Comment Submitted by
Joseph Harrison
2008-09-05 18:38:22
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This ballot proposes to prescribe in the standard the NSF interpretation and practice for information that certifiers would be required to obtain is assessing product compliance to the standard - - i.e., “complete formulation information (equal to 100.0%) for each water contact material.” This could negate improved procedures used by other accredited certifiers to achieve comparable and better materials safety and public heath protection through analytical scans that reveal substances in products that are not revealed through formulation information. This ballot’s interpretation relies too heavily on formulation information to identify toxicologically significant chemicals. A Mass Spectrometry (MS) analysis, for example, may not be performed per this proposed change unless a compound from the formulation information indicates MS is necessary. Self-supplied formulation information can be very lacking and incomplete. What about the misunderstandings of sub-suppliers of wetted-parts and ingredients that are two or more levels down the supply chain, the completeness or awareness of what has been the full exposure, for example, to coconut shells or coal seams used to make water filtration media, chemicals that get introduced to the product after its manufacturing formulation, such as in packaging, handling, or transporting, and the general trust of self-declared information that is a determining factor in ones success or failure in product certification? WQA routinely runs complete Mass Spectrometry analyses on all its tests for certifications of materials safety. WQA also checks for substances in the NSF list of High Performance Liquid Chromatography (HPLC) chemicals. Untold many compounds, tentatively identified compounds (TICs), and unknown compounds are regularly surfaced in the WQA procedure, and they each must be cleared via further toxicological assessment prior to WQA’s certifications. The prescribed interpretation proposed by ballot number 61 i77 r1 steps back from this improved interpretation and implementation of the standard.
The other accredited certifiers (UL, CSA, IAPMO, and WQA) voted no to this ballot because certification policies are not appropriate for the product performance standards and because, as Margaret Whittaker of ToxServices LLC voiced in the Joint Committee meetings, there are valid exceptions to the NSF procedures that did not make it into the ballot proposals. The DWTU JC members voted down the Standard 42 ballot with these same proposals in 2007. A number of the DWTU manufacturer members wrote reservations about the benefit, need, cost, and practicality of such added prescription in the standards. Without resolving these concerns or presenting them to the DWA JC, the Standard 61 ballot was issued in January 2008 exactly the same as the Standard 42 ballot was issued in November 2007. As with the Standard 42 proposal, this too is much too prescriptive and costly without a concomitant improvement in public health protection. This proposal has not been adequately vetted through the toxicology support services of all ANSI-accredited certifiers. At a minimum a Joint Committee task group should be organized of representatives from the toxicology support services of each of the ANSI-accredited certifiers and this task group should be tasked to report appropriate consensus recommendations on this issue to the JC.
Concerns about these standard changes:
1. They will increase the cost and time to get products certified.
a. Margaret says NSF remarked at the 11/07 DWA JC meeting that the costs could increase by 40% but should be less than 200%.
b. Months will be added in trying to obtain all chemical abstract service number (CAS no.) formulation chemical identifications for each ingredient, each reactant, each processing aid, and each component on the wetted parts list (WPL) of drinking water treatment unit and other drinking water mechanical device systems.
c. Product parts are increasingly coming from off shore sources, formulation information is self-declared, and many times it can be impractical to impossible to obtain such proprietary component information that can be relied upon as being thorough.
d. It is important to preserve the discretion of qualified toxicologists that are familiar with drinking water treatment units and drinking water system components to specify the appropriate analytical test batteries in instances where the WPL information cannot be reasonably known to the CAS number level.
2. They will give a business advantage to NSF.
a. Because NSF does not share component ingredient forms or how they evaluated the product with even the manufacturer of the product who has paid for the evaluation, NSF feels they have built up a large data bank of proprietary component ingredient evaluation forms that can benefit other manufactures who want to use these same materials and components in their assemblies if they come to NSF for their certifications.
3. They may not (some say will not) improve public health protection over other alternatives.
a. Margaret Whittaker is a highly respected toxicologist who serves many of the accredited certifiers. She says that while some of these revisions may benefit public health, others are needlessly costly and will not result in any significant public health benefit.
b. Self-submitted ingredient forms, many of which are years old in the NSF files, may not be complete and accurate.
c. Analytical scans available today can be more objective than manufacturer-submitted ingredient lists.
d. Experience has shown that modern analytical scans have found extractants that previously were not looked for and not indicated by “complete” formulation information.
e. Manufactures often prefer to spend the money for additional scans versus the time and uncertainty regarding self-declared ingredient formulations from independent proprietary component suppliers.
4. Is it the role of NSF and the Joint Committees to make “clear the minimum effort that should occur by all certifiers” when evaluating whether a product meets the requirements of the standard or is that more appropriately the role of the certification body accreditors, the American National Standards Institute (ANSI) and the Standards Council of Canada (SCC)?
a. These revisions place the sole interpretation and practice of NSF International into the Standard(s).
b. Better consensus among other certifiers and other toxicologists should be developed on whether these “clarifications” or which parts of them are needed and appropriate in the standards.
To get to the bottom of this, I suggest Margaret Whittaker should be allowed to present her case to the members of the Joint Committee, and we should consider commissioning an independent toxicology task group to hear the arguments and advise on this issue. I believe members of the task group should include a panel of respected toxicology peer reviewers. For example, these are names in the toxicology field that could be used:
Sherry P. Parker, Ph. D.
ANSI Technical Toxicology Expert
Robert (Bob) Howd, Ph. D.
Office of Environmental Health Hazard Assessment at California EPA
Helen M. Goeden, Ph. D.
Environmental Health Division of the Minnesota Department of Health
Ms. Nancy Anne M. Berdasco, M.S., D.A.B.T.
Senior Toxicology Consulting Specialist
The Dow Chemical Company
Joseph Cotruvo, PhD.
President of Joseph Cotruvo & Associates
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