US EPA, Pesticide Product Label, PURE BRIGHT DISINFECTANT
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I UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 January 16, 2013 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION Ms. Cristina Griffin, Agent for KIK International, Inc. Delta Analytical Corporation 12510 Prosperity Drive, Suite 160 Silver Spring, Maryland 20904 Subject: Notification of Minor Label Changes per PR Notice 98-10 Product Name: Pure Bright Disinfectant Bleach EPA Registration Number: 70271-3 Application Date: January 14, 2013 Application Receipt: January 15,-2013 Dear Ms. Griffin: This acknowledges receipt of your Notification application, submitted pursuant to the provisions of FIFRA section 3 (c) 9 and PR Notice 98-10. Proposed Notification: KIK International, Inc. is submitting a Notification per PR Notice 98-10 to add optional graphics for EPA Reg. No. 70271-3: On Page Seventeen: Add a graphic to indicate "Fast Acting;" Add a graphic to indicate "Controls Algae & Bacteria;" Add a graphic to indicate "Calcium Free." General Comments: Based on a review of the material submitted the following comment applies. The Notification application is Acceptable. A copy of the accepted Notification is attached in your Regulatory File Jacket ( EPA Reg. No. 70271-3 ) for future reference. I you have questions or comments with regard to this Agency Letter, please contact Killian Swift via email at Swift.Killian(g),epa.gov or by telephone at 703-308-6346. When you are submitting information or data in response to this Agency Letter, please send a copy of this Agency Letter with your response in order to facilitate processing. Sincere! Monisha Harris, EPA Product Manager 32 Regulatory Management Branch II Antimicrobials Division ( 751 OP.) Please read instructions on reverse before comple.. orm. Form Approved. OMB No. 2070-0060. United States D Registration OPP Identifier Number Environmental Protection Agency ment Washington, DC 20460 D Amend EPA X Other NOTIF Application for Pesticide - Section I 1. Company/Product Number 70271-3 2. EPA Product Manager 3. Proposed Classification Monisha Harris D None D Restricted 4. company/Product (Name) KIK International, Inc. / PM#32 Pure Bright Disinfectant Bleach 5. Name and Address of Applicant (Include ZIP Code) 6. Expedited Review. In accordance with FIFRA Section 3(c)(3)(b)(i), my product KIK International, Inc. is similar or identical in composition and labeling to: • c/o Delta Analytical Corp. EPA Reg. No.. 12510 Prosperity Drive, Suite 160 Silver Spring, MD 20904 Check if this is a new address Product Name Section - II D Amendment - Explain below D Final printed labels in response to Agency letter dated_ D Resubmission in response to Agency letter dated_ D "Me Too" Application. X Notification - Explain below. D Other - explain below. Explanation: Use additional page(s) if necessary. (For section I and Section II.) Notification per PR Notice 98-10 to add graphics; response to EPA letter of 12/26/12 This notification is consistent with the provisions of PR Notice 98-10 and EPA regulations at 40 CFR 152,46, and no other changes have been made to the labeling or the confidential statement of formula of this product. I understand that it is a violation of 18 U.S.C. Sec. 1001 to willfully make any false statement to EPA. I further understand that if this notification is not consistent with the terms of PR Notice 98-10 and 40 CFR 152.46, this product may be in violation of FIFRA and I may be subject to enforcement action and penalties under sections 12 and 14 of FIFRA. Section -III 1. Material this Product will be Packaged in: Child-Resistant Packaging Unit Packaging Water Soluble Packaging 2. Type of Container X Yes* For retail ' DYes DYes D Metal D No XNO " XNO X Plastic D Glass If "Yes," If "Yes," D Paper * Certification must Unit Package wgt. No. per Unit Package wgt. No. per container X Other (Specify) Bulk be submitted. container 3. Location of Net Contents Information 4. Size(s) of Retail Container 5. Location of Label Directior," •• , t '. <- L 'J 48, 60, 96, 128, 174, 182 oz; X On Labei ort i_ c c 5, 15, 30, 55, 250, 300, 330 gallons, bulk X Label D Container X On Lafeling.accompanying product 6. Manner In Which Label Is Affixed to Product D Lithograph X Other: Under 2 gallons plastic sleeve; Bulk-' E^per-accompah-ies product Over 2 gallons: X Paper glued D Stenciled Section - IV 1. Contact Point (Complete items directly below for identification of individual to be contacted, if necessary, to process this application.) Name Title Telephone No Jjrfolucie Area Code) Cristina Griffin Agent for KIK International, Inc. 301-680-7971 Certification 6. Date Application Received I certify that the statements I have made on this form and all attachments thereto are true, accurate and complete. I acknowledge that any kind of knowingly false or misleading statement may be punishable by fine or imprisonment or both under applicable law. (Stamped) 3. Title Agent for KIK International, Inc. 4. Typed Name 5. Date Cristina Griffin January 14, 2013 EPA Form 8570-1 (Rev. 8-94) Previous editions are obsolete. White - EPA File Copy (original) Yellow-Applicant copy DELTA ANALYTICAL CORPORATION January 14, 2013 ;===.