Now's the Time to Restore Integrity to EPA Regulatory Science

Guest essay by E. Calvin Beisner

For decades the federal Environmental Protection Agency (EPA) has gotten away with creating regulations that lack sound scientific basis, costing Americans hundreds of billions of dollars without solid evidence that those costs were justified.

It’s done this in two ways.

Sometimes it’s simply thrown out scientific results and regulated to satisfy a political pressure group. That was largely the case when in 1972, contrary to its own scientific findings but under heavy pressure from environmentalists, it banned the use of DDT, the most effective, least expensive, safe pesticide by which to control or eradicate disease-carrying insects like mosquitos and lice.

The U.S. had already largely eliminated malaria by widespread spraying of DDT from the 1940s into the 1960s, so the ban didn’t have immediate, large-scale negative consequences here. But it has made it more difficult to combat the recent spread of other insect-borne diseases like West Nile Virus, Zika, Lyme, and spotted fever, and even malaria is making a comeback.

The greater impact of the DDT ban has been in developing countries. The EPA persuaded other federal agencies to withhold foreign aid from countries that used DDT. Most developing countries complied. The result has been hundreds of millions of cases of malaria every year and tens of millions of malaria-caused deaths over the last 45 years.

At other times the EPA has built new regulations on “secret science”—studies whose authors refuse to grant other scientists access to the data, computer code, and methodology behind them. Such studies are not subject to replication by other scientists. Yet replication is the acid test of scientific research.

“Secret science” has been especially common as the basis for pollution regulation dependent on dose/response relationships and for regulation related to anthropogenic global warming (AGW).

Last month EPA Administrator Scott Pruitt requested public comment on a new rule, “Strengthening Transparency in Regulatory Science” (STRS), designed to solve that problem.

STRS provides that “When promulgating significant regulatory actions, the Agency shall ensure that dose response data and models underlying pivotal regulatory science are publicly available in a manner sufficient for independent validation.” It codifies what was intended in the Secret Science Reform Act of 2015, and the Honest and Open New EPA Science Treatment Act of 2017 (HONEST Act), both of which passed the House but never came up for vote in the Senate.

The Cornwall Alliance for the Stewardship of Creation—a network of scientists, economists, and religious leaders dedicated to environmental stewardship and economic development for the poor—has issued and is gathering signatures to an open letter supporting the STRS that calls the proposed rule “badly needed to assure American taxpayers that the EPA is truly acting in their best interests.”

Opponents of STRS raise three common, and at first sight credible, objections.

The first is that peer review ensures the quality of studies published in refereed journals. But there is actually no empirical evidence that peer review works well. Drummond Rennie, deputy editor of the Journal of the American Medical Association and intellectual father of the international congresses of peer review held quadrennially starting in 1989, has said, “If peer review was a drug it would never be allowed on the market.” In fact, as John P.A. Ioannidis demonstrated in a celebrated article in PLOS/Medicine, “most scientific research findings are false.”

The second common objection is that the rule would prevent the EPA from using studies that involved confidential information, such as personal health data or corporate proprietary information. In an open letter to EPA Administrator Scott Pruitt, the Leftist, political-activist Union of Concerned Scientists (UCS) argued, “there are multiple valid reasons why requiring the release of all data does not improve scientific integrity and could actually compromise research, including intellectual property, proprietary, and privacy concerns.”

Yet Section 30.5 of the rule expressly states: “Where the Agency is making data or models publicly available, it shall do so in a fashion that is consistent with law, protects privacy, confidentiality, confidential business information, and is sensitive to national and homeland security.” Section 30.9 allows the Administrator to make exceptions when compliance isn’t feasible.

A third common objection, also expressed in the UCS letter, is that “many public health studies cannot be replicated, as doing so would require intentionally and unethically exposing people and the environment to harmful contaminants or recreating one-time events (such as the Deepwater Horizon oil spill).” But what need to be replicable in studies of such events are not the events themselves but the procedures used to collect and analyze data and make inferences from them.

Consider, for example, a study that used tree-rings as proxy temperature measurements and purported to find that neither the Medieval Warm Period nor the Little Ice Age had occurred but that a rapid and historically unprecedented warming had begun in the late 19th century. The study became iconic for claims of dangerous AGW driven by human emissions of carbon dioxide.

No one needed to use a time machine to return to the 11th through 20th centuries and regrow trees to recognize that the authors had committed confirmation fallacy by excluding certain data and misused a statistical procedure, resulting in false results. All anyone needed was access to the raw data and the computer code used to analyze it.

Yet the lead author’s long refusal to allow access to raw data and computer code delayed discovery of these errors for years, during which the Intergovernmental Panel on Climate Change, the public, and governments all over the world were led to believe its claims and formulate expensive policies based partly on them.

