1 2 3 4 UNITED STATES DISTRICT COURT 5 NORTHERN DISTRICT OF CALIFORNIA 6 7 FOOD & WATER WATCH, INC., et al., Case No. 17-cv-02162-EMC
8 Plaintiffs, FINAL PRETRIAL CONFERENCE 9 v. ORDER (PHASE TWO)
10 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY, et al., 11 Defendants. 12
13 I. TRIAL DATES & LENGTH 14 A bench trial shall be held beginning on January 31, 2024. Trial days are: January 31, 15 February 1, 2, 5, 6, 7, 9, 12, 13 (nine days total) with one extra day available in case of logistical 16 issues: February 14. Trial days shall begin at 8:30 a.m. and end at 1:30 p.m. Counsel are expected 17 to be present at 8:00 a.m. at least, unless the Court orders otherwise. 18 Each side shall have 18 hours to present their case. This includes opening statements, 19 direct and cross-examinations, and closing arguments. 20 II. TRIAL PROCEDURES 21 A. Evidence and Objections 22 A party must give the opposing party at least forty-eight (48) hours’ notice of witnesses it 23 intends to call, exhibits it intends to use, and/or demonstratives it intends to use. Saturdays and 24 Sundays do not count. Thus, e.g., for a Monday trial day that starts at 8:30 a.m., a party must give 25 the opposing party notice by 8:30 a.m. on Thursday. 26 If the opposing party has an objection, then it must notify the party by 6:00 p.m. the same 27 day of notice, and the parties shall meet and confer to see if they can resolve their differences. If 1 they cannot, then they shall file with the Court a joint statement twenty-four (24) hours in advance 2 of the relevant trial day. In short, the Court requires a full day to resolve any objections. 3 The Court emphasizes that, because this will be a bench trial, it expects objections to be 4 kept to a minimum. 5 B. Broadcast of Trial 6 The emergency CARE act has sunsetted and the Judicial Conference of the United States 7 has enacted an advisory policy that limits broadcasting in civil cases to audio-only nonevidentiary 8 hearings. However, the Ninth Circuit has yet to rescind its broadcast policy which allows for 9 broadcasting civil proceedings by e.g. Zoom. In light of the benefits (including educational 10 benefits and public interest) of broadcasting, the Court will broadcast the trial live via Zoom 11 Videoconference. 12 C. Trial and Evidentiary Format 13 The trial is to take place in-person. Witnesses will be testifying in person with the 14 exception of one witness that will be testifying via deposition video. Exhibits will be displayed 15 electronically at trial to allow for a more efficiently display of evidence. 16 D. Proposed Findings of Fact 17 The parties are to submit a merged document with proposed findings of fact and 18 conclusions of law by one week prior to the start of trial, i.e., by January 24, 2024. The Court 19 shall require the parties to file on a rolling basis iterative proposed findings of fact based on the 20 specific evidence that was presented on a given trial day. Citations to the relevant witness 21 testimony and/or exhibit number will be helpful but are not necessary; the document need not 22 include reference to specific pin-cites during the trial. The parties will work together to merge the 23 documents under a single framework for organizing the proposed findings of fact and shall file the 24 proposed findings one week before trial.1 25 // 26 // 27 1 III. UNDISPUTED FACTS 2 The parties do not dispute the following facts: 3 A. Undisputed Facts from First Trial 4 1. According to the United States Centers for Disease Control and Prevention (CDC), as of 5 2014, approximately 200,000,000 people in the United States live in communities that add 6 fluoridation chemicals to the drinking water. 7 2. Plaintiffs’ Citizen Petition sought to prohibit the addition of fluoridation chemicals to 8 water on the grounds that this condition of use presents an unreasonable risk of neurologic 9 harm. 10 3. Fluoridation chemicals are added to drinking water to prevent tooth decay (i.e., dental 11 caries). In addition to being added to water, fluoride is added to dental products and certain 12 pesticides. 13 4. In epidemiology, a cross-sectional study is a comparison of the prevalence of a specific 14 health outcome across levels of a specific exposure in study subjects (or vice versa), with 15 the exposure and outcome both measured at a given time, providing a “snapshot” of the 16 association between the exposure and the health outcome at one time. 17 5. In epidemiology, a cohort study is a comparison of incidence rates of a specific health 18 outcome between study subjects with various levels of a specific exposure who are 19 observed over time. 20 6. A person’s individual response to fluoride exposure depends on factors such as age, kidney 21 function, body weight, activity level, nutrition, and other factors. 22 7. Human urine fluoride concentrations (biomonitoring) measure an internal dose. 23 8. Various factors can affect the concentration of fluoride in a urine sample, such as an 24 individual’s metabolism, when a urine sample is collected, and the time since the last void 25 of the individual who provided the sample. 26 9. Historically, most studies to investigate the impact of fluoride on IQ in humans have used 27 cross-sectional study designs. Most of these cross-sectional studies have been conducted in 1 in water. By contrast, fluoride is added to water in the United States to reach a 2 concentration of 0.7 mg/L. 3 10. Prospective cohort studies have been conducted in Mexico City (ELEMENT cohort), 4 where fluoride is added to salt, and Canada (MIREC cohort), where fluoride is added to 5 water. These studies are the most methodologically reliable human studies to date on the 6 impact of fluoride on neurodevelopment.2 7 11. Risk assessment is the process by which scientific judgments are made concerning the 8 potential for toxicity in humans. 9 12. The National Research Council (NRC, 1983) has defined risk assessment as including the 10 following components: hazard identification, dose-response assessment, exposure 11 assessment, and risk characterization. 12 13. The term “risk evaluation” is a specialized term under TSCA. 13 14. Together, the components of EPA’s risk assessment process, coupled with the ultimate risk 14 determination, constitute a “risk evaluation” under TSCA. 15 15. The final step of a risk evaluation is to weigh a variety of factors to determine whether the 16 chemical substance, under the conditions of use, presents an unreasonable risk of injury to 17 health or the environment, referred to as the “risk determination” step in the TSCA risk- 18 evaluation process. 19 16. EPA does not require that human exposure levels exceed a known adverse effect level to 20 make an unreasonable risk determination under TSCA.3 21 17. In the ideal world, all risk assessments would be based on a very strong knowledge base 22 (i.e., reliable and complete data on the nature and extent of contamination, fate and 23 transport processes, the magnitude and frequency of human and ecological exposure, and 24 the inherent toxicity of all of the chemicals). However, in real life, information is usually 25
