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Case number 20 as 1335 natural resources defense council petitioner versus Michael S Reagan administrator, U.S.

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Environmental Protection Agency and Environmental Protection Agency.

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Ms.

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Ford for the petitioner, Ms.

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Buckley for the respondent, Ms.

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Snow for the intervener.

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Thank you.

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We're ready to hear our first case this morning.

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Ms.

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Ford.

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Good morning, Your Honor.

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May it please the court, Sarah Hort, presenting on behalf of Petitioner and RDC.

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I'd like to reserve three minutes for a bottle.

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Your Honor, drinking perchlorate can cause permanent and irreversible harm to the developing brains of fetuses, infants, and children.

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Nevertheless, EPA has decided not to set limits on the amount of perchlorate in drinking water and not to require public drinking water systems to test for it

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or inform people if it's found in their water.

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We challenge that decision on a number of grounds.

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I'm of course happy to answer any questions the court has today, but I'd like to focus my arguments on the reasons that it's arbitrary and capricious because it's not supported by the record and is inconsistent with the Safe Drinking Water Act.

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Now let me just ask you a preliminary question to that.

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If we determine that the agency does not have the power to

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uh, delete the rule in the first place.

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Do we need to answer the other questions?

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Your honor, I don't believe the court needs to answer the other questions.

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Thank you.

[00:01:34] Speaker 01:
Why don't you start?

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Why don't you just say a few minutes, a few words about your statutory about the statutory argument?

[00:01:41] Speaker 02:
Sure.

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Your honor.

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Um, EPA is a creature of statute.

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It has only the powers in this case that the Safe Drinking Water Act granted either explicitly or implicitly

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And it's clear here from the text, structure, and purpose of the statute that EPA didn't have the authority to reverse a regulatory determination that it made nine years prior.

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To begin, you see that in the text.

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The statute says not once, but twice, that once EPA makes a regulatory determination, the agency shall regulate.

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The second time the statute sets out a clear deadline,

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by which EPA has to do that.

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It has 24 months to propose a standard and then another 18 months to finalize the standard.

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Does it say that the EPA can't withdraw a determination or can't change a determination?

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Well, Your Honor, it certainly

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gives clear textual commands that the agency can't do so nine years after the.

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Where's the textual support for that?

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Because a standard is due within, in this case was due by 2014 at the latest.

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And once a standard is in place, there's an anti-backsliding provision that protects against.

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But that's once there's a regulation, they actually didn't promulgate a regulation.

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You're right, Your Honor, because the agency has failed to comply with the Safe Drinking Water Act, they've missed that deadline.

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Correct, but anti-backsliding doesn't apply unless there's already a regulation.

[00:03:17] Speaker 02:
No, Your Honor, but a statute can... Do you agree with that?

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that the anti-backsliding provision, I agree that there is no regulation in place right now.

[00:03:31] Speaker 01:
No, wait, wait.

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Do you agree, because the government, the EPA says this too in the brief, that the anti-backsliding requirement isn't triggered until there's a final regulation?

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Your Honor, I think the statute says that the anti-backsliding provision applies once there is a regulation.

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However, it's clear from the text of the statute

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the Congress expected there would be a binding regulation in place within three and a half years.

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That's a different argument that the anti-backsliding provision says any revision of a national primary drinking water regulations shall be promulgated in accordance with the section, except that each revision shall maintain or provide for greater protection of the health of persons.

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It specifically deals with regulations.

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So anti-backsliding does not apply to a determination to regulate, correct?

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Yes, I agree with that.

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However, there are a number of other provisions in the statute that indicate that Congress meant for the agency to take two steps in deciding whether to regulate.

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There is a ton of process that precedes a determination to regulate.

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And that is the stage at which EPA is tasked with deciding whether to regulate.

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And the agency has a ton of discretion in that.

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It gets to the pick.

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by consulting with the scientific community and SAB, which contaminants it's going to focus on.

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So I understand that, but it seems that the same amount of thought and process went into the decision to withdraw the determination.

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It seems that, yes, there is a framework put in place for a two-step process, which involves a lot of

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thought and care and research.

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But it seems to me that this statute doesn't say that you can't withdraw a determination or change your determination.

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And in this particular case, it seems that the decision to withdraw or change the determination also was accompanied by thought and care and regulation, although perhaps not as much thought and care as they should have put into it, which I'd like to hear more about.

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But in terms of just

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the agency's ability to withdraw a determination.

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I don't see where in the statute, in the text, it says they can't do that.

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Whether they did a good job of that is something I definitely want to hear about.

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But just can they do it?

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It seems that they can.

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Your Honor, we believe that Congress, in setting out the structure, was trying to demarcate two specific steps to the regulatory process.

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And there's a reason for that.

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Congress was trying to do multiple things

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in the 1996 amendments.

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It is true, as EPA and AWA say, that Congress was trying to protect against any truly inefficient regulations.

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But Congress was also trying to force an agency that had been recalcitrant in issuing regulations to regulate.

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It was saying, go through a bunch of process, make a determination.

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But once you've made that determination, we're going to hold you to it.

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You need to issue regulations.

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Didn't they change their determination in this case?

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Because they previously determined not to regulate.

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That was a preliminary determination, Your Honor.

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They made a preliminary determination as the statute calls for.

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They took public comment as the statute calls for.

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And then they made a final determination as the statute calls for.

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The statute is clear of what the agency is supposed to do after that.

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And it's not to flip flop back and forth on that regulatory determination.

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In fact, the statute says,

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consult with the Science Advisory Board, but under no circumstances is that to delay your promulgation of a regulation.

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Congress knew that the agency would continue to consider the science, and nonetheless wanted to hold the agency to the clear, unequivocal command, you shall issue a regulation.

[00:07:27] Speaker 01:
What's your answer to EPA's argument that if you're right about this,

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They lose the agency loses all flexibility to that to newly discovered evidence or or better best evidence.

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And that they're locked in by the anti backslide.

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That's simply true.

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The statute provides for a number of programs now.

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I think.

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it's understandable to be concerned about what is the possibility, what if there's truly a scientific breakthrough and we realize this isn't a problem at all.

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That situation is vanishingly, vanishingly unlikely.

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Well, suppose it happens.

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Suppose, for example, after 10 years of regulation for various economic reasons, the contaminant is simply no longer being produced.

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after 10 years of regulation, the anti-backsliding provision would be in place.

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So it's clear that science isn't, Congress knew that there might be- But there's no more, the contaminants no longer being produced.

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In other words- The statute provides a number of programs- The anti-backsliding provision, the EPA said they would not be able to change the standards.

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They would not be able to weaken the public health protection.

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That's true.

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They could,

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change monitoring requirements to reduce the burdens on water systems.

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States can issue variances for systems that can demonstrate that they're unlikely to have the contaminant in their drinking water system.

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There's a number of other operands that the statute provided to deal with that situation.

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But even if the court is not convinced by our statutory argument, the way the agency undertook this decision here is not consistent with the Safe Drinking

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And I'd like to start by explaining the problems with the levels of public prochlorate contamination that EPA selected as its levels of public health concern.

