3. INJUNCTIVE RELIEF, REFORMULATION, TESTING AND WARNINGS
3.1 Beginning on the Effective Date, GRENADE shall be permanently enjoined from marketing any Covered Products in the State of California, 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 expose 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 GRENADE 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, minus the “Naturally Occurring Lead” (defined below) as outlined in Section 3.1.3, 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 In calculating the Daily Lead Exposure Level for a Covered Product, GRENADE shall be allowed to deduct the amount of lead which is deemed Naturally Occurring Lead in any ingredient listed in Table 1 (Lead Ingredient) that is contained in that Covered Product under the following conditions: (a) GRENADE itself or from its Lead Ingredient supplier shall obtain either (i) a valid test result showing lead is present in the Lead Ingredient at a specific concentration or in a range; or (ii) a certificate of analysis or certificate of compliance that sets a maximum or average range or tolerance for lead in the Lead Ingredient at a specific concentration or in a range delivered within twelve (12) months of the Effective Date; and (b) GRENADE shall document the total amount (in grams) of each Lead Ingredient contained in the Covered Product. If the documentation obtained pursuant to Section 3.1.3(a) and (b) documents the presence of lead in any Lead Ingredient in Table 1, GRENADE shall be entitled to deduct the amount of the Naturally Occurring Lead for that Lead Ingredient, as listed in Table 1. If the Covered Product does not contain a Lead Ingredient listed in Table 1, GRENADE shall not be entitled to a deduction for the Naturally Occurring Lead in Table 1 for that Covered Product.
To deduct the Naturally Occurring Lead in any Covered Product for purposes of determining the Daily Lead Exposure Level under this Consent Judgment, as provided in this Section 3.1.3, GRENADE shall provide to ERC, within thirty (30) days after the first anniversary of the Effective Date, the documentation required under Section 3.1.3(a)-(c). Thereafter, for three (3) additional consecutive anniversaries after the Effective Date, if GRENADE deducts Naturally Occurring Lead in a Lead Ingredient in calculating the Daily Lead Exposure Level, GRENADE shall provide to ERC, within thirty (30) days after each such anniversary date, the documentation for each Lead Ingredient required under Section 3.1.3(a)-(c) for each such applicable twelve (12) month period. GRENADE shall be entitled to redact such documentation to avoid disclosing the identities of its suppliers.
ERC shall keep the information supplied pursuant to Section 3.1.3(a)-(c) and all test results strictly confidential and shall not disclose such information or documents provided by GRENADE to any third party, except as required by the terms of this Consent Judgment or by compulsory legal process. If ERC receives a subpoena, discovery request, or any similar legal process calling for disclosure of documents or information provided by GRENADE, it shall promptly notify GRENADE and cooperate in any effort by GRENADE to resist such disclosure.
TABLE 1
INGREDIENT NATURALLY OCCURING AMOUNTS OF LEAD
Cocoa-powder 1.0 micrograms/gram
Chocolate Liquor 1.0 micrograms/gram
Cocoa Butter 0.1 micrograms/gram
3.2 Clear and Reasonable Warnings
If GRENADE 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 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.
GRENADE shall use the phrase “cancer and” in the Warning if GRENADE 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 or if GRENADE has reason to believe that another Proposition 65 chemical is present which may require a cancer warning.
The Warning shall be securely affixed to or printed upon the container or label of each Covered Product. If the Warning is provided on the label, 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 its website or on the label or container of GRENADE’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, 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.
GRENADE must display the above Warning with such conspicuousness, as compared with other words, statements or designs on the label or container, 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.
3.3 Reformulated Covered Products
A Reformulated 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 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, GRENADE shall arrange for 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 GRENADE 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.
3.4.2 For purposes of measuring the “Daily Lead Exposure Level,” the average 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. If testing is performed in a jurisdiction other than the United States and GRENADE is unable to secure testing from a laboratory that meets these same performance and quality control factors, the testing shall be performed using a laboratory method that complies with substantially equivalent performance and quality control factors.
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, an independent third-party laboratory that is registered with the United States Food & Drug Administration, or, if testing is performed in a jurisdiction other than the United States and GRENADE is unable to secure testing from a laboratory that meets these same registrations and/or certifications, by an independent third-party laboratory that is registered and/or accredited by an equivalent governmental agency or standard-setting body.
3.4.5 Nothing in this Consent Judgment shall limit GRENADE’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, GRENADE shall deliver lab reports obtained pursuant to Section 3.4 to ERC. GRENADE shall retain all test results and documentation for a period of three (3) years from the date of each test.