The UCS letter asserted that concerns about transparency and certainty raised by supporters of the rule “are phony issues that weaponize ‘transparency’ to facilitate political interference in science-based decision making, rather than genuinely address either.” But the irreproducibility crisis is real, not phony. Furthermore, enhanced transparency works against politicization, not for it. This objection is so patently invalid as to suggest that those who offer it are themselves weaponizing confidentiality to facilitate their own political interference in science-based decision making.

STRS will improve, not harm, the EPA’s mission to protect Americans from real environmental risks. It will also reduce the risks caused by unjustified but costly regulations. It should be adopted.

E. Calvin Beisner, Ph.D., is Founder and National Spokesman of The Cornwall Alliance for the Stewardship of Creation.

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45 thoughts on “Now's the Time to Restore Integrity to EPA Regulatory Science

  1. It is overdue that government agencies pushing the climate advocates’ version of climate change be subject to thorough scrutiny and standards.
    If people at the EPA don’t like it they can resign by way of protest.
    Bob Hoye

    • If they resign, will their pensions and health benefits come to an end?
      Presumably accrued pension benefits would be protected.
      But – I guess – no further pension benefit would accrue.
      Auto
      Asking because that is – more-or-less – what happens in the UK.

  2. What Pruitt is proposing looks to be a demand for rigorous science. Treating health effects seriously also means testing to determine the risk is real, with the PM2.5 proposal a current example of a rule that might misallocate resources into dealing with a problem that does not exist, or is inconsequential.

    • Not really. He wants to eliminate epidemiology studies on health effects because the patients data is protected, i.e., not “transparent”. An approach advocated by the cigarette industry long ago.

      • You are using green talking points, down to the comparison with tobacco companies. The only tobacco study this is comparable to is the “second-hand smoke” studies, which relied on a meta-analysis to combine a group of insignificant studies into one purportedly valid study.Can we cook one for you?

      • De-individualizing data is a technique that was perfected 30 years ago.
        As usual, the troll is putting forth bogus objections.

      • Real skeptical. Medical data does not identify individuals. It is used for statistical purposes. Raising this as a concern about providing info in a form that replication studies can be done is either grossly ingenuous or far worse – support for fr*odulent political agenda driven science.
        I’m sickened by the amorality of this post normal age and the deteroration and nefarious repurposing of scholarship. Its impossible to have a productive debate with people who believe there is a more important goal than getting closer to the truth. Indeed lies seem to be a perfectly legitimate means to an end for the justice warriors or worriers whatever all that means.Another generation or two of students “processed” through today’s schools and universities and the task will be enormous.
        Still, I guess the fall of the Iron Curtain happened despite a 97% consensus and a hardy, brave 3% of the population being intellectual dissidents. Yeah I guess I can understand why those in dark places wont debate the 3%.

      • Reallyskeptical
        He wants to include epidemiological studies with the release of the trial description, the method, the cohort studied, the method of analysis and the results, not keep them out. Then it can be reviewed for bias, errors and replicability. Generally the methods have to be accepted by ‘the profession’.
        Novel and invalid methods, such as that used to create the ‘Hockey Stick Chart’ would not be allowed. Indeed the first journal that promised to publish MBH98, which allowed them to include it in the 1997 literature, refused later when none of the normal supplementary material was available. It was published later somewhere else more compliant and less fussy about details like proper peer review and technical validity. The first journal was right: it should not have been published absent those materials.

      • Let me put it another way.
        We audit the banks because we do not trust the bankers.
        We have now reach the point of having to audit the epidemiologists because we no longer trust them.

      • Greg, don’t forget that the “97%” includes Willis, Anthony, the Viscount, myself, and essentially all of the guest authors as well. You have to be pretty out there to be in the 3%. Remember the question is: “does global warming exist and can humans affect it”. No mention of CO2, just humans affecting the environment, which any idiot who’s ever seen deforestation can agree with.

      • reallyskeptical, I call BS. Please cite where he “wants to eliminate epidemiology studies on health effects”. Patient data is already de-individualized in such studies thus you don’t need the private data information in order to replicate. So, again I have to call BS on your nonsense talking points

  3. Where the USA leads, typically the rest of the world follows. Environmental rules first cast by the EPA in the USA have a tendency to propagate outward to the rest of the world in a copycat manner. This is often justified by appeal to the scientific authority of the EPA. So the impact of non-reproducible science ends up being wider than you might at first think.

    • The European Union chemical exposure rules make the US ones look reasonable. And they are influential beyond their borders, because any company that want to export to the EU either needs an EU-specific product (expensive), or has to make all their products comply with the EU rules.

