Document Rj3V85O6JjOQKkBNrn92vgqB8

BFGoodrich The BFGoodrich Company Geon Vinyl Division 61000akTree Boulevard Cleveland, Ohio 44131 216-447-6000 frk-b f' June 2, 1992 Ms. Cindy Tchilinguirian Additives Toxicology Group NSF International (NSF)3475 Plymouth Rd. P.0. Box 130140 Ann Arbor, MI 48113-0140 Dear Ms. Tchilinguirian: I am enclosing a completed TDRS - Section B form for Geon 102 EPF 5. The composition of Geon 102 EPF 5 is confidential to BFGoodrich and therefore subject to the generic secrecy agreement signed by BFGoodrich and the National Sanitation International, October 24, 1979. Sincerely, THE BFGOODRICH COMPANY GEON VINYL DIVISION Connie N. Dillon Regulatory and Data System Specialist CND/jp Attachments cc: Joe Kelley/Doug Wetzig BFG15167 21559000 Initial if NSF Std. 60/61-Listed NSF USE ONLY [ Document Control Code: Supplier Co. No. 10810 Accepted By ] IA02221-001 TOXICOLOGY DATA REVIEW SUBMISSION - FORM NSF International (NSF) STANDARD 60/61: DRINKING WATER SYSTEM COMPONENTS (CONFIDENTIAL INFORMATION) FOR ASSISTANCE: 1-800-252-6010 From 9am to 4pm Eastern Time m TO BE COMPLETED BY INGREDIENT SUPPLIER, unless the ingredient is currently Oa^teafietfeamder NSF Standard 60 or 61 or has preliminary acceptance by NSF. (See sitkstructionS ij^ic)re*Comp1 eting) Please return form within 30 days or call for assistance. I. IDENTIFICATION INFORMATION Company name Address B.F. GOODRICH Geon Vinyl Division 6100 Oak Ttpp. Blvd. Cleveland, OH 44131 Company contact J. C. Kelley Tulftphan&^Nvupber;^ 16 ) 447-6567 fax Number (216 ) 447-6262 Plant name Address siplant contact Telephone Number ( iFAXsi-Number ( )_ ) 1. Name of chemical or materiai:.-(use afipeptable;;chemica 1 nomenclature) 2. Trade Designation 302 EPF 5 Please specify other namesounder which you market this product 3. Structural formula:*;::.:!f applicable (Note: C^H^0^ is NOT structural) *1559001 4. ^Chemical Abstracts Services (CAS) number (if applicable) 1 of 5 BFG15168 04/05/91 Std60/61B  Copyright 1991 NSF All Rights V.  III. PRODUCTION AND CHEMICAL INFORMATION 1. Is the product X manufactured or___ mined? a. If mined, is it purified? YES___ NO_____ If YES, how?__________________________________________________ Is it ground or mixed to a homogeneous mixture YES___ NO. b. If manufactured or synthesized, provide the following: Please provide separate attachments as necessary. Manufactured: 1. Process description______ Polymerized_______________ 2. Literature and/or patent reference for synthesis method___ Synthesized: 1. Recognized name of synthesis:________________________ 2. Literature and/or patent reference for synthesis method:. 3. Purification procedure.. ______________ _______ ________ 4. Provide the analytical procedure for the analysis of your product. Provide either a literature reference or a written procedure,f|;,"Ilk, 5. Molecular weight (molecular weight distribution for polymers! 'life, - 1.13 *'!! 6. Itemize the reaction products of initiators, stabilizers, and catalysts used in the manufacture or synthesis of your product. c.____Product is handled/bagged by a single use (dedicated) system. ____Product is handled/bagged by a multiple use;(aon-dedfcated) system. If multiple products are handled, show other products handled by the system: 2. What is the specified purity range (if applicable)? 3. Itemize below, known or suspected impuritiesln the product including, but not limited to, unreacted starting materials, by-products, low moleculanweight polymers; etc. If available, provide literature reference(s) or written procedure(s) for the identifidSbn of impurities in your product and starting materials. Cheaeal.Niil_____________ ... CAS# ____ Analytical Method 21559004 3 BFG15170 ctv3/i/TDRS-BJ>M3 IV. MIGRATION/EXTRACTION INFORMATION 1. If the product is not intended to be dissolved in water, has the solubility of the product been determined? ___ YES ____NO ____NOT APPLICABLE If yes, what is the solubility?