Label Review Training: Module 3: Special Issues, Page 19
Section 4: How should I review directions for use?
- When reviewing directions for use, it is critical to distinguish between statements that are intended to be enforceable and those that are included for informational purposes.
- Suggested formats for directions for use include bulleted format, tabular format, and modified paragraph format.
- The Directions for Use Checklist includes questions to ask when conducting a label review.
- Label reviewers should use policy documents along with the applicable laws to make case-by-case determinations on the acceptability of label language.
- When is it appropriate to use the phrase “For Use Only by”?
When referring to a group that can be clearly defined by FIFRA, an applicable regulation, or an EPA policy.
- What features of the modified paragraph format help to organize information?
Subheadings and highlighted key words and phrases.
- Where can the label reviewer find questions to ask when conducting a review of directions for use? The Directions for Use Checklist in Chapter 11 of the Label Review Manual.
The Directions for Use Checklist in Chapter 11 of the Label Review Manual.
- Name three additional resources label reviewers can consult when reviewing directions for use.
Registration review decision documents; RED documents; BRADs; science assessments; product–specific data evaluation records and assessments; labels of substantially similar products (for me–too registrations); available science/technical reviews; the efficacy reviewer; PR notices; 40 CFR, Part 180; and subject matter experts.
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