Document LgbgvxExqeZOExGkRVjvMzErd

Initial if NSF Std. 60/61-Listed NSF USE ONLY [ J-,------------------Document Control Code ^IA02221-003 ^) Supplier Co. No. 19653 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 ctfifYently Certified Under NSF Standard 60 or 61 or has preliminary acceptance by NSl^I (See -instructions Before Completing) Please return form within 30 days or call for assistance. '- !l|i I. IDENTIFICATION INFORMATION Company name Address SHEPHERD CHEMICAL CO. Company -Numb eif i < FAXiNVunber ( )_ ) Plant name Address ifplant contact Telepbbhe Number ( sssFAXiSHumbe r ( )_ )_ 1. Name of chemical or materiitl&.luse acceptable*chemical nomenclature) 2. Trade Designation BLUEsNO. 1 Please specify other names, under which you market this product 3. Structural formutfc.., if applicable (Note: C-^Hj^O^ is NOT structural) 4. Chemical Abstracts Services (CAS) number (if applicable)_ 1 of 5 W i CO 04/05/91 Std60/61B Rpnisnni 0 . . . v-* x*/W i- BFG15002 J Copyright 1991 NSFAII Rights 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:. 3. Purification procedure____________________________________________________________ ______________ 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)____________________ 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 (non-dedicated) 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 suspectedimpuritiesfn the product including, but not limited to, unreacted starting materials, by-products, low molecufaisweight polymers, etc. If available, provide literature reference(s) or written procedure(s) for the identification of impurities in your product and starting materials. Chemical Name____________ CAS# ____ Analytical Method 21543030 3 civ3/yTDRS-BJPM3 BFG15003 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 It 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?we.ter. 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 (MCL) may require additional toxicity testing according to the guidelines of NSF Standard 61, Appendix A; Information yousprovide (as attachments to this form) regarding your knowledge of specific toxicology studies wilfexpedite thpapplicanfs Certification and may alleviate the need for additional toxicity testing. 1. Toxicology Studies: As an attachment to this form, please provide a detailed listingdf 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 indude: 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 all treatment-related effects; provide youf opinion, with justification, for any results you feel should be discounted; attadi complete reports, if desired). ___ (Check if no knowledge of toxicity data exists within your company.) 2. If any product, material, ingredient, or impuritiy potentially contributed 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 (21GFR, ERA National Primary Drinking Water Regulations, etc.), please complete below: Product, material, Complete Reference ingredient, or impurity Justification (provide documentation) or opinion ---------------------------------------------------------------------------^ ---------------------------------------------------------------------------------------- CA H1 o 4 CD BFG15004 cav3AAT>RSB.PM3 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 pages. I hereby certify that the information provided is accurate and complete, and that i* 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 SignatureJWDate Typed or printed name^^__ ________ Position/Title_______________________________ ___________ * I Company_______________________________ ___________ _________________________ PhoneTelexmFAX The following authorization is OPTIONAL. Jt in no 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 referenced ingredient/material/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 the referencedsingredient/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 1991 NSF All Rights Reserved ctv3/iVTDRS-Di>M3 BFG15005 S B O S t-S T g 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 foroutproduct ___________________ under the Document Control Code (found in the upper righfiand comer 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 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 andiclosed tosall, but NSF authorized personnel, according to NSF Confidential Information Security Procedures. Name Signature*, Company (Ingredient SuppHer)_______________ Telephone Number ______________ __________________________Date s e o e w iz Signature must be notarized: Subscribed andsworn to before me thisday of, 19____________________ . Notary Public My Commission Expires: Copyright 1991 NSF All Bights Reserved cv/s*>PT6I.PM3 l i i BFG15006