The chemical industry has an important role when it comes to ensuring that the government produces timely, credible chemical assessments to help guide regulatory efforts to protect human health and the environment. This includes engaging in and supporting valuable scientific research as well as participating in robust peer review of draft assessments. We certainly support a rigorous and fair process for selecting experts to serve on advisory committees and peer review panels—a process that first and foremost bases selection on the expertise of the scientist and employs procedures that comply with laws governing conflict of interest and ensures that panels have a balance of scientific perspectives.
Science is the lifeblood of the chemical industry: it drives innovation in our products and processes, while increasing our knowledge about the safe use of chemical products. The business of chemistry conducts extensive scientific research and testing on their products to implement product stewardship programs like Responsible Care® to ensure compliance with governmental requirements. This work is conducted both directly by companies and indirectly through contracts with and grants to external scientists and research institutions. As a result, the products of chemistry are among the most thoroughly evaluated and regulated in commerce.
The research and testing conducted by the chemical industry is conducted in accordance with the highest standards for scientific practices and is absolutely necessary, as it provides valuable information on the potential health and environmental risks of substances on which manufacturers, users and government agencies all rely to determine the conditions under which chemical products can be used safely.
We believe in the importance of fair and equal representation on scientific review panels. That means enlisting qualified scientists—from academia, industry and not-for-profit organizations—that can have “an open, engaged and comprehensive discussion of the issues before them,” as a 2009 Bipartisan Policy Center report states.i
We strongly believe that EPA policies should clearly address both conflict of interest and bias, recognizing that these are separate matters and are to be dealt with differently. Agency policies for scientific panel formation, including guidelines for addressing conflict of interest, bias and balancing panel composition, should be clear and robust. But, the affiliation or perspective of a qualified expert (“bias”) must not be confused with conflict of interest.
As described in the OMB Peer Review Bulletin, industry scientists or consultants are not to be singled out when inquiring about potential conflicts of interest. Nor should they automatically be presumed to have a conflict of interest merely because they are affiliated with industry. Questions as to financial arrangements, sources of contracts and grants, honoraria and expert witness work (for plaintiff or defendant) are equally applicable to individuals affiliated with academic institutions, research organizations, governmental organizations and non-governmental organizations. Candidates from industry should not be unfairly removed from consideration. The OMB Peer Review Bulletin is clear, “[w]ith respect to reviewers who are not federal employees, agencies shall adopt or adapt the NAS [National Academy of Sciences] policy for committee selection with respect to evaluating conflicts of interest. Both the NAS and the federal government recognize that under certain circumstances some conflict may be unavoidable in order to obtain the necessary expertise.” ii ACC supports the policy of the EPA Science Advisory Board of making public any waivers that it issues to enable persons to serve on advisory panels despite having a financial conflict of interest.
As a recent Keystone Center report points out, “[b]ecause biases exist, an agency should strive to engage a wide range of perspectives of qualified scientific experts.” Moreover, “[a]gencies need to recognize that all potential panelists will have conscious and unconscious biases, and the panel selection process requires review of the disclosed information and a judgment as to the ability of each prospective panelist to participate in open discussion and to consider other perspectives. Panelists selected should be able to have an open exchange of opinions. At a minimum, panelists need to be able to engage in give and take and to consider different views that are supported by alternative data or interpretations of data.” iii
We agree with the National Academies, which explains, “...it may be important to have an ‘industrial’ perspective or an ‘environmental’ perspective...because such individuals, through their particular knowledge and experience, are often vital to achieving an informed, comprehensive and authoritative understanding and analysis of the specific problems and potential solutions to be considered by the committee.” iv
Let Science Lead
ACC is committed to helping ensure that federal chemical assessments follow the best scientific processes and procedures including transparency, reproducibility, robust peer review and public comment.
i Bipartisan Policy Center’s Science for Policy Project, Improving the Use of Science in Regulatory Policy: Final Report (Aug. 5, 2009). Available at http://bipartisanpolicy.org/sites/default/files/BPC%20Science%20Report%20fnl.pdf
ii Office of Management and Budget, Final Information Quality Bulletin for Peer Review (Dec. 16, 2004). Available at http://www.whitehouse.gov/sites/default/files/omb/memoranda/fy2005/m05-03.pdf
iii The Keystone Center, Research Integrity Roundtable, Improving the Use of Science in Regulatory Decision-Making: Dealing with Conflict of Interest and Bias in Scientific Advisory Panels, and Improving Systematic Scientific Reviews (Sept. 18, 2012). Available at https://www.keystone.org/images/keystone-center/spp-documents/Health/Research%20Integrity%20Rountable%20Report.pdf
iv The National Academies, Policy on Committee Composition and Balance and Conflicts of Interest for Committees Used in the Development of Reports (May 12, 2003). Available at http://www.nationalacademies.org/coi/bi-coi_form-0.pdf