Volume 47 Number 10
Rationale for Change in California Water Treatment Device Certification Program
STATEMENT OF THE PROBLEM
The California Water Treatment Device Certification program (WTDC) reviews and certifies in-home water treatment systems for which health-related contaminant removal claims are made. These products range from faucet mounted filters to whole-house systems used for nitrate and arsenic removal. They are increasingly popular items for California consumers seeking to remove contaminants to a point lower than established Maximum Contaminant Levels. This includes household devices as small as faucet mounted filters and as large as an appliance used for nitrate removal.
The program needs to be reevaluated for the following reasons:
* The number of products submitted by manufacturers for certification has quadrupled since the programs inception even as staff has been reduced. The Department of Health Services (DHS) program cannot keep up with the demands being placed on it. Over the last few months, the situation has worsened. DHS staff is backed-up and it is causing expensive product delays, missed production deadlines and other operational problems for manufacturers who end up absorbing the sizable costs associated with the uncertainties of the California device certification program.
* DHS Policies in this program are sometimes confusing and inconsistent. For example, one manufacturer was told (after it submitted an application) that it could no longer use a literature format that it had used (with DHS approval) for ten years. Its application was held up until the company reprinted all its product materials at a cost of nearly $2 million. Similarly, the California program held back applications by several companies because they did not comply with a new DHS web site policy that we do not believe had ever been announced or written down.
* It now takes staff months to begin an initial review to judge an application package complete or incomplete. Current regulations set a limit of 45 days for this action and if the application is complete, another 90 days for processing. The current processing time has climbed well beyond this 135 day timeframe, reaching up to six months in more and more cases.
* These delays are costing some manufacturers millions of dollars in lost sales, delays in production, tooling and redeployment of employees. One manufacturer alone estimates these delays cost $300,000 to $400,000 per week per product.
* The inefficiencies of an outmoded system are glaring. When a testing protocol or justification is new or flagged by DHS staff for review, it can sit for weeks without being forwarded for review. To make matters worse, the companys project manager who submits the justification or protocol has no access to this expert reviewing it. Because most of the DHS engineers are trained to work on municipal systems and not home treatment devices, most submissions flagged by non-engineering device certification staff require little more than a short five-minute explanation from the manufacturer. Instead, communications can drag on for weeks, even months.
* Manufacturers now wait until the completion of a product review to be assigned a certificate number. By the time manufacturers receive the final certificate number and print it on packaging and product information sheet, several more weeks are added to the over-all process. A simple notification of sale with an ANSI certification should be all that is required for California to list a product on its consumer information website.
* Manufacturers are rethinking the California market and cutting back on the number and types of products they have certified by DHS. Compared with consumers in other states, the California consumer has a limited choice of products and innovative technologies as manufacturers reduce California product lines. This is especially difficult for small California manufacturers who have fewer resolves than larger ones.
This situation is abnormal and begs to be fixed. We think it can be. It is the very success of the WTDC program in accomplishing its goals that make the solution necessary and possible. The program has driven professionalism within the water treatment industry to such a degree that close to 100% of products submitted for certification to California have already been put through the rigorous testing protocols of an ANSI-accredited certification program. This was not the case 15 year ago. The ANSI-accredited certification programs offer virtually identical programs to what is called for in California. We present logic and reasons for a major change in conduct of this program by CA DHS.
"The department may accept a water treatment device certification issued by an agency of another state, by an independent testing organization, or by the federal government in lieu of its own, if the department determines that certification program meets the requirements of this chapter."
Yet with such clear authority for the use of private sector based third party certifications the California Department of Health Services (CA DHS) has not accepted any such independent certifications in lieu of its own program for drinking water treatment devices, while at the same time the DHS does recognize certifications by third party ANSI-accredited organizations for all water contact products used in public water systems. Water treatment device manufacturing industry members do not oppose the California certification programs: however they strongly feel that DHS must give credence to this portion of the law as passed by the California legislature.
CALIFORNIA LAW Vs ANSI/NSF STANDARDS
The California law (S.B. 2119) defines minimum standards for the specific factors to be regulated by the DHS. They are as listed below:
1. Performance requirements
Each of the ANSI/NSF standards has comparable specific sections matching each of those specified in the California law and covering the following factors:
1. Materials allowed, toxicology reviews, and materials safety extraction testing
These sections are functionally equivalent to the requirements spelled out in the California law as shown above. ANSI accredited certifiers use these standards and protocols to certify water treatment devices making health related claims.
