California Code of Regulations (Title 3. Food and Agriculture)
Division 6. Pesticides and Pest Control Operations

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Division 6. Pesticides and Pest Control Operations
Chapter 2. Pesticides
Subchapter 1. Pesticide Registration
Article 3. Supplemental Data Requirements


6176. Safety Related to Exposure.

Dermal Absorption. Each applicant to register a pesticide product that has an active ingredient with an acute dermal toxicity (LD50) of 2,000 or less milligrams per kilogram of body weight for a 24-hour period shall submit to the director dermal absorption data.

NOTE: Authority cited: Sections 11456, 11502, 12005, 12111, 12531, 12561, 12781, 12976, 12981, 14005 and 14006.7, Food and Agricultural Code.

Reference: Sections 11401-12121, 12501-12671, 12751-13102 and 14001-14104, Food and Agricultural Code.

6177. Mixer, Loader, Applicator Exposure.

Each applicant to register a pesticide product in toxicity category one or two, the use of which may be expected to result in significant respiratory or dermal exposure during mixing, loading, or application shall submit appropriate, dermal or inhalation exposure data. Studies required by this section that involve human participants, to be conducted in California, shall meet the requirements of section 6710.

NOTE: Authority cited: Sections 12781 and 12981, Food and Agricultural Code.

Reference: Sections 12815, 12824, 12980, 12981, 12987 and 12988, Food and Agricultural Code.

6178. Management of Poisoning.

Each applicant to register a new pesticide product or a new use of a previously registered product shall submit to the director a protocol supported by data for the practical treatment of poisoning and other injury cases.

NOTE: Authority cited: Sections 11456, 11502, 12005, 12111, 12531, 12561, 12781, 12976, 12981, 14005 and 14006.7, Food and Agricultural Code.

Reference: Sections 11401-12121, 12501-12671, 12751-13102 and 14001-14104, Food and Agricultural Code.

6179. Spray Adjuvants.

Each applicant to register a spray adjuvant that is exempt from a tolerance pursuant to U.S. EPA regulations shall submit to the director acute toxicity data on the formulated product including oral, dermal and inhalation toxicity values, and the results of eye and skin irritation tests. If the director determines that the data indicate a risk of chronic effect, the applicant shall submit data relating to such chronic effect.

NOTE: Authority cited: Sections 11456, 11502, 12005, 12111, 12531, 12561, 12781, 12976, 12981, 14005 and 14006.7, Food and Agricultural Code. Reference: Sections 11401-12121, 12501-12671, 12751-13102 and 14001-14104, Food and Agricultural Code.

6180. Rodenticides.

(a) Each applicant to register a pesticide that is a rodenticide shall submit biochemical data describing the metabolic pathway and the mode of action in animal models suitable for extrapolation of the data to people.

(b) Anticoagulant rodenticide baits intended for home use shall contain a color additive of such intensity as to be readily evident.

(c) Suggested dyes for anticoagulant baits are listed in the department's Vertebrate Pest Control Handbook (Publication No. 410).

(d) Baits containing strychnine shall be dyed with a green color additive as specified in the department's Vertebrate Pest Control Handbook.

(e) Subsections (b) and (c) do not apply to bird control materials or animal repellents.

NOTE: Authority cited: Section 12781, Food and Agricultural Code.

Reference: Sections 11501 and 12824, Food and Agricultural Code.

6181. Foliar Residue and Field Reentry.

Each applicant proposing to register a new pesticide product or new use of a previously registered pesticide product that is intended for use on a commercially grown crop where there may be substantial exposure by field workers, shall submit acceptable foliar and soil residue data, including data on toxic alteration products if (a) any active ingredient or alteration product has an acute dermal toxicity (LD50) of 2,000 or less milligrams per kilogram of body weight for a 24-hour period, (b) is highly irritating to the skin, (c) is a sensitizer, or (d) involves a potential risk of a chronic health effect.

NOTE: Authority cited: Sections 11456, 11502, 12005, 12111, 12531, 12561, 12781, 12976, 12981, 14005 and 14006.7, Food and Agricultural Code.

Reference: Sections 11401-12121, 12501-12671, 12751-13102 and 14001-14104, Food and Agricultural Code.

6182. Field Reentry.

(a) A proposed pesticide use that poses a safety hazard to field workers will not be registered until a safety interval to protect such workers has been established and is in effect by regulation or label statement.

(b) Reentry intervals shall be established on the basis of data on dermal absorption, inhalation and dermal/oral-response studies in animal models in conjunction with foliar and soil dissipation data and any available human exposure data. The selected reentry interval will be sufficiently long to ensure that a safe (no-effect) level is present on foliage and the soil when workers may reenter previously treated areas.

(c) In the case of a safety interval set without a human reentry study, the director may require a field monitoring study of workers during the first year of use.

NOTE: Authority cited: Sections 11456, 11502, 12005, 12111, 12531, 12561, 12781, 12976, 12981, 14005 and 14006.7, Food and Agricultural Code.

Reference: Sections 11401-12121, 12501-12671, 12751-13102 and 14001-14104, Food and Agricultural Code.

6183. Indoor Exposure.

Each applicant to register a pesticide product, the use of which in houses, institutions, or other buildings may result in dermal or respiratory exposure after application, shall submit exposure data. Studies required by this Section that involve human participants, to be conducted in California, shall meet the requirements of Section 6710.

NOTE: Authority cited: Sections 12781 and 12981, Food and Agricultural Code. Reference: Sections 12815, 12824, 12980, 12981, 12987 ans 12988, Food and Agricultural Code.

Reference: Sections 11401-12121, 12501-12671, 12751-13102 and 14001-14104, Food and Agricultural Code.

