3. INJUNCTIVE RELIEF, REFORMULATION, TESTING AND WARNINGS 3.1 Beginning 30 days after the Effective Date (the “Compliance Date”), TEAMI 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 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 TEAMI knows or has reason to know will sell the Covered Product in California. The injunctive relief in Section 3 does not apply to any Covered Product that has left the possession, and is no longer under the control, of TEAMI prior to the Compliance Date and all claims as to such Covered Products are released in this Consent Judgment.
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 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 TEAMI is required to provide a warning pursuant to Section 3.1, one of the following warning must be utilized (“Warning”):
Option 1:
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.
Option 2:
,L,
TEAMI shall use the phrase “cancer and” in the Warning if TEAMI 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 TEAMI has reason to believe that another Proposition 65 chemical is present which may require a cancer warning. As identified in the brackets, the warning shall appropriately reflect whether there is lead or cadmium present in each of the Covered Products. TEAMI need not identify both lead and cadmium unless one chemical is identified as a carcinogen and the other chemical is identified as a reproductive toxicant. Otherwise, if both chemicals are present, TEAMI may identify either lead or cadmium in the Warning.
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 in full text or through a clearly marked hyperlink using the word “WARNING” when a California delivery address is indicated for any purchase of any Covered Product. If a hyperlink is used, the hyperlink must go directly to a page prominently displaying either the Option 1 Warning or the Option 2 Warning without content that detracts from the Warning. An asterisk or other identifying method must be utilized to identify which products on the checkout page are subject to the Warning.
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. For the Option 2 Warning, 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.”
TEAMI 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.
For purposes of this Consent Judgment, when TEAMI is required to provide a warning pursuant to Section 3.1, TEAMI may satisfy the warning requirement by complying with 27 C.C.R. § 25600.2 (2021) and providing the information required by 27 C.C.R. § 25600.2 (2021) to any business that is subject to California Health and Safety Code § 25249.6 and to which TEAMI is selling or transferring the Covered Product.
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 3.4, and that is not known by TEAMI 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, TEAMI shall arrange for lead and cadmium testing of the Covered Products at least once a year for a minimum of three 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 TEAMI 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, TEAMI changes ingredient suppliers for any of the Covered Products and/or reformulates any of the Covered Products, TEAMI 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” 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 TEAMI’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, TEAMI shall deliver lab reports obtained pursuant to Section 3.4 to ERC. TEAMI shall retain all test results and documentation for a period of five years from the date of each test.
3.4.7 Nothing in this Consent Judgment shall require TEAMI to conduct testing on any Covered Product that TEAMI is no longer Distributing into the State of California, as that term is defined in Section 3.1. TEAMI shall comply with the testing requirements of this Section 3.4 prior to the date it ceases Distributing such Covered Product into the State of California.
