For more information about the work and relevance of ASTM D22.04 and ISO TC 146 SC 2, see
Ashley and Harper [2004, 2005].

Q. What is the current phase of the standards development process for this technology?

Response: Regarding air sampling and analysis, Ashley and Harper [2004, 2005] address
advancements in sampling methods, analytical protocols, and instrumentation. Many examples
can be given for other NIOSH research and development activities; some are included in this
response.

Most standards development activities with NIOSH participation have established revision cycles.
A typical periodicity for technical revision is five years, and the cycles vary according to the SDO
responsible for the standard and the date of its last revision.

Q. How has the process worked so far?

Response: Participation in consensus standards development activities has proved to be an
effective use of NIOSH resources for the transfer of technology developed in NIOSH research.
For air sampling and analysis, see Ashley and Harper [2004, 2005]. Many examples exist for other
NIOSH research and development activities.

Q. When developing standards, how are the standards-setting processes managed and
coordinated?

Response: Ashley and Harper [2004, 2005] address the processes for air sampling and analysis.
The consensus standards organizations (i.e., ASTM International and ISO) have their own
well-developed and well-managed processes.

NIOSH helps prevent work-related injury, illness, and death by advancing the state of knowledge
and application of PPT through relevant and timely PPT research, training, and evaluation.
NIOSH activities include the following:

Respirator certification and technology development
Policy, standards, and guidance development
Technology research

Surveillance and communications

PPT in this context is defined as the technical methods, processes, techniques, tools, and materials
supporting development and use of PPE worn by individuals to reduce the effects of their exposure
to a hazard. NIOSH standards development activities fall under Item 6 (page 76397): “Other
technologies involving significant Federal agency participation in standards setting” and include
performance criteria, certification standards, and selection, care, and maintenance standards for
PPE and protective clothing.

Q. Is there a strategic plan that identifies the standards needs and defines the standards
development life cycle?


Response: Assuring dedicated time for staff to work on the standards to which they have been
approved as NIOSH representatives is very important. Support for travel to committee meetings
and similar events is also needed. Currently, many standards development activities are
accomplished through electronic exchange of information and web-based meetings to reduce the
need and expense of travel. However, face-to-face participation is important for frank and open
discussion.

Q. What resource constraints impact the successful completion of the standards efforts?

Response: There has been no specific Institute barrier to the participation of NIOSH researchers.
However, resources necessary for participation, particularly for meeting attendance, compete with
other budget priorities. Support for consensus standards activities within Agency structures is
needed to positively impact the success of standards development. A strong commitment to
budgetary support coupled with recognition and appreciation for continued participation would
provide direct, positive motivation for participation.

Process Review and Improvement Metrics

Q. How has this information been documented or disseminated, and implemented?

Response: In the field of air sampling and analysis, much of this is covered in Ashley and Harper
[2004, 2005]. Collaboration with national and international researchers in standards-setting

activities has led to valuable research studies and numerous peer-reviewed publications.

Q. What kinds of performance metrics are appropriate to measure the effectiveness of the
standards-setting process?

Response: Useful performance metrics are: the standards promulgated, peer-reviewed articles
published, and agency compliance with the NTTAA.

Q. If any such performance metrics have been used, what are the results?
Response: In air sampling and analysis, there are many scientific products generated in addition

to the standards themselves, notably peer-reviewed scientific papers and publications, and
numerous intangible benefits.


exemplary and laudable. There can be challenges in the ISO process if some countries act as a bloc
and publish standards against the wishes of other national representatives.

Q. How could the methods be improved?

Response: Consensus standards activities are well established in ASTM International and ISO. In
ASTM International standards development, every member has a vote. In the ISO process, it is
one vote per country which occasionally results in bloc voting (as stated above).

Q. What other methods should the Federal agencies explore?
Response: Consider education of agency leadership regarding requirements of the NTTAA.
Q. What impact have Federal agencies had on standards activities?

Response: NIOSH impact has been extensive. Participation allows NIOSH experts to provide an
impartial contribution to the process that may not be feasible in the private sector. Many published
international standards promulgated by ASTM International and ISO had NIOSH
authorship/co-authorship.

