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Pesticide News Story: Extension of Time for Data Submission for Inert Ingredient Tolerance Exemption Reinstatements; Status of Revoked Inert Ingredient Tolerances

For Release: August 6, 2008

EPA has extended the time available to companies who notified EPA of their intent to submit data in support of reinstatement of inert ingredient tolerances that were due to expire on August 9, 2008. The new effective date for tolerance expiration will be August 9, 2009. EPA has reviewed the industry data development plans and has concluded that additional time is necessary for study generation and the development of EPA’s risk assessments. EPA revoked these exemptions because insufficient data were available to the Agency to allow for an assessment of risk (Federal Register, August 9, 2006, 71 FR 45415). Based on the review of the submitted data, EPA will conduct rulemaking to establish new tolerance exemptions where appropriate.

In a separate Federal Register notice, EPA has described the status of each revoked inert ingredient tolerance exemption. The tolerance exemptions being supported by industry will expire on August 9, 2009 (as discussed above). No extensions are granted for revoked tolerance exemptions where EPA has not received a demonstration of intent to support, therefore, the revocation date for unsupported tolerance exemptions remains August 9, 2008.

Note that the revocation action only affects the use of these inert ingredients in food-use pesticide products. Therefore, any current use of these inert ingredients in non-food use pesticide products is not affected.

EPA is no longer accepting or processing applications for registration for food-use pesticide products containing an inert ingredient with a tolerance exemption that expires on August 9, 2008, unless it is accompanied by a petition for a new tolerance or exemption, together with all necessary supporting data. All commodities containing residues of these revoked inert ingredients on food are adulterated under FFDCA 408 if the residues are the result of applications of pesticide products made after August 9, 2008. The following website provides useful information: https://www.epa.gov/pesticides/fees/questions/pria21day_wrksht.pdf. Currently approved food-use inert ingredient tolerance exemptions are found in 40 CFR part 180. Contact EPA’s Inert Ingredient Assessment Branch at inertsbranch@epa.gov for information about how to establish a new inert ingredient or with questions about these actions.

The two Federal Register notices are now available - time extension, and revoked ingredient status.

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