Document a1ekvMZG9RgOmxRz2dzDXpqqa
NSF
NSF International
June 9, 1992
Ms. Connie N. Dillon Regulatory and Data System Specialist The BFGoodrieh Company Geon Vinyl Division 6100 Oak Tree Boulevard Cleveland, OH 44131 Dear Ms. Dillon: I have enclosed a TDRS-A form for Geon 87431 Blue 440. I am sending this form directly to you on behalf of BFGoodrich's customer Specialty Manufacturing Company. Please complete and return this form to NSF's Additives Toxicology Group. If you have any questions or require some assistance, please contact me at 800-252-6010. Sincerely,
Cindy icmnnguinan Additives Information Specialist Drinking Water Additives Program
3795008
3475 Plymouth Road, PO Uox 130140. Ann Arbor, Michigan 48113-0140 USA Telephone: 313-769-8010 FAX: 313-769-0109 Telex: 763215 NSF INTL
BFG27263
GENERAL INSTRUCTIONS FOR COMPLETING TDRS FORMS A & B
Applicants seeking Certification under NSF Standards 60/61 will have their evaluations expedited if the information in the TDRSA form is complete, accurate, and promptly Tetumed. Likewise, the Ingredient Supplier (TDRS-B Form) can expedite the process for the Applicant by promptly returning the forms with complete and accurate information.
SECTION V - HEALTH EFFECTS:
Any toxicology, mutagenicity, teratology, or supporting research reports known to the Applicant or the Suppliers should be identified. Submission of such reports may shorten the overall time needed to complete NSF's toxicology evaluation and may reduce required extraction testing, thereby reducing the amount of the NSF testing and toxicology 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. Detailed data may be required at a lata date. NSF strongly encourages the Applicant and its suppliers to collaborate in the review and submission of supporting toxicology data.
Toxicology information from 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 from 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 used by the 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.
Material: A homogeneous and defined formulation of ingredients composing a component in 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 ot 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.
Contaminant: Any physical, chemical, biological, or radiological substance or matter in water.
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<0 Copyright 1991 NSF All Rights
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REGULATORY COMMENTS INQUIRY GEON PROD
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