60 Day Notice 2016-01130

3. INJUNCTIVE RELIEF, REFORMULATION, TESTING AND WARNINGS 3.1 Beginning on the Effective Date, ESSANTE 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 Products which exposes a person to a “Daily Lead Exposure Level” of more than 0.5 micrograms of lead per day unless it 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 ESSANTE knows or has reason to know will sell the Covered Product in California. 3.1.2 For purposes of this Consent Judgment, the “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. 3.2 Clear and Reasonable Warnings If ESSANTE is required to provide a warning pursuant to Section 3.1, the following warning must be utilized (“Warning”): WARNING: This product can expose you to chemicals including [lead] which is known to the State of California to cause [cancer and] birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov. ESSANTE shall use the phrase “cancer and” in the Warning only if the “Daily Lead Exposure Level” is greater than 15 micrograms of lead as determined pursuant to the quality control methodology set forth in Section 3.4. The Warning shall be provided on the invoice in boxes of Covered Products shipped to California. ESSANTE shall provide one invoice Warning for each Covered Product in a box or one invoice Warning that lists all of the Covered Products in the box. The Covered Products may be returned by the consumer for a refund within 30 days of the invoice date at no cost to the consumer if the consumer references the Warning as a reason for the return. The Warning must be present on the front of the invoice. The Warning shall be at least the same size as the largest of any other health or safety warnings also appearing on the invoice and the word “WARNING” shall be in all capital letters and in bold print. No statements intended to or likely to have the effect of diminishing the impact of, or reducing the clarity of, the Warning on the average lay person shall accompany the Warning. Further no statements may accompany the Warning that state or imply that the source of the listed chemical has an impact on or results in a less harmful effect of the listed chemical. ESSANTE must display the above Warning with such conspicuousness, as compared with other words and statements on the invoice, 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” is no greater than 0.5 micrograms of lead 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 Effective Date, ESSANTE shall arrange for lead testing of the Covered Products at least once a year for a minimum of five 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 ESSANTE intends to sell or is manufacturing for sale in California, directly selling to a consumer in California or “Distributing into the State of California.” If tests conducted pursuant to this Section demonstrate that no Warning is required for a Covered Product during each of five consecutive years, then the testing requirements of this Section will no longer be required as to that Covered Product. However, if during or after the five-year testing period, ESSANTE changes ingredient suppliers for any of the Covered Products and/or reformulates any of the Covered Products, ESSANTE shall test that Covered Product annually for at least four (4) consecutive years after such change is made. 3.4.2 For purposes of measuring the “Daily Lead Exposure Level,” the highest lead 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 and approved by the Court through entry of a modified consent judgment. 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 ESSANTE’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 Within thirty (30) days of ERC’s written request, ESSANTE shall deliver lab reports obtained pursuant to Section 3.4 to ERC. ESSANTE shall retain all test results and documentation for a period of five years from the date of each test.