2668. “Poison Papers” Snapshot: HOJO Transcript Illustrates EPA Collusion With Chemical Industry

By Rebeka Wilce, Independent Science News, July 27, 2017

The world of independent chemical testing has a shiny veneer. The public is reassured that chemicals they’re exposed to on a daily basis are certified by technicians in spotless white lab coats who carefully conduct scientific studies, including on animals in neat rows of cages.

But a federal grand jury investigation that ended with convictions in the early 1980s discovered that Industrial Bio-Test Laboratories (IBT), the largest such lab in the United States, conducted trials with mice that regularly drowned in their feeding troughs. The dead animals would decompose so quickly that “their bodies oozed through wire cage bottoms and lay in purple puddles on the dropping trays.” IBT even invented an acronym “TBD/TDA” for its raw safety data, later discovered to mean “too badly decomposed.”

That was just one of a host of problems uncovered at IBT which conducted an estimated 35 to 40 percent of all the toxicology tests performed in the United States including for FDA regulated products and EPA regulated pesticides and chemicals. Scientists at the FDA were the first to spot the fraud and misconduct and blew the whistle on IBT in Senate hearings in the late 1970’s. Soon after, the EPA was forced to deal with the issue and estimated behind the scenes that some 80 percent of the data provided to them for chemical registration from IBT was nonexistent, fraudulent, or invalid.

The IBT scandal presented EPA with a potentially immense crisis. Knowing that almost every IBT test it had looked at was seriously flawed and presumptively fraudulent, it could order retests and withdraw its approval from every IBT-tested chemical. This course of action would have been fully warranted, scientifically. But it would have had drastic effects on the chemical industry, on public confidence, and on the newly-formed EPA itself.

What EPA did instead is revealed in a transcript of a meeting that took place at the Howard Johnson Motor Inn in Arlington, Virginia on October 3rd, 1978. This secret meeting was between senior figures at EPA, Canada’s Health Protection Branch, and executives of the chemical industry, and was intended to solve the IBT “problem.”

This transcript is part of more than 20,000 documents, weighing over three tons, just released by the Bioscience Resource Project and the Center for Media and Democracy (CMD), on the “Poison Papers.” website. Most of the Poison Papers were collected by author and activist Carol Van Strum, who used documents obtained through public interest lawsuits and open records requests to investigate chemical pollution, and digitized by journalist Peter von Stackelberg. Van Strum’s remarkable story was detailed this week in the Intercept. 

A conversation about collusion

The Poison Papers represent a vast trove of rediscovered chemical industry and regulatory agency documents and correspondence stretching back to the 1920s. Collectively they shed light on what was known about chemical toxicity, when, and by whom, in the often-incriminating words of the participants themselves.

The Howard Johnson’s transcript is a prime example of the materials in the trove. It allows us to “listen in” on a conversation that took place decades ago, but still has implication for us today.

The transcript “exemplifies as well as any other single document among the Papers the history of everyday regulatory failures and agency complicity that is the unknown story of the EPA and its enduring collusion with the chemical industry, and whose result is a systemic failure to protect the American public from chemical hazards,” says Dr. Jonathan Latham, Director of the Bioscience Resource Project.

“Not one” IBT study free of errors

The Howard Johnson’s meeting was called to discuss the IBT scandal and plan a way forward. No consumer groups, environmental groups or members of the public were present that day in Arlington under HoJo’s cheerful orange roof when the topic of how to deal with the dead animals, the fraudulent, and the corrupt data was discussed.

Near the outset of the meeting, the EPA’s Fred Arnold, Acting Branch Chief of Regulatory Analysis & Lab Audits, assured the chemical company representatives present that no chemicals would be removed from the market, even though the studies supposedly showing their safety had been proven fraudulent:

“We determined that [i]t was neither in EPA’s interest or the public interest or the registrants’ interest [to replace all IBT data] because a large number of studies, which were performed at IBT, were performed satisfactorily,” Arnold said. (p. 6).

Yet Arnold’s contention that some of the studies were “satisfactory” was contradicted multiple times in the same meeting. It was later stated, for example, that not one IBT study was free of errors (p. 16). Dr. Arthur Pallotta, Consultant to the Special Pesticide Review Division in the EPA’s Office of Pesticide Programs, stated that “there were few [IBT] studies that did not have discrepancies, errors and omissions” (p. 27). Elsewhere in the transcript, EPA accepted that over 80 percent of the test results from IBT were invalid (p. 123).

But Arnold’s assertion that it wasn’t in anyone’s interest to demand new studies had striking ramifications. It was the grounds for not removing any chemicals from the market, for reassuring the public, and for kicking the IBT mess down the road. By 1983, EPA had determined that over 90 percent of IBT’s studies submitted to them had serious, invalidating problems.

A “salvage operation”: ignoring scientific controls

Early in the meeting, EPA presented a list of IBT errors that it planned to ignore to make the task of “validating” IBT’s studies manageable.

