Judge David J. Cowan, Case Number: BC665798, Date: 2024-02-21 Tentative Ruling

Consumer Advocacy Group (“CAG”) seeks to exclude evidence that Proposition 65 should not be the law and the opinions of Nega Beru, PhD. Beru contends that food content should be exclusively regulated by the FDA, not the states or private enforcers.

In opposition, Defendants argue that the motion misstates their position: Instead, they are arguing that the Prop 65 warnings are compelled speech in violation of the First Amendment and that Prop 65 conflicts with federal law which preempts it.

This motion was filed October 25, 2022. The opposition was filed November 3, 2022. On December 5, 2022, Judge Beaudet granted the motion of CAG for summary judgment rejecting Defendants’ defenses that Prop 65 was preempted by federal regulations, violated Defendants’ First Amendment rights and the Commerce Clause to the US Constitution. The Court therefore finds that there is no need to hear from Dr. Beru concerning these issues.

CAG seeks to exclude evidence that Prop 65 warnings are a bad idea for public health. Specifically, they contend there is no reason to hear from Joseph Sala, a PhD in psychology, and Beru because Prop 65 is the law and policy issues as to the effect of the law or its wisdom are not relevant.

Defendants argue that these experts will provide foundation for their assertion that Prop 65 violates their First Amendment rights and is preempted by federal law.

As discussed above, these papers were also filed before the ruling on CAG’s motion for summary judgment. Given that ruling, there is no need to now hear from these witnesses where the subject of their testimony is no longer relevant.

CAG seeks to exclude testimony of Arnold Bloom, a plant biologist, on the grounds that his testimony concerning lead “naturally occurring” in the spices at issue is not relevant where Defendants are not asserting the defense under 27 CCR sec. 22501(a); namely, that there is an exemption for naturally occurring lead.[1] (See Nicolle-Wagner v. Deukmejian (1991) 230 Cal.App.3d 652, 660-661 (exposure subject to Prop 65 is knowing and intentional exposure, not exposure naturally occurring in the environment, noting special treatment for foodstuffs despite small amounts of naturally occurring toxins)) In addition, CAG contends that his opinions are speculative related to lead naturally occurring in plants.

In opposition, Defendants acknowledge that they are not relying on the “naturally occurring” defense but clarify that they are not doing so because they contend that it would be impossible to prove that defense precisely because the science is lacking to distinguish between naturally occurring lead and lead that Defendants intentionally caused to be part of the products. Defendants therefore assert that finding them responsible to post warnings under Prop 65 would be a violation of their due process rights. Hence, Bloom’s inability to lay foundation to provide an opinion on these issues is precisely Defendants’ point. In addition, Defendants argue his testimony is necessary to rebut CAG’s experts to the degree they testify on this issue.

The Court finds that the October 2, 2022 order granting summary judgment in favor of CAG on due process issues does not address this specific due process issue, but only other due process concerns raised by Defendants. Therefore, it appears Defendants may permissibly assert the due process defense at least as concerns their purported inability to claim that the lead in the spices at issue should be deemed exempt. As a result, the inability of Gross to document the basis for showing how lead is naturally occurring is not a basis to exclude his testimony. The Court therefore does not need to decide whether his testimony is necessary to rebut CAG’s experts.

CAG seeks to exclude testimony of blood lead level modeling, as stated in the proposed opinion of Dr. Barbara Beck, as contrary to the relevant standard for exposure, bodily “intake,” citing Consumer Cause v. Weider Nutrition (2001) 92 Cal.App.4^th 363, 368-370 (“exposure” for purposes of sec. 25249.10 means “ingest, inhale, contact via body surfaces” or “directly bringing individuals into contact…at the first point at which the body connects with a chemical from outside the body. It does not include what happens inside the body to transform the chemical into something else….There is nothing…which suggests Proposition 65 was intended to apply when a person is exposed to a noncarcinogenic chemical which then causes a substance naturally occurring in the body to become carcinogenic.”) CAG argues that Beck’s analysis of whether the products here exceed the maximum allowable dose level (“MADL”) for lead is based not on “intake’ but “uptake.” It argues that this difference is reflected in the measurement Beck uses; namely, ug/decileter versus ug/day. CAG relies on its expert Dr. Paul Damian’s view that considering blood level is different than exposure because not all that a person has contact with directly is absorbed into the blood.

