Supreme Court Depublishes Prop 65 Cereal Preemption Case

The California Supreme Court in October denied the Petition for Review of the Second District  Court of Appeal's opinion that a  Proposition 65 suit concerning acrylamide in breakfast cereals was preempted by federal law.  Although the trial court  rejected this argument the cereal manufacturers successfully appealed  

to the Court of Appeals. The Court found that  a Prop. 65 cancer warning on whole grain cereal would pose an "obstacle" to Congress' nutrition policies that encourage the consumption of whole grain foods.The Supreme Court denied the Petition to review, however they did grant the request by the California Attorney General and several environmental groups to depublish the lower court decision. Consequently this case cannot be cited as precedent

"The petition for review is denied. The requests for an order directing depublication of the opinion are granted. The Reporter of Decisions is directed not to publish in the Official Appellate Reports the opinion in the above entitled appeal filed July 16, 2018, which appears at 25Cal.App.5th 278. (Cal Const., art. VI, section 14; rule 8.1125(c)(1), Cal. Rules of Court.) Corrigan, J., was absent and did not participate." 

Cal.Supreme Court 10/31/2018.  POST FOODS v. S.C. (SOWINSKI) Division SF Case Number S250937 

OEHHA has Proposed Amendments to Warning Regulations to Clarify the Definitions of Registered Agent and Actual Knowledge

The Office of Environmental Health Hazard Assessment (OEHHA) adopted amendments to the Clear and Reasonable Prop 65 regulations on November 20, 2017 to clarify certain provisions.

The changes relate to two mains topics:  

The first is to clarify the definition of a Registered Agent for the purposes of providing notice of the Prop 65 requirements. These changes were required as manufacturers and distributors needed clarification as to the definition of  a Registered Agent  for the purposes of allowing the transmittal of notice requirements to downstream transferees that is now permitted to transfer responsibility for warnings under the 2016 regulations.

 The changes add language to the relevant provisions of the regulations that an authorized agent is the authorized agent for the business to which they are selling or transferring the product.

This clarifies that the upstream entities need only to give the notice to their immediate downstream customers, which has been a question for entities attempting to comply with the 2016 regulations:

(b)  The manufacturer, producer, packager, importer, supplier, or distributor of a product

may comply with this article either by providing a warning on the product label or labeling that satisfies Section 25249.6 of the Act, or by providing a written notice directly to the authorized agent for the business to which they are selling or transferring the product or to the authorized agent for a retail seller who is subject to Section 25249.6 of the Act, which:

(1)  States that the product may result in an exposure to one or more listed chemicals;

(2)  Includes the exact name or description of the product or specific identifying information for the product such as a Universal Product Code or other identifying designation;

(3)  Includes all necessary warning materials such as labels, labeling, shelf signs or tags, and warning language for products sold on the internet, that satisfies Section 25249.6 of the Act; and

(4)  Has been sent to the authorized agent for the business to which they are selling or transferring the product who is subject to Section 25249.6 of the Act or to the authorized agent for the retail seller, and the manufacturer, producer, packager, importer, supplier, or distributor has obtained confirmation electronically or in writing of receipt of the notice.

(c)  If the manufacturer, producer, packager, importer, supplier, or distributor of a product is complying with this section by providing a written notice directly to the authorized agent for the business to which they are selling or transferring the product who is subject to Section 25249.6 of the Act or to the authorized agent for the retail seller:

(1)  Confirmation of receipt of the notice must be received electronically or in writing, and must be renewed, and receipt of the renewed notice confirmed electronically or in writing by the authorized agent for the business to which they are selling or transferring the product who is subject to Section 25249.6 of the Act or the authorized agent for the retail seller's authorized agent no later than February 28, 2019, then annually thereafter during the period in which the product is sold in California by the retail seller.

(2)Where a business has not designated an authorized agent, the manufacturer, producer, packager, importer, supplier, or distributor may serve the notice on the legal agent for service of process for the business.

(b) The manufacturer, producer, packager, importer, supplier, or distributor of a product

may comply with this article either by providing a warning on the product label or labeling that satisfies Section 25249.6 of the Act, or by providing a written notice directly to the authorized agent for the business to which they are selling or transferring the product or to the authorized agent for a retail seller who is subject to Section 25249.6 of the Act....

 The second change relates to what "actual knowledge" means with respect to duties of the retailers under the Prop 65,  2016 Amendments to the Clear and Reasonable Warnings. 

