On March 3, 2020 EPA announced a supplemental proposal
Public comments are due by April 17, 2020
Read the Supplemental Proposal @ https://www.federalregister.gov/documents/2020/03/18/2020-05012/strengthening-transparency-in-regulatory-science
Comment @ regulations.gov docket No.: EPA-HQ-OA-2018-0259
Public Comments on the Original Rollback Proposal Were Due on
August 16, 2018
Get docket information @ https://www.regulations.gov/docket?D=EPA-HQ-OA-2018-0259
What’s at Risk and Talking Points
Trump Administration Rollback Proposal
The Environmental Protection Network, a volunteer group that includes former EPA employees, has conducted detailed analyses of Administrator Scott Pruitt’s proposed regulation to restrict EPA’s use of sound science.[i] Some of the key points from the EPN analysis are:
“EPA is proposing to restrict its use of scientific studies in developing rules and other policies, unless the raw underlying data and the analytical models are available for public review. The proposal disingenuously positions itself as supporting “transparency” when in fact it makes it impossible for EPA to consider the full array of well-conducted, relevant, and peer-reviewed scientific studies of the health effects of pollution. …”
“EPA’s regulatory protections over the last five decades have relied on assessments of many thousands of health-related studies of pollutants, … [including epidemiological studies with human subjects] that examine the relationship between concentrations of various pollutants and their effects on people’s health. For many of these studies, ethical and legal considerations rightly restrict the release of personal data such as dates of birth and death, health, lifestyle information and subjects’ locations.”
“Under [the proposed] restrictions, some of the most useful and influential studies might have to be redone – at great expense and considerable time and resources – in order to sustain some existing regulations. On a practical basis, the level of detail contained in certain human studies would make it impossible to simply redact portions of the information to protect privacy. Even for studies for which the release of data might not pose ethical problems, the underlying data may no longer be accessible years after publication.”
In other words, the practical impact of the proposed restrictions would be to make important health studies unavailable for EPA to use in deciding what requirements are needed to protect public health or in estimating benefits of potential regulations, unless the EPA administrator granted a waiver from the policy.
The origin of this proposal dates back over twenty years ago to EPA’s use of a landmark set of studies by scientists at the Harvard School of Public Health to support air quality standards. Those studies examined the health effects of air pollution on more than 8,000 adults and 14,000 children in six U.S. cities over 14 to 16 years and, over the years, resulted in publication of more than 100 peer-reviewed papers detailing the findings. Particularly important was the finding in the 1990s that exposure to fine particle pollution contributes to mortality. The American Cancer Society also published a large and important study in 1995 linking fine particle pollution and mortality.
The researchers had promised study participants confidentiality. Both for legal and ethical reasons, they could not share the raw data. Opponents of the regulations seized on the confidentiality of the underlying health data to attempt to undermine the validity of EPA’s regulation.
To address concerns about the validity of the studies without releasing confidential data, Harvard and the American Cancer Society arranged for an independent reanalysis of both studies by the independent Health Effects Institute. The re-analysis was completed in 2000 and confirmed the findings of the studies. A new study from the Harvard School of Public Health found that even at levels well below EPA's regulations, exposure to particle and ozone pollution was linked to premature death among the elderly in the U.S.
Nonetheless, regulatory opponents continue to denigrate the scientific underpinnings of EPA regulations based on these and other studies for which raw data is kept confidential. In EPA Administrator Scott Pruitt, they have an ally.
Among key provisions of the proposal are the following:
- When promulgating significant regulatory actions, the Agency would be required to ensure that certain health data and models underlying “pivotal regulatory science”are publicly available in a manner sufficient for independent validation, including replication of study findings.
- In making data or models publicly available, the agency would be required to do so in a fashion that is consistent with law, protects privacy, confidentiality, confidential business information, and is sensitive to national and homeland security.
- EPA would be required to conduct independent peer review on all “pivotal regulatory science”used to justify regulatory decisions, …”
- The EPA Administrator could grant an exemption on a case-by-case basis if he or she determined that compliance was impracticable for certain specified reasons.