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Now, let me just pause for a minute and explain why the maximum contaminant level goal standard is relevant to this case.

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We're not arguing that the Safe Drinking Water Act requires EPA to set a level of public health concern that meets the maximum contaminant level

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But this court reviews an agency's action on the basis and the rationale that the agency provided in the record.

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And here, if you look at the final decision document, specifically, if you look at 85, February 43, 995, EPA equates the levels of public health concern with the maximum contaminant level goal standard.

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The agency says, we are selecting, as our levels of public health concern,

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three levels that we propose as maximum contaminant level goals.

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And if you want to find our rationale for how we selected those numbers, look at a technical supporting document that we issued at the time of the 2019 regulations.

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And if you look at that technical supporting document, and I'm looking particularly at JA373 and JA415, it is very clear that the agency selected these levels because it believed they would avoid any adverse health

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So either there is no basis in the record that explains how EPA selected these levels or the basis that the court has with which to evaluate these levels is the level that EPA explains, which is the level that's set for maximum contaminant level goals.

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Here, the thresholds that EPA set do not meet that level.

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EPA selected three potential levels of public health concern, all of which

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correspond with measurable decreases in the average level of IQ across the sensitive population.

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IQ loss, whether it's one point or two points or three points, is an adverse health effect.

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That's clear from common sense.

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You can imagine a doctor prescribing a medication to a patient, and they would never tell the patient that this will have no adverse health effects

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knowing that there is a population of patients who would suffer on average one to three IQ points loss.

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And those losses are very significant when you look particularly at the ends of the bell curve of IQ, particularly low IQs and higher IQs, it has significant impacts for those populations.

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Is it your view that the MCLG has to be zero?

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Is that the level of the Chlorate has to equate to a zero?

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percent drop in IQ or can it be like five or?

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It has to equate to no adverse health effect.

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So I presume there is some level of IQ loss that will not be measurable on a population level and I certainly think

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EPA could set the level if there's no measurable IQ loss.

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Do you know what that level is in terms of parts per billion?

[00:12:36] Speaker 02:
I don't, Your Honor, because there's nothing in the record that establishes that record, that level.

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What the record establishes is that it's not 1856 or 90.

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Your Honor, I see that I'm into my rebuttal time.

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So if the court doesn't have any further questions at this point, I'll reserve my remaining.

[00:13:01] Speaker 04:
All right, that's fine.

[00:13:02] Speaker 04:
Thank you.

[00:13:04] Speaker 04:
We'll hear from Ms.

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Buckley.

[00:13:11] Speaker 05:
Good morning, Your Honors.

[00:13:12] Speaker 05:
May it please support Sarah Buckley from the Department of Justice on behalf of EPA.

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With me at council table is Pooja Puri from the Office of General Counsel.

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I want to first address briefly EPA's authority to withdraw the regulatory determination

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and then address why EKS technical analysis was a rational exercise of a technical scientific judgment.

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This word is long recognized that agencies have the power to reverse course change position.

[00:13:39] Speaker 01:
Wait, can, let's, let's, let's just, before you get into that, to me, you know, as I read your brief, the brief argues that the agency has inherent, right?

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That's what, in fact, your brief mentions the word inherent authority, I think, 13 times.

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But this board has made quite clear that agencies don't have any inherent, that authority has to come from a statute, either expressly or implied.

[00:14:13] Speaker 01:
So the question before us is where in the statute does the agency have the authority to withdraw?

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Do you agree with me that that's the question?

[00:14:23] Speaker 05:
Yes, Your Honor.

[00:14:24] Speaker 05:
I would say that this court has characterized the power to reconsider a decision as inherent authority as inherent in the power to decide.

[00:14:34] Speaker 01:
No, I don't think so.

[00:14:36] Speaker 01:
I think agencies have implied authority to change or withdraw a regulation when the statute permits it or when the statute's silent and there's an ambiguity there.

[00:14:50] Speaker 01:
But I don't know of any case that says that, any recent case, which says that agencies have inherent authority to change a regulation.

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They only have the authority that comes from the statute.

[00:15:00] Speaker 01:
And all the cases you cite here, every one of them, every one of them, including Fox television, they are all cases where it's a generic statute.

[00:15:11] Speaker 01:
The agency issues a right, Congress directs the agency to regulate, and there's no precise provisions about when

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I don't know what circumstances that are listed in this statute.

[00:15:24] Speaker 01:
They're totally different statutes.

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So you have to, you can't, you're not going to get anywhere by citing cases that rely on different statutes.

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It seems to me the agency to prevail here, and you know, you might, but you have to point to implied, you agree it's not express, so you have to point to implied statutory authority.

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And the question I have is where does that come from?

[00:15:50] Speaker 05:
Well, Your Honor, I think that is implied by the statutory structure and the text that Congress provided for when EPA can make the determination and what factors it has to rely on.

[00:16:02] Speaker 05:
Congress made clear that the determination of whether drinking water regulation is worthwhile when EPA has the authority to regulate depends on several factors, including whether in the administrator's sole judgment,

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there's a meaningful opportunity for health risk reduction.

[00:16:24] Speaker 00:
You go ahead.

[00:16:25] Speaker 01:
I'm sorry.

[00:16:26] Speaker 01:
You're absolutely right.

[00:16:27] Speaker 01:
You know, and if you look at the statute carefully, um, that's basically the only place where Congress has given the agency any discretion.

[00:16:37] Speaker 01:
It says, it says, uh, if the administrator makes that determination and sole judgment, you're right about that.

[00:16:46] Speaker 01:
But,

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There's no other discretion here.

[00:16:49] Speaker 01:
It says, it says that once the determination is made, the agency, it says shall regulate and then it says shall issue the regulation within a specified number of years and then shall issue the final regulation.

[00:17:06] Speaker 01:
So it says shall three times there.

[00:17:10] Speaker 01:
Elsewhere it uses may, so Congress clearly knows the difference.

[00:17:15] Speaker 01:
So I don't,

[00:17:16] Speaker 01:
I guess I don't see where the implied discretion to withdraw regulation comes from.

[00:17:25] Speaker 05:
Well, in two other places of note in the statute itself.

[00:17:29] Speaker 05:
First, the fact that Congress expressly makes a negative regulatory determination, not to regulate, judicially reviewable, and does not do the same for a positive determination.

[00:17:41] Speaker 01:
I'm not sure that helps your case.

[00:17:44] Speaker 01:
In fact, I actually think it hurts your case.

[00:17:47] Speaker 05:
Well, your honor, I think.

[00:17:48] Speaker 01:
Because Congress is basically saying no reason to review the determination because it will end up in a regulation which will be reviewed then.

[00:17:58] Speaker 05:
Right, your honor.

[00:17:59] Speaker 01:
Doesn't that make sense?

[00:18:00] Speaker 01:
I mean, I think that hurts your case.

[00:18:02] Speaker 05:
Well, your honor, to try to change your mind on it.

[00:18:05] Speaker 05:
Sure.

