use as a plant regulator, defoliant, or 
desiccant, as defined in the Federal Insecticide, Fungicide, and 
Rodenticide Act of 1947, as amended (7 U.S.C. 135-135k), excluding 
fumigants which are applied as gases or vapors or in a solid or liquid 
form as pellets or poured liquids for subsequent release as gases or 
vapors.
    (d) Radionuclide means an atom identified by the constitution of its 
nucleus (specified by the number of protons Z, number of neutrons N, and 
energy, or, alternatively, by the atomic number Z, mass number A=(N+Z), 
and atomic mass) which exists for a measurable time; decays or 
disintegrates spontaneously, emits radiation, and results in the 
formation of new nuclides.
    (e) Smoke means the products of incomplete combustion of organic 
substances in the form of solid and liquid particles and gaseous 
products in air, usually of sufficient concentration to perceptibility 
obscure vision.



Sec. 84.1102  Examination, inspection and testing of complete respirator 

assemblies; fees.

    The following fees shall be charged by the Institute for the 
examination, inspection and testing of complete respirator assemblies 
approved under this subpart:
    (a) Gas masks with particulate filter, including pesticide gas 
masks--
    (1) Single hazard--$1,100.
    (2) Type N--$4,100.
    (b) Dust, fume and mist respirators--
    (1) Single particulate hazard having an Air Contamination Level more 
than 0.05 mg./m.\3\ or 2 million particles per cubic foot--$500.
    (2) Combination particulate hazards having an Air Contamination 
Level more than 0.05 mg./m.\3\ or 2 million particles per cubic foot--
$750.
    (3) Particulate hazards having an Air Contamination Level less than 
0.05 mg./m.\3\ or 2 million particles per cubic foot, radon daughters--
$1,250.
    (4) All dusts, fumes and mists--$2,000.
    (c) Paint spray respirators--$1,600.
    (d) Pesticide respirators--$1,600.
    (e) Chemical cartridge respirators with particulate filter--$1,150.



Sec. 84.1103  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 MSHA and the Institute for approval.
    (b) Approval labels for non-powered and powered air-purifying dust, 
fume, mist respirators approved prior to July 10, 1995 under the 
provisions of subpart K of 30 CFR part 11 (See 30 CFR Part 11 edition, 
revised as of July 1, 1994.) shall bear the emblem of the Mine Safety 
and Health Administration and the seal of the Department of Health and 
Human Services, the applicant's name and address, an approval number 
assigned by the Institute, a statement that the respirator was tested 
and approved under subpart K of 30 CFR part 11 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) Approval labels for powered air-purifying respirators approved 
under the provisions of this subpart shall

[[Page 547]]

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, a statement stating the respirator was tested under the 
provisions of this subpart, 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
------------------------------------------------------------------------
Gas mask with a particulate     Entire...........  Mask and container.
 filter, including pesticide
 gas mask.
Dust, fume, and mist            Entire...........  Respirator container
 respirators.                                       and filter
                                                    container.
                                Abbreviated......  Filters.
Chemical-cartridge respirator   Entire...........  Respirator container,
 with a particulate filter,                         cartridge container,
 including paint spray                              and filter
 respirator.                                        containers (where
                                                    applicable).
                                Abbreviated......  Cartridges and
                                                    filters and filter
                                                    containers.
Pesticide respirator..........  Entire...........  Respirator container,
                                                    and cartridge and
                                                    filter containers.
                                Abbreviated......  Cartridges and
                                                    filters.
------------------------------------------------------------------------

    (f) The use of any MSHA and 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.

    Editorial Note: At 60 FR 30388, June 8, 1995, Sec. 84.1103 was 
added with two paragraph (c) designations.



Sec. 84.1130  Respirators; description.

    (a) Dust, fume, and mist respirators, including all completely 
assembled respirators designed for use as respiratory protection during 
entry into and escape from atmospheres which contain adequate oxygen to 
support life and hazardous particulates, are described as follows:
    (1) Air-purifying respirators, either with replaceable or reusable 
filters, designed as respiratory protection against dusts:
    (i) Having an air contamination level not less than 0.05 milligram 
per cubic meter of air, including but not limited to coal, arsenic, 
cadmium, chromium, lead, and manganese; or
    (ii) Having an air contamination level not less than 2 million 
particles per cubic foot of air, including but not limited to aluminum, 
flour, iron ore, and free silica, resulting principally from the 
disintegration of a solid, e.g., dust clouds produced in mining, 
quarrying, and tunneling, and in dusts produced during industrial 
operations, such as grinding, crushing, and the general processing of 
minerals and other materials.
    (2) Air-purifying respirators, with replaceable filters, designed as 
respiratory protection against fumes of various metals having an air 
contamination level not less than 0.05 milligram per cubic meter, 
including but not limited to aluminum, antimony, arsenic, cadmium, 
chromium, copper,

[[Page 548]]

iron, lead, magnesium, manganese, mercury (except mercury vapor), and 
zinc, which result from the sublimation or condensation of their 
respective vapors, or from the chemical reaction between their 
respective vapors and gases.
    (3) Air-purifying respirators, with replaceable filters, designed as 
respiratory protection against mists of materials having an air 
contamination level not less than 0.05 milligram per cubic meter or 2 
million particles per cubic foot, e.g., mists produced by spray coating 
with vitreous enamels, chromic acid mist produced during chromium 
plating, and other mists of materials whose liquid vehicle does not 
produce harmful gases or vapors.
    (4) Air-purifying respirators, with replaceable filters, designed as 
respiratory protection against dusts, fumes, and mists having an air 
contamination level less than 0.05 milligram per cubic meter, including 
but not limited to lithium hydride and beryllium, and against 
radionuclides.
    (5) Air-purifying respirators, with replaceable filters, designed as 
respiratory protection against radon daughters, and radon daughters 
attached to dusts, fumes, and mists.
    (6) Air-purifying respirators, with replaceable filters, designed as 
respiratory protection against asbestos-containing dusts and mists.
    (7) Air-purifying respirators, with replaceable filters, designed as 
protection against various combinations of particulate matter.
    (8) Air-purifying dust respirators designed as respiratory 
protection against pneumoconiosis- and fibrosis-producing dusts, or 
dusts and mists, including but not limited to aluminum, asbestos, coal, 
flour, iron ore, and free silica.
    (b) Gas masks containing filters for protection against dusts, 
fumes, mists, and smokes in combination with gases, vapors, or gases and 
vapors. These respirators are not for use against gases or vapors with 
poor warning properties (except where MSHA or Occupational Safety and 
Health Administration standards may permit such use for a specific gas 
or vapor) or those which generate high heats of reaction with sorbent 
material in the canister.
    (c) Pesticide respirators, including all completely assembled 
respirators which are designed for use as respiratory protection during 
entry into and escape from atmospheres which contain pesticide hazards, 
are described according to their construction as follows:
    (1) Front-mounted or back-mounted gas masks;
    (2) Chin-style gas mask;
    (3) Chemical cartridge;
    (4) Air-purifying respirator with attached blower; and,
    (5) Other devices, including combination respirators.
    (d) Respirators with cartridges containing or having attached to 
them, filters for protection against mists of paints, lacquers, and 
enamels. These respirators are not for use against gases or vapors with 
poor warning properties (except where MSHA or Occupational Safety and 
Health Administration standards may permit such use for a specific gas 
or vapor) or those which generate high heats of reaction with sorbent 
material in the cartridge.
    (e) Respirators with cartridges containing or having attached to 
them filters for protection against dusts, fumes, and mists, except the 
mists of paints, lacquers, and enamels. These respirators are not for 
use against gases or vapors with poor warning properties (except where 
MSHA or Occupational Safety and Health Administration standards may 
permit such use for a specific gas or vapor) or those which generate 
high heats of reaction with sorbent material in the cartridge.



Sec. 84.1131  Respirators; required components.

    (a) Each respirator described in Sec. 84.1130 shall, where its 
design requires, contain the following component parts:
    (1) Facepiece, mouthpiece with noseclip, hood, or helmet;
    (2) Filter unit, canister with filter, or cartridge with filter;
    (3) Harness;
    (4) Attached blower; and
    (5) Breathing tube.
    (b) The components of each respirator shall meet the minimum 
construction requirements set forth in Subpart G of this part.

[[Page 549]]



Sec. 84.1132  Breathing tubes; minimum requirements.

    (a) Flexible breathing tubes used in conjunction with respirators 
shall be designed and constructed to prevent:
    (1) Restriction of free head movement;
    (2) Disturbance of the fit of facepieces, mouthpieces, hoods, or 
helmets;
    (3) Interference with the wearer's activities; and
    (4) Shutoff of airflow due to kinking, or from chin or arm pressure.



Sec. 84.1133  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. 84.1134  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. Except for dust, fume, 
and mist respirators, the commercial designation of the respirator it 
contains shall be shown.
    (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.
    (c) Containers for gas masks combinations shall be designed and 
constructed to permit easy removal of the mask.



Sec. 84.1135  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, as determined by the 
Institute's facepiece tests in Sec. Sec. 84.1141, 84.1142, and 
84.1156(b).



Sec. 84.1136  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 eyepieces.
    (b) All eyepieces of gas masks combinations 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.

[[Page 550]]



Sec. 84.1137  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, cartridges, and canisters, except where filters of 
dust, fume, and mist respirators are specifically designed to resist 
moisture as prescribed in Sec. 84.1145.
    (c) Exhalation valves shall be:
    (1) Provided where necessary;
    (2) Protected against damage and external influence; and
    (3) Designed and constructed to prevent inward leakage of 
contaminated air.



Sec. 84.1138  Head harnesses; minimum requirements.

    (a) All facepieces shall be equipped with 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) Facepiece head harnesses, except those employed on single-use 
dust, fume, and mist respirators, shall be adjustable and replaceable.
    (c) Mouthpieces shall be equipped, where applicable, with adjustable 
and replaceable harnesses, designed and constructed to hold the 
mouthpiece in place.



Sec. 84.1139  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 and shall not exceed 80 
dBA.



Sec. 84.1140  Dust, fume, and mist respirators; performance requirements; 

general.

    Dust, fume, and mist respirators and the individual components of 
each such device shall, as appropriate, meet the requirements for 
performance and protection specified in the tests described in 
Sec. Sec. 84.1141 through 84.1152 and prescribed in Tables 12 and 13.



Sec. 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.

    (a) The respirator will be modified in such a manner that all of the 
air that normally would be inhaled through the inhalation port(s) is 
drawn through an efficient activated charcoal-filled canister, or 
cartridge(s), without interference with the face-contacting portion of 
the facepiece.
    (b) The modified respirator will be worn by persons for at least 2 
minutes each in a test chamber containing 100 parts (by volume) of 
isoamyl-acetate vapor per million parts of air.
    (c) The odor of isoamyl-acetate shall not be detected by the wearers 
of the modified respirator while in the test atmosphere.



Sec. 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.

    (a) The applicant shall provide a charcoal-filled canister or 
cartridge of a size and resistance similar to the filter unit with 
connectors which can be attached to the facepiece in the same manner as 
the filter unit.
    (b)(1) The canister or cartridge will be used in place of the filter 
unit, and persons will each wear a modified half-mask facepiece for 5 
minutes in a test chamber containing 100 parts (by volume) of isoamyl-
acetate vapor per million parts of air.
    (2) The following work schedule will be performed by each wearer in 
the test chamber:
    (i) Two minutes walking, nodding, and shaking head in normal 
movements; and
    (ii) Three minutes exercising and running in place.
    (3) The facepiece shall be capable of adjustment, according to the 
applicant's instructions, to each wearer's face, and the odor of 
isoamyl-acetate

[[Page 551]]

shall not be detectable by any wearer during the test.
    (c) Where the respirator is equipped with a full facepiece, hood, 
helmet, or mouthpiece, the canister or cartridge will be used in place 
of the filter unit, and persons will each wear the modified respiratory-
inlet covering for 5 minutes in a test chamber containing 1,000 parts 
(by volume) of isoamyl-acetate vapor per million parts of air, 
performing the work schedule specified in paragraph (b)(2) of this 
section.



Sec. 84.1143  Dust, fume, and mist air-purifying filter tests; performance 

requirements; general.

    Dust, fume, and mist respirators will be tested in accordance with 
the schedule set forth in Table 13 of this subpart to determine their 
effectiveness as protection against the particulate hazards specified in 
Table 13.



Sec. 84.1144  Silica dust test for dust, fume, and mist respirators; single-

use or reusable filters; minimum requirements.

    (a) Three non-powered respirators with single-use filters will be 
tested for periods of 90 minutes each at a continuous airflow rate of 32 
liters per minute.
    (b) The relative humidity in the test chamber will be 20-80 percent, 
and the room temperature approximately 25[deg] C.
    (c) The test suspension in the chamber will not be less than 50 nor 
more than 60 milligrams of flint (99+ percent free silica) per cubic 
meter of air.
    (d) The flint in suspension will be ground to pass 99+ percent 
through a 270-mesh sieve.
    (e) The particle-size distribution of the test suspension will have 
a geometric mean of 0.4 to 0.6 micrometer, and the standard geometric 
deviation will not exceed 2.
    (f) The total amount of unretained test suspension in samples taken 
during testing shall not exceed 1.5 milligrams for a non-powered air-
purifying respirator.
    (g) Three non-powered respirators with reusable filters will be 
tested and shall meet the requirements specified in paragraphs (a) 
through (f) of this section; each filter shall be tested three times: 
Once as received; once after cleaning; and once after recleaning. The 
applicant's instructions shall be followed for each cleaning.



