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Label Review Training: Module 1: Label Basics, Page 22

Section 6: Which labels require review?

















Labels That Require Review

The following require EPA review:

No. Labels Requirements
1 Labels for products containing new active ingredients and/or new uses This type of submission involves a new active ingredient that is currently not registered by EPA as a pesticide or a new use of an existing product.;
2 Labels for new products containing existing active ingredients This type of submission involves an application for registration of a product containing an active ingredient that is currently registered for use as a pesticide in other products.
3 Labels for technical grade and manufacturing use products This type of submission involves a product that is used to manufacture or formulate other pesticides.
4 Labels for products requiring amendments

This type of submission involves an application for an amendment to a currently registered pesticide. There are two kinds of amendment submissions:

  1. No data review required.
    An example is an amendment for the addition to the label of a new site or pest that has been previously approved by EPA for other products containing the same active ingredient. For products composed of multiple active ingredients, the proposed new site or pest must be previously approved for all of the active ingredients.
  2. Data review required.
    An example is an amendment involving a new use, a new application rate, or a change in precautionary statements. This is an action not previously approved by EPA, and a data submission and review is necessary. Review of the label will be based on the conclusions of the data reviews from the product chemists, toxicologists, or efficacy reviewers. Generally, the specific reviews will only affect a small portion of the label; the rest of the text should remain unchanged from the originally accepted label. 
5 Fast track labels This type of submission involves no data or only product chemistry data.
6 Me-too registration labels This type of submission involves a pesticide product and proposed use that is identical or substantially similar to a currently registered pesticide or differs only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment.
7 Labels for products with efficacy data requirements This type of submission involves products for which efficacy data is required. Efficacy studies document how well pesticide products perform as pest control agents. Even though registrants/applicants must conduct efficacy studies, the Agency only routinely requires the submission of these studies for certain types of products. EPA reviews efficacy data (also referred to as product performance data) when a pesticide product bears a claim to control pest organisms that pose a threat to human health. Such pests include, but are not limited to:
  • Microorganisms that are infectious to man in any area of the inanimate environment.
  • Vertebrates (e.g., rodents, birds, bats, and skunks) that may directly or indirectly transmit diseases to or injure humans.
  • Insects that carry human diseases (e.g., mosquitoes, ticks).
Public health pests are listed in Pesticide Registration (PR) Notice 2002-1. EPA also requires submission of efficacy data to support claims for the control of termites. On a case-by-case basis, the Agency may require substantiation of an efficacy claim. 
8 Labels for special local need (SLN) products This type of submission involves products for which particular states register additional uses to meet their specific needs. Such registrations are for distribution and use only within a particular state to meet an SLN. Unlike other labels, EPA does not actively accept SLN labels. Instead, EPA has 90 days to disapprove it; otherwise it is considered an accepted FIFRA label.
9 Experimental use permits Experimental use permits authorize testing (across an area greater than 10 acres of land or one acre of water) of unregistered pesticides or registered pesticides' unregistered uses.

Resources

For more information about labels that require review, see Chapter 4, Section III of the Label Review Manual. For a list of public health pests, see PR Notice 2002-1.

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