Document JyandoaaLJBwMgv77q780z1a

BFGoodrich The BFGoodrich Company Geon Vinyl Division 6100 Oak Tree Boulevard Cleveland, Ohio 44131 216-447-6000 June 2, 1992 Ms. Cindy Tchilinguirian Additives Toxicology Group NSF International (NSF) 3475 Plymouth Rd. P.O. Box 130140 Ann Arbor, MI 48113-0140 Dear Ms. Tchilinguirian: I am enclosing a completed TDRS - Section B form for Geon 110X388. The composition of Geon 110X388 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 We/tzig N BFG15178 1560001 Initial if NSF Std. 60/61-Listed NSF USE ONLY [ ] Document Control Code: PL00950-001 Supplier Co. No. 10810 Accepted By_____________________________________ 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 TO BE COMPLETED BY INGREDIENT SUPPLIER, unleaa the ingredient ia currently Certified Under NSF Standard 60 or 61 or has preliminary acceptance by NSF. (See In*:tsructlona Before completing) . Pleaae return form within 30 days or call for assistance. I. IDENTIFICATION INFORMATION Company name Addreaa B.F. GOODRICH Company contact | J. C. Kelley Geon Vinyl Division ainn rioV Ri-.rd Telephone NwrO?>r''( 16) 4^7-6567 _____ Cleveland. OH 44131 'FAX Number ( 216) 447-6262 Plant name Addreaa Plant contact TelephonesiNumber ( #AX. Number ( ) ) 1. Name of chemical or material ,;:;(aae acceptable chemical nomenclature) 2. Trade Deaignation .110 X 388 -rnm-:, Pleaae apecify other names under which\fnpu market thia product 3. Structural formula, if applicable (Note: C^Hj^O^ ifl NOT atruetural) 21560002 4. Chemical Abatracts Services (CAS) number (if applicable) 1 of 5 BFGl517g 04/05/91 Std60/61B  Copyright 1991 NSF All Right? 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______________________________________ _____________________ _i: 4. Provide the analytical procedure for the analysis of your product; Provide either a literature reference or a written procedure___________________________________________________ ___________________ 5. Molecular weight (molecular weight distribution for polymers) . %y = 1. 1A 6. Itemize the reaction products of initiators, stabilizers, and catalystssused 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 (non-dedicated) system. If multiple products are handled, show other produc&handled by .the system: 2. What is the specified purity range (if applicable)? 3. Itemize below, known or suspected impurities: in the product including, but not limited to, unreacted starting materials, by-products, low molecular weight polymers, etc. If available, provide literature reference(s) or written procedure(s) for the identifid&tion of impurities in your product and starting materials. _Cherp,ipal Name_________________________ CAS # ____ Analytical Method fro o o e s iz 3 civ3/t/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. V. HEALTH EFFECTS An extraction test of the applicant's product will be conducted to identify potential contaminants to the drinking water. 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 (MCfc^may 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 wliexpedite tfce 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 eaqh reference include: a. Name of specific material, ingredient, or impurity addressed by theetudy. b. Type of study (Ames, Sister Chromatid Exchange, etc-)* c. Complete reference: (authors], title, source, volume, pages, year). d. Summary of study results (include all treatment-related effects; provideyour opinion, with justification, for any results you feel should be discounted; attach completesreports, if desired). ___ (Check if no knowledge of toxicity data exists within your company.) - 2. If any product, material, ingredient, or impuritiy potentially.contributedto the drinking water by your product should, in your opinion, either be exempt from toxicology evaluafion :(non-migratory, no-residual, etc.) or should be evaluated in light of previous regulatory ctearariob (21 CFR, EPA National Primary Drinking Water Regulations, etc.), please complete below: Product, material, Complete Reference: ingredient, or impurity Justification (provide documentation) or opinion Z1 >0005 4 BFG15182 mv3//TDRS-BJ>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 formNo. 