August 12, 2018
Beware politicians who pose as “protectors of science.” After years of failing in attempts to pass legislation through Congress that would forbid federal agencies from making use of scientific results unless all the underlying raw data were publicly available, some of these politicians have recently collaborated with the EPA during the Trump Administration to propose a new EPA rule that would accomplish the task for them. The proposed rule has by now attracted some 235,000 public comments on regulations.gov. Many of these comments are clearly organized attempts to “stuff the ballot box” with very similar-sounding one-liners imploring EPA to “show their work” and reject “secret science.” These comments simply avoid mentioning the complicated underlying issue that raw data dealing with health issues of relevance to EPA regulatory policy are often subject to privacy or intellectual property restrictions that rule out public release. This is the case for many of the EPA regulations that have led, for example, to the impressive reductions in air pollution within the U.S. over the past four decades, as summarized in the plot below. Those reductions and similar improvements in water quality have contributed to rapid growth in life expectancy of the U.S. population.
We have recently submitted, on behalf of the group Concerned Scientists @ IU, a long, detailed comment on the above proposed EPA rule, that we reproduce here below. This comment points out in detail the dangers of giving authority to a political appointee to decide when science should or should not be considered in determining regulatory policy.
Comment on Proposed EPA Rule “Strengthening Transparency in Regulatory Science”
(In reference to Docket ID No. EPA-HQ-OA-2018-0259)
We are writing on behalf of Concerned Scientists @ IU, a grass-roots, non-partisan community organization consisting of over 950 members—scientists, students, and supporters of science—from the south-central Indiana region. While many of our members are faculty, students or staff at Indiana University, our organization does not officially represent the University. Concerned Scientists @ IU is dedicated to strengthening the essential role of science in public policy and evidence-based decision making.
All scientists support efforts to improve the transparency and replicability of research results. We oppose the proposed EPA rule because it will not serve that goal. The process it prescribes is vague and invites the imposition of political preferences on the selection of scientific input to the formulation of Agency standards.
A central element of the proposed rule is the vague definition of “pivotal regulatory science” to which the rule would apply. “Pivotal regulatory science” is not a phrase defined in the laws, rules or court decisions that have established EPA’s authorities and responsibilities, nor is it defined or widely used in the scientific literature. There is no useful guidance in the language of the proposed rule for an EPA Administrator to apply in deciding which issues fit and which do not fit the fluid definition of “pivotal.” We believe this ambiguity invites intrusion of political preference and prejudice into the essential scientific process of public health risk assessment.
The stated goal of the proposal is “to change agency culture and practices regarding data access so that the scientific justification for regulatory actions is truly available for validation and analysis.” Making research results available for validation and analysis is and should be the responsibility of scientists and of the peer-review process overseen by scholarly journals. Indeed, scientists have organized workshops to address instances where replicating reported research results has been a problem.1 The problems most often result from variability of conditions on which the results were not at first known to depend. Among recommended improvements1 to reporting procedures, intended to enhance replicability, are more complete descriptions in published papers of measurement conditions, subject demographics, analysis procedures, assumptions, and computer codes used, as well as making raw data publicly available, so far as possible in light of privacy and intellectual property concerns. Scientific journals have been updating their publication policies to facilitate much more detailed reporting and data archiving.2
As we detail below, it is neither practicable nor wise for a government agency to attempt to substitute its processes for the ongoing processes scientific communities have adopted. In order to meet its statutory responsibilities for protecting public health and the environment, the EPA must consider the totality of relevant, reliable, peer-reviewed scientific research. The Agency’s responsibility regarding public access to raw data is already the subject of a regulation requiring EPA, in response to Freedom of Information Act requests, to request and make public “research data relating to published research findings produced under an award” of an EPA grant, subject to privacy and other considerations. Changing agency culture can be accomplished by a thorough airing of internal guidelines, without resort to a new federal rule subject to considerable political abuse.
Footnote number 3 in the proposal justifies the perceived need to change agency culture by noting that “EPA has not consistently observed the policies underlying this proposal, and courts have at times upheld EPA’s use of non-public data in support of its regulatory actions.” However, in the two court cases highlighted in the footnote, the United States Court of Appeals for the District of Columbia Circuit found unpersuasive the petitioners’ claim that the raw data in some of the referenced studies was not publicly accessible. In addition, the Court dismissed each of the industry petitioners’ more technical claims that EPA had imposed “arbitrary and capricious” standards without adequate research support.
In dismissing the last-resort claim of data inaccessibility in the case of American Trucking Associations, Inc. v. EPA, the Court pointed out that the Clean Air Act imposes no obligation on the EPA to obtain and publicize the raw data underlying published studies on which the Agency relies. The Court distinguished EPA’s reliance on a study’s results from its reliance on the raw data underlying such results, noting that raw data often are unavailable due to proprietary interests of a study’s scientific investigators or confidentiality agreements with study participants. The Court endorsed EPA’s own claim submitted in that case:
“If EPA and other governmental agencies could not rely on published studies without conducting an independent analysis of the enormous volume of raw data underlying them, then much plainly relevant scientific information would become unavailable to EPA for use in setting standards to protect public health and the environment․ [S]uch data are often the property of scientific investigators and are often not readily available because of ․ proprietary interests ․ or because of [confidentiality] arrangements [with study participants].”