Additional consensus standards-setting organizations with NIOSH collaboration include:
1) National Fire Protection Association (NFPA) Technical Committees on:

* Fire and Emergency Services Protective Clothing and Equipment (FAE-ACC)
* Electronic Safety Equipment (FAE-ELS)

Emergency Medical Services Protective Clothing and Equipment (FAE-EMS)
Hazardous Materials Protective Clothing and Equipment (FAE-HAZ)
Respiratory Protective Clothing and Equipment (FAE-RPE)

Special Operations Protective Clothing and Equipment (FAE-SCE)

* Structural and Proximity Protective Clothing and Equipment (FAE-SPF)

* Wildland Fire Fighting Protective Clothing and Equipment (FAE-WFF)

NIOSH chairs the overarching Technical Correlating Committee on Fire and Emergency Services
Protective Clothing and Equipment and the Technical Committee on Emergency Medical Services
Protective Clothing and Equipment, and the Principal and Alternate members on all NFPA
Technical Committees listed above. The following are examples of NIOSH leadership roles and
research leading to revisions to NFPA protective clothing and equipment standards:

+ Development and incorporation of optional CBRN protective ensemble performance
requirements into NFPA 1971 Standard on Protective Ensembles for Structural Fire
Fighting and Proximity Fire Fighting, 2007 Edition.

+ Development and incorporation of mandatory CBRN performance requirements into NFPA
1981 Standard on Open-Circuit Self-Contained Breathing Apparatus (SCBA) for Emergency
Services, 2007 Edition.


Response: Organizations such as ASTM International and ISO have established strategic plans.
NIOSH does not define standards needs and standards development life cycles. However, the
NIOSH Strategic Plan recognizes that improvements in personal protective technology are
realized through better standards and regulations and subsequent availability of PPE that complies
with standards and regulations.

Commitment to continuous improvement of PPE is reflected in program actions such as (1)
conducting research projects addressing technology gaps and providing research data used by
SDOs in their standards development activities; (2) establishing Memoranda of Understanding
with NFPA, ASTM, and ISEA to define cooperative partnerships that include standards
development activities; (3) sponsoring active participation of program scientists in SDO
committee meetings and associated activities; and (4) establishing annual performance plans for
staff defining their SDO activities.

Commitment also is demonstrated through research emphasis areas in Chemical, Biological,
Radiological and Nuclear (CBRN) protection requirements and in national protective clothing
standards.

NIOSH actively participates in standards development activities with the ISO, American National
Standards Institute (ANSI), NFPA, ASTM, Canadian Standards Association International (CSA),
and the International Safety Equipment Association (ISEA) in the areas of respiratory protection,
hearing protection, eye and face protection, fall protection, industrial head protection, and
protective clothing. These standard writing activities address PPT performance, use, and
maintenance. User involvement in SDO activities helps improve comfort, utility, and wearability.

Q. Are there barriers to developing high level strategies for standard-setting activities?

Response: Indifference, unfamiliarity with the National Technology Transfer and Advancement
Act of 1995 (NTTAA), and lack of resources, funding, and support can be barriers.

Q. What methods of engagement are used by Federal agencies to participate in private sector led
standards development?

Response: Ashley and Harper [2004, 2005] address the engagement methods for air sampling and
analysis. Other examples are given elsewhere in this response. NIOSH makes an effort to support
in-person attendance of researchers at meetings so they may actively participate in standards
development activities.

Q. How transparent is each method?

Response: For air sampling and analysis, this matter is addressed in Ashley and Harper [2004,
2005]. The ASTM International process is one of the best methods; it is open and due process is


EEE Ee

4) ANSI:

+ ANSI Z88 ASC — Respiratory Protection

* ANSI Z88.2 Respiratory Selection and use

* ANSI Z88.6 Medical Qualifications for Respirator Wearers
* ANSI Z88.7 Color Coding for Cartridge and Canisters

* ANSI Z88.10 Fit Test Methods

* ANSI Z88.12 Respirator Selection for Biohazards

* ANSI Z88.14 CBRN Respirator Selection and Use

5) ISEA:

* ISEA-ANSI Z87.1 Eye and Face Protection

* ISEA-ANSI Z89.1 Head Protection

* ISEA-ANSI 103 Classification and Performance Requirements for Chemical Protective
Clothing

* ISEA-ANSI 110 Smoke Hoods

6) CSA:

* CSA Z94.4 Respirator Selection and use
* CSA Z180.1 Breathing Air Systems

7) ISO:

* ISO TC94/SC6 Eye Protection
* ISO TC94/SC13 Protective Clothing
* ISO TC94/SC15 Respiratory Protective Devices

NIOSH scientists also participate in non-government organizations developing consensus
guidance for selection, care, and maintenance of PPE, Examples include the American Industrial
Hygiene Association (AIHA) Protective Clothing and Equipment Committee and Respiratory
Protection Committee.

