Plant-Incorporated Protectants; CBI Substantiation and Adverse Effects Reporting (Renewal)

This ICR addresses the two information collection requirements described in regulations pertaining to pesticidal substances that are produced by plants (plant-incorporated protectants) and which are codified in 40 CFR part 174. A plant-incorporated protectant (PIP) is defined as ``the pesticidal substance that is intended to be produced and used in a living plant and the genetic material necessary for the production of such a substance.'' Many, but not all, PIPs are exempt from registration requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Registrants sometimes include in a submission to EPA for registration of PIPs information that they claim to be CBI. CBI is protected by FIFRA and generally cannot be released to the public. For most pesticide registration applications, the current CBI regulations at 40 CFR part 2 require that claimants substantiate their CBI claims for their own records when the claim is made, and subsequently provide the substantiation to EPA only if requested. However, under 40 CFR part 174, whenever a registrant claims that information submitted to EPA in support of a PIP registration application contains CBI, the registrant must substantiate such claims to EPA when they are made. In addition, 40 CFR part 174 also requires manufacturers of PIPs that are otherwise exempted from registration requirements to report any adverse effects of the PIP to the Agency within 30 days of when the information is first obtained. Such reporting will allow the Agency to determine whether further action is needed to prevent unreasonable adverse effects to human health or the environment.

The latest form for Plant-Incorporated Protectants; CBI Substantiation and Adverse Effects Reporting (Renewal) expires 2021-02-28 and can be found here.

Plant-Incorporated Protectants - Substantiation of Confidential Business Information Claims

Federal Enterprise Architecture: Environmental Management - Environmental Monitoring and Forecasting