The Congress has consistently declined to adopt legislation that would add an explicit requirement to provide public access to raw data. The EPA, in its proposed rule, is attempting to delegate to itself this clearly legislative authority, with no evidence for the allegedly “secret science” raised by a small group of legislators who seek to undermine traditional EPA authority to regulate environmental hazards. That small group of legislators has had a barely concealed focus on several particular studies that have been foundational in establishing the very real connections between exposure to air pollution and adverse public health impacts.
The difficulties of dealing with those proprietary and confidentiality issues are at the heart of the serious problems with this proposed new rule. The rule addresses specifically the dose response data and models underlying “pivotal regulatory science” and informing cost-benefit impact analyses. It emphasizes “growing empirical evidence of non-linearity in the concentration-response function for specific pollutants and health effects.” It is often difficult to acquire high-quality data on health impacts of low pollutant exposures, especially for particularly vulnerable sub-populations that the courts have decided must be protected.3 Research funded by industry and research funded by federal agencies often disagree on evidence for such non-linearity, with industry generally preferring models that incorporate a threshold below which the pollutants are harmless,4 while independent research often finds harmful effects even at quite low doses.5 Thus, the issue of who is to decide which studies have given “appropriate consideration to … a broad class … of models” of dose response becomes critical in guaranteeing balanced consideration of public health risks and industry concerns. Such balance is required, for example, by the Supreme Court’s ruling in Whitman v. American Trucking Associations that the Clean Air Act requires EPA to “set air quality standards at the level that is ‘requisite’ – that is, not lower or higher than is necessary – to protect the public health with an adequate margin of safety.”
In the light of other recent EPA directives, the proposed rule can be fairly judged to favor the industry perspective at the expense of public health protection, in violation of the Court-mandated balance. The Agency is currently operating under a directive that eliminates EPA-funded scientists from consideration for membership on EPA scientific advisory boards, such as the Clean Air Scientific Advisory Committee (CASAC) mandated by the Clean Air Act. Even if they are subject experts on research relevant to regulatory considerations, scientists with some EPA funding are judged too conflicted to provide advice, while industry representatives are judged to have no such automatic conflicts. Is the advice of such now unbalanced scientific advisory boards to be critical in judging which published research is acceptable for EPA to include in formulating standards? Are intellectual property claims of proprietary data by industry to be handled consistently with claims of confidentiality by independent researchers? Will internal industry memos establishing research programs and judging whether results are consistent with industry goals be made publicly accessible, as well as raw data, to strengthen transparency and enable independent judgments on the validity of that research?
Further evidence of an industry bias is reflected in the proposed rule itself by the complaint in footnote 3 about the Court decision in the case of Coalition of Battery Recyclers Association v. EPA, in which a central issue was precisely the “growing empirical evidence of non-linearity in the concentration-response function” that EPA now claims is its primary concern. In Battery Recyclers, the D.C. Circuit Court supported the EPA’s current practice with respect to scientific evidence, rather than that proposed in the new rule. In particular, the Court upheld EPA’s use of evidence revealing important non-linearity in dose response to lead concentrations in the atmosphere, in the face of industry arguments opposing the claim of non-linearity. The EPA now appears to support the Battery Recyclers’ opposition, because the evidence used suggested a non-linearity opposite to that preferred by industry. The evidence comprised four independent research studies of correlations between blood lead levels and the IQ of young U.S. children. Rather than supporting a threshold effect, the data indicated that incremental IQ loss actually increased at lower blood lead levels. The Agency thus based its revised standard for atmospheric lead concentrations on analyses of children with blood lead levels closest to the low average levels of children in the United States today. Having failed to persuade the Circuit Court of its position, industry, it appears, has now found a friendly audience in the current EPA administration.
The petitioners in the above case complained that EPA had relied more on actual research data for the most vulnerable population sector than on generic risk assessment models that would have suggested greater uncertainty regarding the non-linearity. The petitioners ignored the general argument that models are useful only to the extent that they maintain consistency with actual research data. The issue of lack of public access to the raw underlying data was raised for only one of the four independent research studies on which EPA relied. Had EPA been required to eliminate that study from consideration, as suggested by the proposed new rule, the Agency would have had a more difficult task to convince a court that they were fulfilling their responsibility “to protect the public health with an adequate margin of safety.”
