About Reference Materials and the Evolution of the BERM Series of Symposia (1983-2015)


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Contributed by Peter Jenks, F.R.S.C.; member of the BERM 14 Technical Committee

BERM: a symposium with its origins in Biological and Environmental chemical metrology has evolved and extended its reach over a 32-year lifespan, and now touches almost every field of chemical measurement. Certified Reference Materials (CRMs) have always been at the heart of the Symposium; in particular, their preparation, use and availability. More recently, the scope of the meetings was extended to cover related topics such as Quality Control Materials (QCM), Proficiency Testing (PT) and Accreditation.

At BERM 14 in 2015, there will be presentations and lively discussion about not only chemical but biochemical, pharmaceutical, clinical and microbiological metrology – indeed almost any aspect of metrology that isn’t physical!

Reference Materials
History of BERM: 1983-2015

About Reference Materials

The growth in the use of CRMs and PT over the last 32 years has been remarkable, and has increased seemingly exponentially to the point where it is now a competitive multi-million dollar global business, including a significant portion of publicly funded production and development.

How has this happened? Growth has been driven by the widespread adoption of ISO/IEC 17025 as the quality standard for accreditation and the requirement for such third-party assessments by regulatory agencies in many fields of analytical science. But third party accreditation of testing laboratories is not a new phenomenon; in the EU and some Asia-Pacific countries accreditation of food control laboratories has a long history, as does the accreditation of clinical diagnostic labs in the USA and EU. However, it was only after the release of the current edition of ISO/IEC 17025 in 2005 that demand for accreditation really started to accelerate. This growth, and the resultant demand for CRMs, surprised many, not the least a number of the National Metrology Institutes (NMIs). Some were already struggling to meet demand for their CRMs, and in 1990 a ground-breaking decision had been made to support accreditation to an ISO Guide issued by ISO/REMCO, the ISO Committee on Reference Materials. This allowed producers other than NMIs, and some NMIs, to be accredited to produce CRMs, thus helping to meet the growing demand.

In its latest edition, ISO Guide 34:2009 ‘General requirements for the competence of reference material producers’ is closely aligned with the quality system requirements of ISO/IEC 17025, and links in a number of other reference material-related ISO Guides.

Accreditation to a Guide has always had its critics within some conformity assessment circles. It is argued that a Guide is not prescriptive and may be subject to wider interpretation. After much discussion over recent years, at the ISO/REMCO Meeting in Boulder, Colorado, USA, (2014), it was agreed in principle that the ISO Guide 34 would migrate into an international standard.

History of BERM: 1983-2015

For more than 30 years, the BERM Symposia have been the centre of discussion and debate about the production, use, and sometimes abuse of CRMs. As we approach the 14th meeting in the series it is worth looking back at the formative years, when method validation, ongoing proficiency testing and laboratory accreditation was a specialist area.

We have to turn back to the early 1980s for the start of the changes that took analytical chemistry, and now biochemistry and microbiology, into the regulated and accredited environment we now recognise and which, almost incidentally, created a global business for both the accreditation of testing laboratories and for reference material producers.

Demand for matrix material reference materials for biological analysis, especially food nutrition and quality testing had already started to grow when, in the summer of 1982, Dr Wayne Wolf of the United States Department of Agriculture (USDA) took a trip around Europe by train – no “low budget” airlines then – to find out what the Europeans were doing to develop matrix samples of plant and soil suitable for analysis. He met with Dr Markus Stoeppler, who was then running the Environmental Specimen bank at the KFA (Kernforschungsanlage) Jülich in Germany. His discussions with Markus and others who were working on food and environmental analysis resulted in the conclusion that there was a need for a meeting to talk about the production of matrix reference materials to support chemical analysis of biological materials.

After a suitable gestation period the first BRM – Biological Reference Materials – symposium was organised by Dr Wolf and took place in Philadelphia, (USA), in September 1983. Just 25 people shared 16 presentations on food and nutrition analysis and the proceedings were published by Wiley Interscience.

BRM 1 was considered a success; so, to extend the reach further into Europe, BRM 2 was organised by Dr Stoeppler near Munich (Germany) and took place in the spring of 1986. This event attracted 111 participants from 29 countries and lasted for 4 ½ days. BRM 2 highlighted the distinction between primary CRMs and secondary CRMs, and started a debate which has yet to reach a conclusion. The proceedings, amounting to some 35 papers, were published by Fresenius Zeitschrift für Analytische Chemie.

Two years later Dr Stoeppler organised BRM 3 which took place in Bayreuth (Germany) in 1988, with 115 registered participants from 17 countries, and resulted in 63 papers. One key result was the identification of the need for the production of matrix materials containing analytes at varying levels, raising the issue of fortification or spiking of samples and the associated analytical challenges. At BRM 3 the decision was taken to change the name of the series to BERM, the additional “E” reflecting the rapid growth of interest in Environmental analysis.

The responsibility for organising BERM 4 fell back on Dr Wolf and it took place in Orlando, Florida, (USA), in February 1990. It attracted 100 participants and resulted in 70 papers. A key topic that came out of this meeting was an awareness that the logistics needed to run inter-laboratory comparisons – then a key part of value assignment for CRM production, and were a challenge when dealing with materials that were regulated, especially plant and animal materials. Twenty-four years later, CRM and proficiency testing suppliers are still wrestling with this thorny topic.

A return to Europe resulted in Dr Stoeppler organising BERM 5 in Aachen, (Germany), held in May 1992 with 141 registered delegates from 30 countries who spent 4 ½ days captivated by more than 130 oral and poster presentations. The key result from that meeting was a realization that written analytical methods needed to be supported, or validated, by the use of Certified Reference Materials.

