(Beyond Pesticides, February 12, 2024) Public Comments Due February 23, 2024. As the U.S. Environmental Protection (EPA) takes public comments on its updated scientific integrity policy (until February 23, 2024), Beyond Pesticides issued an action and reminds the agency that when it fails to carry out its mission to protect health and the environmentâ€”by allowing use of pesticides that are known to be hazardous and not fairly and scientifically evaluated, it is responsible for a toxic tragedy that has debilitating and deadly consequences for people and the ecosystems critical to sustaining life. Key to the recommendations Beyond Pesticides is urging EPA to consider are the following: (i) incorporate independent and emerging science into its chemical reviews; (ii) Update protocol to keep pace with new science; (iii) address vulnerabilities of those at highest risk, including those with preexisting health conditions; (iv) consider safer alternatives in calculating unreasonable risk; (v) disclose uncertainties associated with agency science or data gaps, and (vi) establish criminal penalties for EPA staff integrity violations.
In the wake of intense criticism of the U.S. Environmental Protection Agency’s (EPA) scientific integrity, the agency has announcedÂ updatesÂ to its scientific integrity guidelines. As the agency acknowledges in its 2012 Scientific Integrity Policy: â€śEPA’s ability to protect human health and the environment depends upon the integrity of the science on which it relies. The EPA Scientific Integrity Policy provides both a vision and a roadmap for scientific integrity at the Agency. Issued in 2012, the Policy builds upon EPA’s significant earlier scientific integrity efforts and addresses four areas: Promotion of a culture of scientific integrity at EPA; Release of scientific information to the public; Peer review and the use of federal advisory committees; Professional development of government scientists.â€ťÂ
It is one thing to have a policyâ€”it is another to implement it with integrity. The EPA’s Office of the Inspector General last year (2023), in its report on perfluorobutane sulfonic acid (a PFAS chemical), concluded thatÂ EPA’sâ€Ż2021 PFBS Toxicity Assessmentâ€Żfailed to â€śuphold the agency’s commitments to scientific integrity and information quality,â€ť and that the agency’s actions â€śleft the public vulnerable to potential negative impacts on human health.â€ť At the time of the reportâ€”The EPA’s January 2021 PFBS Toxicity Assessment Did Not Uphold the Agency’s Commitments to Scientific Integrity and Information Qualityâ€”agency officials disagreed with all five recommendations of the inspector general. However, EPA did provide very general aspirationalÂ responses to the OIG’s report, which include the updating of its scientific integrity policy in this latest proposal open to public comment.Â
Earlier in 2021, Public Employees for Environmental Responsibility (PEER) hadÂ filed complaintsÂ with EPA’s Office of the Inspector General (OIG) on behalf of four EPA whistleblower scientists, who said that, during the Trump administration, risk assessments for both new and existing chemicals were improperly changed by agency managers to eliminate or reduce risk calculations. At the time,â€ŻBeyond Pesticides coveredâ€Ża report inâ€ŻThe InterceptÂ that examined the multiple aspects of undue industry influence on the regulation of pesticide chemicals. While the PEER complaints address regulation of toxic chemicals not classified as pesticides, the misconduct identified by OIG andÂ The InterceptÂ represents an agency-wide problem. Nevertheless, EPA considers its updated proposed policy an enhancement of existing processes in place, saying, â€śThis policy replaces the Environmental Protection Agency’s (EPA) 2012 Scientific Integrity Policy and reaffirms and reestablishes the expectations and procedures needed to maintain scientific integrity at EPA. It also reaffirms the scope and role of a Scientific Integrity Official (SIO), a standing committee of Agency-wide deputy SIOs (DSIOs), and establishes the role of the Chief Scientist.â€ťÂ
EPA traces its history on scientific integrity back to 1983 and the â€śFishbowl Memoâ€ť issued by the first EPA Administrator William Ruckelshaus. Mr. Ruckelshaus, according to the agency, established a culture of integrity and openness for all employees by promising EPA would operate “in a fishbowl” and would “attempt to communicate with everyone from the environmentalists to those we regulate, and we will do so as openly as possible.” Then, in 1999, EPA developed Principles of Scientific Integrity in consultation with a group, the National Partnership Council, which it describes as “a partnership of Agency labor unions and management.” This document, EPA says, â€śset forth the Agency’s commitment to conducting science objectively, presenting results fairly and accurately, and avoiding conflicts of interest.â€ť Then, in 2003, EPA issued a policy and procedures to address â€śfabrication, falsification, and plagiarism.â€ť The following events included a 2009 Presidential Memorandum on Scientific Integrity, a 2010 Office of Science and Technology, followed by the agency’s first Scientific Integrity Policy in 2012 and the appointment of the first full-time scientific integrity official in 2013. The SIO is a senior career employee who is tasked with championing and promoting â€śscientific integrity throughout the Agency, and to oversee implementation and iterative improvement of scientific integrity policies and processes.â€ť
Then, nearly a decade after the establishment of the scientific integrity office, there was the issuance of the 2022 National Science and Technology Council Scientific Integrity Fast Track Action Committee report,Â Protecting the Integrity of Government ScienceÂ (SI-FTAC Report) and the National Science and Technology CouncilÂ 2023 Framework for Federal Scientific Integrity Policy and Practice. Most recently, EPA has adopted the official federal definition of scientific integrity from the National Science and Technology Council’sÂ 2023 Framework for Federal Scientific Integrity Policy and Practice: Â
Scientific integrity is the adherence to professional practices, ethical behavior, and the principles of honesty and objectivity when conducting, managing, using the results of, and communicating about science and scientific activities. Inclusivity, transparency, and protection from inappropriate influence are hallmarks of scientific integrity.Â