[00:18:05] Speaker 05:
We would be left in the anomalous situation that the only way to address an error or a change of circumstances that is relevant to the factors that Congress gave EPA

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would be a judicial review of a regulation that EPA has put?

[00:18:19] Speaker 01:
Well, is that really right?

[00:18:22] Speaker 01:
You mentioned two things.

[00:18:23] Speaker 01:
You mentioned an error and a change in circumstances.

[00:18:25] Speaker 01:
OK, so let's take the error.

[00:18:31] Speaker 01:
First of all, there's two sets of notice and comment rulemaking and judicial review, right, over the initial determination.

[00:18:40] Speaker 01:
So it's pretty unlikely that an error is going to creep through there.

[00:18:46] Speaker 01:
I mean, it seems to me quite unlikely that that would ever happen.

[00:18:52] Speaker 01:
Your stronger argument is future developments, right?

[00:18:55] Speaker 01:
Change circumstances, better research, correct?

[00:18:58] Speaker 05:
Yes, your honor.

[00:18:59] Speaker 01:
But I don't see why the agency doesn't have the authority.

[00:19:04] Speaker 01:
You say in your brief you can't have less stringent regulations, but that's not what the anti-backsliding provision says.

[00:19:11] Speaker 01:
It says that you have to maintain the level of protection.

[00:19:16] Speaker 01:
And it seems to me that if there's new research which shows that less less stringent standard would maintain existing health protections that the agency could change.

[00:19:30] Speaker 01:
There's nothing in the statute that would prohibit.

[00:19:33] Speaker 05:
Well, Your Honor, the statute would continue to apply no matter what monitoring and record keeping requirements, which do impose a cost on public water systems.

[00:19:42] Speaker 05:
And in fact, those kinds of monitoring requirements for contaminants that are very unlikely to be there is the concern, one of the concerns about costs that motivated the 1996 amendments discussed in the Senate report.

[00:19:56] Speaker 05:
So if EPA is forced to go to regulation

[00:20:00] Speaker 05:
even when new information or a more sophisticated analysis as was done here demonstrates that the contaminant is not actually present at levels of public health concern with a sufficient frequency, then EPA would be forced in the position that Congress expressly said it was trying to avoid.

[00:20:20] Speaker 01:
But it wouldn't, you're talking about the anti-vaxxing provision, right?

[00:20:23] Speaker 05:
Not only anti-vaxxing provision, your honor, but the

[00:20:27] Speaker 05:
the regulation would necessarily include monitoring.

[00:20:30] Speaker 05:
So the anti-backsliding.

[00:20:31] Speaker 01:
Well, can't, can't, doesn't EPA have authority under the statute to provide exemptions for monitoring?

[00:20:36] Speaker 05:
Yes, your honor, but only after several years of initial monitoring for the public water system to then demonstrate.

[00:20:43] Speaker 01:
And also, what do you think about the provision that says, okay, so it says, it says shall issue regulation, shall issue within specified number of months.

[00:20:53] Speaker 01:
And then it says, it also says the agency, excuse me, shall review and revise the regulation every X number of years, right?

[00:21:03] Speaker 01:
That's correct.

[00:21:05] Speaker 01:
It doesn't say, by the way, it says shall review and revise.

[00:21:09] Speaker 01:
It doesn't say, does it?

[00:21:10] Speaker 01:
Revoke.

[00:21:12] Speaker 05:
It does not say that the agency can revoke a regulation, but this regulatory determination is a preliminary step on the road

[00:21:22] Speaker 05:
And so the fact that the statute speaks expressly about the national primary drinking water standards and what EPA cannot do with respect to those once they are promulgated implies that there is more discretion and the power implicit.

[00:21:38] Speaker 00:
In this particular statute that we're concerned with here, Congress says if that first determination is made, then EPA shall, right?

[00:21:46] Speaker 00:
EPA has to regulate it that way, right?

[00:21:49] Speaker 05:
Yes, Your Honor.

[00:21:50] Speaker 00:
Now, once that's done, there is nothing in the statute that says then they can do away with the regulation, right?

[00:21:57] Speaker 06:
That's correct.

[00:21:58] Speaker 00:
And Congress has a parent purpose.

[00:22:00] Speaker 00:
You can consider the purpose of the statute is to make sure that contaminants that have that, that have passed that first step are regulated, are regulated.

[00:22:10] Speaker 00:
That would be fair to say, wouldn't it?

[00:22:12] Speaker 05:
Your honor, I would amend that to say it's fair to say that Congress was very concerned with regulating where the administrator determines that there's a meaningful opportunity for health risk reduction and that the change in statute from a system prior to 1996 where EPA was obligated to regulate 25 new contaminants every three years to one that moves that into a discretionary determination where the agency... I'm having a hard time getting that moved into her

[00:22:40] Speaker 00:
discretionary determination.

[00:22:41] Speaker 00:
I do not understand why statute doesn't seem to say, if that threshold is passed, then you shall regulate.

[00:22:49] Speaker 00:
And in this case, for example, you say, well, in two states they were able to reduce it, so therefore we take it away.

[00:22:58] Speaker 00:
Congressman doesn't seem to have wanted that.

[00:23:00] Speaker 00:
They did not give you the authority to do that.

[00:23:03] Speaker 00:
And I'm not, I'm like Judge Taylor, I'm not sure there is an inherent authority.

[00:23:07] Speaker 00:
I'm not sure there's even an implied authority here

[00:23:10] Speaker 05:
uh do away with the regulation that congress told you you had to put there well you're under in similar circumstances such as new jersey versus epa where epa the court has assumed that epa would have the authority to undo a decision except if there is another mechanism capable of rectifying error

[00:23:32] Speaker 05:
And in that case and in others, it is only where EPA did not follow the process that Congress has set out.

[00:23:41] Speaker 00:
Congress didn't set one out here, right?

[00:23:44] Speaker 05:
That's right.

[00:23:45] Speaker 00:
So that could be an indication that Congress didn't want one.

[00:23:48] Speaker 00:
Congress did not want a way out.

[00:23:52] Speaker 00:
I hate to suggest this, but the lawmaking branch of government is the legislature.

[00:23:57] Speaker 00:
And if they chose to change that, they could.

[00:24:00] Speaker 00:
But at this time, they didn't put it in there that the agency could do it for them.

[00:24:04] Speaker 00:
I'm not sure where it's coming from that they have an implied authority to undo what Congress told them they had to do.

[00:24:10] Speaker 04:
So if you look at the statutory language, what triggers the obligation to regulate, shall regulate, is the determination.

[00:24:19] Speaker 04:
That's correct.

[00:24:21] Speaker 04:
You make a determination, then you shall regulate.

[00:24:24] Speaker 04:
But if before you actually promulgate, you withdraw the determination,

[00:24:30] Speaker 04:
or you change the determination, is there still a duty to regulate based on the withdrawn determination?

[00:24:38] Speaker 05:
Is EPA's position that there is no longer a duty and in fact no longer authority to regulate?

[00:24:43] Speaker 04:
So I think that the statutory language does seem mandatory.

[00:24:47] Speaker 04:
Once there's a determination, you shall regulate.

