§ 159.184 Toxic or adverse effect incident reports.

(a) General. Information about incidents affecting humans or other non-target organisms must be submitted if the following three conditions are met:

(1) The registrant is aware, or has been informed that a person or non-target organism may have been exposed to a pesticide.

(2) The registrant is aware, or has been informed that the person or non-target organism suffered a toxic or adverse effect, or may suffer a delayed or chronic adverse effect in the future.

(3) The registrant has or could obtain information concerning where the incident occurred, the pesticide or product involved, and the name of a person to contact regarding the incident.

(b) Exceptions. Information regarding an incident need not be submitted if any of the following conditions are met:

(1) The registrant is aware of facts which clearly establish that the reported toxic effect, or reported exposure, did not or will not occur.

(2) The registrant has been notified in writing by the Agency that the reporting requirement has been waived for this incident or category of incidents, and the registrant has not been notified in writing by the Agency that the waiver is rescinded.

(3) It concerns a toxic effect to non-target plants, which were at the use site at the time the pesticide was applied, if the label provides adequate notice of such a risk.

(4) It concerns non-lethal phytotoxicity to the treated crop if the label provides an adequate notice of such a risk.

(5) It concerns a toxic effect to pests not specified on the label, provided that such pests are similar to pests specified on the label.

(6) It concerns minor skin or eye irritation effects warned of on the label of a product which is registered for use in residential use sites, and the effects occurred as a result of use in a residential site.

(c) Required information on individual incidents. To the extent that the registrant has any of the information listed in paragraphs (c)(1) through (c)(4) of this section, the registrant must supply the information on each pesticide incident that meets the requirements outlined in paragraph (a) of this section. If the registrant acquires additional information concerning an incident previously reported to the Agency under this part, such information shall be reported if it meets the criteria set forth in paragraph (f) of this section. In the future, the Agency may by notice specify a format for such submissions. The Administrative, Pesticide, Circumstance and Exposure Type(s) of information must be reported for individual incidents, except where the provisions of paragraph (e) of this section allow for aggregated summary forms of reporting, or if EPA in the future grants permission in writing for alternative reporting formats. The registrant must also provide one or more Exposure Type and Severity categories and their designations for each incident as set forth in paragraph (c)(5) of this section, depending on the applicability of the criteria listed below. The criteria listed should be used in assigning a category. For example, an incident which allegedly caused serious but non-fatal effects to human beings and domestic animals might be designated “H-B: D-B.” When a single incident involves multiple pesticides, the registrant need only report on their specific product. However, if a single incident involves more than one type of non-target organism—for example, both humans and domestic animals are involved—all appropriate available information dealing with each of the victims must also be reported. The informational items below are grouped by sections for ease in reporting pesticide incidents.