It planned to ignore whenever animals were missing from (or added to) studies. No statistic existed then – nor does it now – to compensate for such measurement irregularities, but this difficulty was glossed over by the EPA.

Just as bad, many IBT studies appeared to be shorter in time than protocols called for. As David Clegg of Canada’s Health Protection Branch explained to the meeting:

“Now, we have come across the 90-day study where the study started on, let’s say, the 1st of June. The invoice for shipment of the test material from the firm was the 9th of June, and the diet preparation sheets are for the 12th of June. In other words, by the time the diet was prepared, according to the raw data, the study has been underway for 12 days for a 90-day study. This does not necessarily invalidate the study, of course. You can still get some information from it, but the whole base line, which you are working from, has to be altered to deal with an 88-day [sic] study or whatever length it is and conclusions have to be drawn on this sort of basis.”(pp. 34-35).

EPA also noted that IBT had major problems with its controls. It had run a system known as “common controls.” These controls were often in different rooms or carried out at different times, presumably with rats from different batches. EPA proposed cobbling such experiments together and thus making use of these controls. Clegg’s tone was apologetic:

“I can’t say that I am very happy about this on scientific grounds, but we are trying to run this as a salvage operation and, if we can come up with something which gives us a reasonable base line for controls which may be applicable to a number of studies, then, when controls are not available, we’ll compare them against those controls,” he said (p. 41).

EPA adopts unsigned studies

EPA’s Arnold also admitted at the meeting what appeared to be EPA’s own historical fraud. In revisiting original data sent to them by IBT, manufacturers might find that, in the past, EPA had itself examined the tissue samples and determined there to be “no significant finding” when in fact “the truth of the matter is the organ was never examined” (Arnold, p. 102).

By the time the FDA and EPA had taken a strong interest in the testing lab, IBT had begun a “policy not to sign” its own reports, according to the transcript, indicating that staff were unwilling to stand behind the findings.

As Fred Arnold told the attendees, “A number of scientists, who may have been involved in the early states of a test, are no longer there and nobody can state, categorically, that everything reflected in the report, in fact, is borne out by the raw data” (pp. 63-64).

Arnold admitted that EPA had in the past sometimes accepted unsigned studies. So he stated that its remedy to the new signature problem would be to adopt such unsigned studies in order not “to create a double standard now” (p. 64), effectively adopting IBT’s unprecedented practices as its own.

It was later uncovered in court proceedings that IBT also forged signatures.

The Howard Johnson Take Home

Three IBT officials went to prison, closing a chapter on a massive scientific fraud, but the book was never closed.

“As the Howard Johnson transcript reveals, a majority of the IBT studies were never intended to be redone, and still underlie the U.S. chemical regulatory system,” said Latham.

The Poison Papers website and document trove is a project of the Bioscience Resource Project of Ithaca, New York, and the Center for Media and Democracy of Madison, Wisconsin. You can explore the Poison Papers documents at PoisonPapers.org. You can read the Howard Johnson manuscript here.

2666. The Biotech Industry Is Taking Over the Regulation of GMOs from the Inside

by Jonathan Latham, Independent Science News, July 19, 2017

The British non-profit GMWatch recently revealed the agribusiness takeover of Conabia, the National Advisory Committee on Agricultural Biotechnology of Argentina. Conabia is the GMO assessment body of Argentina. According to GMWatch, 26 of 34 its members were either agribusiness company employees or had major conflicts of interest*.

Packing a regulatory agency with conflicted individuals is one way to ensure speedy GMO approvals and Conabia has certainly delivered that. A much more subtle, but ultimately more powerful, way is to bake approval into the structure of the GMO assessment process itself. It is easier than you might think

I recently attended the latest international conference of GMO regulators, called ISBGMO14, held in Guadalajara, Mexico (June 4-8, 2017). ISBGMO is run by the International Society for Biosafety Research (ISBR). When I first went to this biennial series of conferences, in 2007, just one presentation in the whole four days was by a company. ISBR had some aspirations towards scientific independence from agribusiness.

I went for a second time in 2011, to the ISBGMO held in Buenos Aires, Argentina. Company researchers and executives were frequent speakers and the conference had become an opportunity for agribusiness to present talking points and regulatory initiatives as if they had the blessing of science. This year, in Guadalajara, companies were now on the conference organising committee and even conferring conference travel scholarships from the podium. A former conference organiser and ISBR board member told me that the previous ISBGMO (St. Louis, USA, in 2015) had been almost entirely paid for by Monsanto.

Spreading the industry message

In Guadalajara, industry speakers were clearly working from a scripted list. That list translates as the key regulatory objectives of the biotech industry.

Prominent on that list was “data transportability”. Data transportability is the idea that regulators from different jurisdictions, say India, or the EU, should accept identical biosafety applications. Implementation of data transportability would mean that although each country has unique ecosystems and species, applicants ought not to have to provide studies tailored to each. For example, when it comes to assessing effects on non-target organisms, for example of a GMO crop producing an insecticide, regulators in Australia should accept tests on European ladybird species or earthworms as showing that a GMO cotton can safely be grown there.

