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(1) Pheromones and identical or substantially similar compounds labeled for use only in pheromone traps (or labeled for use in a manner which the Director determines poses no greater risk of adverse effects on the environment than use in pheromone traps), and pheromone traps in which those compounds are the sole active ingredient(s), as specified in 40 Code of Federal Regulations 152.25(b).
(2) Preservatives for biological specimens, including:
(A) Embalming fluids;
(B) Products used to preserve animal or animal organ specimens, in mortuaries, laboratories, hospitals, museums and institutions of learning; and
(C) Products used to preserve the integrity of milk, urine, blood, or other body fluids for laboratory analysis.
(3) Products consisting of foods that are used to attract pests and which contain no active ingredient(s).
(4)(A) Natural cedar blocks, chips, shavings, balls, chests, drawer liners, paneling, and needles that meet all of the following criteria:
1. The product consists totally of cedar wood or natural cedar.
2. The product is not treated, combined, or impregnated with any additional substance(s).
3. The product bears claims or directions for use solely to repel arthropods other than ticks or to retard mildew, and no additional claims are made in sale or distribution. The labeling must be limited to specific arthropods, or must exclude ticks if any general term such as "arthropods," "insects," "bugs," or any other broad inclusive term is used.
(B) The exemption does not apply to natural cedar products claimed to repel ticks. The exemption also does not apply to cedar oil, or formulated products which contain cedar oil, other cedar extracts, or ground cedar wood as part of a mixture.
(5)(A) Products containing the following active ingredients alone or in combination with other substances listed in paragraph (5)(A), provided that all the criteria specified in paragraphs (5)(C) and (5)(D) are met:
Castor oil (U.S.P. or equivalent)
Cedar Oil [FN1]
Cinnamon
Cinnamon oil [FN1]
Citric acid [FN1]
Citronella (non-topical uses only)
Citronella oil (non-topical uses only)
Cloves [FN2]
Clove oil [FN1], [FN2]
Corn gluten meal
Corn oil
Cottonseed oil
Dried blood
Eugenol [FN1], [FN2]
Garlic
Garlic oil [FN1]
Geraniol [FN2]
Geranium oil [FN2]
Lauryl sulfate [FN1]
Lemongrass oil [FN1]
Linseed oil
Malic acid [FN1]
Mint
Mint oil [FN1]
Peppermint [FN2]
Peppermint oil [FN1], [FN2]
2-Phenethyl propionate (2-phenylethyl propionate) [FN1]
Potassium sorbate [FN1]
Putrescent whole egg solids
Rosemary [FN2]
Rosemary oil [FN1], [FN2]
Sesame (includes ground sesame plant)
Sesame oil
Sodium chloride (common salt)
Sodium lauryl sulfate [FN1], [FN2]
Soybean oil
Thyme [FN2]
Thyme oil [FN1], [FN2]
White pepper [FN1]
Zinc metal strips (consisting solely of zinc metal and impurities)
[FN1] Products containing 8.5% or more of this active ingredient in the formulated product must at a minimum bear the signal word "CAUTION," the phrase "Keep Out of Reach of Children," appropriate precautionary language, and a requirement for appropriate protective eyewear and gloves.
[FN2] Products containing this active ingredient intended for topical application to human skin must at a minimum bear the signal word "CAUTION," the phrase "Keep Out of Reach of Children," a dermal sensitization precautionary statement, a prohibition against application to the hands of children, and use directions requiring adult supervision during application to children.
(B) Topical use products containing less than or equal to 1% of the following active ingredients alone or in combination with each other provided: (i) the product label carries as a minimum the signal word "CAUTION," the phrase "Keep Out Of Reach of Children," a dermal sensitization precautionary statement, a prohibition against application to the hands of children, and use directions requiring adult supervision during application to children, and (ii) all the criteria specified in paragraphs (5)(C) and (5)(D) are met:
Citronella
Citronella oil
(C) A pesticide product exempt under paragraphs (5)(A) and (5)(B) of subsection (a) may include as inert ingredients only those substances listed in the U.S. Environmental Protection Agency's most current List 4A "Inerts of Minimal Concern." U.S. EPA's list of minimal risk inert ingredients is updated periodically and is published in the Federal Register.
(D) In addition, all of the following conditions must be met for products to be exempted under subsection (a)(5):
1. Each product containing the substance must bear a label identifying the name and percentage (by weight) of each active ingredient and the name of each inert ingredient.
2. The product must not bear claims either to control or mitigate microorganisms that pose a threat to human health, including but not limited to disease transmitting bacteria or viruses, or claims to control insects or rodents carrying specific diseases, including, but not limited to ticks that carry Lyme disease.
3. The product must not include any false and misleading labeling statements, including those listed in 40 CFR 156.10(a)(5)(i) through (viii).
(b) Whenever the manufacturer of, importer of, or dealer in any product exempted pursuant to this section has factual or scientific evidence of any adverse effect or risk to human health or the environment that has not previously been submitted to the department, the manufacturer, importer, or dealer shall report the evidence to the department within 60 days of learning of the information.

