{"id":29931,"date":"2021-10-01T00:01:33","date_gmt":"2021-10-01T04:01:33","guid":{"rendered":"https:\/\/beyondpesticides.org\/dailynewsblog\/?p=29931"},"modified":"2021-09-30T14:59:35","modified_gmt":"2021-09-30T18:59:35","slug":"epa-decisions-lacking-scientific-integrity-still-in-place-under-biden-administration-say-whistleblowers","status":"publish","type":"post","link":"https:\/\/beyondpesticides.org\/dailynewsblog\/2021\/10\/epa-decisions-lacking-scientific-integrity-still-in-place-under-biden-administration-say-whistleblowers\/","title":{"rendered":"EPA Decisions Lacking Scientific Integrity Still In Place Under Biden Administration, Say Whistleblowers"},"content":{"rendered":"\r\n

(Beyond Pesticides<\/em>, October 1, 2021) With this article, Beyond Pesticides rounds out its coverage of recent revelations about compromised science integrity at the U.S. Environmental Protection Agency (EPA). As Sharon Lerner reports in her September 18 (and third in a series) article in The Intercept<\/em><\/a>, new documents and whistleblower interviews reveal additional means by which EPA officials have gone out of their way to avoid assessing potential health risks of hundreds of new chemicals. Ms. Lerner writes that \u201csenior staff have made chemicals appear safer \u2014 sometimes dodging restrictions on their use \u2014 by minimizing the estimates of how much is released into the environment.\u201d Beyond Pesticides regularly monitors and reports on scientific integrity at EPA<\/a>, including two recent articles that reference Ms. Lerner\u2019s The Intercept<\/em> reporting; see \u201cEPA Agenda Undermined by Its Embrace of Industry Influence<\/a>,\u201d and \u201cWhistleblowers Say EPA Managers Engaged in Corrupt and Unethical Practices, Removed Findings, and Revised Conclusions<\/a>.\u201d<\/p>\r\n

Whistleblowers had already provided evidence<\/a> of agency malfeasance, particularly in EPA\u2019s New Chemicals Division (NCD), such as<\/a> \u201cmanagers and other officials . . . pressuring [EPA scientists] to assess chemicals to be less toxic than they actually are \u2014 and sometimes removing references to their harms from chemical assessments.\u201d Now, these career scientists have added new revelations to that tranche of disturbing information, evidenced by internal emails, meeting summaries, screenshots from EPA\u2019s internal computer system, and testimony offered in interviews with them and other EPA scientists.<\/p>\r\n

In its August 6 Daily News Blog article<\/a>, Beyond Pesticides also wrote about the whistleblowers\u2019 experiences of management retaliation for their outspokenness and advocacy for public health \u2014 including functional reassignment or demotion. A high-profile case is that of Ruth Etzel<\/a>, MD, PhD, the former director of the EPA\u2019s Office of Children\u2019s Health Protection, who is among the (now five) current or former EPA scientists who have\u00a0recently come forward<\/a>\u00a0with allegations of corruption at the agency. Dr. Etzel maintains that EPA officials tried to silence her because of her insistence on stronger lead poisoning prevention programs. She was\u00a0placed on leave<\/a>\u00a0without pay in September 2018; in a mid-September 2021 hearing before the federal Merit Systems Protection Board she testified<\/a> that EPA had \u201cissued public statements designed to discredit and intimidate her,\u201d and that the agency has become deeply corrupted by corporate and political influence.<\/p>\r\n

A little context for the recent revelations: EPA uses two measures to assess a chemical\u2019s potential health risks. One is its toxicity; the other is the amount of the compound people are likely to be exposed to in the environment. Previous whistleblower evidence, as noted above, shows that officials have pressured agency scientists to distort toxicity assessments. On the exposure front: since 1995, EPA has operated under a rubric that says, basically, if exposures are below a given threshold \u2014 the \u201cbelow modeling threshold\u201d \u2014 safety is presumed. If exposures are considered to rise above that threshold, EPA scientists are required to quantify the precise risk posed by the chemical.<\/p>\r\n

However, in recent years, scientists have determined<\/a> that \u201csome of the chemicals allowed onto the market using this [threshold] loophole do in fact present a danger, particularly to the people living in \u2018fence-line communities\u2019 near industrial plants,\u201d or proximate to other sources of chemical pollution, including chemically managed (with synthetic pesticides) agricultural fields. Agency scientists became increasingly concerned, given emerging information on low-level exposures<\/a>, that use of these \u201cexposure thresholds\u201d might be putting the public at unnecessary risk, including for cancers.<\/p>\r\n