6184. Residue Test Method.

(a) Each applicant for the registration of a pesticide product shall provide the director with a method and a standard sample for accurately determining residues of (1) each active ingredient in the pesticide product and (2) each metabolite that may result from the active ingredient for which a tolerance has been established by the U.S. EPA in the Code of Federal Regulations. Test methods shall allow the director to determine residues in or on plant or animal tissue, soil, and water.
(b) In the case of a pesticide intended for use on a food crop for which a residue tolerance has been established, the method shall allow the director to determine the residue on each crop within a continuous 24-hour period. Registration may be allowed for a reasonable time during which the applicant can comply with this subsection. The registration shall not be allowed to continue for more than 2 years without compliance with this subsection unless the applicant provides the director with an equally effective procedure for accomplishing the protection offered by the 24-hour method.

NOTE: Authority cited: Sections 11456, 11502, 12005, 12111, 12531, 12561, 12781, 12976, 12981, 14005 and 14006.7, Food and Agricultural Code.

Reference: Sections 11401-12121, 12501-12671, 12751-13102 and 14001-14104, Food and Agricultural Code.

6185. Residue Data.

Residue data required by sections 6159 and 6181 shall be obtained under California or similar environmental use conditions. Such data shall take into consideration differences in plants, soils, climatic conditions, and application techniques.

NOTE: Authority cited: Sections 11456, 11502, 12005, 12111, 12531, 12561, 12781, 12824, 12976, 12981, 14005 and 14006.7, Food and Agricultural Code. Reference: Sections 11401-12121, 12501-12671, 12751-13102 and 14001-14104, Food and Agricultural Code.

6186. Efficacy.

Each application for registration or amendment to the labeling of a pesticide shall be accompanied by data supporting each efficacy claim. If data supporting such claims are in the public domain and copies of the data are provided, the submission of such data may satisfy the requirement of this Section. Such data shall be obtained under California or similar environmental use conditions and shall take into consideration differences in plants, soils, climate conditions, and application techniques.

NOTE: Authority cited: Sections 14004.5 and 14006.7, Food and Agricultural Code.

Reference: Sections 11501, 12561, 12824, 12825 and 12854, Food and Agricultural Code.

6187. Hazards to Bees.

Each applicant to register a pesticide product which, under field conditions, may be likely to contact commercial apiaries or pollinating bees shall submit to the director test data indicating the product's acute chronic toxicity to bees. Testing procedures shall be those described by the University of California laboratory studies included in Leaflet 2287, or equivalent procedures.

NOTE: Authority cited: Sections 11456, 11502, 12005, 12111, 12531, 12561, 12781, 12976, 12981, 14005 and 14006.7, Food and Agricultural Code.

Reference: Sections 11401-12121, 12501-12671, 12751-13102 and 14001-14104, Food and Agricultural Code.

6188. Closed System Compatibility.

(a) Each applicant to register a liquid pesticide product bearing the label statement, "Fatal if absorbed through skin," "May be fatal if absorbed through skin," "Corrosive, causes skin damage," or other comparable language labeled for any use for the production of an agricultural commodity shall submit to the Director data on the product's viscosity and such other data the Director may require to comply with sections 6188(b) and 6746.

(b) No liquid pesticide labeled for any use for the production of an agricultural commodity and bearing the label statement, "Fatal if absorbed through skin," "May be fatal if absorbed through skin," "Corrosive, causes skin damage," or other comparable language shall be registered unless the product is compatible with closed mixing systems as defined in section 6746.

NOTE: Authority cited: Sections 11456, and 12781, Food and Agricultural Code. Reference: Sections 11501, 12815 and 12824, Food and Agricultural Code.

6189. Effects on Pest Management.

Each applicant to register a pesticide for use on a crop for which it was not previously registered shall submit data to the director concerning any adverse effect of the product on pest management systems for that crop.

NOTE: Authority cited: Sections 11456, 11502, 12005, 12111, 12531, 12561, 12781, 12976, 12981, 14005 and 14006.7, Food and Agricultural Code.

Reference: Sections 11401-12121, 12501-12671, 12751-13102 and 14001-14104, Food and Agricultural Code.

6190. Copper-based Antifouling Paints and Coatings.

(a) Each applicant to register a copper-based antifouling paint or coating shall submit the daily mean copper release rate for the product using the International Organization for Standardization (ISO) method 10890:2010, “Paints and varnishes – Modelling of biocide release rate from antifouling paints by mass-balance calculation,” hereby incorporated by reference, and supporting data used for the calculation.

(b) Using the rate and data provided pursuant to (a) of this section and a correction factor of 2.9, the Director will calculate an adjusted daily mean copper release rate to account for environmental conditions.

(c) The provisions in this subsection pertain to copper-based antifouling paint or coating products except when labeled for commercial vessel use only or prohibited from use on recreational vessels. For the purposes of this subsection, “recreational vessel” means any vessel manufactured or used primarily for pleasure or leased, rented, or chartered to a person for the person’s pleasure, and/or used as a residence. “Commercial vessel” means any private, commercial, government, or military marine vessel that does not otherwise meet the definition of recreational vessel, including, but not limited to, passenger ferries; excursion vessels; tugboats; ocean-going tugboats; towboats; push-boats; crew and supply vessels; work boats; pilot vessels; supply boats; fishing vessels; research vessels; U.S. Coast Guard vessels; hovercraft; emergency response harbor craft; and barge vessels.

(1) Effective July 1, 2018, no copper-based antifouling paint or coating shall be registered that exceeds the adjusted daily mean copper release rate of 9.5 micrograms per square centimeter per day, as determined by the Director pursuant to (b) of this section.

(2) Effective July 1, 2018, any currently registered copper-based antifouling paint or coating that exceeds the adjusted daily mean copper release rate of 9.5 micrograms per square centimeter per day, as determined by the Director pursuant to (b) of this section, will be subject to cancellation pursuant to Food and Agricultural Code section 12825.

NOTE: Authority cited: Sections 11456, 12781 and 12976, Food and Agricultural Code. Reference: Sections 12824, 12825 and 14102, Food and Agricultural Code.