26 2 EPA’s position is that this fact, as drafted, is no longer undisputed given the publication of the Spanish (INMA) and Danish cohort studies. 27 1 limited on one or more of these key data needed for risk assessment calculations. This 2 means that risk assessors often have to make estimates and use judgment when performing 3 risk calculations, and consequently all risk estimates are uncertain to some degree. For this 4 reason, a key part of all good risk assessments is a fair and open presentation of the 5 uncertainties in the calculations and a characterization of how reliable (or how unreliable) 6 the resulting risk estimates really are. 7 18. EPA’s Guidelines for Neurotoxicity Risk Assessment were designed in 1998 to guide 8 EPA’s evaluation of substances that are suspected to cause neurotoxicity, in line with 9 substantive standards established in the statutes administered by the Agency. 10 19. EPA’s Guidelines for Neurotoxicity Risk Assessment preceded the 2016 TSCA 11 amendments. 12 20. The current non-enforceable health goal for fluoride under the Safe Drinking Water Act 13 (“SDWA”), or Maximum Contaminant Level Goal (MCLG), of 4.0 mg/L was promulgated 14 in 1985 to protect against a condition known as crippling skeletal fluorosis (i.e., “stage III 15 skeletal fluorosis”). Crippling fluorosis is the final, and most severe, stage of skeletal 16 fluorosis. 17 21. Based on its 2006 review, the National Research Council (NRC) of the National 18 Academies of Science (NAS) recommended that the MCLG of 4 mg/L be lowered to 19 prevent children from developing severe dental fluorosis and reduce the lifetime 20 accumulation of fluoride into bone that the majority of the committee concluded is likely 21 to put individuals at increased risk of bone fracture and possibly skeletal fluorosis. 22 22. Based on the NRC’s recommendation, in 2010, EPA’s Office of Water completed a dose- 23 response analysis using available data between 2000 and 2010 to calculate a reference dose 24 (“RfD”)—an estimate of the fluoride dose protective against severe dental fluorosis, stage 25 II skeletal fluorosis, and increased risk of bone fractures— of 0.08 milligrams per 26 kilograms per day (mg/kg/day), a measure of daily intake by body weight. 27 23. In addition to the tooth and bone effects, the NRC also evaluated neurotoxicity as an effect 1 data were inadequate to demonstrate a risk for neurotoxicity at 4.0 mg/L and made 2 recommendations for additional research. Since that time, additional research has been 3 conducted and the scientific database for studies that have examined neurotoxicity as an 4 effect of fluoride exposure has grown. 5 24. In determining whether adding fluoridation chemicals to drinking water presents an 6 unreasonable risk of neurotoxic effects under TSCA, EPA’s Office of Pollution Prevention 7 and Toxics would not rely on the 2010 RfD, but would instead apply a weight of the 8 scientific evidence approach for identifying and characterizing the best available science 9 from the most up-to-date scientific database of studies that have examined neurotoxicity as 10 an effect of fluoride exposure. 11 25. In conducting TSCA risk evaluations, EPA generally uses the Margin-of Exposure (MOE) 12 approach to characterize the risk as a step in the risk assessment process. Using this 13 approach, an MOE is calculated by comparing (dividing) the point-of departure directly to 14 the expected exposure level. The MOE is then compared to a benchmark MOE, which is 15 the product of all relevant uncertainty factors. 16 26. EPA considers the MOE, relative to the benchmark MOE, in addition to other factors, in 17 determining whether risks are unreasonable under TSCA. 18 27. The National Research Council has stated that “the inference that results from animal 19 experiments are applicable to humans is fundamental to toxicologic research.” 20 28. EPA agrees that effects observed in animals are relevant to humans unless human data 21 counterindicate. 22 29. The developing brain is distinguished by the absence of a bloodbrain barrier. The 23 development of this barrier is a gradual process, beginning in utero and complete at 24 approximately 6 months of age. 25 30. Fluoride passes through the placenta and gets into the fetal brain. 26 31. Whether harm would actually occur depends on the dose and nature of exposure. 27 Docket No. 378 (Joint Pretrial Statement) at 2-6. 1 B. Additional Undisputed Facts for the Second Phase of Trial 2 32. In addition to the ELEMENT and MIREC studies, prospective cohort studies on fluoride 3 and IQ have now been conducted in Denmark (OCC cohort), Mexico (PROGRESS 4 cohort), and Spain (INMA cohort). 5 33. Subsequent to the first phase of the trial, two pooled benchmark dose analyses have been 6 published on the relationship between maternal urinary fluoride levels and childhood IQ. 7 Plaintiffs’ expert Dr. Philippe Grandjean is the lead author of both studies. One of the 8 analyses, published in 2022, pooled the data from the ELEMENT and MIREC studies. The 9 other analysis, published in 2023, pooled the data from the ELEMENT, MIREC and OCC 10 cohorts. 11 34. The National Toxicology Program (NTP) has released two updated drafts of its State of the 12 Science Monograph of fluoride neurotoxicity: one dated May 2022, and the other dated 13 September 2022. 14 35. NTP has released an updated draft of its meta-analysis manuscript of fluoride and IQ, 15 dated July 2022. 