In 1995, Congress enacted the National Technology Transfer and Advancement Act to bring technology and industrial innovation to the marketplace for the economic, environmental, and social well-being of U.S. citizens. Known as Public Law 104-113 or the NTTAA, the Act was also established to foster cooperative research and development agreements with federal laboratories to help U.S. businesses speed the development of new products and processes and to commercialize the innovative technologies created.
One of the technologies commercialized since the advent of the NTTAA of interest to industrial hygienists is the use of optical fluorescence to determine beryllium in dust by wipe, in air sampling media, and in bulk samples, developed by the Department of Energy. This technology is the focus of analytical methods from NIOSH that describe the use of field-portable fluorometry to analyze beryllium in air (method 7704) and in surface wipes (method 9110). ASTM methods also use optical fluorescence technology for the determination of beryllium in the workplace (method D7202) and in soil, rock, sediment, and fly ash (method D7458). Other IH-related technologies facilitated by the NTTAA include soaps, wipes, and cleaning liquids for removing lead and other metals, oxides, and radioisotopes from skin developed by NIOSH; a colorimetric screening method for lead on skin and wipes also developed by NIOSH (see NIOSH method 9105); and the Polymerase Chain Reaction (PCR) mold identification methods based on an EPA patent used by environmental microbiology laboratories accredited by AIHA Laboratory Accreditation Programs, LLC.
The NTTAA also requires that government agencies use consensus standards developed by nonprofit standards development organizations whenever possible. Section 12 of the law states that, except after evaluation to the contrary by the U.S. Office of Management and Budget, “all Federal agencies and departments shall use technical standards that are developed or adopted by voluntary consensus standards bodies, using such technical standards as a means to carry out policy objectives or activities determined by the agencies and departments.” Further, the Act states that “Federal agencies and departments shall consult with voluntary, private sector, consensus standards bodies and shall, when such participation is in the public interest and is compatible with agency and departmental missions, authorities, priorities, and budget resources, participate with such bodies in the development of technical standards.”
In an amplification of the NTTAA in 2017, the executive branch of the federal government expressed its preference for consensus standards. A revised instruction published by the Office of Management and Budget as Circular A-119 “establishes a preference for the use of voluntary consensus standards in lieu of government-unique standards” and directs federal agencies to adopt voluntary consensus standards wherever possible to avoid development of unique government standards. The OMB instruction states that “all Federal agencies must use voluntary consensus standards in lieu of government-unique standards in their procurement and regulatory activities, except where inconsistent with law or otherwise impractical.” OMB also requires federal agencies to show a “strong preference for using voluntary consensus standards” and states that these policies are intended to encourage federal agencies to benefit from the expertise of the private sector, promote federal agency participation in standards bodies to support the creation of standards that are useable by federal agencies, and minimize reliance on government-unique standards where an existing standard would meet the objectives of the federal government.
As a result, federal agencies and their representatives, and federal employees and contractors, have become more involved in the creation and revision of consensus standards, both internationally and domestically. Consensus standards have begun to appear with more regularity in federal directives, guidelines, regulations, and requirements by citation or by reference.
Outside of government, the courts have heard more arguments for compliance to consensus standards in tort cases; and, of direct interest to the IH communities, an unofficial hierarchy for the use of standards for analytical methods has developed. That hierarchy, in descending order of preference of application, is:
- consensus standard methods
- methods from authorities having jurisdiction and governmental agencies (for example, EPA, NIOSH, and OSHA)
- methods from peer-reviewed publications
- methods from other sources (such as manufacturers’ methods)
The consensus standards process provides the following benefits:
- It brings together people with diverse backgrounds, expertise, and knowledge.
- It provides a balanced representation of interests (for example, the interests of industry, government, and other users).
- Consensus standards are reviewed and updated at regular intervals. Governmental methods typically are not.
- Quality is enhanced by strict balloting and due-process procedures.
- Test methods are typically validated by multiple laboratories.
