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Comment by May 18th on the Environmental Protection Agency (EPA) Proposed Rule, which is misnamed “Strengthening Transparency in Regulatory Science”. Related information, Open Docket Folder and comment here: https://www.regulations.gov/docket?D=EPA-HQ-OA-2018-0259 Comments can be anonymous.

Comment and Memo from PSR:
Physicians for Social Responsibility (PSR) respectfully submits the attached comments regarding the U.S. Environmental Protection Agency (EPA)’s proposed Supplemental Notice of Proposed Rulemaking related to the original proposed regulation “Strengthening Transparency in Regulatory Science,” Docket ID No. EPA-HQ-OA-2018-0259; FRL-10004-72-OR.

PSR is a 501(c)(3) scientific and educational organization headquartered in Washington DC with 30,000 health professionals, medical students and concerned citizen advocates in chapters across the country. Our mission is to protect human life from the gravest threats to health and survival.

PSR submits these comments in strong opposition to the criteria proposed in the Supplemental Notice of Proposed Rulemaking (SNPR) put forth by the EPA relative to its rule, “Strengthening Transparency in Regulatory Science.” The proposal fails to adequately justify the proposed rulemaking as it applies to “influential scientific information as well as significant regulatory actions.”

For Physicians for Social Responsibility,

Alan H. Lockwood, MD, FAAN, FANA
Physicians for Social Responsibility Past President, Member Board of Directors, and Senior Scientist
Emeritus Professor of Neurology, University at Buffalo

ID: EPA-HQ-OA-2018-0259-10866
Tracking Number: 1k4-9g9u-tvbx
Document Information
Date Posted:
Apr 28, 2020
RIN:
2080-AA14
https://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-10866

M E M O R A N D U M

To: U.S. Environmental Protection Agency From: Physicians for Social Responsibility Re: Comments concerning Proposed Supplemental Notice of Proposed Rulemaking re: Proposed regulation “Strengthening Transparency in Regulatory Science” Docket ID No. EPA-HQ-OA-2018-0259; FRL-10004-72-OR Date: May 22, 2020

Physicians for Social Responsibility (PSR) respectfully submits the following comments regarding the (EPA)’s proposed Supplemental Notice of Proposed Rulemaking related to the original proposed regulation “Strengthening Transparency in Regulatory Science,” Docket ID No. EPA-HQ-OA-2018-0259; FRL-10004-72-OR.

PSR is a 501(c)(3) scientific and educational organization headquartered in Washington DC with 30,000 health professionals, medical students and concerned citizen advocates in chapters across the country. Our mission is to protect human life from the gravest threats to health and survival.

PSR submits these comments in strong opposition to the criteria proposed in the Supplemental Notice of Proposed Rulemaking (SNPR) put forth by the EPA relative to its rule, “Strengthening Transparency in Regulatory Science.” The proposal fails to adequately justify the proposed rulemaking as it applies to “influential scientific information as well as significant regulatory actions.”

The SNPR refers to “influential scientific information” and “pivotal science” with regard to data and models. However, the terms “pivotal regulatory science and/or pivotal science” are undefined and therefore arbitrary. EPA should utilize evidence-based criteria to determine whether studies are considered in the rulemaking process, but the SNPR fails to indicate that they are relying on anything but subjective decisions,

We are concerned by EPA’s stated attention to “give greater consideration to studies where the underlying data are available in a manner sufficient for independent validation.” Many well-designed, well-conducted scientific studies are conducted on large datasets such as those that draw on hospital records. The SNPR and associated rule, by requiring that the entire dataset be made available, would expose to public scrutiny data that would allow the identification of individual persons included in the study. Because this would violate legally mandated privacy protections, this step would result in the de facto exclusion from EPA consideration of valuable and significant research studies. EPA fails in making its proposal to acknowledge two critical facts: first, that research studies can be both evaluated and replicated without the release of such individual data; second, that such studies have provided the foundation for much of the data that the Agency has used in the past to craft regulations that are protective of health and, parenthetically, that save enormous amounts of money that would have been associated with the morbidity and mortality likely to take place in the absence of health-protective regulation. The proposal that the Agency would use a “tiered access” strategy for consideration of protected health information is insufficient, as it does not adequately protect the identity and health information of participants included in research studies. For these reasons, PSR finds that EPA’s call for so-called “transparency” in science would in fact have the effect of weakening, not strengthening, Agency efforts to protect health.

