Judge: Teresa A. Beaudet, Case: BC665798, Date: 2022-10-03 Tentative Ruling

Case Number: BC665798    Hearing Date: October 3, 2022    Dept: 50

 

 

Superior Court of California

County of Los Angeles

Department 50

 

consumer advocacy group, inc., et al.,

                        Plaintiff,

            vs.

gel spice company, inc., et al.

                        Defendants.

Case No.:

BC665798 [c/w 19STCV24048]

Hearing Date:

October 3, 2022

Hearing Time:

2:00 p.m.

[TENTATIVE] ORDER RE: 

 

PHASE TWO COMBINED MOTION FOR SUMMARY JUDGMENT OR, IN THE ALTERNATIVE SUMMARY ADJUDICATION BY DEFENDANTS GEL SPICE CO., INC, BIG LOT STORES, INC., GROCERY OUTLET, INC. AND TARGET CORPORATION ON STATUTORY AFFIRMATIVE DEFENSES ON THE

MERITS (HSC 25249.10(c))

 

           

Background

Plaintiff Consumer Advocacy Group, Inc. (“Plaintiff”) filed this Proposition 65 (“Prop 65”) action on June 20, 2017. The operative Second Amended Complaint (“SAC”) was filed on January 19, 2021 against, inter alia, Gel Spice Company, Inc. (“Gel Spice”), Big Lots Stores, Inc., Grocery Outlet, Inc., and Target Corporation (collectively, “Defendants”). The SAC alleges ten causes of action for violations of Prop 65.

In the SAC, Plaintiff alleges that Defendants exposed California consumers and users of ground cinnamon, ground cumin, ground sage, ground cloves, poultry seasoning, garlic powder, and ground turmeric, which Defendants manufactured, distributed, or sold, to lead, without first providing any type of clear and reasonable warning of such to the exposed persons before the time of exposure. (SAC, ¶¶ 49, 61, 72, 83, 93, 104, 115, 126, 137, 247.) Plaintiff alleges that Defendants thereby violated Prop 65. (Ibid.)

On October 23, 2019, the Court issued an Order consolidating this action with Consumer Advocacy Group, Inc. v. Viva Bargain Center, Inc., et al. (Case No. 19STCV24048), in which one cause of action is alleged for violations of Prop 65. In Consumer Advocacy Group, Inc. v. Viva Bargain Center, Inc., et al., Plaintiff alleges that the defendants (including Gel Spice) exposed California consumers and users of ground sage, which defendants manufactured, distributed, or sold, to lead and arsenic, without first providing any type of clear and reasonable warning of such to the exposed persons before the time of exposure. (Defendants’ RJN, Ex. D, Compl., ¶ 32.)

Defendants now move for an order granting summary judgment, or in the alternative, summary adjudication on each cause of action, on the grounds that there is no triable issue of material fact with respect to Plaintiff’s allegation that Defendants exposed California consumers to lead and arsenic without warnings required under Prop 65. Plaintiff opposes.

Requests for Judicial Notice

            The Court grants Defendants’ request for judicial notice in support of the motion as to Exhibits A, B, C, D, G, H, I, J, K, L, M, N, O, and P. The Court denies the request as to Exhibits E and F.

The Court grants Plaintiff’s request for judicial notice in support of the opposition as to Exhibits A, B, E, and F. The Court denies the request as to Exhibits C and D.

            The Court denies Defendants’ request for judicial notice filed in support of the reply. The Court notes that “[t]he general rule of motion practice…is that new evidence is not permitted with reply papers. (Jay v. Mahaffey (2013) 218 Cal.App.4th 1522, 1537.)