Note: Authority cited: Sections 11456, 12781 and 12803, Food and Agricultural Code. Reference: Section 12803, Food and Agricultural Code.

s 6148. Fee for Each Product Submitted for Registration.
(a) The fee for each pesticide product submitted for registration is $750. The fee applies to each:
(1) New pesticide product;
(2) Additional brand name of a pesticide product; and
(3) Pesticide product where there is a change in business ownership of the product.
(b) If the Director returns an incomplete application for product registration to the applicant, the applicant has 180 days from the date the Director initially returned the application to resubmit a complete application without payment of a new registration fee. A new registration fee must accompany applications resubmitted after 180 days from the date the Director returned the application.

Note: Authority cited: Sections 12781 and 12812, Food and Agricultural Code. Reference: Section 12812, Food and Agricultural Code.

s 6148.5. Fees for Amendments to Registered Pesticide Products.
(a) Each application to amend the labeling of a registered pesticide product, where the amendment must be supported by scientific data, shall be accompanied by a fee of $100. This fee does not apply to special local needs labeling.
(b) If the Director returns an incomplete application to amend the labeling of a registered pesticide product to the applicant, the applicant has 180 days from the date the Director initially returned the application to resubmit a complete application without payment of a new fee. A new fee must accompany applications resubmitted after 180 days from the date the Director returned the application.

Note: Authority cited: Sections 12781 and 12813, Food and Agricultural Code. Reference: Section 12813, Food and Agricultural Code.

s 6151. Evaluation Time Frames.
The director shall complete the evaluation of data submitted pursuant to Section 6170 for a pesticide containing any active ingredient not currently registered by the director or for any new major use within 120 days of receipt of all such data, and within 60 days of receipt of such data for all other pesticides. When additional specific data are requested, evaluation of it shall be completed within 30 days of receipt. During the evaluation of data, the director shall determine if the pesticide should be classified as a restricted material pursuant to Section 14004.5 of the Food and Agricultural Code.

Note: Authority cited: Sections 12781, 12976, 14004.5 and 14005, Food and Agricultural Code. Reference: Sections 12824 and 14004.5, Food and Agricultural Code.

s 6152. Brands.
(a) A pesticide may be registered under more than one brand name, but the same brand name cannot be registered for products of different chemical composition, or different physical condition sufficient to affect its pesticide properties.
(b) When a registrant submits revised labeling for a currently registered pesticide to the director all changes from the previous labeling shall be clearly specified by the registrant.

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.

s 6153. Transfer of Registration.
A certificate of registration cannot be transferred if there is a change of business ownership, but a new application and fee are necessary.

