Consensus Building: Federal Agencies Engage in Standards Development
When the U.S. Food and Drug Administration wanted to encourage the pharmaceutical industry to modernize its manufacturing processes, the agency decided to kick-start voluntary standards development. So did the National Institute of Standards and Technology when it saw the need to develop standards for the emerging 3D imaging systems industry. The Federal Aviation Administration did likewise to update standards for airplane electrical wiring systems, as did the U.S. Environmental Protection Agency for a needed heat metering standard.
Now the Obama administration is signaling its support for developing voluntary consensus standards as a way to spur technological breakthroughs and advance national priorities, among them, electronic health record systems and smart grid technologies.
In January, in the wake of the president's 2011 Strategy for American Innovation, the Office of Science and Technology, the U.S. Trade Representative and the Office of Management and Budget - all of which report directly to the president - issued a memorandum clarifying how federal agencies should engage in standards development.
Using standards to boost technology, broaden its acceptance, encourage innovation and achieve competitive market outcomes isn't a new concept. The National Technology Transfer and Advancement Act of 1995 instructs federal agencies to partner with the private sector and standards development organizations to improve government efficiency and effectiveness, and strengthen the U.S. position in global markets. The U.S. Office of Management and Budget Circular No. A-119, Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities, issued in 1998, notes that, "When properly conducted, standards development can increase productivity and efficiency in government and industry, expand opportunities for international trade, conserve resources, improve health and safety, and protect the environment."1 In the recent memorandum, federal agencies are directed to actively engage with standards development organizations or take a "convening role" to start standards development with SDOs. Agencies are also expected to clarify their goals, maintain open communications, support technical expertise, minimize duplicative testing, utilize existing best practices and keep in mind "the impact of their standards-related choices on innovation and the global competitiveness of U.S. enterprises."2
Here are some examples of how ASTM International has responded in partnership with industry when federal agencies have taken on that convening role.
The FDA was the catalyst for the 2003 formation of what was then called ASTM Committee E55 on Pharmaceutical Application of Process Analytical Technology. Even though the agency knew the industry was providing quality drug products to the American public, it was missing opportunities to improve efficiency, process control, safety, and ultimately, product quality and public health. In taking a measure of responsibility, the FDA launched its Good Manufacturing Practices for the 21st Century campaign to create opportunities for change. The agency's goal was to develop standards to support process analytical technology, a system that focuses on building quality into the manufacturing process to ensure a quality product. But, in order to succeed, the FDA acknowledged that it needed an open, consensus-based standards development process, along with active participation from the private sector, government and academia.
If growth is an indication of success, then the FDA's approach has been more than justified. By 2006, Committee E55's scope had broadened to address all aspects of pharmaceutical manufacturing, necessitating a change in name to Committee E55 on the Manufacture of Pharmaceutical Products. Its scope expanded again in February 2012 when Subcommittee E55.04 was formed to manage biopharmaceutical manufacturing standards previously developed by Committee E48 on Biotechnology.
According to Ali Afnan, president of Step Change Pharma Inc., in Olney, Md., tablets and caplets are the dominant dosage forms of the pharmaceutical industry. "We have a wealth of information on the best practices for manufacturing solid oral dosages, but have not gained from standardization of manufacturing practices," Afnan says. "Theoretically, we should be able to use a set of standards for the manufacture of these products, assuring high quality and performance."
To date, Committee E55 has published nine standards and has six under development. One of the original and still most used standards is E2500, Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment. Pfizer Inc., one of the world's largest research-based pharmaceutical companies, has embraced that standard as "a streamlined science- and risk-based approach to ensuring that its manufacturing systems and equipment are capable of supporting processes that deliver quality products for our patients," says Graham Cook, current E55 committee chairman and senior director, process knowledge/quality by design, for Pfizer, in Maidenhead, England.
