California Code of Regulations (Title 3. Food
and Agriculture)
Division 6. Pesticides and Pest Control Operations
Division 6. Pesticides and Pest Control Operations
Chapter 2. Pesticides
Subchapter 1. Pesticide Registration
Article 4. Conditional Registration
6200. Conditional Registration.
The director may waive specific data requirements in this subchapter for a
period reasonably sufficient, not to exceed three years, for the generation
and submission of such required data provided:
(a) The pesticide product is registered pursuant to the Federal Insecticide,
Fungicide and Rodenticide Act, the product is to be used under a Federal Experimental
Use Permit, or the product is for use in California only.
(b) The applicant has provided the director with all data the applicant has
available required by the U.S. EPA and by this subchapter to support registration
of the pesticide product.
(c) No conditional registration shall be granted unless the data includes all
of the following:
(1) Acute oral and dermal LD50 data on the product.
(2) Acute LC50 data on products which produce respirable aerosols or gases.
(3) Primary eye and skin irritation data on the product.
(4) When human contact is likely with soils or foliage containing residues,
foliar and soil residue data as specified in Sections 6181 and 6182, sufficient
to establish safe reentry level or interval.
(5) Analytical methods to determine residues of (1) each active ingredient and
(2) each toxic metabolite that may result from the active ingredient for which
a tolerance has been established by the U.S. EPA in the Code of the Federal
Regulations. Test methods shall, as applicable, allow the director to determine
residues in or on plant tissue, soil, and water.
(6) Preliminary efficacy data indicating the product is effective for the proposed
use.
(d) The director complies with Section 6158.
(e) That each item of data waived is for a specific period.
Such period shall be no more than necessary for the applicant using good faith
efforts to develop the information required by Sections 6176-6179, 6180(a),
6181-6183.
(f) The director makes a written finding, supported by substantial evidence,
that the use of the pesticide during the periods while data are being developed,
is not expected to cause any significant adverse effect on the environment,
that a clear need for the use of the product in California exists while the
data is being developed, and that specified benefits of using the pesticide
outweigh specified risks to human health and the environment.
(g) The director requires the use of the best pest control methods and technology
available including, but not limited to, methods of application to protect human
health and the environment, and limitations to mitigate adverse effects to nontarget
organisms or areas.
(h) Each registrant be required to submit a report to the director annually
(with product renewal application if such a waiver extends over January 1 of
any year) and whenever specifically requested by the director, detailing progress
made towards development of each item of the waived data.
(i) Where the application is for a pesticide product containing a new active
ingredient, the applicant has provided the following data in addition to the
data required by section 6200(c), (1)-(6) when required by the U.S. EPA to support
the full unconditional registration of the product pursuant to Section 3 of
the Federal Insecticide, Fungicide and Rodenticide Act and when specifically
requested by the director:
(1) Results of a two-year feeding study on oncogenicity on active ingredients
in at least one animal species.
(2) Results of a teratogenicity study and one generation of a two-generation
combined male-female reproductive study on active ingredients.
(3) Results of three mutagenicity studies on active ingredients that detect
gene mutations, chromosomal aberrations, and DNA damage/repair.
(4) Data to support medical management of poisoning or injury.
NOTE: Authority cited: Sections 11456 and 12781, Food and Agricultural Code. Reference: Sections 11501 and 12824-12825, Food and Agricultural Code.