Me-too product

{
  "id": "MLC-T-ENV-017146",
  "term": "Me-too product",
  "field": "Environment",
  "term_source": "Me-Too Product",
  "definition": "1. A \"Me-Too\" pesticide registration application refers to a request to register a new pesticide product that is identical in its uses and formulation or substantially similar in its uses and formulation to one or more products currently registered and marketed in the United States, or differing only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment. These applications are also called \"Fast Track New Products,\" though the preferred term consistent with FIFRA is \"identical or substantially similar product.\" For all \"me-toos,\" the Agency must also find that approving the registration or amendment in the manner proposed would not significantly increase the risk of any unreasonable adverse effect on the environment. Common terms used for some \"Me-Toos\" are: Identical Repack Registrations: A complete (100-percent) repackaging of an identical, already registered product, where the same label is used for the product other than name , address, name of product, and registration number.; Old Chemical New Product Registrations: A previously registered active ingredient that is being reformulated to make a new product with the same use pattern as the registered active ingredient. (Note: the applicant will be required to explain how the labeling has been derived and justify certain aspects of the labeling.)\n\n2. The following are examples of when an application is not considered to be a \"me too.\" These are differences between the currently registered product and the application for registration: the maximum use rate of the product is increased beyond that which is currently registered; a pre-harvest interval (PHI) is changed; any other changes are made that might affect the pesticide residues in food or feed commodities or exposure to nontarget organisms; the source of the active ingredient is not registered; inert ingredients do not currently exist in any other pesticide formulation; a reference is made to a cancelled product (link to NPIRS); significant changes in the percentage of active ingredient; new formulation types; differences in directions for controlling new, non-public health pests; differences in directions for new dosage rates; differences in directions for different frequency and timing of applications; differences in directions for use in geographical locations other than those previously registered; and differences in directions for use on new sites and for new methods of application for that active ingredient or ingredients. Other examples of applications that are not \"me-too\" product applications include: Applicant submits required acute toxicity and efficacy data for EPA review.; Applicant references similar, registered pesticide product and submits product chemistry and required efficacy for specific formulation purposes.; Applicant asserts similarity, but does not reference a registered pesticide product. Submits product chemistry.; Applicant references a similar pesticide product and submits product chemistry and required nitrosamine data for a specific formulation.; Applicant does not reference a pesticide product. Submits product chemistry and required nitrosamine data for a specific formulation.; Applicant does not reference a pesticide product. Submits product chemistry and the full battery of acute data.; Applicant references a similar registered pesticide product. Submits product chemistry, the full battery of acute data and required efficacy data.; Applicant references a pending registration.\n\n3. A \"Me-Too\" pesticide registration application refers to a request to register a new pesticide product that is identical in its uses and formulation or substantially similar in its uses and formulation to one or more products currently registered and marketed in the United States, or differing only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment. These applications are also called \"Fast Track New Products,\" though the preferred term consistent with FIFRA is \"identical or substantially similar product.\" For all \"me-toos,\" the Agency must also find that approving the registration or amendment in the manner proposed would not significantly increase the risk of any unreasonable adverse effect on the environment.",
  "subject": "Chemicals, toxics and pesticides",
  "references": [
    "PRIA Fee Determination Glossary",
    "Original Definition has been truncated; PRIA Fee Determination Glossary"
  ],
  "url": "https://mlchart.com/terminology/environment/me-too-product/"
}