Article 16 - The Interim Data Gap Exemption for Qualified Federally Registered Pesticides

California Food and Agricultural Code — §§ 13161-13170

Sections (10)

Added by Stats. 1993, Ch. 963, Sec. 2. Effective January 1, 1994.

For the purposes of this article, the following definitions apply:

(a)“Feasible alternative” means other chemical or nonchemical procedures that can reasonably accomplish the same pest control function as existing procedures with comparable effectiveness and reliability, taking into account economic, environmental, sociological, technological, and ecological factors, including impact on beneficial and other nontarget organisms, pest resistance to pesticides, and timeliness of control.

(b)“Pest management system” means a systematic approach to pest control that stresses the application of biological and cultural pest control techniques with the selective use of pesticides when necessary to achieve acceptable levels of control with the least possible harm to nontarget organisms and the environment as described in subdivision (f) of Section 11501.

§ 13162

Added by Stats. 1993, Ch. 963, Sec. 2. Effective January 1, 1994.

The director may issue a certificate of interim registration allowing the sale and use of a pesticide that otherwise meets the requirements of this chapter if all of the following conditions are met:

(a)The certificate stipulates which of the California data requirements listed in Section 13163 are being deferred for completion during the time of interim registration.

(b)The certificate stipulates a period of time, not to exceed three years, for each deferral determined by the director as reasonably sufficient for the generation, submission, and review of the data.

(c)The certificate stipulates any limitations on the use of the pesticide that the director may deem appropriate pursuant to Section 13166 or on the sale of the pesticide.

§ 13163

Added by Stats. 1993, Ch. 963, Sec. 2. Effective January 1, 1994.

In granting a certificate of interim registration, the director may defer no more than three of the following registration data requirements:

(a)Efficacy studies pursuant to Section 12824.

(b)KOW (octanol water partition coefficient) pursuant to paragraph (3) of subdivision (a) of Section 13143.

(c)Soil photolysis pursuant to paragraph (6) of subdivision (a) of Section 13143.

(d)A field dissipation study pursuant to paragraph (6) of subdivision (a) of Section 13143.

(e)A study pursuant to subdivision (a) of Section 13143 that will be redone to correct errors or a study conducted under California conditions or guidelines, if the weight of evidence from all other submitted data support a scientific judgment in favor of interim registration.

§ 13164

Added by Stats. 1993, Ch. 963, Sec. 2. Effective January 1, 1994.

Consistent with the limitations of Section 13163, a registrant or a user group of any pesticide registered by the United States Environmental Protection Agency may apply for a California certificate of interim registration if the applicant does all of the following:

(a)The applicant provides information that the product would fill a need and significantly enhance a systems approach to pest management during the period the applicant completes requirements for a full California registration. Additionally, the information supporting an interim registration shall be based upon one or more of the following conclusions that the product will:

(1)Reduce risks to the public health, the pesticide workplace, or the environment by reducing the overall use of chemical controls within a pest management system.

(2)Reduce risks to the public health, the pesticide workplace, or the environment by providing a more benign alternative to an existing use pattern.

(3)Reduce risks of pest resistance problems such as loss of economic efficacy and increased amounts or frequency of chemical applications by providing better integrated management of a pest or pest complex.

(4)Reduce a substantial economic hardship to a segment of California’s agricultural industry due to a pest infestation for which there is no other feasible alternative.

(b)The applicant provides the director with all data that is required to support the federal and California registrations of the pesticide product, except the data which may be deferred pursuant to Section 13163, and any other available data that the director may deem appropriate.

(c)The applicant makes a commitment to generate all data required in California for a full certificate of registration within a reasonable period of time to be determined by the director and reflected in the certificate of interim registration. The written commitment shall identify the developing party or parties for each deferred data requirement within 90 days of the issuance of the certificate of interim registration and identify a schedule of quarterly progress reports that will be submitted.

§ 13165

Added by Stats. 1993, Ch. 963, Sec. 2. Effective January 1, 1994.

Notwithstanding Section 13163, the director shall not grant a certificate of interim registration unless he or she consults with the Pesticide Registration and Evaluation Committee on the proposed interim registration, and makes a written finding, after consultation, declaring all of the following:

(a)That the pesticide is needed and will be a significant component of a pest management system as demonstrated by the applicant pursuant to subdivision (a) of Section 13164.

(b)That the interim use of the pesticide, in conformance with the limitations established by the director pursuant to Section 13166, is not expected to cause any significant adverse effect on the public health, the safety of the pesticide workplace, or the environment, including a finding that the pesticide does not threaten to pollute the groundwater of the state.

(c)That the weight of evidence supports a scientific judgment in favor of interim registration.

§ 13166

Added by Stats. 1993, Ch. 963, Sec. 2. Effective January 1, 1994.

The director shall limit the use of any pesticide granted a certificate of interim registration to specific uses within a pest management system meeting the requirements of subdivision (a) of Section 13164. The director may place additional restrictions on the use of any pesticide granted a certificate of interim registration, including, but not limited to, requiring a restricted material permit or the written recommendation of a specially trained pest control advisor or specially trained certified private applicator, or limiting the quantity, area, and manner of application.

§ 13167

Added by Stats. 1993, Ch. 963, Sec. 2. Effective January 1, 1994.

The director shall revoke or refuse to renew a certificate of interim registration at any time that he or she finds that the interim registration no longer meets all the requirements of this article, including the registrant’s failure to submit a progress report for any deferred study, a failure to show in the report that a good faith effort to complete an acceptable study is making satisfactory progress, or the period of time from the issuance of the certificate has exceeded the three year limit set forth in Section 13162. The director shall provide the registrant with the basis for the decision in writing.

§ 13168

Added by Stats. 1993, Ch. 963, Sec. 2. Effective January 1, 1994.

The director may adopt regulations to carry out this article.

§ 13169

Added by Stats. 1993, Ch. 963, Sec. 2. Effective January 1, 1994.

To the extent that this article conflicts with other provisions in Article 15 of this chapter, this article shall prevail. Unless otherwise specified in this article, a certificate of interim registration shall be subject to all other provisions governing certificates of registration in Division 6 (commencing with Section 11401) and this division.

§ 13170

Added by Stats. 1993, Ch. 963, Sec. 2. Effective January 1, 1994.

The department shall impose a fee in an amount sufficient to cover the department’s costs of reviewing and processing the application on any person who applies for a certificate of interim registration pursuant to this article. Fee revenue shall be deposited in the Department of Pesticide Regulation Fund and shall be available, upon appropriation by the Legislature, to offset the department’s costs to process and review these applications.