Still, though the pharmaceutical industry is highly regulated, it's a global industry with differing systems and standards. These differences can add complexity and cost to pharmaceutical manufacturing and impact the availability of pharmaceutical products to patients.
"It would be advantageous to have more globally harmonized standards for the industry that help to improve manufacturing efficiency and support quality goals," says Cook, who notes that international representatives now constitute about a third of the Committee E55 membership. "Once firms become willing to use consensus standards like other industries, we could see a reduction of development and manufacturing costs and a market-driven force for change," says Afnan. He adds that some biopharmaceutical manufacturers are actively looking to standardize their practices (an example is the draft standard WK36552, Practice for Process for Inactivation of Retrovirus by pH), which may lead the way to comprehensive acceptance of pharmaceutical manufacturing standards.
According to Yolanda Fultz-Morris, spokeswoman with the FDA's Center for Drug Evaluation and Research, the FDA is satisfied with PAT standards developed to date and continues to lend support by reviewing work items and providing comments during ASTM's balloting process.
NIST and the FAA opted for a competitive process and issued requests for proposals when they needed assistance with organizing standards development for 3D imaging. NIST, the primary measurement laboratory for the United Sates, required standard test protocols for evaluating the performance and accuracy of 3D imaging systems while the FAA wanted to ensure safety without hampering innovation in the design and long-term airworthiness of electrical wiring systems.
Although the technology for 3D imaging has existed for decades, its applications have expanded rapidly. The industry makes and uses a variety of laser systems - including laser scanners, 3D range cameras and 3D flash LADARs (also known as laser radars or laser scanners) - to capture, in thousands of measurements per second, 3D information on a scene or object. Currently, 3D imaging systems have applications in construction, mining, heritage preservation, forensics, entertainment, transportation, manufacturing, homeland security, military operations and law enforcement. The technology has tremendous global market potential, but the absence of standards could limit industry acceptance and consumer confidence, and inhibit new commercial uses.
NIST spearheaded action on standards development, holding a series of three workshops with stakeholders starting in 2003, and then initially having a NIST employee chair ASTM Committee E57 on 3D Imaging Systems when it was organized in 2006. In addition to NIST representation on the committee, it has continued to provide the basic research required to support the development of standards and in turn, lend more legitimacy to standards.
So far, three standards have been published: terminology, best practices for safe application of the technology and 3D imaging data exchange.3 All are key to increasing market confidence and acceptance of the technology, says Kamel Saidi, a research engineer with NIST's Sensing and Perception Systems Group, in Gaithersburg, Md., and current E57 membership secretary.
Gene Roe indicates that standards development for assessing performance has been a challenging task. Roe chairs Subcommittee E57.04 on Data Interoperability and has been an E57 committee member for most of the six years since its origin. "Hardware test methods and best practices are what end users really want and need," he says. "If end users can't determine whether claims of accuracy are valid, they have no way of knowing how to evaluate or compare different products, or therefore, what to buy."
Roe, who also serves as editor of LiDAR News, in Hampton, N.H, suggests that additional industry commitment is needed to develop best practices and testing methods - including publishing current working standards for the evaluation of medium-range 3D imaging systems (WK12373) and static pose measurement systems (WK31638) - so that the United States remains competitive in 3D imaging technology.4 Participation is welcome.
Saidi, however, confirms that the best practice and testing standards in process have priority. And he looks forward to future standards, such as those that will address an expanding commercial application: the ability of 3D imaging technology to enable robots, used on manufacturing lines, to sense the location and orientation of an object, no matter whether one or the other is moving or stationary or both are moving at the same time.
ASTM Committee F39 on Normal and Utility Airplane Electrical Wiring Systems, organized in 2003, was sparked by a joint FAA and National Transportation Safety Board investigation that pointed to aging wiring systems as a culprit in aircraft accidents. In addition to agency officials, the committee brought together leading manufacturers and trade associations to develop voluntary consensus standards for the design, fabrication, installation, modification, repair and inspection of electrical wiring systems in small, or Part 23, aircraft.5
The committee's first priority was to split an existing standard, which was originally published in an FAA advisory circular, into four standards, and then update and clarify them.