Sec. 84.1145  Silica dust test; non-powered single-use dust respirators; 

minimum requirements.

    (a) Three respirators will be tested.
    (b) As described in Sec. 84.1144, airflow will be cycled through 
the respirator by a breathing machine at the rate of 24 respirations per 
minute with a minute volume of 40 liters; a breathing machine cam with a 
work rate of 622 kg.-m.2/minute shall be used.
    (c) Air exhaled through the respirator will be 35[deg] 2[deg] C. with 94 3 percent 
relative humidity. 
    (d) Air inhaled through the respirator will be sampled and analyzed 
for respirator leakage.
    (e) The total amount of unretained test suspension, after drying, in 
samples taken during testing, shall not exceed 1.8 milligrams for any 
single test.



Sec. 84.1146  Lead fume test for dust, fume, and mist respirators; minimum 

requirements.

    (a) Three non-powered respirators will be tested for a period of 312 
minutes each at a continuous airflow rate of 32 liters per minute.
    (b) The relative humidity in the test chamber will be 20-80 percent, 
and the room temperature approximately 25[deg] C.
    (c) The test suspension in the test chamber will not be less than 15 
nor more than 20 milligrams of freshly generated lead-oxide fume, 
calculated as lead (Pb), per cubic meter of air.
    (d) The fume will be generated by impinging an oxygen-gas flame on 
molten lead.
    (e) Samples of the test suspension will be taken during each test 
period for analysis.
    (f) The total amount of unretained test suspension in the samples 
taken during testing, which is analyzed and calculated as lead (Pb), 
shall not exceed 1.5 milligrams of lead for a non-powered air-purifying 
respirator.



Sec. 84.1147  Silica mist test for dust, fume, and mist respirators; minimum 

requirements.

    (a) Three non-powered respirators will be tested for a period of 312 
minutes each at a continuous airflow rate of 32 liters per minute.

[[Page 552]]

    (b) The room temperature in the test chamber will be approximately 
25[deg]C.
    (c) The test suspension in the test chamber will not be less than 20 
nor more than 25 milligrams of silica mist, weighed as silica dust, per 
cubic meter of air.
    (d) Mist will be produced by spraying an aqueous suspension of flint 
(99+ percent free silica), and the flint shall be ground to pass 99+ 
percent through a 270-mesh sieve.
    (e) Samples of the test suspension will be taken during each test 
period for analysis.
    (f) The total amount of silica mist unretained in the samples taken 
during testing, weighed as silica dust, shall not exceed 2.5 milligrams 
for a non-powered air-purifying respirator.



Sec. 84.1148  Tests for respirators designed for respiratory protection 

against more than one type of dispersoid; minimum requirements.

    Respirators designed as respiratory protection against more than one 
particulate hazard (dust, fume, or mist) shall comply with all the 
requirements of this part, with respect to each of the specific hazards 
involved.



Sec. 84.1149  Airflow resistance tests; all dust, fume, and mist respirators; 

minimum requirements.

    (a) Resistance to airflow will be measured in the facepiece, 
mouthpiece, hood, or helmet of a dust, fume, or mist respirator mounted 
on a test fixture with air flowing at a continuous rate of 85 liters per 
minute, both before and after each test conducted in accordance with 
Sec. Sec. 84.1144 through 84.1147.
    (b) The maximum allowable resistance requirements for dust, fume, 
and mist respirators are as follows:

                           Maximum Resistance
                        [mm. water-column height]
------------------------------------------------------------------------
                                     Initial       Final
        Type of respirator          inhalation   inhalation   Exhalation
------------------------------------------------------------------------
Pneumoconiosis- and fibrosis-               12           15           15
 producing dusts, or dusts and
 mists...........................
Dust, fume, and mist, with single-          30           50           20
 use filter......................
Dust, fume, and mist, with                  20           40           20
 reusable filter.................
Radon daughter...................           18       \1\ 25           15
Asbestos dust and mist...........           18           25           15
------------------------------------------------------------------------
\1\ Measured after silica dust test described in Sec.  84.1144.



Sec. 84.1150  Exhalation valve leakage test; minimum requirements.

    (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. 84.1151  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.

    (a) All single air-purifying respirator filter units will be tested 
in an atmosphere concentration of 100 micrograms of DOP per liter of air 
at continuous flow rates of 32 and 85 liters per minute for a period of 
5 to 10 seconds.
    (b) Where filters are to be used in pairs, the flow rates will be 16 
and 42.5 liters per minute, respectively, through each filter.
    (c) The filter will be mounted on a connector in the same manner as 
used on the respirator, and the total leakage for the connector and 
filter shall not exceed 0.03 percent of the ambient DOP concentration at 
either flow rate.



Sec. 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 cubic meter and against radionuclides; minimum 

requirements.

    (a) Three non-powered respirators will be tested in accordance with 
the

[[Page 553]]

provisions of Sec. 84.1144, or equivalent, and shall meet the minimum 
requirements of Sec. Sec. 84.1144 and 84.1149.
    (b) Three powered air-purifying respirators will be tested in 
accordance with the provisions of Sec. 84.1144 except they will be 
tested for a period of 4 hours each at a flowrate not less than 115 
liters per minute to tight-fitting facepieces, and not less than 170 
liters per minute to loose-fitting hoods and helmets. The total amount 
of unretained test suspension in samples taken during testing shall not 
exceed 14.4 milligrams for a powered air-purifying respirator with 
tight-fitting facepiece, and 21.3 milligrams for a powered air-purifying 
respirator with loose-fitting hood or helmet. They shall meet the 
minimum requirements of Sec. 84.1149.



Sec. 84.1153  Dust, fume, mist, and smoke tests; canister bench tests; gas 

masks canisters containing filters; minimum requirements.

    (a) Gas mask canisters containing filters for protection against 
dusts, fumes, mists, and smokes in combination with gases, vapors, or 
gases and vapors, will be tested as prescribed in Sec. 84.1140 except 
for the breathing resistance which will be in accordance with Sec. 
84.122.
    (b) Gas mask canisters designed for protection against smokes will 
be tested in an atmospheric concentration of 100 micrograms of dioctyl 
phthalate per liter of air at continuous flow rates of 32 liters per 
minute and 85 liters per minute for a period of 5 to 10 seconds, and the 
DOP leakage through the canister shall not exceed 0.03 percent of the 
test concentration.
    (c) Gas mask canisters containing filters for protection against 
dusts, fumes, mists, and smokes in combination with gases, vapors, or 
gases and vapors, will be tested as prescribed in Sec. 84.126.



Sec. 84.1154  Canister and cartridge requirements.

    (a) Where two or more canisters or cartridges are used in parallel, 
their resistance to airflow shall be essentially equal.
    (b) 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.



Sec. 84.1155  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 into 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 on the 
canister or cartridge.



Sec. 84.1156  Pesticide respirators; performance requirements; general.

    Pesticide respirators and the individual components of each such 
device shall, as appropriate, meet the following minimum requirements 
for performance and protection:
    (a) Breathing resistance test. (1) Airflow resistance will be 
measured in the facepiece, mouthpiece, hood, or helmet of a pesticide 
respirator mounted on a test fixture with air flowing at a continuous 
rate of 85 liters per minute, both before and after each test conducted 
in accordance with paragraphs (c) and (f) of this section.
    (2) The maximum allowable resistance requirements for pesticide 
respirators are as follows:

[[Page 554]]



                           Maximum Resistance
                        [mm. water-column height]
------------------------------------------------------------------------
                                          Inhalation
   Type of pesticide respirator   --------------------------  Exhalation
                                     Initial     Final \1\
------------------------------------------------------------------------
Front- or back-mounted gas mask..           70           85           20
Chin-style gas mask..............           65           80           20
Powered air-purifying \2\........       \2\ 50       \2\ 70           20
Chemical Cartridge...............           50           70           20
------------------------------------------------------------------------
\1\ Measured at end of the service life specified in Table 14 of this
  subpart.
\2\ Resistance of filter(s), cartridge(s), and breathing tube(s) only
  with blower not operating.

    (b) Facepiece test. (1) The complete pesticide respirator will be 
fitted to the faces of persons having varying facial shapes and sizes.
    (2) Where the applicant specifies a facepiece size or sizes for his 
respirator together with the approximate measurements of faces they are 
designed to fit, the Institute will provide test subjects to suit such 
facial measurements.
    (3) Any pesticide respirator part which must be removed to perform 
the facepiece fit test shall be replaceable without special tools and 
without disturbing facepiece fit.
    (4) The facepiece or mouthpiece fit test using positive or negative 
pressure recommended by the applicant and described in his instructions 
will be used during each test.
    (5)(i) Each wearer will enter a chamber containing 1,000 p.p.m. 
isoamyl-acetate vapor for a respirator equipped with a full facepiece, 
mouthpiece, hood, or helmet and 100 p.p.m. isoamyl-acetate vapor for a 
respirator equipped with a half-mask facepiece.
    (ii) The facepiece, mouthpiece, hood, or helmet may be adjusted, if 
necessary, in the test chamber before starting the test.
    (iii) Each wearer will remain in the chamber while performing the 
following activities:
    (A) Two minutes, nodding and turning head;
    (B) Two minutes, calisthenic arm movements;
    (C) Two minutes, running in place; and
    (D) Two minutes, pumping with a tire pump into a 28-liter (1 cubic 
foot) container.
    (iv) Each wearer shall not detect the odor of isoamyl-acetate during 
the test.
    (c) Silica dust test. Three completely assembled pesticide 
respirators will be tested with a mechanical-testing apparatus as 
follows:
    (1) Temperature in the test chamber will be approximately 25[deg] C.
    (2) Continuous airflow through the respirator will be 32 liters per 
minute for front-mounted, back-mounted, and chin-style gas mask 
pesticide respirators and chemical cartridge pesticide respirators, and 
not less than 115 (4 cubic feet) liters per minute to tight-fitting 
facepieces and 170 liters (6 cubic feet) per minute to loose-fitting 
hoods and helmets of powered air-purifying respirators.
    (3) The test aerosol will contain 50-60 milligrams of 99+ percent 
free silica per cubic meter of air.
    (4) The particle size distribution of the test suspension will have 
a geometric mean diameter of 0.4 to 0.6 micrometer, with a standard 
geometric deviation less than 2.
    (5) Front-mounted, back-mounted, and chin-style gas mask pesticide 
respirators and chemical cartridge pesticide respirators will be tested 
for 90 minutes and powered air-purifying respirators will be tested for 
4 hours.
    (d) Lead fume test. Three completely assembled pesticide respirators 
will be tested with a mechanical-testing apparatus as follows:
    (1) Continuous airflow through the respirator will be 32 liters per 
minute for front-mounted, back-mounted, and chin-style gas mask 
pesticide respirators and chemical cartridge pesticide respirators and 
not less than 115 liters (4 cubic feet) per minute, for powered air-
purifying respirators with tight-fitting facepieces, and not less than 
170 liters (6 cubic feet) per minute for powered air-purifying 
respirators with loose-fitting hoods and helmets.

[[Page 555]]

    (2) The test aerosol will contain 15-20 milligrams of freshly 
generated lead-oxide fume, calculated as lead, per cubic meter of air.
    (3) The fume will be generated by impinging an oxygen-gas flame on 
molten lead.
    (4) Front-mounted, back-mounted, and chin-style gas mask pesticide 
respirators and chemical cartridge pesticide respirators will be tested 
for 90 minutes and powered air-purifying pesticide respirators will be 
tested for 4 hours.
    (5) The total amount of unretained test suspension, which is 
analyzed and calculated as lead, shall not exceed:
    (i) 0.43 milligram for any 90-minute test;
    (ii) 4.8 milligrams for any 4-hour test made at 115 liters (4 cubic 
feet) per minute; or
    (iii) 6.2 milligrams for any 4-hour test made at 170 liters (6 cubic 
feet) per minute.
    (e) Dioctyl-phthalate test. (1) All canisters submitted for use with 
front-mounted and back-mounted gas mask pesticide respirators will be 
tested in an atmospheric concentration of 100 micrograms of dioctyl-
phthalate per liter of air at continuous flow rates of 32 and 85 liters 
per minute for a test period of 5 to 10 seconds.
    (2) The DOP leakage through the canister shall not exceed 0.03 
percent of the ambient DOP concentration.
    (f) Bench tests for pesticide respirators. (1)(i) Bench tests will 
be made on an apparatus that allows the test atmosphere at 50 5 percent relative humidity and at room temperature 
(25[deg]2.5[deg] C.) to enter the canister or 
cartridge at predetermined concentrations and rates of flow, and that 
has a means for determining the test life of the canister or cartridge 
against carbon tetrachloride.
    (ii) Canisters and cartridges will be tested as they are used on 
each pesticide respirator, either singly or in pairs.
    (iii) Three canisters or cartridges or pairs of cartridges will be 
removed from containers and tested as received from the applicant.
    (iv) Two canisters, cartridges, or pairs of cartridges will be 
equilibrated at room temperature by passing 25 percent relative humidity 
air through them at the following flow rates (expressed as liters per 
minute (l.p.m.)) for 6 hours:

------------------------------------------------------------------------
                                                                Airflow
                Type of canister or cartridge                    rate,
                                                                 l.p.m.
------------------------------------------------------------------------
Air-purifying canister.......................................         64
Air-purifying cartridge......................................         25
Powered air-purifying with tight-fitting facepiece...........        115
Powered air-purifying with loose-fitting hood or helmet......        170
------------------------------------------------------------------------

    (v) Two canisters, cartridges, or pairs of cartridges will be 
equilibrated at room temperature by passing 85 percent relative humidity 
air through them at the flow rates stated in paragraph (f)(1)(iv) of 
this section for 6 hours.
    (vi) The equilibrated canisters or cartridges will be resealed, kept 
in an upright position at room temperature, and tested within 18 hours.
    (2) Canisters and cartridges tested in accordance with the 
provisions of this section shall meet the requirements specified in 
Table 14 of this subpart.