Q. When Federal agencies have been involved in standards setting efforts in a technology sector,
how has the progress of standards setting efforts in this technology sector changed after Federal

agencies became involved?

Response: Federal regulatory responsibilities, such as NIOSH respirator certification
requirements, often are strong motivators for standards-setting efforts.

Adequacy of Resources

Q. What resources are needed to successfully complete the efforts?


DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service

Centers for Disease Control and Prevention
National Institute for Occupational
Safety and Health
Robert A. Taft Laboratories
4676 Columbia Parkway
Cincinnati OH 45226-1998

February 16, 2011

National Institute of Standards and Technology
100 Bureau Drive

Stop 1060

Gaithersburg, MD 20899-1060

Docket Number 0909100442-1012-03

Dear Sir/Madam:

The National Institute for Occupational Safety and Health (NIOSH) has reviewed the National
Institute of Standards and Technology (NIST) request for information on Effectiveness of
Federal Agency Participation in Standardization in Select Technology Sectors for National
Science and Technology Council's Sub-Committee on Standardization published in the Federal

Register on December 8, 2010 [75 FR 76397]. Our comments and references are enclosed.
Please do not hesitate to contact me at 513/533-8302 if I can be of further assistance.

Sincerely yours,

Paul A. Schulte, Ph.D.
Director
Education and Information Division

3 Enclosures


References

Ashley K, Harper M [2004]. ASTM Standards for monitoring chemical hazards in the workplace.
Standardization News 32(4):22-25.

Ashley K, Harper M [2005]. ASTM International Standards for monitoring chemical hazards in
workplaces. J Occup Environ Hyg 2:D44-47.

10


2)

+ Revision of NFPA 1982 Standard on Personal Alert Safety Systems (PASS), 2007 Edition
with new testing procedures and performance criteria to overcome high temperature
performance failures.

+ Development of NFPA 1994 Standard on Protective Ensembles for First Responders to
CBRN Terrorism Incidents, 2007 Edition.

* Development of additional performance requirements based on NIOSH research into NFPA
1999 Standard on Protective Clothing for Emergency Medical Operations, 2008 Edition.

ASTM International:

+ E54 Homeland Security Applications Committee
* _E54.04 Personal Protective Equipment

* F23 Protective Clothing and Equipment Committee
* F23.20 Physical Hazards

* F23.30 Chemical Hazards

* F23.40 Biological Hazards

* F23.60 Human Factors

* F23.70 Radiological Hazards

F23.80 Thermal Hazards

F23.95 Planning

F23.97 Sub-committee on Liaisons

F23.96 ISO Technical Advisory Committee

E56 Nanotechnology Committee

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NIOSH personnel had committee leadership roles and provided supporting research that led to the
development and release of the following ASTM standards:

3)

+ ASTM F2588-07 Standard Test Method for Man-In-Simulant Test (MIST) for protective
ensembles

+ ASTM F2704-10 Standard Specification for Air-Fed protective ensembles

+ ASTM F2668-07 Standard Practice for Determining the Physiological Response of the
Wearer to protective clothing ensembles

* ASTM F2731-10 Standard Test Method for measuring the transmitted and stored energy of
firefighter protective clothing systems

U.S. Department of Justice (DOJ) and National Institute of Justice (NIJ):

NIOSH scientists served on the Special Technical Committee established by DOJ and NIJ that
developed the “CBRN Protective Ensemble Standard for Law Enforcement, NIJ Standard-006.00”
released in November 2010.


Examples of NIOSH products emanating from standards development activities are listed in
subsequent responses.

Q. How do the standards impact organizations and their competitiveness?

Response: Organizations could include Federal agencies, their partners, and their stakeholders.
For NIOSH, standard-setting activities help identify research opportunities and emerging health
and safety issues. For manufacturers, they provide performance and design requirements for their
products and a minimum level of quality and performance for competing products. Consumers
(employers and workers) receive assurance in expectations of product quality, level of safety, and
performance commensurate with certification of conformance to the standard.

Q. How has standardization spurred innovation in the technology sector(s) that is the subject of
your comment?

Response: There are many examples in NIOSH. In the case of worker protective clothing and
equipment, the activities of standards development organizations is vital to enhancing the
protective performance of PPE and the development of new performance criteria in product
certification standards. Revisions to current standards and the development of new standards
encourages product manufacturers to develop PPE with improved worker protection levels and
drives research into improved products offering enhanced protection. Good examples are the
National Fire Protection Association (NFPA) fire and emergency services protective clothing and
equipment standards and the ASTM International protective clothing and equipment standards.