 

 

 

Evidentiary Objections

            The Court rules on the parties’ “Joint Statement Regarding Parties’ Respective Objections to Evidence Related to Motions for Summary Judgment Re: ‘Merits’ Affirmative Defenses” as follows:[1]

            Plaintiff’s Objections:

           

Objection No. 1 to Dr. Bloom’s Testimony: overruled

 

Objections to the Declaration of Dr. Barbara Beck: overruled

 

Objection No. 1 to the Declaration of Barbara J. Petersen: overruled

                        Objection No. 2 to the Declaration of Barbara J. Petersen: overruled      

                        Objection No. 3 to the Declaration of Barbara J. Petersen: overruled

                        Objection No. 4 to the Declaration of Barbara J. Petersen: overruled

                        Objection No. 5 to the Declaration of Barbara J. Petersen: overruled

                        Objection No. 6 to the Declaration of Barbara J. Petersen: overruled

                        Objection No. 7 to the Declaration of Barbara J. Petersen: overruled

 

                        Objection No. 1 to the Declaration of Carla Kagel: overruled

 

                        Objection No. 1 to the Declaration of Dr. Chris Mackay: sustained as to ¶ 6, p.2, l. 28 - p. 3, l. 1; otherwise overruled

                        Objection No. 2 to the Declaration of Dr. Chis Mackay: sustained as to ¶ 8, ll. 1 starting with “Results” through l. 14 ending with “results;” otherwise overruled

 

Defendants’ Objections:

 

            Objection No. 1 to the Declaration of Paul Damian: overruled

            Objection No. 2 to the Declaration of Paul Damian: overruled

            Objection No. 3 to the Declaration of Paul Damian: overruled

            Objection No. 4 to the Declaration of Paul Damian: overruled

            Objection No. 5 to the Declaration of Paul Damian: overruled

            Objection No. 6 to the Declaration of Paul Damian: overruled

           

Objection No. 7 to the Declaration of Gagik Melikyan: sustained as to paragraph 28, overruled as to the remainder.

Objection No. 8 to the Declaration of Gagik Melikyan: overruled

Objection No. 9 to the Declaration of Gagik Melikyan: sustained as to “USDA-affiliated website” and “the website appears to be affiliated with the authoritative federal agency, i.e., USDA,” overruled as to the remainder

 

Objection No. 10 to the Declaration of Stacia DeSantis: overruled

Objection No. 11 to the Declaration of Stacia DeSantis: overruled

 

Objection No. 12 to the Declaration of Walter Meneses: overruled

Legal Standard

[A] motion for summary judgment shall be granted if all the papers submitted show that there is no triable issue as to any material fact and that the moving party is entitled to a judgment as a matter of law.” (Code Civ. Proc., § 437c, subd. (c).) “A party may move for summary adjudication as to one or more causes of action within an action, one or more affirmative defenses, one or more claims for damages, or one or more issues of duty, if the party contends that the cause of action has no merit, that there is no affirmative defense to the cause of action, that there is no merit to an affirmative defense as to any cause of action, that there is no merit to a claim for damages, as specified in Section 3294 of the Civil Code, or that one or more defendants either owed or did not owe a duty to the plaintiff or plaintiffs.” (Code Civ. Proc.,       § 437c(f)(1).) “A motion for summary adjudication shall be granted only if it completely disposes of a cause of action, an affirmative defense, a claim for damages, or an issue of duty.” (Ibid. 

The moving party bears the initial burden of production to make a prima facie showing that there are no triable issues of material fact. (Aguilar v. Atlantic Richfield Co. (2001) 25 Cal.4th 826, 850.) If the moving party carries this burden, the burden shifts to the opposing party to make a prima facie showing that a triable issue of material fact exists. (Ibid.) Courts “liberally construe the evidence in support of the party opposing summary judgment and resolve doubts concerning the evidence in favor of that party.” (Dore v. Arnold Worldwide, Inc. (2006) 39 Cal.4th 384, 389.) 

When a defendant seeks summary judgment or summary adjudication, he/she must show either (1) that one or more elements of the cause of action cannot be established; or (2) that there is a complete defense to that cause of action. (Code Civ. Proc., § 437c(p)(2).)

Discussion

Defendants contend that warnings are not required for the spice products at issue in this case because any exposures are below the Prop 65 “safe harbor” exemption.

