Document Gmn7y5wVveOVVRYr46ROY6o3v

BFGoodrich The BFGoodrich Company Geon Vinyl Division 61000akTree Boulevard Cleveland, Ohio 44131 216-447-6000 May 19, 1992 Gary Strassell The Shepherd Color Company 4539 Dues Drive P.O. Box 465627 Cincinnati, OH 45246 RE: Blue No. 1 (CAS. No. 1345-16-0) Dear Mr. The Sheph (our Code productic Qjx. fj ^ r Lu /---rf-- 1 l/r^ foodrich with Blue No. 1 gredient in the I have en >1. if -L/tf "Form B" l. of receip r? : " - : eview Submission (TDRS) to NSF within 30 days rian A ix ihxJLL-inAc.^ Wi eU ecialist Program tMJ -f- OUeJuJ rsF) If you need assistance in completincr assistance hotline (1-800-252-6' EST) which is available ex'"' 0140 e form, call the \ A.M. to 4:00 P.M. iiswer supplier's BFG14997 GENERAL INSTRUCTIONS FOR COMPLETING TDRS FORMS A &B s Vj ^ Applicants seeking Certification under NSF Standards 60/61 will have their evaluations expedited if the information in theTDRS- A form is complete, .accurate, and promptly returned. Likewise, the Ingredient Supplier CTDRS-B Form) can expedite the process for the Applicant by promptly returning the forms with complete and accurate information.* " v A* SECTION V- HEALTH EFFECTS: " * if Any toxicology, mutagenicity, teratology, or supporting research reports known to the Applicant or the Suppliers should be 1 identified. Submission of such reports may shorten the overall time needed to complcteNSF's toxicology evaluation and may: reduce required extraction testing, thereby reducing the amount of the NSF testing andtoxicology review :fees.' 'Literature ' references are sufficient when the information is available in scientific journals. Summaries of studies completed within-your organization or, by contract laboratories, should be appended directly to the Form.; Detaileddata may be required (it a-later date::. NSF strongly encourages the Applicant and its suppliers to collaborate in the review and isubmission'of supporting-toxicology data. , - -.-V. -v ; , v Toxicology information horn the US Food and Drug Administration (21 CFR), US Environmental Protection Agency (Drinking . Water Regulations), World Health Organization, etc. will be used in support of product applications. However; consideration will be given to the basis of regulatory approval (usage, restrictions, current literature, and state of the science). If the supplier asserts that any product, ingredient, impurity, or other chemical introduced into drinking water as a result of product use should be exempt horn toxicology review and evaluation, justification must be provided. (For example, a detailed justification report would need to be appended where the applicant or supplier claims that no residual is found tinder potable water use conditions,' an ingredient is non-migratory, etc.) Reports justifying an exemption must be appended to this application. ' DEFINITIONS - TDRS FORMS A AND B: Applicant: A corporation, company, or individual that manufactures, mines, blends, assembles, packages, repackages, or otherwise produces a direct or indirect additive product or material to drinking water for which a Listing is sought. Material Supplier (Form A): A corporation, company, or individual (possibly the Applicant) which manufactures a material used in the final production of the Applicant's product. Ingredient Supplier (Form B): A corporation, company, or individual that provides an ingredient usedby die Component Supplier to produce its material. --^ Component: A sub-unit or part of the Applicant's product; e.g., a valve, a valve stem, a tank liner, a pump, a filter, etc. V/ : ; Material: A homogeneous arid defined formulation of ingredients, composing a componentin the Applicant's product; e.g., PVC in a plastic pipe, a rubber gasket in a valve, activated carbon in a filter, brass in a valve body, etc. Product: For the purpose of completing the TDRS-A and -B Forms, the subject of the form (i.e., the chemical material for which the form is requested) will be considered the' "product-" .' Ingredient: As used in Forms A and B, a constituent used in the production of the "product" for which the form has been requested. " .^ Impurity: A chemical or substance present in the product which contributes neither to the manufacturing process, nor to the function of the "product." By-Product: A chemical produced during the manufacturing process which is not part of the original starting materials and which is not the major or intended final "product." Reactant: A chemical used in the manufacturing process of the Applicant Product, or a substance that enters into, and/or is altered in the course of a chemical reaction. Direct Additives: Contaminants added to water in the production of drinking water. i Contaminant: Any physical chemical biological or radiological substance or matter in water. H* 4bASfti4tUzt BFG14998 .4 . GENERAL INFORMATION FORMSWWB' ' ' ' '$&?' , WHO IS NSFZxiNSFJntematipnal (NSF) is an .independent; not-for-profit'organization -of scientists, engineers, technicians, educators,-and analysts. -It is a trusted neutral agency, serving government,-industry.'sand'consumers in achieving solutions to problems relating to public health and the environment since 1944. The mission rofsNSF is to provide clients and the general public with objective, high quality, timely, third-party services at acceptable cost Services include development of consensus standards, voluntary product testing and certification with policies and practices which'protect the integrity of registered Marks, education and training, and research and demonstration, all relating to public health and the environmental sciences. ... - -v'-v, -v'r.':- VWHAT IS THE DREEING WATER ADDITIVES PROGRAM?, ANSHNSF^Standard hO (Drinking Water Treatment