In opposition, Defendants contend use of blood lead modeling to determine the MADL for lead is scientifically appropriate and in fact mandatory under secs. 25801(a) and 25821(b) and (c) since it was used as the basis to list lead as a carcinogen causing cancer. Further, they argue blood lead levels are needed to determine whether lead has any “observable effect” in the required amount for MADL under sec. 25249.10(c). In addition, they point to the Court’s reliance on Beck’s testimony as to blood lead modeling in Environ. Law Found. v. Beech-Nut Nutrition (2015) 235 Cal.App.4^th 307 and Mateel Environ. Justice Found. v. OEHHA (2018) 24 Cal.App.5^th 220, 226, fn. 6 (noting that ug/decileter is the functional equivalent of ug/day and is just a conversion method for blood), thereby refuting CAG’s claim it is not relevant or that blood level would be a proverbial uptake rather than intake. Finally, they contend the chemicals at issue in Weider is a different situation to the lead at issue here that is carcinogenic. The chemicals in Weider were noncarcinogenic and the issue was the chemical reaction thereafter in the body by production of testosterone.

Sargon Enterprises v. Univ. Southern California (2012) 55 Cal.4th 747, 772 holds courts should not act to decide scientific questions in acting as “gatekeeper” for admissibility purposes. The Court therefore cannot now wade into whether Damian is correct in viewing blood level as different than initial contact or if there may be some level of difference of exposure if a product is not absorbed into the blood notwithstanding initial exposure – that might be material for determining the risk of exposure for MADL. Similarly, the Court cannot now address whether even if blood lead level monitoring may be properly used for determining the level of exposure that this necessarily means the same method can be used for risk of exposure. On the other hand, the Court does not see any “leap of logic” that needs to be made, as necessary foundation under Sargon for the opinion to now exclude Beck from testifying. The issues on this motion related to the most appropriate methodology are the underlying questions to be tried.

CAG seeks to exclude opinions relying on improper input data and unscientific methods. CAG argues that the National Health and Nutrition Examination Survey commissioned by the Center for Disease Control (“NHANES”) on which Petersen and Barraj rely does not include consumption of spices. Those responding to the survey are advised not to record spices as “additions” to food. In addition, they contend the Food and Nutrient Database for Dietary Studies (“FNDDS”) likewise is an inaccurate source where it does not include ingredients that “contribute minimally to the nutrient content of food” and Petersen assumes spices do not to add to nutrient content.[2] CAG argues further that the NPD Group’s National Eating Trend (“NET”) data is proprietary and therefore does not allow it to determine the validity of the data. It is also argued that Petersen’s method of coordinating this data, through another proprietary database, FARE, to reach a conclusion is unreproducible, again making it impossible to scrutinize. Moreover, CAG contends this nationwide data is significantly different to California data where 15.9% of Californians identify as Asian compared to 1.9% nationally (and allegedly the Asian subpopulation uses more spice than the general population.)

In opposition, Defendants point out the following: NHANES does not include spice as an addition because spice is already included as an ingredient in the food itself. FNDDS does not need to include spices separately because the purpose of this database is to convert the ingredients (including spice) already in the food. Moreover, sec. 2582(c)(2) contemplates reliance on the data in NHANES and FNDDS – both federal government affiliated sources, the use of which databases was approved of in Beech-Nut, supra, as well as by other trial courts hearing Prop 65 cases. Petersen has provided the foundation of her opinion to CAG that is based on NET so it is not necessary to investigate that data further or to reproduce her analysis, including her use of “surrogation” or application of a scientific substitute where sufficient data is unavailable. In the alternative, CAG has not shown it could not have obtained further necessary information from NET or that the proprietary aspects of these databases is material here. Petersen’s use of several databases to reach her opinion is generally accepted within the scientific community.

As with the last motion, under Sargon, courts are not to decide scientific questions in acting as “gatekeeper” for admissibility purposes. The issues on this motion concerning allegedly improper input data and unscientific methods fall precisely within this prohibition. None of the issues identified rise to the level where the court can now exclude all consideration of the various opinions. It will be the court’s function as trier of fact to hear the reports in question, and after consideration of cross-examination, and other witnesses, make determinations based upon the weight the court accords the evidence. The motion and opposition will hopefully be useful in educating the court concerning the issues to be decided later.

CAG seeks to exclude testimony and documentation of irrelevant test results on the basis that the samples Defendants selected in 2019 and 2020 for testing are not the same spice products made available to consumers in 2016 for sale - after the manufacturing, shipping, storage and distribution process – which is what this case is about. CAG argues that the samples Defendants used were not from a retailer in California but rather from ones taken after the notice of violation and only submitted to K-Prime after Gel Spice had screened them in a different lab. It further contends that Defendants also in the interim undertook remedial measures in distribution that would have lowered the lead levels in the products that were on the shelves before the notices were sent.