[00:24:50] Speaker 04:
But there is nothing in the statute that says that before you've actually promulgated, if you withdraw the determination or you change the determination,

[00:25:00] Speaker 04:
that you still have to regulate according to a determination that has now been withdrawn.

[00:25:06] Speaker 05:
We agree.

[00:25:07] Speaker 05:
And this court has never found that the existence of a deadline and a statute is a reason to indicate that the authority to reconsider a determination is abrogated.

[00:25:19] Speaker 05:
And this court has also not seen that language such as shall abrogates.

[00:25:24] Speaker 05:
In the Idaho Conservation League decision, the EPA's prioritization, the deadline was 26 years prior.

[00:25:32] Speaker 05:
And the court still affirmed that EPA had the authority to determine not to issue regulations, if that's what the record before the agency demanded.

[00:25:43] Speaker 05:
And here, I think it's important that we're not in a situation, an extreme situation, that could arise in that NRDC's position would hold EPA's

[00:25:53] Speaker 05:
incapable of rectifying a clear error, like a study that the determination was relying on is retracted or there's a computational error.

[00:26:01] Speaker 04:
I understand that.

[00:26:02] Speaker 04:
And I'm just wondering if the statute does not speak to whether a determination can be withdrawn or changed prior to promulgation.

[00:26:12] Speaker 04:
Is the agency entitled to any deference about that?

[00:26:16] Speaker 05:
Deference in

[00:26:19] Speaker 04:
in determining whether it has the power to withdraw or change a determination before promulgation.

[00:26:26] Speaker 05:
I think the agency would be entitled to some deference rather, but I think it's their best reading of the statute and clearly in line with this court's precedent about agency's reconsideration.

[00:26:39] Speaker 01:
Let me make sure I understand your question to Judge Fanz, your answer to Judge Fanz question.

[00:26:47] Speaker 01:
You're saying that

[00:26:49] Speaker 01:
It requires no deference on our part to accept your argument that you can, the agency can withdraw a determination anytime prior to issuing a regulation.

[00:27:03] Speaker 01:
If that's clear in the statute, is that your point?

[00:27:06] Speaker 01:
I'm not challenging, I'm just asking you.

[00:27:08] Speaker 01:
In other words, in the old days when we had Chevron, we used to talk about Chevron one and Chevron two.

[00:27:14] Speaker 01:
Is this clear as far as you're concerned or is this something

[00:27:20] Speaker 01:
the agency's judgment.

[00:27:22] Speaker 05:
I think it is clear, Your Honor.

[00:27:23] Speaker 01:
And where does the clarity come from?

[00:27:26] Speaker 05:
It clearly comes from the implied elements of the statute that we've discussed about the factors EPA is to apply, the judicial review provision, anti-backsliding only attaching after a regulation is promulgated.

[00:27:41] Speaker 05:
But it is also clear from this court's precedent about

[00:27:44] Speaker 05:
the power to reconsider, the power to reverse course being implicit in, if not inherent in, the power to decide in the first place.

[00:27:54] Speaker 01:
So if I were to think, you know, maybe EPA is right about this.

[00:28:02] Speaker 01:
Maybe it does have the power to withdraw before it regulates.

[00:28:06] Speaker 01:
I'm not saying I do.

[00:28:07] Speaker 01:
But if I did, but if I don't think it's clear,

[00:28:14] Speaker 01:
That is, if I think it's a ambiguity in the statute, what would we do there?

[00:28:19] Speaker 01:
You don't claim any Chevron deference in your brief.

[00:28:23] Speaker 05:
That's correct, John.

[00:28:24] Speaker 05:
We didn't raise that.

[00:28:25] Speaker 01:
So what would we do?

[00:28:27] Speaker 05:
I think you should deny the petition for review.

[00:28:30] Speaker 01:
Well, we can.

[00:28:31] Speaker 01:
You haven't claimed Chevron deference, and I think the statute's ambiguous.

[00:28:39] Speaker 08:
I'm not saying I think it's ambiguous.

[00:28:40] Speaker 08:
This is my hypothetical.

[00:28:42] Speaker 08:
I understand.

[00:28:46] Speaker 05:
I cannot think of another case that involved this implicit or implied agency authority to reconsider resting on the agency's interpretation of its statute.

[00:29:03] Speaker 04:
Is there some reason why you don't want to rely on Chevron or ask us to defer to the agency?

[00:29:10] Speaker 04:
I'm just wondering.

[00:29:11] Speaker 05:
Well, Your Honor, I'm not sure that in the agency decision itself, Chevron or

[00:29:16] Speaker 05:
or the agency's interpretation was invoked, and the agency discussed the reasons that I've laid out for you today as its interpretation of why it had the authority.

[00:29:29] Speaker 05:
So I suppose, yes, without invoking

[00:29:33] Speaker 05:
chevron by name the agency certainly offered an interpretation of the statute and to the extent that you think that the statute is maybe you just don't want to sign in the sat cnrdc versus chevron because nrdc lost that case well i'm trying to stick to the arguments that we advanced in our brief and um grounds that the agency set out in the regulation i apologize i'm talking around it but i i guess but yes chevron waivable chevron deference

[00:30:04] Speaker 05:
I know, Your Honor, it's a interpretation canon, interpretive canon.

[00:30:11] Speaker 05:
In any event, just to briefly touch on the merits of the decision here and to explain what EPA did from a technical standpoint, I think there's two parts to this analysis.

[00:30:25] Speaker 05:
First is the legal question of what target was EPA shooting at in this analysis.

[00:30:31] Speaker 05:
And I think it's

[00:30:34] Speaker 05:
hear from EPA's preamble here, that it was making a determination about the levels of public health concern.

[00:30:41] Speaker 05:
Yes, it relied on a health effects analysis that was developed for the purpose of setting an MCLG, but it never finalized a regulatory determination that those were the levels that met the MCLG standard.

[00:30:55] Speaker 05:
It's final action here was applying that health effects analysis, knowing what we know about how perchlorate actually leads to adverse effects,

[00:31:04] Speaker 05:
that it is not present in public water systems with a sufficient frequency at levels of public concern.

[00:31:10] Speaker 05:
And then on the underlying merits of that technical analysis, EPA rationally and at the behest of the Science Advisory Board developed a state of the science cutting edge model for the first time to connect the literature on iodine uptake inhibition.

[00:31:28] Speaker 04:
So I find it really surprising

[00:31:31] Speaker 04:
and disturbing that the EPA proposed a MCLG that is associated with a 2% drop in IQ in the sensitive subpopulation.

[00:31:47] Speaker 04:
And the definition of an MCLG is a level at which no known or anticipated adverse effects on the health of persons occur and which allows an adequate margin of safety.

[00:31:59] Speaker 04:
How could the agency possibly find that a 2% drop in IQ has no adverse effect on the health of persons?

[00:32:09] Speaker 05:
The question boils down, Your Honor, to a data interpretation question.

[00:32:13] Speaker 05:
For this type of modeling, biologically based dose response modeling, the way that you interpret whether you are observing an effect from the contaminant is to look at a relative change from the mean.