• Document Processing Desk (NOTIF) Office of Pesticide Programs (7504P) Environmental Protection Agency One Potomac Yard 2777 S, Crystal Drive, Room S-4900 Arlington, VA 22202 Attn: Monisha Harris, PM 32/Killian Swift RE: Notification per PR Notice 98-10 to add graphics; response to EPA letter of 12/26/12 Product: Pure Bright Disinfectant Bleach, EPA Reg. No.: 70271-3 Company: KIK International, Inc Dear Ms. Harris and Mr. Swift: On behalf of KIK International, Inc., I am submitting a notification per PR Notice 98-10 to add optional graphics for the product Pure Bright Disinfectant Bleach, EPA Reg. No. 70271-3. On 12/7/12 we submitted a notification to add minor claims and graphics to the labeling for the subject product. On December 26, 2012, EPA approved the changes to the claims, but rejected the graphics. We have been in contact with the reviewer, Mr. Killian Swift, and have made explanations/revisions to satisfy EPA's concerns as follows: EPA comments and KIK responses: EPA's letter (attached) detailed concerns about the three new graphics: "Fast Acting," "Controls Algae & Bacteria," and "Calcium Free." KIK's intent is that these claims will be used only for swimming pool/spa uses, but although we had made this clear for the EPA approved label claims on page 3, we had not made it equally clear for the new graphics on page 17. KIK has now corrected this by adding the reader's note: [The following optional graphics are for product labeling with Swimming Pools and/or Spas as the major use sites:] The graphics on page 17 are consistent with the swimming pool/spa claims on page 3 which EPA approved in October 2012, and that EPA has approved for many other EPA registered KIK Pool swimming pool products. Below is an explanation of the terms, and what we have added to clarify the graphics/terms: C c "Fast acting:" ' tLCccc cCLtuc • This term "fast acting" is intended only for pool and spa products, so addition of !;:he reader's note above the graphics on page 17 clarifies this: "[The following optional grsf-hiGG^are for product > <: labeling with Swimming Pools and/or Spas as the major use sites:]". \c • The term 'fast acting" is informational only. Sometimes pool/spa customers need fast acting pool chlorination products (granular or liquid products) and sometimes they need slovf^pool chlorination products as explained below: • c -Pool/spa customers need fast acting products when they want to shock or boost t [ pool/spa chlorine levels quickly. tc Examples of EPA previously approved "fast acting:" The EPA approved swimming" pool/spa granular product, "Kem-Tek All-in-One Chlorinating Granules," EPA Reg. 12510 Prosperity Drive Suite 160 Silver Spring, Maryland 20904 (301)680-7971. fax (301) 680-7975 www.delta-ac.com No. 7616-70, includes "Fast Acting" and "Fast Dissolving." (see label attached; page has been tabbed and relevant portion highlighted). The EPA approved 10% liquid sodium hypochlorite product EPA Reg. No.7616-45 also includes "Fast Acting" and the same graphic, (see both labels attached; pages have been tabbed and relevant portion highlighted). -Pool/spa customers use slow products when they want to maintain chlorine levels in a pool or spa; tablets dissolve more slowly. Example of previously approved "slow dissolving" or "slow release:" The EPA approved tablet product "KT Chlorinating Tablets," (EPA Reg. No. 7616-76) includes the claims "Slow Dissolving" or "Slow Release." (see label attached; page has been tabbed and relevant portion highlighted.) It is information for the consumer only, and common for swimming pool products. • In our e-mail correspondence, you asked how a chemist would know that a product is fast acting or slow. A chlorinating product that is a liquid or granule will dissolve much more quickly than a chlorinating product that has been compressed into tablet form. "Calcium Free:" We have added the reader's note [INFO FOR CUSTOMERS WHO NEED A CALCIUM FREE PRODUCT FOR POOL] below the graphic on page 17. Excessive calcium in pool water, can become a problem in a pool by building up on the pool's surfaces and equipment. Calcium (i.e., water hardness) in the incoming water can vary according to area. Pool owners that want to keep their pool water's calcium (hardness) level down look for products that are calcium free as there are chlorine products, such as shocks, that contain calcium hypochlorite, which can raise calcium or hardness levels in pool. Many pool owners, do not know exactly what chemicals contain calcium.