All ANSI/NSF standards are developed following a very formal and open procedure set in place by the ANSI-accredited procedures and policies. A committee made up of essentially an equal proportion of members from industry, users, and regulatory groups develops the detailed standards. Each of the standards is then reviewed and approved by an independent regulatory group prior to adoption and final release for use by all interested parties in the public domain. All but two of the seven ANSI/NSF drinking water treatment unit standards address health related contaminant reductions.
ANSI ACCREDITATION OF CERTIFIERS
The American National Standards Institute (ANSI) accredits organizations as certifiers of product conformity assessment. The assiduous procedure to achieve accreditation by ANSI is a comprehensive 30-step process with an independent committee at ANSI overseeing the program and the final outcome. Five organizations are accredited by ANSI to carry out product conformity assessment of Drinking Water Treatment Units per the protocols in the ANSI/NSF Drinking Water Treatment Unit Standards, as well as for the safety of materials used in water treatment systems per ANSI/NSF Drinking Water Additive Standards (60&61).
* CSA International (CSA)
The ANSI accreditation process is the procedure by which ANSI gives formal recognition that an organization is competent to carry out specific tasks in accordance with requirements defined in International or American National Standards.
* ANSIs assessment is a very comprehensive procedure that provides assurance to consumers and regulators when products are evaluated following the ANSI-accredited procedures against the requirements of the approved health standards. ANSI's annual audits of the accredited organizations insure conformity across the board. The ANSI procedure insures independence of the certification and testing program. Product certification thus attests that a product meets specified standardsespecially for quality, safety and health issues.
* A certification mark provides unique credibility when granted by an independent third party that is accredited under a globally-recognized process. An ANSI-accredited certification mark carries a distinct message that a product certification program has been thoroughly evaluated in a respected manner and can be completely trusted.
* ANSI is also involved in several international and regional arrangements for mutual recognition of equivalency across boundaries. As a result, many of the ANSI-accredited certification programs are recognized as equivalent to commensurate programs around the world.
With such detailed and formal procedures involved, any organization achieving such accreditation has every reason to be proud of its achievement. It strives to make sure it meets the ongoing requirements of ANSI to maintain its policies and procedures independent of any bias and void of any errors. Thus ANSI-accredited bodies can be relied upon to provide credible product certifications.
CONCLUSIONS AND RECOMMENDED SOLUTION
Evaluation of these facts must lead to the natural conclusion that a product that has been certified by one of the ANSI-accredited organizations should be accepted as in compliance with the California Water Treatment Device Certification Law. The current practice of re-certifications by CA DHS requires manufacturers to wait unnecessary and very disruptive additional months after all product development and testing is completed before beginning to market and sell their merchandise. Industry manufactures now report that they must shut down and place their production and marketing plans on hold for additional months to await California DHS reviews and approvals. This unreasonable holdup costs millions of wasted dollars every year. We are recommending that DHS rather focus on collecting the necessary fees to maintain the States register of products, auditing the certifiers, and enforcement of required ANSI-accredited certifications. Following are worthy points for consideration and action:
* WQA believes any risk to public health lies more with a program so overwhelmed with certification demands that market oversight and enforcement efforts falter than with an ANSI-based certification process. Most importantly, the law anticipates and permits DHS to use the testing and certification by third parties and other states.
* The ANSI/NSF standards set the requirements essentially the same way as the California law requires. ANSI standards and accredited certifications cover the same factors spelled out in the law in a detailed manner.
* ANSI-accredited certification programs achieve the same purpose as that provided by the California Water Treatment Device Certification Law.
* ANSIs accreditation program is very formal, detailed, and internationally recognized. If the American National program and accreditation is recognized in other parts of the world making the ANSI-accredited US made products accepted worldwide, it is unreasonable and contradictory to refuse to accept the ANSI program and to require that products meet separate and unique individual state requirements. (Again, California DHS does not operate approvals of the drinking water contact products used in public water systems this way, where certifications by ANSI accredited certifiers to the ANSI/NSF standards 60 and 61 are required and automatically accepted. These accepted certifiers are the same five ANSI- accredited organizations that certify water treatment devices as well.)
* ANSI accredited organizations such as NSF, WQA, and others have been practicing such voluntary testing and certification efforts for many decades. In this day and age when uniform American National efforts by private non-profit organizations are preferred over the potentially untenable situation of different product requirements and uneven delays created by product approvals distinctly repeated at state and local government levels, it does not stand to reason to continue DHSs duplicative and redundant product evaluations that are excessively time-consuming and costly to US industry manufacturers.
* Instead a new DHS program of auditing such accredited certification organizations should be implemented. It would be welcomed by the industry and the certifiers.
* Fees for certifications may continue as required to more effectively administer these oversight activities as well as to more actively participate in the development and maintenance of the relevant ANSI/NSF standards, and to find and enforce against noncompliant products that may exist in the California marketplace.