In January 2019, I attended ASTM International Committee Week, which consisted of a consensus-building format for a small set of focused committees including D37 on cannabis testing. ASTM has over 12,000 technical documents supporting 140 topic groups under its global umbrella.
At a status meeting that included all ASTM members, Dr. Taco van der Maten, ASTM’s Chairman of the Board of Directors for 2019, provided an update on several key programs. I met with him afterwards.
RLS: ASTM previously had the tagline “Standards Worldwide” and, more recently, “Helping Our World Work Better.” How is it going?
TM: I see that the ASTM core philosophy and process of building global consensus standards is providing a valuable service to our global society. Commerce is global. Plus, most transactions involve critical quality attributes (CQAs) of a product or service. This often is reduced to a few specifications agreed to by both vendor and buyer as the basis for the transaction.
Quality, matched to fit-for-purpose, is the concern of the buyer. Quality is also a concern of the vendor, who is focused on building a business by delivering a product or service that leads to a successful, hassle-free transaction. For both, quality needs to be defined and measured. After all, if you cannot measure it, you cannot specify or regulate it. Thus, metrology is a key part of global commerce. Metrology is the focus of ASTM International.
RLS: Tell us a little about your background and how you become interested in metrology.
TM: My professional career as an analytical chemist started in 1985 at Heineken as a research chemist working on staling (aging) of beer using a variety of techniques including HPLC. I took some business development courses and moved on to business development manager in DSM’s program to sell high-end analytical chemistry services. In 2006 I took a position at PANalytical (now called Malvern Panalytical), where I am marketing manager, Oils, Fuels, Chemicals, and Polymers. About seven years ago, I joined ASTM F40, which focuses on restricted materials such as REACH (EU Regulation for Registration Evaluation, Authorisation and Restriction of Chemicals) RoHS (EU Directive 202/95/EC on the Restriction of Hazardous Substances), etc. I’ve moved up in ASTM and am extremely flattered to be chosen as Chairman of the Board of Directors for 2019.
RLS: Our subscribers work in chemistry and life science laboratories. How will ASTM impact them?
TM: Metrology, including reproducibility and accuracy, is a key issue today in life science research, cannabis commerce, and pharmaceuticals and vaccines. Reproducibility between results from different laboratories is a particularly difficult and frustrating problem. ASTM’s consensus-building program for standard assay methods is focused on mitigation of this issue. ASTM provides a forum for stakeholders to meet to develop metrology protocols to support the needs of the various stakeholders including buyers, vendors, and regulators. These protocols help the world work better. The tremendous range of topics in ASTM Methods attests to the needs and our success in providing help.
RLS: ASTM began offering proficiency testing (PT) several years ago, and the programs are designed to improve the performance of laboratories and data quality. Please discuss.
TM: Yes, this is a relatively new endeavor. We found that lab managers did not know how well they had done in implementing a protocol, even when they followed a particular ASTM method. Standard reference materials are one step, but often not enough. Then there is language. Method transfer to another lab can be difficult, and mainlining the parity over time is a challenge. Add in other factors such as supporting instruments, different water supplies, etc. It is not easy.
The ASTM PT program already involves over 50 different topics ranging from assay of sulfur in diesel fuels, cauterization of polyethylene, gases in transformer oils, etc. For example, samples for sulfur in diesel are sent out according to a monthly schedule. The lab assays the sample, usually by X-ray, and reports. After the cut-off date, ASTM aggregates the responses and compiles the mean and standard deviation. Then an individualized report is sent back to each participant showing their performance compared to the blinded entire cohort.
This service is invaluable in assuring all stakeholders that their commercial or process specifications are being met. In response to initial success, we are actively expanding this program.
RLS: In your position, you must see unusual problems. Are there any you can talk about?
TM: Yes, it is in D02, which is petroleum. ASTM was founded in 1898, and assays for petroleum were some of the first. Lead in gasoline is an example of an assay that is out of date, since lead is no longer permitted due to well-known toxicity. If we strictly followed our own s8 year sunset clause, Method D5059 (Standard Test Methods for Lead in Gasoline by X-Ray Spectroscopy), with the last review in 2014, would be withdrawn in 2022 due to non-use.
However, lead has been replaced by manganese, which is much less toxic. The problem is that many jurisdictions have codified the ASTM Method number in local regulations. Changing the number would take several acts of Congress and legislative bodies. Most of the current members were not living when the original lead regulations were written. They implore ASTM to update Lead in Gasoline to include Manganese in Gasoline as a new section to the existing, obsolete protocol. This would give the laboratory the option of measuring manganese rather than lead. This solution is very unusual, but we may do just it.
Sustainability is another issue of growing importance that I’m personally interested in.
RLS: Please explain.
TM: The United Nations has listed 17 points of concern regarding sustainability of our world. Several of them fall into the focus of one or more ASTM committees. For example, polymers are beginning to pollute the oceans. The scope of one of our committees is on classification of pieces of polymer using carbon isotope ratios to aid in polymer recycling.
RLS: Are you concerned about the health of ASTM?
TM: Several members of the board are concerned about the antitechnology attitudes from the public. Part of the problem is that political leadership can appeal to technology-naïve individuals. They do not understand or appreciate new technology. Worse, they distrust what they do not understand. Some political leaders seem to see an opportunity to appeal to these marginalized constituents. This is a real communications problem for ASTM. We know that science-based regulation is effective in improving living conditions, including safety.
RLS: Any other large issues?
TM: Look at the members of the work groups. What do you notice? The members qualify as experts in their field. Ask them a detailed question, and you can probably find several in the group that can talk knowledgeably about it. But what comes with such experience? Age, of course.
Several past chairs have also shared this concern. How can we get younger people involved? Three years ago, we started a new professionals program to encourage recent graduates to participate. We reviewed progress this week. I’m pleased to report that 84 young professionals have been invited to join ASTM and more than half have already assumed leadership positions as staff or committee members. This is an outstanding success. We will continue to actively recruit newly minted professionals with interest in our committees.
RLS: How did ASTM decide to add a Cannabis Committee?
TM: This decision was made easier by a confluence of two factors: need and opportunity. The need was expressed by a multitude of requests for assay methods for cannabis, particularly medicinal cannabis, from many of our members, especially in the U.S.A. The opportunity was presented by Dr. Ralph Paroli, who preceded me three years ago as chairman of the board. Ralph was and is still director of measurement science R&D, National Research Council of Canada. His team is working on a countrywide program supporting legalization of cannabis in Canada. Stage one started on October 17, 2018 and needs to be in place and fully operational by October 19, 2019. This is a tremendous challenge and opportunity for ASTM to provide leadership in what will certainly be a large global business.
The board sees an opportunity to provide global harmonization of cannabis standards, assays, and indirectly regulations—all this while the biggest market, the U.S.A., is fragmented with conflicts between stakeholders. It will be especially hard to convince many customers about the value-add for assured safety and efficacy.
Personally, I’m pleasantly surprised by the interest in ASTM’s nascent program. D37 now has over 600 members, which is double the count in June 2018. The subcommittees are active and starting to produce drafts of guidances, standards, practices, and methods. Much of this is accomplished with the cooperation of other organizations such as the AOAC, USP, American Herbal Pharmacopoeia, and Europe’s International Cannabis and Cannabinoids Institute (Czech Republic).
I see that ASTM D37 shares my vision of providing all stakeholders in the cannabis sector a series of work products generated from the common interest of stakeholders that will make the cannabis world work better. It is truly a unique opportunity.
Robert L. Stevenson, Ph.D., is Editor Emeritus, American Laboratory/Labcompare; e-mail: [email protected]