6191. Volatile Organic Compounds.

The director, after consultation with the Air Resources Board, shall determine under what circumstances interference with the attainment and maintenance of ambient air quality standards is likely to result from the evaporative emission of volatile organic compounds contained in a pesticide product and may require the applicant to supply data regarding such emissions.

NOTE: Authority cited: Sections 11456, 11502, 12005, 12111, 12531, 12561, 12781, 12976, 12981, 14005 and 14006.7, Food and Agricultural Code.

Reference: Sections 11401-12121, 12501-12671, 12751-13102 and 14001-14104, Food and Agricultural Code.

6192. Other Data.

Each applicant to register a pesticide product shall submit to the director any other data determined by the director to be necessary to carry out the provisions of Section 12824 of the Food and Agricultural Code. Each data request pursuant to this section shall include the director's reason for the request. Such data may include, but is not limited to the following:
(a) Pesticide drift.
(b) Phytotoxicity.
(c) Environmental effects.
(d) Analytical and environmental chemistry.
(e) The effect from the use of mixtures of two or more products in combination.
(f) Contaminants in pesticide products.

NOTE: Authority cited: Sections 11456, 11502, 12005, 12111, 12531, 12561, 12781, 12976, 12981, 14005 and 14006.7, Food and Agricultural Code.

Reference: Sections 11401-12121, 12501-12671, 12751-13102 and 14001-14104, Food and Agricultural Code.

6193. Wettable and Soluble Powders.

NOTE: Authority cited: Sections 407, 12781 and 14005, Food and Agricultural Code.

Reference: Sections 12751-12994, Food and Agricultural Code.

6193.5. Acute Effects Data for Dietary Risk Assessment.

(a) For the purposes of this Section, "acute exposure" is defined as a single treatment or repeated treatments during a period normally not to exceed seven days. Signs of acute toxicity are physical, behavioral, or biochemical manifestations, resulting from acute exposure, which are relevant to assessing dietary risks resulting from acute exposures of humans. Relevant observations of acute toxicity are described in the U.S. EPA Pesticide Assessment Guidelines, Subdivision F.

(b) The following data, from studies using active ingredients, are required to assess dietary risk resulting from acute exposures:

(1) Acute oral LD50 toxicity data as required pursuant to Title 40 Code of Federal Regulations, Part 158.340; and

(2) Oral toxicity data demonstrating a No Observed Effect Level (NOEL) for signs of acute toxicity following acute exposure and oral toxicity data sufficient to produce a dose-response curve for active ingredients with known biological indicators (e.g., cholinesterase inhibition) when this response is relevant to the NOEL. For active ingredients with anticholinesterase activity, at a minimum, red blood cell cholinesterase activity must be reported.

(c) The data listed in subsection (b) shall be submitted with each application for registration of:

(1) A pesticide product intended for use on food or feed crops and containing an active ingredient not currently registered for food or feed use; or

(2) Amended labeling which would add directions for use on food or feed crops to the label of a pesticide product containing an active ingredient not currently registered for food or feed use.

(d) Pursuant to Section 13060 of the Food and Agricultural Code, when notified by the department, registrants of pesticides labeled for use on food or feed crops must submit the acute effects data listed in subsection (b). Registrants shall have nine months from the date of the department's notice to submit the data.

(e) The department will not require the data listed in subsections (b) for active ingredients for which the department has made a written determination that existing data demonstrates that acute dietary exposure is not of toxicological concern.

NOTE: Authority cited: Section 12781, Food and Agricultural Code.

Reference: Sections 12824 and 13060, Food and Agricultural Code.

6194. Required Submission of Data.

(a) Registrants required to submit data in support of registrations pursuant to Food and Agricultural Code Sections 13060(c)(1), 13127, 13143 or 13146 shall respond to the director's notices of the data and study requirements. Where the notice pertains to data required pursuant to Food and Agricultural Code Section 13127, the data shall be one or more of the mandatory health effects studies specified in Food and Agricultural Code Section 13123. Where the notice pertains to data required pursuant to Food and Agricultural Code Sections 13143 or 13146, the data shall be all or some of the information specified in Food and Agricultural Code Section 13143(a)(1) through (6). Where the notice pertains to data required pursuant to Food and Agricultural Code Section 13060(c)(1), the data shall be that listed in Section 6193.5(b). Not later than 90 days after the date of such a notice, registrants shall inform the director in writing as to how they will comply with the data requirements by choosing one or more of the following options:

(1) Submit the data with their response to the notice.

(2) Develop and submit the data.

(3) Agree to jointly develop and submit the data with one or more parties and provide a copy of the agreement signed by the participating parties.

(4) Acquire authorization to use data being developed and submitted by another party and provide a copy of the authorization signed by that party.

(5) For data required pursuant to Sections 13127, 13143 or 13146 of the Food and Agricultural Code, offer to compensate the developer(s) of the data and provide a copy of the offer, together with evidence that the data developer(s) received the offer.

(6) Claim the data requirements are not applicable to the registered use patterns of the registrant's pesticide products and provide information supporting the claim.

(7) When applicable to the particular notice, claim an exemption from the mandatory health effects data requirements pursuant to Food and Agricultural Code Section 13128, or claim an exemption from the acute effects data requirements pursuant to Food and Agricultural Code Section 13060(c)(2), and provide the information specified in subsection (c).

An option shall be chosen for each data requirement; however, different options may be chosen for different data requirements. When requested by the director, registrants who have chosen options (2) and/or (3) shall submit a written status report to the director regarding the development of the data which shall include, but is not limited to:

(1) The name and address of the person/organization conducting the study.

(2) The initiation and expected completion dates; and

(3) The scheduled date of submission of the data to the department. The status report shall be submitted not later than 30 days after the date of the director's request, unless a later date is specified.

