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Daily News Blog

26
Jul

Inspector General Finds Secret EPA Meetings with Industry and Use of Untested Science to Lower Cancer Risk for Dangerous Fumigant

(Beyond Pesticides, July 26, 2022) Secret meetings with industry, the elevation of unqualified individuals to decision-making roles, using an untested scientific approach, failing to conduct a simple literature review, and an overall absence of public transparency. This is how the U.S. Environmental Protection Agency’s (EPA) conducted its cancer review for the potent fumigant pesticide 1,3-Dichloropropane (1,3-D; brand name: Telone), according to a report from EPA’s Office of Inspector General (OIG). EPA’s actions allowed a product once considered to pose a 1 in 10,000 risk of cancer to Americans to increase exposure by 9,000% (from 7.7 μg/m3 to 690 μg/m3). “These departures from established standards during the cancer assessment for 1,3-D undermine the EPA’s credibility, as well as public confidence in and the transparency of the Agency’s scientific approaches, in its efforts to prevent unreasonable impacts on human health,” the OIG report states. Yet, even with the agency’s failings laid out in clear view, EPA’s lackluster response to OIG’s corrective actions in this case add insult to its injurious actions against public health.

OIG initiated a review of EPA’s cancer assessment for 1,3-D after the submission of multiple complaints. 1,3-D is a highly toxic fumigant used on a variety of crops, but primarily on potatoes, tobacco, strawberries, peanuts, and tomatoes to manage nematode pests in soils. The chemical has increased in use by roughly 40% over the last 20 years, with almost 37 million pounds used on 300,000 acres across the United States each year. EPA first classified 1,3-D as “likely to be carcinogenic to humans” in 1985. The chemical retained that designation until the primary manufacturer, Dow Chemical Company (recently transferred to a subsidiary called Salt Lake Holding LLC), requested EPA conduct the current cancer re-evaluation. EPA review resulted in 1,3-D being downgraded from “likely” to “suggestive evidence of carcinogenicity.”

As part of this new evaluation, a Cancer Assessment Review Committee (CARC) within EPA’s Office of Pesticide Programs is tasked with determining whether to update a chemical’s cancer classification. The process is relatively straightforward, and includes a literature search, statistical analysis, draft review, CARC vote and final posting on the pesticide’s review docket. Yet OIG found a range of serious discrepancies from the start.

One of the most basic steps – searching the open scientific literature for relevant studies on the chemical – was not properly conducted. While EPA searched for “1,3-D” and “Telone,” the full chemical name “1,3-Dichloropropene” was not included, and no one raised a red flag when only eight search results were found. OIG notes that EPA rejected consideration of all eight of these studies, and did not provide a reason, failing to follow its own guidelines. “Therefore, the OPP should have provided the rationale and methodology for excluding each study in 1,3-D’s draft human health risk assessment, but it did not,” the report notes.

In addition to this basic failing, EPA utilized a novel approach to evaluate 1,3-D’s carcinogenicity. Rather than following a process in place since 1978, EPA utilized an untested scientific approach outside of EPA’s guidance documents. At issue is how to determine the highest exposure that can occur without harming an animal long-term or causing other non-cancer effects. This value allows scientists to determine a pesticide’s carcinogenicity. Rather than the traditional maximum-tolerated-dose approach, EPA utilized an approach called kinetically-derived maximum dose (KMD). This method is so new that without guidance determining how EPA applies the information it analyzes, third parties have no way to independently evaluate EPA’s determinations. OIG notes that even after EPA applied the approach, it has participated in symposiums questioning the value of the KMD and noting its rarity in assessments. Independent scientific literature has a range of assessments on this method, with one recent study including a recommendation “to abolish the KMD concept for selecting top doses in toxicity testing.”

Not only did EPA apply a novel process to evaluating the carcinogenicity of 1,3-D, OIG interviews with EPA CARC officials reveal that members lacked knowledge on how to implement the KMD approach.  “Some believed that not all members possessed the appropriate scientific expertise for using and implementing the KMD approach for evaluating the evidence of the carcinogenic potential of 1,3-D,” the report indicates.

OIG notes that “novel, precedent-setting, or controversial influential scientific information” by the agency should be subject to external peer-review. The report quotes from EPA’s own guidelines which explain that novel scientific procedures can “undercut the scientific credibility of a risk assessment.”

Beyond the nuts and bolts of the opaque process OIG was able to reconstruct, lies the failure of EPA officials to record meetings with chemical’s primary manufacturer. Between 2016 and 2018, as EPA was in the midst of its cancer review for 1,3-D, officials met with Salt Lake Holding LLC/Dow Agrosciences at least five times. “No information from these meetings appeared in the pesticide-registration review docket, even though some of these meetings included discussions on the application of KMD for the 1,3-D cancer assessment,” the report reads. EPA claims that its cancer-related meetings were not required to go on the pesticides’ registration review docket because those actions are separate. OIG rejected that argument out of hand, referencing the fact that EPA incorporated the cancer determination into its review documents.

