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Reevaluation of Existing Formulants (Inert Ingredients) in Pesticide Products

Information provided for informational purposes only

Note: This information is provided for reference purposes only. Although the information provided here was accurate and current when first created, it is now outdated.

Committee to Advise on
Reassessment and Transition

Paper # 19

EPA Reevaluates Existing Formulants (Inert Ingredients) in Pesticide Products

  • In 1987, EPA announced a policy to reduce the potential for adverse effects from the use of pesticide products containing toxic formulants or inert ingredients. The primary objective of the 1987 policy was to significantly reduce the use of toxic inerts and to obtain data sufficient to determine conditions of safe use for all inerts.
  • The policy categorized inert ingredients into four lists by toxicity potential.
  • Currently the 55 inert ingredients classified as List 2 (potentially toxic) inerts are being reviewed to determine if sufficient data are now available to permit reclassification to either List 1 (toxic inerts–mandatory disclosure of all ingredients on the label) or to List 4 (minimal risk inerts).
  • If such data are not available, OPP will use its authority under FIFRA to require the submission of data needed to determine the risks posed by the use of List 2 inert ingredients.
  • The results of OPPT Structure Activity Team’s (SAT) reviews and other information on List 3 (inerts of unknown toxicity) substances are being examined to identify candidates for potential reclassification, particularly reclassification to List 4.

Development of FQPA-Compliant Inert Ingredient Risk Assessment Methodology

  • Risk assessments for food use inert ingredients must address the numerous safety provisions of the Food Quality Protection Act of 1996 (FQPA).
  • OPP is establishing a risk assessment methodology for inert ingredients that will address the aggregate exposure, common mechanism of toxicity, special sensitivities of infants and children, and endocrine-disrupting effects provisions of FQPA.
  • OPP will then use this method to review all new petitions for inert ingredient tolerances or exemptions from tolerance as well as the reassessment of inert ingredients under FQPA.

Formation of a Inert Disclosure Stakeholder Workgroup

  • Early this year, EPA established the Inert Disclosure Stakeholder Workgroup to advise the Pesticide Program Dialogue Committee, an EPA advisory group, on ways of making information on inert ingredients more available to the public while working within the mandates of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and related Confidential Business Information concerns.
  • Additional information about the Inert Disclosure Stakeholder Workgroup’s activities is available on the Internet at: http://www.epa.gov/pesticides/ppdc/inert/

Data Submitter Rights for Data Submitted in Support of Tolerance Actions

  • FQPA included amendments to section 408(i) of the Federal Food, Drug, and Cosmetic Act to address exclusive use and compensation rights for data submitted to EPA in support of tolerance and tolerance exemption actions.
  • The new provision may affect manufacturers of inert ingredients.
  • EPA solicited comment on an Agency options paper discussing implementation of the 408 (i) provision, (65 FR 19755, April 12, 2000). The Agency is currently reviewing the comments.

For more information:

  • Additional information about inerts or other ingredients is available on the Internet at: http://www.epa.gov/opprd001/inerts/
  • Additional information about the Inert Disclosure Stakeholder Workgroup’s activities is available on the Internet at: http://www.epa.gov/pesticides/ppdc/inert/
  • Contact the National Pesticide Telecommunications Network 800-858-7378; http://npic.orst.edu/ Exit EPA disclaimer for information on the toxicity of pesticides.
  • EPA’s pesticide homepage www.epa.gov/pesticides has information about pesticide regulation as well as publications about pesticide issues for consumers.

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