Source: https://www.cdpr.ca.gov/docs/registration/canot/ca02-3.htm
Timestamp: 2018-12-17 08:28:41
Document Index: 669577088

Matched Legal Cases: ['§13141', '§13141', '§13121', 'art 158', 'art 158', 'art 158', 'art 158']

DATA REQUIREMENTS AND LETTERS OF AUTHORIZATION
California Notice 2002-3
TO:	PESTICIDE REGISTRANTS AND OTHER INTERESTED PERSONS
SUBJECT: DATA REQUIREMENTS AND LETTERS OF AUTHORIZATION
The purpose of this notice is to set forth in as clear and complete a manner as possible, the Department of Pesticide Regulation's general data requirements and the statutes and regulations that support those requirements. Since DPR's data requirements and the potential need for a letter of authorization are related, this notice also addresses when a letter of authorization is required.
DPR's general pesticide product data requirements have not changed for a number of years. However it has come to DPR's attention that there is confusion and misleading information being distributed by others amongst the regulated community as to DPR's data requirements and/or when a letter of authorization is required. Some have incorrectly assumed that DPR has the same data requirements for registration actions, such as amendments to currently registered pesticides and new products containing currently registered active ingredients, as it does for new pesticide products containing new active ingredients. This notice is intended to correct any misconceptions and to restate DPR's existing general data requirements for pesticide products.
DPR requires the following general data to register a new pesticide product containing a currently registered active ingredient:
Residue Chemistry for food or feed crop uses (except certain crops grown for seed) unless U.S. EPA has exempted the active ingredient from its food tolerance requirement.
Environmental Fate (FAC §13141 et. seq), if registration is for the first agricultural use of a pesticide product containing a currently registered active ingredient.
Efficacy, except for manufacturing-use only products.
Phytotoxicity, if applicable.
Fish and Wildlife, if applicable.
Worker/User Safety.
Dermal absorption, if applicable.
Indoor exposure, if applicable.
Mixer, loader, applicator, if applicable.
All data that the DPR applicant submitted to the U.S. EPA in support of its application for federal registration of the pesticide product for which the applicant is seeking DPR registration.
In general, DPR requires the following data to register a pesticide product containing a
new active ingredient:
All data listed above for registering a new pesticide product containing a currently registered active ingredient.
Environmental Fate (FAC §13141 et seq.), if the product is intended for agricultural use.
Chronic Toxicology/ Health Effects Data (FAC §13121 et seq.).
Further information about DPR's data requirements can be found in DPR's Registration Desk manual, available on DPR's Home Page at <www.cdpr.ca.gov/docs/registration/manual/toc.htm>.
Pesticide Product Amendments
If the request is for an amendment to a currently registered pesticide product, DPR only requires scientific data applicable to support the amendment. For example, if the application rate were being lowered, DPR would require a new efficacy study to assure that the product will be effective at the new rate. As specified below (section 6170), the applicant for an amendment is to submit in full to DPR all data that the applicant submitted to the U.S. EPA to support federal amendment of registration of the product.
In lieu of submitting data required by DPR, section 6170(c) permits the applicant to reference data that it previously submitted to DPR, and/or to use data previously submitted by another company when a written authorization is submitted to DPR by the owner of the data.
Enacted in 1996, FAC section 12811.5 codified DPR's letter of authorization process. FAC section 12811.5 states that DPR cannot consider data previously submitted by one company to either the U.S. EPA or DPR to support an application for registration by another person, without the written permission of the data owner. FAC section 12811.5 was sponsored by DPR and added to the FAC because DPR wanted to prevent a company that physically and lawfully obtains another company's scientific data, either from U.S. EPA through the Freedom of Information Act or from DPR through the Public Records Act, from later submitting that data to DPR to support the registration of its pesticide product without the permission of the data owner.
Letters of authorization are needed only for data that DPR requires and that have not been submitted by the applicant.
DPR's data requirements, as listed above, are established in various statutes and regulations, some of which are discussed below.
Food and Agricultural Code (FAC) section 12824 requires that DPR make a thorough evaluation before a substance is registered as a pesticide for the first time. FAC section 12824 provides no specific data requirements. FAC section 12824 does provide that the Director may establish "performance standards and tests" that are to be conducted or financed, or both conducted and financed, by the applicant for registration. In order to implement, interpret, and make specific FAC section 12824, DPR's predecessor, the California Department of Food and Agriculture, adopted regulations in Subchapter 1, Chapter 2, Division 6, Title 3 of the California Code of Regulations (3 CCR).
In 1984 and 1985, the Legislature enacted the Birth Defect Prevention Act (BDPA) and the Pesticide Contamination Prevention Act (PCPA), respectively. These two statutes established a data call-in for active ingredients that were then currently registered and ongoing data requirements for new pesticide products containing new active ingredients.