Note: Authority cited: Sections 11456, 12781 and 14005, Food and Agricultural Code. Reference: Sections 12751-12994, Food and Agricultural Code.


s 6154. Change of Name.
Change of the name of a registrant may be made without additional fee by submission of the following papers to the director:
(a) The current certificate of registration;
(b) A new completed application form; and
(c) An affidavit of no change of business ownership.

Note: Authority cited: Sections 11456, 12781 and 14005, Food and Agricultural Code. Reference: Sections 12751-12994, Food and Agricultural Code.

s 6156. Registration Date.
Registration of a pesticide shall become effective on the date the certificate of registration is issued. Such certificate shall not be issued if the director determines the pesticide is to be classified as a restricted material until the pesticide has been so classified.

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.

s 6157. Certification.
(a) Each applicant shall certify, by an authorized official of the registrant, under penalty of perjury that to the best of the applicant's knowledge, based upon all information available to the applicant, all information submitted in connection with the application for registration or renewal is accurate and complete.
(b) If the director finds that the applicant has submitted inaccurate or incomplete information, the director shall initiate action to refuse or cancel the registration pursuant to Section 12825(f) of the Food and Agricultural Code.

Note: Authority cited: Sections 11456 and 12781, Food and Agricultural Code. Reference: Sections 12753, 12758, 12815, 12825, 12827, 12827.5 and 14102, Food and Agricultural Code.

s 6158. Review and Evaluation.
During the review and evaluation of proposed pesticide labeling and data to support registration, the director shall give special attention to the provisions of Sections 11501, 12824, 12825, 12826, 14102, and 14103 of the Food and Agricultural Code and to each of the following factors, when applicable, in reaching a decision to register or not register the pesticide:
(a) Acute health effects such as oral toxicity, dermal toxicity, inhalation toxicity, acute eye and skin damage potential, or sensitization potential.
(b) Evidence of chronic health effects such as carcinogenicity, teratogenicity, mutagenicity, fetal toxicity, and delayed neurotoxicity.
(c) Potential for environmental damage, including interference with the attainment of applicable environmental standards (e.g., air quality standards and water quality objectives).
(d) Toxicity to aquatic biota or wildlife.
(e) Method of medical management of poisoning or other injuries.
(f) Analytical methods.
(g) The availability of feasible alternatives.
(h) Efficacy.
If any of these factors are anticipated to result in significant adverse impacts which cannot be avoided or adequately mitigated, registration will not be granted unless the director makes a written finding that anticipated benefits of registration clearly outweigh the risks. When deciding whether or not to register a pesticide for which feasible alternatives exist, the director shall consider any substantial adverse environmental impact which would likely occur from a lack of additional pest control options for the specific proposed use.

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.

s 6159. Data Requirements.
The director finds that the data required by the United States Environmental Protection Agency (U.S. EPA) regulations governing pesticide registration, reregistration, and classification adopted in Title 40, Code of Federal Regulations pursuant to authority in the Federal Insecticide, Fungicide and Rodenticide Act substantially meet the data requirements of Section 12824 of the Food and Agricultural Code, except as provided in this section and sections 6158, 6170, 6172, 6176-6179, 6180(a), 6181-6192, 6200, 6210, 6215, and 6222. Information meeting such regulations shall be supplemented as specified in this section and sections 6158, 6170, 6172, 6176-6179, 6180(a), 6181-6192, 6200, 6210, 6215, and 6222. Data waived by the U.S. EPA shall be submitted to the director except when the director makes a written finding that such data are not required to meet the purposes of Sections 11501, 12824, 12825, 12826, 14102, or 14103 of the Food and Agricultural Code.

Note: Authority cited: Sections 11456 and 12781, Food and Agricultural Code. Reference: Sections 11501, 12824, 12825, 12826, 14102 and 14103, Food and Agricultural Code.

s 6160. Operational Protocol for Pesticide Registration and Evaluation Manual.

