60 Day Notice 2016-00275

3. INJUNCTIVE RELIEF, REFORMULATION, TESTING AND WARNINGS 3.1 Beginning on the Effective Date, unless MXI no longer qualifies as a “Person in the course of doing business,” as the term is defined in Cal. Health & Safety Code § 25249.11(b), including by employing fewer than 10 employees in its business, MXI 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 and/or “Daily Cadmium Exposure Level” of more than 4.1 micrograms of cadmium per day, calculated as set forth in Section 3.1.2, or 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 MXI 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” 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, but excluding any amounts of lead deemed “naturally occurring” as set forth in Section 3.1.4 below, 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 recommended daily servings appearing on the product label), which equals micrograms of lead or cadmium exposure per day.. 3.1.4 For purposes of this Consent Judgment, the amount of lead deemed “naturally occurring” in each of the Covered Products is the sum of the amounts of “naturally occurring” lead from each ingredient listed in Table 3.1.4 below TABLE 3.1.4 Ingredient Amount of Lead Per Gram of Ingredient Deemed “Naturally Occurring” For Purposes of This Consent Judgment Only. Cocoa Powder 1.0 μg Cocoa Liquor 1.0 μg Cocoa butter 0.1 μg Within thirty (30) days of ERC’s written request, MXI must supply ERC with the amount of each ingredient in each Covered Product for which the “naturally occurring” allowance is being applied. MXI is entitled to submit this information to ERC confidentially. 3.2 Clear and Reasonable Warnings If MXI is required to provide a warning pursuant to Section 3.1, the following warning must be utilized (“Warning”): WARNING: Consuming this product can expose you to chemicals including [lead] [and] [cadmium] which is [are] 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/food. MXI 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 appropriately reflect whether there is either lead or cadmium present in each of the Covered Products in accordance with 22 Cal. Code Reg. tit. 27 § 25601(b) (as amended, operative August 30, 2018). If the phrase “cancer and” is used, the Warning must reflect that lead is present in the Covered Product. The Warning shall be securely affixed to or printed upon the container or label of each Covered Product. To the extent such a warning is affixed to or printed upon the container or label of a covered product, a website warning need not be provided. 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 MXI’s product packaging 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 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. MXI must display the above Warning with such conspicuousness, as compared with other words, statements, design of the label, container, or on its website, 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” is no greater than 0.5 micrograms of lead per day and/or “Daily Cadmium Exposure Level” is no more than 4.1 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 Within one year of the Effective Date, unless MXI no longer qualifies as a “Person in the course of doing business,” as the term is defined in Cal. Health & Safety Code § 25249.11(b), including by employing fewer than 10 employees in its business, MXI shall arrange for lead and/or cadmium 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 from two or more lots of each of the Covered Products, in the form intended for sale to the end-user, which MXI intends to sell or is manufacturing for sale in California, directly selling to a consumer in California or “Distributing into the State of California.” The tem “lot” as used herein shall mean a manufacturing cycle or series of manufacturing cycles producing Covered Products that are designated with the same date code. 3.4.2 For purposes of measuring the “Daily Lead Exposure Level” and/or “Daily Cadmium Exposure Level,” the arithmetic mean lead and/or cadmium dectection result of the five (5) randomly selected samples from two or more lots of each Covered Product 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 MXI’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, MXI shall deliver lab reports obtained pursuant to Section 3.4 to ERC. MXI shall retain all test results and documentation for a period of five years from the date of each test.