Current reregistration procedures involve submission of data that resulted from studies performed prior to the effective date of GLPS. Do GLPS apply to such data, and if so, how?
Any data presently submitted in support of a pesticide research or marketing permit must be accompanied by a true and correct compliance statement as described at 40 CFR 160.12 regardless of when the study was performed. Therefore, data submitted to meet reregistration requirements are required to be accompanied with a true and correct compliance statement informing EPA in detail of all differences between the practices used in the study and those required by GLPS. It is not unlawful to truthfully admit that studies supporting such submissions did not comply with GLPS, nor would such an admission necessarily lead to rejection of the data. The compliance statement will help the Agency to determine the reliability of the data based on current data requirements. Note that such an admission may nevertheless result in an enforcement action if they indicate that an unlawful act has occurred. For example, other regulations, i.e., books and records as stated at 40 CFR 169.2(k), require retention of raw data generated in support of registered pesticides prior to the effective date of GLPS. Admitting to destruction of records would not exclude the Agency from taking enforcement actions for the books and records violation.
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