Despite the extensive efforts of EPA, as outlined above, scientific fraud in support of regulatory decisions has plagued the Office of Pesticide Programs for decades. During the 1970’s and 1980’s, there was theÂ Industrial Biotest and Craven LaboratoriesÂ scandals that brought to public attention fraudulent laboratory animal test data that supported the registration and tolerances (acceptable residues), respectively, of pesticides. At best, the scandals showed that EPA had inadequate oversight and audit procedures of those who produced the scientific data it used for pesticide registration. At worst, it represented EPA turning a blind eye to a culture of corruption. Things blew up in 1984 when Congress held hearings on another corruption blow-up dubbed the â€ścut-and-pasteâ€ť scandal, where EPA staff were found to use verbatim chemical company toxicology review analyses, pasting them on to EPA letterhead as if they were independently reviewed by Office of Pesticide Programs staff. Â
But, it is the more recent disclosure that raises modern-day concerns about scientific integrity at EPA. At the 2018Â Beyond Pesticides 36th National Pesticide Forum, Carey Gilliam, a veteran journalist, then-research director for U.S. Right to Know, and author ofÂ Whitewash: The Story of a Weed Killer, Cancer, and the Corruption of Science, told participants: Â
As a result of . . . litigation [associated with health effects of glyphosate/Roundup], Monsanto is forced to turn over millions of pages of internal reports, documents, emails, memos, and different studies. When you look at those along with documents that I and my colleagues at U.S. Right to Know have obtained through the Freedom of Information Act from EPA, the U.S. Department of Agriculture (USDA), the Food and Drug Administration (FDA), and various state universities, it’s a pretty incredible picture of collusion, deception, and deceit.Â
The documents show all of these different things: ghost-written research papers that assert glyphosate’s safety for publication and regulatory review; alternative assessments provided for studies that indicate harm. So if a regulator is looking at a study and says, â€śGosh, this looks like it causes cancer,â€ť Monsanto will then give them the rationale for how to interpret the data in a different way. They have networks of European and U.S. scientists that push the safety message to lawmakers and regulators. They appear to be independent, so they appear to be more authoritative and authentic. But behind the scenes we see documents that show that Monsanto is helping them or telling them what to say, or assigning them a task.Â
They provide the EPA with talking points to address. That one got me when I saw that: â€śTalking points. From Monsanto to the EPA.â€ťÂ
The influence that Monsanto has had over regulators and the stifling of independent science is, according to Ms. Gilliam, quite astounding. It plays out in successful attempts to squelch or slow down reviews.Â Click here to watch Ms. Gilliam’s Forum presentation.
Comment to EPA
Much of what EPA establishes to nurture scientific integrity and honesty of EPA staff is critical to creating a culture of true independent science, which is essential to public trust in the decisions of the agency.Â Â
Independent scienceâ€”EPAâ€™s Office of Pesticide Programs does not adequately incorporate into its protocol the independent scientific literature that informs a more robust analytical review of potential adverse health and environmental effects. The integrity of its work products, including the registration of pesticides and registration review, requires the agency to closely track and incorporate into its evaluation emerging science in the independent peer reviewed literature.Â
Updating protocol to keep pace with new scienceâ€”In 2018, then-director of the National Institute for Environmental Health Sciences Linda Birnbaum, PhD coauthored In PLOS Biology a review article of seven peer-reviewed studies of federal toxics regulation and found that â€śexisting US regulations have not kept pace with scientific advances showing that widely used chemicals cause serious health problems at levels previously assumed to be safe.â€ť The most vulnerable population, our children, face the highest risks.â€ť
Addressing vulnerabilities of those at highest riskâ€”Integrity requires attention to those who are disproportionately affected because of cumulative exposure and all vulnerabilities. For human threats, this requires an assessment of exposure associated with air, land, water, food, employment, location of residence and schools, and preexisting illnesses. Similarly, the constellation of ecosystem effects associated with endocrine disruptors, for example, requires EPA to address its failure to evaluate the full effect of pesticide use and disposal and undermines the scientific integrity of the agencyâ€™s registration of pesticides. The same holds for all pesticide active ingredients, inert ingredients, contaminants, and metabolites, if final agency actions are to be viewed as having scientific integrity. The lack of attention to synergistic effects adds to the limitations for which the agency is not transparent. Without a robust scientific review process, the value of the agencyâ€™s regulations and pesticide registrations lack integrity.
Safer alternatives in calculating unreasonable riskâ€”Decisions that implement the standard to protect against unreasonable adverse effects under FIFRA must consider the availability of alternatives that may present lower risk. A failure to evaluate alternative practices and products to the proposed or existing pesticide registration results in a decision that lacks scientific integrity.
Disclose uncertainties associated with agency science or data gapsâ€”Under the principle of transparency, a failure to disclose scientific uncertainties to the public lacks integrity.
Criminal penalties neededâ€”The failure of EPA staff to meet the scientific integrity standards as set by agency policy, in light of the harm that is caused to human health and the environment, rises to the status of a criminal act and should be enforced as such.
Thank you for your consideration of these comments.
See EPA announcement: EPA-HQ-ORD-2023-0240-0001â€”on Regulations gov.