Passed in 1986 by California voters to protect the health and safety of Californians, Proposition 65 requires California to create and maintain a list of chemicals ‘known to the state to cause cancer or reproductive toxicity.’” (Physicians Committee for Responsible Medicine v. McDonald’s Corp. (2010) 187 Cal.App.4th 554, 566, citing Health & Saf. Code, § 25249.8, subd. (a).) Pursuant to Health and Safety Code section 25249.6, “[n]o person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual, except as provided in Section 25249.10.”

“Lead has been identified as a known carcinogen and reproductive toxin under Proposition 65.” (Environmental Law Foundation v. Beech-Nut Nutrition Corp. (2015) 235 Cal.App.4th 307, 312.) In addition, inorganic arsenic is listed as a chemical known to the state to cause cancer and reproductive toxicity. (Cal. Code Regs., tit. 27, § 27001.) 

Health and Safety Code section 25249.10, subdivision (c) provides that “Section 25249.6 shall not apply to…(c) An exposure for which the person responsible can show that the exposure poses no significant risk assuming lifetime exposure at the level in question for substances known to the state to cause cancer, and that the exposure will have no observable effect assuming exposure at one thousand (1000) times the level in question for substances known to the state to cause reproductive toxicity, based on evidence and standards of comparable scientific validity to the evidence and standards which form the scientific basis for the listing of such chemical pursuant to subdivision (a) of Section 25249.8. In any action brought to enforce Section 25249.6, the burden of showing that an exposure meets the criteria of this subdivision shall be on the defendant.” “This exemption is sometimes referred to as the ‘safe harbor’ defense.” (Environmental Law Foundation v. Beech-Nut Nutrition Corp., supra, 235 Cal.App.4th at p. 313.) 

The no observable effect level, or NOEL, is a scientific term denoting the maximum dose level at which a chemical is found to have no observable reproductive effect. The NOEL is determined through scientific inquiry and assessment as detailed in the framework set forth in the regulations. In turn, the NOEL is divided by 1,000 to arrive at the maximum allowable dose level (MADL), which is the threshold warning level for a listed chemical. Thus, the MADL (maximum allowable dose level) is set as one one-thousandth of the NOEL. At trial, a defendant can secure the protection of the exposure exemption by establishing (1) the NOEL; (2) the level of exposure in question, and ultimately that the level of exposure was 1,000 times below the NOEL. (Environmental Law Foundation v. Beech-Nut Nutrition Corp., supra, 235 Cal.App.4th at p. 313 [internal quotations and citations omitted].) “The Office of Environmental Health Hazard Assessment (OEHHA) has already determined the MADL for lead. The regulations set the ‘safe harbor’ warning threshold for carcinogenicity as to lead at 15 micrograms per day. (Regs., § 25705.) The regulatory safe harbor level for reproductive toxicity for lead is 0.5 micrograms per day. (Id., § 25805, subd. (b).)(Environmental Law Foundation v. Beech-Nut Nutrition Corp., supra, 235 Cal.App.4th at p. 313.) 

Defendants assert that the spice products at issue in this case (the “Spice Products”)[2] do not exceed the “safe harbor” exemption to Prop 65’s warning requirement for lead or arsenic, as the exposure to lead for any of the Spice Products is below 0.5 micrograms/day, and the exposure to inorganic arsenic is below 0.1 micrograms/day.[3] Defendants indicate that for lead, the 0.5 micrograms/day MADL for reproductive toxicity is lower than the 15 micrograms/day No Significant Risk Level (“NSRL”) for cancer. (Cal. Code Regs., tit. 27, §§ 25705(b), 25805(b)). For inorganic arsenic, a 0.1 micrograms/day MADL for reproductive toxicity is lower than the 10 micrograms/day NSRL for cancer. (Cal. Code Regs., tit. 27, § 25709(b).) Defendants indicate that their motion thus “addresses the lower, more restrictive MADL for both chemicals.” and “[i]f Gel Spice establishes that each Spice Product is within the Safe Harbor for reproductive toxicity, it will have also demonstrated no warning is required for cancer.” (Mot. at p. 14:6-9.)