Inadequate protection from exposure of children to lead is only one example among many of potential EPA failures if the proposed rule were to be adopted. A second example concerns national ambient air quality standards (NAAQS) for fine particulate matter (PM), whose presence can aggravate respiratory conditions such as asthma and chronic bronchitis, cause increased susceptibility to respiratory infections and heightened risk of premature death. Had the proposed rule been in effect, EPA would likely have rejected the use of critical research that led to revised 1997 NAAQS that included an annual primary standard of 15 micrograms per cubic meter on PM less than 2.5 micrometers in diameter. But that air quality standard has been shown to be of clear importance to public health: research6 carried out in 2012 demonstrates after the fact the continuing health benefits to the American public that have resulted from the revised fine PM standard.
In particular, Correia et al. analyzed6 publicly accessible data from 545 U.S. counties that reported annual ambient fine PM levels in 2000 and 2007, along with county-specific life expectancies and other data used to unravel effects of potentially confounding variables, such as socioeconomic status, smoking prevalence and demographic characteristics. Among these 545 counties, they found a strong correlation of reduced life expectancy with increased fine PM levels (see figure below), and even the small changes in fine PM levels from 2000 to 2007, resulting from efforts to address EPA’s revised 1997 standards that reduced emissions of PM and PM precursors, caused clearly discernible incremental improvements in life expectancy. The unveiled correlation indicated that a reduction in fine PM level of 10 micrograms per cubic meter would increase life expectancy by 0.35 years when averaged over all counties, but by nearly one year when averaged over urban counties only, and presumably even more when considered for particularly vulnerable segments of the population. Furthermore, this incremental improvement in life expectancy had no discernible correlation with the year 2000 baseline PM level of the county, a result consistent with the absence of any “harmless threshold” effect within the reported range of PM levels.
To cite only a few more examples with clear public health implications, if the proposed new rule were to go into effect, EPA could also be forced to roll back current: (1) water quality criteria and safe levels for fish consumption of pollutants such as methylmercury and PCBs; (2) drinking water standards and health advisories for pollutants such as arsenic and nitrate; (3) standards for toxic chemical usage, such as pesticides in agriculture and formaldehyde in furniture manufacturing. In short, under the proposed rule, an EPA Administrator could undo much of the successful protection of public health and the environment that EPA has managed over decades in response to mandates passed by Congress. Industry compliance costs to address public health issues as expressed in EPA regulations might decrease, but as Justice Antonin Scalia wrote in the Supreme Court opinion in Whitman v. American Trucking Associations, “economic considerations [may] play no part in the promulgation of ambient air quality standards.”
Finally, to quote the Federal Register notice:
“The proposed rule includes a provision allowing the Administrator to exempt significant regulatory decisions on a case-by-case basis if he or she determines that compliance is impracticable because it is not feasible to ensure that all dose response data and models underlying pivotal regulatory science are publicly available in a fashion that is consistent with law, protects privacy and confidentiality, and is sensitive to national and homeland security…”
This clause, in concert with the ambiguity in defining “pivotal regulatory science,” is an open invitation to arbitrary and capricious decisions in selecting scientific input and to the suppression of health risk data whose release industry views as economically undesirable. If compliance with the rule is judged impracticable in some cases, it is best to consider it impracticable for EPA to impose in all cases, rather than providing the Administrator with essentially unguided discretion to decide when science is acceptable and when it is not. Leave the decision on whether sufficient information is provided in publications to allow for independent validation and analysis to the journals publishing the research and to the peer review process controlled by scientists, rather than by politicians.
In conclusion, we believe that the proposed rule undermines the essential role of science in the regulatory process, and would open the door to partisan manipulation of EPA risk assessment science, jeopardizing the Agency’s responsibility to “protect the public health with an adequate margin of safety,” and we strongly oppose its adoption.
1. For example, see the report of the Workshop on Robustness, Reliability, and Reproducibility in Scientific Research.
2. J. Berg, P. Campbell, V. Kiermer, N. Raikhel and D. Sweet, “Joint Statement on EPA Proposed Rule and Public Availability of Data,” Science, Vol. 360, Issue 6388, eaau0116 (May 4, 2018) [DOI: 10.1126/science.aau0116]
3. For example, in American Lung Association v. EPA (1998) the D.C. Circuit Court concluded that national ambient air quality standards (NAAQS) “must protect not only average healthy individuals, but also ‘sensitive citizens’ “ such as children, and “[i]f a pollutant adversely affects the health of these sensitive individuals, EPA must strengthen the entire national standard.”
4. For example, see J. Bukowski, M. Nicolich and R.J. Lewis, “Extreme Sensitivity and the Practical Implications of Risk Assessment Thresholds,” Dose-Response 11, 130 (2013).
5. For example, see M. Lippmann, “The Search for Non-Linear Exposure-Response Relationships at Ambient Levels in Environmental Epidemiology,” Nonlinearity in Biology, Toxicology and Medicine 3, 125 (2005).
6. A.W. Correia, et al., “Effect of Air Pollution Control on Life Expectancy in the United States,” Epidemiology 24, 23 (2013).