Stop EPA from relying upon unpublished and secret data

No American should argue against the use of science in public policy and rule making.

The decision by United States Environmental Protection Agency Administrator Scott Pruitt to require public disclosure of all data used to inform EPA decisions is a attempt to increase the use of traditional data driven science and the classical scientific method and restrict the use of unsupported and agenda-driven opinion in regulatory decision making.

 

Starting over?

For the first time since it was spawned from the environmental awakening of the late 1960s and delivered by Congress to an unsuspecting American people by the National Environmental Policy Act, EPA is trying to meet its original objectives without the agendas that have made it the darling of green extremists and the scourge of entrepreneurs.

In the past, the EPA has permitted opinion from non-governmental organizations and from fully-federally-funded academics, including those funded by the EPA itself, to drive their decisions. Those opinions were often unsupported by substantial credible data. Many of those opinions really cannot be termed “scientific” because the “data,” if any, upon which they are based is not available to either supporters and critics of agency actions. Nevertheless those opinions became the basis for rules and regulations which have serious impact on the physical and economic health of taxpayers, businesses, and local governments

House Science, Space and Technology Chairman Lamar Smith (R-Texas) and others argue that EPA has been crafting regulations based on “secret science” to advance its regulatory agenda. In a “closed-door” meeting at the Heritage Foundation on Monday, 19 March 2018, Administrator Pruitt said that he expects to require EPA — when making rules — to rely only on scientific studies where the underlying data are made public.

In comments on the 2019 budget proposal, the Republican majority on the Science panel chaired by Smith suggested that EPA funding should be contingent upon the requirement “that all scientific and technical information and data relied on to support a risk, exposure, or hazard assessment; criteria document; standard; limitation; regulation; regulatory impact analysis; or guidance issued by the EPA is made publicly available.”

In March, 2017, the House of Representatives passed a bill dubbed the “Honest and Open New EPA Science Treatment (HONEST) Act” — requiring that EPA rules be based on science for which underlying data is publicly available and reproducible; but the measure has gone nowhere since it was referred to the Senate Environment and Public Works Committee. One of the problems was the word “reproducible”

Is data public or private?

Yogin Kothari with the Union of Concerned Scientists claims “A lot of the data that EPA uses to protect public health and ensure that we have clean air and clean water relies on data that cannot be publicly released.” He claimed that many scientific studies rely on data that can’t be made public for reasons like patient privacy concerns or industry confidentiality.

However, patient privacy is protected by other laws and regulations such as HIPAA (Health Insurance Portability and Accountability Act of 1996), and industry confidentially must give way to the public right to know when the industry uses its data to influence rule-making.

Unpublished data may be protected, but not if used in rulemaking. Use in rule-making constitutes publication. So does reporting study results prior to peer-reviewed publication.

Use of raw data that has not been peer-reviewed or not publically disclosed by the scientists responsible for providing the data is not consistent with the scientific method which has been accepted by the scientific community since the time of Sir Francis Bacon in the late sixteenth century.

 

Replication and singular events

One issue to be resolved is the use and reliance upon data from singular events where the event or the experiment cannot be replicated.

There are numerous examples of groundbreaking studies that cannot or should not be replicated such as human health studies on the effects of atomic radiation following the atomic bombing of Hiroshima and Nagasaki or the ecological effects of a major oil spill. However, this should not be an obstacle to rational science driven by data becoming the basis for rulemaking or litigation in the public interest by the EPA or any other federal or state government agency.

Scientists have been studying singular events for hundreds of years and there are well-established procedures for evaluating the data from those events and generally accepted rules for testing the data itself and the way it was collected, organized and presented as well as the interpretations of that data. For example the effects of the ash cloud from the Mt. St. Helens eruption in Oregon; the acid mine water release at the Gold King mine in Colorado by the United States government (EPA); the climate effects of the eruption of Mt. Pinatubo in the Phillipines; all are singular events whose parameters are now well enough documented to permit prediction.

 

How much will open data cost? How much is open data worth?

Some career EPA officials claim that requiring data transparency would cost hundreds of millions of dollars because it would require EPA staff to track down data from the study authors and create an online management system to store and present those data. EPA career staff estimated that requiring disclosure of data would add $250 million in costs annually for the first few years after it was implemented, yet there was no discussion of how much unsupported and unsubstantiated rule making costs the national economy each year. Most estimates of costs to the economy are in the billions of dollars.

While EPA staffers might not wish to have additional oversight, they must explain to the American taxpayers why, after 40 years of unconstrained bureaucratic growth and mission creep, they do not have the data upon which their regulations are based readily available in a form that can be published and examined? Is it because their rulemaking is agenda-driven, not science-driven?

According to EPA bureaucrats the EPA staff would have to spend time redacting personally identifiable information in the studies, and study authors would likely require payments for preparing and sending their data. This specious argument begs the question of why irrelevant personal identification data was not removed from the study immediately after it was verified upon delivery to EPA, especially if the taxpayers of the United States supported the research.