@Temperature andpH 2. Have tests been run on your product to examine migration/extraction of a MATERIAL(s) or IMPURITY(s) from your product into water? ___ YES ____NO If yes, please append the complete report(s) for every component or impurity studied. TM V. HEALTH EFFECTS An extraction test of the applicant's product will be conducted to identify potential contaminants to the drinkjrtgwater. Laboratory values of contaminant concentrations will be normalized to "at-the-tap" values. Those contaminants for which the Environmental Protection Agency has not established a Maximum Contaminant Level (MCb)smay require additional toxicity testing according to the guidelines of NSF Standard 61, Appendix A; Information you provide (as attachments to this form) regarding your knowledge of specific toxicology studies will expedite ^applicant's Certification and may alleviate the need for additional toxicity testing. 1. Toxicology Studies: As an attachment to this form, please provide a detailed listing Of all known toxicology studies (acute, subchronic, chronic, mutagenicity, teratogenicity, reproductive, carcinogenicity, epidemiology, etc.) relevant to your product, materials, ingredients, and/or impurities. For each reference include: a. Name of specific material, ingredient, or impurity addressed by the study. b. Type of study (Ames, Sister Chromatid Exchange, etc.). c. Complete reference: (authors], title, source, volume, pages, year). d. Summary of study results (include ail treatment-related effects; provide youf opinion, with justification, for any results you feel should be discounted; attach complete reports, if desired). ___ (Check if no knowledge of toxicity data exists within your company.) 2. If any product, material, ingredient, or impuritiy potential^ contnbuted to the drinking water by your product should, in your opinion, either be exempt from toxicology evaluation (non-migratory, no-residual, etc.) or should be evaluated in light of previous regulatory clearance (21 GFR, EPANational Primary Drinking Water Regulations, etc.), please complete below: Product, material, ingredient, or impurity Complete Reference Justification (provide documentation) or opinion 4 BFG15171 civ3//TDRS-Bi>M3 3. A toxicology literature search provided by your company may expedite the toxicology review and minimize costs to the applicant for obtaining toxicology data. For each literature search appended to this form, itemize as described below: Database File # Keywords Date ________________________ ________________________ ________________________ __________________________ ________________________ ________________________ ________________________ __________________________ _______________________ _ ________________________ ________________________ __________________ (Check if no literature search has been, or will be, conducted by your Company.) VI. ATTACHMENTS AND SIGNATURE List Attachments to this form____________ 5 No. of pages. I hereby certify that the information provided is accurate and complete, and that! and the Company I represent, know of no reason the product described herein should not be used in the Applicanfs product which is used in contact with drinking water. - -V -v- X Signature. QjiwUj , Sf, .Ouu. Date 06/02/92 Typed or printed name. Position/Title__________ Connie N. Dillon Regulatory and..Data Sy&feem Spelcalist Company_____________ The BFGoodrich Company Phone 216/447-7831 _Tefex.. FAX 216/447-6459 The following authorization is OPTIONAL, (tin no way authorizes NSF to share the information with other Applicants. Authorized NSF staff ONLV|pti be allowed access to this information. By completing this authorization, this Form B may be used to support the referenced ingredientfmaterial/product as part of another applicants package. I give NSF permission to use the information contained in this TDRS Form B as a basis for reviewing/accepting other products which use the:referenced ingredient/material/product covered by this form. Optional Authorization __________ WHERE TO MAIL? Insert the completed form in an envelope marked "CONFIDENTIAL BUSINESS INFORMATION," seal in an outer envelope, and return to: VIA U.S. MAIL: VIA COURIER SERVICE: (.Additives Toxicology Group NSF international (NSF) POBox 130140 Ann Arbor, Ml 48113-0140 Additives Toxicology Group NSF International (NSF) 3475 Plymouth Road Ann Arbor, Ml 48105 Copyright 1991 NSF All Rights Reserved cv3/VTDRS-BJ>M3 BFG15172 9QOGSSIZ Permission to Use TDRS Form Information For Multiple Applicants To be completed when a TDRS form for a particular product has previously been submitted