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Label Review Training: Module 3: Special Issues, Page 15

Section 4: How should I review directions for use?

Reviewing Directions for Use for Enforceability

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. If you aren't able to tell the difference, users and enforcement agents won't be able to either. The following list will help to eliminate some common enforceability problems in directions for use:

  • State any direction or precaution that is necessary to reduce risk in mandatory terms (e.g., must, will, do not).
  • Do not state in mandatory terms any direction that is not truly necessary, or that is too vague or subjective for a user to clearly follow.
  • Use terms with specific definitions (such as terms defined by FIFRA and federal agencies) whenever possible.
  • Clearly separate advisory and mandatory statements.
  • Ensure that section headings are appropriate to all material contained beneath them.
  • Do not approve “For Use Only by” statements unless they refer to a group that can be clearly defined by FIFRA, an applicable regulation, or an EPA policy (e.g., persons licensed by the state for termite control). Do not approve statements such as “For professional use only” or “For commercial use only.” “Intended for use by,” however, is allowable, because it no longer appears to be an enforceable restriction on who may use it (which it is not).
  • Do not use the term “avoid.” EPA views “avoid” as mandatory; however, it also recognizes that some users may perceive the term as advisory.

Resources

For more information on mandatory and advisory language, see Chapter 3, Section III of the Label Review Manual and Pesticide Registration (PR) Notice 2000-5.

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