(b) Pursuant to Food and Agricultural Code Sections 13060(c)(2) and 13128, data requirements noticed pursuant to Food and Agricultural Code Sections 13060(c)(1) and 13127, respectively, shall not apply to applicants or registrants of end use products that are formulated using another producer's pesticide product which is registered with the United States Environmental Protection Agency (U.S. EPA), provided all pesticide active ingredients in the formulated product are derived solely from one or more EPA registered pesticide products and the producer(s) has/have chosen from options (1), (2), (3) and/or (5) in subsection (a) of this Section, and is/are in compliance with the requirements of Sections 13060(c)(1) or 13127 whichever applies, of the Food and Agricultural Code and the director's regulations in chapter 6 of Title 3 of the California Code of Regulations.

(c) The director shall grant an exemption as authorized by Sections 13060(c)(2) and 13128 of the Food and Agricultural Code to an applicant or registrant that meets the conditions specified in subsection (b). To apply for an exemption, the applicant or registrant shall submit the following:

(1) The name and the EPA registration number of each pesticide product purchased to formulate the end use product; and

(2) The name of the producer(s) from whom the applicant or registrant purchases the active ingredient(s) used to formulate the product(s), who has/have chosen from options (1), (2), (3) and/or (5) in subsection (a) of this Section, and is/are in compliance with the requirements of Sections 13060(c)(1) or 13127, whichever applies, of the Food and Agricultural Code, and the director's regulations contained in chapter 6 of Title 3 of the California Code of Regulations. If the active ingredient(s) is/are not purchased directly from the producer(s), but through a supplier, include a statement identifying the producer(s) by name and certifying that the active ingredient(s) used to formulate the product(s) is/are purchased indirectly from a producer(s) who has/have chosen from options (1), (2), (3) and/or (5) in subsection (a) of this Section, and is/are in compliance with the requirements of Sections 13060(c)(1) or 13127, whichever applies, of the Food and Agricultural Code and the director's regulations contained in chapter 6 of Title 3 of the California Code of Regulations.

(d) If a registrant that has been granted an exemption pursuant to Sections 13060(c)(2) or 13128 of the Food and Agricultural Code purchases a pesticide product different from that reported in accordance with subsection (c), the registrant shall notify the director of the change. If the registrant still meets the conditions specified in subsection (b) and wishes to request an exemption, the registrant shall reapply for the exemption following the procedure described in subsection (c).

(e) An applicant or registrant that has been granted an exemption pursuant to Sections 13060(c)(2) or 13128 of the Food and Agricultural Code will be exempt as long as the producer(s) of the pesticide active ingredient(s) in its end use product has/have chosen from options (1), (2), (3) and/or (5) in subsection (a) of this Section, and is/are in compliance with the requirements of Sections 13060(c)(1) or 13127, respectively, of the Food and Agricultural Code and the director's regulations contained in chapter 6 of Title 3 of the California Code of Regulations. An applicant or registrant that no longer qualifies for such an exemption is subject to the requirements of Sections 13060(c)(1) or 13127, whichever applies, of the Food and Agricultural Code.

NOTE: Authority cited: Sections 12781 and 13145, Food and Agricultural Code.

Reference: Sections 13060, 13127, 13128, 13143 and 13146, Food and Agricultural Code.

6195. Acceptability of Submitted Studies.

(a) The director will determine whether information and studies submitted pursuant to Sections 13127, 13143 and 13146 of the Food and Agricultural Code are valid, complete, and adequate. The determination will be made by considering the following factors including, but not limited to:

(1) Study design and conduct,

(2) Test substance characterization,

(3) Collecting and reporting of data,

(4) Statistical analysis of study results, and

(5) A showing by the registrant that the information and studies meet the requirements of Food and Agricultural Code Sections 13123.5 or 13143.

(b) The director's determination of acceptability shall be final unless, within 90 days after notice to the registrant of disapproval, the registrant petitions for reconsideration and shows in detail therein the particular matters alleged to have been improperly evaluated by the director and the reasons supporting a different evaluation. The director may grant reconsideration upon such showing and may permit the registrant to supplement the material previously submitted, or otherwise show that the studies submitted are acceptable. The time periods and procedures in such reconsideration actions shall be set by the director in consideration of the particular matters involved.

NOTE: Authority cited: Sections 12781 and 13145, Food and Agricultural Code.

Reference: Sections 13127, 13143 and 13146, Food and Agricultural Code.

6196. Adoption of Federal Authority.

As authorized by Sections 13127 and 13146 of the Food and Agricultural Code, the director adopts the provisions of subparagraph (B) of paragraph (2) of subdivision (c) of Section 136a of Title 7 of the United States Code, as applicable to compensation for data development pursuant to Food and Agricultural Code Sections 13127, 13143 and 13146 and for suspension of registrations pursuant to Food and Agricultural Code Sections 13127, 13127.2, 13127.6, 13127.91, 13127.92 and 13146. References therein to the authority of the Administrator of the United States Environmental Protection Agency (U.S. EPA), acting pursuant to the provisions of the Federal Insecticide, Fungicide and Rodenticide Act, shall be deemed to refer to the director, acting under the provisions of the Food and Agricultural Code and regulations in Title 3 of the California Code of Regulations. The following provisions shall apply to the adoption of the federal authority:

(a) The director's authority under other provisions of law is not affected.

(b) Compensation procedures under federal law are exclusive at any time such federal procedures can be initiated before an arbitration award under this Section becomes final. A later award under federal law for submission of the same data, or substantially the same data, shall supersede an award under this Section.

(c) Arbitration proceedings under this Section shall be conducted by arbitrators of the American Arbitration Association using federal procedures to the extent practicable.

(d) Arbitration awards under this Section shall be subject to review in courts of competent jurisdiction to the same extent as judgments of California superior courts.

(e) No compensation proceedings are authorized of resubmission of public literature studies.

