3. INJUNCTIVE RELIEF, REFORMULATION, TESTING AND WARNINGS
3.1 Beginning on the Effective Date, REBBL 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 that expose 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 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 REBBL 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, excluding, pursuant to Section 3.1.3, amounts of allowances of lead in the ingredients listed in Table 1 below. If the label contains no recommended daily servings, then the number of recommended daily servings shall be one.
3.1.3 In calculating the Daily Lead Exposure Level for a Covered Product, REBBL shall be allowed to deduct the amount of lead which is deemed “naturally occurring” in any ingredient listed in Table 1 that is contained in that Covered Product under the following conditions: For each year that REBBL claims entitlement to a “naturally occurring” allowance, REBBL shall provide ERC with the following information: (a) REBBL must produce to ERC a list of each ingredient in the Covered Product, and the amount, measured in grams, of each such ingredient contained therein, for which a “naturally occurring” allowance is claimed; (b) REBBL must provide ERC with documentation of laboratory testing that complies with Sections 3.4.3 and 3.4.4 and that shows the amount of lead, if any, contained in any ingredient listed in Table 1 that is contained in the Covered Product and for which REBBL intends to deduct “naturally occurring” lead; (c) If the laboratory testing reveals the presence of lead in any ingredient listed in Table 1 that is contained in the Covered Product, REBBL shall be entitled to deduct up to the full amount of the allowance for that ingredient, as listed in Table 1, but not to exceed the total amount of lead actually contained in that ingredient in the Covered Product; and (d) If the Covered Product does not contain an ingredient listed in Table 1, REBBL shall not be entitled to a deduction for “naturally occurring” lead in the Covered Product for that ingredient. The information required by Sections 3.1.3 (a) and (b) shall be provided to ERC within thirty (30) days of the Effective Date or anniversary thereof for any year that REBBL shall claim entitlement to the ”naturally occurring” allowance.
TABLE 1
INGREDIENT ALLOWANCES OF AMOUNT OF LEAD
Cocoa-powder Up to 1.0 micrograms/gram
Chocolate Liquor Up to 1.0 micrograms/gram
Cocoa Butter Up to 0.1 micrograms/gram
3.1.4 For purposes of this Consent Judgment, the “Daily Cadmium Exposure Level” shall be measured in micrograms, and shall be calculated using the following formula: micrograms of 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 recommended daily servings appearing on the label), which equals micrograms of cadmium exposure per day. If the label contains no recommended daily servings, then the number of recommended daily servings shall be one.
3.2 Clear and Reasonable Warnings
If REBBL 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.
REBBL shall use the phrase “cancer and” in the Warning if REBBL has reason to believe that 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. As identified in the brackets, the warning shall appropriately reflect whether there is lead, cadmium, or both chemicals present in each of the Covered Products, to the extent required under California regulations and law.
The Warning shall be securely affixed to or printed upon the label of each Covered Product and 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 on the checkout page when a California delivery address is indicated for any purchase of any Covered Product. An asterisk or other identifying method must be utilized to identify which products on the checkout page are subject to the Warning. In no event shall any internet or website Warning be contained in or made through a link.
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.
REBBL 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.
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 and/or “Daily Cadmium Exposure Level” is no more than 4.1 micrograms of cadmium per day as determined by the exposure methodology set forth in Section 3.1.2 and the quality control methodology described in Section 3.44.
3.4 Testing and Quality Control Methodology
3.4.1 Beginning within one year of the Effective Date, REBBL shall arrange for lead and cadmium testing of the Covered Products at least once a year for a minimum of five 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 REBBL 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, REBBL changes ingredient suppliers for any of the Covered Products and/or reformulates any of the Covered Products, REBBL 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” and/or “Daily Cadmium Exposure Level,” the highest lead and/or cadmium 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 0.005 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 REBBL’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, REBBL shall deliver lab reports obtained pursuant to Section 3.4 to ERC. REBBL shall retain all test results and documentation for a period of five years from the date of each test.