Label Review Training: Module 3: Special Issues, Page 9
Section 2: How should I review precautionary statements?
Determining First Aid Statements
A first aid statement is required when any acute toxicity study result is classified as category I, II, or III. It is acceptable for the registrant to include first aid statements for study results that are classified as category IV.
First aid statements should be brief, clear, and simple, and should use straightforward language so that the average person in an emergency can easily and quickly understand the instructions. First aid statements should apply to all ages or, when necessary, should include distinctions between the treatments for different age groups. Any reasonably competent individual should be able to follow the instructions set out in first aid statements.
To determine first aid statements for fumigant products, refer to RED or registration review documents, and in some specific cases PR Notice 84-5 or a registration standard.
To determine first aid statements for nonfumigant products and products that contain an organophosphate, an N-methyl carbamate, zinc phosphide, or petroleum distillates, refer to Chapter 7 of the Label Review Manual.
EPA encourages, but does not require, registrants to include a company telephone number or toll-free hotline number for emergency information in the first aid section. If a number is included, place emergency numbers with the “First Aid” or “Hot Line Number” text to avoid confusion. If a number is included, it should include a phrase or statement indicating the kinds of information the number should be used for, and it may include hours of service. For example:
“Have the product container or label with you when calling a poison control center or doctor, or going for treatment. For non-emergency information, on product usage for example, call (1-XXX-XXX-XXXX), Monday through Friday, 9:00 a.m. to 5:00 p.m. For medical emergencies, call your poison control center at 1-800-222-1222.”
If a registrant does not have its own number, the registrant may use the National Pesticide Information Center (NPIC) 800 number. However, NPIC does not provide emergency information. The section could read:
“Have the product container or label with you when calling a poison control center, doctor, or going for treatment. For non-emergency information concerning this product, call the National Pesticide Information Center (NPIC) at 1-800-858-7378. (NPIC Web site: www.npic.orst.edu).”
The first aid statement may also include a note to physicians, which should be clearly distinguished from the rest of the first aid statement text. Procedures that must be performed by medical personnel or require specialized equipment must appear here and nowhere else. See Chapter 7, Section III.F.10 of the Label Review Manual for more information about determining notes to physicians.
Resources
For guidance on determining first aid statements, see Chapter 7 of the Label Review Manual.
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