[00:32:25] Speaker 05:
As EPA's benchmark technical dose guidance said, a range of those relative changes from the means have been used.

[00:32:32] Speaker 05:
One standard deviation, 10%, or data such as here, data from epidemiological studies, 1%.

[00:32:40] Speaker 05:
EPA considered the range, proposed the range of 1% to 3%, and in the end, finalized the determination that it does not appear with sufficient frequency at levels of 3%.

[00:32:50] Speaker 04:
I still don't understand, because it still boils down to a 1% to 3% drop in IQ and a finding by the agency that this is not an anticipated adverse effect on the health of persons.

[00:33:03] Speaker 04:
And if we think that that's arbitrary and capricious, you would lose on the merits of

[00:33:08] Speaker 04:
of your exercising authority if we find that you have the authority to change this.

[00:33:14] Speaker 05:
Yes, Your Honor.

[00:33:15] Speaker 05:
I think that the important point is that this is a data interpretation exercise that when you have a continuous outcome like IQ and you're using a model such as this, you have to be sure or have some degree of certainty that what you're observing is not natural variation, but you're observing the effect of the

[00:33:36] Speaker 05:
And it's the relative change from the mean that scientists use to determine whether they are actually seeing that adverse effect.

[00:33:44] Speaker 05:
That's consistent with the technical dose guidance.

[00:33:47] Speaker 05:
And as you heard earlier, NRDC hasn't been able to identify in the record anything that would have supported EPA using a lower level.

[00:34:01] Speaker 09:
So these levels of

[00:34:05] Speaker 04:
Prochlorate are associated with drops in IQ.

[00:34:09] Speaker 04:
1%, 2%, or 3% drops in IQ.

[00:34:14] Speaker 04:
And you do not look, and there's nothing in the record, as we just discussed with opposing counsel, about a lower level, which would be associated with no drop in IQ, which would seem to fit the statutory definition of MCLG.

[00:34:30] Speaker 04:
So if you didn't consider that,

[00:34:34] Speaker 04:
How is your action not arbitrary and capricious?

[00:34:38] Speaker 05:
Well, Your Honor, because the approach to defining the adverse effect, there are multiple approaches that one can take.

[00:34:47] Speaker 05:
One could take a no adverse effects level approach.

[00:34:50] Speaker 05:
That is, as I understand it, a technical way of interpreting data using different tools.

[00:34:55] Speaker 04:
Is that statutorily required by the definition of an MCLG?

[00:34:59] Speaker 05:
No, your honor.

[00:35:00] Speaker 05:
Our position is that the statute does not dictate what particular technical approach EPA has to... No, no, no, but it has to have no anticipated adverse effects on the health of persons.

[00:35:10] Speaker 05:
I understand, your honor.

[00:35:11] Speaker 05:
Statutorily.

[00:35:13] Speaker 05:
Statutorily, correct.

[00:35:14] Speaker 05:
And EPA attempted to design this model in order to set that level.

[00:35:19] Speaker 05:
It's multiple peer review panels determined that its model was fit for purpose for doing that.

[00:35:25] Speaker 04:
And when you have that kind of model.

[00:35:27] Speaker 04:
But I'm not reviewing fit for purpose.

[00:35:29] Speaker 04:
I'm reviewing whether you've met the statutory definition of an MCLG, which based on the record, it seems that you have not.

[00:35:38] Speaker 04:
And then you equated that with the standard to regulate.

[00:35:42] Speaker 04:
You equated it with the standard for levels of public health concern.

[00:35:47] Speaker 05:
The statute contains two legal standards there for EPA to interpret health effects.

[00:35:52] Speaker 05:
I understand, but you equated them.

[00:35:55] Speaker 05:
What EPA did and what EPA said was that it used the public health effects analysis that it did admittedly create for purposes of setting the MCLG and said that, well, at those levels, even at our most stringent proposed MCLG level, not defending that as the MCLG.

[00:36:13] Speaker 04:
At your proposed level, there could have been a lower one.

[00:36:19] Speaker 05:
Your Honor, the agency put those levels out for public comment.

[00:36:24] Speaker 05:
There is no public comment supporting using a smaller than a 1% relative change from the mean for this purpose, for this technical purpose.

[00:36:34] Speaker 05:
And part of the reason why EPA had to use this particular model is that there is not, in fact, literature that directly says that perchlorate causes adverse neurological developmental effects.

[00:36:46] Speaker 05:
What we have is a literature

[00:36:47] Speaker 05:
that connects perchlorate to iodide uptake inhibition, which both the National Research Council and the Science Advisory Board hold EPA is a precursor to adverse effects.

[00:36:59] Speaker 05:
So when EPA brought this problem of how should we send an MCLG to the SAD in 2012, the SAD recommended that EPA develop this kind of model in order to actually connect that literature to the other existing literature, which was how does thyroid disorders

[00:37:17] Speaker 05:
and iodide insufficiency relate to neurodevelopmental effects.

[00:37:22] Speaker 05:
So EPA developed the model to connect the two lodgers for the first time to actually connect for chloride to adverse effects.

[00:37:28] Speaker 05:
And it did so because it needed to meet that statutory standard.

[00:37:33] Speaker 05:
It didn't believe that relying on the health reference levels that it had used for the 2011 determination and before, which again focused on iodide uptake inhibition, would support a determination under the statutory standard for an MCLG.

[00:37:47] Speaker 05:
In doing that, EPA then found for reasons that include the body's ability to generate other thyroid hormones to make up for an iodine deficiency, that the actual level that would be associated with adverse neurodevelopmental effects in the sensitive cell population was higher than what they had considered based on the health reference levels from iodine uptake condition.

[00:38:12] Speaker 05:
And so given that conclusion and using the interpretive questions there,

[00:38:17] Speaker 05:
EPA then said, well, our levels of public health concern, that is a different, that's different text than the standard that applies to the MCLG.

[00:38:26] Speaker 05:
It's substantially something different.

[00:38:28] Speaker 05:
We think it means it's flexible.

[00:38:30] Speaker 05:
We think we have used health reference levels before.

[00:38:33] Speaker 05:
And we think that given the data before us, that this contaminant is not present with a sufficient frequency at levels of public health concern and that we lack the authority

[00:38:48] Speaker 04:
So I'll just say that you seem to be trying to to rely on this model, which is subject to criticism from the scientist.

[00:39:01] Speaker 04:
But the bottom line is,

[00:39:04] Speaker 04:
what you came up with is a level of perchlorate that is associated with significant drops in IQ level.

[00:39:14] Speaker 04:
And there's a statutory standard that talks about adverse effects on people, and I don't see how that fits.

[00:39:20] Speaker 04:
And then in the regulation, it says EPA used these potential MCLGs as the levels of public health concern.

[00:39:28] Speaker 04:
And so if you're going to equate these MCLGs that do not meet the statutory standard with the levels of health concern, it seems that you have not properly performed your function.

[00:39:40] Speaker 04:
Because there's, in my view, clearly an error in terms of setting prochlorate levels that allows what appears to me a significant adverse effect on persons and therefore does not meet the statutory definition of an MCLG.

