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The U.S. EPA is trying to block some of the best scientific studies from being used in formulating the regulation of dangerous pollutants. In a new “supplemental” provision to a proposed rule, EPA would prohibit the use of studies that are supported, in part or whole, by data that is not publicly available for re-analysis or that cannot be replicated.
The problem is that some of the best research available is epidemiological studies that utilize hospital records—and that data cannot be released, since doing so would violate the laws protecting patient privacy. For example, the data may include such details as diagnoses, causes of hospitalization or death, and even patient addresses.
By excluding studies that use real-world data, EPA would be rejecting the very kind of research that should inform its policy.
Please send a comment to EPA today telling them why you strongly disapprove of this proposal. Note, comments will appear on the EPA public docket.
Put this at the top of your comment: Re: Docket ID No. EPA–HQ–OA–2018–0259
Please draft your comment, then cut and paste it into EPA’s online docket. Here is some guidance that might help. Be sure to put it in your own words.
- Are you a medical or health professional? If yes, say so.
- State your strong opposition to the criteria proposed in the Supplemental Notice of Proposed Rulemaking put forth by the EPA relative to its rule entitled “Strengthening Transparency in Regulatory Science.”
- Feel free to indicate your strong support for EPA’s mission to protect human health and well-being and the environment. Note that you oppose this proposed Supplemental rule because it would weaken the scientific underpinnings, and thus the strength, of EPA’s health-protective actions.
- Put this basic argument into your own words:
This proposal would prohibit EPA from setting regulations that are supported, in part or whole, by data that is not publicly available for re-analysis or that cannot be replicated. The problem is that many of the most robust scientific studies rely on hospital records that cannot be released publicly, since doing so would violate patient privacy laws. (For example, the data may include such details as diagnoses, causes of hospitalization or death, and even patient addresses.) By excluding such data, EPA would be rejecting valuable, real-world research that should be used to inform its policy. At the same time, research studies can be evaluated and replicated without the release of such individual data.
- Then choose a few specifics, again putting them in your own words:
- The rule would favor information submitted by industry. It would allow EPA to consider industry information even if it is shielded from public review as “Confidential Business Information.” This unequal treatment is unfair and hypocritical.
- The Supplemental proposal fails to apply rigorous standards to EPA’s own internal processes. It refers to utilizing “influential scientific information” and “pivotal science.” However, these terms are undefined and therefore arbitrary. Thus, the Supplemental fails to indicate that it relies on anything but subjective decisions.
- The Supplement indicates that the proposed rule would be retroactive. This could lead to the dismantling of many important existing EPA regulations.
Add your name, health credentials if any, and if you are willing, your city and state. Thank you!