      • This applies to asparagus and bananas even! Brussell’s definition of asparagas disqualified Britain’s product because it wasnt grown the prescribed way. They could sell it but not call it asparagus! Apparently bananas had to not have too small a radius of curvature, too. Talk about regulations! Turn the marxbrothers loose in the bureaucracy and you’ll get an idea of how far things can go.

  4. As an old geaser substitute teacher and retired engineer it drives me crazy to see our kids being exposed to “Silent Spring” quotations, the book which helped ban ddt and create the EPA. They are getting their non science to the kids early, propaganda to sixth graders from Scholastic International from the far left.

  5. “The greater impact of the DDT ban has been in developing countries. The EPA persuaded other federal agencies to withhold foreign aid from countries that used DDT. Most developing countries complied. The result has been hundreds of millions of cases of malaria every year and tens of millions of malaria-caused deaths over the last 45 years.”
    The bigger problem is that most mosquitoes are now resistant to DDT, which develops in less than 10 years of its use in a local area. So the benefits of DDT has always been a little dubious, esp. what with its affect on upper level predators.

    • It took only 10 years for mosquitoes to develop resistance to a chemical that wasn’t being used.
      Fascinating.

    • The bigger problem is that most mosquitoes are now resistant to DDT …

      http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0000716

      …Of many chemicals tested, three were selected for testing in experimental huts to confirm that chemical actions documented in laboratory tests are also expressed in the field. The laboratory tests showed the primary action of DDT is repellent, alphacypermethrin is irritant, and dieldrin is only toxic. These tests were followed with hut studies in Thailand against marked-released populations. DDT exhibited a highly protective level of repellency that kept mosquitoes outside of huts.

    • ReallySkeptical has just proved why science needs to be open because otherwise “wive tails” and “pseudoscience” start being used instead of real science.
      The term own goal comes to mind.

    • “The bigger problem is that most mosquitoes are now resistant to DDT, which develops in less than 10 years of its use in a local area”
      That a pretty good trick, considering it’s been banned for 45+ years.

  6. Transparency and replication, the foundations of honest science. Who could possibly object to that?
    A less-than-honest person would…..

    • The fact that honest people have to fight to re-introduce transparency and replication into government funded scientific research illustrates just how corrupt government research has become.
      This is a ‘no brainer’ for honest people.

  7. EPA and other Federal agencies should have to economically justify every regulatory proposal under comparable rules to SEC requirements for booking of oil & gas reserves.

  8. I was horrified when Trump proved the best of a bad pair, but I’m warming to him as a robust advocate of Capitalism.
    socialism (yes, small ‘s’) is an ideology, a political construct. Capitalism and free trade has evolved man, not the other way around, as the earliest evolution of man was made possible by trade.
    However, I’m eternally mindful of the expression “Timeo Danaos et dona ferentes”.
    Beware of Greeks bearing gifts. No offence to our Greek brethren, but the phrase is relative to the Trojan Horse of Troy.
    Whilst Pruitt’s endeavours to bring the EPA to heel are laudable, politicians rarely operate with a linear motive.

  9. The worldwide phosphate ban in washing detergents is another example of woeful flimsy science.
    Phosphates are non toxic, effective, cheap detergents and the claims of them being the cause of harmful algal blooms were wildly exaggerated.

    • Having witnessed phosphate induced algae blooms in Albany Harbour in Western Australia I would have to disagree. It has also happened in Peel Inlet near Mandurah Western Australia as well. To be fair in the Albany case it had a phosphate fertilizer works pumping out a toxic mix of phosphates and heavy metals….but never the less it is science that has been proven.
      https://link.springer.com/article/10.1007/BF00747579

    • Phosphate is a known fertilizer, that is, is often the limiting factor for growth of plant, so it would rather be a surprise is it did NOT cause algal bloom. People dislike algal bloom, they makes living matter, and living matter turns dead, and dead matter stink. This is enough to make them harmful.
      Now, some entrepreneurial being would had found a way to turn the harmful into some benefice and profit. Algal biofuel, maybe.

  10. The result has been hundreds of millions of cases of malaria every year and tens of millions of malaria-caused deaths over the last 45 years.
    Well the left is after all the advocate of Eugenics.

    • “…the left is after all the advocate of Eugenics.”
      Apparently they don’t recognize that a truly effective Eugenics program would eradicate liberalism.

  11. The EPA must face up to the fact that the AGW conjecture is based on a radiant greenhouse effect that has not been observed anywhere in the solar system including the Earth. The radiant greenhouse effect is science fiction so hence the AGW conjecture is nothing but science fiction. The EPA needs to stop basing policy of science fiction.

