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).
Inspection Uncovers Data Falsification
In May 2023, the EPA reviewed two suspicious studies conducted at Palamur, leading to concerns about possible data falsification. The EPA’s Good Laboratory Practice Standards Compliance Monitoring Program raised the issue through the Organization for Economic Co-operation and Development’s (OECD) GLP workgroup and Mutual Acceptance of Data Program. Following this, NGCMA was requested to inspect the laboratory and audit 58 product chemistry and acute toxicity studies.
NGCMA Confirms Non-Compliance
In July 2023, NGCMA conducted an inspection of Palamur and confirmed that data were falsified for most of the 58 studies, which were conducted between January 2020 and July 2023. The NGCMA issued a ‘Not in Compliance’ status for the laboratory, which the EPA received in September 2023. As a result, the EPA has stopped accepting any data generated by Palamur.
Impact on Pesticide Registrants
The EPA advises pesticide registrants not to submit any new data from Palamur. The EPA has evaluated all pending submissions and found that only one registrant has pending registration actions relying on Palamur-generated data. This registrant has been informed that they need to replace the Palamur-conducted studies to meet the relevant data requirements for registration. Additionally, the EPA will contact four companies with existing registrations based on data from Palamur to obtain replacement data or take other appropriate actions such as cancellation or suspension.
Guidelines for GLP Compliance
Generally, the EPA accepts studies from pesticide registrants for review as long as the conducting laboratory states that the studies follow Good Laboratory Practice (GLP) standards. The EPA has the discretion to accept a non-GLP compliant study if the submitter provides a detailed statement explaining why the studies were not conducted according to GLP standards or provides sufficient rationale for accepting the study despite non-compliance.
Future Actions and Compliance
The EPA will provide additional information if Palamur returns to GLP compliance and if the agency determines it will accept data conducted by the laboratory again. The EPA remains committed to ensuring the integrity and reliability of data used in pesticide registration to protect public health and the environment.