“Under California Code of Regulations, title 27, section 25821, subdivision (a), [t]he procedures for calculating the exposure to a chemical in food start with the quantification of the chemical concentration of a listed chemical for the exposure in question. This concentration is called the level in question. The level in question is then multiplied by the reasonably anticipated rate of exposure for an individual to the food. This rate of exposure must be based on the pattern and duration of exposure that is relevant to the reproductive effect which formed the basis for listing the chemical as causing reproductive toxicity. Thus, an exposure of short duration is the appropriate frame of reference for a teratogenic chemical. A teratogen is a chemical that can cause birth defects.” (Environmental Law Foundation v. Beech-Nut Nutrition Corp., supra, 235 Cal.App.4th at pp. 312-313 [internal quotations and references to [Citation.] omitted].)

A.    Application of the “Safe Harbor” Exemption for Lead

As to the level in question, Defendants’ expert Dr. Barbara J. Petersen indicates that in calculating the level of lead or inorganic arsenic (or total arsenic) in the Spice Products, she calculated the geometric mean and the arithmetic mean of the combined Defendant and Plaintiff data sets. (Petersen Decl., ¶ 24, Ex. B). Dr. Petersen prepared a spreadsheet identifying the average lead and arsenic content levels in parts per million for the relevant products, identified as both the arithmetic mean and geometric mean. (Petersen Decl., ¶¶ 24, 42, Ex. B). As to the “reasonably anticipated rate of exposure, Dr. Petersen indicates that to estimate the amount of each Spice Product consumed in an eating occasion, she used the National Health and Nutrition Examination Survey’s (“NHANES”) two-day 24-hour dietary recall study. (Petersen Decl.,         ¶ 29.) In addition, because the NHANES survey does not contain frequency data for spices, she obtained data from another national survey, the NPD Group’s NET (National Eating Trends), to characterize the consumption of the Spice Products. (Petersen Decl., ¶ 34.) Based on the NET data, Dr. Petersen generated the arithmetic and geometric mean of the long-term frequency of consumption of the Spice Products “(EO/day).” (Petersen Decl., ¶ 39, Ex. D.)

Dr. Petersen prepared a spreadsheet concerning the “estimated mean daily exposure to stated chemical from consumption of Products (µg/day).” (Petersen Decl., ¶ 43, Ex. E). Dr. Petersen determined that the average user’s calculated daily intake of lead from the consumption of each of the Spice Products range from 0.002 micrograms to 0.019 micrograms when calculated using the geometric mean and from 0.01 to 0.40 micrograms when calculated using the arithmetic mean, depending on the product in question. (Defendants’ Undisputed Material Fact (“UMF”) No. 28; Petersen Decl., ¶ 43, Ex. E.) Dr. Petersen determined that the “level of exposure” of lead for each of the Spice Products is below the 0.5 microgram/day warning threshold. (UMF No. 29). Defendants assert that accordingly, no Prop 65 warning is required. Based on the foregoing, the Court finds that Defendants have met their burden as to their “safe harbor” defense with regard to the alleged lead exposure.

In the opposition, Plaintiff submits the declaration of its expert, Dr. Paul Damian,

who asserts that the appropriate averaging time for lead exposure is one day, not a 30-day or

other long-term average. (Damian Decl., p. 6:17-18; Damian Decl., ¶ 27.) Dr. Damian indicates that “long-term averages are irrelevant and inappropriate when one is attempting to evaluate for, and protect against, the potential for short term (i.e. acute) developmental effects on the fetus, where very short (acute) exposures occurring over a day or a few days may be sufficient to produce adverse effects. Such averaging would mask potentially adverse spikes in lead exposure occurring on a given day or just a few days...adverse effects of lead on the neurologic development of the child can occur over much shorter exposure time frames than 30 days.” (Damian Decl., ¶ 14.) Dr. Damian cites to a California Attorney General letter dated March 3, 2008, providing that “[f]or a reproductive toxicant such as lead, the usage on a given day is considered the appropriate measure of exposure, not the long-term daily average.” (Damian Decl., ¶ 17.)[4]

