Label Review Training: Module 3: Special Issues, Page 18
Section 4: How should I review directions for use?
Resources for Determining Directions for Use Language
Label reviewers should use policy documents along with the applicable laws to make case-by-case determinations on the acceptability of label language. Reviewers should consult:
- Applicable documents and guidance policies for the active ingredient(s), such as registration review decision documents, reregistration eligibility decision (RED) documents, biopesticide registration action documents (BRADs), and science assessments.
- Applicable product-specific data evaluation records and assessments.
- For me-too applications, labels of substantially similar products.
- The registration standard (if there is one not superseded by an RED).
- For new or revised uses, available science/technical reviews, or the efficacy reviewer.
- The 40 CFR, Part 180 for published tolerances supporting food and feed uses.
- Current PR notices.
- Subject matter experts. If a label seems to present problems of clarity, organization, enforceability, or consistency with EPA policy, reviewers should seek advice. Reviewers should first consult team leaders or efficacy reviewers. Team leaders may consult their branch chief or OECA staff for advice. At the discretion of branch chiefs or team leaders, label questions may be forwarded to the Office of Pesticide Programs' (OPP's) Label Committee. Other authorities or sources of information (e.g., commodity groups, State FIFRA Issues Research and Evaluation Group [SFIREG], or EPA Regional offices) may be consulted as appropriate.
To check the status of each chemical in the reregistration review process, and to find links to a chemical's Web page and any available RED documents or fact sheets, visit EPA's Pesticide Reregistration Status Web page.
Find out more about tolerances and exemptions for pesticide chemical residues in food at 40 CFR, Part 180.
Learn about important policies, procedures, and regulatory decisions by reviewing current PR notices.