3. INJUNCTIVE RELIEF, REFORMULATION, TESTING AND WARNINGS
3.1 Any Covered Products that are manufactured six (6) months after the Effective Date (the “Compliance Date”) that Defendants thereafter distribute into the State of California, offer for sale to a third party for retail sale in California, or directly sell in the State of California, shall either (1) contain no more than 0.5 micrograms of lead per day as calculated pursuant to Section 3.1.2, excluding allowances pursuant to Section 3.3, and as validated by the quality control methodology described in Section 3.4; or (2) meet 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 Defendants 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 Defendants are required to provide a warning pursuant to Section 3.1, the following warning must be utilized:
WARNING: This product contains a chemical known to the State of California to cause [cancer and] birth defects or other reproductive harm.
Defendants shall use the phrase “cancer and” in the warning only if the maximum daily dose recommended on the label contains more than 15 micrograms of lead as determined pursuant to the quality control methodology set forth in Section 3.4.
The warning shall be securely affixed to or printed upon the container or label of each Covered Product. Or, for Covered Products sold over Defendants’ website, the warning may appear on Defendants’ checkout page on their website for California consumers marketing any Covered Product, or appear prior to completing checkout on Defendants’ website when a California delivery address is indicated for any purchase of any Covered Product.
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 Defendants’ product packaging and the word “WARNING” shall be in all capital letters. No other statements about Proposition 65 or lead may accompany the warning.
Defendants must display the above warnings with such conspicuousness, as compared with other words, statements, or design of the label or container, 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 when the maximum suggested dose is taken as directed on the Reformulated Covered Product’s label, contains no more than 0.5 micrograms of lead per day as determined by the quality control methodology described in Section 3.4, excluding amounts of naturally occurring lead in the ingredients listed in the table below, in accordance with the Attorney General’s Stipulation
Modifying Consent Judgments in People v. Warner Lambert, et al., San Fran. Sup. Ct. Case No. 984503.
INGREDIENT NATURALLY OCCURING AMOUNT OF LEAD
Calcium 0.8 micrograms/gram
Ferrous Fumarate 0.4 micrograms/gram
Zinc Oxide 8.0 micrograms/gram
Magnesium Oxide 0.4 micrograms/gram
Magnesium Carbonate 0.332 micrograms/gram
Magnesium Hydroxide 0.4 micrograms/gram
Zinc Gluconate 0.8 micrograms/gram
Potassium Chloride 1.1 micrograms/gram
If, at any time after the Compliance Date, ERC tests a Covered Product and the test results indicate that the Daily Lead Exposure Level is greater than 0.5 micrograms per day, Defendants agree to confidentially supply to ERC within 30 days a list of ingredients, including the percentage of each ingredient (“Ingredient List”), of that particular covered product so that ERC may be able to calculate the daily exposure based on the allowances contained in the table above.
In the event that a dispute arises with respect to compliance with the terms of this Consent Judgment as to any contribution from naturally occurring lead levels under the Section, the Parties shall first meet and confer in an effort to fully resolve any dispute. If the meet and
confer process is unsuccessful, any Party may elect to proceed pursuant to the enforcement provisions of Section 5.4 below. In the event that Court intervention is sought by any Party, the Parties shall employ good faith efforts to seek entry of a protective order by the Court that limits public access to and disclosure of the Ingredient List provided prior to disclosure of the Ingredient List in any enforcement proceedings before the Court.
3.4 Testing and Quality Control Methodology
3.4.1 Beginning within one year of the Compliance Date, Defendants 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 Defendants intend to sell or are manufacturing for sale in California, directly selling to a consumer in California or “Distributing into California.” The testing requirement does not apply to any of the Covered Products for which Defendants have provided the warning specified in Section 3.2. 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. Defendants shall retain all test results and documentation for a period of five years from the date of each test.
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.
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 Beginning on the Compliance Date and continuing for a period of three years, upon demonstration by ERC of test results showing a Daily Lead Exposure Level above 0.5mcg/day, Defendants shall arrange for copies of all laboratory reports for the product in question showing lead content results under Section 3.4.1 to be sent to ERC within ten days after receipt of ERC’s written request.