Sec. 84.1157  Chemical cartridge respirators with particulate filters; 

performance requirements; general.

    Chemical cartridge respirators with particulate filters and the 
individual components of each such device shall, as appropriate, meet 
the following minimum requirements for performance and protection:
    (a) Breathing resistance test. (1) Resistance to airflow will be 
measured in the facepiece, mouthpiece, hood, or helmet of a chemical 
cartridge respirator mounted on a test fixture with air flowing at a 
continuous rate of 85 liters per minute, both before and after each test 
conducted in accordance with paragraphs (d) through (f) of this section.
    (2) The maximum allowable resistance requirements for chemical 
cartridge respirators are as follows:

[[Page 556]]



                           Maximum Resistance
                        [mm. water-column height]
------------------------------------------------------------------------
                                          Inhalation
    Type of chemical cartridge    --------------------------  Exhalation
            respirator               Initial     Final \1\
------------------------------------------------------------------------
For gases, vapors, or gases and             50           70           20
 vapors, and dusts, fumes, and
 mists...........................
For gases, vapors, or gases and             50           70           20
 vapors, and mists of paints,
 lacquers, and enamels...........
------------------------------------------------------------------------
\1\ Measured at end of service life specified in Table 11 in subpart L
  of this part.

    (b) Facepiece test. The facepiece test will be conducted as 
specified in Sec. 84.205.
    (c) Lacquer and enamel mist tests; general. (1) Three respirators 
with cartridges containing or having attached to them, filters for 
protection against mists of paints, lacquers, and enamels shall be 
tested in accordance with the provisions of paragraph (f) of this 
section.
    (2) In addition to the test requirements set forth in paragraph 
(c)(1) of this section, three such respirators will be tested against 
each aerosol in accordance with the provisions of paragraphs (d) and (e) 
of this section.
    (d) Lacquer mist test. (1) Temperature in the test chamber will be 
approximately 25[deg] C.
    (2) Continuous airflow through the respirator will be 32 liters per 
minute for air-purifying respirators, and not less than 115 liters per 
minute to tight fitting facepieces and 170 liters per minute to loose-
fitting hoods and helmets of powered air-purifying respirators.
    (3) Airflow through the chamber will be 20-25 air changes per 
minute.
    (4) The atomizer employed will be a No. 64-5 nozzle with setup 3, or 
equivalent, operating at 69 kN/m.\2\ (10 pounds per square inch gage).
    (5) The test aerosol will be prepared by atomizing a mixture of one 
volume of clear cellulose nitrate lacquer and one volume of lacquer 
thinner. The lacquer described in Federal Specification TT-L-31, October 
7, 1953, is an example of an acceptable lacquer. Copies of TT-L-31 may 
be inspected or obtained from the NIOSH, Certification and Quality 
Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888.
    (6) The concentration of cellulose nitrate in the test aerosol will 
be 95-125 milligrams per cubic meter.
    (7) The test aerosol will be drawn to each respirator for a total of 
156 minutes for air-purifying respirators and 240 minutes for powered 
air-purifying respirators.
    (8) The total amount of unretained mist in the samples taken during 
testing, weighed as cellulose nitrate, shall not exceed 5 milligrams for 
an air-purifying respirator, 28 milligrams for a powered air-purifying 
respirator with tight-fitting facepiece, and 41 milligrams for a powered 
air-purifying respirator with loose-fitting hood or helmet.
    (e) Enamel mist test. (1) Temperature in the test chamber will be 
approximately 25[deg] C.
    (2) Continuous airflow through the respirator will be 32 liters per 
minute for air-purifying respirators, and not less than 115 liters per 
minute to tight-fitting facepieces and 170 liters per minute to loose-
fitting hoods and helmets of powered air-purifying respirators.
    (3) Airflow through the chamber will be 20-25 air changes per 
minute.
    (4) The atomizer employed will be a No. 64 nozzle with setup 1A, or 
equivalent, operating at 69 kN/m.\2\ (10 pounds per square inch gage).
    (5) The test aerosol will be prepared by atomizing a mixture of 1 
volume of white enamel and 1 volume of turpentine. The enamel described 
in Federal Specification TT-E-489b, May 12, 1953, with amendment-1 of 9 
November 1955 is an example of an acceptable enamel. Copies of TT-E-489b 
may be inspected or obtained from the NIOSH, Certification and Quality 
Assurance Branch, 1095 Willowdale Road, Morgantown, WV 26505-2888.
    (6) The concentration of pigment in the test aerosol, weighed as 
ash, will be 95-125 milligrams per cubic meter.

[[Page 557]]

    (7) The test aerosol will be drawn to each respirator for a total of 
156 minutes for air-purifying respirators and 240 minutes for power air-
purifying respirators.
    (8) The total amount of unretained mist in the samples taken during 
testing, weighed as ash, shall not exceed 1.5 milligrams for any air-
purifying respirator, 8.3 milligrams for a powered air-purifying 
respirator with tight-fitting facepiece, and 12.3 milligrams for a 
powered air-purifying respirator with loose-fitting hood or helmet.
    (f) Bench tests; gas and vapor tests. (1) Bench tests will be made 
in accordance with Sec. 84.207 and tested cartridges shall meet the 
minimum requirements set forth in Table 11 of subpart L of this part. 
Cartridges will be equilibrated in accordance with paragraph (f)(2) of 
this section.
    (2)(i) Two powered air-purifying cartridges or pairs of cartridges 
will be equilibrated at room temperature by passing 25 percent relative 
humidity air through them at the following flow rates (expressed in 
liters per minute (l.p.m.)) for 6 hours:

------------------------------------------------------------------------
                                                                Airflow
                      Type of cartridge                          rate,
                                                                 l.p.m.
------------------------------------------------------------------------
Powered air purifying with tight-fitting facepiece...........        115
Powered air purifying with loose-fitting hood or helmet......        170
------------------------------------------------------------------------

    (ii) Two powered air-purifying cartridges or pairs of cartridges 
will be equilibrated by passing 85 percent relative humidity air through 
them at the flow rates stated in paragraph (f)(2)(i) of this section.
    (iii) All cartridges will be resealed, kept in an upright position, 
at room temperatures, and tested within 18 hours.



Sec. 84.1158  Dust, fume, and mist tests; respirators with filters; minimum 

requirements; general.

    (a) Three respirators with cartridges containing, or having attached 
to them, filters for protection against dusts, fumes, and mists, except 
the mists of paints, lacquers, and enamels, will be tested in accordance 
with the provisions of Sec. 84.1157(f).
    (b) In addition to the test requirements set forth in paragraph (a) 
of this section, three such respirators will be tested, as appropriate, 
in accordance with the provisions of Sec. Sec. 84.1141 through 84.1152; 
however, the maximum allowable resistance of complete dust, fume, and 
mist, and gas, vapor, or gas and vapor chemical cartridge respirators 
shall not exceed the maximum allowable limits set forth in Sec. 
84.1157(a)(2).



                  Sec. Tables to Subpart KK of Part 84

                  Table 12--Facepiece Test Requirements
                      [42 CFR Part 84, Subpart KK]
------------------------------------------------------------------------
                                  Pressure       Isoamyl acetate test
       Respirator types           tightness  ---------------------------
                                  test \1\       84.1141       84.1142
------------------------------------------------------------------------
Dusts: Air Contamination Level            X
 not less than 0.05 mg/M\3\ or
 2 mppcf......................
Fumes: Air Contamination Level            X             X
 not less than 0.05 mg/M\3\...
Mists: Air Contamination Level            X
 not less than 0.05 mg/M\3\ or
 2 mppcf......................
Dusts, Fumes, and Mists: Air              X   ............            X
 Contamination Level less than
 0.05 mg/M\3\ or 2 mppcf, and
 radionuclides................
Radon daughters...............            X             X
Asbestos-containing dusts and             X
 mists........................
------------------------------------------------------------------------
\1\ Test is required only where applicable.


[[Page 558]]


         Table 13--Air-Purifying and Powered Air-Purifying Respirator Filter Tests Required for Approval
                                          [42 CFR Part 84, Subpart KK]
----------------------------------------------------------------------------------------------------------------
                                          Silica dust tests
      Respirator types       ------------------------------------------   Lead fume    Silica mist    DOP test
                                 84.1144       84.1145       84.1152    test 84.1146  test 84.1147     84.1151
----------------------------------------------------------------------------------------------------------------
Dusts: Air Contamination                X
 Level not less than 0.05 mg/
 M\3\ or 2 mppcf............
Fumes: Air Contamination      ............  ............  ............            X
 Level not less than 0.05 mg/
 M\3\.......................
Mists: Air Contamination      ............  ............  ............  ............            X
 Level not less than 0.05 mg/
 M\3\ or 2 mppcf............
Dusts, Fumes, and Mists: Air  ............  ............            X   ............  ............            X
 Contamination Level less
 than 0.05 mg/M\3\ or 2
 mppcf, and radionuclides...
Radon daughters.............        \1\ X   ............  ............  ............        \2\ X
Asbestos-containing dusts           \2\ X   ............  ............  ............        \3\ X
 and mists..................
Single use dust and mist      ............        \3\ X   ............  ............        \3\ X
 respirators................
----------------------------------------------------------------------------------------------------------------
\1\ For resistance only.
\2\ For penetration only.
\3\ Test required only where applicable.


            Table 14--Carbon Tetrachloride Bench Tests and Requirements for Canisters and Cartridges
                                          [42 CFR part 84, Subpart KK]
----------------------------------------------------------------------------------------------------------------
                                                                 Test                                  Minimum
               Type of pesticide respirator                 concentration   Flow rate    Number of       life
                                                             p.p.m. CCl4      l.p.m.       tests      minutes\1\
----------------------------------------------------------------------------------------------------------------
Chest-mounted or back-mounted gas mask (as received)......        20,000            64            3           12
Chest-mounted or back-mounted gas mask (equilibrated).....        20,000            32            4           12
Chin-style gas mask (as received).........................         5,000            64            3           12
Chin-style gas mask (equilibrated)........................         5,000            32            4           12
Chemical Cartridge respirator (as received)...............         1,000            64            3           50
Chemical cartridge respirator (equilibrated)..............         1,000            32            4           50
Powered air-purifying respirator (tight-fitting facepiece,         1,000       \2\ 115            3           50
 as received).............................................
Powered air-purifying respirator (tight-fitting facepiece,         1,000       \2\ 115            4           25
 equilibrated)............................................
Powered air-purifying respirator (loose-fitting hood or            1,000       \3\ 170            3           50
 helmet, as received).....................................
Powered air-purifying respirator (loose-fitting hood or            1,000       \3\ 170            4           25
 helmet, equilibrated)....................................
----------------------------------------------------------------------------------------------------------------
\1\ Minimum life will be determined at 5 p.p.m. leakage.
\2\ The flow rate shall be the effective flow rate of the device, but shall be not less than 115 l.p.m.
\3\ The flow rate shall be the effective flow rate of the device, but shall be not less than 170 l.p.m.



PART 85_REQUESTS FOR HEALTH HAZARD EVALUATIONS--Table of Contents




Sec.
85.1 Applicability.
85.2 Definitions.
85.3 Procedures for requesting health hazard evaluations.
85.3-1 Contents of a request for health hazard evaluations.
85.4 Acting on requests.
85.5 Authority for investigations.
85.6 Advance notice of visits.
85.7 Conduct of investigations.
85.8 Provision of suitable space for employee interviews and 
          examinations; identification of employees.
85.9 Representatives of employers and employees; employee requests.
85.10 Imminent dangers.
85.11 Notification of determination to employers, affected employees, 
          and Department of Labor.
85.12 Subsequent requests for health hazard evaluations.

    Authority: Sec. 8(g), 84 Stat. 1600; 29 U.S.C. 657(g) and sec. 508, 
83 Stat. 803; 30 U.S.C. 957.

    Source: 37 FR 23640, Nov. 7, 1972, unless otherwise noted.



Sec. 85.1  Applicability.

    This part 85 applies to health hazard evaluations requested by any 
employer or authorized representative of employees under section 
20(a)(6) of the Occupational Safety and Health Act of 1970 or section 
501(a)(11) of the Federal Mine Safety and Health Act of 1977.

[[Page 559]]

This part is not intended to preclude the use of other channels of 
communication with the National Institute for Occupational Safety and 
Health to obtain information and technical assistance concerning toxic 
substances or physical agents.

[45 FR 2652, Jan. 14, 1980]



Sec. 85.2  Definitions.

