Registration & Product Labeling Manual
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Registration & Product Labeling Manual September 2013 1│ Registration & Product Labeling Manual ◦ September 2013 OB-0012-1309 September 6, 2011 Dear CuVerro Customer, Olin Brass has prepared this Registration and Product Labeling Manual to assist companies manufacturing and marketing products made with CuVerro® bactericidal copper alloy surfaces in complying with federal and state statutes, regulations, and rules. CuVerro is the registered trademark brand of copper alloy products manufactured by GBC Metals, LLC d.b.a Olin Brass, a subsidiary of Global Brass and Copper, Inc. CuVerro copper alloys are registered with the U.S Environmental Protection Agency (U.S. EPA), allowing public health claims that CuVerro products kill bacteria1. CuVerro’s bactericidal properties are unique for solid surfaces. CuVerro is the most effective class of solid material that can claim an inherent ability to kill bacteria; and it was the first class of solid surface material to be registered with the U.S. EPA to make public health claims. Accordingly, this manual will help guide your company with U.S. EPA compliance issues as you manufacture and market products made from CuVerro alloys.2 As you review the prepared information, please consider the following: The U.S. EPA mandates adherence to these requirements in order to make public health claims associated with CuVerro alloys. The information in this manual is provided as a supplement to the complete product labeling and registration requirements found at www.epa.gov. Among the benefits of being a registered CuVerro alloy customer are the breadth of product offerings from alloys and forms (including sheet, strip, tube, castable ingot) to the umbrella U.S. EPA registration available through Olin Brass--negating the need for your company to maintain annual U.S EPA and individual state registrations for each bactericidal product that you offer. Finally, we are committed to supporting the growth of our strategic partners and their products in this developing healthcare marketplace. Sincerely, Thomas J. Werner VP Sales and Marketing, Olin Brass 1 Testing demonstrates effective antibacterial activity against Staphylococcus aureus, Enterobacter aerogenes, Methicillin-Resistant Staphylococcus aureus (MRSA), Escherichia coli O157:H7, Pseudomonas aeruginosa, and Vancomycin-Resistant Enterococcus faecalis (VRE). The use of CuVerro® bactericidal copper products is a supplement to and not a substitute for standard infection control practices; users must continue to follow all current infection control practices, including those practices related to cleaning and disinfection of environmental surfaces. This surface has been shown to reduce microbial contamination, but it does not necessarily prevent cross contamination. It should not be interpreted that CuVerro is making claims to solely prevent bacterial infections nor should it be implied that CuVerro products make such claims. 2 Olin Brass has prepared this Registration and Product Labeling Manual as a courtesy to its customers and to outline the information needed to be provided by customers to meet Olin Brass’ obligations under federal and state statutes, regulations and rules. This is not meant to replace, and may not be interpreted as replacing, guidance and opinions from a licensed attorney. We strongly advise you to seek advice from your own attorney before offering any bactericidal products for sale. Furthermore, the information contained in this Manual is current to the best of our knowledge in the date it is published, but is subject to change with any changes issued by any governmental or regulatory agencies having jurisdiction. You are responsible for keeping abreast of all laws affecting the manufacturing, sale and distribution of items you manufacture using CuVerro® bactericidal copper surfaces. 2│ Registration & Product Labeling Manual ◦ September 2013 OB-0012-1309 CuVerro® Registration & Product Labeling Manual Background and Overview . 4 U.S. EPA Registration. 4 What is Registration? Why do Fabricators Using CuVerro Alloys Need to Register? What Is Olin Brass’ Role in the Registration and Compliance Process? What Does the Registration Process Require? Steps In Obtaining U.S. EPA Registration . 5 STEP 1: Use U.S. EPA Registered Materials . 6 STEP 2: Obtain an U.S. EPA Company Number . 7 STEP 3: Obtain an U.S. EPA Establishment Number. 8 STEP 4: File an Initial U.S. EPA Production Report . 9 Initial Report Annual Reports STEP 5: Obtain California Broker’s License . 10 STEP 6: Maintain Manufacturing Records . 10 STEP 7: Maintain Reporting Records . 13 Reporting to U.S. EPA Reporting to California Reporting to Olin Brass STEP 8: Recreate U.S. EPA-Registered Label for CuVerro Fabricated Products . 