Document 5BEXoXXvRp19YOnYpzb1B81J

BFGoodrich The BFGoodrich Company Geon Vinyl Division 6100 OakTree Boulevard Cleveland, Ohio 44131 216-447-6000 November 18, 1992 Ed Bisinger Toxicologist Akzo Chemicals 300 South Riverside Chicago, IL 60606 Plaza Dear Ed: Akzo Chemical provides BFGoodrich with Interstab G8257 WX PWD (our Code L-35) which is used as an ingredient in the production of one of our products. I have enclosed NSF's Toxicology Data Review Submission (TDRS) "Form B" for completion and submission to NSF within 30 days of receipt. Please forward to: Rebecca L. Collins Additives Information Specialist NSF International 3475 Plymouth Road P.O. Box 130140 Ann Arbor, MI 48113-0140 If you need assistance in completing the form, call the assistance hotline (1-800-252-6010, 9:00 A.M. to 4:00 P.M. EST) which is available exclusively to answer supplier's questions. If Akzo Chemicals has previously completed a TDRS "A" or "B" form for Interstab G8257 WX PWD, you are not required to complete the form again. Instead you should complete the "Permission to Use TDRS Form Information for Multiple Applicants" attached to the enclosed TDRS B. Sincerely, THE BFGOODRICH COMPANY Connie N. Dillon Regulatory and Data System Specialist 1117-3/jp BFG15678 Z1603001 ! 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 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). 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 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 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: Additives Toxicology Group NSF International PO Box 130140 Ann Arbor, MI 48113-0140 USA VIA COURIER SERVICE Additives Toxicology Group NSF International 3475 Plymouth Road Ann Arbor, MI 48105 USA (Ovr forOeaml Inaerucaon* -'TORS Form* A and B) O Copyright 1991 NSF AH fUgfali lUwd 21603002 BFGV5679 4abAS*hi*4U Ingredient Supplier's Representative Date 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 Copyrifbt 1M1 NSF A1 Rlfln Roorrad 4<b<h52dd.ttt 21603004 BFG15681 Initial if NSF Std. 60/61-Listed NSF USE ONLY [ ] Document Control Code: PL00471-003 Supplier Co. No. 17883 Accepted By ________________________________________ TOXICOLOGY DATA REVIEW SUBMISSION - FORM NSF International (NSF) STANDARD 60/61: DRINKING WATER SYSTEM COMPONENTS (CONFIDENTIAL INFORMATION) B FOR ASSISTANCE: 1-800-252-6010 From 9am to 4pm Eastern Time TO BE COMPLETED BY INGREDIENT SUPPLIER, unless the ingredient is currently Certified under NSF Standard 60 or 61 or has preliminary acceptance by NSF~ (See Instructions Before Completing). Please return form within 30 days or call for assistance. I I. IDENTIFICATION INFORMATION Company name Address AKZO CHEMICAL Company contact Telephone"Number ( FAX Number ( f ) Plant name Address Plant contact Te1ephone Number ( FAX Number ( ) ) l Name nf chemical or material (use acceptable chemical nomenclature) 2. Trade Designation INTERSTAB G8257 WX PWD Please specify other names under which you market this product 3. Structural formula; if ..applicable (Note: C7H1204 is NOT structural) 4 Chemical Abstracts Services (CAS) number (if applicable) 1603005 1 of 5 04/05/91 Std60/6IB BFG15682 III. PRODUCTION AND CHEMICAL INFORMATION 1. Is the product___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____________________________________ 2. Literature and/or patent reference for synthesis method___ Synthesized: 1. Recognized name of synthesis: 2. Literature and/or patent reference for synthesis method: ____________________ ____________ ____________________________ jy_______________________________________________________ 'W 3. Purification procedure............................................................................ ............ ..................... '^11?- 4. Provide the analytical procedure for the analysis of your product Provideelther a literature reference or a written procedure____________________________________ _______________ 5. Molecular weight (molecular weight distribution for polymers)__ ^ 6. Itemize the reaction products of initiators, stabilizers, and catalysts used In the manufacture or synthesis of your product. ,L c.___ Product is handled/bagged by a single use (dedicated) system. ___ Product is handled/bagged by a multiple use (non-dedieated) system. If multiple products are handled, show other products handled by thpSystem: 2. What is the specified purity range (if applicable)?_______ ____________________________________________________ 3. Itemize below, known or suspectedimpurities in the product including, but not limited to, unreacted starting materials, by-products, low molecufarweight polymers; etc. If available, provide literature reference(s) or written procedure^) for the identificgion of impurities in your product and starting materials. Chemical Name________ ___ CAS #.. .......Analytical Method 2160300' <5 3 ctv3/t yTDRS -B -PM3 BFG15684 I 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___________ No. of -gfF- ^ 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. X Signature________________________________________________________________ Date Typed or printed namey|:. ........................................................... ............... Position/Title........................................................ ...... ....,.................. ,,,, Company_____________________________________________ ,,,,,, __________________ PhoneTelex _____________ FAX The following authorization is OPTIONAL. Itinno way authorizes NSF to share the information with other Applicants. Authorized NSF staff ONLY will be allowed access to this information. By completing this authorization, this Form B may be used to support the ireferenoed Ingredient/material/product as part of another applicant's package. I give NSF permission to use the iftformation contained in this TDRS Form B as a basis for reviewing/accepting other products which use the referenced tngredient/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) PO Box 130140 Ann Arbor, Ml 48113-0140 Additives Toxicology Group NSF International (NSF) 3475 Plymouth Road Ann Arbor, Ml 48105 @ Copyright 1091 NSF AU Rights Reserved civ3/t:/rDRS-B.PM3 BFG15686 2 1 .6 0 3 0 0 9 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 comer of the original submission):g. 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 the NSF's Drinking Water Additives Program. All applicants Only the following company Company Name: Document Control Code (found in the upper right hand comer 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*^______ ,, Company (Ingredient Suppilsr) I: Telephone Number __________3Date 21603010 `Signature must be notarised: Subscnbed and sworn to before me tNs of ,19. day Notary Public My Commission Expires: Copyright 1991 NSF All Rights Fteserved BFG15687 c*v/.70PT61J>M3 NSF NSF International 7 ;i \ November 3, 1992 Ms. Connie Dillon BF Goodrich 6100 Oak Tree Blvd. Cleveland, OH 44131 Dear Ms. Dillon: We have received the updated formulations you submitted for Geon White 127, Nat 021 and Gray 260. Additional information is required from two of your suppliers. I have enclosed two TDRS-B forms to be sent to Akzo and General Electric for completion. If you have any questions, please do not hesitate to contact me. Sincerely, r> r (i-CO r tA .n 1 C*cL Rebecca L. Collino Information Specialist Additives Toxicology fV- H \\)v ' -' - ; ' `i os A Enclosures: TDRS-B (2) fI I rv- u.( ,/ t . < y ' ' `/ )..K ((!//'',',,, CQ//nr~^7 2 c, -in 3 7 T.ts lJ 1603011 3475 Plymouth Road, PO Box 130140, Ann Arbor, Michigan 48113-0140 USA Telephone: 313-769-8010 FAX: 313-769-0109 Telex: 753215 NSF INTL BFG15688