    Any term defined in the Occupational Safety and Health Act of 1970 
or the Federal Mine Safety and Health Act of 1977 and not defined below 
shall have the meaning given it in the respective Acts. As used in this 
part:
    OSH Act means the Occupational Safety and Health Act of 1970 (29 
U.S.C. 651, et seq.).
    FMSH Act means the Federal Mine Safety and Health Act of 1977 (30 
U.S.C. 801, et seq.).
    Authorized representative of employees means any person or 
organization meeting the conditions specified in Sec. 85.3-1(e) (1), 
(2), or (3).
    Employee has the same meaning as stated in the OSH Act and for the 
purposes of this part includes miner as defined in the FMSH Act.
    Employer has the same meaning as stated in the OSH Act and for the 
purposes of this part includes Operator as defined in the FMSH Act.
    Health hazard evaluation means the investigation and the 
determination of potentially toxic or hazardous effects of: (a) Any 
substance normally used or found in any place of employment to which the 
OSH Act is applicable, or (b) any substance or physical agent normally 
used or found in any place of employment to which the FMSH Act is 
applicable.
    Investigation means a physical inspection of the place of employment 
under section 8 of the OSH Act or section 103 of the FMSH Act and 
includes inspection, sampling, observations, review of pertinent 
records, and other measurements reasonably necessary to determine 
whether any substance or physical agent found in the place of employment 
has potentially toxic or hazardous effects in the concentrations or 
levels used or found.
    NIOSH means the National Institute for Occupational Safety and 
Health, Center for Disease Control, Public Health Service, Department of 
Health and Human Services.
    NIOSH officer means a NIOSH employee who has been authorized by the 
Director, NIOSH, to conduct investigations according to this part.
    Physical agent means any condition produced by the environment and/
or work processes that can result in hazardous effects as defined in 
this section. Examples of physical agents are noise, temperature, 
illumination, vibration, radiation, and pressure.
    Place of employment means any coal or other mine, factory, plant, 
establishment, construction site, or other area, workplace, or 
environment where work is performed by any employee of an employer.
    Substance means any chemical or biological agent or dust which has 
the potential to produce toxic effects.
    Toxic effects or hazardous effects are those effects which result in 
short- or long-term disease, bodily injury, affect health adversely, or 
endanger human life.

[45 FR 2652, Jan. 14, 1980]



Sec. 85.3  Procedures for requesting health hazard evaluations.

    (a) Requests for health hazard evaluations should be addressed to 
the National Institute for Occupational Safety and Health as follows:
    (1) Requests from general industry. Hazard Evaluations and Technical 
Assistance Branch, Division of Surveillance, Hazard Evaluations, and 
Field Studies, NIOSH, 4676 Columbia Parkway, Cincinnati, OH 45226.
    (2) Requests from mining industry. Environmental Investigations 
Branch, Division of Respiratory Disease Studies, NIOSH, 944 Chestnut 
Ridge Road, Morgantown, WV 26505.
    (b) Requests for health hazard evaluations shall be submitted in 
writing and signed by either: (1) The employer in whose place of 
employment the substance or physical agent is normally found, or (2) an 
authorized representative of employees (see Sec. 85.3-1(e)) in the 
place of employment where the substance or physical agent is normally 
found.

[45 FR 2653, Jan. 14, 1980]

[[Page 560]]



Sec. 85.3-1  Contents of a request for health hazard evaluation.

    Each request for health hazard evaluation shall contain:
    (a) The requester's name, address, and telephone number, if any.
    (b) The name and address of the place of employment where the 
substance or physical agent is normally found.
    (c) The specific process or type of work which is the source of the 
substance or physical agent, or in which the substance or physical agent 
is used.
    (d) Details of the conditions or circumstances which prompted the 
request.
    (e) A statement, if the requester is not the employer, that the 
requester is:
    (1) An authorized representative or an officer of the organization 
representing the employees for purposes of collective bargaining; or
    (2) An employee of the employer and is authorized by two or more 
employees employed in the same place of employment to represent them for 
purposes of these Acts (each such authorization shall be in writing and 
a copy submitted with the request for health hazard evaluation); or
    (3) One of three or less employees employed in the place of 
employment where the substance or physical agent is normally found.
    (f) A statement indicating whether or not the name(s) of the 
requester or those persons who have authorized the requester to 
represent them may be revealed to the employer by NIOSH.
    (g) The following supplementary information if known to the 
requester:
    (1) Identity of each substance or physical agent involved;
    (2) The trade name, chemical name, and manufacturer of each 
substance involved;
    (3) Whether the substance or its container or the source of the 
physical agent has a warning label; and
    (4) The physical form of the substance or physical agent, number of 
people exposed, length of exposure (hours per day), and occupations of 
exposed employees.

    Note: NIOSH has developed two forms entitled ``Request for Health 
Hazard Evaluation'' and ``Request for Mining Health Hazard Evaluation'' 
to assist persons in requesting evaluations. The forms are available 
upon request from the offices listed in Sec. 85.3(a) (1) and (2) or 
from the Regional Consultant for Occupational Safety and Health in any 
Regional Office of the Department of Health and Human Services.

[45 FR 2653, Jan. 14, 1980]



Sec. 85.4  Acting on requests.

    (a) Upon receipt of a request for health hazard evaluation submitted 
under this part, NIOSH will determine whether or not there is reasonable 
cause to justify conducting an investigation.
    (b) If NIOSH determines that an investigation is justified, a NIOSH 
officer will inspect the place of employment, collect samples where 
appropriate, and perform tests necessary to the conduct of a health 
hazard evaluation, including medical examinations of employees.
    (c) If NIOSH determines that an investigation is not justified, the 
requester will be notified in writing of the decision.

[45 FR 2653, Jan. 14, 1980]



Sec. 85.5  Authority for investigations.

    (a) NIOSH officers who have been issued official NIOSH credentials 
(Form No. CDC/NIOSH 2.93) are authorized by the Director, NIOSH, under 
sections 20(a) (6) and 8 of the OSH Act and sections 501(a)(11) and 103 
of the FMSH Act: To enter without delay any place of employment for the 
purpose of conducting investigations of all pertinent processes, 
conditions, structures, machines, apparatus, devices, equipment, 
records, and materials within the place of employment; and to conduct 
medical examinations, anthropometric measurements, and functional tests 
of employees within the place of employment as may be directly related 
to the specific health hazard evaluation being conducted. Investigations 
will be conducted in a reasonable manner, during regular working hours 
or at other reasonable times and within reasonable limits. In connection 
with any investigation, the NIOSH officers may question privately any 
employer, owner, operator, agent, or employee from the place of 
employment; and review, abstract, and duplicate records required by the 
Acts and regulations and any other related records.

[[Page 561]]

    (b) Areas under investigation which contain information classified 
by any agency of the United States Government in the interest of 
national security will be investigated only by NIOSH officers who have 
obtained the proper security clearance and authorization.

[45 FR 2653, Jan. 14, 1980]



Sec. 85.6  Advance notice of visits.

    (a) Advance notice of visits to the place of employment may be given 
to expedite a thorough and effective investigation. Advance notice will 
not be given when, in the judgment of the NIOSH officer, giving such 
notice would adversely affect the validity and effectiveness of the 
investigation.
    (b) Where a request in accordance with this part has been made by an 
authorized representative of employees, advance notice in accordance 
with paragraph (a) of this section will be given by NIOSH to the 
requester, the representative of the employees for purposes of 
collective bargaining if such representative is other than the 
requester, and to the employer.
    (c) Where a request in accordance with this part has been made by 
any employer, advance notice will be given by NIOSH to the employer. 
Upon the request of the employer, NIOSH will inform the authorized 
representative of employees of the visit: Provided, The employer 
furnishes NIOSH in writing with the identity of such representative and 
with such information as is necessary to enable NIOSH promptly to inform 
such representative of the visit.



Sec. 85.7  Conduct of investigations.

    (a) Prior to beginning an investigation, NIOSH officers shall 
present their credentials to the owner, operator, or agent in charge at 
the place of employment, explain the nature, purpose, and scope of the 
investigation and the records specified in Sec. 85.5 which they wish to 
review. Where the investigation is the result of a request submitted by 
an authorized representative of employees, a copy of the request shall 
be provided to the employer, except where the requester or any person 
authorizing the requester pursuant to Sec. 85.3-1(e)(2) has indicated 
that NIOSH not reveal his name to the employer, in which case a summary 
of the basis for the request shall be provided to the employer.
    (b) At the commencement of an investigation, the employer should 
precisely identify information which can be obtained in the workplace or 
workplaces to be inspected as trade secrets. If the NIOSH officer has no 
clear reason to question such identification, such information shall not 
be disclosed except in accordance with the provisions of section 
20(a)(6) and section 15 of the OSH Act or section 501(a)(11) of the FMSH 
Act. However, if NIOSH at any time questions such identification by an 
employer, not less than 15 days' notice to an employer shall be given of 
the intention to remove the trade secret designation from such 
information. The employer may within that period submit a request to the 
Director, NIOSH, to reconsider this intention and may provide additional 
information in support of the trade secret designation. The Director, 
NIOSH, shall notify the employer in writing of the decision which will 
become effective no sooner than 15 days after the date of such notice.
    (c) NIOSH officers are authorized to collect environmental samples 
and samples of substances or measurements of physical agents (including 
measurement of employee exposure by the attachment of personal sampling 
devices to employees with their consent), to take or obtain photographs 
related to the purpose of the investigation, employ other reasonable 
investigative techniques, including medical examinations of employees 
with the consent of such employees, and to question privately any 
employer, owner, operator, agent, or employee. The employer shall have 
the opportunity to review photographs taken or obtained for the purpose 
of identifying those which contain or might reveal a trade secret.
    (d) NIOSH officers shall comply with all safety and health rules and 
practices at the place of employment being investigated, and they shall 
provide and use appropriate protective clothing and equipment. In 
situations requiring specialized or unique types of protective 
equipment, such equipment shall be furnished by the employer.

[[Page 562]]

    (e) The conduct of investigations shall be such as to preclude 
unreasonable disruption of the operations of the employer's 
establishment.

[37 FR 23640, Nov. 7, 1972, as amended at 45 FR 2653, Jan. 14, 1980; 49 
FR 4739, Feb. 8, 1984]



Sec. 85.8  Provision of suitable space for employee interviews and 

examinations; identification of employees.

    An employer shall, in request of the NIOSH officer, provide suitable 
space, if such space is reasonably available, to NIOSH to conduct 
private interviews with, and examinations of, employees. NIOSH officers 
shall consult with the employer as to the time and place of the medical 
examination and shall schedule such examinations so as to avoid undue 
disruption of the operations of the employer's establishment. NIOSH 
shall conduct, and assume the medical costs of, examinations conducted 
under this part.



Sec. 85.9  Representatives of employers and employees; employee requests.

    (a) NIOSH officers shall be in charge of investigations. Where the 
request for a health hazard evaluation has been made by an authorized 
representative of employees, a representative of the employer and a 
representative authorized by his employees who is an employee of the 
employer shall be given an opportunity to accompany the NIOSH officer 
during the initial physical inspection of any workplace for the purpose 
of aiding the investigation by identifying the suspected hazard. The 
NIOSH officer may permit additional employer representatives and such 
additional representatives authorized by employees to accompany him 
where he determines that such additional representatives will further 
aid the investigation. However, if in the judgment of the NIOSH officer, 
good cause has been shown why accompaniment by a third party who is not 
an employee of the employer is reasonably necessary to the conduct of an 
effective and thorough investigation of the workplace, such third party 
may accompany the NIOSH officer during the inspection: Provided, 
however, That access by such persons to areas described in paragraph (d) 
of this section shall be in accordance with the requirements of such 
provision, and access to areas described in paragraph (e) of this 
section shall be with the consent of the employer. A different employer 
and employee representative may accompany the officer during each 
different phase of an inspection if this will not interfere with the 
conduct of the investigation.
    (b) NIOSH officers are authorized to resolve all disputes as to who 
is the representative authorized by the employer and employees for the 
purpose of this section. If there is no authorized representative of 
employees, or if the NIOSH officer is unable to determine with 
reasonable certainty who is such representative, he shall consult with a 
reasonable number of employees concerning matters directly related to 
the health hazard evaluation.
    (c) NIOSH officers are authorized to deny the right of accompaniment 
under this section to any person whose conduct interferes with a fair 
and orderly physical inspection.
    (d) With regard to information classified by an agency of the U.S. 
Government in the interest of national security, only persons authorized 
to have access to such information may accompany an officer in areas 
containing such information.
    (e) Upon request of an employer, any representative authorized under 
this Sec. 85.9 by employees in any area containing trade secrets shall 
be an employee in that area or an employee authorized by the employer to 
enter that area.



Sec. 85.10  Imminent dangers.

    Whenever, during the course of, or as a result of, an investigation 
under this part, the NIOSH officer believes that there is a reasonable 
basis for an allegation of an imminent danger, NIOSH will immediately 
advise the employer and those employees who appear to be in immediate 
danger of such allegation and will inform appropriate representatives of 
the Department of Labor or the State agency designated under section 
18(b) of the OSH Act.

[37 FR 23640, Nov. 7, 1972, as amended at 45 FR 2653, Jan. 14, 1980]

[[Page 563]]



Sec. 85.11  Notification of determination to employers, affected employees and 

Department of Labor.