Note: Authority cited: Sections 11456, 12781, 12976, 12981 and 14005, Food and Agricultural Code. Reference: Sections 12751-14104, Food and Agricultural Code.

s 6168. Fee for a Certificate of Interim Registration.
In addition to the application fee required pursuant to section 6148, each application for a certificate of interim registration shall be accompanied by a fee of $5,000 (five thousand dollars) to cover the Department's costs of reviewing and processing the application. The $5,000 fee also applies to applications:
(a) For interim registration of an amendment to the labeling of a currently registered product; and
(b) To amend the labeling and certificate of registration of a product that already has been issued a certificate of interim registration when the amendment will allow additional uses of that product under conditions of interim registration.

Note: Authority cited: Sections 12781, 12812 and 13168, Food and Agricultural Code. Reference: Section 13170, Food and Agricultural Code.

s 6170. Application.
(a) Each application for registration of a pesticide product shall be made on the Application for Pesticide Registration Form 39-030 (Rev. 9/03) prescribed by the director and described in section 6170.5. The application is incomplete and may be returned by the Director if the application is not accompanied by the fee required by section 6148, six copies of the product 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. All data submitted by the applicant to the U.S. EPA in support of federal registration of the product shall be submitted and all studies shall be submitted in full. The product labeling should be printer's proof, final labels, or legible photocopies thereof. If typescript labels are submitted with the application, printer's proof, final labels, or legible photocopies thereof, must be submitted before a Certificate of Registration (License) for the product will be issued. If the label has been approved by a federal agency, proof of such approval shall be submitted with the application.
(b) An application to amend the labeling (including a special local needs labeling) of a pesticide product is incomplete and may be returned by the Director if the application is not accompanied by the fee required by 6148.5, six copies of the labeling and the data required to be submitted by sections 6159, 6170, 6172, 6176-6179, 6180(a), 6181-6192, and 6200 when applicable to the amendment. The application to amend the labeling shall be accompanied by all data submitted by the applicant to the U.S. EPA in support of the federal amended labeling of the product and all studies shall be submitted in full. The product labeling should be printer's proof, final labels or legible photocopies thereof. If typescript labels are submitted, printer's proof, final labels or legible photocopies thereof, must be submitted before the amended label will be accepted for use. If the amended labeling has been approved by a federal agency,proof of such approval shall be submitted with the amendment application.
(c) In lieu of submitting data pursuant to subsections (a) and (b) of this section, an applicant for registration or amendment may reference appropriate data previously submitted to the Director or a pesticide product(s) previously approved by the Director that would be subject to some or all of the same data requirements as applicable to the applicant's product.
(d) If an applicant does not submit or reference its own data to support its application for registration or amendment, it is subject to the requirements imposed under Food and Agricultural Code section 12811.5.

Note: Authority cited: Section 12781, Food and Agricultural Code. Reference: Sections 12811, 12812, 12815 and 12816, Food and Agricultural Code.

s 6170.1. Application for Registration of Economic Poison (Pesticide) Form.

Note: Authority cited: Sections 407 and 12781, 12845, Food and Agricultural Code. Reference: Sections 12811, 12815 and 12821, Food and Agricultural Code.