In opposition, Defendants argue that the motion presents questions as to the foundation for the data that can be decided only at trial after hearing from the witnesses. In any event, they assert that the motion is unsupported by any evidence. Gel Spice’s person most knowledgeable, Andrew Kuszynski, will confirm that the samples used were packed from the same or similar lots to those CAG is seeking to determine if they violated lead levels. Apparently, Gel Spice would ship products with any excessive level of lead to customers outside California. Using a traceability exercise that is part of its Safe Quality Food Program, premised upon the “best by” date on the label, Gel Spice can identify the raw material from which a retailed product was sourced. In turn, Carla Kagel, PhD, lab custodian, will be able to testify to the chain of custody for the samples selected. Finally, they contend that extended time in the distribution process would increase, not lower, the risk of exposure, thereby defeating CAG’s argument.

The Court cannot assess the competing claims here without consideration of the various witnesses whose testimony will need to be heard to determine whether the tests results are valid or relevant. CAG in any event shows no undue prejudice – as needed to prevail on a motion in limine (see Evidence Code sec. 352) - from the Court hearing that testimony prior to deciding whether to admit the test results.

CAG seeks to exclude documents not produced in discovery. Specifically, they seek to exclude a report identified in response to a document request to Gel Spice deriving 1 part per million lead level in spices that it believes was wrongly withheld.

Defendants oppose the motion to the extent it pertains to the above-referenced document which they assert was attorney client privileged and therefore not deliberately withheld. In any event, they do not intend to offer this document or the study that was mentioned at the Gel Spice PMQ deposition.

The Court grants this motion generally but does not need to decide whether this alleged study or report, if documented, is privileged or wrongly withheld where it will not be offered as evidence and CAG does not challenge the assertion of privilege.

CAG seeks to exclude results of testing conducted on one set of lots, so-called “oranges” where the allegations in the complaint are limited to allegedly a different set of lots, so-called “apples.”

CAG acknowledges that this motion overlaps with its motion no. 6, which the Court intends to

deny, as discussed above. The Court will also address this motion as it raises similar but not the same arguments: CAG argues the specific lots referenced in the second amended complaint are all that is at issue and what Defendants tested are not the same products, i.e., apples and oranges and hence irrelevant. CAG argues Defendants’ attempt to use “averaging” of samples, based on Beech-Nut, supra, is not permitted where here there are different lots.

In opposition, Defendants raise numerous issues, some of which go beyond the focus of the motion. The Court will focus here only on those pertaining to the above issue: Defendants argue they are not limited to the specific lots referenced in the complaint reflecting a “best buy” date because part of their defense of the case relies on other lots – which they contend emanate from the same source as the ones CAG complains about – and do not have the level of lead requiring a warning. They explain that the quality evaluation and testing required under FDA regulations Prop 65 follows is performed at the source level. The best-by date concerns freshness as food, not ingredients. In turn, they explain why it is scientifically appropriate to average values across source lots. Finally, they argue that CAG’s reliance on the referenced lots may make the complaint subject to a statute of limitations defense and would be inconsistent with the request for an injunction which would pertain to future lots other than those alleged.[3]

The Court is persuaded at this stage that Defendants may permissibly assert their defense by way of offering evidence concerning lots they allege come from the same source as the lots alleged in the pleading. CAG can then assert why this evidence may be different from the “apples” it is concerned with. Whether the oranges are in fact apples, or are likely have the same amount of lead in them based on the scientific evidence presented, will be decided after hearing that evidence. The Court cannot now determine which is which without consideration of the evidence. Defendants are not restricted in establishing their defense to only offering what CAG wants to present. The two principal cases the parties discuss on this issue in the context of a motion in limine – Geffcken v. D’Andrea (2006) 137 Cal.App.4^th 1298, 1307 and Pannu v. Land Rover NA (2011) 191 Cal.App.4^th 1298, 1321 – do not support CAG’s argument.[4] The Court reserves on the plethora of other issues and sub-issues raised, including the most scientifically reliable form of testing and the permissibility of using an ethnic subpopulation to determine whether Defendants meet their safe harbor defense.

Defendants seek to exclude all testimony that “there is no safe level of lead.” They contend such testimony would be irrelevant where CCR sec 25805(b) provides a safe harbor for MADL, which in the case of lead the Calif. Office of Environmental Health Hazard Assessment (“OEHHA”) has determined an observable effect to be below 0.5 ugd per day. (See Beech-Nut, supra, at 312) As a result, if spices do not exceed the warning threshold pursuant to Health and Safety Code sec 25249(c) Defendants are not required to provide a warning. They contend that such testimony is inconsistent with the regulation and hence raises a due process concern that they might have to give a warning notwithstanding the safe harbor.