Dr. Damian indicates that his “Table 1” shows the calculated daily intakes of lead associated with each of the Spice Products at issue, conservatively assuming a single serving of each spice is consumed on a given day of use and using Plaintiff’s lead concentrations. (Damian Decl., ¶ 28, Table 1.)[5] Table 1 shows that, for all the spices except one of the sage products (Spice Supreme), the lead MADL of 0.5 micrograms/day is exceeded based on a single serving of spice on a given day of use. (Damian Decl., ¶ 28, Table 1.) Dr. Damian indicates that this analysis conservatively assumes only a single serving of spice in a meal on a given day, and if only two servings were consumed on a single day, the “Spice Supreme” sage product would also exceed the lead MADL based on even the lowest lead concentration. (Ibid.)

Defendants contend that Plaintiff’s single day exposure” theory was rejected by the Court in Environmental Law Foundation v. Beech-Nut Nutrition Corp., supra, 235 Cal.App.4th 307. In Beech-Nut, the plaintiff alleged that “certain of defendants’ products contain[ed] toxic amounts of lead sufficient to trigger the duty to provide warnings to consumers. After a bench trial, the trial court entered judgment in favor of defendants, concluding they had no duty to warn because they satisfactorily demonstrated that the average consumer’s reasonably anticipated rate of exposure to lead from their products [fell] below relevant regulatory thresholds.” (Id. at p. 312.) “The court found the expert testimony and analysis presented by defendants to be ‘far more persuasive’ than [plaintiff’s] analysis.” (Id. at p. 322.) The plaintiff appealed from the judgment, and the Court of Appeal affirmed. (Id. at p. 312.)

The products in question include foods intended predominantly or exclusively for babies and toddlers, such as baby foods, fruit juice, and packaged peaches, pears, and fruit cups.” (Environmental Law Foundation v. Beech-Nut Nutrition Corp., supra, 235 Cal.App.4th at          p. 314.) The trial court in Beech-Nut concluded, inter alia, that “there was no scientific support for [plaintiff’s] assertion that exposures to Defendants’ products on a single day would increase the blood lead level of pregnant women enough to cause a central nervous system deficit in the fetus.” (Id. at p. 327 [internal quotations omitted].) The plaintiff claimed “the trial court erred in interpreting the regulations so as to allow defendants to average the level of exposure over multiple days instead of evaluating the exposure on the day the food is actually consumed.” (Ibid.) The Court of Appeal found that “all of defendants toxicology experts opined that the level of lead in the products at issue was insufficient to cause reproductive harm based on a single day of exposure. Thus, absent an underlying legal or scientific error, substantial evidence supports the conclusion that it was appropriate to evaluate the level of exposure over time.” (Ibid.)

But as Plaintiff notes, the Beech-Nut Court concluded that “[i]n sum, on the record here, we cannot conclude that the trial court erred in accepting defendants’ experts’ opinions that the products qualify for the exemption under the safe harbor defense of Regulation 25801, subdivision (b)(2).” (Environmental Law Foundation v. Beech-Nut Nutrition Corp., supra, 235 Cal.App.4th at p. 329, emphasis added.) The Court does not find that Beech-Nut stands for the proposition that a single day exposure” analysis may never be used. The Beech-Nut Court noted that Proposition 65 envisions a case-by-case approach which takes into account the totality of the quantitative risk assessment evidence presented.” (Id. at p. 328 [internal quotations omitted].)[6]

Defendants also cite to multiple new declarations in support of their reply. For instance, Defendants cite to the reply declarations of Barbara J. Petersen and Leila M. Barraj to support the assertion that Dr. Damian’s first assessment is insufficient. (See Reply at p. 10:4-20.) As set forth above, “[t]he general rule of motion practice…is that new evidence is not permitted with reply papers. This principle is most prominent in the context of summary judgment motions… [p]oints raised for the first time in a reply brief will ordinarily not be considered, because such consideration would deprive the respondent of an opportunity to counter the argument. (Jay v. Mahaffey, supra, 218 Cal.App.4th at pp. 1537-1538 [internal quotations omitted].) The Court also notes that “[o]n a summary judgment motion, the court must…consider what inferences favoring the opposing party a fact finder could reasonably draw from the evidence. While viewing the evidence in this manner, the court must bear in mind that its primary function is to identify issues rather than to determine issues.” (Binder v. Aetna Life Ins. Co. (1999) 75 Cal.App.4th 832, 839.) “The trial court may not weigh the evidence in the manner of a fact finder to determine whose version is more likely true. Nor may the trial court grant summary judgment based on the court’s evaluation of credibility.” (Id. at p. 840 [internal citations omitted].)