NIOSH researchers also participate in developing national and international consensus standards
on the measurement of workplace toxins. Those standards are used for health-related research, the
support of implementation of control measures, or decision-making regarding compliance with
good air quality. The national body engaged in their development is ASTM International. NIOSH
researchers obtain Institute permission to become members of ASTM International as an official
duty and may vote according to ASTM International procedures.

The International Standards Organization (ISO) is engaged in similar work. NIOSH researchers
obtain Institute permission to join the U.S. delegation as an official duty and may make technical
contributions to the U.S. position and national vote. Both ASTM International and ISO
committees include sub-committees (SC) specific to standards in workplace atmospheres (i.e.,
ASTM D22.04 and ISO TC 146 SC 2); NIOSH researchers participate in sub-committee activities
and their respective working groups (WGs). The active WGs in ISO TC 146, SC 2 are the
following:

+ WG 1 Particle Size-Selective Sampling and Analysis

* WG 2 Inorganic Particulate Matter

+ WG 4 Organic Vapors

* WG 5S Inorganic Fibers

* WG7 Silica

* WG 8 Assessment of Contamination of Skin and Surfaces from Airborne Chemicals
+ WG 9 Sampling Pump performance


The National Institute for Occupational Safety and Health (NIOSH) has reviewed the National
Institute of Standards and Technology (NIST) request for information (RFI) Effectiveness of
Federal Agency Participation in Standardization in Select Technology Sectors for National
Science and Technology Council's Sub-Committee on Standardization published in the Federal
Register (FR) on December 8, 2010 [75 FR 76397]. The following comments regarding NIOSH
engagement in standard-setting activities are intended to assist NIST in examining the
effectiveness of Federal agency participation in standards-setting efforts led by the private sector.
Our responses correspond to the RFI questions.

Standards-Setting Processes, Reasons for Participation and the Benefits of Standardization

Q. Who participates in standards-setting activities?

Response: NIOSH researchers, scientists, and engineers recognized as subject matter experts
(SMEs) participate on an array of technical committees of numerous national and international
standards development organizations (SDOs). Involvement of some researchers in American
Society for Testing and Materials (ASTM International) and International Organization for
Standardization (ISO) work was initiated by former division directors who saw the value of these
activities in technology transfer, collaboration, and generation of new research ideas.

Q. What are the most important reasons for participation?

Response: Participation in standards setting activities supports the NIOSH mission to generate
new knowledge in the field of occupational safety and health and to transfer that knowledge into
practice for the betterment of workers. NIOSH conducts scientific research to address knowledge
gaps and disseminates scientific knowledge to aid in the development of standards, guidance, and
authoritative recommendations. For example, the mission of NIOSH includes supporting the
development of personal protective equipment (PPE) performance standards to enhance worker
safety. NIOSH research data are used by private standards development organizations to update
existing protective clothing and equipment standards and develop new standards.

Addressing the recommendations of the Institute of Medicine (IOM) report, Certifying Personal
Protective Technologies: Improving Worker Safety (2010), to establish risk-based conformity
assessment processes for non-respiratory PPE may initiate a number of additional
standards-development committees to initiate or upgrade certification standards. If this occurs,
stakeholder interest in participation would likely increase with the expanded number of
standards-setting activities. The report can be accessed at
(http://www.nap.edu/catalog.php?record_id=12962).

Q. What are the benefits of developing standards for this sector?

Response: Employers and workers depend on consensus-based standards developed by private
organizations to insure the availability and use of PPE with appropriate levels of protection against
dermal, inhalation, and physical exposure hazards. PPE is used when engineering controls are not
adequate to reduce exposure hazards to acceptable levels. Involvement in standards development
helps NIOSH maintain awareness of new developments and the state of the art in the field.


‘National I

lOSH Comments to NIST

Comments of the National Institute for Occupational Safety and Health on the
National Institute of Standards and Technology
Request for Information
Effectiveness of Federal Agency Participation in Standardization in
Select Technology Sectors for
National Science and Technology Council’s Sub-Committee on Standardization

Docket No. 0909100442-0563-02

Department of Health and Human Services
Centers for Disease Control and Prevention
National Institute for Occupational Safety and Health
Cincinnati, Ohio

2/16/11