The recent reports from whistleblowers indicate<\/a> that in 2018, a manager in EPA\u2019s Office of Pollution Prevention and Toxics (OPPT) instructed agency scientists \u201cto change the language they used to classify chemicals that were exempted from risk calculation because they were deemed to have low exposure levels. Up to that point, they had described them in reports as \u2018below modeling thresholds.\u2019 From then on, the manager explained, the scientists were to [use] the words \u2018expects to be negligible\u2019 \u2014 a phrase that implies there\u2019s no reason for concern.\u201d<\/p>\r\n

Several of the scientists involved with risk calculations were unhappy about this; they also understood that using this \u201cthreshold\u201d protocol leaves people at risk for health effects of low-level chemical exposures. They suggested to managers that instead, the thresholds be lowered so as to capture more risk data, and that they do calculations for each individual chemical under consideration \u2014 a task they noted would add mere minutes to their assessment process.<\/p>\r\n

But, as Ms. Lerner reports<\/a>, \u201cThe managers refused to heed their request, which would have not only changed how chemicals were assessed moving forward, but would have\u00a0also had implications for hundreds of assessments in the past. \u2018They told us that the use of the thresholds was a policy decision and, as such, we could not simply stop applying them,\u2019 one of the scientists who worked in the office explained to The Intercept<\/em>.\u201d Documents provided by some whistleblowers show that NCD managers have repeatedly been unresponsive to or dismissive of calls to change that policy \u2014 even when scientists have demonstrated that it puts the public at risk.<\/p>\r\n

In February 2021, a small group of agency scientists reviewed EPA\u2019s \u201csafety\u201d thresholds for every one of the 368 new chemicals submitted to\u00a0the\u00a0agency in 2020.\u00a0They found that more than half of the chemicals could pose health risks \u2014 including chemicals whose exposure potentials had already been deemed \u201cexpect[ed] to be negligible,\u201d and thus, for which specific risk calculations had not been done. Once more, the scientists brought this issue to NCD managers, explained their analysis, and requested that the use of these thresholds be terminated. The response from division managers? Crickets. As The Intercept<\/em> writes,<\/a> \u201cSeven months later, the thresholds remain in use and the risk posed by chemicals deemed to have low exposure levels is still not being calculated and included in chemical assessments.\u201d<\/p>\r\n

Such problematic dynamics comprise a substantial part of what the EPA whistleblowers have reported, and would appear to be, efforts by senior staff to undermine and contravene EPA\u2019s actual mission \u2014 \u201cto protect human health and the environment.\u201d The Intercept<\/em> article quotes<\/a> one of the two scientists who filed new disclosures with EPA\u2019s Office of the Inspector General (OIG) on August 31: \u201cOur work on new chemicals often felt like an exercise in finding ways to approve new chemicals rather than reviewing them for approval.\u201d<\/p>\r\n

Ms. Lerner asks<\/a> why it is that \u201csome senior staff and managers within the EPA\u2019s New Chemicals Division seem to feel an obligation not to burden the companies they regulate with restrictions.\u201d Advocates suggest a variety of answers. \u201cThat\u2019s the $64,000 question,\u201d commented PEER (Public Employees for Environmental Responsibility) Director of Science Policy Dr. Kyla Bennett. She has said that some career staff at EPA have been \u201ccaptured by industry.\u201d Government watchdog organizations, such as PEER, as well as Beyond Pesticides, have noted the dysfunctional \u201crevolving door\u201d<\/a> between EPA and industry. Dr. Bennett noted (in a PEER webinar attended by the author on September 22) that one agency manager moved back and forth between EPA and the private chemicals industry four times<\/em>.<\/p>\r\n

According to reporting by Carey Gillam for U.S. Right to Know<\/em><\/a> (RTK<\/em>), a\u00a0research project<\/a>\u00a0out of Harvard University\u2019s Edmond J. Safra Center for Ethics reported that, though EPA has \u201c\u2018many dedicated employees who truly believe in its mission,\u2019 the agency has been \u2018corrupted by numerous routine practices,\u2019 including a \u2018revolving door\u2019 between EPA and industry in which corporate lawyers and lobbyists gain positions of agency power, [and there is] constant\u00a0industry lobbying against environmental regulations, pressure from lawmakers who are beholden to donors, and meddling by the White House.<\/a>\u201d<\/p>\r\n