DPR's pesticide product registration requirements are specified in 3 CCR, Division 6, Chapter 2, Subchapter 1. Article 1 contains general provisions, Article 2 covers registration requirements, and Article 3 addresses supplemental data requirements. Other articles address matters such as conditional registration, exemptions, adverse effect disclosure, research authorization, and renewal of registration.
Section 6159
Section 6159 states the Director's finding that data required by the U.S. Environmental Protection Agency's (U.S. EPA's) regulations in Title 40, Code of Federal Regulations (CFR), would "substantially meet the data requirements of FAC section 12824," except as provided in this section and sections 6158, 6170, 6172, 6176-6179, 6180(a), 6181-6192, 6200, 6210, 6215, and 6222.
Section 6170
Section 6170 establishes which scientific studies applicants for registration or amendment of a pesticide product must submit to DPR along with a completed application form, fee, and product labeling. Section 6170 states that the application is incomplete unless accompanied by the fee, required labeling, and the data required to be submitted by sections 6159, 6170, 6172, 6176-6179, 6180(a), 6181-6192, and 6200 when applicable to support registration of the product. Not all of the data listed in 3 CCR sections 6159, 6170, 6172, 6176-6179, 6180(a), 6181-6192, and 6200 are applicable to a particular pesticide product. Section 6170 authorizes DPR to use its discretion in determining what data are "applicable" to a particular product registration. The data requirements for two pesticide products containing the same active ingredient may be different due to a number of factors, including but not limited to:
Whether the pesticide product contains a new active ingredient substance;
Whether the product is a manufacturing use product or an end-use product;
Whether the product is an agricultural use product, and, if so, whether the labeling provides for the first agricultural use of an active ingredient substance in the product;
The product's use patterns and label directions, and resultant potential exposure of the pesticide product to applicators, other persons, fish and wildlife, or the environment;
Whether the action will be an unconditional registration, conditional registration, interim registration, or emergency registration; and
Whether the request is to register a new product or is for an amendment to a currently-registered product, such as an amendment changing the application rate of a currently-registered product, adding a new use to the label of a currently registered product, or adding another (additional) brand name for a currently-registered product.
Section 6170 also requires that the applicant for registration or amendment of registration submit all data in full to DPR that the applicant submitted to U.S. EPA to support federal registration or amendment of registration of the applicant's product. This requirement assures that DPR will receive all of the data the applicant submitted to U.S. EPA, even though that data may not be required by California's regulations and DPR may not think that the data are applicable to California registration or amendment of the product. This provision assures that DPR receives all data (i.e., any special studies required by U.S. EPA) submitted to U.S. EPA by the applicant.
For the most part, the data that DPR requires an applicant to submit to support the California registration of an end-use product is consistent with the data that U.S. EPA requires end-use product applicants to submit to obtain federal registration of the same product. As long as the end-use product applicant uses a federally registered source product, U.S. EPA does not require the applicant to submit studies on the technical grade active ingredient (TGAI). For example, 40 CFR Part 158.340 (Toxicity Data Requirements) appears to require acute oral, acute dermal, acute inhalation, dermal sensitization, and eye irritation data on the formulated product and the TGAI for an end-use pesticide product. However, a look at the footnotes reveals that an end-use product applicant only has to provide U.S. EPA with toxicity studies on the formulated product, and not the TGAI, if the applicant purchases the active ingredient from a U.S. EPA registered source.
One difference between U.S. EPA and DPR is that U.S. EPA requires the registration of all sources of an active ingredient. California statute requires the registration of pesticide products that will be sold for use in California. If the manufacturing use technical grade active ingredient source product will not be sold for use in California, registration with DPR is not required.
Enclosed is an appendix, which discusses some misconceptions regarding California's data requirements.
If you have questions about data requirements for a particular product, please contact the registration specialist assigned to the company.
Listed below are some misconceptions regarding California's data requirements for pesticide products.
Misconception: DPR recently changed its policies regarding data requirements for pesticide products.
Fact: DPR's general pesticide product data requirements have not changed for many years. DPR did adopt regulations concerning liquid chemical sterilants (section 6146) in 1998; exemptions related to section 25(b) of FIFRA (section 6147) in 2000; and the fee for a certificate of interim registration (section 6168) in 1994, but those regulations did not change California's general data requirements.
Misconception: DPR requires the same data for all registration actions, including amendments to currently registered pesticides, new products containing currently registered active ingredients, and new pesticide products containing new active ingredients.
Fact: Different data requirements apply depending on whether the application is for the registration of a new product containing a new active ingredient, a new product containing a currently registered active ingredient, an amendment to the formulation or label of a currently registered pesticide, etc.