(f) For purposes of subsection (e)(5), “actual knowledge” means specific knowledge of the consumer product exposure with sufficient specificity for the retail seller to readily identify the product that requires a warning, and that is received by the authorized agent or a person whose knowledge can be imputed to the retail seller from any reliable source. If the source of this knowledge is a notice served pursuant to Section 25249.7(d)(1) of the Act, the retail seller shall not be deemed to have actual knowledge of any consumer product exposure that is alleged in the notice until five business days after the retail seller receives a notice that provides a description of the product with sufficient specificity for the retail seller to readily identify the product in accordance with

Article 9, section 25903(b)(2)(D).

The actual knowledge provision is in turn significant because it relates to the instances when a retailer becomes responsible for the warning.

(e) The retail seller is responsible for providing the warning required by Section 25249.6 of the Act for a consumer product exposure only when one or more of the following circumstances exist:

(5) The retail seller has actual knowledge of the potential consumer product exposure requiring the warning, and there is no manufacturer, producer, packager, importer, supplier, or distributor of the product who: (A) Is a “person in the course of doing business” under Section 25249.11(b) of the Act, and (B) Has designated an agent for service of process in California, or has a place of business in California.

OEHHA will receive comments by 5:00 p.m. on December 31, 2018. All comments will be posted on the OEHHA website at the close of the public comment period.

Prop 65 Proposed Changes to Calculating Exposure to Reproductive Chemicals in Food

(OEHHA) has proposed changes to the regulations that govern how Prop 65 reproductive toxicants in foods should be calculated. The proposed changes to the Prop 65 regulations amend 27 CCR §25821(a) and 27 CCR §25821(c) (2) purportedly to prevent incorrect or inconsistent determinations as to the applicability of Prop 65.  https://oehha.ca.gov/proposition-65/crnr/proposed-amendment-sections-25821a-and-c-level-exposure-chemicals-causing.

§ 25821. Level of Exposure to Chemicals Causing Reproductive Toxicity

(a) For purposes of the Act, “level in question” means the chemical concentration of a listed chemical for the exposure in question.  The exposure in question includes the exposure for which the person in the course of doing business is responsible, and does not include exposure to a listed chemical from any other source or product.  For purposes of this section, where a business presents evidence fo r the “level in qu e stio n ”   of a listed chemical in a food product based on the average of multiple samples of that food, the level in question may not be calculated by averaging the concentration of the chemical in food products from different manufacturers or producers, or that were manufactured in different manufacturing facilities from the product at issue.

This proposed rule bars a producer from calculating an average exposure level from multiple samples based on food from different manufacturers or producers or from different manufacturing facilities. OEHHA stated that they believe  that it is inconsistent with the purposes of [Prop. 65] to average concentrations of chemicals in products manufactured over extended periods, and “based on concentrations measured in samples of foods from different manufacturers or producers, or from different manufacturing facilities, because these are not necessarily representative of the levels of the chemical in products an individual would typically be exposed to when consuming a particular product in California.” Initial Statement of Reasons https://oehha.ca.gov/media/downloads/crnr/isor25821100518.pdf at p.9.

OEHHA also made proposed changes to the way the rate of intake or exposure is calculated:

§ 25821.(c)(2) For exposures to consumer products, the level of exposure shall be calculated using the reasonably anticipated rate of intake or exposure for average users of the consumer product, and not on a per capita basis for the general population.  This rate of intake or exposure is calculated as the arithmetic mean of the rate of intake or exposure for users of the product. The rate of intake or exposure shall be based on data for use of a general category or categories of consumer products, such as the United States Department of Agriculture Home Economic Research Report, Foods Commonly Eaten by Individuals: Amount Per Day and Per Eating Occasion, where such data are available.

In this section 27 CCR § 25821(c)(2), OEHHA  attempts to define  the method of calculating  the reasonably anticipated rate of intake  by using the arithmetic mean of differing exposure rates. According to OEHHA the arithmetic mean best captures that variability because it, unlike a geometric mean or median methodology it “accounts for consumption levels at both the low and the high end of the range, weighing the intake of each consumer equally.” Initial Statement of Reasons at p.8.