Dr. Bennett has noted that<\/a>, \u201cEPA staffers may enhance their post-agency job prospects within the industry if they stay in the good graces of chemical companies. . . . [and that] managers\u2019 performance within the division is assessed partly based on how many chemicals they approve. \u2018The bean counting is driving their actions,\u2019 said Bennett. \u2018The performance metrics should be, how many chemicals did you prevent from going onto the market, rather than how many did you get onto the market.\u2019\u201d<\/p>\r\n

Both Dr. Richard Denison of the Environmental Defense Fund, and Tim Whitehouse of PEER (the nonprofit that represents the whistleblowers and has filed complaints on their behalf with the OIG), have described the culture<\/a> of the Office of Chemical Safety and Pollution Prevention, and of OPPT\u2019s New Chemicals Division, especially. Dr. Denison has said, \u201cNCD is a \u2018black box\u2019 that courts excessive confidentiality claims from industry, withholds information from the public, and has an \u2018insular, secretive culture\u2019 that works against the mission of EPA and the interests of the people.\u201d Mr. Whitehouse asserted that \u201cpolitics has overtaken professionalism among managers at EPA.\u201d<\/p>\r\n

Dr. Denison also (in the September 22 webinar) pointed to the insularity of NCD, noting that it has little-to-no engagement with non-industry stakeholders, such as advocates in the health or labor sectors. Further, he charges the program with nurturing a \u201cculture of secrecy\u201d that results in failures to provide timely public access to industry data on chemicals or EPA\u2019s own safety evaluations, and often yields massively redacted health and safety information. This violates stipulations of the Toxic Substances Control Act<\/a> (TSCA), the authorizing law created in 1976 to protect the public from \u201cunreasonable risk of injury to health or the environment\u201d by regulating the manufacture and commercial sale of chemicals.<\/p>\r\n

Ms. Lerner\u2019s The Intercept<\/em> article dives into specifics<\/a> on how NCD\u2019s failure to attend to low-level exposure risks is exacerbating cancer risks. Cancer is a health outcome that can result from even micro-exposures to certain chemical compounds; indeed, EPA\u2019s Guidelines for Carcinogenic Risk Assessment<\/a> instruct agency scientists \u201cto assume that there is no safe level of agents that are \u2018DNA-reactive\u2019 and have \u2018direct mutagenic activity.\u2019\u201d In spite of this, NCD managers have inappropriately ignored or dismissed cancer risks about cancer risks based on the assumption that a chemical would be diluted in the air, according to evidence presented by the whistleblowers.<\/p>\r\n

This was the case for at least two chemicals \u201cassessed\u201d in 2021. EPA\u00a0deemed<\/a>\u00a0one of those (a component of adhesives) \u201cnot likely to present an unreasonable risk of harm.\u201d The other \u2014 a dialkyl sulfate that is one of a class of chemicals that causes cancer in animals \u2014 was one of 13 similar chemical submissions the agency received between June 2020 and August 2021.<\/p>\r\n

According to a whistleblower\u2019s account in late August<\/a>, \u201cEPA managers took several steps to make the dialkyl sulfate chemical appear safer than it really is. . . . Because they didn\u2019t have sufficient testing of the\u00a0substance itself, the scientist assessing it chose a closely related compound to gauge its risks. But a manager replaced that analogue, which causes miscarriages in animal experiments, with another, less harmful chemical, which allowed the agency to officially dismiss concerns about harms to the developing human fetus.\u201d<\/p>\r\n

In addition, exposure information was added to the dialkyl sulfate assessment without notification to the scientist who wrote it. The assessment indicated that the compound poses a cancer risk and acknowledged it could cause genotoxicity; a manager\u2019s change to the assessment added language to indicate that \u201cgenotoxicity is not a concern \u2018due to the dilution of the chemical substance in the media [such as the air].\u2019\u201d<\/p>\r\n

The scientists dissented, citing evidence that related compounds are known to remain in the air for at least eight days. Although EPA has not (officially) calculated potential cancer risks for all the submitted chemicals in the class, one of the whistleblowing scientists has \u2014 and found that some do represent significant cancer risks. In their complaint to the OIG, the scientists wrote: \u201cThe Agency is failing to calculate potential cancer risks to the general population based on the fallacy that a chemical is expected to be \u2018diluted\u2019 in the air. . . . You don\u2019t always find risk when you look for it. But they\u2019re not even trying.\u201d<\/p>\r\n