            In addition to Dr. Damian’s assessment discussed above, Plaintiff also asserts that Defendants’ analysis ignores actual users of the Spice Products. Plaintiff notes that pursuant to California Code of Regulations, title 27, section 25721, subdivision (d)(2), [t]he following assumptions shall be used to calculate the reasonably anticipated rate of exposure to a chemical listed as causing cancer, unless more specific and scientifically appropriate data are available:…(2) For an exposure reasonably anticipated to affect a certain subpopulation of the general population in any geographic area, specific data (if available) relating to that subpopulation shall be used to determine the level of exposure.In addition, pursuant to California Code of Regulations, title 27, section 25821, subdivision (c)(1), “[t]he assumptions set forth in subsection (d) of Section 25721 shall be used to calculate the reasonably anticipated rate

of exposure to a chemical listed as causing reproductive toxicity, unless more specific and scientifically appropriate data are available.”
            Plaintiff indicates that based on a survey of South Asian and Middle Eastern consumers in Los Angeles County, 95.6% of these individuals consumed turmeric and 91% consumed it 4 or more times per week. (Meneses Decl. ¶ 4, Ex. B.) Defendants note that this point only addresses turmeric, not the other spices at issue in this case.[7] In any event, Plaintiff’s subpopulations argument is only one of several arguments raised by Plaintiff in support of its assertion that there are multiple triable issues of material fact. 

Based on the foregoing, the Court finds that Plaintiff has presented sufficient evidence to raise a triable issue of material fact as to whether levels of lead in the subject Spice Products fall within Prop 65’s regulatory “safe harbor.”

B.    Application of the “Safe Harbor” Exemption for Arsenic

Defendants indicate that for arsenic exposure from sage, Dr. Petersen used the same methodology used for lead. (Petersen Decl., ¶¶ 40-42). Dr. Petersen determined that the average user’s calculated daily intake of inorganic arsenic from the consumption of the ground sage product is 0.002 micrograms when calculated using the geometric mean and 0.02 micrograms when calculated using the arithmetic mean. (Petersen Decl., ¶ 43, Ex. E.) Dr. Petersen indicates that while she relied upon the combined Defendant and Plaintiff data for her conclusions, Plaintiff’s data alone also demonstrate an exposure well below the regulatory safe harbor levels for inorganic arsenic in ground sage. (Petersen Decl., ¶ 43.) Based on the foregoing, the Court finds that Defendants have met their burden as to their “safe harbor” defense with regard to the alleged arsenic exposure.

In the opposition, Plaintiff’s expert, Dr. Damian, indicates that the appropriate averaging time for inorganic arsenic exposure is one day, not a 30-day or other long-term average. (Damian Decl., p. 20:16-17.) Dr. Damian indicates that “[i]norganic arsenic has been extensively studied as a teratogen in animals. Data from animal studies demonstrate that arsenic can produce developmental toxicity, including malformation, death, and growth retardation, in four species (hamsters, mice, rats, rabbits). A characteristic pattern of malformations is produced, and the developmental toxicity effects are dependent on dose, route, and the day of gestation when exposure occurs.” (Damian Decl., ¶ 41.) He thus asserts that because inorganic arsenic is a teratogen, a multi-day averaging time is not appropriate and the exposure occurring on a given day of use of the product is the correct basis for evaluating compliance. (Damian Decl., ¶ 44.) Dr. Damian’s Table 1 shows the inorganic arsenic intake based on a single serving of the subject sage product (the only product at issue with regards to inorganic arsenic). (Damian Decl., ¶ 44, Table 1.) Dr. Damian’s calculations resulted in an inorganic arsenic intake of 0.26 micrograms/day. (Damian Decl., ¶ 45, Table 1.)[8]

Based on the foregoing, the Court finds that Plaintiff has presented sufficient evidence to raise a triable issue of material fact as to whether levels of inorganic arsenic in the subject sage product fall within Prop 65’s regulatory “safe harbor.”

