In general, if the resulting residues in food are 200 parts per billion (ppb) or less, EPA wants certain data. For residues greater than 200 ppb, additional data may be required, depending on other conditions – such as test results.
The guidance clarifies that the 200 ppb trigger is based on the total estimated daily dietary intake for an individual, not on the amount of residue present on a single food. This interpretation is consistent with the policy of the US Food and Drug Administration.
The proposed guidance satisfies a condition of a settlement agreement on 2 March 2015 between the EPA and the American Chemistry Council (ACC).
The ACC challenged the data requirements regulation in court in 2013. The EPA promises to make the correction by 2 September 2017. The interim guidance and an implementation letter from the EPA to registrants are available online.
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