May 8, 2020
The Honorable Andrew R. Wheeler
Administrator, U.S. Environmental Protection Agency
EPA Docket Center, Office of Research and Development Docket Mail Code 28221T
1200 Pennsylvania Avenue, NW
Washington, DC 20460
Subject: Supplemental notice of proposed rulemaking, Strengthening Transparency in Regulatory Science
(Docket ID No. EPA–HQ– OA–2018–0259)
Dear Administrator Wheeler:
On behalf of the American College of Occupational and Environmental Medicine (ACOEM), I am pleased to respond to the supplemental notice of proposed rulemaking (SNPRM), “Strengthening Transparency in Regulatory Science.” ACOEM is the premier national medical association representing more than 4,000 occupational and environmental medicine physicians and other related health professionals who champion the health of workers, the safety of workplaces, and the quality of the environment.
ACOEM had significant and multiple concerns about the proposed rule, as outlined in our previous comments of July 9, 2018. The SNPRM only reinforces our concerns. As we stated in 2018, we believe this proposal is inconsistent with the proper conduct of scientific inquiry, and we do not believe that additional burdensome peer-review steps are likely to strengthen confidence in the evidence base for new environmental regulations. Below we address the following changes to the proposed rule outlined in the SNPRM under Section C. “What action is the Agency taking?”
- Expanding the scope of the rule to all data and models, not just dose-response data and dose-response models;
- Expanding the scope of the rule to apply to influential scientific information and pivotal science, in addition to regulatory science;
- Proposing to “only use pivotal regulatory science and/or pivotal science if the data and models are available in a manner sufficient for independent validation.” Additionally, this restriction applies to studies “that include confidential business information (CBI), proprietary data, or Personally Identifiable Information (PII) that cannot be sufficiently de-identified to protect the data subjects”;
- Proposing to use the age of data and models as a factor in the determination that compliance with the rule is impracticable. “EPA requests comments on whether there are aspects other than the year the data or model was collected, completed or updated that EPA should consider in determining whether to grant an exemption in order to evaluate the technological barriers to sharing”; and
- Proposing the option of using its housekeeping authority independently as authority for taking this action.
These changes significantly expand the rule to cover all data and models, not just dose-response data and models, and influential scientific information, not just pivotal regulatory science. EPA notes that this expansion is intended to include confidential personal and business data. EPA then proposes that, when promulgating new regulations, it will only consider (Option 1) or give greater consideration to (Option 2) scientific studies where the data and models are publicly available for reanalysis. ACOEM believes that these changes render the SNPRM unfeasible, unethical, and possibly illegal.
EPA begins this SNPRM by stating that it “does not regulate any entity outside the Federal Government … the proposed requirements would modify the EPA’s internal procedures…” This statement may be meant to downplay the effect of this legislation, but clearly the SNPRM proposal may have a chilling effect on how science is conducted in the U.S. EPA has, in the past, and should continue in the future to consider all scientifically sound research when making policy (Fineberg and Allison, 2020). To exclude or downplay research that uses confidential human data would cripple science. Would researchers be able to obtain grants if the data won’t be usable for policy consideration? Would people be willing to participate in scientific research if they knew their personal information would be open to the public? Will the age of the data ensure that the study will not be considered by EPA? How will the EPA Administrator determine what factors to consider in making “exemptions” to the rule? How can the EPA Administrator ensure that political pressures will not play a part in his/her decisions?
The SNPRM’s focus on independent validation of all research is a mistaken assumption that confidence in science can only be attained by reanalysis of the data. The National Academies of Science (NAS, 2019) notes that “replicability and reproducibility are crucial pathways to attaining confidence in scientific knowledge, although not the only ones
.” (Emphasis added.) NAS describes other widely accepted methods for improving scientific rigor, including research synthesis, systematic reviews, and meta-analyses. In its report, “Reproducibility and Replicability in Science,” NAS outlines issues and makes recommendations on improving reproducibility and replicability in scientific research. NAS specifically notes that “some research involves nonpublic information that cannot legally be shared, such as patient records or human subject data.”
ACOEM strongly disagrees with the proposal to include studies containing PII in this rule. Take for example human epidemiologic studies. Epidemiologic studies are the foundation of many, if not most, environmental and occupational regulations to protect workers and the public. Consider the studies of asbestos-exposed insulators and lung cancer (Selikoff et al., 1979), benzene-exposed rubber workers and leukemia (Rinsky et al., 1987), and in children, low level lead exposure and brain damage (Lanphear et al., 2002). These epidemiologic studies were pivotal research in the subsequent regulations that have saved many workers’ lives and improved the health of millions of children. Yet these studies would likely not have been considered under this SNPRM. The simple but profound reason is the principle of confidentiality.
A key duty in the American College of Epidemiology’s ethical guidelines is the protection of confidentiality and privacy (ACE, 2000; Salerno et al. 2019). This duty echoes the obligation to maintain patient confidentiality in ACOEM’s Code of Ethics (ACOEM, 2010; ACOEM, 2012), as it does for all professional medical and scientific organizations. The 1979 Belmont report laid the groundwork for privacy and confidentiality in human research. The ethical principles guiding the report and underlying the ethical practice of science and medicine are autonomy (respect for persons), beneficence (do no harm), and distributive justice (equitable risks and benefits). The Belmont report led directly to the 1991 Common Rule, which set the regulations for the ethical conduct of human-subjects research (HHS; Salerno, 2019).