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 Applicant's product which is used in contact with drinking water. '- X Signature. C *um4. -- Typed or printed name___ Connie N. Dillon Date Position/Title_____________ Regulatory and...Data Syfirt-em Spefccalist 06/02/92 Company, The BFGoodrich Company Phone 216/447-7831 Telex FAX 216/447-6459 The following authorization is OPTIONAL, It in no way authorizes NSF to share the information with other Applicants. Authorized NSF staff ONLYWlll 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 applicant's 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 trl%9ferencedsingredient/material/product covered by this form. Optional Authorization WHERE TO MAW,? Insert the completed form in an envelope marked "CONFIDENTIAL BUSINESS INFORMATION," seal in an outer envelope, arid return to: VIA U.S. MAIL: VIA COURIER SERVICE: Additives Toxicology Group NSF International (NSF) PO Box 130140 1 Ann Arbor, Ml 48113-0140 Additives Toxicology Group NSF International (NSF) 3475 Plymouth Road Ann Arbor, Ml 48105 5 Copyright 1991 NSF All Rights Reserved BFG15183 cv3/.:/TDRS-BJ>M3 21560006 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 for our product _under the Document Control Code (found in the upper right hand corner of the original submission):.. Permission for NSF to use the above-referenced TDRS form, accompanying information, and appended toxicology data is now given for the following applicant(s) to die NSF's Drinking Water Additives Program. All applicants ______ Only the following company Company Name: Document Control Code (found in the upper right hand corner of the requested submission):___________ ................ ................ .................. I understand that the files will remain confidential and closed to all, but NSF authorized personnel, according to NSF Confidential Information Security Procedures. Name_________________________________________ Signature*_______ ___________ A,, Company (Ingredient Supplier) ; Telephone Number *... IP______ ^Date 21560007 `Signature must be notarized: Subscribed and sworn to before me this ............ day of , 19___________________. Notary Public My Commission Expires: Copyright 1991 NSF All Rights Reserved BFG15184 mv/i^OPT61J`M3 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 relumed. Likewise, the Ingredient Supplier (TDRS-B Form) can expedite the process for the Applicant fey promptly returning the forms with complete and accurate information. SECTION V HEALTH EFFECTS: Any toxicology, mutagenicity, teratology, or supporting research reports known to die 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 die 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 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 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 die 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., 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 die 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 die 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. BFG15185 21560008 rj 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 solutions to 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 die 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 die 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 Data SubmissionForm A (TDRS-A). As the TDRS-A forms are received at NSF, a toxicologist will identify ingredients in die 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 neceasary 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 die 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 die 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 flwwl flTUiirtmi -TDRJ Psn A oi B) O OgyrltW 1991 N3P All SUI* HiiitwiI RET, Kic/; N \ -,60009 i 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 die 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. e Copylifht 1991 NSF All Rlfln Roaorrad 4bAS2dd.txt BFG15187 21560010 p 01 R7i ' H ' 103 F! 3 6 (. b f g o o i) r ::: c h c g m f- a n y m e s s a g e s e r v i c e : C LEVINA IN DOCUMENT: O10O14 ROUTE TO: DILLON, CONN IE f,; : = * w * * * -s GEON VINY TECHNICAL DOCUMEN' ^6 LINES i .3o o ^ 5 0*/01/?2 : )( it V: : W a '!:- o'- R103360 G E (3 N 1 NY RECIPE 0.; / PI 1 / V GEON RESIN 110X388 COMMODITY NO,: 00110 SBC hBR: 1112 !,,.AB REF BASED UN: APPLICATION: 388 0000 LOG: 12 DEPT- 5668 ISSUE EFFECTIVE DATE: Oi/Oi/yv DELETE FLAG: NO CnPR- "'ARTS INGREDIENTS SEQ LUC PERCENT 101,52000 ,07850 ,01710 ,00714 ,10200 ,03300 968 953 957 953 953 911 00003V 709160 00W013 00G127 00G052 00A028 6611 ALCOTEX 72,5% PVA, 88% METHQCEL. F50 PEROXYESTER DTAHO DISPERSION 01 0 020 030 040 050 060 99,766 , 077 .01? , 007 , 1 CO ,032 101,757 74 TYPE SAMPLE ISSUED MARKETING APPROVAL TOTAL 1 AN . 006 P'S zi pXA s< 3 : 00 : 4` 21560011 BFG15188 INTEROFFICE MEMORANDUM Date: From: Dept: Tel No: 29-May-1992 01:54pm EDT JEF JEF@ALTC@MRGATE@CLE TO: DILLON, CONNIE0A1 Subject: RE: GEON 110x388 CONNIE, GEON 110X388 DOES MEET THE GOOD MANUFACTURING PRACTICE SPECIFICATIONS: MAXIMUM VOLATILITY OF 3.0% (1 HOUR AT 105 DEG C) AND AN INHERENT VISCOSITY OF NOT LESS THAN 0.35 BY ASTM D-1243-79. f & ff/\L ED FATTLAR 21560012 BFG15189