  12. ‘The first is that peer review ensures the quality of studies published in refereed journals.’
    Climategateer Phil Jones had published over 200 peer-reviewed papers
    ‘ The most startling observation came when he was asked how often scientists reviewing his papers for probity before publication asked to see details of his raw data, methodology and computer codes. “They’ve never asked,” he said.
    Peer review ‘ensures’ nothing at all.

    • Is there some sort of un-written agreement in the peer review process whereby every reviewer agrees not to ask for the underlying data? (nudge nudge wink wink).That ensures that when a reviewer subsequently submits his/her own paper to a Journal the next peer reviewer will not ask for data either. So then the circle is completed.

      • If the “raw” data has been collected into a spreadsheet and one can write computer code, the data processing can be checked or you could look at the code provided by the authors and check it to see what exactly it is doing. In many studies, however, the actual raw data is written down in the notebooks of researchers, including students, and if one were to ask for that, it would be a complete pain and very time consuming to try to wade through multiple lab notebooks accumulated over several years and try to get the data. So, if you asked for it, you would get a spreadsheet of data, but not the raw data and would not know if or how any data had been thrown out except by what the authors told you they had done. It takes 30 minutes to a few hours to do a minimal review of a paper and see if the data is convincing, if enough details were given to allow the study to be replicated, are there any obvious mistakes or additional experiments that need to be done. To do a more thorough job takes much longer. Most people don’t have the time. In many cases, the readers may share some of the same biases as to which methods to apply or even be “pal” review. Some sciences are much more politicized than others and this leads to additional biases where papers one agrees with may get less scrutiny and papers from the other “team” get more scrutiny. Often people will deliberately not co-author with certain people so that they can be reviewers on each others papers. Does not mean they will just approve anything, but it definitely will be a softer “pal” review from at least one of the reviewers. Not sure if in some fields or some journals they soften the rule about co-authors a bit. They all know they need to publish a lot to be competitive for grants and to get tenure.

  13. “X has gotten away with creating regulations that lack sound scientific basis”
    You can put the name of pretty much any “scientific evaluation agency” here, in any country. Esp. regarding legal drugs or the effects of radiation. In democratic countries. Because most people accepted the official conclusion.
    In many instances, a child could smell a rat in the official narrative, or even determine the correct answer by easily accessible data, like in the case of low dose low dose rate radiation. People have accepted conclusion that go against intuition and common sense because they were taught that the scientific method is the opposite of common sense, which is only true when common sense is defined as the commonly accepted answer to a question, i.e. the consensus.
    People have been trained to ignore their senses in each an every case, and disregard evidence, in the name of “the scientific method” and rejecting common sense.
    It means that the public education system failed. While the scientists and the left in general insisted on teaching evolution (if only to win against the believers in creationism), it failed to even properly teach the basics of genetics. Allegedly, a majority of polled American would like “food containing DNA” to be labeled. And now the French state owned TV channel “franceinfo” is propagating the allegedly “scientific” thesis that men are taller than women because men used to keep mammoth meat for themselves, unlike monkeys where males are taller because nature…

    • What do expect from a propaganda agency? liberal, creationist, narrative of course.
      We have plenty of so called “Venus”, prehistoric depictions of women both in sculpture and painting.
      https://en.wikipedia.org/wiki/Venus_figurines
      They are big and fat, not starved as are our current top models. Doesn’t fit the narrative, but, between a narrative and well established fact, the choice is readymade, isn’t it?
      Just another example. AFP (Agence Fakenews and Propaganda): “NASA announce a satellite to monitor ice loss in Antarctica, which are close to 100 Gt a year”. NASA website “west Antarctica experience lose close to Gt a year, but as a whole Antarctica gains close to 100 Gt a year”

  14. DDT was never completely banned and is allowed to be used indoors if sprayed on walls. Also the bald eagles return is based on phasing out DDT. I’ll take the mosquitoes.
    Better to fight disease with good nutrition which promotes a good immune system. That’s science. Also non toxic low tech like mosquitoe nets at night and repellents based on essential oils. That’s science.
    Pruitt and trump are right about global warming but completely wrong on pesticides
    As bad as gummint science is corporate science is worse. From SSRIs to glyphosate to atrazine Trumpism is here to protect patentable science. Release all the studies.
    Putting huge amounts of poison into the environment is wrong. That’s common sense and science.

  15. My concern is that the already abysmal water standards in the US will now regress further under new EPA rules; ditto for clean air. I’m not looking forward to heavy metals in the drinking water and lead in the air because the EPA can’t “prove” these pollutants are in some way dangerous.

  16. The only way to put any integrity in EPA is through prosecuting all the un-elected scumbags who have been using EPA to destroy our energy production, agriculture and manufacturing industries. Once they are all removed and imprisoned we can move forward.

  17. That whole EPA agency needs to be investigated in detail but with Obama disease at FBI it’s hard to find integrity to do the investigating.

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