By Rick Andrew

Government regulation is a reality for many aspects of our lives, with POU/POE products being one such aspect. In addition to US requirements involving state certifications in three states (California, Iowa and Wisconsin), US EPA regulations for devices considered to provide pesticide functions, lead content limitations in several states and soon the entire country, many other countries around the world regulate POU/POE products in various ways.

It is no small task to keep track of these regulations because they can be promulgated from so many potential government agencies, and promulgations can be announced in so many different fashions. Additionally, regulations can address many different aspects of the products, can spring up from an almost infinite number of possible starting points, and can come about even when we believe that adequate regulations already exist. We see this in the US also; a case in point is how lead content regulations were adopted despite existing standards and code requirements for assessing material safety for water contact of materials and products.

A very interesting example of this is the development of CSA B483.1. Concerns arose that the existing NSF/ANSI POU/POE standards did not adequately address plumbing-related issues, such as life-cycle testing of inlet valves and testing the ability of ion exchange system brine tanks to prevent overflow if the system control valve were to get stuck in the brine refill position. So, the Canadian Standards Association (CSA) assembled a committee to develop CSA B483.1 to become add-on requirements to those in the NSF/ANSI DWTU standards. And now, after several years, Quebec is requiring certification to CSA B843.1, with the upcoming Canadian national plumbing code to reference CSA B483.1 by 2015.

Spectrum of potential scenarios
When it comes to international requirements, there are multiple possibilities, the simplest being the case in which there are no regulations at all. Many countries around the world have absolutely no requirements for testing or certification of POU and POE products. There may be some loose or implied regulation under consumer protection laws, but no direct regulation on the products themselves. Some countries have adopted standards for products, but conformance is voluntary. Taiwan is a good example. The Bureau of Standards, Metrology and Inspection (BSMI) in Taiwan has adopted nearly verbatim NSF/ANSI 42, but there is no required certification.

In Europe, there is a whole family of technology-specific European norms for POU and POE systems, somewhat analogous to the NSF/ANSI Drinking Water Treatment Unit (DWTU) standards. These standards address structural integrity, contaminant reduction and product literature; however, no European countries have instituted mandatory certification to these standards. Many countries do have material safety requirements, though. Examples include the Water Regulations Advisory Scheme (WRAS) in the United Kingdom and Attestation De Conformite Sanitaire (ACS) in France. WRAS involves type testing of materials for acute health contaminants as well as testing for indications of microbiological growth, and physical testing of complete systems (referred to as fittings under WRAS). No formulation disclosures are required for materials. ACS, on the other hand, requires that materials must be on a ’positive list‘ of acceptable materials and does require a very detailed formulation disclosure for each drinking water contact material, along with migration testing and testing for aesthetic issues, such as odor and flavor.

Some countries have required approvals addressing multiple aspects of the products. China, for example, has requirements through its Ministry of Health (MOH) for evaluation of material safety and product function. Brazil requires testing and certification by an InMetro-accredited certifier of both plumbed-in and gravity-fed products for migration of chemicals and contaminant reduction. And Australia requires the WaterMark for POU/POE products, utilizing essentially the NSF/ANSI DWTU standards, with some additional requirements such as dezincification testing on brass parts, backflow prevention and performance indication.

Acceptable laboratory data
Those countries with mandatory requirements tend to specify the credentials for acceptance of laboratory data. Some, such as French ACS, require testing by an in-country laboratory. China requires testing by their Center for Disease Control (CDC) laboratories. Others require the laboratories to be specifically accredited by the government or a designated accrediting body. For example, laboratories testing for Brazilian certification must be accredited/recognized by InMetro, such as NSF, and the Australian WaterMark may be granted only by certifiers accredited by the Joint Accreditation System of Australia and New Zealand (JAS-ANZ), such as NSF. In other cases, specific laboratories may be recognized as providing sufficient data, such as the Standard and Industrial Research Institute of Malaysia (SIRIM) in recognizing test results from NSF.

Other types of regulation
In addition to direct types of regulation, there are regulatory initiatives that capture POU and POE products along a broader scope. Examples of this include the Restriction of Hazardous Substances (RoHS) and Waste Electrical and Electronic Equipment Directive (WEEE) initiatives in Europe. They are designed to reduce the environmental impact of many different types of products that incorporate electronics and/or specific heavy metals and specific flame retardants used in plastics, and include POU/POE. Another example is Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH), intended to document and limit the importation and distribution of chemicals with human health or environmental impact into and throughout Europe. Electrical regulations and schemes certainly impact POU/POE products requiring power. Proposition 65 in California requires full disclosure for products that could expose consumers to specific contaminants. POU/POE manufacturers have certainly felt the impact of Proposition 65 over the years due to lead- and arsenic-related lawsuits.

Efforts to track regulations
As manufacturing has become leaner, so have staffs that track regulations and ensure regulatory compliance. Coupled with an increasingly international scope of businesses and increasingly complex regulatory environment, this has created definite challenges for manufacturers. Responding to this reality, several different initiatives have been undertaken to try to track regulations and help manufacturers be aware of them and stay in compliance.

NSF has developed the NSF Passport: Your Access to Global Market Approvals program. Under this program, NSF International has achieved JAS-ANZ accreditation, allowing NSF to issue the WaterMark directly to manufacturers; in addition, NSF is accredited to ABNT NBR 14908 and ABNT NBR 15176 to offer testing to the Brazilian InMetro requirements. NSF is majority owner of WRc-NSF, allowing manufacturer’s direct access to a WRAS-approved laboratory. This, along with additional relationships, allows manufacturers to seek assistance in understanding the global regulatory compliance landscape and maintain compliance with it.

WQA has long sponsored the International Standards and Regulations Task Force, specifically designated to track this issue. Recently, the Task Force has documented the most important information being tracked in a spreadsheet available to members on the WQA website at www.wqa.org.

Over the coming years, this global regulatory landscape for POU/POE products will only become more complex. These tracking, informational and assistance efforts will become increasingly more valuable and important for manufacturers working to stay lean and stay in compliance.

About the author
Rick Andrew is the General Manager of NSF’s Drinking Water Treatment Units (POU/POE), ERS (Protocols) and Biosafety Cabinetry Programs. He has previously served as the Operations Manager, and prior to that, Technical Manager for the program. Andrew has a Bachelor’s Degree in chemistry and an M.B.A. from the University of Michigan. He can be reached at (800) NSF-MARK or email: Andrew@nsf.org.

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