16 36. The NTP has released its Board of Scientific Counselors Working Group Report on the 17 Draft State of the Science Monograph and the Draft Meta-Analysis Manuscript on 18 Fluoride, May 16, 2023. The report includes interagency review comments, the NTP 19 authors’ responses to those comments, and the BSC Working Group’s assessment of the 20 NTP authors’ responses. 21 37. Subsequent to the first trial, EPA published its first ten risk evaluations of existing 22 chemicals under the Amended TSCA. 23 38. Under the Amended TSCA, EPA has made Unreasonable Risk determinations where it did 24 not have high confidence in the hazard data. 25 39. In its first 10 risk evaluations under the Amended TSCA, EPA made Unreasonable Risk 26 determinations where it had medium confidence in the hazard data. 27 40. Under the Amended TSCA, EPA has made Unreasonable Risk determinations where it did 1 41. In its first 10 finalized risk evaluations under the Amended TSCA, EPA made 2 Unreasonable Risk determinations where it had medium confidence in the exposure data. 3 42. EPA has made Unreasonable Risk determinations for conditions of use where average 4 exposures did not present a risk, but highly exposed individuals (e.g., 95th percentile) had 5 exposures of concern. 6 43. EPA has made Unreasonable Risk determinations for conditions of use that involve fewer 7 than 500 people. 8 Id. at 6-8. 9 IV. DISPUTED FACTUAL ISSUES 10 1. Plaintiffs contend that fluoridation chemicals pose an unreasonable risk of neurotoxicity 11 when added to drinking water because: 12 a. neurotoxicity is a hazard of fluoride exposure when the scientific literature is 13 assessed according to the framework that EPA uses for hazard identification under 14 the Amended TSCA; 15 b. neurotoxicity is a risk at the exposure levels produced by fluoridation chemicals 16 when assessed according to the framework for risk characterization that EPA uses 17 under the Amended TSCA; and 18 c. the risk of neurotoxicity posed by fluoridation chemicals is unreasonable when 19 assessed according to the framework that EPA uses for risk determinations under 20 the Amended TSCA. 21 2. EPA contends that the following disputed facts for the second phase of trial are material to 22 Plaintiffs claim: 23 a. The scientific evidence for evaluating the risk of neurotoxic effects from low-dose 24 exposure to fluoride, especially considering the more recent scientific studies 25 published after the first trial, is insufficient to reach an informed risk determination 26 under TSCA. 27 b. The existing scientific studies do not provide sufficient evidence to support a 1 associated with community water fluoridation in the United States. 2 c. Plaintiffs have not provided any way to convert a urinary-fluoride-based dose 3 response to total intake levels, which is critical to making a risk calculation and 4 subsequent determination. Assuming a one-to-one linear relationship of biomarkers 5 based on dose-response data with intake levels is not supported by limited existing 6 low-exposure data. 7 d. Plaintiffs did not conduct an exposure assessment. 8 e. Uncertainty in the hazard assessment and variability in response between the most 9 reliable and robust studies at this time makes a risk estimation highly uncertain. 10 f. Plaintiffs have not set forth a scientifically defensible basis to conclude that there is 11 an unreasonable risk of neurotoxic harm as a result of exposure to fluoride in the 12 United States through the addition of fluoridation chemicals to drinking water. 13 Id. at 8-9. 14 V. WITNESSES 15 The parties have submitted a joint witness list. The parties are limited to these witnesses 16 for their cases-in-chief. The witnesses are as follows: Plaintiffs’ Witnesses 17 (1) Dr. Stanley Barone Jr., MS, Ph.D., is a scientist at the UPA who the EPA 18 designated as its 30(b)(6) representative.4 19 (2) Dr. Brian Berridge, D.V.M. Ph.D., D.A.C.V.P., (subject of Def’s MIL No. 1), 20 was the Scientific Director of the NTP from 2018 to 2023. 21 (3) Dr. Philippe Grandjean, MD, DMSc, is a physician and environmental 22 epidemiologist who serves as Chair of Environmental Medicine at the University of Southern Denmark. 23 (4) Dr. Howard Hu, MD, MPH, ScD, is the Chair of the Department of 24 Preventive Medicine, Keck School of Medicine, at the University of Southern 25 California. 26 27 (5) Dr. Bruce Lanphear, MD, MPH, is a Professor of Health Sciences at Simon 1 Fraser University in Vancouver, British Columbia. 2 (6) Dr. Kathleen Thiessen, PhD, is a risk assessment scientist and President of 3 Oak Ridge Center for Risk Analysis. 4 Defendants’ Witnesses 5 (7) Dr. David Savitz, MS, Ph.D., is a Professor of Epidemiology at Brown 6 University School of Public Health, a Professor of Pediatrics, Obstetrics and Gynecology at Brown University Medical School, and is an Adjunct Professor 7 of Epidemiology at both the Dartmouth School of Medicine and the Boston 8 University School of Public Health. 9 (8) Dr. Stanley Barone Jr., MS, Ph.D., is the Senior Science Policy Advisor and 10 Deputy Science Integrity Official for the United States Environmental 11 Protection Agency’s (“EPA”) Office of Chemical Safety and Pollution 12 Prevention (“OCSPP”). (9) Dr. Jesús Ibarluzea, Ph.D., is an epidemiologist and Professor at the 13 University of the Basque Country in Spain. Dr. Ibarluzea studies the association 14 between maternal fluoride exposure during pregnancy and neurodevelopmental 15 outcomes in offspring in the INMA Gipuzkoa cohort.5 16 Absent further instruction, witnesses are permitted to watch testimony from other witnesses 17 throughout the trial. 18 VI. MOTIONS IN LIMINE 19 A. Defendants’ MIL No. 1 to Exclude the Testimony of Brian Berridge (Docket No. 374) 20 Defendants seek to exclude the testimony of former National Toxicology Program 21 (“NTP”) Scientific Director, Dr. Brian Berridge. See Docket No. 374 (“Def’s MIL No. 1”) at 1. 