C.    Toxicology and Physiologically-Based Pharmacokinetic Modeling

Defendants also assert that the Spice Products do not require a lead warning, as demonstrated byphysiologically-based pharmacokinetic” (“PBPK”) modeling.

Defendants’ expert, Dr. Barbara Beck, indicates that lead modeling has been used for many years to quantify the impact of lead intake on blood lead, bone lead, and other tissues in the body to assess risks from lead exposure, and to set permissible levels for lead in environmental media, including food, water, air, and soil. (Beck Decl., ¶ 39.)

Dr. Beck indicates that “modeling was performed for a 25 year old male with a baseline lead intake of 0 [micrograms]/day to compare the impact on blood lead and bone lead of the actual consumption amounts and frequencies for the seven products at issue compared to daily consumption at the [sic] of 0.5 [micrograms] MADL. In every instance, the impact on blood lead and bone lead from the actual consumption patterns and amounts of the products is less than the impact from daily consumption of the 0.5 [micrograms] MADL. Because blood lead model results are generally similar for females as for males, and potential reproductive effects are associated with higher blood lead levels in females than in males, my conclusion is also applicable to females.” (Beck Decl., ¶ 53.) Dr. Beck indicates that “[c]onsidering that even a one-time exposure event could result in some lead storage in bone for long durations, with slow release of lead into the blood over time via resorption, it would be appropriate to evaluate lead exposure (in terms of resulting blood lead level) over a longer period of time such as 30 days or more.” (Beck Decl., ¶ 28.) 

Dr. Beck also indicates that she “conducted two separate analyses based on 1) the arithmetic average mass of inorganic arsenic per serving and arithmetic average frequency of consumption (based on the NPD Group/Historical National Eating Trends® Survey data), and 2) the geometric average mass of inorganic arsenic per serving and geometric average frequency of consumption.” (Beck Decl., ¶ 72.) She indicates that for each analysis, the average daily intake of inorganic arsenic fell below 0.1 [micrograms]/day. (Beck Decl., ¶ 73, Ex. 8.)

In the opposition, Plaintiff asserts that Defendants’ blood level modeling is inappropriate to rely upon when evaluating the alleged Prop 65 violations in this matter. Plaintiff’s expert, Gagik Melikyan, indicates that Dr. Beck’s declaration is heavily based on lead blood level modeling in human bodies called All-Ages Lead Model, or AALM. (Melikyan Decl., ¶ 47.)     Dr. Melikyan asserts that modeling has never been a substitute for reliable experimental studies, and results derived from modeling of any type are only predictions, and not scientific facts. (Melikyan Decl., ¶ 47.) Dr. Melikyan also asserts that in the modeling studies, Dr. Beck is using the concept of “exposure frequency” or “intake frequency” that is analogous to the concept of Eating Occasion (“EO”); and that the “EO” concept for assessment purposes is scientifically inaccurate and ignores the published data on metabolism of lead in human bodies. (Melikyan Decl., ¶ 52.) Defendants cite to new evidence in support of the reply to challenge Dr. Melikyan’s declaration. As set forth above, the general rule of motion practice is that new evidence is not permitted with reply papers. (Jay v. Mahaffey, supra, 218 Cal.App.4th at p. 1537.)

In addition, Plaintiff’s expert, Dr. Damian, asserts that blood lead modeling is not relevant for evaluating Prop 65 compliance. (Damian Decl., p. 3:8.) He asserts that the “measure of compliance with PROP65 is not based on the resulting blood level of the chemical but on the intake of the chemical. In the case of a chemical that is ingested, intake is simply the amount consumed, NOT the amount that actually enters the blood.” (Damian Decl., ¶ 3.)