These amendments would arguably abrogate the state appellate court decision in Environmental Law Foundation v. Beech-Nut Nutrition. et al., (2015) 235 Cal.App.4th 307, (“Beech-Nut”) in which the Court allowed exposure calculations based on the average lead levels across different manufacturers and facilities. It also permitted the use of the geometric mean to calculate rates of rather than the arithmetic as these proposed rules require.

OEHHA in the Initial Statement or Reasons makes it clear that they believe that the Court in Beech-Nut was wrong:

Neither [of the Court] finding[s]  is consistent with the intent of OEHHA’s regulations or Proposition 65, which is focused on an individual exposure from a specific product. Therefore, OEHHA believes that the regulations should be clarified so that businesses and courts can apply the correct analysis in the future. It should be noted that it is also inconsistent with the purposes of the Act to average concentrations of chemicals in products manufactured over extended periods. OEHHA considered including a time element in this regulation. Initial Statement of Reasons at p.11

The consequence of these new rules would be to make it more difficult for food producers to support a decision to forego labeling certain food products, as  the proposed  rule makes the Prop 65 threshold more difficult to calculate because of  the inherent variability of constituents in foods with respect to the levels in the foods and the variability of  the rate of exposure to consumers.

 The Public comment cutoff was extended until November 26, 2018 and with a public hearing that will be held on November 19, 2018.Public comments cutoff was extended until November 26, 2018 and with a public hearing that will be held on November 19, 2018.

Proposed Proposition 65 Regulation Concerning Chemicals in Coffee

OEHHA has initiated a proposed regulation to attempt to clarify that exposures to Proposition 65 listed chemicals in coffee are created by the roasting of coffee beans and brewing of coffee and the State asserts that it does not pose a significant cancer risk.  

The proposed language is as follows:


              ARTICLE 7. NO SIGNIFICANT RISK LEVELS § 25704. 

        Exposures to Listed  Chemicals in Coffee Posing No                                              Significant Risk

       Exposures to listed chemicals in coffee created                               by and inherent in the processes of roasting                                     coffee  beans or brewing coffee do not pose a significant               risk of cancer. 

NOTE: Authority cited: Section 25249.12, Health and Safety Code. Reference: Sections 25249.6 and 25249.10, Health and Safety Code

 A public hearing on the proposed rule making is scheduled for August 16, 2018 at 10 am in the CalEPA Headquarters Building, 1001 I Street, Sacramento.  A public-comment period on the proposed rule making will close on August 30, 2018.

Prop 65 Use of IARC Findings for Listing by State is not an Improper Delegation of Authority

The Fifth Appellate District affirmed a judgment from a trial court holding  that Prop 65's definition of hazardous chemicals as including substances identified as such by IARC, an agency of the United Nations does not constitute an improper delegation of authority.

On method for listing  chemicals on the Prop 65 list is whether it is listed as human or animal carcinogens by the International Agency for Research on Cancer (IARC), which is part of the World Health Organization and headquartered in France. 

Monsanto Company and others filed a petition for writ of mandate challenging §6382(b)(1), arguing it is improper for a foreign entity, unaccountable to the citizens of California, to determine what chemicals are known to the state to cause cancer.

The court of appeal held that the procedures by which such listing determinations are made are simply the working details of how to implement the Prop 65's broader policy of notification and warning with respect to carcinogenic compounds. The listing mechanisms themselves are not the fundamental policy decisions underlying the legislation.

Proposition 65 - Adoption of No Significant Risk Level for Roundup/glyphosate

This just in from OEHHA on Roundup:

Proposition 65 - Adoption of No Significant Risk Level for Glyphosate

"The Office of Environmental Health Hazard Assessment has adopted a No Significant Risk Level of 1100 micrograms per day for glyphosate. This means that exposures to glyphosate below 1100 micrograms per day are not considered a significant risk of cancer for purposes of Proposition 65 and would not require a warning. Safe-harbor levels help businesses determine when a warning is required for exposures to listed chemicals. Once the warning requirement takes effect on July 7, 2018, businesses with 10 or more employees who cause exposures above the safe harbor level may need to provide warnings. Enforcement of the warning requirement is currently the subject of pending federal litigation that may affect the duty to warn for glyphosate exposures.  See National Association of Wheat Growers et al., v Lauren Zeise, et al. (Eastern District of California, Case # 2:17-cv-02401-WBS-EFB).  A preliminary injunction has been issued in that case prohibiting enforcement of the warning requirement by the California Attorney General and OEHHA.  The case is still pending in the Federal District Court."