Research Determination

Print Date: 10/3/23

Title:

Data collection, analysis, and dissemination regarding management and use of respirators in the workplace

Project Id:

0900f3eb81c5837d

Accession #:

NIOSH-TRB-12/15/20-5837d

Project Contact:

Emily J Haas

Organization:

NIOSH/NPPTL/TRB

Status:

Pending Regulatory Clearance

Intended Use:

Project Determination

Estimated Start Date:

07/24/2020

Estimated Completion Date:

09/30/2024

CDC/ATSDR HRPO/IRB Protocol #:
OMB Control #:

Determinations
Determination

Justification

HSC:
Does NOT Require HRPO
Review

Not Research - Public Health Surveillance

PRA:
PRA Applies

Completed

Entered By & Role

2/6/21

Moore_Susan M. (sme6) Division HSC

1/24/23

Sawyer Deloney_Tamela (tqs7) OMB / PRA

45 CFR 46.102(l)(2)

Description & Funding
Description
Priority:

Standard

Determination Start Date:

12/15/20

Description:

NPPTL executes NIOSH's Respirator Approval Program. A comprehensive effort to ensure the effectiveness of respiratory
protective equipment requires an ongoing understanding of the types of establishments that purchase respirators, the types of jobs
and occupations that use respirators, why respirators are used, whether they are used properly to optimize worker safety and
health, and how they are managed in the workplace. Surveillance plays an important role in obtaining the above information. In
2001, NIOSH partnered with the Bureau of Labor Statistics to conduct a survey of respirator management and use, estimate the
numbers of U.S. establishments and workers who rely on respirators, and determine why and how respirators were used. Twenty
years after the initial survey, OSHA is collaborating with NIOSH to fund the development and administration of another national
survey similar to that of the BLS, to update surveillance practices around respirator management and use.

IMS/CIO/Epi-Aid/Lab-Aid/Chemical Exposure
Submission:

Yes

IMS Activation Name:

2019 Novel Coronavirus Response

Primary Priority of the Project:

Prevention, mitigation, and intervention strategies

Secondary Priority(s) of the Project:

Not selected

Task Force Associated with the Response:

Health Systems and Worker Safety

CIO Emergency Response Name:

Not selected

Epi-Aid Name:

Not selected

Lab-Aid Name:

Not selected

Assessment of Chemical Exposure Name:

Not selected

Goals/Purpose

The goal of the survey is to derive national estimates of worker exposure to hazardous atmospheres and respirator use and
management for targeted U.S. industries and occupations.

Objective:

For targeted U.S. industries, the survey will measure: 1) Prevalence of hazardous atmospheres 2) Pattern of non-respirator and
respirator mitigation strategies 3) # employees using what types of respirators 4) How respirators are managed 5) Opportunities for
improving respirator technologies

Does your project measure health disparities among Not Selected
populations/groups experiencing social, economic,
geographic, and/or environmental disadvantages?:
Does your project investigate underlying
contributors to health inequities among populations
/groups experiencing social, economic, geographic,
and/or environmental disadvantages?:

Not Selected

Does your project propose, implement, or evaluate
an action to move towards eliminating health
inequities?:

Not Selected

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

Businesses

Tags/Keywords:

Air Pollutants, Occupational ; Occupational Health ; Personal Protective Equipment

CDC's Role:

Activity originated and designed by CDC staff, or conducted at the specific request of CDC, or CDC staff will approve study design
and data collection as a condition of any funding provided

Method Categories:

Analytic Services (can be data/specimen TA for non-research,research,investigations); Secondary Data Analysis; Surveillance
Support; Technical Assistance

Methods:

U.S. industries where there is a known or suspected exposure to hazardous airborne contaminants will define the sampling scope of
the survey. Limiting the sampling scope to industries in which a known or suspected exposure to airborne contaminants exists
minimizes the chance of surveying respondents that have no reason to use respiratory protection. Surveillance data sources will be
purchased and identified via web scraping to define the sampling scope. Within the scope of industries identified, the survey will be
used to estimate the extent to which hazardous atmospheres are present and the extent to which non-respirator hazard control
techniques are used to mitigate airborne hazards. Asking these questions allows us to understand the hazard control portfolio used
in industries. The survey will also be used to estimate the number of employees using respirators and the amount of time respirators
are used. NIOSH-Approved respirator use information will be delineated into the following categories: elastomeric air-purifying
respirators, powered air-purifying respirators, NIOSH approved filtering facepiece respirators, air-supplied respirators, and selfcontained breathing apparatuses. In addition, the survey will ask respondents about how respirators are managed in their
workplaces according to the following: how respirators are selected, how fit testing is conducted, how medical fitness assessment is
conducted, how training is administered, how respirators are maintained, and the respirator protection program. The survey will also
ask respondents their perspectives regarding how respirator technologies may be improved. These questions will be gathered in an
open-ended question format in relation to the following: new respirator technologies that would be beneficial; the usability/ease of
use of respiratory protection; comfort and fit; supply; and durability. This surveillance activity will provide support and direction to
improve NIOSH's respirator approval program for several NIOSH-Approved respirators.

Collection of Info, Data or Biospecimen:

OSHA contractors Abt will oversee all aspects of the survey administration and data collection. OSHA's primary mission is protect
the safety and health of U.S. workers - respiratory protection has played a significant role in worker protection over the last two
years. While OSHA funded contractors will oversee survey administration and data collection, CDC/NIOSH is responsible for OMB
/PRA clearances related to this project and all the labor market statistics they obtain as a component of their congressional
mandate. This project will derive data that becomes a part of the historical record of U.S. labor market statistics. The methodological
approach necessary to produce the desired outcomes include the following. Key informants provided information specific to their
establishment's management and use of respirators under a formerly funded activity with DOL/BLS. The survey that was developed
was subject to cognitive/psychological assessment that measured both effort and question understandability. Using the cognitively
tested survey, questions will be administered via an internet-based questionnaire by OSHA's contracted vendor. The survey
introduction includes a list of definitions and pictures associated with each type of respirator that will be asked about throughout the
survey. Within the survey itself where a question is asked about a type of respirator, a pop-up will provide the picture and definition
when hovered over. This process will ensure that a common understanding of each type of respirator is held by each respondent
that takes the survey. The sample size required to derive reliable national estimates by industrial sector is approximately 80,000. As
many samples as possible will be solicited to respond to the survey, given that it is voluntary and there is a potential for

nonresponse. In order to increase the response rate respondents will be assured anonymity, the process includes temporary
subcontracted staff hired by Abt to follow-up with (through telephone) prospective respondents, and resampling will also be
considered if necessary.

Expected Use of Findings/Results and their impact:

Could Individuals potentially be identified based on
Information Collected?

Dissemination of the survey results will be primarily accomplished through a jointly published NIOSH and OSHA report. This
publication will be consistent with the primary dissemination effort from the 2001-2003 survey (Bureau of Labor Statistics (BLS)
/National Institute for Occupational Safety and Health (NIOSH): Respirator Usage in Private Sector Firms, 2001. Washington, D.C.:
BLS, 2003). In addition, researchers will publish the results in peer-reviewed and industry-specific trade journals and present the
findings at academic and professional conferences, through partnerships with industry, trade, and labor groups, and directly to
partner federal/state governmental organizations. Knowledge from this survey should help guide future programmatic resource
allocation applicable during routine and emergency situations such as research and development programs, enforcement/education
/awareness initiatives, hazard mitigation interventions, supply planning, and respiratory protection product assessment and
development initiatives.
No

Funding

Funding yet to be added .....

HSC Review

HSC Attributes
Program Evaluation

Additional Ethical Considerations
NPPTL executes NIOSH's Respirator Approval
Program. A comprehensive effort to ensure the
effectiveness of respiratory protective equipment
requires an ongoing understanding of the types of
establishments that purchase respirators, the types of
jobs and occupations that use respirators, why
respirators are used, whether they are used properly to
optimize worker safety and health, and how they are

Yes

managed in the workplace. Surveillance plays an
important role in obtaining the above information. In
2001, NIOSH partnered with the Bureau of Labor
Statistics to conduct a survey of respirator management
and use, estimate the numbers of U.S. establishments
and workers who rely on respirators, and determine why
and how respirators were used. Twenty years after the
initial survey, NIOSH seeks to again collaborate with the
BLS to administer a national survey of respirator
management and use. NIOSH meets the definition of a
public health authority. This work will allow NIOSH to
identify and assess conditions of public health
importance related to consumer products, specifically
respirators.

