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Pesticide manufacturers say the EPA should make scientific data relied on for regulations public, while at the same time pressing the agency to ensure patents, trade secrets, and risk data remain private.
The Environmental Protection Agency’s April 24 proposed rule would require that the “best available science” be transparently made available to the public if the agency relies on it in making policy.
But that push is running square into companies’ need to protect trade secrets. While praising the EPA’s plan, industry officials are quickly pointing out that the laws need to go on guaranteeing that some data remain confidential.
The concern has also alarmed high-level EPA pesticide officials, who warned that if the proposal is too broadly written, it could be impractical and impose costly new mandates on companies registering pesticides.
Such companies as DowDupont Inc. and Monsanto Co. frequently urge the EPA to keep toxicity research and chemical patents private. They designate it as “confidential business information” under provisions of chemical laws.
Those data are part of a suite of information they must provide to the EPA as they register or seek approval to manufacture chemicals and pesticides. Both companies didn’t immediately respond to a request for comment.
But these data could be construed as “pivotal regulatory science” under a provision of the April 24 proposal, making public access a possibility. Such data predict the toxicity, extent of exposure, or other features of a chemical, pesticide, air, or water pollutant and could be used by independent scientists or advocacy groups to push for controls.
Pesticide manufacturers are spelling out their concerns early.
“Federal law requires that disclosure of pesticide safety data to the public protect the data from improper use by competitors and provides for the protection of confidential business information,” Jay Vroom, pesticide trade association CropLife America’s president and CEO, told Bloomberg Environment. “This protection of intellectual property contributes to further innovation and helps to ensure that new technologies reach American farmers.”
The group pointed out that, while it supports the April 24 proposal, it expects continued enforcement of intellectual property and confidential business information provisions of current pesticide law as the EPA implements the proposal.
The American Chemistry Council mirrored CropLife’s statement, saying that the chemical industry will work with the agency to “ensure transparency, while still protecting personal privacy, confidential business information, proprietary interest and intellectual property rights.”
The proposed rule’s requirements would apply to “economically significant” regulatory actions under Executive Order 12866 that have an annual economic cost of $100 million or more, interfere with another agency’s action, or raise novel legal or policy issues.
Pruitt or a future administrator could also exempt certain policies from the requirement on a case-by-case basis, according to the proposal—a provision that might raise legal questions.
If the agency sticks with the $100 million threshold under the executive order, then the EPA decisions on whether new chemicals can enter commerce would largely be unaffected, as most wouldn’t meet that threshold, Richard Engler, a senior chemist at Bergeson & Campbell PC who was formerly a senior staff scientist in the EPA’s chemicals office.
Decisions about new pesticides would be unlikely to trigger the rule’s requirements, he said. But the EPA’s decisions about whether to reregister a pesticide used on commodity crops such as wheat, corn, or soybeans could easily trigger the rule, he added.
The new plan set off alarms among high-level EPA chemicals and pesticide officials, according to emails collected by the Union of Concerned Scientists through a Freedom of Information Act request.
Nancy Beck, deputy assistant administrator of EPA’s chemicals office, in late January while the plan was being vetted, urged other EPA staffers to review the proposal to ensure the pesticide and chemical sectors were not adversely affected.
“My understanding is that these studies come in as CBI [confidential business information], but for the large majority of them, the CBI can be waived and the data can be made available (if requested),” she wrote. “Making data available is very different than requiring a publication requirement. Such a requirement would be incredibly burdensome, not practical, and you would need to create a whole new arm of the publishing industry to publish these types of studies that nobody is interested in.”
“This directive needs to be revised,” she wrote. “Without change, it will jeopardize our entire pesticide registration/re-registration review process and likely all Toxic Substances Control Act risk evaluations.”
Under the Federal Insecticide, Fungicide, and Rodenticide Act, the agency still must enforce these companies’ data protections and rights, despite the call to ban “secret science,” Jim Aidala, former official of EPA’s OCSPP, told Bloomberg Environment.
But Aidala, a senior consultant with Bergeson & Campbell PC, said this could be a “tricky issue.”
“There’s a provision for a period of time [under FIFRA] when other competing companies can’t use the data to support an application [for registration], but after that time expires, competitors can use the data, but only if they agree to the FIFRA data compensation rules” to share costs with other users, Aidala said.
“They can’t just take the data and use it,” he said. “These provisions say if you generate the data to get the first approval, you have the rights to be compensated and the EPA is trying to keep that straight. But there’s the concern about making sure it [the April 24 proposal] doesn’t mess” those arrangements up.
If adopted, the plan might shake loose or exclude data from health studies that industry and the EPA have been seeking for some time on major pesticides, such as chlorpyrifos made by Dow Chemical. The insecticide is a crop protection tool for fruit, vegetable and row crop growers.
A 2017 epidemiological study conducted by Columbia University found that chlorpyrifos negatively affected brain development in New York City children exposed in utero.
To bolster its review of the pesticide, the agency asked Columbia for the data, but the university declined, stating it would breach confidentiality pledges they made to the mothers. As part of the study, researchers assured their subjects they wouldn’t reveal their health histories, which, if made public, could negatively affect their employability or insurability.
A former federal agency offical told Bloomberg Environment that it was “frustrating” to try to understand the Columbia group’s study without access to the raw data and even pledges to anonymize sensitive information “couldn’t sway the school to give it up.”
The source — who spoke on the condition of anonymity to speak candidly — said the proposal “would have been better digested” had the agency gone “through the National Academies with this issue.” The ex-official, however, sees some “merit” in using public data.
In 2017, EPA chief Scott Pruitt denied a decade-old petition from environmental groups to ban the use of chlorpyrifos on food, in part because of the Obama-era EPA’s reliance on the Columbia study’s findings without vetting the raw data.
If the public data rule is adopted, important health findings would be unavailable for pesticide or chemical regulation if scientists decline to break confidentiality agreements with the people they studied, according to critics such as the advocacy group Beyond Pesticides.
“This is data that EPA has used in the past from epidemiological studies, especially those involving sensitive worker information and children,” Beyond Pesticides’ Nichelle Harriott told Bloomberg Environment.
“The EPA would be limiting the information it would consider for regulatory decision-making—including those for pesticides. In a roundabout way [the agency’s decisions] could be skewed by certain data,” said Harriot, the organization’s science and regulatory director.
—With assistance from Pat Rizzuto.
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