The Court finds that the proffered testimony is not necessarily inconsistent with the regulations and that even if there is no safe level as a matter of science the government can still conclude as a policy matter that exposure level below an observable level is not so significant as to require a warning to consumers. That said, the issue here is whether the MADL for lead in spices exceeds that permitted not whether there is impact below that level. To the extent that the analysis as to why lead content exceeds the MADL is the same analysis as what led Dr. Damian to reach this conclusion the Court will permit the testimony.

Defendants seek to exclude testimony of Plaintiffs’ expert, Stacia DeSantis, Ph.D, on the four subjects identified in the motion. They contend DeSantis lacks the qualifications to testify on these subjects because her background and work in biostatistics does not include study of foods as are in question here. Her work relates to alcohol and drug dependence. They argue her merely reading professional literature on the subjects here is an insufficient basis to testify as an expert on these subjects. In addition, they contend she lacks knowledge of the issues involved even if she were qualified. Finally, they argue the expert witness declaration did not provide the required narrative of anticipated testimony.

Plaintiff responds that DeSantis is a tenured professor at the University of Texas whose academic work more than qualifies her to testify related to the statistical studies at issue. CAG contends her skills in evaluating studies related to alcohol and drugs crosses over to the studies on spices. Her testimony will not just be a recitation of what she read. It is expected that an expert like her would review professional literature and be able to provide informed analysis that someone without that expertise would not be able to do. CAG states her level of understanding of the studies at issue is no less than Defendants’ expert, Dr. Barbara Petersen. Finally, it argues Defendants are not prejudiced by the declaration provided because they took her deposition and know what her opinions will be.

Defendants reply that DeSantis has not been qualified by a court as an expert on this subject before. Further, the data analysis here involving many food items is different than studies of one product - as DeSantis is familiar with - and hence she is unqualified to testify.

The Court does not know what opinions precisely DeSantis intends to give. The Court will need to know those opinions and what foundation she relies on prior to ruling. It may be she can provide information that will assist the court concerning statistical methodology used in the subject reports based on her knowledge as a biostatistician; even if she had no experience with foods that likely would not preclude her testimony and merely go to the weight of her testimony. On the other hand, the Court questions her qualifications to testify on the underlying substance of the level of use of spice, including for example as to spice consumption of subpopulations or health benefits.

Defendants seek to exclude testimony and exposure assessments based on Damian’s analysis as a toxicologist of internet recipes. Thy contend that these recipes are an inappropriate source for determining rates of intake of spice by average consumers for purposes of 27 CCR sec. 25821(c)(2). They argue that the regulations indicate the source should be based on categories of products reflected in reports “such as” the US Dept. of Agriculture Research Report, the predecessor to NHANES - on which Defendants’ expert Dr. Barbara Petersen relies. They argue these recipes, by contrast, are random and do not provide evidence to show actual consumption of these recipes by consumers, level of consumption, representativeness of these foods to average use of foods and other considerations that would need to be factored in to ultimately determine intake levels.

CAG argues in opposition that it does not have access to the costly proprietary NHANES report, that the regulations do not require the use of the NHANES report and that the motion does not provide a basis for inadmissibility of the recipes (which provide an alternative source to determine levels of lead in a typical array of foods and one more likely to be used by consumers than those in the NHANES report).

In reply, Defendants argue that use of the recipes alone will still not provide sufficient facts to draw the conclusion required as to average intake levels and that Dr. Damian’s opinion will therefore be speculative and inadmissible under Sargon, supra, at 770.

The Court finds the recipes alone likely do not provide sufficient data for Dr. Damian to reach his conclusions for the reasons Defendants argue. However, the “goal of trial court gatekeeping is simply to exclude “clearly invalid and unreliable” expert opinion” (Sargon, supra, at 772). The Court does not find that his reliance on the recipes would be improper or that he cannot use other data as an additional foundation for his opinions. Further, the Court does not find that the recipes are themselves inadmissible at this point such that they could not be used to provide “some” evidence of lead levels in various foods - to the extent they provide that information. Finally, it may be that CAG is in any event able to use the recipes as rebuttal evidence after Defendants rely on the NHANES report to the extent the latter is an inadequate source for determining intake levels. Significantly, the experts on both sides relied on NHANES in Beech-Nut, supra.

Defendants seek to exclude the expert testimony of Gagik Melikyan, a chemistry professor, from testifying as to a method of exposure calculated based on retention of lead over time. They contend this scientific methodology does not meet the requirements of People v. Kelly (1976) 17 Cal.3d 24 in that it is novel and has not been generally accepted as reliable in the scientific community.[5] Melikyan has not published a paper on this methodology. The study he relies on concerns exposure to lead in the air. In addition, he has no qualifications as a chemist to give an opinion about how humans retain lead that is an issue of toxicology.

