Thread by @DBrozeLiveFree

Day 4 of the 2nd Phase of the #FluorideLawsuit has begun.

@FluorideAction Attorney Michael Connett has just finished reading off some exhibits to be submitted to the court.

Connett and EPA agree to switch to a new witness who is only here for today.

Connett calls Brian Berridge, D.V.M., Ph.D., D.A.C.V.P., joined the NIH in January of 2018 as the Associate Director of the National Toxicology Program (NTP).

Connett is asking Berridge to describe the various agencies he has been involved with, the role of the NTP, etc.

Berridge discussing the role of the National Institute of Occupational Safety & Health (NIOSH) and the FDA's National Center for Toxicological Research (NCTR) play in regards to the NTP and the search for toxic hazards.

Connett: what do you understand to the difference between a hazard assessment and a hazard risk?

Berridge: So the hazard is really about understanding if something adverse will happen and at what point, so you can conduct the hazard assessment.

Connett: if we look at the NTP monograph will see discussion of uncertainty factors?

Berridge: No we don't.

Connett: what type of reports does the NTP conduct?

Berridge: describes various types of reports, literature based assessments which are published as monographs, we also published in the peer reviewed journals.

Connett: What are some of the regulatory or govt bodies that rely upon NTP scientific research?

Berridge: in the U.S. FDA, OSHA, names other nations that also rely on the NTP.

Connett: does the WHO rely on the research.

Berridge: yes, including the IARC.

Connett: you said the high dose data can give you a clear indication of the hazard, can you explain that?

Berridge: The higher the exposure the more likely there is to be an adverse effect and the more serious magnitude. So high dose exposure gives you a clear indication.

EPA objects say the witness was not brought in as an expert testimony. Judge Chen asks Connett to elicit whether the witnesses is testifying as an expert or not.

Connett asks Berridge if his answer is informed by his work, he agrees. Chen over rules objection.

Connett: based on your work at NTP and communications with scientists at NTP, have you formed an understanding as to whether the NTP considers higher exposure contrasts to be a strength or weakness?

Berridge: strength.

Connett: based on your work at NTP and communications with scientists at NTP, have you formed an understanding as to whether the NTP considers lower exposure contrasts to be limited?

Berridge: generally, yes.

Connett: let's turn now to the review processes that the NTP uses for its scientific publications. Does the NTP use a peer review process for its studies? Berridge affirms.

Connett: let's focus on the NTP monographs. Can you explain the peer review process?

Berridge explains.

Connett: Is this peer review process always conducted by NASEM (National Academies of Sciences, Engineering, and Medicine)?

Berridge: no, thats unsual.

Connett: do peer reviewers have to agree with every conclusion of a monograph for it to be published?

Berridge: No.

Connett: Prior to the fluoride monograph, had you ever made the decision to publish a monograph during your tenure?

Berridge: yes.

Connett: have you published other types of studies?

Berridge: yes

Connett: prior to the fluoride monograph, when you said a report was complete was it ever not published?

Berridge: no.

Connett: prior to the fluoride monograph, has a report you said was ready for publication has it ever undergone additional review?

Berridge: No.

Connett: when did NTP complete the first draft of the fluoride monograph?

Berridge: 2019.

Connett: did you say it was a rare occurrence to have NASEM serve as the peer reviewer?

Berridge: yes.

Connett: why did NTP have NASEM involved in peer reviewing?

Berridge says they knew it was a sensitive topic and wanted to have the weight of NASEM behind their eventual conclusions.

Connett: when did NTP complete the second draft of the monograph?

Berridge: fall of 2020.

Connett: who completed the 2nd peer review process?

Berridge: NASEM.

Connett: when was that completed?

Berridge: the following February.

Connett asks Berridge how the NASEM review process went.

Berridge says it was rigorous but they never denied the evidence presented.

Connett: at anytime during NASEM's peer reviewed process did it come out and say it doesnt think fluoride causes harm to neurodevelopment?

No.

Berridge explains that after the reviews the NTP realized there was a problem about how to communicate the conclusions so they chose not to do a formal hazard conclusion and instead release a meta analysis and let decision makers come to their own conclusions.

Connett: so after making changes to the 2nd draft to incorporate NASEM's suggestion, what did you do?

Berridge: followed NASEM, published the meta analysis for peer review.

Connett: that external peer review process, when did that start?