The results of federally funded studies and all the data upon which they are based belong to the People. They are not the personal property of the authors. If a study is paid for by the People, the data belong to the People.

Parenthetically, if the burden of supplying the original data is indeed too large for the Agency, then simply providing the original citations of the work in the open scientific literature would be sufficient. However, if the work was not published in the open literature, it should not have been allowed to becme a basis for regulatory action.

 

Hidden or overt bias in EPA studies

The issue of data access is only part of the problem with EPA rule making and regulation. The larger part of the problem is hidden or overt bias by the authors of studies relied upon by EPA and other government agencies and whether those studies were driven by political considerations and economic self-interest or the norms and standards of independent scientific inquiry.

Without full disclosure of the study objectives, funding constraints, and the sources of data as well as public access to the raw data itself, there is no way for the People through their elected representatives in Congress or state legislatures to make informed public policy decisions which will have significant and long lasting effects on the environment and the economy.

 

Who provides the external advice to EPA?

In October, 2017, EPA Administrator Pruitt attempted to reduce or eliminate any incestuous relationship between those who promulgate rules and those who review them by prohibiting researchers who take EPA funding from serving on EPA advisory panels, but he would allow scientists funded by industry and business interests subject to EPA regulation to serve. He was immediately accused of appointing researchers whose work is funded by industry, lobbying groups, and conservative think tanks as science advisers, while forcing out academics from major research institutions whose funding came from EPA.

Perhaps that criticism might be justified, but for the fact that many “academics from major research institutions” and their institutions themselves show no hesitation in accepting funds from business and industry as well as the government to support their “research.”

 

Regulatory Agency decision making

Proposed rules by quasi-scientific federal agencies such as EPA, USDA, FDA, and the Department of the Interior (DOI) are based on the results of government sponsored research. Having those who originated the results also review those results creates a clear and unambiguous conflict of interest.

Traditionally, that inherent conflict was recognized and neutralized by the process of having those whose work is the basis of a decision testify before an independent and occasionally adversarial advisory committee, present their data and defend their conclusions. This is how Science is supposed to work. The funded researchers are not ignored, but become part of the process. They are just not “voting” members of the advisory group or active decision makers.

 

Pesticide regulation at the USDA

Consider the recent past and the basis for transfer of pesticide registration from the USDA to the fledgling EPA in the early 1970s. The “justification” for the transfer of pesticide registration from USDA to the EPA can be found in the testimony of Harry Hays, Director of Pesticide Registration at the United States Department of Agriculture taken from the trial of DDT in Madison, Wisconsin during the spring of 1969.

“If the data appear to us . . . to be adequate . . . the product is registered. We look at the data furnished by the manufacturer, but we don’t look at it analytically . . . . We don’t check it by the laboratory method.”

At long last the people were told that the Department of Agriculture relies entirely upon data furnished by the pesticide manufacturers.

The incredible lack of concern for the safety of the American people became apparent on further cross-examination when Doctor Hays admitted that if a pesticide was checked at all, it was checked by an entomologist only for its effectiveness against the target insect and not for its effect on beneficial insects or other fish and wildlife. “We don’t assume that the intended use will cause any damage,” he explained.

Moreover, Director Hays further admitted that although he had personal knowledge of published scientific studies showing damage to fish and wildlife from DDT, the Division of Pesticide Registration was not doing anything about possible environmental hazards from the pesticide.

Director Hays had proudly testified previously, on behalf of the Industry Task Force for DDT of the National Agricultural Chemicals Association, that the U.S. Department of Agriculture is solely responsible for the registration of pesticides and for determining whether they may be shipped in interstate commerce. He also testified that these determinations are not subject to revision except on appeal by the pesticide manufacturer. Director Hays then reluctantly admitted that the public had no access to USDA records of pesticide registration.

Thus, only in an adversary judicial proceeding was it finally demonstrated that the U.S. Department of Agriculture was really serving the agrichemical industry, while remaining at the same time essentially immune from responsibility to the American people.

 

EPA was doomed from its early days

In 1970, President Nixon signed the National Environmental Policy Act out of which evolved the United States Environmental Protection Agency a year later.

When EPA began it was staffed by inexperienced recent law graduates from some of the nation’s most prestigious law schools, rather than scientists. There were few if any “environmental scientists” available at the time and most of the scientists who had established careers at the well-funded cabinet level departments such as USDA and DOI were not interested in moving to a less prestigious Agency which they never expected to become a cabinet level department of the federal government.

The young lawyers that staffed the nascent EPA were ideologues recruited by the new environmental fund raising organizations. The recruiting criteria were exemplified in the statement from a trustee of the Environmental Defense Fund in December 1969 on the occasion of firing their cofounder, Victor Yannacone, the attorney who led their groundbreaking early lawsuits. This self-proclaimed environmental expert triumphantly proclaimed, “We will never again hire a lawyer who knows any science!”

