Fresenius J Anal Chem (1995) 352:3-4

Fresenius' Journal of

© Springer-Verlag 1995

Editorial

Use, abuse, and availability of certified reference materials Peter J. Jenks Promochem GmbH, Postfach 101340, D-46469 Wesel, Germany

I would like to offer some observations from the view point of a distributor of certified reference materials (CRMs), the interface between many users in industry and the producers. For those of you unfamiliar with Promochem, the Group was established more than 17 years ago, and has specialized in providing through our companies in Germany, the United Kingdom, France, Poland, Sweden, and Spain, chemical reagents, solvents, and accessories required by a range of techniques employed in the more demanding aspects of research, development, and analysis. Close involvement with the analysts led us into the supply of certified reference materials needed to ensure analytical conformity and we have become the major European supplier of certified reference materials used in environmental, medical and trace element analysis. We work with the European Community Measurement and Testing Programme (formerly the BCR), National Institute of Standards and Technology (NIST), College of American Pathologists (CAP), Laboratory of the Government Chemist (LGC), International Atomic Energy Agency (IAEA), various Pharmacopoeias, and the World Health Organization (WHO), and others to meet the rapidly growing demand for fully traceable standards and CRMs. In addition to the supply of CRMs we have started to produce our own reference materials (RMs) and CRMs with the cooperation of IPO and LGC. We also distribute pharmaceutical reference substances from US, European, French, and British Pharmacopoeias and the WHO, together with the production and supply of high purity solvents needed for HPLC and environmental analysis. So we have a fairly good feel for what is going on, at least in Europe. Since the middle of the 1980's sales of CRMs by Promochem have increased between 10% and 20% annually depending on the market sector and application. What has driven this growth? In addition to real growth caused by the intelligent use of CRMs by informed and aware scientists, there has also been what might be described as negative sales influences including: Laboratory Accreditation and "Quality Systems", which together make lab managers look for added security and thus lead the less confidant to fall back on the best available standard. The result is that a CRM is often used instead of a working standard because they are not able to reliably use the CRM to validate their working standard.

Inappropriate Pricing by Producers. There are still some certification organizations (maybe all of them!) who issue CRMs without any regard for the cost of production or the perceived worth of the material. We then find customers using the SRM because it is "better and cheaper" than the commercial secondary standard. The results are situations such as happened in 1991/92 in Holland when a new requirement for within batch control for use by Dutch environmental laboratories resulted in the rapid depletion of BCR CRM 142, 143, and 146. It is worth noting that the BCR priced the replacements at 2.5 times the originals! Nothing Else Available. When there is no commercial working standard, and there is a CRM available, most commercial scientists will not bother to spend the time and effort characterizing an in-house standard. There is no doubt that this rate of growth will continue. What can the CRM producers do to meet the challenge? Firstly, be as commercial as possible. This means where resources and technology allow, make a reasonable sized batch since the work and costs are generally not directly linked to the volume produced (i.e., the analyses to certify are typically the most costly). A batch of 1000 to 4000 units is suggested. When the production breaks new ground and there is both a limit to how much can be produced or there is an enormous pent up demand, do not sell the material too cheap. Secondly, look at the prices that commercial chemical companies charge for similar commercial standards and make sure that your CRM carries a premium. The issue of secondary standards needs to be addressed. Perhaps there is a valid argument for limiting the availability of CRMs. However, there is a need for good materials, produced in bulk and subjected to stringent analysis with data that are traceable to a primary CRM. The U.S. Environmental Protection Agency (EPA) attempted to solve this problem for environmental standards with their CRADAs, but with the EPA certification program ending, will the void be filled by NIST and/or other similar organizations? One paper at the symposium described the NIST Traceable Reference Material (NTRM) program for gas standards which offers a solution to the problem of commercial production of the necessary traceable secondary reference materials. It seems to be limited to only gas standards, but now when EPA Certification is ending can NIST fill the void?

Another route to secondary CRMs is the multilaboratory collaborative study through performance testing. It seems sensible to utilize all the work that goes on every month in countless laboratories around the world testing blind standards as part of performance testing programs to produce a stock of material that could have statistically valid values assigned and then be used as within batch control material. If NIST, IRMM, or similar organizations could set the standard for such materials then so much the better. The College of American Pathologists already do this in many respects for the clinical chemistry community; perhaps the environmental analytical community can learn from them. There is a need to coordinate a "wish list" for new reference materials, and during BERM-6 we have had some discussion on that topic. - A house CRM, i.e., building rubble certified for toxic metals and pesticides; - Many more natural matrices for organics; - Nutritional and food industry-orientated CRMs, especially animal feeds certified for toxic metals, prohibited additives, and nutritional information; and Plastics, certified for identity, toxic metals, and plasticizers. Most of the requests have their origins in some sort of legislation, which when enacted and interpreted by a bureaucrat results in a laboratory somewhere having the need to measure a particular parameter, and.., surprise, surprise.., there is no standard available. To make matters worse, the laboratory trying to do the work is accredited and their procedure book makes an external reference material desirable, so they phone us! Unfortunately, most of those requesting special CRMs have little appreciation of the time scale for development and production, so we will all have to second guess the legislators if we are to have the CRMs needed to meet the new laws. To be fair the BCR/Measurement and Testing Programme are very much aware of this issue, and much of what they have done over the life of the BCR program has been aimed at solving this problem. Having CRMs available is only one thing, getting them is another. During BERM-6 we heard sometimes emotively of the difficulties scientists working in devel-

oping countries face in trying to obtain CRMs, and in educating their colleagues in the need for and correct use of the CRMs. It is not only those working in the developing world that face difficulty and obstruction from Custom's and Quarantine officials; their colleagues in Europe and Australia can be just as helpful. It all depends on the tariff number. All materials that cross most international borders must be accompanied by a document (or maybe 20!). One of the key pieces of information on that document is the customs tariff number. A number of matters depend on the correct allocation of the tariff number to the product, most importantly the rate of import tax and the speed through customs. Unfortunately there is, so far, no specific number for CRMs. We heard that out of the last GATT round will come a specific number, but until then the allocation of a customs tariff number is subject to interpretation. For most producers, tariff number 382 200 00 0 seems to fit the bill; it is not perfect, but it is the best there is. Interpretation always results in more than one possible view point. For example, in one EU country the customs department has spent nearly six months deciding that this number is, after all, the most suitable number for NIST CRMs. During this period of review they insisted that, for example, NIST Total Diet should be coded as a food material! Fortunately, it proved possible to import the materials through another EU country where the customs authorities accepted 382200 00 0 as the tariff number, and of course once in the EU the materials could be transferred to the difficult country without further problems; however, the cost in time and argument cannot be ignored. I will not continue about the problems of currency controls, or bank charges; suffice to say that they do not help the situation. Indeed for many individual users, especially those in heavily regulated markets, importation of one or two CRMs will cost more, often twice or three times more, in freight, duty customs clearance charges, and bank charges than the cost of the original CRM. Volume and experience help smooth the supply between producer and user.