In the 2018 updated Common Rule, confidentiality protections for people who volunteer to participate in research were strengthened. In fact, the public comments leading up to the 2018 updated rule demonstrated overwhelming support (HHS; CFR, Part 46; Menikoff et al., 2017). The public must feel confident that their private information is protected, and researchers must be able to assure their research subjects that confidentiality is maintained. The SNPRM rejects this basic ethical tenet. Even with the unexplained and untested “tiered access” proposition, researchers will be unable to provide that reassurance.
EPA is also taking comments on whether to use its housekeeping authority independently as authority or in conjunction with the environmental statutory provisions cited as authority in the 2018 proposed rulemaking (as clarified in the SNPRM). EPA claims it is not seeking to interpret its own statutory authority and that the changes proposed in the SNPRM are authorized under its housekeeping authority. ACOEM strongly disagrees. The proposed rule creates arbitrary criteria for exclusion of studies considered pivotal science on the basis of use of confidential medical data. The SNPRM significantly increases the number of studies potentially excluded from consideration or subject to down-weighting by the proposed rule, thus far exceeding simple matters of administrative discretion. That the rule is intended to apply to studies in which the potential financial impacts are anticipated to exceed $500,000,000.00 further demonstrates a level of complexity in excess of that intended to be managed through administrative housekeeping alone.
The SNPRM proposes to allow the Administrator to grant an exemption to the proposed public availability requirements for using data and models in significant regulatory decisions and influential scientific information. This is presented as a mitigation of the exclusion of data in the original proposed rule. In practice, it could allow the Administrator even greater discretion, under a rule which already goes beyond Congressional intent in establishing the EPA -- that the best available science be employed to make decisions affecting environmental protection. The danger inherent in this proposal is that the power to decide what science to consider and what to reject lies in one person, a political appointee, who may be swayed by political goals. No matter what factors the Administrator may consider in granting an exemption, whether they be the year or age of the data or other aspects, the danger continues to exist. Justification of these changes under agency housekeeping provisions would arrogate for the Administrator significant powers not specified in enabling legislation. EPA already has scientific advisory committees that provide appropriate, unbiased, and multidisciplinary guidance. For these reasons ACOEM strongly opposes both the use of the housekeeping provisions to make the changes envisioned in the SNPRM and the proposed ability of the administrator to exempt or not exempt scientific research for consideration by EPA, no matter what aspects of the research are used in the decision-making.
In conclusion, the main provisions of this proposed rule are either unnecessary, duplicative, burdensome, or likely to be confusing in their application. The proposed rule will not deliver significant improvements in EPA’s current regulatory processes or improve the public’s confidence in science. In fact, the proposed rule is likely to slow the advancement of science in the U.S. and increase political interference in the conduct of science.
While my comments have been almost exclusively negative, please be aware that ACOEM has many members with vast experience in environmental health who stand ready to work constructively with EPA in crafting future rules which might assure a high level of public trust and confidence in the evidence basis for critically important environmental regulatory policy. Please contact me or Patrick O’Connor, ACOEM’s Director of Government Affairs, at 703/351-6222, if you have any questions or would be interested in our assistance.
Beth A. Baker, MD, MPH, FACOEM
[ACE, 2000] American College of Epidemiology. Ethical Guidelines, 2000. Accessed April 22, 2020: https://www.acepidemiology.org/ethics-guidelines
[ACOEM, 2010] American College of Occupational and Environmental Medicine. Code of Ethics, 2010. Accessed April 22, 2020: https://acoem.org/about-ACOEM/Governance/Code-of-Ethics
[ACOEM, 2012] ACOEM Committee on Ethical Practice in Occupational and Environmental Medicine. Confidentiality of Medical Information in the Workplace. American College of Occupational and Environmental Medicine, November 6, 2012. Accessed April 22, 2020: https://acoem.org/acoem/media/News-Library/Confidentiality-of-Medical-Information-in-
[CFR, Part 46] Code of Federal Regulations, Title 45 – Public Welfare, Part 46 - Protection of Human Subjects, Subpart A - Basic HHS Policy for the Protection of Human Subjects. U.S. Department of Health and Human Services. In effect October 22, 2018. Accessed April 22, 2020: https://www.ecfr.gov/cgi- bin/text- idx?m=10&d=22&y=2018&cd=20181018&submit=GO&SID=83cd09e1c0f5c69 37cd9d7513160fc3f&node=pt45.1.46&pd=20180719#se45.1.46_1102
Fineberg HV, Allison DB. The use and misuse of transparency in research – Science and rulemaking at the Environmental Protection Agency. JAMA
. Published online January 23,2020: http://www.zdrav.by/pdf/1238.pdf
[HHS] Office for Human Research Protection. Federal Policy for the Protection of Human Subjects (‘Common Rule’). U.S. Department of Health and Human Services. Accessed April 22, 2020 at: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html
Lanphear BP, Hornung R, Ho M, Howard CR, Eberly S, Knauf K. Environmental lead exposure during early childhood. J Pediatr
Menikoff J, Kaneshiro J, Pritchard I. The common rule, updated. N Engl J Med
[NAS, 2019] National Academies of Sciences, Engineering, and Medicine. Reproducibility and Replicability in Science. Washington, DC: The National Academies Press; 2019. https://doi.org/10.17226/25303
Rinsky RA, Smith AB, Hornung R, et al. Benzene and leukemia: an epidemiologic risk assessment. N Engl J Med.
Salerno J, Peters ES, Pinney SM, Morain S, Hlaing WM. Untangling the ethical intersection of epidemiology, human subjects research, and public health. Annals of Epidemiology, 2019; https://doi.org/10.1016/j.annepidem.2019.03.009
Selikoff IJ, Hammond EG, Seidman H. Mortality experience of asbestos insulation workers in the United States and Canada. Ann NY Acad Sci