CAG argues in opposition that the methodology is not novel, the time weighted averaging model derived from a 1976 paper that Defendants find no fault with and publication of a paper is not required where Melikyan has a long history working in both chemistry and related areas, including as to Proposition 65 issues. CAG also argues these issues go to the weight his opinion should be given, not its admissibility. In reply, Defendants argue the reliability of testing methods is to be assessed by the scientific community, not a trial judge, in the first instance. (Kelly, supra, at 31)

There is less need for a motion in limine in a bench trial, as here, versus a jury trial. The level of potential prejudice from hearing the testimony is significantly reduced. That said, the Court still needs to assure that the trial is kept to relevant testimony. Admissibility of Melikyan’s opinions is a close call. On the one hand, the 1976 paper may not be sufficient for making his methodology be deemed reliable by the scientific community. It does not appear that any court has found him qualified as an expert in Proposition 65 cases notwithstanding his continued work in this area. In addition, his opinion as a chemist seems peripheral to the toxicity issue here. On the other hand, his use of averaging levels of exposure by retention does not seem novel and Defendants have not shown why his opinions would be unreliable. As explained in the opposition, the underlying theory seems to make sense. Further, his opinion as a scientist may be useful in evaluating other expert testimony and understanding the chemical makeup of lead may help the Court understand the significance of toxicity levels.

In summary, the Court will allow voir dire prior to hearing his opinion. Again, the Court does not resolve scientific controversies (Sargon, supra, at 772). The Court needs to hear other expert opinions on whether his opinions would be reliable; per Kelly, it is appropriate for the Court to assign the task of determining the reliability of Melikyan’s technique to members of the relevant scientific community (Kelly, supra, at 31). Further, it is unclear at this time - solely based on review of the motion - what the accepted practice now is related to toxicity studies to know how far this opinion might vary from accepted methods. Finally, again, where Defendants have the burden of proof during this phase of trial this opinion might still come in on some level by way of rebuttal.

By this motion, Defendants seek to exclude three surveys conducted by Facts and Figures, Inc., and its principal, Walter Meneses, concerning use by South Asian and Middle Eastern consumers in Los Angeles of turmeric, dated July 2, 2021, February 25, 2022 and April 14, 2023. They contend the faulty design of these surveys renders their results meaningless. As a result, they assert CAG should not be able to use these results to artificially inflate exposure levels to this subpopulation as a way to show Defendants violated Proposition 65 by not warning them of risks of exposure - as they seek to do through an expert opinion of DeSantis. They point to the credence given in Korsak v. Atlas Hotels (1992) 2 Cal.App.4th 1516, 1524 to the use of information of a type reasonably relied upon by professionals in the field in forming an opinion.[6] Specifically, they question the conclusion these groups use turmeric more than the average person and do so for alleged health benefits. In addition, they argue the last survey should not be considered as it was provided to Defendants only after close of discovery, submission of the exhibit list and filing of the original motion in limine on this issue.

Defendants raise a number of issues: 1. What countries of origin constitute the subpopulation. 2. How people looked at certain LA supermarkets in terms of their place of origin. 3. Whether the sample group is representative of this subpopulation. 4. Whether this data can be extrapolated statewide to the population in general. 5. The appropriateness of the questions asked of those surveyed, including as to frequency, amount used, whether powder or ground labs as to use for health benefits. 6. Not using a control group.

In opposition, CAG argues that the surveys support its contention related to high level of use of turmeric by South Asians and doing so for health reasons. CAG asserts that Meneses will testify at trial that the surveys were conducted according to generally accepted standards of market research based on his lengthy experience in market research. The specific countries included in the group are not needed because a survey does not need to have the sample be perfectly representative. Validity is tested by what is intended by the survey and here the survey was not intended to have the purpose Defendants are asserting. (Lockyer v. RJ Reynolds Tobacco (2004) 116 Cal.App.4th 1253, 1276; “statistical validity is a measure of whether the test is suitable for its intended purpose”) Those responding to the survey self-identified as South Asian. The sample does not have to be extrapolated statewide or to an average consumer because CAG is seeking only the Court’s consideration of elevated exposure to a subpopulation, as contemplated by 27 CCR sec. 25721(d)(2). The samples are relevant under Evid. Code sec. 210 because they tend to dispute the findings of Barbara Petersen as to use of exposure to an average consumer, for purposes of sec. 25821(c)(2). Defendants have not shown how any lack of precision in the questions should make the surveys inadmissible even if the court can consider what weight they should receive. (Sargon, supra, 55 Cal.4th at 772; “[t]he court must not weigh an opinion's probative value [in determining admissibility]...Rather, the court must simply determine whether the matter relied on can provide a reasonable basis for the opinion or whether that opinion is based on a leap of logic or conjecture.”) No control group was required because the surveys did not purport to perform an experiment wherein a control group might be necessary. Finally, there is no prejudice to Defendants in consideration of the final report where any issues with that report are of the same nature as the earlier reports that they did have and given they have had the final report for over a year before trial.

