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 1. General Provisions


6145. Intended to be Used.

A substance is considered to be "intended to be used," as the phrase is used in Sections 12753 and 12758 of the Food and Agricultural Code, and thus be a pesticide requiring registration, when:

(a) A person who distributes or sells the substance claims, states, or implies, by labeling or otherwise, that:

(1) The substance, either by itself or in combination with any other substance, can or should be used as a pesticide; or

(2) The substance consists of or contains an active ingredient and can be used to manufacture a pesticide; or

(b) A person who distributes or sells the substance has actual or constructive knowledge that the substance will be used, or is intended by the user to be used, as a pesticide; or

(c) The substance consists of or contains one or more active ingredients and has no significant commercially valuable use as distributed or sold other than:

(1) Use as a pesticide, by itself or in combination with any other substance; or

(2) Use in the manufacture of a pesticide.

NOTE: Authority cited: Section 121781, Food and Agricultural Code.

Reference: Sections 12753 and 12758, Food and Agriculture Code.

6146. Liquid Chemical Sterilants.

(a) For purposes of this section, a "critical medical device" is any device that is introduced directly into the human body, either into or in contact with the bloodstream or normally sterile areas of the body, and a "semicritical medical device" is any device that contacts intact mucous membranes but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body.

(b) Manufacturers of, importers of, and dealers in liquid chemical sterilant products (including any such products with subordinate disinfectant claims) intended for use on critical or semicritical medical devices (as device is defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. sec. 321), are exempt from the requirements of Division 7 of the Food and Agricultural Code, providing the following criteria are met:

(1) The product is not included in the federal definition of a pesticide under subdivision (u) of section 2 of the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. sec.136(u)].

(2) The product has premarket clearance from the Federal Food and Drug Administration under section 510(k) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. sec. 360(k)].

(3) The product does not include ethylene oxide as an active ingredient.

(c) Whenever the manufacturer of, importer of, or dealer in any exempted liquid chemical sterilant has factual or scientific information 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 information to the department within 60 days of learning of the information.

(d) Physicians, surgeons, and local health officers remain subject to the illness reporting requirements of Health and Safety Code section 105200 with regard to exempted liquid chemical sterilants.

NOTE: Authority cited: Section 12804, Food and Agricultural Code.

Reference: Section 12804 Food and Agricultural Code.

6147. Exempted Pesticide Products.

(a) Manufacturers of, importers of, and dealers in the following pesticide products or classes of pesticide products are exempt from the requirements of Division 7 of the Food and Agricultural Code, provided the pesticide products are exempt pursuant to section 25(b)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. sec. 136w(b)(2)]:

(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 1

Cinnamon

Cinnamon oil 1

Citric acid 1

Citronella (non-topical uses only)

Citronella oil (non-topical uses only)

Cloves 2

Clove oil 1, 2

Corn gluten meal

Corn oil

Cottonseed oil

Dried blood

Eugenol 1, 2

Garlic

Garlic oil 1

Geraniol 2

Geranium oil 2

Lauryl sulfate 1

Lemongrass oil 1

Linseed oil

Malic acid 1

Mint

Mint oil 1

Peppermint 2

Peppermint oil 1, 2

2-Phenethyl propionate (2-phenylethyl propionate) 1

Potassium sorbate 1

Putrescent whole egg solids

Rosemary 2

Rosemary oil 1, 2

Sesame (includes ground sesame plant)

Sesame oil

Sodium chloride (common salt)

Sodium lauryl sulfate 1, 2

Soybean oil

Thyme 2

Thyme oil 1, 2

White pepper 1

Zinc metal strips (consisting solely of zinc metal and impurities)

1 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.

2Products 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: 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: Section 11456, 12781, and 12803, Food and Agricultural Code.

Reference: Section 12803, Food and Agricultural Code.

6148. Fee for Each Product Submitted for Registration.


(a) Effective October 1, 2015, the fee for each pesticide product submitted for registration is $1,150. 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.


6148.5 Fees for Amendments to Registered Pesticide Products.


(a) Effective October 1, 2015, each application to amend the labeling or formulation of a registered pesticide product shall be accompanied by a fee of $25. This fee does not apply to special local needs labeling.
(b) If the Director returns an incomplete application to amend the labeling or formulation 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: NOTE: Authority cited: Sections 12781 and 12812, Food and Agricultural Code.
Reference: Section 12812, Food and Agricultural Code.

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.

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.

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.

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.

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.

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.

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.

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.

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.

6168. Fee for 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.

 

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