In 1994, BERM 6 was held in the USA – Stan Rasberry, at the time Chief of the SRM Program at NIST, arranged the meeting at Kona, on the big Island of Hawaii from April 17-21. Despite the distance and holiday atmosphere of the location, this scientific event attracted 105 registered delegates from 29 countries, especially from the Pacific Rim, who contributed 110 presentations. The meeting highlighted the growing concern for proper and unambiguous traceability of chemical measurement results and laid some of the groundwork for what became ISO 17025.

Between BERM 6 and BERM 7 we must not forget the first “spin off” meeting, DUERM 1, which took place in New Delhi, (India), in February 1996, to review the developing needs for environmental reference materials in the sub-continent.
The success of BERM 6 meant that BERM 7, organised by Dr Stoppler and Dr Jean Pauwels from the European Commission’s Institute for Reference Materials and Measurements (IRMM) in Antwerp, (Belgium), in 1997, had to scale new heights – it did, and between April 17-21 a total of 211 delegates from 31 countries contributed 182 presentations.

Three years later BERM 8 took place at the National Institutes of Health (NIH) Conference Center in Bethesda, (USA), from Sept 17-21, 2000 and was organised by NIST in association with AOAC International. The involvement of AOAC International was a key development and that organization has been a part of the BERM Symposia ever since. Again a record was reached with almost 250 delegates contributing 187 presentations over 4 days.

BERM 9 took place in June 2003, and was organised by Eurolab along with a team from BAM (German Federal Institute for Materials Research and Testing) in Berlin, (Germany). Led by Harry Klich from BAM, the team prepared for an excellent meeting in Berlin. But the meeting was to be Harry’s epitaph; tragically, he was unable to make the event since he took ill and passed away in September 2002 – he was only 52 years old.

The organisation of BERM 9 was taken over by Dr Pauwels of IRMM who worked closely with BAM and Eurolab, and despite the tragedy it proved to be a great event; it was very well attended, with close to 300 delegates and a contribution of 176 presentations. A striking theme was the number of presentations dealing with reference materials for bio/life science, diagnostic and pharmaceutical analysis.

For BERM, it was time to return to the USA, and BERM 10 took place between April 30 and May 4, 2006 in Charleston, South Carolina. The organization was a collaborative venture between NIST, NOAA (National Oceanic and Atmospheric Administration) and Charleston Events LLC: the involvement of a professional management group resulted in a very successful meeting.

In many ways BERM 11 broke the tradition: up to BERM 10, the symposium had alternated between continental Europe and the USA; but, BERM 11 was organised by the National Metrology Institute of Japan (NMIJ) under the Chair of Dr “Ken” Okamoto and took place from October 29 to November 2, 2007 at the Tsukuba International Congress Center Ibaraki, Japan. By all accounts it was a big success, attracting many delegates from the Asia Pacific region and building on the success of BERM 6.

BERM 12 was held for the first time in the UK, at Keble College, Oxford University from July 7-11, 2009. This time LGC, known as the UK ‘Chemical NMI’, in association with the UK National Metrology System, did all the hard work and the result was an excellent symposium with 153 delegates from 26 countries in attendance. The symposium was opened by the then UK Science Minister, Lord Drayson. Over the three days, the program was made up of 14 sessions, with 69 oral presentations. There was plenty to think about; the use of parallel sessions meant that careful program topic selection was needed. Compared with the last European BERM meeting in Berlin, there was a very noticeable increase in both “bio” and “nano” metrology.

Normally, BERM 13 would have been held in the USA; but the International Atomic Energy Agency (IAEA), a long-time supporter of the BERM Symposia, took over not just the organisation but the financial support, with the result that BERM 13 held in Vienna, (Austria), from June 25-29, 2012, attracted close to 200 delegates and achieved a much wider international audience with delegates from 55 countries, many previously unable to afford to attend BERM.

Now, BERM-14: BERM returns to the USA in 2015, after an absence of 8 years; so there will be much to talk about! The world of reference materials, standards and laboratory accreditation is changing rapidly with a lot happening, or going to happen, over the next 3 years that will have a significant impact on the use of reference materials and the producer community, including:

  • Migration of ISO Guide 34 into a Standard
  • The IUPAC’s critical review of fundamental definitions, including the Mole
  • The full revision of ISO 17025:2005

At the same time the demand for certified reference materials has never been greater; so, there is much unfulfilled demand especially in new areas of measurement science. Therefore, BERM 14 will have a full and exciting scientific program built around some familiar and some less familiar topics:

  • New CRM developments (i.e., new materials, matrices, and analytes).
  • CRMs to support “omics” measurements, e.g., proteomics, metabolomics, genomics, and petroleomics.
  • CRMs for characterization of nanoparticles and nanoparticles in environmental and biological matrices.
  • New areas for CRM development, e.g., microbiology, advanced materials, qualitative analysis (chemical/biological identifications).
  • New approaches to CRM development, with emphasis on approaches for selecting and preparing candidate CRMs.
  • Approaches to chemical purity assessment for CRMs.
  • New analytical methods as applied to CRM certification.
  • Validation of new analytical techniques and methods using CRMs; novel uses of CRMs.
  • Significant applications and impact of CRMs in national and international measurement programs.
  • Role of CRMs in Proficiency Testing and Laboratory Accreditation.

BERM meetings always set the scene for the next 2 or 3 years; BERM 14 will not be different. I urge everyone involved with or interested in any aspect of measurement – chemical, biochemical, pharmaceutical, clinical and microbiological – indeed, almost any aspect of metrology that isn’t physical, to make every effort to join the meeting!

The event dates to record into your diary are: October 11-15, 2015 at the Gaylord National Resort and Convention Center, National Harbor, Maryland, USA.