Berridge: late 2021.

Connett: when did the external independent peer reviewers complete their review of NTP's monograph?

Berridge: early in 2022.

Connett: did they agree with the NTP's conclusions.

Berridge: they did.

Connett: is it correct to say that the NTP monograph received a complete peer review?

Berridge: yes

Connett: when did NTP finish incorporating changes suggested by peer reviewers?

Berridge: would have been April 2022.

Connett: as the NTP director did you approve of the release of the NTP monograph being published?

EPA objects & says witnesses testimony is not supposed to be about publishing. Judge Chen agrees.

Connett: I want to establish one thing & its not about politics. I want to see if in his own capacity as the scientific director if he believed it was ready for publication.

EPA objects again bc they dont want discussion about the political intervention in the release of the NTP report.

Judge allows Connett to continue his questions but cannot get into the politics of why the NTP monograph was never published in its final form.

Connett asks Berridge if his team also believed the draft monograph was ready for release. He agrees.

Connett asks him to explain his feelings about the completeness of the draft monograph.

Connett ends his questioning. Judge Chen has a few questions.

Judge Chen asks Berridge about the difference between the "state of the science" report vs the NTP's usual hazard classification report.

Berridge outlines the differences in the language of the reports.

Berridge explains that there was never any question about the evidence and the validity of the evidence. It's just a difference in how they published the reports.

(side note: this gets into the political interference that the judge doesnt want to hear about. The report was released in a different fashion bc of the political interference. The goal was to keep from making final conclusions to leave some ambiguity.)

EPA commences cross examination of Dr. Berridge.

EPA asks him about his role at the NTP, and the role of the NTP itself.

EPA: the NTP's studies are carried out through a partnership with agencies of the U.S. HHS?

Connett: objects, vague and overbroad. Judge Chen allows it.

Berridge explains the way the "partnership" with various other federal agencies operate.

EPA lists some of the agencies who are partnered with the NTP.

EPA: the authors of the NTP fluoride monograph are all from the National Institute of Environmental Health Sciences (NIEHS)?

Berridge: that is true.

EPA is outlining that the NIEHS conducted the 1st systematic review of fluoride which found that fluoride was an assumed neurotoxin. Berridge agrees.

EPA notes that it was the scientists at NIEHS who got NASEM to do the peer review, the first of its kind.

EPA asks Berridge to confirm that NASEM has never been done a peer review. He does.

EPA asks Berridge if the NASEM was "critical" of the first systematic review. Berridge takes issue with the term "critical". He says NASEM didnt think the evidence was presented clearly.

Berridge says this doesnt mean that NASEM that didnt agree with the conclusions of harm.

EPA asks Berridge to confirm the NASEM's review of the 2019 NTP monograph. Berridge doesnt remember. EPA brings up exhibit 653 to refresh his memory.

EPA gives him time to review, will ask the question after...

EPA asks again that the NASEM didn't agree with the conclusions, Berridge agrees but says again this doesnt mean they didnt agree with the conclusions of harm.

EPA moves to NASEM's 2nd peer review. EPA says the NASEM revised monograph continues to "fall short" of its conclusions.

Berridge continues to reiterate that it didnt meet the requirements for a hazard classification, but they didnt disagree with the data.

EPA continues to go over the timeline, showing that the NTP narrowed their focus to the strongest data and they removed the hazard classification from their report.

EPA discusses the two reports being issued by the NTP, the State of the Science/meta analysis and the monograph.

EPA: the reviewers at the HHS that reviewed the docs were from the CDC and the FDA? Berridge agrees.

EPA: there were nearly 500 comments from the agencies. The agencies were concerned by how the NTP authors handled the comments. EPA asks Berridge to confirm.

He agrees.

Berridge also states that these concerns were in the early drafts of the NTP monograph.

EPA: you are aware that the Director of the NTP enlisted the Board of Scientific Counselors to help review these reports?

Berridge confirms.

EPA asks if that process began to adjudicate the comments from the CDC and FDA?

Berridge says he doesn't have knowledge of that.

EPA asks Berridge if he "has no expertise on fluoride's harm", he says that's a "fair statement".

EPA: your role in this document was to help the authors prepare the report?

Berridge: I did support the scientists.

EPA: you believe the SoS and NTP monograph meet the usual expectation for review?

Berridge: they exceed expectations.

