Thread by @DBrozeLiveFree

4th day of the 2nd phase of the #FluorideLawsuit resumes with FAN Michael Connett questioning witnes Dr. Ralph Barone.

Connett: let's turn to the risk determination portion of the evaluation. EPA does not need to consider every single risk factor to make a risk determination, correct?

Barone agrees with caveats.

Connett: EPA generally consider cognitive deficits to be a critical health effect in a number of hazard assessments? Barone agrees.

For ex, EPA accepted cognitive deficits when considering the regulatory decisions for lead, and other chemicals, correct?

Barone agrees.

Connett: under the lead analysis the EPA tried to set an exposure level where the most vulnerable populations will not suffer a 1-2 point loss of IQ, correct?

Barone agrees.

Connett: the other factor the EPA will consider is the number of chemicals an individual is exposed to, right? Barone agrees.

Connett: one of the reasons that is relevant is bc it helps to understand that potential risk, correct? Barone agrees.

Connett: in general, the larger & more diverse a population is that is exposed to a chemical under the condition of use the greater level of variability within the population, correct?

Barone agrees.

Connett asks Barone to confirm that the EPA has previously made "unreasonable risk determinations for conditions of use" that involves less than 500 people. He does.

Connett asks Barone what EPA's mandate is under TSCA.

Connett: TSCA commands that the EPA considers vulnerable populations when making the risk assessment, correct? Barone agrees.

Connett: let's turn to another factor that EPA considers under risk evaluation, which is uncertainties.

Connett: you would agree that in risk assessments there is always uncertainty? Barone agrees. Connett restates to say "all risk assessments" have some level of uncertainty. Barone agrees.

Connett: you have testified that risk assessment is "laden" with uncertainty, right? Barone agrees.

Connett: you would agree that certainty is not required under TSCA?

Barone: 100% certainty is not required under TSCA.

Connett is asking Barone for clarification about the process for determining a risk determination under TSCA. Connett quotes Barone, Barone disagrees with Connett's assessment of his deposition statements.

Connett asks to pull up statements from Barone's deposition.

EPA objects to say that Barone was testifying as an expert in the deposition and is not currently testifying as an expert. Connett says the questions relate to Barone's specifc statements for impeachment, Judge Chen allows it.

Connett is going through a previous TSCA hazard finding related to HBCD. EPA didnt have any epidemiological related to a HBCD and thyroid issues, correct?

Barone confirms. Connett is making it clear the EPA has acted in the past on hazard risks even without 100% conclusive data

Connett moves to discuss EPA's evaluation of 1,4-Dioxane. Connett says EPA didnt have any direct evidence that 1,4-Dioxane was causing liver issues at any exposure level. Barone agrees.

Connett switches to perchloroethylene, pce. Says PCE is the only risk evluations done by the EPA which selected neurotoxicity as the chronic outcome.

Connett: PCE is also the only chemical in EPA's first 10 risk evaluations where EPA derived the chronic effect from human data, correct?

Barone provides some context and caveats.

Judge Chen interrupts to say he is now lost and asks Barone and Connett are discussing. Connett starts fresh to lay foundation.

Judge Chen still asking questions to Barone.

Connett: for the PCE risk evaluation the EPA used a benchmark dose of 100, correct? Barone affirms. Then used an uncertainty factor of 10? Barone affirms again.

Connett: EPA considered various types of exposure to PCE, correct? Barone affirms.

Connett: one of the categories of types of exposure was for people who are not directly using the PCE but in the vicinity? Barone agrees.

Connett is outlining the process the EPA used to determine that PCE was a risk. Barone is in agreement so far with Connett's assessment.

Connett: I want to be clear on this, do you want me to show you the EPA's words?

Barone: I know what the EPA says, but elaborates (and attempts to downplay) on the results of the EPA's risk evaluation.

Connett: so you would agree for PCE there was only one situation that showed a risk, correct?

BArone deflects and says if we look at other factors we will find other vulnerable sub populations.

Connett is showing trial exhibit 96, page 475, a Summary of risk estimates for inhalation & dermal exposures to workers by conditions of use.

Connett: for this risk evaluation for PCE, the EPA would only find a risk for something that included a risk while using PPE, correct?

Barone agrees but adds caveats. Connett redirects him to focus on the specific evaluation at hand.

Barone outlines risks found relating to PCE.

Connett: all the risks you just described are for people not using PPE, correct? Barone agrees.

Connett: Im gonna show you what EPA says. This is where EPA describes the risks posed for PCE relating to use of PPE.

Barone answers affirmative but adds (again) that the EPA revisited this toxin in the future. Connett tells Judge Chen he wants it noted that witness was non-responsive.

Connett: People don't use PPE when they drink tap water, do they?

Barone: no.

Connett: to wrap this up, this high end worker population was exposed to PCE at 51% less than the level that the EPA determined was a risk.

Connett: let's look at another page relating to PCE. You see here that the EPA discusses the "processing/recycling" use of PCE, correct? Barone agrees.

Connett: based on this data here, the EPA confirmed that these workers were being exposed to an unreasonable risk, correct? Barone agrees.

Connett: am I missing something? Is there a doc where the EPA says we prefer the high exposure data vs the low exposure data?

Barone says there is a difference between risk and hazard, offers some clarity.

Connett picks up the entire 700 page risk assessment for PCE and shows it to Barone. "is there anywhere in this doc, in the hazard assessment, where EPA make a distinction between high dose or low dose data?"

Barone says thats not how the info is broken up.

Connett: I think what you said is we might have more confidence for neurotoxicity than for liver issues, correct? Barone agrees.

Connett clarifies, asks if the EPA states anywhere about having high confidence in the neurotoxicity data (for ex) but not other data?

Barone deflects and explains how the EPA categorizes their data and assesses the confidence in each type of data.

Connett: now let's go to the risk characterization. can you point to us anywhere in this doc where EPA says "we only have X amount of confidence" in this data?

Barone repeats himself. Connett tries again to explain his point and question.

"in all this discussion of the 751 page doc, is there any example where the EPA says they have x% of confidence in this data, but not this data".

Barone says there is some discussion.

Judge Chen has more questions about this (somewhat confusing) back and forth.

Judge Chen is trying to suss out the process in determining risk, the finer points of "confidence interval" for "point of exposure".

Connett continues...

Connett: Dr. Barone could you remind us of the factors of a Bradford-Hill analysis?

Barone describes the analysis.

Connett: you agree that you dont need to establish every one of those Bradford-Hill factors before you determine a risk?

Barone: yes

Barone is explaining that chemicals have different mechanism for acting based on different doses.

Connett: Do you agree that even for the established chemicals that cause harm, such as lead or mercury, you still do not know the mechanism which causes harm?

Barone: agrees, offers some explanation.

Connett wants to discuss the peer review process of NASEM. EPA worries this is going to get into areas that the court has set off limits (the politics of why the NTP report was delayed). Connett says he wont go there, Judge Chen allows him to proceed.

Connett: EPA asked NASEM to look at the systematic review procedures to see if they are objective and transparent, correct?

Barone agrees but adds a qualifier (he likes doing that).

Connett tells Judge Chen, just for the record the NASEM review looked at the following factors, Barone respond... "Again...." and follows with attempts to downplay the NASEM evaluation.

Connett: one of the EPA evaluations that EPA gave to NASEM for review was the Trichloroethylene (TCE) review, correct? Barone agrees adds qualifiers.

Connett says lets put up the NASEM doc relating to "use of systematic review in EPA's TSCA".

Judge Chen calls for a short break