[00:39:58] Speaker 04:
I feel like the agency is trying to hide behind a screen of this is highly technical.

[00:40:04] Speaker 04:
We used a model and saying that that should be enough and I don't see how that fits the statutory regulatory state.

[00:40:10] Speaker 05:
I understand your honor and I won't belabor it much further.

[00:40:14] Speaker 05:
I will say that again there are two questions here.

[00:40:16] Speaker 05:
What is the standard that applied to EPA's action?

[00:40:19] Speaker 05:
EPA did not finalize this as an MCLG.

[00:40:22] Speaker 05:
I'm not here to defend the agency's MCLG decision because it did not make

[00:40:27] Speaker 05:
Instead, it determined whether or not this contaminant was present at levels of public health concern and whether it presents a meaningful opportunity for health risk reduction.

[00:40:36] Speaker 04:
But you define the levels of health concern based on these MCLG's and you don't know anything below the 1%.

[00:40:43] Speaker 04:
We don't have information except about these MCLG's because that's how you define levels of public health concern.

[00:40:49] Speaker 05:
And then again, Your Honor, I think the definition of the levels of public health concern were at

[00:40:54] Speaker 05:
the levels that were also being used for the MCLG.

[00:40:58] Speaker 05:
But that is an underlying scientific analysis, not unlike the health reference levels that were used before, that EPA could then apply to the statutory mandate it was given.

[00:41:08] Speaker 05:
So there is an underlying body of scientific evidence, and EPA applied the statutory standard to making this regulatory determination.

[00:41:17] Speaker 05:
In addition, on the technical point underlying, I think it's important to note that not only one

[00:41:24] Speaker 05:
is this consistent is using a relative change from the mean consistent with how you interpret data in this kind of model.

[00:41:30] Speaker 05:
But EPA built additional conservative assumptions into that model.

[00:41:35] Speaker 05:
First, in defining the sensitive cell population as the thyroid deficient mothers, first trimester mothers, the offspring of those thyroid deficient mothers, and built in a number of extremely conservative assumptions about those mothers, thyroid function, iodide intake, and

[00:41:53] Speaker 05:
TSH loop.

[00:41:55] Speaker 05:
Once after applying the literature to that, it applied additional conservative assumptions about how much those individuals take in chlorine in their drinking water versus their food, their body weight, etc.

[00:42:10] Speaker 05:
All of those conservative assumptions were put in there to be health protective and help support EPA's conclusion that this is a level that would not be associated with public

[00:42:20] Speaker 05:
Um, uh, with effects of concern.

[00:42:24] Speaker 05:
One other point, just a technical one, the, the level 18 micrograms per liter is level that would avoid.

[00:42:33] Speaker 05:
a one percent.

[00:42:34] Speaker 04:
I'd like you to explain that because you say that several times in your your brief, avoid a one percent.

[00:42:39] Speaker 04:
How is it avoid?

[00:42:40] Speaker 04:
I thought these are levels that are associated with a one percent drop, which implies that it causes it, not that it avoids it.

[00:42:47] Speaker 05:
The idea is that if we were to regulate at that level, it would avoid that one percent effect.

[00:42:52] Speaker 04:
It would avoid that one.

[00:42:53] Speaker 04:
Why?

[00:42:53] Speaker 04:
Because they're allowed to be at that level.

[00:42:55] Speaker 04:
That's the maximum level.

[00:42:58] Speaker 05:
That's the maximum level goal is let's have that or less.

[00:43:03] Speaker 05:
And so if you had that or less, it would avoid a 1% IQ effect.

[00:43:07] Speaker 04:
But they can go right up to that, which would be a 1% drop.

[00:43:11] Speaker 04:
They can go right up to 18, if that's the level, right?

[00:43:15] Speaker 04:
So that is associated with a 1% drop.

[00:43:18] Speaker 04:
If you're setting a maximum limit, you can't assume that everybody following your regulation is going to be way below it.

[00:43:23] Speaker 04:
You're going to go right up to what you're allowing.

[00:43:26] Speaker 05:
Your Honor.

[00:43:27] Speaker 05:
One quick point just about MCLGs versus levels that they would have to comply with.

[00:43:33] Speaker 05:
MCLG is the goal, and then a regulatory level can be set higher than the MCLG.

[00:43:41] Speaker 05:
But in any event, here the question was, if there's chlorate out there in drinking water systems at 18 or higher,

[00:43:50] Speaker 05:
Are we concerned about that?

[00:43:51] Speaker 04:
Is that a level of public health?

[00:43:53] Speaker 04:
I understand.

[00:43:53] Speaker 04:
And at 18, it's associated with a 1% drop in IQ.

[00:43:56] Speaker 04:
So I don't see how that avoids a 1% drop.

[00:44:00] Speaker 05:
I think, again, it was because if you regulate that level, it would avoid it because of the terminology that the agency is running.

[00:44:11] Speaker 09:
The court has no other questions.

[00:44:13] Speaker 09:
I see my time is over.

[00:44:14] Speaker 09:
All right.

[00:44:15] Speaker 09:
Thank you.

[00:44:16] Speaker ?:
Thank you.

[00:44:19] Speaker 09:
is snow.

[00:44:27] Speaker 10:
Good morning, Your Honors.

[00:44:28] Speaker 09:
May it please the court?

[00:44:28] Speaker 09:
Good morning.

[00:44:29] Speaker 10:
Laurence Snow on behalf of Interveners American Waterworks Association.

[00:44:33] Speaker 00:
I'm sorry, could you speak up a little, please?

[00:44:35] Speaker 10:
Yes, Your Honor.

[00:44:36] Speaker 10:
I'll start by discussing the authority to withdraw a determination.

[00:44:40] Speaker 10:
I think an important distinction here, Your Honors, is this is not a regulation.

[00:44:45] Speaker 10:
It's a determination.

[00:44:46] Speaker 10:
That is a preliminary step

[00:44:48] Speaker 10:
towards regulating.

[00:44:50] Speaker 10:
And Judge Tatel, I just wanted to clarify that because in talking about some of the case law earlier, you mentioned inherent authority to withdraw regulation.

[00:44:59] Speaker 10:
And here we have what is clear in the statute to be a preliminary step towards that.

[00:45:07] Speaker 10:
Judge Pan, I think you have the absolute right reading of the statute here for that reason, that the provisions that would require a regulation are,

[00:45:18] Speaker 10:
The provisions say when you have a positive determination, then there is a requirement to issue a regulation and to do so on a specific timeline.

[00:45:27] Speaker 01:
But when you no longer have... The statute says... The statute says... Hold on a second, okay?

[00:45:40] Speaker 01:
It says... It says...

[00:45:55] Speaker 08:
So this isn't the statutory.

[00:45:57] Speaker 01:
It says it.

[00:45:58] Speaker 01:
It says it.

[00:46:00] Speaker 01:
It says that once the determination is made, the agency shall bring it right.

[00:46:09] Speaker 01:
That's what that's what it says.

[00:46:10] Speaker 01:
It says once the determination is made, I'm not quoting the statute, but says shall regular.