    (a) Upon conclusion of an investigation, NIOSH will make a 
determination concerning the potentially toxic or hazardous effects of 
each substance or physical agent investigated as a result of the request 
for health hazard evaluation. At a minimum, the determination will: (1) 
Identify each substance or physical agent involved and describe, where 
appropriate, the concentrations or levels of the substance or physical 
agent found in the place of employment and the conditions of use, and 
(2) state whether each substance or physical agent has potentially toxic 
or hazardous effects in the concentrations or levels found, as well as 
the basis for the judgments.
    (b) Copies of the determination will be mailed to the employer and 
to the authorized representatives of employees.
    (c) Except as hereinafter provided, the employer shall post a copy 
of the determination for a period of 30 calendar days at or near the 
workplace(s) of affected employees. The employer shall take steps to 
insure that the posted determinations are not altered, defaced, or 
covered by other material during such period. The employer will not be 
required to post the determination if the employer requests that copies 
of the determination be mailed to affected employees and furnishes NIOSH 
with a list of the names and mailing addresses of the employees employed 
in the workplace(s) designated by the NIOSH Officer. In the latter 
event, NIOSH will mail such copies to affected employees at the mailing 
addresses provided by the employer.
    (d) For purposes of this section, the term ``affected employees'' 
means those employees determined by NIOSH to be exposed to the 
substance(s) or physical agent(s) which is the subject of the health 
hazard evaluation.
    (e) Copies of determinations made under the OSH Act will be 
forwarded to the Department of Labor and the appropriate State agency 
designated under section 18(b) of the OSH Act. Copies of determinations 
made under the FMSH Act will be forwarded to the Mine Safety and Health 
Administration of the Department of Labor; the Bureau of Mines, 
Department of the Interior; and the State agency which, in the judgment 
of NIOSH, would benefit the most from the information. If NIOSH 
determines that any substance or physical agent has potentially toxic or 
hazardous effects at the concentrations or levels at which it is used or 
found in a place of employment, and the substance or physical agent is 
not covered by a safety or health standard established under section 6 
of the OSH Act or section 101 of the FMSH Act, NIOSH will immediately 
submit the determination to the Secretary of Labor, together with all 
pertinent criteria.

[37 FR 23640, Nov. 7, 1972, as amended at 45 FR 2653, Jan. 14, 1980]



Sec. 85.12  Subsequent requests for health hazard evaluations.

    If a request is received for a health hazard evaluation in a place 
of employment in which an evaluation under this part was made 
previously, NIOSH may make another investigation if, as a result of the 
passage of time or additional information, another investigation would 
be consistent with the purposes of the Acts.

[45 FR 2654, Jan. 14, 1980]



PART 85a_OCCUPATIONAL SAFETY AND HEALTH INVESTIGATIONS OF PLACES OF 

EMPLOYMENT--Table of Contents




Sec.
85a.1 Applicability.
85a.2 Definitions.
85a.3 Authority for investigations of places of employment.
85a.4 Procedures for initiating investigations of places of employment.
85a.5 Conduct of investigations of places of employment.
85a.6 Provision of suitable space for employee interviews and 
          examinations.
85a.7 Imminent dangers.
85a.8 Reporting of results of investigations of places of employment.

    Authority: Sec. 8(g), 84 Stat. 1600; 29 U.S.C. 657(g) and sec. 508, 
83 Stat. 803; 30 U.S.C. 957.

[[Page 564]]



Sec. 85a.1  Applicability.

    (a) Except as otherwise provided in paragraph (b) of this section, 
the provisions of this part apply to investigations of places of 
employment which are conducted by NIOSH under sections 20 and 8 of the 
Occupational Safety and Health Act of 1970 and sections 501 and 103 of 
the Federal Mine Safety and Health Act of 1977.
    (b) The provisions of this part do not apply to those activities 
covered by part 85 of this chapter.

[41 FR 45002, Oct. 14, 1976, as amended at 45 FR 2654, Jan. 14, 1980]



Sec. 85a.2  Definitions.

    Any term defined in the Occupational Safety and Health Act of 1970 
or the Federal Mine Safety and Health Act of 1977 and not defined below 
shall have the meaning given it in the Acts. As used in this part:
    (a) OSH Act means the Occupational Safety and Health Act of 1970 (29 
U.S.C. 651 et seq.) and FMSH Act means the Federal Mine Safety and 
Health Act of 1977 (30 U.S.C. 801 et seq.).
    (b) Assistant Regional Director means any one of the ten 
Occupational Safety and Health Administration Assistant Regional 
Directors for Occupational Safety and Health.
    (c) Informed consent means the knowing consent of an individual or 
his legally authorized representative, so situated as to be able to 
exercise free power of choice without undue inducement or any element of 
force, fraud, deceit, duress, or other form of constraint or coercion. 
The basic elements of information necessary to such consent include:
    (1) A fair explanation of the procedures to be followed, and their 
purposes, including identification of any procedures which are 
experimental;
    (2) A description of any attendant discomforts and risks reasonably 
to be expected;
    (3) A description of any benefits reasonably to be expected;
    (4) A disclosure of any appropriate alternative procedures that 
might be advantageous for the subject;
    (5) An offer to answer any inquiries concerning the procedures; and
    (6) An instruction that the person is free to withdraw his consent 
and to discontinue participation in the investigation any time without 
prejudice to the subject.
    (d) Investigation means research projects, experiments, 
demonstrations, studies, and similar activities of NIOSH which are 
conducted under section 20 of the OSH Act and section 501 of the FMSH 
Act.
    (e) Legally authorized representative means an individual or 
judicial or other body authorized under applicable law to consent on 
behalf of a prospective subject to such subject's participation in the 
particular activity or procedure.
    (f) NIOSH means the National Institute for Occupational Safety and 
Health of the Center for Disease Control, Public Health Service, 
Department of Health and Human Services.
    (g) NIOSH authorized representative means a person authorized by 
NIOSH to conduct investigations of places of employment, including any 
person that is fulfilling a contract agreement with NIOSH or is serving 
as an expert or consultant to NIOSH pursuant to the Act.
    (h) NIOSH Regional Office means any one of the ten Department of 
Health and Human Services Regional Offices, the addresses of which are 
specified in Sec. 5.31 of title 45, Code of Federal Regulations.
    (i) Place of employment means any coal or other mine, factory, 
plant, establishment, construction site, or other area, workplace or 
environment where work is performed by any employee of an employer.
    (j) MSHA District Office means any one of the Mine Safety and Health 
Administration's District Offices.
    (k) BOM means the Bureau of Mines, Department of the Interior.
    (l) Employee has the same meaning as stated in the OSH Act and for 
the purposes of this part includes miner as defined in the FMSH Act.
    (m) Employer has the same meaning as stated in the OSH Act and for 
the purposes of this part includes operator as defined in the FMSH ACT.

[41 FR 45002, Oct. 14, 1976, as amended at 45 FR 2654, Jan. 14, 1980]

[[Page 565]]



Sec. 85a.3  Authority for investigations of places of employment.

    (a) NIOSH authorized representatives who have been issued official 
NIOSH credentials are authorized by the Director, NIOSH, under sections 
20 and 8 of the OSH Act, sections 501 and 103 of the FMSH Act, and this 
part. To enter without delay any place of employment for the purpose of 
conducting investigations of all pertinent processes, conditions, 
structures, machines, apparatus, devices, equipment, and materials 
within the place of employment; and to conduct medical examinations, 
anthropometric measurements and functional tests of employees within the 
place of employment as may be directly related to the specific 
investigation being conducted. Such investigations will be conducted in 
a reasonable manner, during regular working hours or at other reasonable 
times and within reasonable limits. In connection with any 
investigations, such NIOSH authorized representatives may question 
privately any employer, owner, operator, agent, or employee from the 
place of employment; and review, abstract, or duplicate employment 
records, medical records, records required by the Act and regulations, 
and other related records. In those instances where systems of records 
subject to review, abstraction or duplication are of a confidential 
nature, such as medical records, and are abstracted or duplicated, NIOSH 
will maintain such systems in accordance with the Privacy Act of 1974 (5 
U.S.C. 552a) and the implementing regulation of the Department of Health 
and Human Services (45 CFR part 5b).
    (b) Areas under investigation which contain information classified 
by any agency of the United States Government in the interest of 
national security will be investigated only by NIOSH authorized 
representatives who have obtained the appropriate security clearance and 
authorization.

[41 FR 45002, Oct. 14, 1976, as amended at 45 FR 2654, Jan. 14, 1980]



Sec. 85a.4  Procedures for initiating investigations of places of employment.

    (a) Except as otherwise provided in paragraph (b) of this section, 
NIOSH authorized representatives will contact an official representative 
of the place of employment prior to any site visits and will provide the 
details of why an investigation of the place of employment is being 
conducted. Prior to the initiation of a site visit of a place of 
employment, representatives of the following organizations will be 
advised of the site visit and the reason for its conduct:
    (1) The appropriate State agency designated under section 18(b) of 
the OSH Act, or if no State agency has been designated under the OSH Act 
and in the case of the FMSH Act, the State agency which, in the judgment 
of NIOSH, would benefit the most from the investigation's findings;
    (2) If there is a local union at the place of employment, the local 
president, business manager or other appropriate individual;
    (3) The appropriate Assistant Regional Director, when investigations 
are conducted under the OSH Act;
    (4) The appropriate MSHA District Office; the Director, BOM, and the 
Assistant Director for Mining, BOM, when investigations are conducted 
under the FMSH Act.
    (b) Advance notice of site visits will not be given to the place of 
employment or local union at the place of employment when, in the 
judgment of the NIOSH authorized representatives, giving such notice 
would adversely affect the validity and effectiveness of an 
investigation. Those individuals and organizations specified in Sec. 
85a.4(a)(1), (a)(3) and (a)(4) will be notified prior to the initiation 
of such a site visit. After the site visit has been initiated, and, as 
soon as possible thereafter, the NIOSH authorized representatives will 
contact those individuals specified in Sec. 85a.4(a)(2) concerning the 
nature and details of the site visit.
    (c) In those instances where site visits are not necessary to the 
conduct of an investigation, the NIOSH authorized representatives will 
contact an official representative of the place of employment either 
verbally or through a written communication and provide the details of 
why an investigation of the place of employment is being conducted. If 
appropriate, the NIOSH authorized representatives will contact

[[Page 566]]

those individuals stipulated in paragraphs (a)(1), (a)(2), (a)(3), and 
(a)(4) of this section about the nature and details of the 
investigation.

[41 FR 45002, Oct. 14, 1976, as amended at 45 FR 2654, Jan. 14, 1980]



Sec. 85a.5  Conduct of investigations of places of employment.

    (a)(1) Prior to beginning a site visit, NIOSH authorized 
representatives will present their credentials to the employer, owner, 
operator or agent in charge at the place of employment, explain the 
nature, purpose and scope of the investigation and the records specified 
in Sec. 85a.3 which they wish to review, abstract or duplicate.
    (2) In those instances where site visits are not necessary to the 
conduct of an investigation and the initial contact is made verbally, 
NIOSH authorized representatives will, at the request of the employer, 
owner, operator or agent in charge at the place of employment, provide a 
written explanation of the nature, purpose and scope of the 
investigation and the records specified in Sec. 85a.3 which they wish 
to review, abstract or duplicate.
    (b)(1) At the commencement of an investigation, the employer, owner, 
operator or agent in charge at the place of employment shall precisely 
identify that information which is trade secret and might be seen or 
obtained by the NIOSH authorized representatives during the 
investigation. If the NIOSH authorized representatives have no clear 
reason to question such identification, such information will not be 
disclosed by NIOSH in accordance with the provisions of section 15 of 
the OSH Act. Generally, NIOSH will not question trade secret 
designations; however, if NIOSH at any time does question such 
identification, not less than 15 days' notice to the employer, owner, 
operator or agent will be given of the intention to remove the trade 
secret designation from such information. The employer, owner, operator 
or agent may within that period submit a request to the Director, NIOSH, 
to reconsider this intention and may provide additional information in 
support of the trade secret designation. The Director, NIOSH, will 
notify the employer, owner, operator or agent in writing of the decision 
which will become effective no sooner than 15 days after the date of 
such notice.
    (2) In those instances where the NIOSH authorized representative is 
a person fulfilling a contact agreement with NIOSH or is serving as an 
expert or consultant to NIOSH pursuant to the Act, the employer, owner, 
operator or agent in charge at the place of employment may, after 
advising the NIOSH contractor or consultant in writing, elect to 
withhold information deemed to be a trade secret from such a NIOSH 
authorized representative or prohibit entry into the area of the place 
of employment where such entry will reveal trade secrets. In those 
instances, where the subject information is needed or access to the area 
of the place of employment is necessary, in the judgment of NIOSH, to 
fulfill the goals of the investigation, NIOSH regular employees will 
then obtain the information or enter the subject area of the place of 
employment.
    (c)(1) NIOSH authorized representatives will be in charge of site 
visits conducted pursuant to this part.
    (2) Where there is a request by the representative of the State 
agency and/or employees, who were notified pursuant to Sec. 85a.4(a)(1) 
or Sec. 85a.4(a)(2) to accompany the NIOSH authorized representatives 
during the site visit of the place of employment, the NIOSH authorized 
representatives will allow this request if they determine that this will 
aid the investigation; or where, in the judgment of the NIOSH authorized 
representatives, good cause has been shown why accompaniment by a third 
party who is not an employee of the employer is reasonably necessary to 
the conduct of an effective and thorough site visit, they may permit 
such third party to accompany them during the site visit: Provided 
however, That access by such person(s) to areas described in Sec. 
85a.5(c)(4) shall be in accordance with the requirements of such 
provision and access to areas containing trade secrets shall be with the 
consent of the employer, owner, operator or agent in charge at the place 
of employment.
    (3) NIOSH authorized representatives are authorized to deny the 
right of accompaniment under this paragraph to

