By Tina Fischer, CWS-VI
It takes time, effort and a bit of genius to manufacture a reliable product to protect the general public from lead, cysts, mercury and the many other contaminants that come into contact with drinking water. When the production has been perfected, product launch is key. Meeting specific launch dates is essential to success in the marketplace. Conscientious manufacturers will subject the new product to rigorous industry third-party testing to obtain NSF/ANSI accredited certifications. These tests verify a product’s material(s) safety, performance and structural integrity. The collateral literature for these products is examined with a fine-toothed comb to ensure that they are free of false and/or misleading claims in association with its certification. The process is simple, but very time consuming. So why, you might ask, must a manufacturer go through an almost identical second submission process when products making health claims (this must be in here because CA. only takes applications for products that make health claims)are to be sold in the state of California? Delaying product launch even further, the submission to California follows the completion of NSF/ANSI certification. In fact, at times, this two-stage process delays launch dates for months, unnecessarily.
California maintains regulations that provide public safety protection as a valued requirement. The California Department of Health Services (CDHS) has always taken tremendous pride in ensuring that drinking water treatment device requirements are met. A thorough review of each device submitted for certification in its program occurs even if the device has previously undergone independent third party testing and certification. The Water Quality Association (WQA) is happy to announce that negotiations are currently underway to streamline the California device registration process for those products that already meet the NSF/ANSI 44 (Cation Exchange Water Softeners) and NSF/ANSI 53 (Drinking Water Treatment Units – Health Effects) Standards through an American National Standards Institute (ANSI) accredited certifier.
The key factor is ANSI accredited
ANSI accreditation ensures that the body that issues the certification is capable, competent and does not hold any bias with respect to issuing the certification. In order to become an ANSI accredited certification agency, the certification body must go through a lengthy three-day initial assessment that includes in-depth reviews of the certification body’s files, quality records and everyday processes. Upon ANSI accreditation approval, annual follow-up inspections are conducted to monitor the certification body’s consistent dedication to maintaining a sufficient program. These ongoing assessments range from two to three days in duration. For this reason, CDHS has opted to only enter into negotiations about the streamlined process with agencies that have already successfully obtained ANSI accreditation. WQA is currently an ANSI accredited product certification agency and is aggressively pursuing an agreement with CDHS to make (we cannot have this word in this article because we cannot imply that our members have special treatment)California-specific certification needs practically effortless.
What does this mean for you?
If your company has ever applied for device registration in the State of California, you know that currently, completing a California registration is time consuming — both for you, the manufacturer, who must submit all the required paperwork, and for the state of California, where the review of the application is a very lengthy process. Parts of it duplicate the procedure you endured to obtain NSF/ANSI 44 or 53 certification. Currently, in order to submit to California, manufacturers are required to fill out an application that includes documenting each and every test report number used to certify the unit, provide the technical justifications used as applicable for certification of units that did not undergo complete testing and provide copies of all literature (including sales material). It is a lengthy, paper-intensive and burdensome job to assemble an accurate and complete packet of information to submit. And who has extra time to push papers?
The new process, when adopted, will allow manufacturers to eliminate most of these steps when the device being submitted for CDHS certification already holds an ANSI accredited certification according to NSF/ANSI 44 or 53. The CDHS and accepted certification agencies will maintain a direct line of communication so the hassles of making copies will be a thing of the past. Preliminary talks have proposed that new process be as simple as providing CDHS an application, the ANSI accredited listing (printable from all ANSI accredited certification agencies’ websites, www.wqa.org, for example) and the required fees. That means you will not be required to put together stacks of duplicative supporting materials for submission anymore.
Additional California requirements
Part of the agreement between CDHS and each certification agency will include issuing final certification only when all requirements, including those that are California-specific, have been met. Some of the additional requirements you can expect to see when registering a device with the state of California include the following.
CDHS’ certification number/certificate: When a product is approved for sale in the state of California, a product-specific number will be issued as its certification number. This number is required to appear on each product’s data label. In addition, a legible copy of the complete California certificate is to be included as part of the performance data sheet (PDS). The certificate may be included as part of the PDS or as an alternative option, it may be simply attached to the PDS in whole.
California specific literature requirements: California also has some specific requirements that must be included in the product literature that are not represented in either of the standards. The data label must include the following statement, “For conditions of use, health claims certified by the California Department of Health Services, and replacement parts, see product data sheet.” Further, the PDS requirements are slightly more specific in that temperature shall be recorded in degrees Fahrenheit and Centigrade while pressure requirements must be recorded in both pounds per square inch and in kilograms per square centimeter. The final specific requirement that will need to be on the PDS is the approximate cost for the replacement components.
Literature cautions: California regulations are very particular regarding statements of claims that are absolute and or too broad. There are six specific examples that, if found in your product literature, will keep the product from being accepted by CDHS:
- Using the word remove must be clearly defined. This word cannot be used without clearly identifying the percent reduction in which the unit is capable of reducing.
- Generalized claims are not allowed. For example, stating that the filter reduces herbicides may not be used, even in instances in which other literature is referenced to point out the specific herbicides which the product reduces.
- Implied health claims cannot be used. Independent studies cannot be referenced to imply that exposure to certain contaminants, that your system reduces, will result in higher incidences of a disease. Further, health claims that have not been approved through testing and certification cannot be referenced in literature even if you believe that the system will reduce them.
- The word pure in any form should not appear in California literature. Using words such as treat and or reduce are acceptable substitutions. CDHS is insistent that the use of the word purifier is solely allocated for systems that have been certified for the reduction of bacteria, virus and cyst.
- Claiming that your replacement element may be used in another manufacturer’s system will not be tolerated by CDHS. California certification is based on your complete system including the filter cartridge and device as one unit.
- Bacteria reducing capabilities can only be claimed if the system was tested according to a protocol that has been previously approved by California. Bacteriostatic testing does not fall under this category.
The good news is that WQA already looks for the general items to review through its Code of Ethics literature guidelines. Because WQA employees are well trained to spot these occurrences even for a NSF/ANSI standard certification, there will not be a learning curve to endure once the process is accepted. Further, because WQA already offers all manufacturers the service of submitting applications to California for registration for them, processes and procedures are already in place to include these additional requirements and staff has been trained to look for the additional statements when conducting a literature review for a product that has been marked as for future sale in California. WQA is at the forefront of adapting a process that will provide manufacturers with the certifications they need without duplicating work.
WQA…the right choice for you
Is it too good to be true? Can the time of California registration taking months to complete be a thing of the past? Keep your fingers crossed – WQA is working hand-in-hand with CDHS to ensure that this more simplified process makes it through the negotiation stages and becomes a reality in the near future. Be sure to get your products submitted now for NSF/ANSI standard certification. Once the agreement is official, WQA will continue to aid you in completing the California application, or complete the new process for you.
About the author
Tina Fischer, CWS-VI, is the Product Certification Supervisor for the Water Quality Association’s Gold Seal Program. She has worked for the Water Quality Association for six years and in that time has developed the Gold Seal Program into an organized ANSI and SCC accredited program. To obtain additional information about the Water Quality Association’s Gold Seal Certification Program, Fischer can be contacted at WQA by telephone (630) 505-0160 ext. 533, Fax: (630) 505-0752 or email [email protected].