22 Dr. Berridge served as the NTP Scientific Director from 2018 to 2023, where he oversaw 23 development of NTP’s May 2022 Monograph on the State of the Science Concerning Fluoride 24 Exposure and Neurodevelopmental and Cognitive Health Effects: A Systematic Review (the “NTP 25 26 5 Dr. Jesús Ibarluzea is no longer available to testify and will not be testifying live. However, 27 Plaintiffs reserve the right to introduce designations of the videotaped deposition of Dr. Ibarluzea 1 May 2022 State of the Science Monograph” or “State of the Science Monograph”) (submitted as 2 Pl’s Exhibit No. 67). Docket No. 378 (Joint Pretrial Statement) at 2. Dr. Berridge also oversaw 3 the development of NTP’s July 2022 manuscript Association between fluoride exposure and 4 children’s intelligence: A systematic review and meta-analysis (the “NTP July 2022 meta- 5 analysis” or “NTP Meta-Analysis”) (submitted as Pl’s Exhibit No. 68). Id. For the reasons 6 discussed herein, the Court GRANTS in part and DENIES in part Defendants’ first motion in 7 limine. Dr. Berridge’s testimony regarding political influence upon the State of the Science 8 Monograph’s draft status is to be excluded. However, Dr. Berridge may testify as to the first two 9 issues identified in the parties’ witness list. See Docket No. 378-1 at 2.6 10 In Plaintiffs’ Initial Disclosures pursuant to Federal Rule 26, submitted on May 8, 2023, 11 Plaintiff disclosed Dr. Berridge as a witness among other “[c]urrent and former NTP scientists 12 who have knowledge of the [NTP] Monograph,” and specifically knowledge of the “history of [the 13 Monograph’s] development, the peer review processes and scientific methodologies that it has 14 employed, and the political pressures that it has been subjected to by officials and agencies with 15 strong policy interests on fluoride.” Docket No. 374, Declaration of Brandon N. Adkins (“Adkins 16 Decl.”), Ex. D (Pl’s Initial Disclosures) at 2. In the pretrial filings, Plaintiffs list Dr. Berridge as a 17 witness testifying to:
18 (1) NTP’s purposes and procedures, including the hazard focused nature of NTP evaluations, as opposed to risk-focused; (2) the 19 extensive review process that the NTP’s fluoride monograph and meta-analysis on fluoride neurotoxicity have undergone, and (3) 20 why Dr. Berridge made the decision to publish the May 2022 monograph, and how in the normal course of events this would have 21 been the final and dispositive step for publishing the monograph, but was not. 22
23 Docket No. 378 (Joint Pretrial Statement) at 2. 24 The NTP May 2022 State of the Science Monograph has not yet been published by NTP, 25 and the parties do not anticipate that it will be published before the second phase of trial. See 26
27 6 This includes “(1) NTP’s purposes and procedures, including the hazard focused nature of NTP 1 Docket No. 376 (Def’s Trial Brief for Second Phase of Trial) at 5; Docket No. 379 (Pl’s Trial 2 Brief for Second Phase of Trial) at 4. Plaintiffs state that on May 11, 2022, NTP announced that 3 the systemic review of the State of the Science Monograph was complete and intended to be 4 released in seven days, but that political leadership of the Department of Health & Human 5 Services (HHS) prevented the publishing of the document. Docket No. 379 at 4. The parties 6 agree the State of the Science Monograph remains unpublished at present. See Docket No. 376 7 (Def’s Trial Brief for Second Phase of Trial) at 5; Docket No. 379 (Pl’s Trial Brief for Second 8 Phase of Trial) at 4. Thereafter, an additional draft was published in September 2022. See Docket 9 No. 378 (Joint Pretrial Statement) at 7.7 Though not published as final, the May 2022 State of the 10 Science Monograph, along with comments and criticisms and responses regarding the State of the 11 Science Monograph have been made publicly available. 12 Defendants take issue with Dr. Berridge testifying as to the alleged impact of political 13 influence upon declining to publish as final the State of the Science Monograph regarding fluoride 14 exposure conducted by NTP in May 2022 when it was completed. Def’s MIL at 1. Defendants 15 argue that this testimony should be excluded pursuant to Federal Rules of Evidence 401, 402, and 16 403. Id. Namely, Defendants argue that the evidence is not relevant pursuant to Federal Rule 401 17 (test for relevancy) and thus should be excluded under Federal Rule 402 (providing that all 18 relevant evidence not otherwise excluded should be admitted). Id. at 1, 3. Additionally, that the 19 evidence should be excluded pursuant to Federal Rule 403 as its probative value is substantially 20 outweighed by the danger of confusing issues, wasting time, or being needlessly cumulative, to the 21 extent it is relevant. Id. at 4. Defendants also argue there is a procedural deficiency here. Id. at 3. 22 Specifically, Defendants argue that the attempt to submit this evidence is unsound because the 23 Court already ruled that political influence upon the publishing of the State of the Science 24 Monograph is not relevant. Id. To revisit this ruling, Defendants argue, Plaintiffs should have 25 sought leave to file a motion for reconsideration pursuant to Local Rule 7-9 which Plaintiffs failed 26 to do. Id. at 3. Defendants also argue that because of the prior ruling by the Court as to relevant 27 1 of political influence, Defendants forewent taking discovery from Dr. Berridge as to political 2 influence and would suffer prejudice now if his testimony were allowed. Id. 3 Plaintiffs’ position is that the issue of political influence upon the decision not to publish 4 the State of the Science Monograph is highly relevant because it impacts the weight afforded that 5 the document, which remains in draft form and is now a central piece of evidence in this case. 6 Pl’s Opp. to MIL (available as attachment to Def’s MIL, Docket No. 374) at 5. Plaintiffs also 7 argue that the Court has yet to opine on the admission of witness testimony on political influence 8 at trial, and the previous ruling was on a distinct issue and that there is no prejudice to Defendants 9 based upon their decision not to take discovery of Dr. Berridge based on the Court’s previous 10 ruling. Id. at 5-7. Additionally, Plaintiffs argue that the issues that Dr. Berridge intends to testify 11 about beyond political influence fall within his purview as a fact witness. Id. at 7. 12 As an initial matter, the Court takes note of its prior rulings relating to the relevancy or 13 admissibility of evidence regarding political influence on the Monograph to assess the import of 14 the Court’s previous ruling here. The Court has yet to rule definitively on the admissibility at trial 15 of such materials, and only considered the propriety of allowing discovery to be taken on the 16 issue. 