[[Page 567]]

any person whose conduct in their judgment interferes with a fair and 
orderly site visit. In all instances, a representative of the employer 
shall be permitted to accompany the NIOSH authorized representatives 
during the site visit of the place of employment.
    (4) With regard to information classified by an agency of the United 
States Government in the interest of national security, only persons 
authorized to have access to such information may accompany NIOSH 
authorized representatives in areas containing such information.
    (d)(1) NIOSH authorized representatives are authorized: To collect 
environmental samples and samples of substances; to measure 
environmental conditions and employee exposures (including measurement 
of employee exposure by the attachment of personal sampling devices to 
employees with their consent); to take or obtain photographs, motion 
pictures or videotapes related to the purpose of the investigation; to 
employ other reasonable investigative techniques, including medical 
examinations, anthropometric measurements and standardized and 
experimental functional tests of employees with the informed consent of 
such employees; to review, abstract, and duplicate such personnel 
records as are pertinent to mortality, morbidity, injury, safety, and 
other similar studies; and to question and interview privately any 
employer, owner, operator, agency, or employee from the place of 
employment. The employer, owner, operator, or agency shall have the 
opportunity to review photographs, motion pictures, and videotapes taken 
or obtained for the purpose of identifying those which contain or might 
reveal a trade secret.
    (2) Prior to the conduct of medical examinations, anthropometric 
measurements or functional tests of any employees, the NIOSH authorized 
representatives will obtain approval of the procedures to be utilized 
from the NIOSH Human Subjects Review Board and no employee examination, 
measurement or test will be undertaken without the informed consent of 
such employee.
    (e) NIOSH authorized representatives will comply with all safety and 
health rules and practices at the place of employment and all NIOSH, 
Occupational Safety and Health Administration, and Mine Safety and 
Health Administration regulations and policies during a site visit and 
will provide and use appropriate protective clothing and equipment. In 
situations requiring specialized or unique types of protective 
equipment, such equipment shall be furnished by the employer, owner, 
operator or agent in charge at the place of employment.
    (f) The conduct of site visits will be such as to preclude 
unreasonable disruption of the operations of the place of employment.

[41 FR 45002, Oct. 14, 1976, as amended at 45 FR 2654, Jan. 14, 1980; 49 
FR 4739, Feb. 8, 1984]



Sec. 85a.6  Provision of suitable space for employee interviews and 

examinations.

    An employer, owner, operator or agent in charge at the place of 
employment shall, on request of the NIOSH authorized representatives, 
provide suitable space at the place of employment, if such space is 
reasonably available, to NIOSH to conduct private interviews with, and 
medical examinations, anthropometric measurements and functional tests 
of employees. NIOSH authorized representatives will consult with the 
employer, owner, operator or agent as to the time and place of the 
private interviews, medical examination, anthropometric measurements and 
functional tests and will schedule same so as to avoid undue disruption 
of work at the place of employment. NIOSH will conduct the medical 
interviews, measurements, examinations and tests specified under this 
part at its own expense.

[41 FR 45002, Oct. 14, 1976]



Sec. 85a.7  Imminent dangers.

    Whenever, during the course of, or as a result of, an investigation 
under this part, the NIOSH authorized representatives believe there is a 
reasonable basis for an allegation of an imminent danger, NIOSH will 
immediately advise the employer, owner, operator or agent in charge at 
the place of employment and those employees who appear to be in 
immediate danger of such allegation

[[Page 568]]

and will inform the agencies identified in Sec. 85a.4(a)(1), (a)(3), 
and (a)(4).

[41 FR 45002, Oct. 16, 1976, as amended at 45 FR 2654, Jan. 14, 1980]



Sec. 85a.8  Reporting of results of investigations of places of employment.

    (a)(1) Specific reports of investigations of each place of 
employment under this part, with identification of the place of 
employment, will be made available by NIOSH to the employer, owner, 
operator or agent in charge at the place of employment, with copies to 
the appropriate officials and Agencies notified pursuant to Sec. 
85a.4(a). Prior to release of such reports, a preliminary report will be 
sent by NIOSH to the employer, owner, operator or agent for review for 
trade secret information and technical inaccuracies that may 
inadvertently be presented in the report. If requested in writing, the 
data used to compile the reports will be made available by NIOSH to the 
employer, owner, operator or agent in charge at the place of employment, 
except that data will not be released in a form that is individually 
identifiable.
    (2) All specific reports of investigations of each place of 
employment under this part will be available to the public from the 
NIOSH Regional Consultant for Occupational Safety and Health in the 
appropriate NIOSH Regional Office.
    (3) In certain instances, specific reports of investigations of each 
place of employment will not be prepared. In such instances, a closing 
conference at the place of employment will be conducted by the NIOSH 
authorized representatives and those individuals participating in the 
site visit to discuss the findings of the site visit and appropriate 
recommendations.
    (b)(1) Any specific findings of individual employee medical 
examinations, anthropometric measurements and functional tests will be 
released by NIOSH authorized representatives to the company physician, 
private physician, or other person only pursuant to the written 
authorization of the employee; otherwise, the specific findings and 
other personal records concerning individuals will be maintained in 
accordance with 45 CFR part 5b and section 3 of the Privacy Act of 1974 
(5 U.S.C. 552a). Notice of all NIOSH systems of records as defined in 45 
CFR 5b.1(n) as a result of the investigations of places of employment 
pursuant to this part will be published in the Federal Register under 
Notices of Systems of Records for the Department of Health and Human 
Services.
    (2) In cases where an employee shows positive significant medical 
findings, the employee and the physician(s) designated by the employee 
under Sec. 85a.8(b)(1) will be immediately notified by NIOSH.
    (3) A summary of the findings of the examinations for each employee 
will be sent by NIOSH to the individual.
    (c) The findings of a total investigation generally will be 
disseminated as part of NIOSH criteria documents, NIOSH technical 
reports, NIOSH information packets, scientific journals, presentations 
at technical meetings, or in other similar manners. These findings of a 
total investigation will be presented in a manner which does not 
identify any specific place of employment; however, it should be noted 
that the specific reports of investigations of each place of employment 
under this part are subject to mandatory disclosure, upon request, under 
the provisions of the Freedom of Information Act (5 U.S.C. 552).

[41 FR 45002, Oct. 14, 1976]



PART 86_GRANTS FOR EDUCATION PROGRAMS IN OCCUPATIONAL SAFETY AND HEALTH--Table 

of Contents




                            Subpart A_General

Sec.
86.1 Applicability.
86.2 Definitions.
86.3 Inventions and discoveries.
86.4 Publications and copyrights.
86.5 Grant appeals procedure.

        Subpart B_Occupational Safety and Health Training Grants

86.10 Nature and purpose of training grants.
86.11 Eligibility.
86.12 Application for a grant.
86.13 Project requirements.
86.14 Evaluation and grant award.
86.15 Payments.
86.16 Use of project funds.
86.17 Nondiscrimination.
86.18 Grantee accountability.

[[Page 569]]

86.19 Human subjects; animal welfare.
86.20 Additional conditions.
86.21 Applicability of 45 CFR part 74.

      Subpart C_Occupational Safety and Health Direct Traineeships

86.30 Nature and purpose of direct traineeships.
86.31 Eligibility; minimum requirements.
86.32 Application for direct traineeship.
86.33 Human subjects; animal welfare.
86.34 Evaluation and award of direct traineeships.
86.35 Payments.
86.36 Duration and continuation.
86.37 Terms and conditions.
86.38 Accountability.
86.39 Termination of direct traineeship.

    Authority: Sec. 8(g), 84 Stat. 1600, 29 U.S.C. 657(g); sec. 21(a), 
84 Stat. 1612, 29 U.S.C. 670(a).

    Source: 40 FR 29076, July 10, 1975, unless otherwise noted.



                            Subpart A_General



Sec. 86.1  Applicability.

    The regulations of this part are applicable to the award of training 
grants and direct traineeships pursuant to section 21(a)(1) of the 
Occupational Safety and Health Act of 1970 (29 U.S.C. 670(a)(1)) to 
assist in providing an adequate supply of qualified personnel to carry 
out the purposes of the Act.



Sec. 86.2  Definitions.

    Any term not defined herein shall have the same meaning as given it 
in the Act. As used in this part:
    (a) Act means the Occupational Safety and Health Act of 1970 (29 
U.S.C. 651 et seq.).
    (b) [Reserved]
    (c) Secretary means the Secretary of Health and Human Services and 
any other officer or employee of the Department of Health and Human 
Services to whom the authority involved has been delegated.
    (d) State means a State of the United States, the District of 
Columbia, Puerto Rico, the Virgin Islands, American Samoa, Guam, and the 
Trust Territory of the Pacific Islands.
    (e) Training means job-specific skill development, the purpose of 
which is to provide qualified personnel to carry out the purposes of the 
Act.

[40 FR 29076, July 10, 1975, as amended at 47 FR 53012, Nov. 24, 1982]



Sec. 86.3  Inventions and discoveries.

    Any grant award pursuant to Sec. 86.14 or Sec. 86.33 is subject to 
the regulations of the Department of Health and Human Services as set 
forth in 45 CFR parts 6 and 8, as amended. Such regulations shall apply 
to any activity for which grant funds are in fact used whether within 
the scope of the project as approved or otherwise. Appropriate measures 
shall be taken by the grantee and by the Secretary to assure that no 
contracts, assignments or other arrangements inconsistent with the grant 
obligation are continued or entered into and that all personnel involved 
in the supported activity are aware of and comply with such obligations. 
Laboratory notes, related technical data, and information pertaining to 
inventions and discoveries shall be maintained for such periods, and 
filed with or otherwise made available to the Secretary, or those he may 
designate at such times and in such manner, as he may determine 
necessary to carry out such Department regulations.



Sec. 86.4  Publications and copyrights.

    Except as may otherwise be provided under the terms and conditions 
of the award, the grantee may copyright without prior approval any 
publications, films or similar materials developed or resulting from a 
project supported by a grant under this part, subject, however, to a 
royalty-free, nonexclusive, and irrevocable license or right in the 
Government to reproduce, translate, publish, use, disseminate, and 
dispose, of such materials and to authorize others to do so.



Sec. 86.5  Grant appeals procedure.

    The informal Public Health Service procedure for resolution of post-
award grant disputes set forth in subpart D of part 50 of this title and 
the Department post-award grant appeals procedure in 45 CFR part 16 are 
applicable to any award made pursuant to this part.

[[Page 570]]



        Subpart B_Occupational Safety and Health Training Grants



Sec. 86.10  Nature and purpose of training grants.

    (a) Long-term training project grant. A long-term training project 
grant is an award of funds to an eligible institution or agency, 
hereinafter called the ``grantee,'' to pay part or all of the costs of 
organized identifiable activities, hereinafter termed the ``project,'' 
that are undertaken to establish, strengthen, or expand graduate, 
undergraduate, or special training, of persons in the field of 
occupational safety and health. Such grants may be used to support 
training in, for example, occupational medicine, industrial hygiene, 
industrial nursing and occupational safety engineering and the training 
of technicians and paraprofessionals in such areas.
    (b) Short-term training project grant. A short-term training project 
grant is an award of funds to an eligible institution or agency, 
hereinafter called the ``grantee,'' to pay part or all of the costs of 
organized identifiable activities, hereinafter termed the ``project'' 
that are undertaken to provide intensive training programs of less than 
1 year for any one or a combination of the following purposes:
    (1) To provide specialized instruction for occupational safety and 
health professional or career personnel which will increase their 
competence in an area in their respective fields.
    (2) To prepare or expand the capabilities of occupational safety and 
health professional or career personnel for leadership roles as 
administrators or supervisors, and
    (3) To prepare or expand the teaching capabilities of occupational 
safety and health professionals and career personnel.
    (c) Educational Resource Center Grant. An educational resource 
center grant is an award of funds to an eligible institution or agency, 
hereinafter called the ``grantee,'' to pay part or all of the costs of 
organized identifiable activities, hereinafter termed the ``project,'' 
that are undertaken to provide for the combination of long-term and 
short-term training activities as described in Sec. 86.13 (c).

[40 FR 29076, July 10, 1975, as amended at 42 FR 52401, Sept. 30, 1977]



Sec. 86.11  Eligibility.

    (a) Eligible applicants. Any public or private educational or 
training agency or institution located in a state is eligible to apply 
for a grant under this subpart.
    (b) Projects eligible for long-term or short-term training grants or 
educational resource center grants. Any project found by the Secretary 
to be a long-term training project within the meaning of Sec. 86.10(a) 
or a short-term training project within the meaning of Sec. 86.10(b) or 
an educational resource center grant project within the meaning of Sec. 
86.10(c) shall be eligible for a grant award. However, no applicant is 
eligible for assistance for a separate training project grant in any 
project period in which it receives an educational resource center 
grant. Nothing in the section shall prevent an existing training grant 
from being incorporated into an educational resource center grant award.

[40 FR 29076, July 10, 1975, as amended at 42 FR 52401, Sept. 30, 1977; 
47 FR 53012, Nov. 24, 1982]



Sec. 86.12  Application for a grant.