[00:46:15] Speaker 01:
Your honor, it says doesn't say the next sentence says.

[00:46:18] Speaker 01:
Shall issue regulation within a certain number of years, but it does say.

[00:46:23] Speaker 01:
Determination is made, it shall regulate.

[00:46:25] Speaker 01:
Isn't that what the statute says?

[00:46:27] Speaker 10:
It says for each contaminant that the administrator determines to regulate.

[00:46:32] Speaker 10:
And here we no longer have that positive determination.

[00:46:35] Speaker 10:
It shall regulate.

[00:46:39] Speaker 10:
But here we no longer have that positive determination.

[00:46:42] Speaker 10:
And I think, Your Honor, the more important piece here to fit into that is the three statutory criteria for regulating have to be present at the time of regulation.

[00:46:52] Speaker 10:
If EPA determines that those statutory criteria are not present when it goes to issue that regulation, it cannot issue a regulation.

[00:47:03] Speaker 10:
And so it cannot be that this determination is the final question, especially because we know that Congress specifically added these three statutory criteria out of the concern with over-regulation of substances that just weren't occurring at frequencies and levels of public health concern.

[00:47:22] Speaker 10:
it would make no sense for Congress to have added those three statutory criteria and then not give the agency the ability when it went to issue that regulation to withdraw that determination.

[00:47:34] Speaker 10:
So I do think Judge Pan has the best reading of this statute that there is a requirement as long as there is a positive determination.

[00:47:42] Speaker 10:
But if there's no longer a positive determination, then there's no longer a requirement to issue a regulation.

[00:47:52] Speaker 04:
And do you have an opinion about deference to the agency on this?

[00:47:57] Speaker 10:
Your honor, again, I don't think we believe that you need to have deference to the agency on its interpretation here, because I think it's clear from the statute that you have to have those three statutory criteria.

[00:48:09] Speaker 10:
But you certainly could defer, because this is how EPA also explained why it was withdrawing its determination.

[00:48:17] Speaker 10:
And again, I think

[00:48:19] Speaker 10:
Congress would not have thought that they needed to say anything different about this, given that this was just meant to be a preliminary step towards regulation, and regulation would then occur on the basis of those three statutory criteria.

[00:48:36] Speaker 10:
Judge Pan, I also just wanted to address your concern about the proposed levels that EPA is talking about here.

[00:48:46] Speaker 10:
Again, unfortunately, the science is quite complicated in a situation where you don't have a binary good IQ, bad IQ.

[00:48:54] Speaker 10:
It's not the same as, are you sick with this?

[00:48:56] Speaker 10:
Are you not?

[00:48:57] Speaker 10:
And so the agency had to take a number of steps to try and correlate what we do know about perchlorate and iodide inhibition with any possible neurological impacts.

[00:49:08] Speaker 10:
So unfortunately, there's not a smoking gun

[00:49:12] Speaker 10:
study here that shows that perchlorate and drinking water at these low levels corresponds to any specific neurological impact.

[00:49:20] Speaker 10:
What we have instead is knowing that perchlorate given at very high levels in medical doses impacts iodine intake and we know that that can lead to impacts of iodine deficiency and we know that those can lead to impacts on maternal hormones.

[00:49:40] Speaker 10:
We know that that can lead to neurological development.

[00:49:43] Speaker 10:
issues.

[00:49:43] Speaker 10:
So the agency was trying to connect all of these dots and pick numbers that they could then use to look at the occurrence data we have for the public water systems and determine if there was going to be a meaningful impact or opportunity for national regulations to have a meaningful impact.

[00:50:01] Speaker 10:
Now what we know and what's in the record is not just that EPA looked at these three levels that they picked as ways to correspond

[00:50:12] Speaker 10:
the best version they could of figuring out whether or not there'd be a health impact at levels of perchlorate.

[00:50:18] Speaker 10:
But we also have all of the data from the national survey that EPA did under UMCR 1.

[00:50:26] Speaker 10:
But we know that perchlorate, even at the lowest levels of detection, was still showing up in less than 2% of those surveyed results.

[00:50:38] Speaker 10:
So the agency had before in the record evidence not only at these three levels, but evidence of the overall level of happening in our water systems.

[00:50:49] Speaker 10:
And I think that's important because these statutory criteria were meant to address

[00:50:53] Speaker 10:
not just levels but also levels of occurrence.

[00:50:59] Speaker 10:
So here we know that only based on EPA's record only 15 water systems out of more than 62,000 around the country.

[00:51:08] Speaker 10:
Less, this is about 0.02% of the water systems would have perchlorate at these levels that would need to be regulated.

[00:51:16] Speaker 04:
We didn't get a chance to address this with the EPA but they

[00:51:20] Speaker 04:
in determining what the prevalence was, they apparently updated data from 2001 to 2005 with more recent data from California and Massachusetts, but only replaced the samples that were positive for prochlorate.

[00:51:40] Speaker 04:
Why didn't they replace all of the samples from California?

[00:51:44] Speaker 04:
Why did they focus only on the ones that were positive for prochlorate?

[00:51:47] Speaker 04:
Because the claim is that that biases the data.

[00:51:50] Speaker 10:
So, your honor, first, I just want to point out that you can look at the also in the record, the two thousand eight determination where EPA didn't remove any of these samples and they came to the exact same conclusion removing these samples really didn't.

[00:52:04] Speaker 10:
move the needle.

[00:52:06] Speaker 10:
Even there, they said less than 1% of water systems in this country had perchlorate levels there.

[00:52:12] Speaker 10:
They looked at 15 parts per billion, which is even lower than the levels they looked at here.

[00:52:17] Speaker 10:
So again, we're talking about a very, very small percentage.

[00:52:21] Speaker 10:
So what happened in 2008?

[00:52:23] Speaker 10:
That was when they made the preliminary determination not to regulate perchlorate.

[00:52:27] Speaker 10:
So EPA has reached the same.

[00:52:29] Speaker 10:
But they use the UCMR?

[00:52:32] Speaker 10:
They use the UCMR.

[00:52:32] Speaker 10:
So the exact same set of data without removing any of these samples came to the same conclusion.

[00:52:38] Speaker 10:
Again, found that less than 1% of our water systems had perchlorate even at their 15 parts per billion, so lower than the 18 parts per billion that they used here, and determined that regulation, they made a negative determination, regulation was not warranted

[00:52:56] Speaker 10:
because of the very low levels of occurrence happening around the country.

[00:53:00] Speaker 10:
As to the specific pieces of data that they removed here, so EP actually used neutral criteria in what they were doing.

[00:53:12] Speaker 10:
They did a couple of things.

[00:53:14] Speaker 10:
One, where there was updated information from the states that now regulated, indicating that there were no

[00:53:21] Speaker 10:
violations of those state regulations, which I believe California's is a six parts per billion, then they knew that those water systems no longer had those elevated levels of chlorate.

[00:53:33] Speaker 10:
And so they updated based on that.

[00:53:35] Speaker 04:
Yeah, they selectively updated, correct?