Misconception: DPR requires the submission of chronic health effects data and environmental fate data, studies that are conducted using the technical grade active ingredient (TGAI), with each application for registration regardless of whether the product contains a new active ingredient or an active ingredient that is already registered for use in the State of California.
Fact: DPR only requires the submission of chronic health effects and environmental fate data with each application for registration of a new pesticide product containing a new active ingredient. (Note: Environmental fate data are required only if the product is intended for an agricultural use.) Subsequent applications for registration of pesticide products containing the same active ingredient are not required to submit chronic health effects data. However, environmental fate data are required if the subsequent product label provides the first agricultural use of a currently registered active ingredient. These requirements are consistent with DPR's regulations (e.g., section 6172) and with FAC Division 7, Chapter 2, Articles 14 and 15. In addition, U.S. EPA does not require subsequent end-use product applicants to submit such data.
Misconceptions: U.S. EPA regulations in 40 CFR Part 158 require each product to be supported by a complete set of supporting data for each and every end-use product. DPR regulations require submission of the same data required by U.S. EPA and, thus, each applicant for DPR registration of an end-use product containing a currently DPR-registered active ingredient must submit to DPR all of the data listed in 40 CFR Part 158, including chronic health effects and environmental fate data.
Fact: End-use product applicants are only required to submit a limited set of data to U.S. EPA (e. g., product chemistry, acute toxicity studies on the formulated product, etc.). 40 CFR Part 158 specifies, for each type of scientific study, which data are required for manufacturing use pesticides and which data are required for end-use products. Further specification with regard to data requirements for end-use products is provided in the footnotes of U.S. EPA's data requirement tables. Asterisks identify those data requirements that end-use applicants must satisfy, if the active ingredient in their product is purchased from a U.S. EPA registered source.
Misconception: DPR must require subsequent applicants for registration of a pesticide product containing a currently registered active ingredient to obtain a letter of authorization from the original company that submitted chronic health effects and environmental fate data on the active ingredient.
Fact: Applicants for registration of pesticide products containing currently registered active ingredients are not required to submit chronic health effects data. Environmental fate data are required if the subsequent product label provides the first agricultural use of a currently registered active ingredient. These requirements are consistent with FAC Division 7, Chapter 2, Articles 14 and 15, and DPR's regulations. When the data are not required, no letter of authorization is required.
Misconception: Section 6170 provides that every application for DPR-registration must be accompanied by all data submitted to U.S. EPA by any company to support the federal registration of all products containing the same active ingredient as the DPR applicant's product.
Fact: Section 6170, which was developed by DPR, is entitled "Application" and requires each applicant for DPR registration of a pesticide product to submit all data that the applicant submitted to U.S. EPA to support the federal registration of the same product. Section 6170 does not require each applicant to submit to DPR all data that may have been submitted to U.S. EPA by other applicants for federal registration of all pesticide products containing the same active ingredient.
Misconception: DPR only requires a letter of authorization under the limited circumstances where an applicant cites data on file with DPR and DPR staff are physically required to again review the data in order to make a determination on the application under review.
Fact: Whether or not DPR physically reviews previously submitted data again is not relevant to the requirement for a letter of authorization. If data are required by DPR and an applicant chooses to reference data submitted by another company instead of submitting its own data, then DPR requires a letter of authorization. DPR may or may not reread the data being referenced. However, if data are not DPR-required, then no letter of authorization is required for such data.
Misconception: DPR requires registrants to submit a letter of authorization when designating a new or alternate active ingredient source product.
Fact: DPR does not require registrants to submit data or a letter of authorization when designating a new or alternate active ingredient source product, unless the change also results in a significant formulation change. When there is an accompanying change in formulation that may alter the toxicity of the product, DPR may require additional data. For active ingredient source product changes, registrants are not even required to notify DPR of the change. The only exception would be source changes with an accompanying significant formulation change, which would be a product amendment.
Misconception: The 1980 case of National Agricultural Chemicals Association v. Rominger prohibits DPR from registering new pesticide products containing currently DPR-registered active ingredients unless the applicant submits a letter of authorization from the company that first registered the active ingredient for use in California.
Fact: The lawsuit did not address what data are required to support different types of registration actions in California. At the time of the lawsuit, the Department of Food and Agriculture (CDFA) was planning to allow applicants for registration of new pesticide products to use data submitted and owned by other companies to support their registrations. In response to the lawsuit, CDFA announced that any releases of data to the public would be subject to the requirements of the Public Records Act. In addition, CDFA agreed that applicants for registration would not be allowed to submit or cite CDFA-required data owned by another company unless the owner of the data provided CDFA with a letter of authorization. DPR continues these two policies today.