Chemicals- Hwldi'j^e^!) and ANSI/NSF Standard 61 (Drinking Water System Components - 'Health Effettsj are voluntary .consensus smntodsj;deyeloped by regulators, industry, and product users arid^tpeafiasftinderVthe guidance of NSF and its consensus standards.;process,. Standard 61: addresses two aspects: (1) Dp contaminants;leactfor -migrate from the material into the ,dnnkmg:wa^^d|C2),If so,: is the level -of migration acceptable:from a public^liealth yiewpoint? Standard 60 addresses direct treatment'chemicals and their contaminants and if the levels of these chemicals are acceptable from a public health viewpoint NSE's Drinking Water Additives -program is a third-party Certificationwhich includes auditing, sampling, testing, , toxicology review; -md&valuation relating to the potential health effects of drinking water prodiKts/materials, in accordance with the criteria eStablished'in Standards 60/61. 'AT- ` HOW DOES THE PROCESS WORK? The first step toward Certification under'NSF Standard 61 requires the Applicant to complete a Product/Materials Information Form (P/MI). After the form is reviewed by NSF, the Applicant is provided with one Toxicology Data ReviewSubmission Fpim A (TDRS-A), for each material determined to be in contact with drinking water. The Applicant must either,complete this form (if the Applicant manufactures the material) OR, forward the form to the appropriate Material Supplier (if the Applicant merely assembles or repackages the material). The first step towards Certification under NSF Standard 60 requires the Applicant to complete a Toxicology Dam SubmissionForm A (TDRS-A)., As the TDRS-A forms are received at NSF, a toxicologist will identify ingredients in the material which require additional information. A TDRS-B form will then be prepared for each ingredient and forwarded to the Material Supplier who, in turn, forwards the forms to the appropriate Ingredient Suppliers for completion. Once all Of the TDRS forms have been returned, a Formulation Review is conducted by authorized NSF chemists and toxicologists to determine which analytical tests are necessary to evaluate the Applicant's product During the selection of the testing protocol for potential contaminants, consideration is given to the degree of toxicological concern as well as the economic and practical' limitations of the analytical tests within the constraints of the Standard. Measured contaminant concentrations are normalized to reflect the levels anticipated "at the tap." Regulated contaminants (those which have a Maximum Contaminant Level set by the USEPA) do not requirfe further toxicology evaluation. However, establishing Maximum Allowable Levels for nonregulated contaminants will require additional toxicology review data, either from new toxicology studies initiated at the time of the testing or previously completed and defensible studies. Should additional toxicology data be necessary, NSF toxicologists will work with the Applicant to determine whether or not previous studies or literature sources fulfill the requirements of Standards 60/61. CONFIDENTIALITY: Only personnel authorized by NSF shall be allowed to review form A and B Applicant and Supplier information, which shall be secured according to NSF Confidential Information Security Procedures. Proprietary information will not be revealed or provided to Applicants or their Suppliers or third parties unless there is prior notarized written approval. However, the sharing of toxicological information between companies is encouraged where such sharing may expedite product certification. WHERE TO SEND THIS FORM: Insert the completed form in an envelope marked "CONFIDENTIAL BUSINESS INFORMATION," seal in an outer envelope, and return to: VIA US MAIL: VIA COURIER SERVICE Additives Toxicology Group NSF International PO Box 130140 Ann Arbor, MI 48113-0140 USA Additives Toxicology Group NSF International 3475 Plymouth Road Ann Arbor, MI 48105 USA (Over forGenetcl bilnKtiaM -TDRS Poona A cad B) O 1991 NSF All RJgbu Pacerved BFG14999 Date Ingredient Supplier's Representative Company Name Address Applicant's Product: As a material supplier for NSF International (NSF) Certification under ANSI/NSF Standard 61 (Drinking Water Additives program), information is required from each of our Ingredient Suppliers regarding ingredients used in our products. Please complete the attached Toxicology Data Review Submission form (TDRS-B) for your product and mail it to NSF within 30 working days. All information supplied to NSF by you will be held in strict confidence. Only NSF authorized personnel will have access to this information. The completeness and timeliness of your response is important to expediting our application. If previously you submitted a TDRS form for this product on behalf of another manufacturer, please do not complete the TDRS form again. Instead, authorize NSF's use of your original TDRS form in support of our product by completing the last page of the attached form only. If assistance is needed in completing the TDRS-B form, please do not hesitate to call the NSF Ingredient Supplier Hotline (800/252-6010) which has been established to answer ingredient supplier questions. If you act solely as a distributor for this ingredient, please forward this correspondence immediately to the manufacturers) that supplies your organization. I would like to thank you in advance for your assistance in expediting our application. Your cooperation is appreciated. Sincerely, Material Supplier Representative Company IMPORTANT: PLEASE DO NOT PHOTOCOPY THE ENCLOSED TDRS FORM B FOR USE WITH OTHER INGREDIENTS: The Document Control Code(s) are product Specific. O Copyright 1991 NSF AB Ritte Jtemed 4b*52^4d.W r BFG15000 21545027