    (a) An application for a grant under this subpart shall be submitted 
to the Secretary at such time and in such form and manner as the 
Secretary may prescribe. \1\ The application shall contain a full and 
adequate description of the project and of the manner in which the 
applicant intends to conduct the project in accordance with the 
requirements of this subpart, and a budget and justification of the 
amount of grant funds requested, and such other pertinent information as 
the Secretary may require.
---------------------------------------------------------------------------

    \1\ Applications and instructions may be obtained from the 
Procurement and Grants Office, Centers for Disease Control, Atlanta, GA 
30333.
---------------------------------------------------------------------------

    (b) The application shall be executed by an individual authorized to 
act for the applicant and to assume for the applicant the obligations 
imposed by the

[[Page 571]]

---------------------------------------------------------------------------
regulations of this subpart and any additional conditions of the grant.

[40 FR 29076, July 10, 1975, as amended at 49 FR 38117, Sept. 27, 1984]



Sec. 86.13  Project requirements.

    (a) An approvable application for a long-term training grant must 
contain each of the following, unless the Secretary determines that the 
applicant has established good cause for its omission.
    (1) Provision of a method for development of the training curriculum 
and any attendant training materials and resources;
    (2) Provision of a method for implementation of the needed training;
    (3) Provision of an evaluation methodology, including the manner in 
which such methodology will be employed, to measure the achievement of 
the objectives of the training program; and
    (4) Provision of a method by which trainees will be selected.
    (b) In addition to the requirements set forth in paragraph (a) of 
this section, an approvable application for a short-term training grant 
must contain each of the following, unless the Secretary determines that 
the applicant has established good cause for its omission.
    (1) Provision of a methodology to assess the particular skills, or 
knowledge that prospective trainees need to develop;
    (2) Provision of at least 18 hours of formal instruction for a 
period of not less than 2\1/2\ days and not more than 1 academic year; 
and
    (3) Assurances that no portion of the Federal funds will be used for 
(i) inservice training courses designed only for employees of a single 
agency, institution, or organization; (ii) correspondence courses; (iii) 
regular courses usually given for academic credit; or (iv) training the 
grantee's financial officers, program director, or the official who 
executed the application.
    (c) In addition to the requirements set forth in paragraphs (a), 
(b)(1), and (b)(3) (ii), (iii) and (iv) of this section, an approvable 
application for an educational resource center grant must contain each 
of the following, unless the Secretary determines that the applicant has 
established good cause for its omission:
    (1) A description, supported by appropriate documents, of 
cooperative arrangements to conduct an educational resource center among 
a medical school (with an established program in preventive or 
occupational medicine), a school of nursing, a school of public health 
or its equivalent, and a school of engineering or its equivalent. Other 
schools or departments with relevant disciplines and resources--e.g., 
toxicology, biostatistics, environmental health, law, business 
administration, education--may be represented and contribute as 
appropriate to the conduct of the total program.
    (2) The identification of an educational resource center Director 
who possesses a demonstrated capacity for sustained productivity and 
leadership in occupational safety and health training who shall oversee 
the general operation of the educational resource center program and 
shall, to the extent possible, directly participate in training 
activities.
    (3) A description of the full-time professional staff representing 
various disciplines and qualifications relevant to occupational safety 
and health and capable of planning, establishing, and carrying out or 
administering training projects undertaken by the educational resource 
center.
    (4) A description of the training and research expertise, 
appropriate facilities and ongoing training and research activities in 
occupational safety and health areas.
    (5) A description of its program for conducting education and 
training of occupational health physicians, occupational health nurses, 
industrial hygienists/engineers and safety personnel. There shall be 
full-time students in each of these core disciplines, with a goal of a 
minimum total of 30 full-time students. Training may also be conducted 
in other occupational safety and health career categories, e.g., 
industrial toxicology, biostatistics, epidemiology, and ergonomics. 
Training programs shall include appropriate field experience including 
experience with public health and safety agencies and labor-management 
health and safety activities.

[[Page 572]]

    (6) A specific plan for making an impact on the curriculum taught by 
relevant medical specialties, including radiology, orthopedics, 
dermatology, internal medicine, neurology, perinatal medicine, and 
pathology.
    (7) A description of its program to assist other institutions or 
agencies located within the applicant's region including schools of 
medicine, nursing and engineering, among others, by providing curriculum 
materials and consultation for curriculum/course development in 
occupational safety and health, and by providing training opportunities 
for faculty members.
    (8) A specific plan for preparing, distributing, and conducting 
courses, seminars and workshops to provide short-term and continuing 
education training courses for physicians, nurses, industrial 
hygienists, safety engineers and other occupational safety and health 
professionals, paraprofessionals and technicians, including personnel of 
labor-management health and safety committees, in the geographical 
region in which the educational resource center is located. The content 
and orientation of the curriculum/courses shall take into consideration 
and address problems relevant to the geographic region served. The goal 
shall be that the training be made available each year to a minimum of 
200-250 trainees representing all of the above categories of personnel 
with priority given to providing occupational safety and health training 
to physicians in family practice, as well as in industrial practice, and 
industrial nurses. These courses shall be structured so that educational 
institutions, public health and safety agencies, professional societies 
or other appropriate agencies can utilize them to provide training at 
the local level to occupational safety and health personnel working in 
the workplace. Further, the educational resource center shall have a 
specific plan and demonstrated capability for implementing such training 
directly and through other institutions or agencies in the region 
including cooperative efforts with labor unions and industry trade 
associations where appropriate.

[40 FR 29076, July 10, 1975, as amended at 42 FR 52401, Sept. 30, 1977]



Sec. 86.14  Evaluation and grant award.

    Within the limits of funds available for such purpose the Secretary 
may award grants to assist in the establishment and operation of those 
projects which will in his judgment best promote the purposes of section 
21(a)(1) of the Act, taking into account:
    (a) In the case of long-term training grants:
    (1) The need for training in the area or areas of study outlined in 
the application;
    (2) The degree to which the proposal represents a strengthening or 
expansion of the applicant's program in such areas;
    (3) The record of the applicant's effectiveness in training in these 
or related areas as indicated, among other things, by the placement of 
its graduates;
    (4) The competence of the project staff in relation to the service 
to be provided;
    (5) The reasonableness of the budget in relation to the proposed 
project;
    (6) The applicant's resources, including equipment, facilities, and 
funds, available for the project;
    (7) The current and potential availability of students in the area 
of study to be offered and their prospective employability as a result 
of the proposed training;
    (8) The extent to which the applicant expects to absorb faculty 
positions initiated as a result of the grant; and
    (9) The degree to which the project adequately provides for the 
requirements set forth in Sec. 86.13(a).
    (b) In the case of short-term training:
    (1) The relationship of the contents of the course to the current 
and emergency training needs to carry out the purposes of the Act;
    (2) The qualifications of the instructional staff;
    (3) The speed with which the training can be put to use by the 
persons proposed to be trained;
    (4) The reasonableness of the budget in relation to the proposed 
project;
    (5) The success of previous offerings of this course, or related 
courses;
    (6) Evidence of ability to recruit trainees and the estimated number 
to be enrolled during each course offering; and

[[Page 573]]

    (7) The degree to which the proposed project adequately provides for 
the requirements set forth in Sec. 86.13(b).
    (c) In the case of educational resource center grants:
    (1) The criteria set forth in paragraphs (a) and (b) of this 
section.
    (2) The degree to which the proposed project adequately provides for 
the requirements set forth in Sec. 86.13(c).
    (d) The amount of any award shall be determined by the Secretary on 
the basis of his estimate of the sum necessary for all or a designated 
portion of direct project costs plus an additional amount for indirect 
costs, if any, which will be calculated by the Secretary either (1) on 
the basis of his estimate of the actual indirect costs reasonably 
related to the project, or (2) on the basis of a percentage, not to 
exceed 8 percent, of all, or a portion of, the estimated direct costs of 
the project when there are reasonable assurances that the use of such 
percentage will not exceed the approximate actual indirect costs. Such 
award may include an estimated provisional amount for indirect costs or 
for designated direct costs (such as travel or supply costs) subject to 
upward (within the limits of available funds) as well as downward 
adjustments to actual costs when the amount properly expended by the 
grantee for provisional items has been determined by the Secretary.
    (e) All grant awards shall be in writing, shall set forth the amount 
of funds granted and the period for which support is recommended.
    (f) Neither the approval of any project nor any grant award shall 
commit or obligate the United States in any way to make any additional, 
supplemental, continuation, or other award with respect to any approved 
project or portion thereof. For continuation support, grantees must make 
separate application annually at such times and in such form as the 
Secretary may direct.

[40 FR 29076, July 10, 1975, as amended at 42 FR 52402, Sept. 30, 1977]



Sec. 86.15  Payments.

    The Secretary shall from time to time make payments to a grantee of 
all or a portion of any grant award, either in advance or by way of 
reimbursement for expenses incurred or to be incurred in the performance 
of the project to the extent he determines such payments necessary to 
promote prompt initiation and advancement of the approved project.



Sec. 86.16  Use of project funds.

    (a) Any funds granted pursuant to this subpart as well as other 
funds to be used in performance of the approved project shall be 
expended solely for carrying out the approved project in accordance with 
section 21(a) of the Act, the regulations of this subpart, the terms and 
conditions of the award, and the applicable cost principles prescribed 
by subpart Q of 45 CFR part 74.
    (b) Prior written approval by the Secretary of revision of the 
budget and project plan is required whenever there is to be a 
significant change in the scope or nature of project activities, which 
in the case of short term training grants, includes any change in the 
course dates or training sites.
    (c) Grant funds are available for trainee stipends and for tuition, 
including fees and instructional materials, for travel costs related to 
training allowances. Stipends and allowances may not be increased or be 
paid beyond the term of the stipend on account of vacation an individual 
might have been entitled to but did not take.
    (d) Stipends may only be paid to a trainee who is a citizen of the 
United States, an alien lawfully admitted to the United States for 
permanent residence, or a permanent resident of Guam, American Samoa, or 
the Trust Territory of the Pacific Islands.
    (e) In the case of short term training grants, stipends may not be 
paid to persons receiving lecture fees, salary, travel expenses, or 
payment in any form as members of the course instructional staff.
    (f) Grant funds used for alterations and renovations shall be 
subject to the condition that the grantee shall comply with the 
requirements of Executive Order 11246, as amended, and with the 
applicable regulations prescribed pursuant thereto.



Sec. 86.17  Nondiscrimination.

    (a) Attention is called to the requirements of title VI of the Civil 
Rights

[[Page 574]]

Act of 1964 (78 Stat. 252, 42 U.S.C. 2000d et seq.) and in particular 
section 601 of such Act which provides that no person in the United 
States shall on the grounds of race, color, or national origin be 
excluded from participation in, be denied the benefits of, or be 
subjected to, discrimination under any program or activity receiving 
Federal financial assistance. A regulation implementing such title VI, 
which applies to grants made under this subpart, has been issued by the 
Secretary of Health and Human Services with the approval of the 
President (45 CFR part 80).
    (b) Attention is called to the requirements of title IX of the 
Education Amendments of 1972 (86 Stat. 373, 20 U.S.C. 1681 et seq.) and 
in particular to section 901 of such Act which provides that no person 
in the United States shall, on the basis of sex, be excluded from 
participation in, be denied the benefits of, or be subjected to 
discrimination under any education program or activity receiving Federal 
financial assistance.
    (c) Attention is called to the requirements of section 504 of the 
Rehabilitation Act of 1973, as amended, which provides that no otherwise 
qualified handicapped individual in the United States shall, solely by 
reason of his handicap, be excluded from participation in, be denied the 
benefits of, or be subjected to discrimination under any program or 
activity receiving Federal financial assistance.



Sec. 86.18  Grantee accountability.

    (a) Accounting for grant award payments. All payments made by the 
Secretary shall be recorded by the grantee in accounting records 
separate from the records of all other grant funds, including funds 
derived from other grant awards. With respect to each approved project 
the grantee shall account for the sum total of all amounts paid by 
presenting or otherwise making available evidence satisfactory to the 
Secretary of expenditures for direct and indirect costs meeting the 
requirements of this part: Provided, however, That when the amount 
awarded for indirect costs was based on a predetermined fixed-percentage 
of estimated direct costs, the amount allowed for indirect costs shall 
be computed on the basis of such predetermined fixed-percentage rates 
applied to the total, or a selected element thereof, of the reimbursable 
direct costs incurred.
    (b) Accounting for interest earned on grant funds. Pursuant to 
section 203 of the Intergovernmental Cooperation Act of 1968 (42 U.S.C. 
4213), a State will not be held accountable for interest earned on grant 
funds, pending their disbursement for grant purposes. A State, as 
defined in section 102 of the Intergovernmental Cooperation Act, means 
any one of the several States, the District of Columbia, Puerto Rico, 
any territory or possession of the United States, or any agency or 
instrumentality of a State, but does not include the governments of the 
political sudivisions of the State. All grantees other than a State, as 
defined in this section, must return all interest earned on grant funds 
to the Federal Government.
    (c) Grant closeout--(1) Date of final accounting. A grantee shall 
render, with respect to each approved project, a full account, as 
provided herein, as of the date of termination of grant support. The 
Secretary may require other special and periodic accounting.
    (2) Final settlement. There shall be payable to the Federal 
Government as final settlement with respect to each approved project the 
total sum of:
    (i) Any amount not accounted for pursuant to paragraph (a) of this 
section; and
    (ii) Any credits for earned interest pursuant to paragraph (b) of 
this section; and
    (iii) Any other amounts due pursuant to subparts F, M, and O of 45 
CFR part 74.

