​US EPA halts acceptance of data for pesticide registration from a non-compliant laboratory

The U.S. Environmental Protection Agency (EPA) has halted the acceptance of studies generated by Palamur Biosciences Lab (Palamur) in Telangana, India, due to the possible falsification of data following an inspection by the Indian National Good Laboratory Practice Compliance Monitoring Authority (NGCMA). These data are typically submitted by pesticide registrants or applicants as part of the pesticide registration process. At this time, EPA is not accepting any studies from this lab, and registrants should not submit any new data from this lab.

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 our reviewer to conclude there was possible 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’s GLP workgroup and Mutual Acceptance of Data Program, which requested that the laboratory be inspected and 58 product chemistry and acute toxicity studies be audited. In July 2023, 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 laboratory, which the Agency received in September 2023.

As a result, EPA is not currently accepting any data generated by Palamur and advises registrants to not submit any new data from this lab. Over the past several months, EPA has evaluated all pending submissions and determined that only one registrant has pending registration actions that rely on Palamur-generated product chemistry or acute toxicity data. EPA has contacted this registrant and informed them that they will need to replace the Palamur-conducted studies in order to meet the relevant data requirement(s) for registration. EPA will also be contacting the four companies that have existing registrations that rely on product chemistry or acute toxicity data generated by Palamur lab during this time-frame. EPA will work with each affected registrant to obtain appropriate replacement data or take other appropriate action such as cancellation or suspension.

The Agency will provide additional information if Palamur returns to GLP compliance and EPA determines that it will again accept data conducted by the laboratory.