Pesticides; Data Requirements for Plant-Incorporated Protectants (PIPs) and Certain Exemptions for PIPs
EPA will propose codifying data requirements that specifically address the registration data needs of plant-incorporated protectants (PIPs). These data requirements are intended to provide EPA with data and other information necessary for the registration of a PIP or the issuance of an experimental use permit for a PIP. These requirements would improve the Agency?s ability to make regulatory decisions about the human health and environmental effects of these products. By codifying data requirements specific to PIPs, the regulated community would have a better understanding of and could better prepare for the PIP registration process. This proposed rule is one in a series of proposals to update and clarify pesticide data requirements. In general, pesticide data requirements are codified in 40 CFR 158, which describes the minimum data and information EPA typically requires to support an application for pesticide registration or amendment; support the maintenance of a pesticide registration by means of the data call-in process, e.g., as used in the registration review program; or establish or maintain a tolerance or exemption from the requirements of a tolerance for a pesticide chemical residue. This part establishes general policies and procedures associated with the submission of data in support of a pesticide regulatory action. It does not, however, include study protocols, methodology, or standards for conducting or reporting test results; nor does this part describe how the Agency uses or evaluates the data and information in its risk assessment and risk management decisions, or the regulatory determinations that may be based upon the data. Also, EPA will propose to exempt cisgenic PIPs from registration to encourage research and development of useful biotechnology and reduce the number of PIPs seeking registration. Cisgenic PIPs are formed when genetic material is transferred, using bioengineering technology, between plants that could transfer the genetic material naturally.
1 action from April 2012