Document OqnVyVRqb2XGwM1YYjYqxRoX

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 and. -pH 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 (MCL) may require additional toxicity testing according to the guidelines of NSF Standard 61, Appendix A5;,lnfoi|ation youprovide (as attachments to this form) regarding your knowledge of specific toxicology studies will expediteIhe applicanfs Certification and may alleviate the need for additional toxicity testing. 1. Toxicology Studies: As an attachment to this form, please provide a detailed listing ofcail known toxicology studies (acute, subchronic, chronic, mutagenicity, teratogenicity, reproductive,;g?arcinogenicity,opidemiology, 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, yeaf). d. Summary of study results (include all treatment-related effects; provide your 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 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 (21 CFR, ERA National Primary Drinking Water Regulations, etc.), please complete below: Product, material, Complete Reference: ingredient, or impurity Justification (provide documentation) or opinion 21545031 4 cav3AVTDRS-B.PM3