In response to near universal outcry from the science community, EPA in March 2020, issued a rewritten version that would allow use of these studies but gives preference to studies that publish their data. In other words, it holds the very studies that are the most important because they rely on human data, as less likely to be relied on. Further, the authority to make decisions as to what studies can be used, is the Administrator, a political appointee. Thus a political appointee rather than scientific experts can decide what science can and cannot be used in decision making. In addition to new proposal applies to an expanded list of agency actions beyond regulatory actions including public health information.
Suggested Talking Points
Although the proposal claims its intent is to ensure the quality and transparency of the science the EPA uses, the proposal would as a practical matter dramatically reduce the number of human health studies the EPA can use to support development of health-protective regulations, eliminating critically important research from the policy-making process.
In the absence of expensive and time-consuming work to re-create health study databases in a way that excludes personal identifiers, the proposal to make use of studies contingent upon the release of raw data would disqualify epidemiological studies that are based on confidential health data. Researchers conducting epidemiological studies typically offer confidentiality so that people will be willing to participate, and such health data is legally and ethically required to be kept confidential.
Ultimately, the policy’s effect would be to prevent or delay use of important scientific studies by EPA in regulatory decision-making – which would prevent or delay new requirements needed to protect public health.
Published, peer-reviewed health studies are not “secret science.” In health research, it is standard practice that information given with a guarantee that it be kept confidential, is kept confidential. That is ethically and legally required.
The fact that the policy is aimed solely at EPA, and not other federal agencies, shows that the purpose of this proposal is not science transparency; the purpose is to inhibit EPA’s use of science to support regulations. For example, the Trump Administration is not suggesting this policy for the Food and Drug Administration’s approval of drugs for human use. Inhibiting use of peer-reviewed health studies by FDA for regulatory decision-making would endanger public health – and the same is true for EPA.
The requirement that a study be able to be replicated would mean that examinations of the long-term impacts of pollution events such as toxic spills, for example, would be off-limits, because those events can’t be recreated. Nor as a practical matter can studies that have followed health effects for many years be replicated without continuing to expose people to pollutions for many more years.
The level of detail contained in human studies often would make it terribly costly to redact portions of the information to protect privacy. Especially at a time when budget cuts are threatening EPA’s ability to continue to protect the environment and public health, these costs represent a barrier to use of available science.[ii]
The proposal’s restrictions on use of science are unnecessary to provide assurance that studies are credible. The proposal ignores other available approaches used and supported by reputable scientists to ensure the credibility of scientific studies that may be useful for regulatory purposes. These include reanalysis by qualified scientists who are not employed by EPA or the regulated community, and replication of studies by different researchers using different data sets. This is what was done to address concerns raised in the 1990s about the validity of two studies on fine particles and mortality that EPA relied upon in issuing air regulations, and that involved confidential patient data.
EPA already has strong criteria and review processes to ensure use of sound science. The agency relies on scientific studies that are peer-reviewed to evaluate questions such as how well a study is designed and whether the analysis is valid. When appropriate, EPA requests scientific reviews by EPA’s own scientific advisors including the Scientific Advisory Board (SAB) and the Clean Air Scientific Advisory Committee (CASAC), now under separate threat by Trump/Pruitt’s dismissal of qualified independent experts and replacement by industry scientists.[iii]
Although the proposal states it would apply “prospectively” to significant regulatory actions, it could encourage opponents to seek redo of existing health-protective rules that relied upon scientific studies which would now be disallowed under this proposal. In this way it would open the door to attack on standards that are in existence today – standards that are currently providing protection for human health and the environment. For example, eight EPA programs adopted to reduce pollutants that contribute to fine particle pollution prevent more than 50,000 premature deaths annually.[iv]
In spite of all of this, the proposed rule does not include any assessment of its impact on public health and the environment.
For more suggested talking points, see Save EPA's Comments on Proposed Rule Titled:"Strengthening Transparency in Regulatory Science," submitted to EPA 7/30/2018.
