60 Day Notice 2015-00284

3. INJUNCTIVE RELIEF, REFORMULATION, TESTING AND WARNINGS 3.1 Beginning on the Compliance Date, SDC shall be permanently enjoined from manufacturing for sale in the State of California, “Distributing into the State of California,” or directly selling in the State of California, any Covered Product which exposes a person to a “Daily Lead Exposure Level” of more than 0.5 micrograms per day of lead or a “Daily Cadmium Exposure Level” of more than 4.10 micrograms per day of cadmium when the maximum suggested dose is taken as directed on the Covered Product’s label, unless SDC meets the warning requirements under Section 3.2. 3.1.1 As used in this Consent Judgment, the term “Distributing 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 SDC knows will sell the Covered Product in California. 3.1.2 For purposes of this Consent Judgment, the “Daily Lead Exposure Level” and “Daily Cadmium Exposure Level” shall be measured in micrograms, and shall be calculated using the following formula: micrograms of lead or cadmium 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 or cadmium exposure per day. 3.2 Clear and Reasonable Warnings If SDC is required to provide a warning pursuant to Section 3.1, the following warning must be utilized: WARNING: This product contains a chemical known to the State of California to cause [cancer and] birth defects or other reproductive harm. SDC shall use the phrase “cancer and” in the warning only if the maximum daily dose recommended on the label contains more than 15 micrograms of lead as determined pursuant to the quality control methodology set forth in Section 3.4. The warning shall be securely affixed to or printed upon the container or label of each Covered Product. The warning shall be at least the same size as the largest of any other health or safety warnings also appearing on its website or on the label or container of SDC’s product packaging and the word “WARNING” shall be in all capital letters and in bold print. No other statements about Proposition 65 or lead or cadmium may accompany the warning. SDC must display the above warnings with such conspicuousness, as compared with other words, statements, or design of the label or container, as applicable, to render the warning likely to be read and understood by an ordinary individual under customary conditions of purchase or use of the product. 3.3 Reformulated Covered Products A Reformulated Covered Product is one for which the Daily Lead Exposure Level or Daily Cadmium Exposure Level when the maximum suggested dose is taken as directed on the Reformulated Covered Product’s label, contains no more than 0.5 micrograms of lead or no more than 4.10 micrograms of cadmium per day as determined by the quality control methodology described in Section 3.4. 3.4 Testing and Quality Control Methodology 3.4.1 Beginning within one year of the Compliance Date, SDC shall arrange for cadmium and/or lead testing of the Covered Products at least once a year for a minimum of three consecutive years by arranging for testing of five randomly selected samples of each of the Covered Products, in the form intended for sale to the end-user, which SDC intends to sell or is manufacturing for sale in California, directly selling to a consumer in California or “Distributing into California.” The testing requirement does not apply to any of the Covered Products for which SDC has provided the warning specified in Section 3.2. If tests conducted pursuant to this Section demonstrate that no warning is required for a Covered Product during each of three consecutive years, then the testing requirements of this Section will no longer be required as to that Covered Product. 3.4.2 For purposes of measuring the “Daily Lead Exposure Level” or “Daily Cadmium Exposure Level,” the highest lead or cadmium detection result of the five (5) randomly selected samples of the Covered Products will be controlling. 3.4.3 All testing pursuant to this Consent Judgment shall be performed using a laboratory method that complies with the performance and quality control factors appropriate for the method used, including limit of detection, qualification, accuracy, and precision that meets the following criteria: 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 subsequently agreed to in writing by the Parties. 3.4.4 All testing pursuant to this Consent Judgment 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. 3.4.5 Nothing in this Consent Judgment shall limit SDC’s ability to conduct, or require that others conduct, additional testing of the Covered Products, including the raw materials used in their manufacture. 3.4.6 Beginning on the Compliance Date and continuing for a period of three years, SDC shall provide ERC copies of test results for lead and cadmium content under Section 3.4.1 within ten business days after completion of the testing.