The Court concurs with CAG that the surveys are relevant to its response to Defendants’ evidence in support of its meeting its burden in this phase of trial. Defendants have not presented any fundamental basis to not allow CAG to put on this evidence in support of its case. This is not to say, however, that Defendants have not raised significant issues in terms of what weight the court should give these surveys (to the extent even relevant depending on how the Court determines the applicability of the ethnic subpopulation analysis). Finally, Defendants have not identified specific prejudice from the Court now considering the third survey where the issues with it may be the same as with the earlier surveys which Defendants are already prepared to address. The Court will consider this issue again if at trial it develops that there was some discovery that Defendants would have otherwise undertaken that is material to how the Court might view the survey.

Defendants seek to preclude Meneses from testifying as an expert witness. They contend he was not designated as an expert and hence may not give opinions based on the surveys he conducted. Defendants are concerned that in other proceedings he has sought to do so. They do not contest his testifying as a percipient witness related to conducting the surveys. They request that the Court draw the line in the grey area as between testimony as an expert and as a percipient witness.

CAG does not seek to call Meneses as an expert witness. Instead, CAG will call who it has designated as an expert to testify what conclusions to draw from the surveys. Meneses will only testify to how he conducted the surveys.

The Court agrees there may be potential ambiguity as to the permissibility of his testimony related to whether his surveys were conducted according to generally accepted methods for surveys. Defendants’ motion in limine E raised numerous issues still to be decided concerning the methods used for collecting the data in the surveys. CAG can seek testimony from Meneses necessary to establish the foundation for admissibility of the surveys, including defending against any objections to their admissibility - such as that the methods used made the surveys unreliable and or were of the type that they should not be received into evidence. However, this testimony would not need to reach into the different issue of whether the data in the surveys or the compilation of that data should be a foundation for CAG’s designated expert to be able to rely upon for purposes of presenting evidence of exposure levels.

Defendants seek to exclude evidence based on U.S. Food and Drug Administration Reference Amounts Customarily Consumed (“RACC”) or Fatsecret as sources for determining rate of intake of lead for Proposition 65 exposure assessments. RACC is for the purpose of identifying a serving size for development of caloric and nutrient content. In this way, consumers can compare nutrient content for different foods, not how much the average consumer intakes products daily. 21 C.F.R. Sec. 101.12(b), which governs RACC, allegedly points to NHANES data to determine exposure - contrary to the way Plaintiffs’ expert Damian is using it. Similarly, Fatsecret is an online “weight loss community” that allows unidentified users to track their nutrition and weight goals. Neither source they therefore argue is a matter that an expert would “reasonably rely upon” in toxicology for exposure assessments. (Korsak, supra) Contrary to what CAG’s expert Melikyan understood, Fatsecret is not affiliated with the FDA but is a company promoting a weight loss and nutrition service.

In opposition, CAG asserts that Defendants’ expert Petersen likewise uses RACC in the same fashion. Damian’s use of RACC is by way of rebuttal. CAG also disputes that the regulations dictate use of the NHANES data and points to language in sec. 25821(c)(2) referencing use of NHANES data to calculate anticipated rate of exposure to chemicals causing toxicity “unless more specific and scientifically appropriate data are available.” Concerning Fatsecret, CAG indicates it provides useful data that NHANES does not show – namely, how much consumers intake by the size of portions, which negates the need to work backwards based on food logs to estimate what the spice content of the food might be. CAG argues Fatsecret is heavily relied upon by consumers and more accurate than the NHANES data. Moreover, use of these different sources is consistent with Prop 65 which “envisions a case-by-case approach which takes into account the totality of the quantitative risk assessment evidence presented.” (Beech-Nut, supra, 235 Cal.App.4th at 328) Notably, sec. 25821(c)(2) does not require data exactly determining exposure or it would not have allowed data to be focused on the food category as opposed to the brand (given that this might make obtaining relevant data very difficult.) Finally, CAG argues that it would be improper to exclude expert opinions based on these sources because the opinions may be based on more than one source, not just these- including, in Damian’s case, FDA data. These issues go to the weight to be given to the data, not its admissibility.