Such total sum shall constitute a debt owed by the grantee to the 
Federal Government and shall be recovered from the grantee or its 
successors or assignees by setoff or other action as provided by law.



Sec. 86.19  Human subjects; animal welfare.

    No grant award may be made under this subpart unless the applicant 
has complied with:
    (a) 45 CFR part 46 pertaining to the protection of human subjects; 
and

[[Page 575]]

    (b) Chapter 1-43 of the Department Grants Administration Manual \2\ 
concerning animal welfare.
---------------------------------------------------------------------------

    \2\ The Department Grants Administration Manual is available for 
inspection at the Public Information Office of the several Department 
Regional Offices and available for purchase at the Government Printing 
Office, GPO Document No. 894-523.
---------------------------------------------------------------------------



Sec. 86.20  Additional conditions.

    The Secretary may with respect to any grant award impose additional 
conditions prior to or at the time of any award when in his judgment 
such conditions are necessary to assure or protect advancement of the 
approved project, the interests of public health, or the conservation of 
grant funds.



Sec. 86.21  Applicability of 45 CFR part 74.

    The provisions of 45 CFR part 74, establishing uniform 
administrative requirements and cost principles, shall apply to all 
grants under this part to States and local governments as those terms 
are defined in subpart A of that part 74. The relevant provisions of the 
following subparts of part 74 shall also apply to grants to all grantee 
organizations under this part:

                             45 CFR Part 74

Subpart and Subject
A General.
B Cash depositories.
C Bonding and insurance.
D Retention and custodial requirements for records.
F Grant-related income.
G Matching and cost sharing.
K Grant payment requirements.
L Budget revision procedures.
M Grant closeout: Suspension, and termination.
O Property.
Q Cost principles.



      Subpart C_Occupational Safety and Health Direct Traineeships



Sec. 86.30  Nature and purpose of direct traineeships.

    A direct traineeship is an award of funds directly from the Federal 
Government to an individual (herein called the ``trainee'') for his 
subsistence and other expenses during a period in which he is acquiring 
training (a) in the occupational safety and health professions, (b) for 
research relating to occupational safety and health, or (c) for teaching 
in occupational safety and health.



Sec. 86.31  Eligibility; minimum requirements.

    In order to be eligible for an award under this subpart an applicant 
must:
    (a) Have been accepted by a public or private institution for the 
purpose of the activity for which the traineeship is sought.
    (b) Be a U.S. citizen, an alien lawfully admitted to the United 
States for permanent residence or a permanent resident of Guam, American 
Samoa, or the Trust Territory of the Pacific Islands.

[40 FR 29076, July 10, 1975, as amended at 47 FR 53012, Nov. 24, 1982]



Sec. 86.32  Application for direct traineeship.

    An application for a direct traineeship under this subpart shall be 
submitted to the Secretary at such times and in such form and manner as 
he may prescribe. \1\ In addition to the information supplied by the 
applicant in his application, such further information may be required 
as is necessary to determine his or her qualifications.
---------------------------------------------------------------------------

    \1\ Applications and instructions may be obtained from the 
Procurement and Grants Office, Centers for Disease Control, Atlanta, GA 
30333.

[40 FR 29076, July 10, 1975, as amended at 49 FR 38117, Sept. 27, 1984]



Sec. 86.33  Human subjects; animal welfare.

    Where the application is for training at a non-Federal institution, 
no award may be made under this subpart unless said institution has 
complied with:
    (a) 45 CFR part 46 pertaining to the protection of human subjects; 
and
    (b) Chapter 1-43 of the Department Grants Administration Manual \2\ 
068 concerning animal welfare.
---------------------------------------------------------------------------

    \2\ See footnote 2 to Sec. 86.19.
---------------------------------------------------------------------------



Sec. 86.34  Evaluation and award of direct traineeships.

    Within the limits of funds available for such purpose and subject to 
the regulations of this part, the Secretary

[[Page 576]]

may award direct traineeships to those qualified applicants who are in 
his judgment best able to carry out the purpose of the traineeships 
taking into consideration the need for training in the area of study 
specified in the application.



Sec. 86.35  Payments.

    (a) Individuals receiving awards shall be entitled to such stipends 
and allowances as the Secretary may designate, taking into account such 
factors as the needs of the program, the cost of living, and the 
availability of funds.

    (Note: These are prescribed in chapter 3-140 of the Department 
Grants Administration Manual \2\).

    (b) Payments of stipends and allowances will, at the discretion of 
the Secretary, be made directly to the trainee or to the sponsoring 
institution for payment directly to the trainee.



Sec. 86.36  Duration and continuation.

    Direct traineeship awards may be made for varying periods not in 
excess of 2 years. The Secretary may make one or more continuation 
awards for an additional period if he finds that satisfactory progress 
is being made toward accomplishment of the purpose of the initial 
traineeship award. Additional support may be provided on appropriate 
justification after expiration of the period of support in the previous 
award.



Sec. 86.37  Terms and conditions.

    All direct traineeship awards shall be subject to the following 
terms and conditions:
    (a) Training must be carried out at an institution found by the 
Secretary to provide a well-rounded course of instruction in the 
particular area of training for which the traineeship is awarded.
    (b) No direct traineeship may be utilized to compensate any trainee 
for personal services or employment on behalf of the United States or 
any person.



Sec. 86.38  Accountability.

    Accountability for payments will be subject to such requirements as 
may be specified by the Secretary.



Sec. 86.39  Termination of direct traineeship.

    (a) The Secretary may terminate a direct traineeship at any time 
upon request of the trainee.
    (b) After reasonable notice to the trainee and an opportunity for 
the presentation of the trainee's views and relevant evidence, the 
Secretary may terminate any direct traineeship prior to the date it 
would otherwise expire upon a determination that the trainee's 
performance is unsatisfactory, that the trainee is no longer attending 
the sponsoring institution, or that he or she is unfit or unable to 
carry out the purpose of the traineeship.
    (c) The views and evidence of the trainee shall be presented in 
writing unless the Secretary determines that an oral presentation is 
desirable.



PART 87_NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND 

DEMONSTRATION GRANTS--Table of Contents




Sec.
87.1 To which programs does this regulation apply?
87.2 Definitions.
87.3 Who is eligible to apply for a grant under this part?
87.4 For what purposes may grants be awarded?
87.5 What information must be included in the grant application?
87.6 How will grant applications be evaluated and the grants awarded?
87.7 For what period of time will grants be awarded?
87.8 How may a grantee use grant funds?
87.9 Which other HHS regulations apply?

    Authority: Sec. 8(g), 84 Stat. 1600 (29 U.S.C. 657(g)), sec. 508, 83 
Stat. 803 (30 U.S.C. 957).

    Source: 46 FR 58676, Dec. 3, 1981, unless otherwise noted.



Sec. 87.1  To which programs does this regulation apply?

    This regulation applies to research and demonstration project grants 
under:
    (a) Section 20(a)(1) of the Occupational Safety and Health Act of 
1970 (29 U.S.C. 669(a)(1)) for the support of studies related to 
occupational safety and health, and

[[Page 577]]

    (b) Section 501 of the Federal Mine Safety and Health Act of 1977 
(30 U.S.C. 951) for the support of health research in mining. These 
grants are awarded and administered by the National Institute for 
Occupational Safety and Health, Centers for Disease Control, of the 
Public Health Service.



Sec. 87.2  Definitions.

    As used in this regulation:
    Demonstration project grant means an award of funds to an eligible 
applicant to assist in meeting the cost of conducting a demonstration, 
either on a pilot or full-scale basis, of the technical or economic 
feasibility or application of a new or improved procedure, method, 
technique, or approach that will further the research purposes described 
in Sec. 87.4.
    Principal investigator for a research project, or project director 
for a demonstration project, means a single individual who is 
responsible for the scientific and technical direction of the project.
    Research project grant means an award of funds to an eligible 
applicant to assist in meeting the costs of conducting an identified 
research activity or program, study, or experiment that will further the 
research purposes described in Sec. 87.4.
    Secretary means the Secretary of Health and Human Services and any 
other officer or employee of the Department of Health and Human Services 
to whom the authority involved has been delegated.



Sec. 87.3  Who is eligible to apply for a grant under this part?

    Any public or private agency or institution is eligible to apply for 
a grant under this part, except Federal agencies or institutions not 
specifically authorized by law to receive such a grant.



Sec. 87.4  For what purposes may grants be awarded?

    (a) The Occupational Safety and Health Act authorizes grants for 
research, experiments, and demonstrations relating to occupational 
safety and health, including studies of the psychological factors 
involved. This authority includes projects to develop innovative 
methods, techniques, and approaches for dealing with occupational safety 
and health problems.
    (b) The Federal Mine Safety and Health Act authorizes grants for 
research projects designed to:
    (1) Improve working conditions and practices affecting health in 
coal or other mines and to prevent occupational diseases originating in 
the mining industry.
    (2) Develop epidemiological information to (i) identify and define 
positive factors involved in occupational diseases of miners, (ii) 
provide information on the incidence and prevalence of pneumoconiosis 
and other respiratory ailments of miners, and (iii) improve health 
standards.
    (3) Develop techniques for the prevention and control of 
occupational diseases of miners, including tests for hypersusceptibility 
and early detection.
    (4) Evaluate the effect on bodily impairment and occupational 
disability of miners afflicted with an occupational disease.
    (5) Study the relationship between coal or other mine environments 
and occupational diseases of miners.
    (6) Study matters involving the protection of life and the 
prevention of diseases in connection with persons who, although not 
miners, work with or around the products of coal or other mines in areas 
outside of such mines and under conditions which may adversely affect 
the health and well-being of such persons.
    (7) Develop effective respiratory equipment.



Sec. 87.5  What information must be included in the grant application?

    The application must contain a complete description of the objective 
of the project and the plan for carrying out the research or 
demonstration, the name and qualifications of the principal investigator 
or project director and principal staff members, the total resources and 
facilities that will be available, and a justification of the amount of 
grant funds requested.



Sec. 87.6  How will grant applications be evaluated and the grants awarded?

    (a) The Secretary may award grants to those applicants whose 
approved

[[Page 578]]

projects will best promote the purposes of either the Occupational 
Safety and Health Act or the Federal Mine Safety and Health Act on the 
basis of an evaluation conducted by experts or consultants engaged for 
this purpose.
    (b) This evaluation will take into account the scientific merit and 
significance of the project, the competency of the proposed staff in 
relation to the type of research or demonstration involved, the 
feasibility of the project, the likelihood of its producing meaningful 
results, the proposed project period, the adequacy of the applicant's 
resources available for the project, the amount of grant funds necessary 
for completion, and for mining grant applications, the recommendations 
of the Mine Health Research Advisory Committee.
    (c) The Secretary may evaluate and approve two or more concurrent 
applications, each dealing with one or more specified aspects of the 
project, and make two or more concurrent grant awards for the project. 
This may be necessary when a project involves a number of different but 
related problems, activities, or disciplines which would require 
evaluation by different groups, or when support for a project could be 
more effectively administered by separate handling of various aspects of 
the project.



Sec. 87.7  For what period of time will grants be awarded?

    (a) The notice of grant award specifies how long the Secretary 
intends to support the project without requiring the project to 
recompete for funds. This period, called the project period, will 
usually be for 3-5 years.
    (b) Generally, the grant will initially be for 1 year and subsequent 
continuation awards will also be for 1 year at a time. A grantee must 
submit a separate application to have the support continued for each 
subsequent year. Decisions regarding continuation awards and the funding 
level of such awards will be of such factors as the grantee's progress 
and management practices, and the availability of funds. In all cases, 
continuation awards require a determination by the Secretary that 
continued funding is in the best interest of the Federal Government.
    (c) Neither the approval of any application, nor the award of any 
grant commits or obligates the Federal Government in any way to make any 
additional, supplemental, continuation, or other award with respect to 
any approved application or portion of an approved application.



Sec. 87.8  How may a grantee use grant funds?

    A grantee shall only spend funds it receives under this part 
according to the approved application and budget, the authorizing 
legislation, the terms and conditions of the grant award, the applicable 
cost principles specified in subpart Q of 45 CFR part 74, and the 
regulations of this part.



Sec. 87.9  Which other HHS regulations apply?

    Several other regulations apply to grants under this part. These 
include, but are not limited to:

42 CFR part 50, subpart D--Public Health Service grant appeals procedure
45 CFR part 16--Procedures of the Departmental Grant Appeals Board
45 CFR part 46--Protection of human subjects
45 CFR part 74--Administration of grants
45 CFR part 75--Informal grant appeals procedures
45 CFR part 80--Nondiscrimination under programs receiving Federal 
assistance through the Department of Health and Human Services 
effectuation of title VI of the Civil Rights Act of 1964
45 CFR part 81--Practice and procedure for hearing under part 80 of this 
Title
45 CFR part 84--Nondiscrimination on the basis of handicap in programs 
and activities receiving or benefiting from Federal financial assistance
45 CFR part 91--Nondiscrimination on the basis of age in HHS programs or 
activities receiving Federal financial assistance

[49 FR 38117, Sept. 27, 1984]

[[Page 579]]