New Brief by Kip Hansen – 6 March 2020

 

The NY Times’ Lisa Friedman continues to misrepresent the EPA’s proposed “Strengthening Transparency in Regulatory Science” rule, making the same unsubstantiated and false claims she made last November.  Her new attack was prompted by the EPA’s issuance of a “ Supplemental notice of proposed rulemaking” [link is a .pdf] making revisions to the originally proposed wording of the rule.

Friedman’s new attack article appears in the 4 March 2020 online issue of the NY Times as  “E.P.A. Updates Plan to Limit Science Used in Environmental Rules”.  The last time Friedman wrote about the rule (November 2019) her reporting was so blatantly inaccurate that the E.P.A. issued an official press release titled “The New York Times’ Several Glaring Inaccuracies ‘That’s Fit To Print’” documenting her errors and false statements, using such language as:  “….  This is completely false…. which is completely false.…This is not true…. The story continues with more false information….This is just wrong….This is just bad reporting. It is completely misleading, and lacks the understanding of the rule making process…. “ – you get the idea.  Despite the exceptionally strong language of the E.P.A. rebuttal, neither Friedman or the NY Times issued any correction to the November 2019 article – in fact, not a single word was printed in the Times even acknowledging that there had been an E.P.A. press release.

As the E.P.A. pointed out in its November 2019 Press Release, Friedman does not seem to understand the Federal rulemaking process.  There is no “plan” and it has not been “updated”.  There is a Proposed Rule [ repeating the link to the .pdf ].  The Proposed Rule is undergoing the required steps of the Federal Rulemaking Process,  a simplified explanation is available here.  The process being followed can be summarized like this:

Proposed Rule. In this step, the agency publishes the actual proposed regulatory language in the Federal Register; in which a discussion of the justification and analysis behind the rule is printed, as well as the agency’s response to any public comment on the advance notice.

Public comment. Once a proposed rule is published in the Federal Register, a public comment period begins, allowing the public to submit written comments to the agency. Most agencies are required to respond to every issue raised in the comments. Depending on the complexity of the rule, comment periods may last for 30 to even 180 days.

Final Rule. Usually, the proposed rule becomes the final rule with some minor modifications. In this step, the agency publishes a full response to issues raised by public comments and an updated analysis and justification for the rule, including an analysis of any new data submitted by the public. In some cases, the agency may publish a second draft proposed rule, especially if the new draft is so different from the proposed rule that it raises new issues that have not been submitted to public comment. This again appears in the Federal Register, and if no further steps are taken by the public or interested parties, it is codified into the Code of Federal Regulations.

In the case of the E.P.A.’s “Strengthening Transparency in Regulatory Science” rule, there have been several Supplemental Notices that have revised the original wording of the rule, responding to public comments and clarifying various points of the rule.  The latest Supplemental includes several critical definitions of terms.

I will try to save the Environmental Protection Agency some time and effort by pointing out some of the falsehoods and misrepresentations in the latest Friedman article:

Friedman:  The rule “would significantly restrict the type of research that can be used to draft environmental and public health regulation”.

This is simply false.  Nothing in the rule restricts any “type” of research – neither past research or future research.

Friedman:  “The revisions made public Tuesday evening mean the Environmental Protection Agency would give preference to studies in which all underlying data is publicly available.”

This is incorrect and misleading – the proposed rule and the supplemental notice do not require “all underlying data [to be] publicly available”.  The revisions specifically clarify what the transparency requirements are and “EPA is also proposing options that would allow EPA to consider studies even if the underlying data and models are not publicly available.”  And “the Agency will only use pivotal regulatory science and/or pivotal science if the data and models are available in a manner sufficient for independent validation.”

Friedman:  “That slightly relaxed restrictions in an earlier draft that would have flatly excluded any research that did not offer up its raw data, even if that data included medical information protected by privacy laws or confidentiality agreements.”

Friedman apparently learned nothing from the E.P.A.’s previous press release and has not actually read (or, if read, did not understand) the Proposed Rule or its Supplementals.  The previous E.P.A. Press Release clearly stated:  “This is not true. In the originally proposed regulation and in the leaked supplemental, EPA maintains protecting confidential personal information just as other federal health agencies regularly do. The reporter clearly does not understand the terms in the context of science transparency.”