At the end of its report, OIG made nine recommendations for corrective action by EPA. The agency accepted the recommendation to update the document with past meeting information, and issue guidance to clarify when meetings are reported to the docket. It also agreed to update CARC’s standard operating procedures, take steps to ensure individuals with the appropriate expertise are represented at each CARC meeting, and that the committee is regularly monitored and assessed to ensure it is following internal standards. EPA agreed with OIG over the need to require external peer review of risk assessments using novel approaches that set precedent for future risk assessments.

EPA also agreed to re-conduct a comprehensive literature search on 1,3-D. Yet the review conducted exemplifies EPA’s attitude both before and after the OIG report. In a corrected memo published the 1,3-D’s docket, EPA ascribes the mistake to a “transcription error.” Despite OIG finding over 100 studies, EPA explains that “no changes were necessary or made to our analysis or conclusion.” Rather than corrective, this response continues the agency’s disdain for independent, peer-reviewed literature in favor of untested, novel approaches influenced by industry without any external peer-review.  

The recommendations EPA rejected from OIG bring this disdain into sharp relief. EPA rejected the idea that KMD represented a novel approach, and indicated the information was used merely to “interpret” tumor findings in mouse carcinogenicity studies. EPA is thus refusing to issue guidance on how to conduct KMD analysis, and instead proposed to link to a non-EPA, third-party website for guidance.  OIG rejected this proposal and considers its recommendation for EPA to issue its own guidance unresolved.

EPA also rejected OIG’s recommendation to conduct an external peer review of the 1,3-D cancer risk assessment. The agency’s reasoning? That “the external peer review sponsored by the registrant meets the intent of the recommendation to conduct an external peer review.” In other words, EPA is indicating that the review conducted by Dow Agrosciences for chemical they intend to sell for profit is an acceptable form of peer-review. OIG’s response is as follows: “While the registrant-sponsored peer review appears to have many similarities to a peer review that would be conducted by the FIFRA Scientific Advisory Panel, it lacks specific elements—such as independence from the regulated business, a preparatory public meeting to consider the scope and clarity of the draft charge questions for the peer review, an opportunity for written public comments to be considered by the peer review, and public participation for oral comments during the peer review meeting. These elements are needed to improve the transparency and scientific credibility of the 1,3-D cancer-assessment process. Thus, Recommendation 8 is unresolved.”

EPA’s response to being caught playing fast and loose with a highly carcinogenic chemical shows that no lessons are being learned. Advocates are fed up with EPA’s behavior, as it perverts its mission to comply with as little as possible to protect public health while continuing to satisfy industry stakeholders and their executive compensation. “These are not honest mistakes but carry the earmarks of deliberate malfeasance,” stated Tim Whitehouse, executive director of Public Employees for Environmental Responsibility and a former EPA enforcement attorney, noting that this fits a pattern of industry manipulation of EPA’s chemical regulation process. “This example of misconduct is egregious but, unfortunately, is not isolated.” PEER and other advocates raised the alarm about 1,3-D, and were joined in their concern by eight Attorney’s General, which urged EPA to revise its health risk assessment for 1,3-D.

For those that may consider this issue outside of their concern, note that a recent study focusing on the Western United States determined fumigant pesticides to be the class of chemicals most closely linked to county-level cancer rates. Regarding the cancer connection to fumigant use, study co-author Naveen Joseph, PhD, University of Idaho noted, “We have not seen it expressed in a fumigant like this before, and it’s absolutely striking.”

EPA was recently cited by a federal judge for its dangerously inept cancer review of glyphosate, holding that EPA unlawfully concluded that glyphosate does not pose a cancer risk. The court criticized EPA for its “disregard of tumor results;” its use of “bare assertions” that “fail[] to account coherently for the evidence;” making conclusions that do not “withstand[] scrutiny under the agency’s own framework,” and “fail[ing] to abide by” its own cancer guidelines. In sum the court noted EPA’s “inconsistent reasoning” made its decision on cancer “arbitrary,” and struck it down. The agency has a long history, such as with the synthetic pyrethroids, of uncritically accepting industry-created health models over those time-tested by peer-reviewed science.

It’s time for meaningful change to our federal pesticide laws. While EPA continues to function as protective agency in many other areas, advocates say the agency is not just failing, but antagonistic to its mission to protect public health and the environment from toxic pesticides. To remedy this, industry influence within the Office of Pesticide Programs must be rooted out and cleaned up. Only through pressure to our public officials can this occur. Take action today to tell your Senators to support needed reforms to EPA through the Protect America’s Children from Toxic Pesticides Act and Saving America’s Pollinators Act.

All unattributed positions and opinions in this piece are those of Beyond Pesticides.

Source: EPA OIG, PEER press release

 

 

 

 

 

 

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