60 Day Notice 2015-00856

Beginning on the Effective Date, Settling Companies shall not manufacture for sale in the State of California , “Distribute into the State of California,” or directly sell in the State of California, any Covered Product which exposes a person to a “Daily Lead Exposure Level” of more than 0.5 micrograms of lead per day when the maximum suggested dose is taken as directed on the Covered Product’s label, unless each such unit of the Covered Product that is sold or offered for sale to California consumers bears the following warning statement (“Warning”) on its individual unit label packaging or by sticker securely affixed on the container or bottle cap: “WARNING: This product contains [lead, ] a chemical known to the State of California to cause [cancer and] birth defects or other reproductive harm.” i. As used in this Settlement Agreement and Release, the term “Distribute into the State of California” shall mean to directly ship a Covered Product into California for sale in California or to sell a Covered Product to a distributor that Settling Companies know will sell the Covered Product in California. ii. For the purposes of this Agreement, “Daily Lead Exposure Level” shall be measured in micrograms, and shall be calculated using the following formula: micrograms of lead per gram of product, multiplied by grams of product per serving of the product (using the largest serving size appearing on the product label), multiplied by servings of the product per day (using the largest number of servings in a recommended dosage appearing on the product label), which equals micrograms of lead exposure per day. iii. The bracketed terms in the Warning are optional; provided however, the phrase “cancer and” in the Warning must be included in the warning if the maximum recommended daily dose causes an exposure to more than 15 micrograms of lead when taken as directed on the Covered Product’s label. At Settling Companies’ option, the Warning may refer to “chemicals” in the plural. Any reference to “chemicals” in the plural may be used only if Settling Companies have a reasonable basis to believe that more than one Proposition 65 chemical exists in the product at levels in excess of the Proposition 65 warning threshold. b. The Warning shall be prominent and displayed securely on either the cap, the unit packaging, or by a sticker securely affixed to the Covered Products with such conspicuousness, as compared with other words, statements, or designs so as to render it likely to be read and understood by an ordinary individual purchasing or using the Covered Products. The warning appearing on the label or container shall be at least the same size as the largest of any other health or safety warnings correspondingly appearing on the label or container, as applicable, or such product, and the word “WARNING” shall be in capital letters and in bold print. Apart from the Warning, no additional statement discussing Proposition 65 or lead may be stated on the Covered Product or on the unit packaging of the Covered Product. c. Settling Company shall arrange, for at least five (5) consecutive years and at least once per year, commencing one year from the Effective Date, for the lead testing of three (3) randomly-selected samples of three separate lots, or from as many lots as are available if there are fewer than three, each year for each Covered Product that it continues to sell or distribute to confirm whether the Daily Lead Exposure Level is more or less than 0.5 micrograms of lead when the maximum suggested dose is taken pursuant to the directions on the Covered Product’s label. Settling Company shall provide ERC with any related documentation pursuant to Section 3d. below, and shall include the lot identification numbers of the lots tested. Settling Company shall test samples in the form intended for the end-user to be distributed or sold to California consumers. The requirements of Section 3c.and 3d. are not applicable to any Covered Products for which Settling Company has provided the Warning under Section 3a. d. If Settling Companies are successful with reformulation for any of the Covered Products which reduces the Daily Lead Exposure Level to 0.5 micrograms of lead or below when taken pursuant to the maximum suggested dose as directed on the Covered Product’s label, the Parties agree that the Covered Products may be offered for sale in California without the Warning set forth in Section 3a. If Settling Companies are successful with reformulation on any of the Covered Products, Settling Companies shall notify ERC and provide any test results for the Covered Products that document this change in formulation, no longer than 10 working days after Setting Companies receive the test results and prior to Settling Companies manufacturing for sale in the State of California, or directly selling in the State of California, any Covered Products without the Warning set forth in Section 3a. i. Pursuant to Sections 3c. and 3d., any such testing shall be performed by an independent third-party laboratory certified by the California Environmental Laboratory Accreditation Program or an independent third-party laboratory that is registered with the United States Food & Drug Administration. The method of selecting samples for testing must comply with the regulations of the Food & Drug Administration as set forth in Title 21, Part 111, Subpart E of the Code of Federal Regulations, including Section 111.80(c). Testing for lead shall be performed using Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) achieving a limit of quantification of less than or equal to 0.010 mg/kg or any other testing method agreed upon in writing by the Parties. Nothing in this Agreement shall limit Settling Companies’ ability to conduct or require that others conduct additional testing of the Covered Products, including raw materials used in their manufacture. ii. Pursuant to Sections 3c. and 3d., Hsin Ten shall retain copies of its test data for a period of at least five (5) years. Upon fifteen (15) days of receipt of a written request by ERC, Hsin Ten shall provide ERC with documentation of results of testing undertaken pursuant to this Agreement.