Regulation and Policy
Do you anticipate this project will need IRB review
by the CDC IRB, NIOSH IRB, or through reliance on
an external IRB?

No

Estimated number of study participants

Population - Children

Protocol Page #:

Population - Minors

Protocol Page #:

Population - Prisoners

Protocol Page #:

Population - Pregnant Women

Protocol Page #:

Population - Emancipated Minors

Protocol Page #:

Suggested level of risk to subjects
Do you anticipate this project will be exempt
research or non-exempt research

Requested consent process waviers
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Alteration of authorization under HIPPA Privacy
Rule

No Selection

Requested Waivers of Documentation of Informed Consent
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Consent process shown in an understandable language
Reading level has been estimated

No Selection

Comprehension tool is provided

No Selection

Short form is provided

No Selection

Translation planned or performed

No Selection

Certified translation / translator

No Selection

Translation and back-translation to/from target
language(s)

No Selection

Other method

No Selection

Clinical Trial
Involves human participants

No Selection

Assigned to an intervention

No Selection

Evaluate the effect of the intervention

No Selection

Evaluation of a health related biomedical or
behavioral outcome

No Selection

Registerable clinical trial

No Selection

Other Considerations

Exception is requested to PHS informing those
bested about HIV serostatus

No Selection

Human genetic testing is planned now or in the
future

No Selection

Involves long-term storage of identfiable biological
specimens

No Selection

Involves a drug, biologic, or device

No Selection

Conducted under an Investigational New Drug
exemption or Investigational Device Exemption

No Selection

Institutions & Staff
Institutions
Name

FWA #

FWA Exp Date

IRB Title

IRB Exp Date

Funding #

U.S. Bureau of Labor Statistics
Occupational Safety and Health Administration

Staff
Staff
Member

SIQT Exp.
Date

CITI Biomedical
Exp. Date

Patrick
Yorio

08/08/2026

10/22/2021

CITI Social & Behavioral
Exp. Date

02/02/2024

Data
DMP
Proposed Data Collection Start Date:

CITI Good Clinical Practice
Exp. Date

8/1/23

Staff Role

Email

Phone

Organization

Project
Officer

wjc8@cdc.
gov

412-3865568

TECHNOLOGY RESEARCH
BRANCH

Proposed Data Collection End Date:

4/1/24

Proposed Public Access Level:

Restricted

Restricted Details:
Memorandum of Understanding

Data Use Type:
Data Use Type URL:
Data Use Contact:

Public Access Justification:

The data derived via this survey will be subject to DOL requirements-National estimates related to the objectives will be published
and made available to the public for secondary analysis, raw data used to derive the national estimates and the qualitative
responses will be made available via an official data use agreement between the researchers and OSHA but made available to the
public.

How Access Will Be Provided for Data:

Published national estimates are for U.S. industries (by NAICS code) and occupation (by standard occupational classification code).
All data is deidentified and establishment level information is not available or provided when the data is released by OSHA or
NIOSH in any form-via published national estimates or through data use agreement.

Plans for Archival and Long Term Preservation:

The data derived from the survey becomes part of the historical record of U.S. DOL procedures.

Spatiality

Spatiality (Geographic Locations) yet to be added .....

Dataset
Dataset
Title

Dataset
Description

Dataset yet to be added...

Supporting Info

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date

Current

CDC Staff
Member and
Role
Haas_Emily
(wcq3)
Project Contact

Yorio_Patrick
(wjc8)
Project Contact

Date Added

Description

Supporting Info Type

Supporting Info

01/24/2023

Statement of work provided by
OSHA to contract with Abt on
survey data collection

Statement of Work

SOW_AbtSRUP_1.18.23.docx

12/15/2020

The attached file provides
documentation regarding NIOSH's
determination of this project as
non-research.

Other-NIOSH IRB Determination
Form

19 - Data collection, analysis, and dissemination regarding
management and use of respirators in the workplace (Yo.
pdf