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NRDC Consent Decree - 3rd Annual Report

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 Although the information provided here was accurate and current when first created, it is now outdated.

September 24, 2004: EPA Actions Implementing Regulatory Determinations Required under Certain Provisions of the NRDC Consent Decree


In September 2001, the Federal Court for the Northern District of California entered a Consent Decree to conclude litigation in the case, Natural Resources Defense Council v. Whitman. Under the Consent Decree, among other things, EPA is required to issue an annual report providing information on the steps that the Agency has taken to implement certain regulatory determinations that it is required to make by the Consent Decree. Specifically, the Consent Decree directs EPA, beginning one year after the entry of the Consent Decree and annually for several years thereafter, to issue a report addressing the risks identified in certain previously issued Reregistration Eligibility Decisions (REDs) and Interim Reregistration Eligibility Decisions (IREDs). With respect to each covered RED and IRED, EPA is to identify any risks from pesticide use and/or any pesticide tolerances that the Agency has determined do not meet applicable statutory standards and to describe its plans for addressing the risk or tolerance. For REDs and IREDs discussed in the first two annual reports, EPA must describe its steps toward completing its plan to address identified risks or tolerances.

In addition, with respect to certain groups of pesticides which EPA has determined share a common mechanism of toxicity, the Consent Decree required the first annual report on the group to contain a schedule for issuing a preliminary cumulative risk assessment and a revised cumulative risk assessment for the group. The second and subsequent annual reports for the group must describe EPA's steps toward completion of its schedules for completing these preliminary and revised cumulative risk assessments. The Consent Decree also requires EPA to post each annual report on its website.

Under the terms of the Consent Decree, the annual report must describe risks or tolerances of concern and EPA's plan for addressing those risks or tolerances for any REDs or IREDs issued at least three months prior to the annual reporting date of September 26. EPA therefore is providing this information on carbaryl, for which the Agency issued an IRED on June 30, 2003. The third annual report also must describe EPA's steps toward completing its plan, discussed in the first two annual reports, for addressing unreasonable risks associated with:

Finally, the third annual report must provide updates on EPA's steps toward meeting its schedules for completing preliminary and revised cumulative risk assessments for the triazines and the thiocarbamate and dithiocarbamate pesticides, common mechanism groups discussed in the first and second annual reports.

Implementing REDs and IREDs

A number of steps must take place in order to translate risk mitigation determinations contained in RED or IRED documents into label language on pesticide products in the marketplace. Typically, EPA signs a RED or IRED document and then sends it, along with its attachments and appendices, to affected registrants for follow-up actions. Unless all products containing the pesticide active ingredient are being voluntarily canceled, a product-specific Data Call-In (DCI) is sent to the affected end-use product registrants along with the RED or IRED so that EPA can obtain product chemistry, acute toxicity, and other data that are required for product reregistration. If the RED or IRED includes additional confirmatory data requirements, EPA also issues a generic DCI to the affected technical or manufacturing use product registrants. Typically, EPA transmits the DCI to registrants of the pesticide along with the RED or IRED. The RED or IRED contains instructions to the registrants about when and how to submit applications for amended registration reflecting the risk mitigation measures contained in the RED or IRED. Following receipt of the applications, EPA reviews and, if appropriate, approves the amendments by sending a stamped copy of the new labeling to the registrant. Either the approval of the amendment or the RED or IRED will establish a time frame for the registrant to implement the new labeling.

Because of its concerns about the pesticides discussed below, EPA has expedited the process of implementing the risk mitigation measures for several of them. Using Memoranda of Agreement, shorter deadlines for submission of applications, and other changes to our typical procedures, EPA is achieving implementation of the risk mitigation measures for these pesticides more quickly than usual.

Availability of REDs and IREDs

REDs and IREDs as well as many supporting documents for the pesticides discussed in this third annual report are available from the pesticide reregistration status Web page . Many related support documents also are available from Regulations.gov.

I. REDs and IREDs

A. IRED Covered for the First Time

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B. Updates on REDs and IREDs Covered in the First and Second Annual Reports

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II. Common Mechanism Determinations

The discussion below provides EPA's current thinking and plans for addressing the cumulative risks of certain groups of chemicals identified pursuant to the NRDC Consent Decree.

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