EPA is reviewing statements made previously by Berridge to impeach his character. EPA ends questioning.

FAN Connett picks it back up for redirect.

Connett asks Berridge if he believes the CDC's Division of Oral Health to be a fair agency to judge the report, EPA objects for opinion testimony, judge sustains.

Connett is attempting to go back to Berridge's statements regarding NASEM's "critical" review of the NTP report.

EPA is objecting bc they believe its get into the political interference. Connett explains to Judge Chen that he wants to get into Berridge's statement about "critical comments".

Chen: I am more interested what was criticized than how they said it. I am going to exclude this.

Connett says he will move on.

Connett asks Berridge if there is a difference in the reviews conducted by NASEM.

Connett: is it fair to say that NASEM's criticism was more about the communication than the underlying data?

Berridge: I think that's fair to say.

Connett attempts to ask a question, EPA objects for opinion testimony, Judge sustains. Connett has no further questions. Neither does the EPA. Witness is excused.

Judge Chen instructs FAN Connett to pick back up their questioning of witness Dr. Stanley Barone of the EPA.

Connett reiterates what has been stated, asks Barone about his process for Hazard Identification.

Barone: what we do under Hazard ID is identify the quality of the studies.

Judge Chen and Connett have questions about what Barone called "hazard integration".

Connett and Barone are dissecting the various terms and processes for the NTP's Hazard Assessment.

Connett and Barone move to discuss step 2. Exposure Assessment, a process which examines the exposure level of a specific chemical.

Connett asks Barone if its true the TSCA allows researchers to consider aggregate exposure to a chemical. Barone agrees, but says not necessary.

Connett shows Barone a statement from the EPA's risk evaluation of Perchloroethylene, which Barone conducted himself.

Connett shows statement which says "EPA typically uses the 95th percentile value of the reasonably available dataset"

Barone agrees but says there's more to it

Connett shows Barone another statement which says "under the amended TSCA, EPA has made unreasonable risk determinations where it did not have high confidence". Barone agrees but adds some caveats.

Connett: most of the exposure levels where the EPA found a risk it was less than the hazard level, correct?

Barone agrees.

Connett shows Barone a true/false document he filled out where he checked "true" to the statement "EPA did not require evidence that the chemical causes the hazard under the condition of use before making an Unreasonable Risk Determination".

Barone agrees with his previous statement but again adds caveats.

Connett shows Barone another True/False statement, "EPA did not require that there be human studies associating the hazard with the condition of use before making an unreasonable risk determination", to which he said "True".

Barone is explaining again the caveats he believes are important to know about the hazard assessment process.

Judge Chen asks Barone to clarify the above statement regarding "the condition of use".

Barone explains that in some cases the EPA doesnt have human data or dont have clear findings, so they work from the animal data whether an association is strong enough to do a risk assessment.

Connett: in order to determine if the margin between hazard level and exposure level, whether there is going to be a risk, we compare that to a Benchmark MOE?

Barone: says yes and elaborates.

Connett: 1 uncertainty factor the EPA uses that informs the Benchmark MOE is the intraspecies variability, correct? Barone offers clarification.

Connett: the EPA uses an uncertainty factor for intraspecies variability to account for variations and uncertainty, correct? Yes

Connett is explaining toxicokinetics and toxicodynamics and how it relates to the EPA's uncertainty factor process in determining hazard of a chemical.

Connett: so the EPA's default is an uncertainty factor of 10 for intraspecies variability, correct?

Barone agrees.

Connett asks Barone about the cases where the EPA did not use an uncertainty factor of 10.

Connett moves to discuss another method the EPA interprets data for hazard assessment.

Connett: the benchmark MOE is the product of all uncertainty factors that are thought to be applicable for a given hazard, correct? Barone agrees.

Connett asks Barone about the math used for determining the hazard assessment.

Connett gives a few examples and asks Barone if his math is correct. Barone agrees.

Connett shows Barone a document from his deposition which states, "A risk is indicated if the MOE for highly exposed persons (those at the 95th percentile) is less than than the Benchmark MOE even if average exposures are acceptable". Barone confirms the statement.

Connett is establishing that the EPA has made previous hazard/risk assessment conclusions in the past when there are risks at higher levels but not in average exposure bc you have to worry about the most at risk people.

Connett goes to switch topics, Judge Chen calls for first break. Court goes into recess.