(f) Compensation for the use of data submitted to the director is applicable only for studies initiated after January 1, 1985 to fill the data requirements of Food and Agricultural Code Section 13127 and studies initiated after January 1, 1986 to fill the information requirements of Food and Agricultural Code Sections 13143 and 13146. When submitted to the director, use of these data is subject to protection only to the same extent and for the same time periods as such use would be subject to protection by the U.S. EPA Administrator, had the data been submitted to U.S. EPA pursuant to 7 U.S.C. 136a(c)(2)(B)(v).

(g) The director may include in each Notice of Intent to Suspend such provisions as the director deems appropriate concerning the continued sale of existing stocks of the products included in the Notice.

(h) The only matters for resolution at the hearing, called pursuant to the Notice of Intent to Suspend, shall be whether the registrant has failed to take the action that served as the basis for the Notice of Intent to Suspend, including, but not limited to, failing to take appropriate steps to submit the data required, to participate in a procedure for reaching agreement concerning a joint data development arrangement, to participate in an arbitration proceeding as required, to comply with the terms of an agreement or arbitration decision concerning a joint data development arrangement, and/or whether the director's determination with respect to the disposition of existing stocks is appropriate.

(i) If a hearing is held, the decision after completion of such hearing shall be final.

NOTE: Authority cited: Sections 12781, 13127 and 13146, Food and Agricultural Code.

Reference: Sections 13127, 13127.2, 13127.6, 13127.91, 13127.92 and 13146, Food and Agricultural Code.

6196.1. Provisions for Suspension.

As authorized by Section 13123(m) and Section 13127(c), the following provisions shall apply to suspensions of registrations pursuant to Food and Agricultural Code Sections 13127, 13127.2, 13127.6, 13127.91 and 13127.92:

(a) The provisions of Chapter 5 of the California Administrative Procedure Act (Government Code Sections 11500-11528) apply to any hearing requested except for the following provisions which do not apply to the actual conduct of the hearing: 

(1) Government Code Sections 11503-11507. Suspension actions under the above-cited Food and Agricultural Code Sections are commenced with the filing and service of the Notice of Intent to Suspend. All references to, and requirements for, Accusations or Statements of Issues in Government Code Sections 11500-11528 shall be deemed to apply to Notices of Intent to Suspend.

(2) Government Code Sections 11517 and 11521. The Administrative Law Judge prepares and issues a final decision in hearings under the above-cited Sections of the Food and Agricultural Code.

(3) Government Code Section 11520. If the registrant does not request a hearing within 30 days after receiving the Notice of Intent to Suspend, the suspension takes effect automatically.

(b) The final decision of the Administrative Law Judge in any suspension action under the above-cited Food and Agricultural Sections shall be issued at the earliest possible time.

NOTE: Authority cited: Sections 12781, 13127 and 13146, Food and Agricultural Code.

Reference: Sections 13127, 13127.2, 13127.6, 13127.91 and 13127.92, Food and Agricultural Code.

6197. Applicability of Section 6196 to Data Obtained Pursuant to Food and Agricultural Code Section 12824.

(a) Data protection and compensation otherwise applicable to the adoption of federal authority by Section 6196 does not apply to situations described in subsection (d)(1) of Section 13127 and subsection (d) of Section 13146 of the Food and Agricultural Code in which the director obtains data and makes assessments on registrants for the costs thereof pursuant to Section 12824 of the Food and Agricultural Code.

(b) The director will determine in each matter under subsection (a) the appropriate means of making and collecting the assessments. The amount of the assessment shall be the total cost to the department to obtain the data less any appropriation the director may have requested, provided such appropriation will be received by the department. The assessments shall be charged to the registrants of an active ingredient for which data gaps exist in proportion to the total amount of the registrant's economic poison products containing the active ingredient which the registrant reported sold pursuant to Section 6388 for the most current year prior to the assessment for which such records are available. The assessments will be collected before the director initiates the required tests.

(c) The adoption of federal authority pursuant to Section 6196 does not affect the director's authority to suspend or cancel registrations for failure of registrants to submit data, or comply with assessment orders made pursuant to Food and Agricultural Code Section 12824, either separately or in conjunction with other authority.

NOTE: Authority cited: Sections 12781, 13127 and 13146, Food and Agricultural Code.

Reference: Sections 13127 and 13143, Food and Agricultural Code.

6197.5. Assessment of Pesticide Registrants.

(a) Notice of a proposed assessment made pursuant to Food and Agricultural Code Section 13127(d) shall be given to each registrant of the active ingredient for which the data gap(s) exist(s) except those granted an exemption pursuant to Food and Agricultural Code Section 13128, and to each legislative committee which, during the previous and current year, considered legislation involving pesticides. Written comments on the proposed assessment will be accepted for 30 days. After the 30 days, if the director orders the assessment, notice thereof shall also be given to each such registrant and committee.

(b) The notice of proposed assessment and the assessment order shall contain the findings of the director as to each of the following:

(1) The active ingredient involved;

(2) A list of the specific studies for which there are data gaps;

(3) The reasons for requiring the assessment to obtain data;

(4) The total estimated cost of all of the required studies and the estimated cost of each individual study;

(5) The legislative appropriation, if any, authorized to be used to reduce the assessment to registrants and the balance remaining after application of any such appropriation; and

(6) Each registrant and its proportional share of the total assessment based upon its reported sales for the most current year prior to the assessment for which such records are available as determined pursuant to Section 6197(b). Registrants that did not report any sales will be assessed the same amount as the registrant(s) reporting the least amount of sales, but not to exceed ten percent (10%) of the total assessment. If no sales were reported by any registrant, the total assessment will be divided equally among the registrants of the active ingredient involved.

(c) The assessment order shall provide that, within 30 days of the date of the assessment order notice:

(1) An affected individual registrant may, in lieu of payment, surrender its registration of all products containing the active ingredient which is the subject of the assessment; and

(2) Any individual registrant may, in lieu of payment, file with the director an agreement signed by another California or a U.S. EPA registrant of the same active ingredient to pay the individual registrant's assessment.

