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What Are EBDCs & ETU Why Use EBDCs Re-Registration Update What Others Are Saying Health Assessment Our Position and Commitment
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EBDC Registration Background

EBDCs were first registered in the United States in the 1940s. Because of their importance to global agriculture, EBDCs have been extensively reviewed by regulatory authorities around the world. Modern science demonstrates that EBDCs can be used without unreasonable risks to man and the environment.  This conclusion was affirmed by the successful conclusion of the EPA reregistration and Food Quality Protection Act (FQPA) assessment, with the Reregistration Eligibility Decision (RED) published on December 28, 2005. 

Additionally, the European Union recently approved Annex listing for mancozeb.  Thus, mancozeb has passed the rigid tests of both the United States and Europe.

EBDCs Thoroughly Studied
Science Supports Continued Use
Use Patterns Established Recently, Residue Levels Accepted Globally

EBDCs Thoroughly Studied. Besides classical studies required for the registration, the EBDC dossier includes monitoring studies measuring the level of exposure in actual conditions of use (epidemiologic studies in manufacturing plants, supermarket monitoring, monitoring water from rural wells and community water supplies). It is fair to say that more is known about the actual consumer exposure to EBDCs and their common metabolite, ethylenethiourea (ETU), than any other crop protection chemical.

Science Supports Continued Use. The current and previous EPA reviews of mancozeb have concluded that the currently labeled crops for mancozeb use meet the criteria for continued use, with the exception of the five uses discussed in Use Withdrawals. The mancozeb manufacturers voluntarily withdrew these five uses in order to save EPA and industry resources.

Specifically:

A notice in the December 28, 2005 Federal Register, Volume 70, Number 248, Pages 76828-76829, announced the availability of EPA’s RED for mancozeb.  The RED can be found at www.regulations.gov, EPA docket number OPP-2005-0176.  EPA concluded that the risks from mancozeb for the uses that were maintained were below the levels of concern.

The prior review by the United States Environmental Protection Agency (EPA) was an extensive review of the EBDCs. In a Special Review of the EBDCs from 1987 until March 1992, EPA reviewed the dietary risks of ETU to consumers from food treated with EBDCs. EPA concluded that there was only a negligible theoretical dietary risk from 45 uses and EPA allowed these 45 uses to remain on the EBDC labels. In his concluding remarks, the EPA Administrator said, “Today’s decision follows the most extensive review, analysis and assessment of data ever undertaken on any pesticide. The fact that EPA is allowing many uses of EBDCs to continue should be good news for farmers and consumers alike. . . .”

Use Patterns Established Recently, Residue Levels Accepted Globally. At the time of the Special Review, EPA established the use patterns that are still on the current EBDC labels. Thus, the maximum application rate, the interval between applications, the maximum seasonal application allowed, and the pre-harvest interval on the EBDC labels today were set by EPA in 1992. The new mancozeb RED established new use patterns for turf uses, which were not part of the 1992 Review.  With the exception of the five uses voluntarily withdrawn by the mancozeb registrants, the mancozeb use patterns for all other crops will remain the same as those established in 1992.

 The EPA is not the only body that has reviewed EBDCs. As noted above, the European Union recently approved Annex 1 listing of mancozeb.  The World Health Organization (WHO) and the Food and Agriculture Organization (FAO) reviewed EBDCs and ETU at the 1993 and 1995 Joint Meeting of Pesticide Residues (JMPR). On the basis of the JMPR recommendations and an acceptable risk assessment, the Codex Alimentarius Commission established over 35 new Maximum Residue Limits (MRLs) in 1999, demonstrating that these uses were supported by the WHO and the FAO. These MRLs also facilitate international trade of foodstuffs treated with EBDCs.


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