US EPA resumes accepting data for pesticide registration from Palamur Laboratory

In May 2024 the U.S. Environmental Protection Agency (EPA) announced it had stopped accepting studies from Palamur Biosciences Pvt. Ltd. (Palamur) in Telangana, India, due to falsification of data discovered in numerous studies. EPA is now announcing it will resume the acceptance of studies initiated on or after October 1, 2024, by Palamur following the Agency’s verification of the lab’s implementation of additional internal controls. These studies are typically submitted by pesticide registrants or applicants as part of the pesticide registration process.

Generally, EPA accepts studies from pesticide registrants for review as long as the conducting laboratory states that the studies follow good laboratory practice (GLP) standards. EPA has the discretion to accept a non-GLP compliant study if the submitter provides a detailed statement as to why the studies were not conducted according to GLP standards, or provides sufficient rationale for why the study should be accepted despite not being conducted by a GLP lab. EPA information regarding data requirements for pesticide registration is available online.

In May 2023, EPA reviewed two suspicious studies conducted at Palamur, which led the Agency to conclude there was likely falsification of data. In response to this concern, EPA’s Good Laboratory Practice Standards Compliance Monitoring Program raised this issue through the mechanism provided by the Organization for Economic Co-operation and Development (OECD) GLP workgroup and Mutual Acceptance of Data Program. In turn, EPA requested that the laboratory be inspected and 58 product chemistry and acute toxicity studies be audited. In July 2023, the Indian National Good Laboratory Practice Compliance Monitoring Authority (NGCMA) conducted an inspection of Palamur and confirmed that data were falsified for most of those 58 studies, which were conducted between January 2020 and July 2023. NGCMA issued a ‘Not in Compliance’ status for the studies, which the Agency received in September 2023.

On June 25, 2024, EPA received Palamur’s request for reacceptance of laboratory data along with supporting documentation that detailed internal controls, which include third party auditors, a whistleblower policy, regular audits and inspections, and an ethics oversight committee to review study protocols. Palamur also noted that the study directors identified in NGCMA’s audit report are no longer employed by the lab. With the completion of EPA’s review of these controls, along with renewal of the lab’s OECD GLP certification, the Agency will once again accept data from Palamur for review. Any studies initiated on or after October 1, 2024 will be accepted for review by EPA. The Agency will also accept large animal studies that were initiated after July 27, 2023, but that were not completed until on or after October 1, 2024. Many of the sponsors of these large animal studies conducted, and continue to conduct, in-process inspections of the laboratory. Any study (other than the aforementioned large-animal studies) which Palamur initiated, generated data for, or completed between January 1, 2020, and September 30, 2024, will not be accepted for review by EPA. EPA’s Office of Pesticide Programs will conduct a technical review of each study and may reject any that were not conducted in accordance with EPA or OECD GLP.