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NRDC Consent Decree - 4th 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 Although the information provided here was accurate and current when first created, it is now outdated.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 26, 2005: 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, in previous annual reports, EPA identified any risks from pesticide use and/or any pesticide tolerances that the Agency determined did not meet applicable statutory standards and described its plans for addressing the risk or tolerance. In this annual report, EPA describes steps toward completing its plan for addressing unreasonable risks associated with:

In addition, with respect to certain groups of pesticides which EPA has determined share common mechanisms of toxicity, the Consent Decree required the first annual report to include schedules for issuing preliminary and revised cumulative risk assessments. Like the second and third annual reports, this fourth annual report provides an update on EPA's steps toward meeting its schedule for completing preliminary and revised cumulative risk assessments for the triazines, and discusses the Agency's cumulative determination for the thiocarbamate and dithiocarbamate pesticides.

Finally, the Consent Decree requires EPA to post each annual report on its website. The four annual reports are available on the Agency's website from the pesticides progress and status reports Web page.

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 in conjunction 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 included in this report, EPA has expedited the process of implementing 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 has sought to achieve 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 the NRDC annual report are available from the pesticide reregistration status Web page. Many related support documents also are available from Regulations.gov.

I. Updates on REDs and IREDs Covered in the Consent Decree

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II. Common Mechanism Determinations; Update on Pesticide Groups Addressed in Earlier Reports

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


The cascade of biological events triggered by atrazine exposure leading to mammary gland tumors in female SD rats is not expected to occur in humans given the species difference in reproductive aging. However, the potential for disruption of the hypothalamic pituitary axis and consequent attenuation of the LH surge leading to other health consequences not associated with reproductive aging (e.g., delay in pubertal development) can not be dismissed. Thus, EPA has determined that the triazine pesticides (with a common mechanism group of atrazine, propazine, simazine, and their chlorometabolites) have a common mechanism of suppression of LH surge and consequent reproductive and developmental effects. EPA expects to complete a preliminary cumulative risk assessment in early 2006; this is contingent on completion of the IREDs for the individual chemicals. The revised Atrazine IRED was completed on October 31, 2003, while the IRED for simazine and the work on propazine is slated for completion in 2006. EPA expects to complete the revised cumulative risk assessment for the triazines in summer 2006.


The thiocarbamate pesticides (EPTC, molinate, pebulate, and cycloate) were determined not to share a common mechanism of toxicity. See "Thiocarbamates: A Determination of the Existence of a Common Mechanism of Toxicity and A Screening Level Cumulative Food Risk Assessment," December 19, 2001 (51 pp, 480k, About PDF).


The dithiocarbamate pesticides (mancozeb, maneb, metiram, Na-dimethyldithiocarbmate, ziram, thiram, ferbam, and metam sodium) were determined not to share a common mechanism of toxicity based on neuropathy. See "The Determination of Whether Dithiocarbamate Pesticides Share a Common Mechanism of Toxicity," December 19, 2001 (46 pp, 348k, About PDF).

A subset of the dithiocarbamate pesticides (mancozeb, maneb, and metiram) was determined to induce a common effect (thyroid cancer) by the formation of the common metabolite, ETU. The Agency determined that these three chemicals should be grouped, as in the past, when conducting a risk assessment. Thus the mancozeb, maneb, and metiram REDs, to be completed in September 2005, all consider aggregate risks from ETU.

Another subset (ziram and metam sodium) was determined to share a common mechanism based on the inhibition of cholinesterase. However, the data available do not support cholinesterase inhibition as being a common effect of the entire group of dithiocarbamates. Further, a cumulative assessment is not needed for ziram and metam sodium because EPA is regulating these two pesticides on more sensitive endpoints than cholinesterase inhibition, which will be more protective in terms of any potential cumulative risk.

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