17 In the first instance, in March 2023, the Court adjudicated a discovery letter brief wherein 18 Defendants moved to quash two subpoenas for fact depositions of Jayanth Kumar and Christine 19 Wood. Docket No. 346 (Joint Discovery Brief Regarding Depositions of Jayanth Kumar and 20 Christine Wood). The depositions fell within the presumptive limit of ten depositions to be taken 21 by Plaintiffs. See id. Defendants argued that the then-current scope of discovery (pertaining to 22 subject matter, and not number of depositions) identified by the Court did not allow the 23 depositions. Id. at 1. Specifically, the Court determined at a prior status that limited discovery 24 would be permitted only: (1) fact discovery only to “allow for the production of the May 2022 25 NTP draft review . . . [to] help the Court determine future scheduling,” and (2) expert discovery 26 insofar as to allow “commencement of expert review of the new scientific evidence.” ECF No. 27 319 at 5. Defendants also argued that the depositions were unfairly prejudicial, irrelevant, and 1 subjected to improper ‘partisan’ interference” and further that this issue “is of little-to-no- 2 relevance to the issues in this litigation, and it is not proportionate to the needs of this case.” Id. at 3 2. The Court allowed taking of the depositions, in part because the State of the Science 4 Monograph is “the centerpiece of this dispute.” Docket No. 346 (Order Denying Request for 5 Emergency Hearing and Clarifying Discovery Scope) at 2. The Court explained that because Dr. 6 Kumar and Mr. Wood may have knowledge as to why the May 2022 monograph was not 7 published, the testimony of these witnesses “may shed light on EPA’s defenses regarding the draft 8 status and industry criticisms of the NTP monograph.” Id. As such, allowing the depositions, 9 which fell within the scope of depositions allotted to Plaintiffs, was warranted. See id. Of course, 10 relevance for discovery purposes is not the same as admissibility at trial. 11 Subsequently, in April 2023 the parties submitted their Seventh Joint Status Report 12 identifying a dispute between the parties as to whether Plaintiffs should be granted leave to exceed 13 the presumptive limit of ten depositions. Docket No. 350 (Seventh Joint Status Report) at 3. 14 Specifically, the parties provided “the parties continue to meet and confer regarding fact 15 depositions, and whether Plaintiffs will need to seek leave of the Court to exceed 10 depositions in 16 this litigation (including the depositions taken prior to the first trial.).” Id. At the status 17 conference, Plaintiffs explained they intended to seek leave to conduct fact depositions of federal 18 officials at the Department of Health and Human Services (“HHS”) regarding alleged political 19 pressures imposed upon NTP leading up to its decision not to publish the State of the Science 20 Monograph. See Docket No. 352 (Minute Entry, April 11, 2023, Status Conference). 21 At that time, Plaintiffs argued that the depositions were needed because the decision not to 22 publish the State of the Science Monograph in the first instance speaks to the weight and scientific 23 merit of the report as evidence. Id. at 1. Plaintiffs explained that the Court would eventually be 24 confronted with “the question of how much weight do you give to the NTP’s May 2022 25 assessment because . . . by the time we got to trial next January, there [may not] be a final NTP 26 monograph for us all to rely upon.” Docket No. 374, Adkins Decl., Ex. A (April 11, 2023, Status 27 Conference Transcript) at 10:4-10. Plaintiffs further argued that they suspected that at trial, EPA 1 given much weight. See id. at 10:11-15. Plaintiffs’ position was that the Monograph was not 2 published in May due to political pressure. Id. at 11:19-20. 3 Defendants argued in rebuttal that the comments and NTP’s responses to comments 4 regarding the State of the Science Monograph’s draft have since been made public, thus, enlarging 5 the number of depositions allotted to Plaintiffs to assess political impact upon the decision to delay 6 publication of the State of the Science Monograph were not needed. Id. at 2. Additionally, 7 because Plaintiffs would be able to put on expert testimony regarding the legitimacy of the State 8 of the Science Monograph substantively at trial, depositions were not necessary. Id. Specifically, 9 “Counsel can rebut [claims made by EPA with respect to the draft monograph] by putting on 10 expert testimony, explaining what the comments were, and whether it was reasonable or not to 11 stop publication.” Id. at 12:32-7. In other words, Plaintiffs could put on evidence speaking to the 12 merits of the State of the Science Monograph to rebut EPA’s arguments the draft should be given 13 less weight, instead of context regarding e.g., political reasons not to publish it. See id. 14 Ultimately, Defendants’ position was that the decision not to initially publish the May 2022 draft 15 was a tangential issue not speaking to the heart of the matter which is whether fluoridation in the 16 water supply presents a hazard. Id. 17 As explained in the minutes for the April 11, 2023, status conference hearing, the Court 18 sided with Defendants and ordered—without prejudice—that allowing additional depositions 19 beyond the presumptive limit to depose government officials related to NTP’s decision not to 20 publish the State of the Science Monograph would not be permitted. See Docket No. 352 (Minute 21 Entry, April 11, 2023, Status Conference). The Court reasoned the relevancy of the issue was not 22 obvious and/or was limited, as the report and criticisms of the draft have since been made public. 23 Id. As the Court explained, “[a]bsent good cause, the Court . . . must proceed on the merits of the 24 science which does not require the information Plaintiffs seek in the depositions.” Id. To this end, 25 the Court explained at the status conference: 26 // 27 // 1 [W]e ought to focus on the science to the extent [EPA] attempt[s] to criticize the monograph and to down-play the importance of the 2 draft that will be the scientific debate that I am going to have to listen to. That’s more important [than] whether politicians got 3 involved and tried to squelch this thing. Whether they did or not, I have to look at the science at the end of the day. So the motive for 4 delaying the publication now that it’s all out is not really on point.
