Expect the Unexpected in Bottled & Beverage Water Purity - and Regulations

We all understand the Environmental Protection Agency regulates drinking water in the United States, but that the Food & Drug Administration regulates bottled and beverage make-up water. Most of us know the FDA inspects bottling plants for compliance with current good manufacturing practices (CMGPs), and may review treatment processes and equipment used. Some of us are aware that when the EPA adds a substance to its primary list of regulated water contaminants, the FDA must add a new limit for it within 180 days. Fewer of us are aware the FDA has the right to sample and analyze beverages and bottled water for known and suspected contaminants. But, what is known and what’s suspected is a matter of what was discovered recently - too often by accident. The smallest group is probably those regulatory affairs people at major bottlers and equipment suppliers who know the regulatory definition of “adulteration.” The risk-averse bottler and equipment manufacturer will ask themselves what they can do to stay ahead of the contaminant learning curve.

Let’s review some examples. The initial contaminants of concern in bottling water were microbes, for which ozone offered an effective solution. That’s until the EPA targeted disinfection by-products and started focusing on bromate levels and formation mechanisms. Some was good, more was not better. Ozone is still used commonly but in a more refined way; combined with submicron filtration (more on filter media later). The bromate problem looks predictable and even obvious in hindsight. Another example is arsenic; the limit in bottled water was just lowered to 10 ppb. No problem anticipating that - arsenic has been on everyone’s radar in the United States for quite a while - and the horrible story of arsenic poisoning from “tube wells” in Bangladesh illustrates just how easy it is to miss the obvious. The latest contaminant problem in the bottling industry is benzene, a carcinogen formed by predictable chemistry from commonly added preservatives. This was a surprise when it was first discovered, although when that was, and what the response was, is a matter that may become controversial due to recent litigation.

In any case, an ounce of prevention...

What’s the next contaminant, or source of contaminants, the bottling industry can expect? It’s hard to say, but perhaps not difficult to know where to look. The plastics industry continues to create new chemicals almost weekly, some intentionally and some as reaction by-products. In addition, there are always new - or newly added - structural additives, surface modifiers and processing aids. The obvious place to look first is at bottle materials, and therefore the industry has studied these carefully. But what about other polymeric surfaces water comes in contact with? There are separations media (filters, membranes, and ion exchange resins), tanks and pipes and their linings, pump casings and impellers, and more. New materials and processing improvements are routine in the water treatment industry. How are they evaluated to assure they’re not adding contaminants? One well-known avenue is through ANSI/NSF standards certification, which typically includes a materials safety component. But will simply following the minimum process there find all potential contaminants: It’s a voluntary program, and tests are predicated on information supplied to the certifying bodies’ labs, often by a company that’s not the basic materials producer. The results are also limited to analytical capabilities of the certifying labs (NSF, WQA, UL, PACE, CSA, etc) and what they’re looking for. A good system, but not necessarily one that will catch everything that a proactive manufacturer would. Or what a bottler could prevent if it had a program to evaluate its equipment suppliers’ materials, their engineering change processes, and their materials safety assurance program.

It’s always a better experience to find your own contaminants than to have the regulators do it for you.

About the Author: David J. Paulson is an industry consultant and partner in Water Science and Marketing LLC, based in Cedar, MN, near Minneapolis. His 35 year career in water treatment and membrane science includes 18 years at Osmonics Inc. as research and development director. He also held positions in design engineering, manufacturing and quality control management, and as director of both intellectual property and regulatory affairs. He most recently served as global product stewardship leader for all GE Water equipment and component products. Contact: [email protected].