On Friday, the Energy and Environment Subcommittee held the second hearing “Fostering Quality Science at EPA: Perspectives on Common Sense Reform.” At this hearing, the overarching theme was attack and response of the EPA research and risk analysis process. Again, Representative Harris and Representative Miller acted in dichotomous, conflicting positions attacking and defending the EPA, respectively. The two sides were formed, with a highly qualified research panel including Mr. Daniel Greenbaum, the President and Chief Executive Officer at the Health Effects Institute (HEI), Dr. Deborah Swackhamer, Professor, Environmental Health Sciences at the University of Minnesota and Chairwoman of EPA Science Advisory Board (SAB), Mr. Michael Walls, Vice President of Regulatory and Technical Affairs at the American Chemistry Council, Dr. Richard Belzer, the President of Regulatory Checkbook, Dr. Jerald Schnoor, the Allen S. Henry Chair in Engineering in the Department of Civil and Environmental Engineering at the University of Iowa, and finally, Dr. S. Stanley Young, the Assistant Director for Bioinformatics at the National Institute of Statistical Sciences.
Mr. Greenbaum and Dr. Swackhamer began discussion with the admonition that though EPA research is not perfect, it’s as high quality as humanly possible, in terms of the objective nature, unbiased quality, and peer-review certified. The leaders of the HEI and SAB truly expressed how the full-range of quality of EPA research should not come under fire, as Publication Bias is mitigated, Peer Review is Maximized, and at least 2 Statisticians always approve results prior to publication of work. This process, they argued, offers full transparency of the position, and certainly allows for an interdisciplinary, informed policy process to be undergone. Mr. Greenbaum also touched on how this process follows the predesigned process of the EPA for risk analysis, through utilizing the steps of risk assessment, risk management, and risk communication in an organized flow, and universally accepted process.
Following these remarks came two critics of EPA policy, found in Mr. Michael Walls and Dr. Richard Belzer. Mr. Walls opened with the statement that “Chemistry is Science,” and the continued to attack the critical review of the EPA’s utilization of chemical policy. He citied the IRIS program as the fundamental flaw in this reasoning. He began by expressing concerns how 2-butanol risk assessment used statistically irreverent (outlier) data sets for the policy creation. In conjunction, 80% of the IRIS program exposures are nearly 15 years old, and 90% of all IRIS analyses were over 10 years old. In conjunction with this, peer review was not consistent due to unsound risk assessment, biased peer review, and inconsistent peer review. In conjunction, Dr. Richard Belzer followed explaining how since science is the backbone for policy, all science should be considered, as opposed to searching for specific research to back up a claim. In conjunction, he followed that the risk assessment process is not objective because of this bias in research to support a claim, and suggested that both a revamping of the peer review process and a creation of a congressional advisory committee to oversee improvement of EPA information quality would be beneficial to the entire process.
Dr. Jarold Schnoor and Dr. S. Young offered the final witness testimonies at this hearing. Dr. Harold Schnoor spoke on how the quality research at the EPA has led to progress legislation such as the Clean Air Act (CAA), expressing how though this has been the most costly piece of American Legislation to date, the cost has been offset by the benefit in a 30:1 fashion. In conjunction, the CAA, according to Schnoor, has created 1.5 million jobs. Finally, Dr. Young ended the witness testimonial showing that 90% of the claimed medical problems claimed by the EPA are failed to be shown as medically relevant when expressed in terms of clinical trial testing. In conjunction, without the public access to data sets, EPA is allowed to simply present data (whether from their institution or another private area), and present the data as true. Dr. Young expressed how this allows for questionable data, and how all Epidemiology, Environmental Toxicology, and EPA cost-benefit analysis calculations and statistical analysis should be released to the public, in order for a true peer review to be undergone by the public; the peer review as it currently stands simply is a qualitative assessment of if the data is viable, not if the data calculations express true conclusions.
Representative Harris piggybacked off this, and expressed concern over the legislation of the CAA. When the CAA was initially presented, a major medical goal was to reduce asthma incidence by 2,000 cases/year. Ever since the introduction of the CAA, though, asthma incidence has been rising. With this, the cost-benefit incorporated a cofactor of medical costs, showing increased benefit arising from these reduction of cases, when, in reality, the opposite was occurring with a rise of cases showing an increase of cost, and decrease of benefit. Senator Harris was not so uneducated to claim that clean air was the cause, but instead, expertly noted that “this legislation does not seem to be helping in the reduction of the incidence of asthma, and further suggests a fundamental flaw in the EPA’s cost-benefit system”. He proposed a retrospective review to the policy, to correct this inflated 30:1 prediction to a more accurate figure. In conjunction, he demanded for a more transparent peer review process. Senator Miller then took the floor, and almost immediately suggested that a Top Scientific Panel was something the EPA has been attempting to implement, but has not been given the funds to do. In a proposition to all the witnesses, he asked if this would help the research process. All reluctantly agreed, and most claimed this would probably be feasible. In conjunction, he showed that in EPA protocol, unless data is asked for, the EPA is not required to give the data sets by federal mandate, and therefore a change of law would be necessary to blame EPA for not including data sets.
All information from this hearing is interesting. The question here really is based in bias. There are multiple ways to read statistics. Therefore, if one as a 95% Confidence Interval within a range of 2 significant figures, one could claim that any of those values are relevant. Therefore, the question of statistical significance really does not fall in to the realm of question if the EPA’s data is statistically significant and on the lower end of significance. In conjunction, the risk assessment is not really flawed, since the EPA follows a set process in the Risk Analysis Phase of experimentation.
This being said, three great points were brought up. Why doesn’t the EPA cite its data set? It’s a simple day task in order to comply with true transparency, so why not perform it? Why doesn’t the EPA provide prospective analysis for their inflated cost-benefit programs to show a true cost next to a true benefit? Why does the EPA not have an unbiased panel of top scientific officials overlook data, and why doesn’t the peer review happen using solely non-EPA officials? These are all great questions. I wonder why the process isn’t more objective. This being said, I feel the research is sound, but the agency really needs to focus on scientific review of this sound literature (by allowing for more scientists to comment by posting a data set), and also allowing for a true analysis of cost-to-benefit. If the EPA were to do this, I feel regulation would not question the laws as much. As long as room for major flexibility in this scientific policy exists, one needs to question the un-cited data set.
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