5 Docket No. 374, Adkins Decl., Ex. A at12:16-13:12 (cleaned up). Accordingly, the Plaintiffs 6 were not permitted to take additional depositions of witnesses beyond the presumptive limit. See 7 Docket No. 352 (Minute Entry, April 11, 2023, Status Conference). 8 The Court maintains the focus at trial should be on the scientific merits as opposed to 9 ancillary issues including, e.g., political influence upon the “draft” status of the State of the 10 Science Monograph. Though there is a path to relevancy for the testimony regarding the decision 11 not to publish as final the State of the Science Monograph, the probative value of that testimony is 12 outweighed by the undue delay it will cause. 13 Federal Rule 401 provides that evidence is relevant if “(a) it has any tendency to make a 14 fact more or less probable than it would be without the evidence; and (b) the fact is of 15 consequence in determining the action.” Fed. R. Evid. 401. “To be ‘relevant’ evidence need not 16 be conclusive proof of a fact sought to be proved, or even strong evidence of the same. All that is 17 required is a ‘tendency’ to establish the fact at issue.” United States v. Curtin, 489 F.3d 935, 943 18 (9th Cir. 2007) (citing Fed. R. Evid. 401). 19 The issue of publishing the State of the Science Monograph is somewhat relevant, but its 20 probative value is limited and attenuated. At bottom, the issue in this suit is whether and at what 21 amount fluoridation chemicals added to public drinking water presents an unreasonable risk of 22 injury to health under the Toxic Substances Control Act (“TSCA”), 15 U.S.C. § 2620(b)(4)(B). 23 See Docket No. 376 (Def’s Trial Brief) at 1; Docket No. 379 (Pl’s Trial Brief). To be sure, the 24 State of the Science Monograph, i.e., NTP’s latest study addressing the impact of fluoridation on 25 health, is a key piece of evidence in answering that question. See, e.g., Docket No. 346 (Order 26 Denying Request for Emergency Hearing and Clarifying Discovery Scope) at 2 (monograph is 27 “centerpiece” of dispute); Docket No. 262 (Order Holding Proceedings in Abeyance) at 4 (holding 1 case in abeyance in part because of “imminent” publishing of monograph among other 2 forthcoming scientific research); Docket No. 290 (Ordering Granting Pl’s Mot. for Leave to File 3 Supp. Compl.) at 5 (citing Docket No. 279-1 (“Proposed Supp. Compl.”) ¶¶ 30, 32)) (granting 4 leave in light of supplemental evidence included in propose amended complaint including a 5 summary of the draft monograph along with the Benchmark Dose (BMD) pooled analysis of the 6 data used in previously considered ELEMENT and MIREC studies). 7 Plaintiffs explain that Dr. Berridge, the former Director of Science for NTP, decided to 8 publish the State of the Science Monograph, which in his opinion, absent improper political 9 influence would have been the final word on this issue of publication. See Pl’s Opp. at 2 (citing 10 Connett Decl., Ex. 1, Ex. 5). Insofar as Defendants intend to argue that the State of the Science 11 Monograph, and its conclusions therein, should be afforded less weight as evidence in assessing 12 health impacts of fluoridation, as Plaintiffs anticipate, the circumstances leaving the State of the 13 Science Monograph in draft form are relevant. In other words, as explained previously in relation 14 to the motion to quash, the political interference issue “may shed light on EPA’s defenses 15 regarding the draft status” of the Monograph. Docket No. 346 (Order Denying Request for 16 Emergency Hearing and Clarifying Discovery Scope) at 2. 17 However, per Defendants’ trial brief, it appears that Defendants are not focusing upon the 18 draft status of the document in arguing that the State of the Science Monograph does not support 19 finding an unreasonable risk presented by fluoridation in water but focuses instead upon the 20 substance of the draft including its “methodolog[y] and the scientific quality of the presented 21 information.” 8 Def’s Trial Brief at 2. As the Court understands it, Plaintiffs’ primary contention 22 is not that political influence impacted the scientific conclusions expressed in the State of the 23 Science Monograph in the first instance, only its draft status.9 See Pl’s Opp. at 1-2, 5-6. 24 8 Insofar as Defendants take a different approach at trial such that the draft status of the document 25 becomes highly relevant the Court reserves the right to revisit this finding.
26 9 There seems to be some suggestion that the decision to delay publication opened the State of the Science Monograph up to additional and unnecessary rounds of criticism and comment, thus, in a 27 sense impacting the outcome of the monograph. See Pl’s Exhibit No. 76 (email from Dr. Berridge 1 Accordingly, the draft status will not be highly pertinent in the suit in assessing the probative 2 value of the State of the Science Monograph. The Court will afford the Monograph the weight 3 that it deserves based on the merits; its status as an unpublished draft will have little bearing on 4 that question. 5 Additionally, for the testimony at issue to be relevant, Plaintiffs would need to show that 6 absent political influence the monograph would have been published, i.e., that neutral non-political 7 factors were not a separate and legitimate basis to stall its publishing and ask for additional 8 comment. This question itself could warrant an entire trial considering e.g., typical procedures by 9 the agency, motives, and intent of particular actors, and would require assessing the hypothetical 10 but-for world in which the alleged political influence did not exist. This would present the classic 11 trial-within-a-trial on a collateral issue against which Fed. R. Evid. 403 is design to safeguard. 12 Hence, testimony regarding political influence upon the draft status of the State of the Science 13 Monograph will be excluded. See Fed. R. Evid. 403.10 See also Denker v. Ricchio, 2022 WL 14 17885690, at *6 (C.D. Cal. Nov. 22, 2022) (excluding evidence that could “easily devolve into a 15 time-wasting trial within a trial”); Ohio House LLC v. City of Costa Mesa, 2022 WL 2189541, at 16 *6 (C.D. Cal. Mar. 28, 2022) (finding admission of evidence leading to a “trial within a trial,” was 17 not warranted as it would impose an “undue consumption of time”); United States v. Sathre, 2022 18 WL 889285, at *3 (D. Alaska Mar. 25, 2022) (excluding evidence that may result in a sub-trial 19 where evidence presented minimal probative value).11 20 On the other hand, Plaintiffs set forth two topics that are both relevant and pose little risk 21 ensure balance and accuracy to one that could be construed as attempting to influence the 22 outcomes.”). But the comments discussed have been made public and can be properly assessed based on their substance at trial. 23
10 Plaintiffs correctly note that Federal Rule of Evidence 403 is of lesser import in the context of a 24 bench trial rather than a jury trial, particularly as it relates to potential for prejudice, but it is not to be ignored entirely. See, e.g., E.E.O.C. v. Farmer Bros. Co., 31 F.3d 891, 898 (9th Cir. 1994) 25 (recognizing reduced risk of prejudice in bench trial compared to jury trials); United States v. Ziska, 267 F. App'x 717, 719 (9th Cir. 2008) (explaining that risk of unfair prejudice is 26 “lessen[ed]” in a bench trial). Here the issue is not so much prejudice as it is a waste of time.
