Department of Pesticide Regulation Logo

Paul E. Helliker Director

Department of Pesticide Regulation


   
   
   
   
  California Notice 2001-9

California State Seal
Gray Davis
Governor

Winston H. Hickox
Secretary, California
Environmental
Protection Agency

NOTICE TO PESTICIDE REGISTRANTS
REGARDING PRIORITIZATION OF PESTICIDE
ACTIVE INGREDIENTS FOR RISK ASSESSMENT

This notice announces the Department of Pesticide Regulation's (DPR) intention to conduct risk assessments on the following pesticide active ingredients:

Glutaraldehyde High Priority
Milbemectin* High Priority
Pyraclostrobin* High Priority
Tralkoxydim* High Priority

Acetamiprid* Moderate Priority
Bifenazate* Moderate Priority
Buprofezin* Moderate Priority
Chlorflurenol* Moderate Priority
Dimethomorph* Moderate Priority
Methoxyfenozide* Moderate Priority
1-Napthalene acetic acid (NAA) Moderate Priority
Novaluron* Moderate Priority
N,N-Diethyl-2-(4-Methylbenzyl Oxy) Ethylamine hydrochloride (PT 807-HCL)* Moderate Priority

Diflufenzopyr* Low Priority
Imazamox* Low Priority
Nithiazine* Low Priority
Octhilinone* Low Priority
Pyrazon Low Priority
Tebuthiuron* Low Priority

* New active ingredient

Food and Agricultural (FAC) sections 13121-13130 require DPR to review the toxicology database of all registered pesticide active ingredients. If DPR identifies possible adverse effects, then it evaluates the significance of the adverse effects. DPR determines the significance of the adverse effects by conducting a risk assessment. If DPR decides that the use of a pesticide results in a significant adverse effect, the law requires DPR to suspend or cancel the pesticide. In addition, FAC section 12824 requires DPR to endeavor to eliminate from use in California any pesticide that endangers the agricultural or nonagricultural environment. DPR intends to complete risk assessments on the active ingredients identified as high priority first, before conducting risk assessments on those identified as moderate or low priority.

Unless registrants or other persons submit additional data, DPR plans to use data currently on file to conduct risk assessments on each of the active ingredients listed above. Submission of the following data would be useful:

1. Metabolism studies conducted in a mammal, such as a rat. Please include the active ingredient and major metabolites in the study. Use the
U.S. Environmental Protection Agency/Office of Pesticide Programs (U.S. EPA/OPP) study protocol. The studies should characterize the
pharmacokinetics of the active ingredient and metabolites and include oral absorption, tissue distribution, biotransformation, and excretion properties.

2. Dermal absorption studies using doses relevant to expected exposures on one or more appropriate laboratory animal species (mouse, rat, rabbit, or monkey). The studies need to characterize the rate and extent of dermal absorption for at least eight hours and preferably up to 24 hours. Use the U.S. EPA/OPP study protocol. Before initiating the study, we recommend submitting the protocol to DPR for review.

3. Data on at least one mixer-loader-applicator exposure study using the active ingredient in question. Conduct the study using at least one formulation of a pesticide product by an application method used in California. Please measure potential dermal and inhalation exposure. Measure the use of the pesticide product anticipated to provide the maximum human exposure consistent with current and proposed label instructions for use in California. If possible, provide urinary metabolite data on the persons exposed. Use the U.S. EPA study protocol in Subdivision U of their regulations.

4. If the pesticide is applied to the foliage of crops, provide data on dislodgeable residue decay for at least one crop that will be a major use for the chemical in California. Use the U.S. EPA study protocol in Subdivision K of their regulations.

DPR may not have on file the types of data described above. Additionally, many studies already submitted to DPR do not meet the criteria described above. Without acceptable data on dermal absorption and worker exposure, DPR intends to assume a dermal absorption rate of 50 percent and use the highest estimated user exposure in conducting the risk assessment. In addition to the data listed above, DPR encourages registrants to conduct and submit the results of their own risk assessments.

DPR intends to notify registrants when it initiates the risk assessment process for any of the pesticide active ingredients listed above. When DPR initiates the risk assessment process, it is unlikely that you will have sufficient time to conduct additional studies. Therefore, do not wait for DPR's notification of initiation of the risk assessment before conducting and/or submitting all data that you want DPR to consider during the risk assessment process.

Please address all data submissions as follows:

Risk Assessment
Attn: Ann Prichard
Pesticide Registration Branch
California Department of Pesticide Regulation
1001 I Street
P.O. Box 4015
Sacramento, California 95812-4015



Please address all requests for additional information to Ms. Ann Prichard, at (916) 324-3931
or by e-mail at <aprichard@cdpr.ca.gov>.


original signed by Barry Cortez


11/5/2001


Barry Cortez, Chief
Pesticide Registration Branch
(916) 445-4377

Date

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1001 I Street - P.O. Box 4015 - Sacramento, California 95814-4015 - www.cdpr.ca.gov
A Department of the California Environmental Protection Agency