There Is More That You Can Do
It would be great if well-reasoned, fact-based comments were enough to win the day, but in today's deregulatory environment, raising the political stakes of regulatory rollbacks is crucial to stopping or slowing them down. Submitting comments is a good first step. For rules that are particularly important to you, please consider taking one or more of the following steps, too. These methods can help to mobilize public opinion and spur elected leaders to fight the destructive changes that the Trump Administration is promoting.
Write to your members of Congress and other elected officials. Let them know your concerns and ask them to weigh in on this rollback and speak out publicly in favor EPA’s existing statements on this issue. These links make it easy to write your members of Congress (your representative in the House of Representatives and your two senators). If you're willing to register with Countable, this link -- https://www.countable.us/ -- allows you to identify your members of Congress and send a message to all three at once. Or, you can write them separately -- you can use https://whoismyrepresentative.com/ or https://www.usa.gov/elected-officials/ to find your members' email contact forms or snail mail addresses.
Let your state officials know that you are concerned about this issue. Write to your elected leaders, get involved with local activists who are encouraging local or state action. Voice your concern and encouragement in the media, social media, at local meetings, and at every opportunity. In the absence of federal leadership, it is vitally important that states and local governments fill the void.
Write letters to the editor and even op-eds in your local papers. Letters to the editor should be fairly brief.
Organize or participate in campaigns to make phone calls or write letters to members of Congress and make phone calls to radio stations during call-in days, or take other actions to spread the word.
Inform your local officials about these issues and ask them to make a public statement or submit comments on a proposed rollback if your jurisdiction has a stake in these issues. Bring up these issues at town hall meetings.
Spread the word via social media. Tag your elected officials so they know how you feel.
Join or organize demonstrations.
Talk to your friends, colleagues and neighbors and encourage them to comment and otherwise join in this effort.
Links For More Information
Environmental Protection Network analyses of science restriction proposal, and related letters, including:
Attack on Science Executive Summary (April 2018)
Attack on Science Policy Analysis (April 2018)
Attack on Science Legal Analysis (April 2018
EPN’s Written Statement to Science Advisory Board (May 2018)
EPN’s Request to Extend the Deadline for Comments (May 2018)
All documents available at: https://www.environmentalprotectionnetwork.org/regulatory-rollbacks
Harvard T.H. Chan School of Public Health, “Prevailing Winds”, Fall 2012 https://www.healtheffects.org/system/files/Reanalysis-ExecSumm.pdf.
Health Effects Institute, “Special Report, Reanalysis of the Harvard Six Cities Study and the American Cancer Society Study of Particulate Air Pollution and Mortality” July 2000,https://www.healtheffects.org/system/files/Reanalysis-ExecSumm.pdf
New England Journal of Medicine, "Validation of the Harvard Six Cities Study of Particulate Air Pollution and Mortality", Jan. 8, 2004, https://www.nejm.org/doi/full/10.1056/NEJM200401083500225
Qian Di, MS; Lingzhen Dai, ScD; Yun Wang, PhD; et al., "Association of short-term Exposure to Air Pollution with Mortality in Older Adults", Journal of the American Medical Association, December 26, 2017. https://jamanetwork.com/journals/jama/article-abstract/2667069
[i] Environmental Protection Network, “Preliminary Assessment of Pruitt’s Proposed Regulation to Restrict EPA’s Use of Sound Science: Summary,” April 26, 2018. https://www.environmentalprotectionnetwork.org/regulatory-rollbacks
[ii] American Association for the Advancement of Science, “Scientific Leaders Speak Out on EPA’s Proposed ‘Transparency’ Rule”, April 30, 2018, https://www.aaas.org/news/scientific-leaders-speak-out-epa-s-proposed-transparency-rule
[iv] Environmental Protection Network, “Preliminary Assessment of Pruitt’s Proposed Regulation to Restrict EPA’s use of Sound Science,” Policy Analysis, April 26, 2018. https://www.environmentalprotectionnetwork.org/regulatory-rollbacks