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It is time for the American people to recover their Environmental Protection Agency

No competent voter will 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.

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 of 1970, 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 which impact the health of taxpayers, businesses, and local governments. Those opinions were often unsupported by substantial credible data. Many of those opinions really cannot be termed “Science” because the “data,” if any, upon which they are based is not available to either supporters and critics of agency actions.

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”

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, as does reporting study results prior to peer-reviewed publication.

Use of raw data that has not been peer-reviewed or 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.

Data from “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 ash cloud from the Mt. St. Helens ereuption in Oregon; the acid mine water release by the United States government near Creede, CO; the eruption of Mt. Pinatubo in the Phillipines; …

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 answer 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 be a basis for regulatory action.

Bias: hidden or overt

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 (but only those 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 unequivocal 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 works. 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 Registration: a sorry example of what is still wrong

Rather than speculate on the future, 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 DDT trial 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 is 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 is 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 primarily by young, inexperienced recent law graduates from some of the nation’s most prestigious law schools. 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 kind of young lawyers that soon staffed 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 tell the media that “DDT caused cancer” and launch their cynical “carcinogen of the week fund raising campaign.” He had decided, as a trial lawyer, that the flawed study upon which the statement 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 the 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 first decades of the 21st into the equivalent of the Vatican curia at the time of Galileo. In large measure, they succeeded and destroyed the public credibility of the EPA.

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 necessary.

Decisions of the EPA will always be controversial. 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 the scorn by 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.
It is time for our elected representatives in the Congress to face their responsibility to both protect the environment and grow our economy. They should not be allowed to hide behind an inscrutable bureaucracy filled with faceless 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.

But 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.