14 STEP 9: Develop Appropriate Marketing Collateral . 17 Fabricated Product Packaging Marketing Claims Description of Fabricated Products Permission and Usage of Trademarks STEP 10: Sign CuVerro Bactericidal Copper Alloy Supply Agreement . 22 Finalize Registration Continued Activities with Olin Brass Appendix I: California DPR Quarterly Mill Assessment Instructions . 24 Appendix II: CuVerro Fabricated Product Labels . 27 Appendix III: CuVerro Graphic Standards . 32 Appendix IV: Representative Copy of CuVerro Supply Agreement . 39 3│ Registration & Product Labeling Manual ◦ September 2013 OB-0012-1309 Background and Overview In offering copper-based bactericidal materials, Olin Brass provides a broad range of alloys, forms and support services that can help suppliers of healthcare equipment and furnishings develop products with inherent abilities to kill harmful bacteria that are claimed to be responsible for two million hospital acquired infections each year, resulting in a hundred thousand deaths. It is Olin Brass’ goal to assist companies in the development of a suite of products with these built-in bactericidal properties that can enhance current cleaning and disinfecting practices, and benefit a broad range of healthcare, educational, hospitality and institutional applications. In order for companies to market products with these bactericidal properties, they must be registered with the U.S. Environmental Protection Agency (U.S. EPA) and conform to prescriptive rules for marketing and distribution. This manual addresses these issues. U.S. EPA Registration What is Registration? Olin Brass’ CuVerro® bactericidal surfaces have been registered with the U.S. EPA to legally make claims that these materials kill infectious bacteria. In particular, this Public Health Claim states that registered CuVerro surfaces kill specific bacteria tested according to U.S. EPA protocols: “Testing demonstrates effective antibacterial activity against Staphylococcus aureus, Enterobacter aerogenes, Methicillin-Resistant Staphylococcus aureus (MRSA), Escherichia coli O157:H7, Pseudomonas aeruginosa, and Vancomycin-Resistant Enterococcus faecalis (VRE).” The U.S. EPA examines the ingredients of materials that make public health claims to insure that they will not have “unreasonable adverse effects on humans, the environment and non-target species” (i.e. species other than the infectious bacteria identified above.)3 Why do Fabricators Using CuVerro Alloys Need to Register? In order for manufacturers of furnishings, equipment and/or components using CuVerro materials (i.e. CuVerro Partners) to legally market products that include these claims, companies need to: a) Register company information with the U.S. EPA b) Obtain an Establishment Number from the U.S. EPA c) File initial and annual production reports with the U.S. EPA, and d) Insure that future use of products under these claims is consistent with the directions- for-use listed on the U.S. EPA-approved product labels. 3 Source: http://www.epa.gov/pesticides/regulating/registering/index.htm 4│ Registration & Product Labeling Manual ◦ September 2013 OB-0012-1309 What Is Olin Brass’ Role in the Registration and Compliance Process? U.S. EPA requires that if public health claims are made for touch-surfaces on healthcare equipment and furnishings, it is the responsibility of THE ORIGINAL METALS SUPPLIER (i.e. Olin Brass) to oversee that all labeling and marketing materials meet specific U.S. EPA guidelines. Olin Brass is required to insure that any downstream manufacturer using CuVerro® metals follows proper registration requirements, packaging and labeling formats, and guidelines for acceptable marketing collateral. Olin Brass is required to review and approve the CuVerro partners’ marketing materials, and retained copies of approved materials in our files. What Does Registration Process Require? Global Brass and Copper, Inc. has obtained a primary product registration for CuVerro alloys with both the U.S. EPA and all state regulatory agencies. This registration permits customers of Olin Brass to make human health claims on items containing CuVerro copper touch surfaces. As Federal and State registration (and filing costs) must be maintained on an annual basis, Olin Brass allows CuVerro customers to market and sell bactericidal products with minimal cost and administration as outlined below. STEPS IN OBTAINING U.S. EPA REGISTRATION CuVerro partners need to follow 10 easy steps in complying with the U.S. EPA’s registration process and the CuVerro Supply Agreement terms as summarized in Table 1, and outlined in the detail below. Table 1: Registration Process STEP Frequency Detail 1: Select U.S. EPA Registered Material. Continually Fabricated products making public health claims must utilize material from a U.S. EPA registered