The proposed revisions include provisions such as: “…other things being equal, the Agency will give greater consideration to studies where the underlying data and models are available in a manner sufficient for independent validation either because they are publicly available or because they are available through tiered access when the data includes CBI, proprietary data, or PII that cannot be sufficiently de-identified to protect the data subjects.” [CBI – confidential business information.  PII – personally identifiable information.]

Friedman: “Under the new version of the plan, the E.P.A., when writing or revising environmental regulations, would have to give greater weight to research in which the underlying data are available to be retested.”

Again, this is simply poor reporting.  There is no “new version of the plan” – there is no plan.  There is a Proposed Rule and it is undergoing the required federal rulemaking process, being revised and modified to answer the concerns raised by public comments.  There is nothing in the Proposed Rule about data being “retested”.

The Supplemental Notice does include precise proposed definitions (on which it requests public comment) such as:  “EPA is proposing to define “independent validation” as the reanalysis of study data by subject matter experts who have not contributed to the development of the original study to demonstrate that the same analytic results are capable of being substantially reproduced. “Capable of being substantially reproduced” means that independent analysis of the original or supporting data using identical methods would generate similar analytic results, subject to an acceptable degree of imprecision or error.”

Yes, E.P.A. will insist that pivotal science, pivotal studies, if they are to weigh heavily in decisions about regulation, must be able to be  reviewed by independent scientists, expert in the subject matter,  to determine if  the results be can validated, substantially reproduced.  Answering the basic question:  Is the science sound or not?  Advocacy Science from Advocacy Scientists – valid only from their advocacy biased points of view – will no longer be accepted without independent validation.

Friedman:  “Seminal research that has definitively linked polluted air to premature deaths, like a 1993 Harvard University report known as the Six Cities study, often persuaded participants to offer personal health information and other private data by extending strict confidentiality.  Environmental activists and former Obama administration leaders said the new rule would make it easier for the E.P.A. to weaken or repeal existing health regulations because studies that had previously been used to show the benefits might now be discarded or assigned less importance.”

Relying on the opinions of  “Environmental activists and former Obama administration leaders” Friedman raises what is apparently the greatest fear surrounding the Transparency Rule – that the Harvard Six City study, and its companion, the CPS II study,  will be closely examined and found scientifically wanting.  E.P.A. has already specifically responded to this in their previous press release, stating clearly:  “The reporter [Friedman] again says the proposal would apply retroactively to existing regulations, which is completely false. The supplemental (and the original proposal) allow studies like the Harvard Six City study to be used. The agency has not rejected or otherwise eliminated that option in anyway in its original proposal or supplemental. In fact, the supplemental makes it even clearer that such studies must be properly considered and takes comment from the public on this issue.”

The secondary issue concerns  patient confidentiality  — E.P.A. clearly stated in November that “EPA maintains protecting confidential personal information just as other federal health agencies regularly do” and proposes  “tiered access when the data includes CBI, proprietary data, or PII that cannot be sufficiently de-identified to protect the data subjects.”  Note that the full data set for the Harvard Six City study has already previously been made available to independent researchers and scientists.

Friedman:  “Gina McCarthy, who led the E.P.A. under former President Barack Obama, said the Trump administration already was facing scrutiny over its handling of the coronavirus, and she criticized the agency for moving forward with the new rule in the middle of a public health crisis.”

Friedman again shows her ignorance of (or intentional disregard for) the Federal rulemaking process.  The E.P.A. is required to respond to issues raised by public comments within a specified or reasonable amount of time. This timing is not controlled by other political considerations.  Again, either McCarthy or Friedman, or both, incorrectly call the latest issuance of a “Supplemental notice” a “new rule”, there is no new rule.  The Proposed Rule was entered into the Federal Register in 2018 and the rulemaking process has been ongoing since then.    It is the FDA, NIH and the CDC that are involved in the coronavirus pandemic  – not the E.P.A.

