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California Notice 2011-5: Prioritization of Pesticide Active Ingredients for Risk Assessment
(July 2011)

The California Department of Pesticide Regulation (DPR) announces its intention to conduct risk assessments for several new pesticide active ingredients.

The Department of Pesticide Regulation (DPR) has issued a notice to pesticide registrants announcing risk assessment prioritization of various active ingredients found in pesticides.

Risk assessments will be conducted based on the level of priority of the ingredient, ranging from high to low. Ingredients listed under high priority include Cyflufenamid, Fluazinam, Prothioconazole. Listed as moderate is Flazasulfuron, and under low priority ingredients include Ametoctradin and N, N-Methylenebis-morpholine. All the ingredients listed above are new active ingredients and are not currently registered in California.

DPR is required to review the toxicology database of all active ingredients in registered pesticides under the Food and Agricultural Code (FAC). If possible adverse effects are identified; their significance would have to be evaluated by conducting a risk assessment. If DPR determines that the use of a pesticide results in a significant adverse effect, by law, DPR is required to suspend or cancel the pesticide. In addition, FAC requires DPR to attempt to eliminate the use of any pesticide that poses a threat to the agricultural or nonagricultural environment in California.

To conduct the risk assessments, DPR plans to use data currently on file for each of the listed active ingredients; however registrants or other persons are invited to submit additional data. DPR suggests that submissions of the following data would be useful:

▲ Metabolism studies conducted on mammals, with information on the active ingredient and major metabolites used in the study. The studies should
characterize the pharmacokinetics of the active ingredient and metabolites and include tissue distribution, biotransformation, oral absorption, and
excretion properties.
▲ Dermal absorption studies on appropriate laboratory animal species using doses that reflect expected human exposure. The studies must characterize
the dermal absorption time between eight to ten hours.
▲ Data on studies of handler exposure (i.e. mixer-loaders or applicators) to a product containing the active ingredient. It is advised to conduct the studies
with pesticide product formulations and application methods used in California, and to measure potential dermal and inhalation exposure. In addition,
it is asked to measure the use of the pesticide product expected to provide the maximum amount of human exposure consistent with current and
proposed label instructions for use in California, and if possible, to provide urinary metabolite data on persons exposed.
▲ If the pesticide is applied to the foliage of crops, data submissions are welcomed on dislodgeable foliar residue decay for crops on which the chemical
will be used in California.
▲ If the pesticide is used on turf, it is encouraged to provide data on transferable turf residue. If the pesticide has indoor uses, dislodgeable surface residue
data on indoor surfaces is also requested.

When conducting the studies, it is encouraged to comply with the U.S. Environmental Protection Agency /Office of Pesticide Programs (EPA/OPP) study protocol. It is also recommended to use pesticide assessment guidelines and submit the protocol to DPR for review prior to beginning the study.

If data submissions do not meet the criteria described by DPR, DPR will assume a dermal absorption rate of 50 percent and will use the highest estimated human exposure in conducting the risk assessments.
 
DPR will notify registrants when the risk assessment process is initiated for any of the listed active ingredients; however data should be submitted prior to initiation.

For more information, please
Contact TSG.
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