WHO DEVELOPS CONSENSUS STANDARDS?
For IH professionals, the most active and most recognized sources of IH-applicable consensus standards are the International Organization for Standardization, the American National Standards Institute, and ASTM International.
ISO is an independent, non-governmental international organization with a membership of 162 national standards bodies and a Central Secretariat in Geneva, Switzerland. ISO members represent individual countries, and each country has one vote for final approval of an ISO standard. To date, ISO has published more than 22,000 international standards. Examples of ISO standards of interest to IH professionals include:
- ISO 7708, Air Sampling—Particle-size Fraction Definitions for Health-related Sampling
- ISO 8672, Air Quality—Determination of the Number Concentration of Airborne Inorganic Fibres by Phase Contrast Optical Microscopy—Membrane Filter Method
- ISO 15202, Workplace Air—Determination of Metals and Metalloids in Airborne Particulate Matter by Inductively Coupled Plasma Atomic Emission Spectrometry (separate parts for sampling, sample preparation, and analysis)
- ISO 19087, Workplace Air—Analysis of Respirable Crystalline Silica by Fourier-Transform Infrared Spectroscopy
One of the more visible ISO examples, at least for sampling and laboratory analysis, is ISO/IEC 17025:2017, General Requirements for the Competence of Testing and Calibration Laboratories, which is the basis for accreditation of sampling and laboratory activities worldwide. (For more information, see the article “New Requirements for Labs” in the August 2018 Synergist.)
ISO recognizes one organization within each of its member countries to oversee development and approval of consensus standards. As the ISO representative for the U.S., ANSI oversees the development of voluntary consensus standards for products, services, processes, systems, and personnel. The organization also coordinates U.S. standards with international standards so that American products and services can be used worldwide.
More than 230 standards developers are accredited by ANSI including the Acoustical Society of America; the American Society of Heating, Refrigerating and Air-Conditioning Engineers; the American Society of Mechanical Engineers; the American Society of Safety Professionals; ASTM International; the U.S. Department of Defense; ISO; the International Safety Equipment Association; the National Fire Protection Association; and SAE International.
ANSI itself does not develop standards but recognizes standards created by its member organizations. These consensus standards are sometimes referred to as “ANSI standards.” All ANSI-recognized standards from accredited standards developers, including ISO standards, are available from ANSI. Examples of ANSI American national standards of interest in industrial hygiene include:
- ANSI/AIHA/ASSP Z9.5, American National Standard for Laboratory Ventilation
- ANSI/ASSP Z88.2, American National Standard Practices for Respiratory Protection
- ANSI/ISEA 104-1998 (R2009), American National Standard for Air Sampling Devices—Diffusive Type for Gases and Vapors in Working Environments
- ANSI/ASA S1.4-2014, American National Standard Electroacoustics—Sound Level Meters—Part 1: Specifications
ASTM International, as an ANSI-accredited developer of consensus standards that are used worldwide, is a significant contributor of standards of interest to IHs. ASTM standards include the following types:
- Guide: a compendium of information or series of options that does not recommend a specific course of action
- Practice: a definitive set of instructions for performing one or more specific operations that does not produce a test result
- Specification: an explicit set of requirements to be satisfied by a material, product, system, or service
- Terminology Standard: a document comprising definitions of terms, explanations of symbols, abbreviations, or acronyms
- Test Method: a definitive procedure that produces a test result
Of direct interest to IH professionals are the standards under the jurisdiction of ASTM Committee D22 on Air Quality. The committee has subcommittees on Quality Control; Workplace Air Quality; Indoor Air; Sampling and Analysis of Asbestos; Assessment, Sampling, and Analysis of Microorganisms; and Sampling and Analysis of Lead for Exposure and Risk Assessment. These subcommittees have more than 130 current standards that may be of interest to IHs. Also, ASTM Committee E34 on Occupational Safety and Health has over 20 standards, primarily for metalworking fluids.