In reply, Defendants argue Damian admitted that he relied on more reliable sources than these in reaching his opinions. They also indicate Petersen was using the RACC data only as a hypothetical in rebuttal to show that, even if that data was used, the products would still fall within the safe harbor level. Petersen does not intend to rely on the RACC data if the Court excludes it. Defendants argue this data is not a more scientifically appropriate source than NHANES and therefore should not be admitted as it would allow resulting opinions to be speculative. That Fatsecret is used frequently does not mean it is more scientific than the government study or that it identifies average consumption.

The Court finds that the regulations do not mandate use of the government study. Whether these other databases provide pertinent information is unclear where the Court does not yet know what the limitations may be with the NHANES data. The use of more than one study is consistent with the Prop 65 approach articulated in Beech-Nut, supra. The Court also cannot now exclude opinions relying on these sources as it appears Damian, for example, relied on multiple sources - which may in combination provide sufficient foundation for his conclusions. The Court does not read the opposition to suggest CAG agrees that it will not be using these sources or that use of these studies would not be relevant. Damian merely answered candidly at his deposition that he was using several sources given the weaknesses of each.

Defendants seek to exclude evidence that the level of lead in sage and clove products exceeds the safe harbor limits. The basis of the motion is Damian’s deposition testimony wherein he states that as to sage and clover “they come in at or under the MADL based on the average amount consumed per serving under the recipe analysis, but they – they exceeded based on the maximum amount consumed per serving based on the recipe analysis.” Defendants argue that Prop 65 is concerned with assessment of the reasonable use of each product by the “average” consumer. Here, Damian appears to admit that usage by the average consumer falls within the safe harbor limits.

In opposition, CAG argues lead levels are still relevant because Damian testified that they exceed the MADL based on the “maximum” amount consumed per serving. Damian used the maximum amount to better represent ethnic subpopulations that use more spice per serving. CAG argues this Court has already determined that ethnic subpopulation analysis is relevant under secs. 25821(c)(2) and 25721(d)(2). Hence, CAG argues that the Court should hear its case as to why the maximum use is more appropriate than the average use. CAG argues NHANES provides only one set of data whereas the Court should consider that some subpopulations use it more frequently and in greater amount and that the data should reflect this range of use. In addition, it contends in any event that it is not proper to dispense with its case by a motion in limine.

In reply, Defendants argue the “maximum” amount conflicts with the regulations, which provides for assessing the “average” use. They dispute that the Court has ruled already that ethnic subpopulations can be used as a basis to deviate from the regulations. Further, CAG does not explain how review of recipes establishes a “maximum” use to assess – as argued on another motion in limine.

The Court finds that on June 16, 2022 Judge Beaudet (who was previously assigned this case) adopted her tentative ruling denying the motion of Defendants for determining the applicability of secs. 25821(c)(1) and 25721(d)(2) herein. On page 5, the Court notes in italics concerning the interpretation of sec. 12721(d)(2) in the Final Statement of Reasons of OEHHA: “Certain subpopulations need to be addressed where circumstances involve particular products or environmental conditions which may pose a possible exposure risk to a distinct group of people.” In turn, on p. 6, after noting that in New York there appears to be consideration of exposure on ethnic lines, the Court states:

“Lastly, Defendants seek an order that section 25721(d)(2)’s use of the phrase “certain subpopulations in a geographic area” does not support using ethnic subpopulations for exposure assessments under either sections 25721(d)(2) and 25821(c)(2), or any other Prop 65 regulation. But Defendants cite to no legal authority indicating that ethnic subpopulations may not be considered. Moreover, whether there is available and admissible data pertaining to a certain subpopulation in this case is a different question than the applicability of section 257219d)(2), and is thus outside the scope of this briefing.”

In view of the foregoing, the undersigned finds that the Court has not already determined that ethnic subpopulation analysis is relevant under secs. 25821(c)(2) and 25721(d)(2). The Court has determined only that the regulations do not rule out consideration of subpopulations if there is reason to do so. For example, women may use a product that men do not and hence there may be reason to assess exposure only in women. Alternatively, it may make sense to assess exposure of a geographic subpopulation in proximity to a source of lead exposure as opposed to the general population. The Court has not determined to date whether there is reason to assess lead exposure along ethnic lines or if there is reason to do so whether there is data to assess exposure to an ethnic subpopulation. OEHHA has not taken a position as to whether averaging exposures to lead is appropriate when performing evaluations under Prop 65 (Beech-Nut, supra, at 317).

Therefore, at least at this time, the Court cannot conclude that it is permissible under the regulations for Damain to have used the “maximum” level of exposure over the “average” level of exposure.