"We don't want standards to stifle creativity or innovation," notes Richard Peri, vice president of government and industrial affairs for the Aircraft Electronics Association in Washington, D.C., and chairman of Committee F39. "The FAA owns and must own performance and safety standards for aircraft, but we own the design standards and use them to prove compliance with the safety standards."
Having served on the original FAA committee that identified and analyzed hazards in large aircraft and business jets, Peri is confident that the current standards meet FAA expectations and private sector needs even though the committee is currently negotiating with FAA to ensure that the maintenance standard is better embraced by the industry.
Once that issue is resolved, the next standard to be developed is what Peri terms a "Cliff Notes version" of F2639, Practice for Design, Alternation and Certification of Airplane Electrical Wiring Systems, that can be applied to maintenance.
FAA continues to support to ASTM Committee F39, viewing its standards as an acceptable means of compliance and having FAA staff serve as committee members, says Elizabeth Cory, spokeswoman with the FAA's External Communications/Public Affairs Office.
A recent example of federal initiation of standards development occurred at the end of 2011. The U.S. Environmental Protection Agency acted as facilitator, hosting an October meeting to collect views from a variety of public and private stakeholders on the need for a U.S. heat meter standard. EPA then requested that the International Association of Plumbing and Mechanical Officials and ASTM International cooperate on developing ASTM standards for heat metering\; IAPMO and ASTM signed a memorandum of understanding about the work in December 2011.
Heat meters measure thermal heat - that is, heat absorbed (for heating) or given off (for cooling) by a heat conveying liquid across a heat exchange circuit. For example, a heat meter could be installed in a solar thermal system for heating hot water.
"Heat metering plays a critical role in thermal energy project development," said James Critchfield, director of EPA's Clean Energy Technologies Market Development. ‘In line with the federal government's objective to promote the use and development of private sector standards, the EPA reached out to a broad coalition of stakeholders, including ASTM International and IAPMO, to outline the need and justification for the development of a U.S. heat meter standard."
The heat meter standard will be developed by newly formed Subcommittee E44.25 on Heat Metering, within ASTM Committee E44 on Solar, Geothermal and Other Alternative Energy Sources. Critchfield is serving as E44.25 chair.
"If we can measure that heat energy and demonstrate how much it saves and reduces the use of carbon-based fuels, utilities and homeowners will have an incentive to install thermal energy systems," says Pete DeMarco, director of special programs for IAPMO, who's based in Dayton, N.J. He adds that, "Once a standard is created, it creates a level playing field for manufacturers. They can act confidently, investing in product development resources." And that can lead to energy, financial and environmental benefits derived from clean energy sources.
DeMarco is predicting success. "Developing consensus standards is something we do better than anyone else in the world. Government doesn't give us an edict. We work with public and private sectors to embody the needs of all stakeholders and that results in a superior product."
1. Office of Management Budget Circular No. A-119 Revised, February 10, 1998, Section 6e.
2. Memorandum for the Heads of Executive Department and Agencies, M-12-08, January 17, 2012, p. 4.
3. The standards are E2544, Terminology for Three-Dimensional (3D) Imaging Systems\; E2641, Practice for Best Practices for Safe Application of 3D Imaging Technology\; and E2807, Specification for 3D Imaging Data Exchange, Version 1.0.
5. U.S. Federal Aviation Administration, 14 Code of Federal Regulations 23, Airworthiness Standards: Normal, Utility, Acrobatic and Commuter Category Airplanes.Adele Bassett is a freelance writer who has covered everything from youth gangs in Colorado to earthquakes in Connecticut while working for a variety of corporations and publications. She holds a B.A. in English, an M.S. in journalism and an M.B.A.