(d) As soon as practicable after determining the voluntary surrenders, if any, as provided in subsection (c)(1), the director shall recalculate the percentage of costs to the remaining registrants and provide notice of the recalculated assessments, or provide notice that there were no voluntary surrenders and that the assessments are those specified in the assessment order.

(e) After 30 days of the issuance of the notice provided in subsection (d), the director may order the suspension of the registration of products containing the active ingredient of any registrant that fails to pay, or fails to have the registrant who signed the agreement as provided in subsection (c)(2) pay, its assessment. The suspension order shall order the registrant to discontinue sales of such products to distributorships/dealers within California.

(f) After 90 days of the issuance of the notice provided in subsection (d), the director may take the action specified in subsection (e) against all registrations of products containing the active ingredient, except for the products of registrants excluded pursuant to Section 13128 of the Food and Agricultural Code, if the total amount of the assessment has not been paid to the director or funds have not been made available from other sources to conduct the required studies.

(g) If the original assessment did not provide adequate funds to complete the work being funded, the director may order a supplemental assessment or assessments to provide such necessary additional funds. Notice of the supplemental assessment order shall be given to each registrant, person and committee identified in subsection (a) and include: (1) the additional total amount needed for completion of the studies, (2) any legislative appropriation available, to be used to reduce the supplemental assessment, and (3) each registrant's apportionment based upon its proportional share of the original assessment. The provisions of subsections (c), (d), (e) and (f) will apply to supplemental assessment orders.

(h) Any registrant that has surrendered its registration or had its registration suspended pursuant to the provisions of this Section, or its successors in interest to surrendered or suspended products, shall not be allowed to register or sell any products containing the active ingredient which was subject to assessment unless the studies have been initiated and/or the data gaps filled and the registrant, or its successor in interest, complies with the following procedure:

(1) Within 60 days of its application for registration, the applicant/registrant shall submit to the director a statement, signed by each registrant that paid all or a share of the applicable assessment, stating that the registrant has no objection to such product registration; or

(2) Present to the director an order of a court of competent jurisdiction determining that the applicant/registrant is entitled to registration based upon the payment, or offer of payment, of reasonable compensation to concerned registrants, or upon such other basis as the court may deem appropriate; or

(3) Pays the assessment owed at the time it surrendered its registration or had its registration suspended.

(i) Monies received in excess of the total cost of obtaining the studies will be returned to registrants in proportion to each registrant's paid share of the total assessment.

NOTE: Authority cited: Sections 11456, 12781, 13127 and 13146, Food and Agricultural Code.

Reference: Sections 13127 and 13146, Food and Agricultural Code.

6198. Determination of Critical Need.

Pursuant to Food and Agricultural Code Section 13146(d), the determination of whether an active ingredient or pesticide is "critical to agricultural production" shall be based upon, but is not limited to, the following factors:

(1) Loss of the active ingredient or pesticide could prevent the commercial production of an agricultural crop;

(2) No other effective active ingredients or other alternative methods are available for the same use(s);

(3) Loss of the active ingredient or pesticide could result in the introduction or dissemination of a pest new or not theretofore known to be widely prevalent or distributed within and throughout California;

(4) Loss of the active ingredient or pesticide could cause a health hazard to animals such as livestock, horses, cattle, sheep, goats, canines and furbearing animals;

(5) Loss of the active ingredient or pesticide could cause hardship on California's agricultural industry.

NOTE: Authority cited: Sections 12781 and 13146, Food and Agricultural Code.

Reference: Sections 13143 and 13146, Food and Agricultural Code.

6198.5. List of Active Ingredients Identified Pursuant to Section 13127 of the Food and Agricultural Code.

(a) Section 13127(a) of the Food and Agricultural Code requires the department to identify 200 active ingredients which the department determines have the most significant data gaps, widespread use, and which are suspected to be hazardous to people. The active ingredients are listed below in alphabetical order:

1. Acephate

2. Acrolein

3. Alachlor

4. Aldicarb

5. Aldrin

6. Alkyl (50%C14, 40%C12, 10%C16) Dimethyl Benzyl Ammonium Chloride

7. Allethrin

8. (Reserved)

9. Amitraz

10. Amitrole

11. Arsenic Pentoxide

12. Arsenic Trioxide

13. Asulam, Sodium Salt

14. Atrazine

15. Azinphos-Methyl

16. Barban

17. Bendiocarb

18. Benomyl

19. Bentazon, Sodium Salt

20. Boric Acid

21. Bromacil

22. Bromoxynil Octanoate

23. Captafol

24. Captan

25. Carbaryl

26. Carbofuran

27. Carbon Tetrachloride

28. Carboxin

29. Chloramben

30. Chlordane

31. Chlordimeform

32. Chlorflurenol, Methyl Ester

33. (Reserved)

34. Chlorobenzilate

35. Chloroneb

36. Ortho-Benzyl-Para-Chlorophenol

37. Chloropicrin

38. Chlorothalonil

39. Chlorpyrifos

40. Chlorsulfuron

41. Chlorthal-Dimethyl

42. (Reserved)

43. Coumaphos

44. Creosote

45. Cryolite

46. Cyanazine

47. Cyanuric Acid, Monosodium Salt

48. Cycloate

49. Cyhexatin

50. 2,4-D

51. 2,4-D, Dimethylamine Salt

52. Daminozide

53. DDVP

54. Deet

55. Demeton

56. Diazinon

57. Dicamba

58. Diclobenil

59. Para-Dichlorobenzene

60. 1,2-Dichloropropane, 1,3-Dichloropropene and Related C-3 Compounds

61. 1,3-Dichloropropene

62. Diclofop Methyl

63. Dicofol

64. Didecyl Dimethyl Ammonium Chloride

65. Diethatyl-Ethyl

66. Dimethoate

67. Dimethyl phthalate

68. 2,4-Dinitrophenol

69. Dinocap

70. Dinoseb

71. Dioxathion

72. Diphacinone

73. Diphenamid

74. Diphenylamine

75. Dipropyl Isocinchomeronate

76. Diquat Dibromide

77. Diuron

78. Endosulfan

79. Endothall, Mono (N,N-Dimethylalkylamine) Salt

80. Endrin

81. EPN

82. EPTC

83. Ethalfluralin

84. Ethephon

85. Ethofumesate

86. Ethoprop

87. (Reserved)