The NTTAA requires that the National Institute of Standards and Technology report to OMB on federal agencies’ use of consensus standards. Within the report, federal agencies briefly describe their activities undertaken to carry out provisions described in the NTTAA and OMB Circular A-119.
All laboratories accredited by AIHA-LAP are accredited to a consensus standard, ISO/IEC 17025. AIHA-LAP itself conforms to ISO 17011, Conformity Assessment—Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies, and is recognized as such within the framework of the International Laboratory Accreditation Cooperation. One of the requirements for laboratories is to participate in proficiency testing programs such as the AIHA Proficiency Analytical Testing Programs, LLC. AIHA PAT Programs is a proficiency sample provider accredited to ISO 17043, Conformity Assessment—General Requirements for Proficiency Testing.
WHAT'S IN IT FOR YOU?
The IH professional can benefit from consensus standards in many ways:
Initial decision making. Guides such as ASTM E1370 for air sampling and ASTM D7659 for surface sampling describe options to evaluate when developing a sampling plan. Similarly, ANSI/ISEA Z87.1 provides selection criteria for eye- and face-protection devices.
Consistency and reproducibility. Using applicable and appropriate consensus standards to propose, plan, conduct, document, analyze, report, and archive processes for IH projects and the resulting data creates a consistent and reproducible record of the work. This makes the process for reaching a conclusion and developing recommendations much easier.
Data quality objectives. Consensus standards can be used to establish appropriate and consistent data quality objectives, or DQOs, for the results of sampling and analysis. Guidance for DQOs was developed by EPA and has been incorporated into consensus standards such as ASTM D7659 and in the widely-used Visual Sample Plan from the Pacific Northwest National Laboratory.
Data comparability. When consensus standards are used for sampling and laboratory analysis, comparison of the data is much easier. Trending and control banding can also be more consistent across multiple locations or organizations.
Data defensibility. Perhaps most important, the records of the work and processes used, the analysis of the collected data, and the conclusions reached are more easily defended to superiors and clients—and in court—when consensus standards are applied and followed. Imagine providing testimony that says the work was done according to a consensus standard; the data were analyzed and reported according to a consensus standard; and the conclusions reached, recommendations made, and actions taken were according to a consensus standard. Consistent application and use of consensus standards make the requirements for admissibility much easier to achieve.
Participation in their development. IH professionals can participate in the consensus standards process by joining a standards development organization such as ASTM International or ASSP. Being involved in the creation and maintenance of national standards presents a valuable insight into the current state of the profession; the current thinking on possible changes in the application of standards; current conduct of government and commercial research, and other professional work; possible future professional developments and future changes to the profession; and the standard-making and standard-amending process. Participation in the standards process results in knowledge of what is currently happening and a unique view of what is coming. All could be important for career development and career enhancement.
KENNETH T. (KENN) WHITE, MS, MM, CIH, CSP, FAIHA, is the principal of Consultive Services in Virginia Beach, Va. He is a three-time recipient of the AIHA Edward J. Baier Technical Achievement Award, chair of the ASTM International Subcommittee D22.12 on Sampling and Analysis of Lead for Exposure and Risk Assessment, and a member of the AIHA Sampling and Laboratory Analysis Committee, serving as chair of the Environmental Lead Subcommittee.
MICHAEL J. (MIKE) BRISSON, MS, PMP, FASTM, is a fellow technical advisor at Savannah River National Laboratory, Aiken, S.C. He is past chair of the AIHA Sampling and Laboratory Analysis Committee, chair of ASTM International Committee D22 on Air Quality, chair of ISO Technical Committee 146, Subcommittee 4, on Air Quality General Aspects, and convener of three ISO working groups.
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RESOURCES
American National Standards Institute: ANSI/ISEA Z87.1, American National Standard for Occupational and Educational Personal Eye and Face Protection Devices (2010).