The real reason they suddenly decided to remove Yannacone was because he refused to launch their cynical “carcinogen of the week” fund raising campaign by telling the media, “DDT causes cancer.” He had decided, as a trial lawyer, that the flawed study upon which that claim was based would not stand testing in the crucible of cross examination during a trial in court or even an administrative hearing. He was correct at that time.

 

The hidden agenda

After Yannacone left EDF, his former colleagues abandoned their original policy of presenting meaningful cases in the federal courts based on properly gathered real world data validated by the scientific method. Instead EDF and the other environmental fund raising organizations adopted an unstated but obvious mission to infiltrate and co-opt the new Environmental Protection Agency and create within it a culture and ideology driven by environmental theology rather than science validated by the scientific method.

They attempted to make the Environmental Protection Agency during the latter decades of the 20th century and into the first decades of the 21st an equivalent of the Vatican curia at the time of Galileo. In large measure, they succeeded and thereby destroyed the public credibility of the EPA.

 

Regaining credibility

• Public access to the base data of EPA regulatory decisions is one major way the EPA can regain credibility.
• Constant public review of the costs and benefits of its regulations before they are imposed is another.
• Eliminating conflicts of interest and insulating the Agency from pressures to meet political agendas by open public meetings is also critical.

Decisions of the EPA will always be controversial, but public oversight based on transparent Agency operations can make that a strength.

 

It is time for action!

Throughout the history of pesticide registration at the USDA, drug testing at the FDA, and regulation of environmental toxicants and hazardous wastes at EPA, there has been a consistent policy of secrecy and reliance upon untested and unpublished “proprietary” data.

At best, such practice invites scorn from scientists, at worst, it condones agenda-driven regulation.

 

Secrecy breeds corruption

There is still an urgent and pressing need to protect the Environment, particularly the air we breathe, the water we drink, and soils from which support agriculture, as well as the diverse populations of plants and animals which establish the quality of life for the biomes in which we live.

The Environmental Protection Agency has evolved into a bureaucracy that has bungled the task and is patently inadequate for the mission.

Administrator Pruitt has several options to help restore the integrity of the EPA. He seems to understand the need to actively solicit “skeptical” scientists on all major issues. The scientific community and the American people are still waiting for the opportunity to evaluate and test the computer models used to support claims that contributions of carbon dioxide and other “Greenhouse” gases from human activities are responsible for global climate change.

 

Computer models are not meaningful substitutes for data

Numerical computer models have invaded government decision-making at many levels.

Some computer models can be very useful when the human modelers fully understand the variables of their subject and have good data against which to evaluate their results. Modern “fly by wire” aircrafter are a case in point. Others are merely speculation or worse, wishful thinking about what the modelers hope will be “desirable” outcomes.

In 2007, the Supreme Court of United States ruled that greenhouse gases are pollutants under the Clean Air Act and directed EPA to regulate emissions of greenhouse gases from human activity, hopefully excluding the carbon dioxide we exhale as we breathe.

On December 15, 2009, the Environmental Protection Agency (EPA) made an “Endangerment Finding” and began rule making to limit carbon dioxide emissions in ordere to reduce what the EPA staff claimed was the human impact on climate change. The only scientific support for the EPA regulatory effort was opinion testimony about the results of numerical computer modeling of the effects of rising carbon dioxide on global climate based on summary studies published by the United Nations and the federal government summary studies based on those same models.

The actual structure and basis for those models has yet to be disclosed in sufficient detail for their assumptions to be tested. Their output can and may very well have been falsified.

For any numerical model of real world climate change to be validated, it must accurately reproduce published measured temperatures from past recorded history before there can be any confidence in projections about future temperature changes. None of the general circulation climate models EPA relied upon has yet to accomplish this. Real world data has put the lie to the Model-based projections. Nevertheless, although the models on which the regulations are based have failed, it has not stopped the rush to regulate anthropogenic carbon dioxide emissions.

It should be obvious that there is a serious issue of scientific integrity at the EPA.

 

Our elected representatives must act

The holdover staff at EPA—the same lawyers and bureaucrats who subverted the EPA from the beginning—are still making rules and regulations. Although essentially immune to executive action by the federal civil service system, they should be not be permitted to determine national policy without any accountability to the taxpayers who employ them.

It is time for our elected representatives in the Congress to accept their responsibility to both protect the environment and grow our economy. Our elected representatives should not be allowed to abdicate their responsibility to an inscrutable bureaucracy filled with faceless and nameless bureaucrats unaccountable to the American people.

Their job as our elected representatives is to draft and pass ecologically sophisticated, environmentally responsible, socially responsible, economically rational, and politically feasible legislation and to maintain a rigorous oversight on the quality of science in the EPA.

 

Who watches the watchers?

The ancient question of who watches the watchers must be answered by making the information available to all who might want to study it or question it; then let the People and their elected representatives make rational public policy from rational Science. Scientific integrity has a cost but we must not be afraid to pay it.