In light of the foregoing, the Court finds that Plaintiff has presented sufficient evidence to raise a triable issue of material fact as to whether levels of lead and arsenic in the subject Spice Products fall within Prop 65’s regulatory “safe harbor.”

Conclusion 

For the foregoing reasons, Defendants’ motion for summary judgment or in the alternative, summary adjudication, is denied.

Defendants are ordered to provide notice of this ruling. 

 

DATED:  October 3, 2022                                  ________________________________ 

Hon. Teresa A. Beaudet 

Judge, Los Angeles Superior Court 

 



[1]The Court notes that Plaintiff includes in the joint statement a number of “remaining objections” as to the “legal” motion for summary judgment. The Court’s February 1, 2022 Order regarding the instant phase two motion on statutory affirmative defenses on the merits provides, inter alia, “[i]if any material objections remain unresolved, the parties are to set them forth in a joint statement…” The February 1, 2022 Order only concerned the instant “merits” motion. Thus, the Court disregards Plaintiff’s evidentiary objections pertaining to the “legal” motion for summary judgment. 

[2]As discussed above, Plaintiff alleges that Defendants violated Prop 65 with respect to the following spices: ground cinnamon, ground cumin, ground sage, ground cloves, poultry seasoning, garlic powder, and ground turmeric.

[3]Defendants indicate that OEHHA developed, but never adopted, a Maximum Allowable Dose Level (“MADL”) of 0.1 micrograms/day for inorganic arsenic. (Beck Decl., ¶ 57.) Plaintiff asserts that “OEHHA has not calculated an MADL, but Dr. Damian [Plaintiff’s expert] has calculated an MADL of 0.01 [micrograms]/day for reproductive toxicity…Defendants calculate an MADL for arsenic of 0.1 [micrograms]/day.” (Opp’n at p. 11:20-22.)

   

[4] In addition, Plaintiff’s expert Stacia DeSantis asserts that peer-reviewed research demonstrates that food “diaries” like NPD NET (used by Defendants’ expert) do no correlate well with spice intake, and specifically, that food diaries significantly underestimate spice intake. (DeSantis Decl., ¶ 13.) 

 

[5]Dr. Damian indicates that a single serving of ¼ teaspoon was assumed for the serving size, and that this is the amount of spice considered to represent a typical serving size (amount consumed per eating occasion) by the Food and Drug Administration. (Damian Decl., ¶ 28.)

[6]In addition, in Beech-Nut, the parties “agreed that the ‘window of susceptibility for exposure to lead’ shall mean the period of time during which exposure may cause a reproductive, including developmental, effect,” and the plaintiff’s expert “admitted he had not seen epidemiological literature that identified a window of susceptibility as an interval shorter than either eight weeks or a single trimester.”  (Environmental Law Foundation v. Beech-Nut Nutrition Corp., supra, 235 Cal.App.4th at p. 319.)

[7]In addition, Defendants assert in the reply that Plaintiff’s ethnic subpopulation theory is inconsistent with Prop 65 regulations. As set forth in the Court’s June 16, 2022 Order, Defendants previously moved for an order finding that (1) 27 Cal. Code Regs. § 25821(c)(2) governs the food exposure at issue; (2) 27 Cal Code Regs. § 25721(d)(2) does not apply to food exposure; and (3) 27 Cal. Code Regs. § 25721(d)(2)’s use of the phrase “certain subpopulations in a geographic area” does not support using ethnic subpopulations for exposure assessments either under sections 25721(d)(2) and 25821(c)(2), or any other Prop 65 regulation. For the reasons set forth in the June 16, 2022 Order, Defendants’ motion was denied. 

[8]Dr. Damian indicates that “[a]lthough OEHHA has not promulgated an MADL for inorganic arsenic, I

have developed an MADL of 0.01 [micrograms]/day using the same procedures required in the PROP65 regulations.” (Damian Decl., ¶ 45.) In an event, the amount of 0.26 micrograms/day exceeds the 0.1 micrograms/day “safe harbor” level for inorganic arsenic used by Defendants in the motion.