The appeal of data transportability for an applicant is clear enough—less cost and less risk of their GMO failing a risk assessment. Not once did I hear mention of an obvious downside to data transportability. The fewer tests to which a novel GMO is subjected the less research there is to detect a significant problem if one exists.

A second standard corporate line was “need to know versus nice to know”. In other words do not ask applicants for more data than they wish to supply. The downsides to this are identical to data transportability. Less data is less testing and less science.

Modernising risk assessment?

Another major theme of the meeting was ‘modernization’ of regulation. In this scheme the most ‘advanced’ nation was proposed to be Canada. Canada has adopted what it calls “trait-based GMO regulation”. In trait-based regulation the method of development (i.e. whether the crop was genetically engineered or not) is considered irrelevant. The trait is the sole focus. So if a GMO crop contains an insecticide it is assessed for risk against non-target organisms. If a GMO improves flavour or nutrition then, since there is presumably no risk from flavours or nutrients, then the crop receives what amounts to a free pass.

The Canadian approach sounds harmless, but it has the crucial property that it hands control of risk assessment to the applicant, because under such a system everything depends on what the applicant chooses to call their trait. Imagine you were asked to review the safety of an aircraft, but the manufacturer wouldn’t tell you if it was propeller-driven or a jet; likewise, if a submarine was diesel or nuclear powered.

The Canadian approach therefore, by just asking what the crop is supposed to do, effectively places outside of regulation most of the standard considerations of risk and hazard. Once upon a time, risk assessment was supposed to be about what a product is notsupposed to do. For proposing non-regulation over regulation, Canadian biosafety officials were given more prominent speaking opportunities at ISBGMO14 than any other national regulator.

Tiered risk assessment

An equivalently unscientific innovation, which seems widely accepted, is called tiered risk assessment. Imagine a company presents to regulators an insect-resistant GMO crop. An obvious question arises. How is a regulator to know, since the crops produces an insecticide, if it will kill beneficial organisms such as the bees that feed on its flowers?

In tiered risk assessment this question is answered by feeding the purified GMO insecticide to a bee species. If no harm is observed the crop is assumed safe. No further tests are required. If the bees are harmed then a larger scale test, presumptively more realistic, is conducted. If harm is not observed the crop is assumed safe and no further tests are required. If harm is shown then an outdoor or larger-level test will be conducted.

Monsanto presented a lengthy exposition, in a plenary session, of the ‘soundness’ and ‘logic’ of this tiered approach. Tiered risk assessment has been the subject of little scientific debate (though see Lang et al., 2007), but the implications of the tiered approach are profound. It is an asymmetrical system in which passing any test leads to approval whereas failing that test does not result in disapproval.

Consider the comparison with pharmaceuticals. Currently, all pharmaceutical drugs must pass through three phases of clinical trials; first animal tests, then small scale human trials, then large scale human trials. Failure at any stage is considered terminal. Without wishing to give them any ideas, suppose the FDA were to replace this three-phase system with one under which approval in phase I (animal tests) allowed the developer to go straight to market. There would be, for good reason, an uproar, followed by an avalanche of dangerous medications on the market. But that is precisely the logic of tiered GMO testing.

Tiered testing is therefore a system in which failure is an unacceptable answer. In the scientific review paper that first proposed tiered risk assessment, there is no provision for rejecting the crop in the main figure, which diagrams the proposed decision tree (See Figure 1 of Romeis et al., 2008). Approvals are guaranteed. Agribusiness knows this perfectly well because many of the principal authors of Romeis et al are from the major seed and biotech companies.

The so-called logical innovations presented at ISBGMO14, such as data transportability, trait-based regulation, and tiered risk assessment, are thus intended as regulatory bypasses. They make it all but impossible for a regulator to turn down a GMO application, or even to collect sufficient information. No wonder the biotech industry likes to refer to risk assessment procedures as approval systems.

Given the lack of objection to these approaches at ISBGMO14, the biotech industry ought now to feel confident that the regulation of biotechnology is largely in their hands, but still it wants more.

In the coming years, an upsurge is expected in the GMO pipeline as new applications and new approaches become possible. This pipeline is predicted to include GMO algae, animal biotechnology, gene drives, and so forth. Many of these opportunities the industry knows will be controversial. A pacified regulatory environment is for them a necessity before that can happen.

This is more than a shame. When a comprehensive evaluation of the weaknesses and inherent limitations of scientific risk assessment is urgently needed to cope with these challenges, the chemical and biotech industries are forcing those assessment systems in the opposite direction.

References

Romeis, Jörg; Bartsch, Detlef; Bigler, Franz; Candolfi, Marco P; Gielkens, Marco M C; et al. (2008) Assessment of risk of insect-resistant transgenic crops to nontarget arthropods. Nature Biotechnology; 26: 203-8.
Andreas Lang, Éva Lauber & Béla Darvas (2007) Early-tier tests insufficient for GMO risk assessment. Nature Biotechnology 25: 35 – 36 doi:10.1038/nbt0107-35