s 6170.5. Application Form.
The form referred to in section 6170(a) shall require registrants to provide the following information when applicable.
(a) Firm name, (same as on file with the United States Environmental Protection Agency (U.S. EPA);
(b) Firm mailing address and street address, if different from mailing address;
(c) Name and telephone number of official authorized to answer questions concerning the application;
(d) Brand name of pesticide product (exactly as shown on label);
(e) U.S. EPA registration number of pesticide product;
(f) Type of U.S. EPA registration obtained;
(g) Type of California registration action being requested;
(h) Whether pesticide product contains biochemicals and/or microbials;
(i) Type(s) and size(s) pesticide product is to be sold in;
(j) Whether pesticide product requires child-resistant packaging;
(k) Signal word on label;
(l) Specific gravity and pounds/gallon of liquid formulations;
(m) Bulk density of solid formulations;
(n) pH of water soluble formulations;
(o) Flash point/flame extension of products containing more than 70% petroleum distillates;
(p) Whether product is intended for commercial agricultural use and/or by householders;
(q) Type of pesticide product;
(r) Method(s) of application;
(s) Type of formulation;
(t) Common chemical name, trade name and CAS number for each active ingredient in the formulation;
(u) Product name(s) and U.S. EPA registration number(s) of the source product(s) of each active ingredient in the formulation;
(v) Percent by weight of source product(s) and of active ingredient(s) in formulated product;
(w) Common chemical name, trade name and the CAS number of each inert ingredient in the formulation (if reporting by trade name only, include Material Safety Data Sheet);
(x) Product name(s) of the source product(s) of each inert ingredient in the formulation;
(y) Purpose of each inert ingredient in formulated product;
(z) Percent by weight of source product(s) and of the inert ingredient(s) in the formulated product.

Note: Authority cited: Sections 12781 and 12845, Food and Agricultural Code. Reference: Sections 12811, 12815 and 12821, Food and Agricultural Code.

s 6171. Document Requests.
Each applicant shall, upon request of the director, submit to the director a copy of any part or all documents the applicant submitted to the U.S. EPA in support of the U.S. EPA action concerning the pesticide product. Each document request pursuant to this section shall include the director's reason for the request.

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.

s 6172. General Toxicity Data.
(a) The following data shall be submitted with every application for registration.
(1) Acute oral and dermal LD 50 data on the product.
(2) Acute LC 50 data on products which produce a respirable aerosol or gas.
(3) Primary eye and skin irritation data on the product.
(b) The following data in addition to the data required by (a), (1)-(3) shall be submitted with each application to register a product containing an active ingredient not previously registered when required by the U.S. EPA to support the full unconditional registration pursuant to Section 3 of the Federal Insecticide, Fungicide and Rodenticide Act. Pesticides which are determined to be biorational pesticides as determined by the director, may be exempted from the chronic toxicity data requirements.
(1) Results of a two-year feeding study for oncogenicity on active ingredients in two animal species.
(2) Results of a teratogenicity study and 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.

Note: Authority cited: Sections 12781 and 12824, Food and Agricultural Code. Reference: Sections 11501 and 12824-12825, Food and Agricultural Code.

s 6176. Safety Related to Exposure.
Dermal Absorption. Each applicant to register a pesticide product that has an active ingredient with an acute dermal toxicity (LD<<sub>>50) 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.

s 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 11456, 12781 and 12981, Food and Agricultural Code. Reference: Sections 12815, 12824, 12980, 12981, 12987 and 12988, Food and Agricultural Code.

s 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.

s 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.

s 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 or 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.

s 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.

s 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.

s 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 appropriate 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.

s 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.

s 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.

s 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.

s 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.

s 6188. Closed System Compatibility.
(a) Each applicant to register a liquid pesticide product carrying the signal word "DANGER" on the label for an agricultural use 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 6744.
(b) No liquid pesticide carrying the signal word "DANGER" on the label shall be registered for an agricultural use unless the product is compatible with closed systems as defined in section 6000.

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.

s 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.

s 6190. Inert Ingredient Hazard.

Note: Authority cited: Sections 407, 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.

s 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.

s 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.

s 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.

s 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 United States Environmental Protection Agency 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 LD 50 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.

s 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 (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 contained 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. Page

Note: Authority cited: Sections 12781 and 13145, Food and Agricultural Code. Reference: Sections 13060, 13127, 13128, 13143 and 13146, Food and Agricultural Code.

s 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.

s 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 developed 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 (USEPA), acting pursuant to the provisions of the Federal Insecticide, Fungicide and Rodenticide Act, shall be deemed to reefer 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 tie 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 USEPA Administrator, had the data been submitted to USEPA 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.

s 6196.1. Provision 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 Section 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. (continued)</sub>