to NSF International (NSF) and that information is authorized for use with other applicant(s). Dear NSF: Our company,, previously submitted a TDRS form forour product ' ^ _______________ under the Document Control Code (found in the upper rightfmnd '4 comer of the cdflinal submission):. \. Permission for NSF to use the above-referenced TDRS form, accompanying infortnationMpd appended toxicology data is now given for the following applicant(s) totfte NSPs Drinking Heater Additives Program. All applicants ______ Only the following company Company Name: _ Document Control Code (found in the upper right hand comer of the requested submission):____________ ______________'r*t I understand that the files will remain confidential and.dosed to all, but NSF authorized personnel, according to NSF Confidential Information Security Procedures. Name Signature*_____________________________ _______________________________ ________________ Company (Ingredient Supplier) Telephone Number ______ ;______ 3Date `Signature must be notarized: Subscribed andsworn to before me thisday of, ___ . Notary Public My Commission Expires: <9 Copyright 1991 NSF All Rights Reserved BFG15173 c*v/tA3PT61-PM3 21559007 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 TDRS- A fomn is complete, accurate, and promptly returned. 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 die 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 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 direcdy to the Form. 'Detailed data may befequired at a later 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 Enviromhental 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 under 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., die 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. Contaminant: Any physical, chemical, biological, or radiological substance or matter in water. !-f i <( 1 21559008 BFG15174 4*b&33tdrUxt GENERAL INFORMATION - FORMS A & B WHO IS NSF? NSF International (NSF) is an independent, not-for-profit organization of scientists, engineers, technicians, educators, and analysts. It is a trusted neutral agency, serving government, industry, and consumers in achieving solutionsto problems relating to public health and the environment since 1944. The mission of NSF 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. WHAT IS THE DRINKING WATER ADDITIVES PROGRAM? ANSI/NSF Standard 60 (Drinking Water Treatment Chemicals - Health Effects) and ANSI/NSF Standard 61 (Drinking Water System Components - Health Effects) are voluntary .. consensus standards developed by regulators, industry, and. product users and specifiers under the guidance of NSF and its consensus standards process. Standard 61 addresses two aspects: (1) Do contaminants leach or migrate from the material into the drinking water; and (2) If so, is the level of migration acceptable from a public health viewpoint? Standard 60 addresses direct treatment chemicals and their contaminants and if the levels of these chemicals are acceptable from a public health ' viewpoint NSF's Drinking Water Additives program is a third-party Certification which includes auditing, sampling, testing, ,, . toxicology review, and evaluation relating to the potential health effects of drinking water products/materials, in accordance with the criteria established in Standards 60/61. '! ; 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 Review Submission Form 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). V/ The first step towards Certification under NSF Standard 60 requires the Applicant to complete a Toxicology Data SubmissionForm A (TDRS-A). As the TDRS-A forms are received at NSF, a toxicologist will identity 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 die 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 require 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 for Oenertl Instructions -TDRS Foods A ead B) O CopyricU 1991 NSF All RJ*)* Rtacmrf 4b<fsS?qdrtJxl Z i >9009 BFG15175 Date Ingredient Supplier's Representative Company Name Address Applicant's Product As a material supplier for NSF International (NSF) Certification under ANSKNSF 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. C Copyright 1991 NSP AH Rights Rmemd 4tb(M^<ddiW BFG15176 21559010