[00:53:37] Speaker 04:
They only updated the samples in the UCMR that were positive for chlorate.

[00:53:43] Speaker 04:
Why did they just replace all of the California data with the new California data?

[00:53:50] Speaker 10:
Your honor, I think because state regulation would have required all of those water systems to be below that level.

[00:53:59] Speaker 10:
So we know that those water systems no longer have the elevated levels.

[00:54:04] Speaker 10:
But again, I don't think that's something that this court needs to get into because within the record that was before the agency, they again had all the data showing that even if you used UMCR 1, even if you didn't remove any of those data samples, you'd get to the same place.

[00:54:21] Speaker 10:
This glory is and this is good news your honors for glory is not occurring in our water systems at levels of public health concern that that should be something that everybody feels very good about because issue in this case that's what your position is but they don't seem to think so.

[00:54:42] Speaker 10:
understood your honor, but we also have a statutory scheme where the third factor is that this has to in the sole discretion of the EPA administrator provide for a meaningful opportunity to impact the public health concern.

[00:54:56] Speaker 10:
I completely understand why it makes everybody uncomfortable to talk about drops in IQ.

[00:55:02] Speaker 10:
And we recognize that iodine deficiency is a real public health concern, but based on the record before the agency

[00:55:11] Speaker 10:
Safe Water Drinking Act regulation doesn't provide a meaningful way to address that public health concern.

[00:55:18] Speaker 10:
A good example or analogy that the EPA has dealt with in the past is sodium.

[00:55:25] Speaker 10:
Sodium is ubiquitous in our drinking water and we know that sodium can cause heart disease or stroke, but EPA came in and did an analysis and found that the contribution of sodium

[00:55:37] Speaker 10:
to the health concern was just not a justification for regulating of our public water systems.

[00:55:44] Speaker 10:
Again, EPA introduced, or I'm sorry, Congress introduced these three statutory factors out of a concern that when we add substances to safe drinking water regulations that just aren't at national frequencies, then frankly what we're really doing is overburdening our public water systems and distracting and distracting from their ability to

[00:56:05] Speaker 10:
monitor and come into compliance with more pressing health concerns.

[00:56:10] Speaker 10:
That's exactly why the statutory scheme was put in place.

[00:56:13] Speaker 10:
And that's really the issue you would have if you were to force the agency to regulate proclorate here, because the record shows that it is just not occurring in public water systems at levels and frequencies on a national basis that would allow for there to be a meaningful opportunity.

[00:56:31] Speaker 01:
Excuse me.

[00:56:31] Speaker 01:
NRDC says in its brief that

[00:56:35] Speaker 01:
that since the passage of these amendments, the 20 some years since these amendments were passed, EPA has been issued final regulations for any contaminant.

[00:56:44] Speaker 01:
Is that true?

[00:56:46] Speaker 10:
That's correct, Your Honor.

[00:56:47] Speaker 10:
Only there are about 90 contaminants that are listed right now.

[00:56:52] Speaker 10:
EPA goes in by statute every five years and has to consider five additional contaminants and whether or not it's appropriate to regulate those.

[00:57:02] Speaker 10:
EPA has to come in every six years and look at the contaminants that are already being regulated and determine if they should make the regulations more stringent.

[00:57:09] Speaker 10:
So there's certainly plenty that's happening under this statute, but thus far, EPA has not determined that there was a reason to regulate additional substances outside of those original 90.

[00:57:21] Speaker 10:
Any other questions?

[00:57:26] Speaker 10:
No.

[00:57:26] Speaker 10:
Thank you very much, Ms.

[00:57:28] Speaker ?:
Snow.

[00:57:31] Speaker 09:
Ms.

[00:57:32] Speaker 09:
Fort, you have two minutes.

[00:57:37] Speaker 09:
All right, Your Honor, so lots have been settled.

[00:57:38] Speaker 09:
I'll try to get to as much of it as I can.

[00:57:40] Speaker 02:
On the occurrence analysis, council's numbers assume that EPA undertook a reasonable update.

[00:57:48] Speaker 02:
And the reality is that the agency did it.

[00:57:50] Speaker 02:
The agency only went back to two states, the two states in the nation that are the only two places that have since regulated perchlorate.

[00:57:58] Speaker 02:
And within those two states only went back to places where per chlorate had previously been detected.

[00:58:05] Speaker 02:
Of course those sites have gotten better.

[00:58:06] Speaker 02:
We know there's a problem and the states have since regulated it.

[00:58:10] Speaker 02:
That says nothing about what is happening on a national basis and is absolutely not a reasonable basis for the agency to decide that per chlorate is getting better.

[00:58:20] Speaker 02:
I will also say that it is not safe to assume that because the other places are subject to state regulation that they are necessarily in compliance.

[00:58:29] Speaker 02:
EPA's own brief at page 51 shows that California has detected per-query exceedances in 11.4% of large public drinking water systems between 2007 and 2018.

[00:58:42] Speaker 02:
It's simply not true that this is a problem that has been solved.

[00:58:46] Speaker 02:
I also want to go back to the EPA's point that this is about a model.

[00:58:50] Speaker 02:
This is its scientific analysis.

[00:58:52] Speaker 02:
We're not challenging the model.

[00:58:54] Speaker 02:
We're not challenging the agency's scientific analysis.

[00:58:57] Speaker 02:
The agency itself described the levels that it selected as a policy decision.

[00:59:02] Speaker 02:
EPA says there's nothing in the record to suggest that a lower level should have been selected.

[00:59:07] Speaker 02:
I'll refer the court to JA 743, which is EPA's own response to a comment from AWWA in which it says,

[00:59:14] Speaker 02:
Small changes in IQ become important when considered on the population level.

[00:59:19] Speaker 02:
For example, one study argues that although a one-point change in IQ is within the standard error of an individual measurement and would not be regarded as clinical disease, it is still highly significant on a population level.

[00:59:31] Speaker 02:
That is completely inconsistent with the statutory command that the Safe Drinking Water Act has given EPA.

[00:59:38] Speaker 02:
I refer the court on the question of whether it avoids

[00:59:42] Speaker 02:
IQ loss to 84, fed rate 3557.01.

[00:59:47] Speaker 02:
And finally, Your Honor, EPA, on the reconsideration point, EPA is trying to preserve its authority to resolve a situation that is entirely hypothetical, the possibility that there might someday be a contaminant on which there is a dramatic change in science.

[01:00:04] Speaker 02:
It is failing to respond to the actual problem that Congress is trying to address, which is that there are a number of contaminants out there that we're not testing for, that people don't know if they're in their public water, and that are causing real harm to public health.

[01:00:19] Speaker 02:
And that is the problem that Congress was trying to solve.

[01:00:22] Speaker 02:
And that is why Congress said, once you make a determination that it meets that criteria, we're going to hold you to it.

[01:00:29] Speaker 02:
And we're going to make you actually protect public health

[01:00:32] Speaker 02:
which is the purpose of this statute.

[01:00:36] Speaker 04:
Thank you.

[01:00:37] Speaker 02:
Thank you.

[01:00:38] Speaker 04:
The case is submitted.