Truly transparent regulatory procedures should be identical or similar to the principles utilized by virtually all medical professional associations, utilizing a structured multi-step process that EPA could readily adopt. Briefly:

a. Develop the question. Find all of the relevant evidence based on pre-established criteria for reviewing the literature; identify the methodologic characteristics of each publication—e.g., anecdote (lowest form of evidence), randomized controlled trial with appropriate blinding (very high level of evidence). Determine risk of bias: high bias from industry-funded studies; low bias from NIH-funded clinical trials. b. Interpret the evidence. Understand association between variables and statistical precision. Synthesize evidence. Formulate evidence-based conclusion. c. Create rule in accordance with established procedures including substantial opportunities for public hearings and comments.

Additional considerations and criteria that may be pertinent include, is the study published in a peer-reviewed journal? In this sphere it should be noted that there are industry-sponsored journals that are peer-reviewed; these studies should not be considered because of the risk of bias. What is the impact factor of the journal? In general, the highest impact factor journals are the sources of the most carefully reviewed and reliable studies. These studies should receive careful attention, but should not be immune to the deficiencies noted above.

PSR is pleased that the Agency proposes deletion of the provision at 40 CFR 30.9 concerning the granting of exemptions based on impracticability of peer review. PSR recognizes that the Administrator must have sufficient authority to supervise the Agency in a manner that is consistent with enabling legislation and the Agency’s stated mission “to protect human health and the environment.” However, the Administrator must always use evidence-based decision-making based on sound science that enhances health and must not utilize arguments related to the “economic burden” placed on regulated entities.

In summary, it is the position of Physicians for Social Responsibility that the Supplemental Notice of Proposed Rulemaking would weaken EPA’s ability to protect human health and wellbeing and should be rejected.

For Physicians for Social Responsibility,

Alan H. Lockwood, MD, FAAN, FANA Physicians for Social Responsibility Past President, Member Board of Directors, and Senior Scientist Emeritus Professor of Neurology, University at Buffalohttps://www.regulations.gov/document?D=EPA-HQ-OA-2018-0259-10866 (Emphasis our own.)

Information-comments from the earlier comment period two years ago:
https://miningawareness.wordpress.com/2018/05/25/trump-pruitts-epa-announces-extended-comment-period-and-public-hearing-on-so-called-transparency-rule/
https://miningawareness.wordpress.com/2018/05/20/nearly-1000-scientists-tell-trump-pruitt-epa-dont-restrict-epas-ability-to-rely-on-science-comment-by-may-30th/
https://miningawareness.wordpress.com/2018/08/16/trump-epa-proposal-re-dose-response-analysis-is-inappropriate-and-not-scientifically-based-say-epidemiologists-comment-by-thursday-night-1159-pm-eastern-time/
https://miningawareness.wordpress.com/2018/08/15/national-tribal-air-association-comment-opposing-proposed-us-epa-rule-comment-deadline-thursday-night-1159-pm-eastern-time/
https://miningawareness.wordpress.com/2018/08/15/the-president-of-harvard-university-letter-opposing-proposed-us-epa-rule-comment-deadline-thursday-night-1159-pm-eastern-time/
https://miningawareness.wordpress.com/2018/08/11/trump-epa-cost-benefit-analysis-pre-rulemaking-comment-deadline-is-monday-august-13th-11-59-pm-eastern/
https://miningawareness.wordpress.com/2018/05/08/new-york-attorney-general-tries-to-protect-people-environment-from-100-fold-increase-in-radiation-and-other-toxic-dangers-gets-accused-of-abuse/