On November 22, 2024, the U.S. Environmental Protection Agency (EPA) announced the availability of more than 4,500 Data Evaluation Records (DER) in ChemView, a public portal that houses data and review of toxic chemicals. EPA defines a DER as the documented EPA review of studies submitted during the request to register a pesticide or during the registration review process. The studies for which EPA may prepare a DER include product chemistry, toxicology, ecological effects, human exposure, spray drift, environmental fate, and residue chemistry. Importantly, EPA states that DERs do not contain confidential business information.

Historically, EPA states it has not routinely released most DERs to the public. Instead, to obtain a DER not included as part of EPA’s registration review docket, including most product chemistry DERs, a requester would need to submit a Freedom of Information Act (FOIA) request separately for each DER. The DERs being released by EPA now are those that have previously been requested through the FOIA process, and are largely product chemistry DERs. EPA states that by releasing the DERs at this time, it aims to reduce the need for submitting FOIA requests for these DERs in the future.

To access DERs in ChemView, select “EPA Assessments” in the output selection box. Results can be filtered using an EPA-issued study number with the document information filter, or product code with the chemical identifier filter. EPA plans on exploring ways to proactively add DERs to ChemView as they are developed.

Commentary

In isolation, since these records are routinely made publicly available, this action is simply a further development of the program’s goals for transparency and communication. The main difference is that now a stakeholder would not need to file a separate FOIA request to obtain these DER records. This may not sound like much to the public generally, other than reducing the burden of filing requests and any effort that goes with it.

Less obvious, however, is a potential increased risk that now that this information is publicly available online, these data evaluations could be used to support market registration in other countries with weaker intellectual property protection than in the United States. This is a long-standing issue between those parties who hold the data rights and the desire of EPA or other regulators to increase transparency into their regulatory decision logic and analysis supporting a registration decision. Eliminating the FOIA requirement could lead to some greater risk of improper use of the data records, but this may not become apparent for an indefinite period as the new policy unfolds. It also is unclear what EPA intends when it states it plans on exploring ways to proactively add DERs to ChemView as they are developed.