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EPA Updates Data Requirements for Registration of Antimicrobials – Effective July 8, 2013
(May 2013)

EPA has published a final rule in the Federal Register revising data requirements for the registration of antimicrobial products. The revisions and updates, which are currently found in Title 40 of the Code of Federal Regulation (CFR) in part 161, are being codified in subpart W of part 158.The rule will go into effect on July 8, 2013.

Updated requirements include, but are not limited to, the following:

▲ Select data requirements changing from conditionally required to required
Change in number of species required for a test or expanding number of use patterns for which a test is required
Elimination of the requirement for a chronic non-rodent study currently required in 40 CFR
Additions and changes to data requirements, specifically:
     Eleven new data requirements for antimicrobial pesticides
    -  Eight new data requirements on developmental neurotoxicity, immunotoxicity, photodegradation in soil, soil residue dissipation, ready biodegradability
study, porous pot study, activated sludge sorption isotherm study, and modified activated sludge respiration inhibition tests
    -  Changes to data requirements for establishing tolerances or tolerance petitions for pesticide residues on food
    -  Twelve antimicrobial use patterns in an Antimicrobial Use Site Index
    -  Alternatives to the porous pot study
    -  Changes to residue chemistry data requirements
    -  Changes to data requirements for wood preservatives
    -  Changes to data requirements for antifoulants
    -  Restructuring of proposed toxicology and residue chemistry data requirement tables

The final rule can be found at www.regulations.gov in Docket ID # EPA-HQ-OPP-2008-0110.

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