ASTM International: ASTM D7659, Standard Guide for Strategies for Surface Sampling of Metals and Metalloids for Worker Protection (2015).
ASTM International: ASTM E1370, Standard Guide for Air Sampling Strategies for Worker and Workplace Protection (2014).
ASTM International: “Determination of a New Fluorescence Method for the Detection of Beryllium on Surfaces” in Beryllium: Sampling and Analysis, ASTM Selected Technical Publication 1473 (2006).
ASTM International: Method D7202, “Standard Test Method for Determination of Beryllium in the Workplace by Extraction and Optical Fluorescence Detection” (2015).
ASTM International: Method D7458, “Standard Test Method for Determination of Beryllium in Soil, Rock, Sediment, and Fly Ash Using Ammonium Bifluoride Extraction and Fluorescence Detection” (2014).
EPA: “Guidance on Systematic Planning Using the Data Quality Objectives Process.”
Federal Register: Revision of OMB Circular No. A-119, “Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities” (January 2016).
Google Patents: U.S. Patent No. 6387652B1, “Method of Identifying and Quantifying Specific Fungi and Bacteria."
Government Publishing Office: Public Law 104-113 (PDF, March 1996).
Hygenall.
National Institute of Standards and Technology: “Twentieth Annual Report on Federal Agency Use of Voluntary Consensus Standards and Conformity Assessment” (August 2017).
NIOSH: Method 7704, “Beryllium in Air by Fluorometry” (PDF, December 2015).
NIOSH: Method 9105, “Lead in Dust Wipes by Chemical Spot Test (Colorimetric Screening Method)” (PDF, March 2003).
NIOSH: Method 9110, “Beryllium in Surface Wipes by Fluorometry” (PDF, December 2015).
Pacific Northwest National Laboratory: Visual Sample Plan, “Data Quality Objectives.”
SKC: “Full Disclosure: Wipes for Disclosing the Presence of Lead” (PDF).
The Synergist: “New Requirements for Labs” (August 2018).
Consensus Standards, Technology, and the IH Professional
BY KENN WHITE AND MIKE BRISSON
First Choice
Although the print version of The Synergist indicated The IAQ Investigator's Guide, 3rd edition, was already published, it isn't quite ready yet. We will be sure to let readers know when the Guide is available for purchase in the AIHA Marketplace.
My apologies for the error.
- Ed Rutkowski, Synergist editor
Disadvantages of being unacclimatized:
- Readily show signs of heat stress when exposed to hot environments.
- Difficulty replacing all of the water lost in sweat.
- Failure to replace the water lost will slow or prevent acclimatization.
- Increased sweating efficiency (earlier onset of sweating, greater sweat production, and reduced electrolyte loss in sweat).
- Stabilization of the circulation.
- Work is performed with lower core temperature and heart rate.
- Increased skin blood flow at a given core temperature.
- Gradually increase exposure time in hot environmental conditions over a period of 7 to 14 days.
- For new workers, the schedule should be no more than 20% of the usual duration of work in the hot environment on day 1 and a no more than 20% increase on each additional day.
- For workers who have had previous experience with the job, the acclimatization regimen should be no more than 50% of the usual duration of work in the hot environment on day 1, 60% on day 2, 80% on day 3, and 100% on day 4.
- The time required for non–physically fit individuals to develop acclimatization is about 50% greater than for the physically fit.
- Relative to the initial level of physical fitness and the total heat stress experienced by the individual.
- Can be maintained for a few days of non-heat exposure.
- Absence from work in the heat for a week or more results in a significant loss in the beneficial adaptations leading to an increase likelihood of acute dehydration, illness, or fatigue.
- Can be regained in 2 to 3 days upon return to a hot job.
- Appears to be better maintained by those who are physically fit.
- Seasonal shifts in temperatures may result in difficulties.
- Working in hot, humid environments provides adaptive benefits that also apply in hot, desert environments, and vice versa.
- Air conditioning will not affect acclimatization.
Acclimatization in Workers