88. Ethylene Dibromide

89. Ethylene Dichloride

90. Ethylene Glycol, Monomethyl Ether

91. Ethylene Oxide

92. Fenamiphos

93. Fenarimol

94. Fensulfothion

95. Fenthion

96. Ferbam

97. Fluchloralin

98. Flucythrinate

99. Fluometuron

100. Fluvalinate

101. Folpet

102. Formaldehyde

103. Fosamine, Ammonium Salt

104. Glyphosate, Isopropylamine Salt

105. Heptachlor

106. (Reserved)

107. Imazalil

108. Iprodione

109. (Reserved)

110. Lindane

111. Linuron

112. Lithium Hypochlorite

113. Malathion

114. Maleic Hydrazide, Diethamolamine Salt

115. Maleic Hydrazide, Potassium Salt

116. Mancozeb

117. Maneb

118. Mefluidide, Diethanolamine Salt

119. Metaldehyde

120. Metam-Sodium

121. Methidathion

122. Methomyl

123. Methyl Bromide

124. Methylene Chloride

125. Methylenebis (Thiocyanate)

126. Methyl Parathion

127. Metolachlor

128. Metribuzin

129. Mevinphos

130. Molinate

131. Monocrotophos

132. MSMA

133. Naled

134. Naphthalene

135. Napropamide

136. Naptalam, Sodium Salt

137. Nitrapyrin

138. Norflurazon

139. Octylbicycloheptene Dicarboximide

140. Oryzalin

141. Oxadiazon

142. Oxamyl

143. Oxycarboxin

144. Oxyfluorfen

145. Oxythioquinox

146. Paraquat Dichloride

147. Parathion

148. PCNB

149. PCP

150. Pebulate

151. Pendimethalin

152. Permethrin

153. Petroleum Distillate, Aromatic

154. Phenothrin

155. Ortho-Phenylphenol

156. Phorate

157. Phosalone

158. Phosmet

159. Phosphamidon

160. (Reserved)

161. Picloram

162. Pine Oil

163. Piperonyl Butoxide, Technical

164. PMA

165. Prometryn

166. Propamocarb

167. Propargite

168. Propetamphos

169. Propoxur

170. Propyzamide

171. Pyrethrins

172. Resmethrin

173. Rotenone

174. Simazine

175. Sodium Arsenite

176. (Reserved)

177. Sulfur Dioxide

178. Sulfuryl Fluoride

179. Terbacil

180. Terrazole

181. Tetrachlorophenol

182. Tetrachlorvinphos

183. Tetramethrin

184. Thiabendazole, Hypophosphite Salt

185. Thiobencarb

186. Thiophanate-Methyl

187. Thiram

188. Toxaphene

189. Triadimefon

190. S,S,S-Tributylphosphorotrithioate

191. Tributyltin Benzoate

192. Tributyltin Oxide

193. Trichlorophon

194. Trichloro-S-Triazinetrione

195. Triclopyr

196. Trifluralin

197. Triforine

198. Vernolate

199. Vinclozolin

200. Ziram

(b) The director has determined that certain of the active ingredients listed in subsection (a) are chemically and toxicologically similar to other active ingredients registered by the department. Such similar active ingredients have been placed into groups. Completion of the mandatory health effects studies, required pursuant to Section 13127 of the Food and Agricultural Code, for an active ingredient listed in the group will satisfy the data requirements for all of the active ingredients in the group, unless adverse effects reported pursuant to Section 6210 indicate that the mandatory health effects studies should be completed for other active ingredients within the group.

In addition, copies of the mandatory health effects studies submitted to the United States Environmental Protection Agency (U.S. EPA) for any of the active ingredients listed below shall also be submitted by the registrant to the department. The groups are listed below, the active ingredient(s) listed in subsection (a) have an * after their name:

1. Alkyl (50%C14, 40%C12, 10%C16) Dimethyl Benzyl Ammonium Chloride *

Alkyl (60%C14, 30%C16, 5%C12, 5%C18) Dimethyl Benzyl Ammonium Chloride

Alkyl (25%C12, 60%C14, 15%C16) Dimethyl Benzyl Ammonium Chloride

Alkyl (47%C12, 18%C14, 10%C18, 10%C16, 15%C8-C10) Dimethyl Benzyl Ammonium Chloride

Alkyl (50%C12, 30%C14, 17%C16, 3%C18) Dimethyl Benzyl Ammonium Chloride

Alkyl (58%C14, 28%C16, 14%C12) MACASK 0 T Dimethyl Benzyl Ammonium Chloride

Alkyl (61%C12, 23%C14, 11%C16, 5%C8-C10-C18) Dimethyl Benzyl Ammonium Chloride

Alkyl (65%C12, 25%C14, 10%C16) Dimethyl Benzyl Ammonium Chloride

Alkyl (67%C12, 25%C14, 7%C16, 1%C8, C8, C10, C18) Dimethyl Benzyl Ammonium Chloride

Alkyl (90%C14, 5%C12, 5%C16) Dimethyl Benzyl Ammonium Chloride

Alkyl (93%C14, 4%C12, 3%C16) Dimethyl Benzyl Ammonium Chloride

Roccal-R (61%C12, 23%C14, 11%C16, 5%C18)

Tetradecyldimethylbenzyl Ammonium Chloride

2. Aluminum Phosphide *

Magnesium Phosphide

Zinc Phosphide

3. Boric Acid *

Boric Oxide

Borax

Sodium Metaborate

Disodium Octaborate Tetrahydrate

Sodium Tetraborate (Pentahydrate)