On the other hand, it may be that CAG can make a case that there is reason to assess an ethnic subpopulation and that therefore use of a maximum level of exposure is a more appropriate measure of assessment. By the same token, however, it is not clear why consideration of average exposure is less appropriate than maximum exposure. Presumably, if some people use more spice than those on average there are also others who use less spice than on average. It may be for this reason that consideration of what an average person would use is the most appropriate. In any event, the Court cannot now exclude evidence of exposure to clove or sage given the Court has not determined what measure of exposure to use. The Court also notes that in Beech-Nut, the trial court rejected, and the Court of Appeal affirmed, plaintiff’s expert’s use of the 85th percentile of the NHANES database (which is also a “maximum”-type approach, as the 85^th percentile is the high end of the distribution of the food consumption data).Instead, the court accepted defendants’ expert’s average consumption per day calculations based on the geometric mean (Beech-Nut, supra, at 322). [7]

Defendants seek to exclude expert testimony regarding turmeric consumption as a dietary supplement or for medicinal use. They contend that where turmeric is used as a supplement, it is not food but a drug and is therefore regulated by the FDA which uses a different measure of assessing exposure.

In opposition, CAG states it is not considering use of turmeric as a drug but as health supplement and that this is relevant to the rate of intake that is part of the exposure analysis. In other words, if a consumer uses turmeric regularly due to its perceived added health benefits this might increase the rate of intake and the subsequent exposure to any lead in the turmeric.

Defendants do not explain why merely because turmeric may also be regulated as a drug when used as a health supplement that this means it is not also regulated as food or that Prop 65 does not apply, however used. Moreover, there is some logic to CAG’s argument that perceived health benefits may be a reason that Petersen’s analysis based on an average person’s use might be inadequate if the rate of exposure does not already factor in regular use for this reason.

Defendants seek an order that Plaintiff’s claim is limited to exposure in utero and to adults of childbearing age and to exclude irrelevant exposures and health effects. Defendants argue that Prop 65 is concerned only with two health effect endpoints: cancer and reproductive toxicity. (27 CCR sec. 25249.6) As concerns the latter, the focus is on male and female reproductive systems and developmental effects from in utero exposure. Alleged postnatal exposure affecting a child is not considered developmental toxicity for these purposes. (Mateel, supra, 24 Cal.App.5^th at 233, 234)

CAG agrees but clarifies that Damian’s testimony concerns the effects of prenatal exposure as opposed to postnatal exposure.

Defendants seek to exclude all documents not produced in response to discovery requests.

CAG opposes the motion in part on the basis that it is not specific to any document that it purportedly did not produce in response to discovery or is mere inuendo that Meneses withheld documents.

[1] It appears that there are eleven spices at issue: four types of ground cinnamon, ground cumin, ground turmeric, garlic powder, two types of ground sage, ground cloves and poultry seasoning.

[2] On a related point, CAG argues that FNDDS does not provide any data on cloves and Petersen therefore instead (improperly) considered nutmeg. Further, Petersen also considered thyme and parsley instead of sage and poultry seasoning in view of the limited amount of data on those spices.

[3] Defendants also note that the notice of violation refers to the lots only as exemplars.

[4] The court in Geffcken did not address the scope of the allegations in plaintiff’s complaint, therefore its holding is not relevant to CAG’s attempt to limit the scope of Defendants’ defense to the lots specified in its complaint. Pannu offers a clear example of “apples” versus “oranges”; a vehicle manufacturer’s expert evidence regarding roof strength was excluded as it was based on a distinguishable vehicle with a different roof composition. Pannu is distinguishable from this case, where the evidence that CAG seeks to exclude is based on the same spice products.

[5] Kelly, supra, adopts the test from Frye v. United States, 293 F. 1013, 1014 (D.C.Cir. 1923) which, when faced with a novel method of proof, requires a preliminary showing of general acceptance of the new technique in the relevant scientific community.

[6] Korsak, supra, held that although the courts have rejected expert opinions which are based on unreliable hearsay, nevertheless, hearsay information of a type reasonably relied upon by professionals in the field in forming an opinion on the subject may be used to support an expert opinion, even though not admissible in court.

[7] The Court notes that a separate though related issue to the “maximum” question is the use of the “geometric mean” versus “arithmetic mean.” In response to CAG’s motion in limine no. 8, Defendants argue that use of the geometric mean is the most scientifically appropriate methodology in this case. In Beech-Nut, defendants’ expert used the geometric mean on the basis that food consumption data is not plotted in a bell-shaped curve; instead, it has peaks due to the presence of some high consumers which will distort the overall estimate if they are not properly accounted for. As noted above, the Court accepted the use of the geometric mean in Beech-Nut. The Court will need to hear further from both parties on this issue as it applies to the data in this case.