To her credit, while not acknowledging E.P.A.’s rebuttal of her previous article, Friedman at least gives a current quote from E.P.A. administrator Andrew R. Wheeler:

“I am committed to ensuring that the science underlying E.P.A.’s actions is of the highest quality,” he said in a statement. Once the rule is finalized, he added, it “will ensure that all pivotal studies underpinning significant regulatory actions at the E.P.A., regardless of their source, are available for transparent review by qualified scientists.” – Andrew R. Wheeler – Administrator of the E.P.A.

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Not to be outdone by the NY Times, Science Magazine online provides an equally biased, inaccurate and misleading article titled “Trump administration expands reach of EPA secret science proposal” penned by Kelsey Brugger of E&E News.

The Science piece starts out with the same inaccuracy as Friedman’s NY Times article:

Brugger:  “The U.S. Environmental Protection Agency (EPA) yesterday evening released a controversial proposal to limit the scientific research used in the federal rulemaking process.” 

The E.P.A. released a Supplemental Notice to rulemaking, part of the mandated Federal rulemaking process, dealing with issues raised by the public regarding the Proposed Rule, proposed in 2018, titled “Strengthening Transparency in Regulatory Science”. While the rule has proved to be controversial it is not intended to “limit the scientific research used in the federal rulemaking process”.  It is intended to “ensure that all pivotal studies underpinning significant regulatory actions at the E.P.A., regardless of their source, are available for transparent review by qualified scientists” and be “independently validated” thus “ensuring that the science underlying E.P.A.’s actions is of the highest quality”.  The Transparency Rule is not about internal rulemaking, it is about regulatory actions at the E.P.A..

Brugger:  “The draft “Strengthening Transparency in Regulatory Science” is part of the agency’s persistent effort to rework the foundation on which public health and environmental rules are crafted.”

This is true but not in the way implied or intended by Brugger.  See the point immediately above.

Brugger:  “….Andrew Wheeler, has sought to shore up shortcomings in the initial proposal while expanding the scope to cover all the agency’s scientific information—not just what’s used in rulemaking.” …. “Another significant change in the draft is that it could apply to all EPA ‘influential science’—not just science used in regulatory efforts”

Brugger seems not to understand the Federal rulemaking process any better than Friedman – either that or they are both being fed the gist of their stories by the same activist and lobbying groups.   The original proposed rule must go through a series of comment periods followed by Agency revisions or explanations, iteratively, until the Agency has satisfied or answered public concerns.

The Supplemental Notice clarifies several points of the original proposed rule as requested by public comment and supplies definitions of terms that were unclear (having no agreed upon meaning in the lexicon of science) in the original.

The Supplemental Notice also clarifies that “This notice proposes definitions and clarifies that the proposed rulemaking applies to data and models underlying both pivotal science and pivotal regulatory science.

Yes, this means that the Science – all of it – not just that bits used to make a particular regulation but the underlying pivotal science itself must be able to be independently validated if it is being used to guide the actions of the Agency.

Yes, this means that Advocacy Science, produced with bias to forward specific advocacy positions, will no longer the basis for E.P.A. actions unless that science can be independently validated by experts in the field not involved in the original research.

This is a Good Thing – but it scares the pants off of those who have built their careers on the kind of epidemiology that produces very thin evidence of tiny effects – often, what in other scientific fields, would be considered null results.

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Thus, the supporters of Secret Science – the supporters of “Trust Us, We’re Scientists – and those guys over there aren’t really scientists unless they agree with us”-style science – continue to battle against Open Science, Transparent Science, Science that can be validated through open scrutiny by unbiased experts.

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Author’s Comment:

It is a sad commentary on the state of Science today that so many so-called scientific associations and organizations line up on the dark side — the side of Secret Science – instead of supporting efforts for transparency and independent validation of important scientific findings that underpin many of our societies reactions to ongoing problems.

The E.P.A. is obligated under the “Information Quality Act”  to ensure that it uses the best information possible to formulate regulations – and in Science, that means information that can be reviewed and validated by independent experts.

It is particularly odd given that many of the same organizations are actively promoting Open Science, Open Data, pre-print over peer-review, and other attempts to deal with Science’s larger Replicability Crisis or Reproducibility Crisis.

I, for one, am a supporter of Open Science.

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