Label Review Training: Module 3: Special Issues, Page 6

Section 2: How should I review precautionary statements?

Determining Hazards to Humans and Domestic Animals Statements

Hazards to humans and domestic animals statements are required when any acute toxicity study results in a product classification of Toxicity Category I, II, or III, and/or when the dermal sensitization study result is positive. Hazards to humans and domestic animals statements may specify both mandatory actions and advisory information.

To determine the hazards to humans and domestic animals statements for fumigant products, refer to PR Notice 84–5, registration standards, and reregistration eligibility decision (RED) documents.

To determine the hazards to humans and domestic animals statements for nonfumigant products, refer to Tables 3–8 in Chapter 7 of the Label Review Manual. Select language that corresponds with the toxicity category assigned to each study. Combine statements from these tables to form a concise paragraph.

Hazards to humans and domestic animals statements must be appropriate for all uses on the label and consistent with each use pattern listed on the label. No statement should be used that is reasonably beyond the control of the typical user. Hazards to humans and domestic animals statements must not require the use of specialized equipment that would not be readily available to the typical user of the product.

Resources

To determine hazards to humans and domestic animals statements for nonfumigant products, see Chapter 7, Section III.D of the Label Review Manual.

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