Chapter 3 - Registration Desk Manual - Procedures for Obtaining Product Registration

Chapter III

PROCEDURES FOR OBTAINING PRODUCT REGISTRATION

A. INTRODUCTION

B. TYPES OF PRODUCT REGISTRATIONS

C. PRODUCTS WHICH DO NOT REQUIRE U.S. EPA REGISTRATION

D. PRODUCTS WHICH DO NOT REQUIRE CALIFORNIA OR U.S. EPA
REGISTRATION

E. PRODUCTS NOT ALLOWED TO BE REGISTERED IN CALIFORNIA

F. EVALUATION AND NOTICE OF DECISION TIME FRAMES

G. THE INITIAL STEP-WISE PROCESS

1. Intake Process
2. Indexing Process
3. List of Required Items for Product Applications
4. Review of the Label
5. Registration Specialist Determines Special Features of Submission
6. Verification of Completeness of Submission
7. Registration Specialist Processes Packages Not Requiring Scientific Evaluation
8. Return to Applicant, Incomplete Submission

H. PREPARING DATA PACKAGE FOR SCIENTIFIC EVALUATION

1. Arrangement and Content of Package
2. Selecting Evaluation Review Stations

I. ENTERING THE SCIENTIFIC EVALUATION PROCESS

1. Tracking and Routing Procedures
2. Early Release of an Evaluation Report
3. Submitting Back into Evaluation Station
4. Withdrawing Submission from Evaluation

J. EXIT SCIENTIFIC EVALUATION, DECISION TO REGISTER OR DENY

K. CONDITIONAL REGISTRATION OPTION

L. 30-DAY PUBLIC COMMENT PERIOD

1. Requirement
2. Resubmission into Evaluation

M. FINAL DECISION

1. Process for Registering the Product
2. Process for Denial of Product Registration

N. ISSUING A PRODUCT LICENSE
_________________________________________________________

Appendix III-1 Evaluation Station Responsibilties and Purpose of Review

Medical Toxicology
Worker Health and Safety
Pest and Disease Protection - Efficacy
Plant Physiology - Efficacy & Phytotoxicity:
Fish and Wildlife
Chemistry
Microbiology - Antimicrobials
Microbiology - Microbials
Endangered Species
Environmental Monitoring
Pest Management and Licensing

_________________________________________________________

Appendix III-2 Sample Status Sheet
Appendix III-3 Identifying a New Active Ingredient
Appendix III-4 Chemical Code Assignment for Microbial Products
Appendix III-5 Guidelines Regarding Format of Data Submissions
Appendix III-6 Chlorinated Isocyanurates for Pools, Spas, Hot Tubs
Appendix III-7 Sodium Bicarbonate and Sodium Carbonate
Appendix III-8 Sample Route Sheet
Appendix III-9 Concurrent Submissions
Appendix III-10 Bacteriostatic Products
Appendix III-11 Medical Waste Products

Chapter III

PROCEDURES FOR OBTAINING PRODUCT REGISTRATION

A. INTRODUCTION TO PROCEDURES FOR OBTAINING REGISTRATION

Pesticide products must be registered by DPR before they can be sold, offered for sale, or used in California. The term pesticide includes any product intended to repel, kill, prevent, destroy, control, or mitigate any pest. Pesticides include insecticides, herbicides, plant growth regulators, rodenticides or other vertebrate control agents, repellents, dessicants, fungicides, miticides, disinfectants, sterilants, and sanitizers. Spray adjuvants are pesticides under California law. 40CFR 152.3, 152; FIFRA Sec 2; FAC 12753, 12754.5, 12811, 12993; CCR 6000, 6145

The registration process includes submission and review of labels, data, application form, and fee. This section discusses the different types of registrations and the processing of registration requests.

Other sections of this desk manual, such as Label Elements, Data Requirements, and Identical Products are to be used as indicated in this chapter.

For a brief overview of the process, including a glossary of terms, see Chapter I.

B. TYPES OF PRODUCT REGISTRATIONS

The following types of registrations are discussed throughout this manual.