The Intercept<\/em> requested comment on its September 18 article from EPA; the agency referred the outlet to the same statement it had provided in response to the first two pieces in the series. As The Intercept<\/em> wrote<\/a>, \u201cThat statement said, in part, \u2018This Administration is committed to investigating alleged violations of scientific integrity. It is critical that all EPA decisions are informed by rigorous scientific information and standards. As one of his first acts as Administrator, Administrator Regan issued a memorandum outlining concrete steps to reinforce the agency\u2019s commitment to science.\u2019\u201d<\/p>\r\n

According to advocates, this seem to be a feeble response to reporting of malfeasance in EPA\u2019s own house. The references to scientific integrity, they say, ring a bit hollow, given the flagrant violations of that very integrity alleged by the whistleblowers.<\/p>\r\n

EPA does, indeed, have a Scientific Integrity Policy<\/a>. It emphasizes the importance of adherence to professional values and practices when conducting and applying the results of science and scholarship. The policy is supposed to ensure objectivity, clarity, reproducibility, and utility, and to \u201cprovide insulation\u201d from bias, fabrication, falsification, plagiarism, outside interference, censorship, and inadequate procedural and informational security.<\/p>\r\n

However, as PEER has written on its website,<\/a> \u201cDuring Trump\u2019s tenure, the record indicates EPA\u2019s Scientific Integrity program was inoperative and it has yet to revive. . . . EPA\u2019s Scientific Integrity program is a beacon of false hope and, in that sense, is worse than useless.\u201d PEER goes on to enumerate the problems: \u201cMajor hindrances in EPA\u2019s Scientific Integrity program include the total lack of investigative staff, the inability to draw upon expertise needed to assess technical issues, and the absence of any protocol for reviewing or investigating complaints. Further, EPA\u2019s Scientific Integrity Policy carries no penalties for violations. As a result, the only tool the program has is trying to persuade non-compliant managers to address their own violations when raised by their subordinates.\u201d<\/p>\r\n

PEER reports<\/a> that EPA\u2019s last annual report on the Scientific Integrity (SI) program was in 2018. PEER obtained outcome data for the period from mid-2018 through mid-2021: 35 allegations were filed, 22 remained \u201cactive\u201d (i.e., unresolved), 12 had been closed or referred \u2014 and exactly one complaint was deemed \u201csubstantiated.\u201d That case was about a staff allegation, brought in November 2020, that a memo that changed policy \u2014 such that human health assessments would be far less likely to find risk for new chemicals being evaluated \u2014 was ignored for months by managers.\u00a0<\/p>\r\n

Of that case PEER writes<\/a>, \u201cThe allegations in the complaint were \u2018sustained,\u2019 and this resulted in managers temporarily revoking the policy memo in question. However, it appears that the memo may be reissued, and the altered assessments were not corrected. Notably, this was the only complaint classified as \u2018sustained\u2019 during the past 30 months.\u201d Dr. Kyla Bennett commented, \u201c\u2018It has become clear that the only way to force EPA to address scientific malpractice is to avoid the Scientific Integrity program altogether and go public.\u2019 [She notes] that the Scientific Integrity program repeatedly acts as if it is a branch of Human Resources, seeking to deflect or suppress staff complaints. \u2018EPA needs to stop protecting\u00a0managers who violate EPA\u2019s scientific integrity policy\u00a0and deal with them appropriately.\u2019\u201d<\/p>\r\n

The above-referenced September 22 PEER webinar \u2014 a panel discussion of how EPA risk assessments for new chemicals have been improperly altered to eliminate or minimize risk calculations \u2014 surfaced a number of reforms promoted by PEER. (The webinar panelists were Dr. Kyla Bennett, Science Policy Director at PEER; Mindi Messmer, Co-founder of New Hampshire Science and Public Health and NH Safe Water Alliance; and Richard Denison, Lead Senior Scientist at the Environmental Defense Fund.)<\/p>\r\n

The top-level recommendation is that NCD needs a \u201cmassive overhaul.\u201d More specifically, Drs. Denison and Bennett point to these reforms:<\/p>\r\n