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Summary of registration process: If a sponsor wants to sell a pesticide product in
California, it must be registered with the state of California in addition to the product's USEPA
registration. In addition, all surfactants must be registered with the state of California. The
agency responsible for granting such registrations is the California Department of Pesticide
Regulation (CDPR) of the California Environmental Protection Agency (CalEPA). The most
general division of registrations includes two major splits: 1) new label acquisitions and (2)
existing label modifications. This section briefly presents some of the considerations involved
in both types of these label registrations.
Before beginning either process, a sponsor must have a current EPA label registration in
place or, at the very least, an exact copy of the label which was submitted to EPA pending
approval. CDPR only works with clients using the current EPA label(s) to develop a research
program to support state registration.
1. New Label Acquisition: CDPR conducts a review of the products crop safety,
performance (efficacy) data, and special considerations.
A. Crops and geographic areas representative of California, leading to the total number of
trials for the program and whether it will all take place in a single year or over multiple years.
B. Product use pattern development, including rates and application types (equipment spray
volume(s) and carrier).
C. Product compatibility / product combination review and, if needed a research program for
them.
Crop safety (phytotoxicity) and efficacy requirements are then discussed in specific detail,
allowed by design of specific protocols which may differ in some of their details between
crops, depending on label specifics.
After reaching agreement with CDPR staff as to the number of geographic distribution of
efficacy trials, the protocols are developed and the field (and, if needed, laboratory) portions of
the study are carried over a time period of one to three years. The study is finished when the
final summary report produced by the study director has been submitted to CDPR.
2. Existing Label Modifications: Although usually less costly and time-consuming than a
full label acquisition, extending an existing label to include modifications may include several
elements. The following paragraphs summarize the major ones.
A. Additional Crops: Adding crops not on a current label requires use pattern development and
agreement on geographical distribution of field trials, phytotoxicity and implementation and
completion.
B. New Use Patterns: Such use pattern changes include making applications at rates which
differ from those on the current label, or using a different form of delivery (i.e., adding aerial
applications to a label which previously restricted applications to ground equipment). Again,
considerations include both phytotoxicity and efficacy data generation through field trials and, if
necessary, residue trial development and completion.
C. Label Update or Data Call In: Such Items are usually precipitated by the USEPA and result
in an official set of requirements for additional or supplemental data as outlined by the agency.
When this happens, CDPR may also issue an additional set of outlined data requirements.
The client will then develop a program will include phytotoxicity and efficacy data requirements
to satisfy CDPR and residue study requirements from USEPA, if such a study is needed.