4. Bromacil *

Bromacil, Dimethylamine Salt

Bromacil, Lithium Salt

Bromacil, Sodium Salt

5. Bromoxynil Octanoate *

Bromoxynil, Butyric Acid Ester

6. Chloramben *

Chloramben, Ammonium Salt

7. Chlordimeform *

Chlordimeform Hydrochloride

8. Ortho-Benzyl-Para-Chlorophenol *

Ortho-Benzyl-Para-Chlorophenol, Potassium Salt

Ortho-Benzyl-Para-Chlorophenol, Sodium Salt

9. Copper Hydroxide *

Copper Sulfate (Anhydrous)

Copper Sulfate (Pentahydrate)

Copper Ammonium Carbonate

Copper Bronze Powder

Copper Carbonate, Basic

Copper Oxide

Copper Oxychloride

Copper Oxychloride Sulfate

Copper-Sulfate (Basic)

Copper-Zinc Sulfate Complex

Cupric Oxide

10. Cyanuric Acid, Monosodium Salt *

Trichloro-S-Triazinetrione *

Dichloro-S-Triazinetrione

Sodium Dichloro-S-Triazinetrione

Sodium Dichloro-S-Triazinetrione (Dihydrate)

11. 2,4-D *

2,4-D, Dimethylamine Salt *

2,4-D, Alkanolamine Salts (Ethanol and Isopropanol Amines)

2,4-D, Butoxyethanol Ester

2,4-D, Butoxypropyl Ester

2,4-D, Butyl Ester

2,4-D, Diethanolamine Salt

2,4-D, Diethylamine Salt

2 ,4-D, N, N-Dimethyloleyl-Linoleylamine Salt

2,4-D, Dodecylamine Salt

2,4-D, 2-Ethylhexyl Ester

2,4-D, Isoocytl Ester

2,4-D, Isopropyl Ester

2,4-D, Morpholine Salt

2,4-D, Octyl Ester

2,4-D, N-oleyl-1, 3-Propylenediamine Salt

2,4-D, Propyl Ester

2,4-D, Propylenegylcolbutylether Ester

2,4-D, Sodium Salt

2,4-D, Tetradecylamine Salt

2,4-D, Triethylamine Salt

2,4-D, Triisopropylamine Salt

12. Dicamba *

Dicamba, Diethanolamine Salt

Dicamba, Dimethylamine Salt

Dicamba, Monoethanolamine Salt

13. Didecyl Dimethyl Ammonium Chloride *

Dioctyl Dimethyl Ammonium Chloride

Octyl Decyl Dimethyl Ammonium Chloride

Octyl Dodecyl Dimethyl Ammonium Chloride

14. Dinoseb *

Dinoseb, Amine Salt

Dinoseb, Ammonium Salt

Dinoseb Sodium Salt

Dinoseb, Triethanolamine Salt

15. Diphacinone *

Diphacinone, Sodium Salt

16. Endothall, Mono (N, N-Dimethylalkylmine) Salt *

Endothall

Endothall, Mono (N, N-Diethylalkylamine) Salt

Endothall, Dipotassium Salt

17. Lithium Hypochlorite *

Calcium Hypochlorite

Sodium Hypochlorite

18. Maleic Hydrazide, Diethanolamine Salt *

Maleic Hydrazide, Potassium Salt *

Maleic Hydrazide

19. (Reserved)

20. MSMA *

DSMA

21. Paraquat Dichloride *

Paraquat Bis (Methylsulfate)

22. PCP *

PCP, Potassium Salt

PCP, Sodium Salt

23. Petroleum Distillate, Aromatic *

Kerosene

Petroleum Oil, Paraffin Based

Isoparaffinic Hydrocarbons

Petroleum Derivative Resin

Petroleum Distillates

Petroleum Distillates, Refined

Petroleum Hydrocarbons

Petroleum Naphthenic Oils

Petroleum Oil, Unclassified

Petroleum, Unrefined

24. Ortho-Phenylphenol *

Ortho-Phenylphenol, Ammonium Salt

Ortho-Phenylphenol, Potassium Salt

Ortho-Phenylphenol, Sodium Salt

25. Picloram *

Picloram, Triisopropanolamine Salt

26. PMA *

Phenylmercuric Oleate

27. Pyrethrins *

Pyrethrum Narc

28. Tetrachlorophenol *

2,3,4,6-Tetrachlorophenol, Potassium Salt

Tetrachlorophenol, Sodium Salt

29. Thiabendazole, Hypophosphite Salt *

Thiabendazole

30. Thiophanate-Methyl *

Thiophanate

31. Tributyltin Benzoate *

Tributyltin Oxide *

Tributyltin Methacrylate

Bis (Tributyltin) Adipate

Tributyltin Acetate Tributyltin Chloride

Tributyltin Chloride Complex of Ethylene Oxide Condensate of Abietylamine

Tributyltin Fluoride

Tri-N-Butyltin Maleate

Tributyltin Monopropylene Glycol Maleate

Tributyltin Neodecanate

Tributyltin Resinate

 

NOTE: Authority cited: Section 12781, Food and Agricultural Code.

Reference: Section 13127, Food and Agricultural Code.

6199. Fines for Ground Water Protection Data Gaps.

NOTE: Authority cited: Sections 407, 12781, 13145 and 13146, Food and Agricultural Code.

Reference: Sections 13143 and 13145, Food and Agricultural Code.

6199.5. Assessment of Pesticide Registrants (The Pesticide Contamination Prevention Act, Sections 13141-13152 Food and Agricultural Code).

NOTE: Authority cited: Sections 407, 12781 and 13146, Food and Agricultural Code.

Reference: Section 13146, Food and Agricultural Code.

6199.7. Submission of Ground Water Protection Data On Specified Ingredients and Degradation Products.

NOTE: Authority cited: Sections 407 and 12781, Food and Agricultural Code.

Reference: Sections 13143 and 13145, Food and Agricultural Code.

 

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