During a recent search for a new apartment, I was presented with some sharply contrasting options. One had a balcony overlooking the carport and dumpsters, while the other had a view of umbrella-shaded tables and lounge chairs surrounding an oval shaped pool. It doesn’t take a lot of brain power to figure out which one I chose. I can now look out onto usually placid waters that make me feel like I have a lakefront property. You can imagine my surprise when I looked out the other day to see that the pool was totally empty -- not only of people, but also of water. There was a notice that the pool was closed indefinitely. It turns out that, following an inspection by the local health department, the pool was deemed unsafe. It needed to be drained and cleaned, and the underwater light (that I had never seen a flicker from) needed to be fixed. After a thorough scrubbing and a multiday refill, the pool was back in service. What this episode drove home for me was not only how much of a pain it can be to maintain a pool, but also that, even when it looks pristine, there are things lurking just below the surface that can be detrimental to your health (watch this webinar for insights into toxic pool disinfection byproducts). It also made me consider that we can often take for granted all the rules and regulations developed over the years to ensure our safety on a daily basis.
As the above illustrates, regulations are needed to assure us that the pool or stream we are swimming in is safe, that what we are buying at our local supermarket is what the label claims it to be (e.g. lactose-free [CAN72633]), and that the water flowing out of our taps is suitable for drinking (see Water Regulations for more info). While almost ubiquitous, the creation of regulations is far from trivial and is often the culmination of many years of effort that took into consideration such factors as the impact on human health from exposure and the economics of testing. This latter aspect requires the development of analytical methods that can be readily adopted by producers and regulatory organizations to verify compliance. Methods can be developed by regulatory organizations (such as EPA Method 557 [AN630]), but in many cases they are developed by groups that are not directly involved in enforcement. A case in point is American Society for Testing and Materials (ASTM) International. In this organization, the collaborative effort of multiple stake holders (e.g. instrument manufacturers, third party testing labs, regulatory agencies) is used to develop new methods to meet an identified need. An example of one such need, in an industrial setting, is the determination of halogens and sulfate that are potentially corrosive to engines and storage vessels (ASTM D7359).
Using ASTM International once again as an example, standard methods are usually initiated when an analytical requirement is presented to a committee. If it is considered appropriate and doable, a working group is created to draft a method. Preliminary data is collected using this method and then modifications are made based on feedback from within the group. The refined method is then voted upon by the appropriate subcommittee, who either rejects or accepts it, with or without revisions. It is then voted on by the overseeing committee and, if it passes, it becomes official. To verify the robustness of a method there is an additional requirement that an inter-laboratory study (ILS) be completed within five years for it to remain an approved method. Methods are then subsequently reviewed and revised as appropriate taking into consideration technological innovations, etc. every five years.
Thermo Fisher Scientific has been a major contributor to method development in collaboration with organizations that include the ASTM, U.S. EPA, FDA, ISO, USP, and AOAC, to name just a few. The roles played have included chairing committees, being technical leads, drafting and revising methods, and participating in ILS.
Awareness of the many steps that are required to develop and have approved a standard method has heightened my appreciation for the effort required for their realization. It takes not just determination, but also a considerable amount of time. So if you need a method developed and approved any time soon, you’d better get the ball rolling. Better yet, consider volunteering your expertise to help make new ones happen even sooner.