3. INJUNCTIVE RELIEF, REFORMULATION, TESTING AND WARNINGS
3.1 Beginning on the Effective Date, MBi DISTRIBUTING 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 that 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 MBi DISTRIBUTING 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 recommended daily servings appearing on the label), which equals micrograms of lead exposure per day. If the label contains no recommended daily servings, then the number of recommended daily servings shall be one.
3.1.3 So long as MBi DISTRIBUTING can provide documentation, if requested in writing by ERC, Covered Products shipped, sold, or Distributed into the State of California by MBi DISTRIBUTING prior to the Effective Date are not bound by the injunctive terms set forth in this Section 3, including but not limited to the Daily Lead Exposure Level and warning and testing requirements, and are instead permitted to be sold as is to California Consumers and are expressly released by Section 8 of this Consent Judgment.
3.2 Clear and Reasonable Warnings
If MBi DISTRIBUTING is required to provide a warning pursuant to Section 3.1, one of the following warnings must be utilized (“Warning”):
WARNING: Consuming this product can expose you to chemicals including [lead] 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.
WARNING: [Cancer and] Reproductive Harm – www.P65Warnings.ca.gov/food
MBi DISTRIBUTING shall use the phrase “cancer and” in the Warning if MBi DISTRIBUTING has reason to believe that the 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 or if MBi DISTRIBUTING has reason to believe that another Proposition 65 chemical is present which may require a cancer warning. For the Option 2 Warning, the entire Warning must be in a type size no smaller than the largest type size used for other consumer information on the product. In no case shall the Warning appear in a type size smaller than 6-point type. Further, for Option 2, a symbol consisting of a black exclamation point in a yellow equilateral triangle with a bold black outline shall be placed to the left of the text of the Warning, in a size no smaller than the height of the word “WARNING.” Where the sign, label or shelf tag for the product is not printed using the color yellow, the symbol may be printed in black and white.
The Warning shall be securely affixed to or printed upon the label of each Covered Product and, if printed upon the label of each Covered Product, it must be set off from other surrounding information and enclosed in a box. In addition, for any Covered Product sold over the internet, the Warning shall appear prior to checkout on the primary product page, or as a pop-up when a California zip code is input into the shipping instructions, or on the checkout page when a California delivery address is indicated for any purchase of any Covered Product. Where a Warning subject to this section is provided on the checkout page, an asterisk or other identifying method must be utilized on the checkout page to identify which product(s) on the checkout page are subject ot the Warning. The Warning may be provided with a conspicuous hyperlink stating “WARNING” in all capital and bold letters so long as they hyperlink goes directly to a page prominently displaying the Warning without content that detracts from the Warning. Given MBi DISTRIBUTING’s lack of control over third-party websites, the online warning requirements expressed in this Section apply only to Covered Products sold through MBi DISTRIBUTING’s website. With respect to any downstream reseller customers of MBi DISTRIBUTING who are subject to Proposition 65, MBi DISTRIBUTING may give written notice, including labels, labeling, shelf signs, or tags bearing the Warning and all other necessary warning materials, to the authorized agent of such downstream reseller customers. Such written notice shall instruct the downstream reseller customers that the labels, labeling, shelf signs, or tags bearing the Warning must be displayed on or in proximity to the Covered Products with such conspicuousness, as compared with other words, statements or designs, as to render the Warning likely to be seen, read, and understood by an ordinary individual prior to sale.
The Warning shall be at least the same size as the largest of any other health or safety warnings also appearing on the website or on the label 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.
MBi DISTRIBUTING must display the above Warning with such conspicuousness, as compared with other words, statements or designs on the label, or on its website, if 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.
For purposes of this Consent Judgment, the term “label” means a display of written, printed or graphic material that is printed on or affixed to a Covered Product or its immediate container or wrapper.
If subsequently enacted changes to Proposition 65 or its implementing regulations require the use of additional or different information on any warning specifically applicable to the Covered Products (the “New Safe Harbor Warning”), the Parties agree that the New Safe Harbor Warning may be utilized in place of or in addition to, as applicable, the warnings set forth in this Section.
3.3 Conforming Covered Products
A Conforming Covered Product is a Covered Product for which the “Daily Lead Exposure Level” is no greater than 0.5 micrograms of lead per day as determined by the the exposure methodology set forth in Section 3.1.2 and the quality control methodology described in Section 3.4, and that is not known by MBi DISTRIBUTING to contain other chemicals that violate Proposition 65’s safe harbor thresholds.
3.4 Testing and Quality Control Methodology
3.4.1 Beginning within one year of the Effective Date, MBi DISTRIBUTING shall arrange for lead testing of the Covered Products at least once a year for a minimum of three (3) consecutive years by arranging for testing of three (3) randomly selected samples of each of the Covered Products, in the form intended for sale to the end-user, which MBi DISTRIBUTING 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 three 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 three-year testing period, MBi DISTRIBUTING changes ingredient suppliers for any of the Covered Products and/or reformulates any of the Covered Products, MBi DISTRIBUTING shall test that Covered Product annually for at least three (3) 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 three (3) 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 and limit of quantification, sensitivity, 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.
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 MBi DISTRIBUTING’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, which request shall not be made more than once per year, MBi DISTRIBUTING shall deliver lab reports obtained pursuant to Section 3.4 to ERC. MBi DISTRIBUTING shall retain all test results and documentation for a period of three years from the date of each test.
3.4.7 The testing and reporting requirements of Section 3.4 do not apply to any Covered Product for which MBi DISTRIBUTING is providing a Warning, continuously and without interruption from the Effective Date, pursuant to Section 3.2 of this Consent Judgment. In the event a Warning is provided after the Effective Date but MBi DISTRIBUTING thereafter ceases to provide the Warning required by Section 3.2, the testing and reporting requirements of Section 3.4 of this Consent Judgment shall apply beginning within one year after the date the Warning ceases to be provided, unless MBi DISTRIBUTING can show to the satification of ERC that the cessation in providing the Warning was a temporary error that was resolved when discovered.