27 11 Because the Court finds exclusion of this testimony is proper, the Court need not address 1 of prejudice or delay upon the case and should be admitted – though with a caveat. Specifically, 2 Plaintiffs wish to have Dr. Berridge testify as a fact witness as to: (1) “ NTP’s purposes and 3 procedures, including the hazard focused nature of NTP evaluations, as opposed to risk-focused;” 4 and (2) “the extensive review process that the NTP’s fluoride monograph and meta-analysis on 5 fluoride neurotoxicity have undergone.” Docket No. 378-1 at 2. Defendants rebut that this 6 testimony will be duplicative as other witnesses are already slotted to testify about the peer review 7 and scientific methodologies of NTP. Def’s MIL at 3-4. And further, because these subjects 8 should be opined upon by an expert witnesses as opposed to fact witness, Dr. Berridge. Id. at 3-4. 9 As a threshold matter, the parties seem to agree that this evidence regarding the scientific 10 methodologies employed by the NTP is relevant, as this evidence impacts the probative value of 11 the substance of the State of the Science Monograph. See Def’s MIL at 3-4 (arguing evidence is 12 already going to be addressed by other witnesses for which the Defendants do not object to 13 testifying on relevancy grounds). The key question is whether the subjects that Dr. Berridge seek 14 to testify about are impermissible lay testimony, i.e., properly the subject of expert testimony 15 only.12 16 Federal Rules 701 and 702 govern the line between lay person testimony and testimony by 17 an expert. Under Rule 701, if a witness is not testifying as an expert, the testimony in the form of 18 an opinion must be limited to one: “(a) rationally based on the witness’s perception;” (b) “helpful 19 to clearly understanding the witness’s testimony or to determining a fact in issue;” and (c) “not 20 based on scientific, technical, or other specialized knowledge within the scope of Rule 702.” The 21 conceptual line between expert and lay testimony rests upon whether the witness is opining as to 22 facts for which they have firsthand knowledge, e.g., observations (lay), or where the witness is 23 using their background or expertise to assess information not observed firsthand, and to provide an 24
25 12 The potential for duplicative testimony is of little concern. Methodologies of the State of the Science Monograph are quite relevant, and Dr. Berridge has unique insight to offer as to 26 methodologies employed by NTP given his position as former Science Director of the NTP during its drafting. See FRE 403. Additionally, Plaintiffs proceed at their own peril in using limited time 27 afforded to them in putting on their case in determining whether and how much time to allot to 1 opinion on that information based more generally on that expertise (expert). Compare United 2 States v. Meling, 47 F.3d 1546, 1156-57 (9th Cir. 1995) cert. denied, 516 U.S. 843 (1995) with 3 United States v. Jackson, 2022 WL 331687, at *1 (9th Cir. Feb. 3, 2022). 4 To illustrate, in United States v. Meling, the Ninth Circuit found that the district court did 5 not abuse its discretion in admitting lay testimony of a 911 operator and paramedic regarding 6 whether the defendant was faking grief at the time of making the call, in a trial against a husband 7 accused of poisoning his wife. 47 F.3d at 1156-57. The court explained that lay opinion 8 testimony is admissible what it is “rationally based on the perception of the witness.” Id. Though, 9 the experience of the witness may properly impact the observation. The court reasoned that, as 10 paramedics are “trained to respond quickly in emergency situations,” and the responder had ample 11 time to form an impression regarding the defendant’s emotional state, the testimony was rationally 12 formed and was admissible. Id. This can be compared with the evidence at issue in United States 13 v. Jackson, 2022 WL 331687, at *1. There, the Ninth Circuit explained that where a treating 14 physician was asked to testify regarding the rate at which alcohol dissipates from the body; this 15 was properly categorized as expert testimony. See id. 16 Accordingly, insofar as Dr. Berridge plans to testify regarding events he has observed 17 firsthand including the processes of the NTP in producing the State of the Science Monograph, 18 i.e., the facts underlying the organization’s methodology, this is properly admissible lay person 19 testimony. 13 See Fed. R. Evid. 701, 702, 602. On the other hand, to the extent that Dr. Berridge 20 intends to offer a general opinion as to the import of those methodologies upon the weight of the 21 monograph or its scientific value, based on his expertise as a scientist and/or epidemiologist, such 22 testimony would cross the line into impermissible expert testimony, and the Court will be inclined 23 to sustain a properly raised objection on this basis at trial. For these reasons, the Court GRANTS 24 in part and DENIES in part Defendants’ First Motion in Limine as described herein. 25 26 13 The Court notes that Defendants elicited this same type of testimony, i.e., regarding 27 methodologies of NTP, from Dr. Kristina Thayer, a fact witness and former NTP scientist working 1 VII. EXHIBITS 2 A. Scope of Exhibit List 3 The exhibit list incorporates exhibits previously admitted in the first phase of trial in this 4 case. As the Court previously explained, those exhibits are subsumed into this phase of trial. 5 Parties need not reintroduce these exhibits and can refer to previous exhibit numbers. 6 B. Bellwether Exhibit Objections 7 Parties jointly filed Bellwether Objections to certain of the opposing parties’ proposed 8 exhibits. Docket No. 382. Plaintiffs have withdrawn objections to EPA Exhibits 653 and 654 and 9 have no objections to EPA’s exhibits in the second phase of trial. See id. at 1. Defendants seek 10 ruling on two exhibits serving as bellwethers in the action. See id. at 1-4. 