40 CFR § 174.71 - Submission of information regarding adverse effects.
(a) Any person who produces, for sale or distribution, a plant-incorporated protectant exempt under subpart B of this part, who obtains any information regarding adverse effects on human health or the environment alleged to have been caused by the plant-incorporated protectant must submit such information to EPA. This requirement does not apply to any person who does not produce a plant-incorporated protectant exempt under subpart B of this part. This may include, for example, researchers performing field experiments, breeders making crosses among plant varieties with the goal of developing new plant varieties, or a person who only sells propagative materials (e.g., seed) to farmers without producing the propagative materials themselves. EPA must receive the report within 30 calendar days of the date the producer first possesses or knows of the information.
(b) Adverse effects on human health or the environment for purposes of plant-incorporated protectant means at a minimum information about incidents affecting humans or other nontarget organisms where both:
(1) The producer is aware, or has been informed, that a person or nontarget organism allegedly suffered a toxic or adverse effect due to exposure to (e.g., ingestion of) a plant-incorporated protectant.
(2) The producer has or could reasonably obtain information concerning where the incident occurred.
(c) All of the following information, if available, must be included in a report.
(1) Name of reporter, address, and telephone number.
(2) Name, address, and telephone of contact person (if different than reporter).
(3) Description of incident.
(4) Date producer became aware of incident.
(5) Date of incident.
(6) Location of incident.
(d) Reports and questions should be submitted to the Office of Pesticide Programs' Document Processing Desk at the appropriate address as set forth in 40 CFR 150.17(a) or (b).