11 1. Exhibit 76: Alleged Political Influence on NTP Draft Monograph 12 Defendants first seek a ruling as to the admissibility of Pl’s Trial Exhibit 76, which serves 13 as a bellwether as to how the Court may rule on EPA’s objections to Pl’s Trial Exhibits 72-80. Id. 14 at 1. Pl’s Trial Exhibit 76 is a May 2022 email exchange between Dr. Berridge, Tara Schwetz, 15 Acting Principal Deputy Director of National Institutes of Health (“NIH”) Rick Woychik, another 16 NIH employee, and other NIH/NTP employees. Plaintiffs primarily seek to introduce the May 17 12, 2022, email authored by Dr. Berridge in this chain and do not oppose eliminating the other 18 email included therein. Docket No. 382 at 4-5. That email involved Dr. Berridge questioning the 19 decision to subject the State of the Science Monograph to additional peer review instead of 20 allowing the document to be published. Exhibit 76 at 2. In a similar vein as discussed above, the 21 purported relevance of this Exhibit is to exemplify the political influence upon the decision to 22 delay publication of the State of the Science Monograph. See Docket No. 378-2 (Exhibit List) at 4 23 (“Goes to the weight the Court should give NTO’s May 2022 Monograph”). Setting aside the 24 issue of hearsay, which is also of concern here, this evidence and evidence that relates to the 25 political influence imposed upon delaying the publication of the State of the Science Monograph 26 is properly excluded for the reasons discussed previously in relation to Defendant’s first motion in 27 limine under, at a minimum FRE 403. Accordingly, Defendant’s objection is sustained as to Pl’s 1 2. Exhibit 89: Incomplete Deposition Exhibits 2 Pl’s Trial Exhibit 89 is a true/false questionnaire that was filled out by EPA’s 30(b)(6) 3 representative Dr. Stanley Barone, assessing EPA’s risk evaluations. This document serves as a 4 bellwether to Pl’s Exhibits 89-93. Defendant argues that these exhibits should be excluded as 5 incomplete deposition exhibits on the grounds that Dr. Barone attempted to clarify the binary 6 responses provided during his deposition but was rebuffed on direct examinations during the 7 deposition. See, e.g., Barone Tr. 121:2–8 (“Q. Okay. So, let’s go back to Exhibit 6 [Trial Exhibit 8 89] the true/false questions. A. May I add to that? Q. I think you’ve answered the question, sir. 9 Counsel can ask you questions later if they want to. A. Okay.”). However, ultimately, Dr. Barone 10 filled in a few written notations and admitted that the statements including those that were 11 modified, reflected in Exhibits 90, 91, and 92, were factually correct at his deposition. See EPA 12 30(b)(6) Dep Tr. at 162:8-12; EPA 30(b)(6) Dep Tr. at 171:16-172:11; EPA 30(b)(6) Dep Tr. at 13 162:8-12. As such, these questionnaires have been adopted by Dr. Barone and are thus 14 admissible. To the extent that Dr. Barone wishes to clarify his responses or add nuances to his 15 binary answers, Defendants’ counsel is free to elicit this information during cross-examination of 16 Dr. Barone. Additionally, several of these statements are to be properly admitted as non-hearsay 17 under FRE 801(d)(2)(A) as a statement made by an opposing party. As stated above, the 18 document is a series of statements made by Dr. Stanley Barone, who was designated as the EPA’s 19 30(b)(6) representative regarding how EPA conducts risk evaluations under the Amended TSCA. 20 The document pertains to precisely that issue. The Court expects that Plaintiffs, in laying the 21 foundation for admission of this document, will clarify the purposes for which it will be used in 22 Plaintiffs’ case. The Court will impose a limiting instruction to ensure that portions of the exhibit 23 not adopted by Dr. Barone or not relevant to Plaintiffs’ case are not improperly admitted, and so 24 that Defendants need not spend unnecessary time examining him on such matters. With this 25 caveat, the Court is inclined to deny Defendants’ objection as to Pl’s Ex. No. 89 and to rule 26 similarly upon Exhibit Nos. 90-93. 27 // 1 Vill. MISCELLANY 2 || A. Legal Dispute: Impeachment Evidence Dr. Ibarluzea 3 The parties have an additional dispute as to how to handle impeachment materials for 4 || EPA’s expert, Dr. Jestis Ibarluzea. When Plaintiffs took the deposition of Dr. Ibarluzea, parties 5 agree that there was an understanding by the parties that Dr. Ibarluzea would be testifying at trial 6 || via Zoom. Docket No. 378 (Joint Pretrial Statement) at 9. Because of this understanding 7 || Plaintiffs forewent a trial preservation examination and thus did not show or question Dr. 8 Ibarluzea regarding impeachment materials probative to credibility. /d. Thereafter parties learned 9 Dr. Ibarluzea will be unable to testify live at trial. Jd. Given this development, the parties have a 10 || dispute about if and how Plaintiffs can introduce materials that impeach Dr. Ibarluzea’s 11 credibility. Jd 12 At the pretrial conference Plaintiffs’ counsel limited their request to introduction of a 5 13 single document for impeachment purposes. The Court is inclined to admit this document but will 14 || provide Dr. Ibarluzea an opportunity to respond to the document in a sworn, written statement or 3 15 via a short (i.e., fifteen minute) deposition. See Fed. R. Evid. 613(b). At the Defendants’ request, 16 || parties are permitted to submit a one-page joint letter brief discussing whether the email should be 3 17 excluded for failure to timely produce the document, notwithstanding obligation to disclose the 18 document during discovery. The Court thus reserves ruling on admissibility of the subject 19 document. 20 21 22 IT IS SO ORDERED. 23 24 || Dated: January 18, 2024 25 LL 26 — flo ED D M. CHEN 27 United States District Judge 28