Product Registration (full or conditional). Most of these are registered federally under Section 3 of FIFRA.
Experiment Use Permit (EUP) conditional registration. Registered federally under Section 5 of FIFRA.
Subregistration/Distributor Registration.
Identical Product Registration.
Spray Adjuvant (California-only Registration).
Special Local Need (SLN) registration issued under Section 24(c) of FIFRA.
Emergency exemption issued under Section 18 of FIFRA.

C. PRODUCTS WHICH DO NOT REQUIRE U.S. EPA REGISTRATION

U.S. EPA does not require registration of certain products. These products do require registration in California.

Spray Adjuvants, California-only. This includes products such as spreader stickers, drift control agents, and water buffers. See Chapter VII, section E, for details.

D. PRODUCTS WHICH DO NOT REQUIRE CALIFORNIA (DPR) OR U.S. EPA REGISTRATION

The following products are not defined as pesticides or are adequately regulated by another agency and, therefore, do not require registration by U.S. EPA or DPR. FIFRA 25b 40CFR 152.20 memo of 11-19-87

Fish drugs. The CDFA Commodities and Regulatory Services Branch regulates commercial aquaculture drugs.

Contact lens solutions. These are defined as medical devices and are regulated by FDA.

Macroorganisms such as insect predators, nematodes, and macroscopic parasites.
40CFR 158.65

Any product intended to be used solely for medicinal or cosmetic use on humans or on commercial feed as stated in FAC 12801.
FAC 12801 40CFR 152.20

Pediculicides (lice control) products on humans (on the body) are defined as a human drug and are regulated by FDA.
40CFR 152.20 memo of 12-15-94 PRNotice 94-6

Deodorizers, deodorants, and cleansers, unless pesticidal claims are made.
CCR 6205 40CFR 152.5, 152.10

Livestock or animal drugs as determined in 40CFR 152.3. These are regulated by CDFA Agricultural Commodities & Regulatory Services Branch.

Ozone generators. These are defined as devices.

Chlorine generators. These are defined as devices.

Devices as defined by FIFRA Section 2(h) , with the exception of those sold for structural pest control of wood-destroying organisms. See FAC 15300 and California Notice to Registrants 2000-7.
40CFR 152.500

Natural cedar. The label cannot claim use against ticks or claims to retard mildew. The exemption does not include cedar oil.
40CFR 152.25

Treated articles. These are treated with a U.S. EPA-registered pesticide (usually antimicrobial), but do not make claims beyond protection of the article itself. Treated lumber is an example.
40CFR 152.25

Preservatives for biological specimens.
40CFR 152.25

Liquid chemical sterilants (including products with subordinate disinfectant claims) used on critical or semi critical devices. To be exempt, the product must be no longer defined federally as a pesticide, have premarket clearance from FDA, and not include ethylene oxide as an active ingredient. See 40CFR Part 152.
FAC 12809 CCR 6146 CANotice 98-5 memo of 2-22-95

Attractants or pheromones used solely for survey or detection purposes and which are not used with a pesticide.
40CFR 152.25, 152.10

Substances intended to inactivate, inhibit growth of, or destroy fungi, bacteria, or virus in or on living man or other animals.
40CFR 152.20, 152.5, 152.8

Substances used to inhibit the growth of, inactivate or destroy bacteria, viruses or fungi in or on processed food, beverages, or pharmaceuticals including cosmetics.
40CFR 152.5, 152.25

Bacteriostatic water filters designated by U.S. EPA as devices. These are considered on a case-by-case basis by DPR.
memo of 2-19-97

Fertilizer products not containing a pesticide. These are regulated by CDFA's Agricultural Commodities and Regulatory Services Branch.. If a product is both a fertilizer product and a pesticide product, the registrant must apply to DPR for registration as a pesticide. They must also submit the product to CDFA. However, we are not involved in that process.
40CFR 152.8

An individual's personal use of a substance to control their residence or garden pests, provided no treated food or feed commodity is sold or distributed or fed to animals that are sold or distributed for human consumption.
CCR 6301

Exempted products described by FAC 12803 and CCR 6147. These include food-grade type products. California's exemption is similar to, but not identical to, U.S. EPA's Section 25(b) and 40CFR 152.25.
Some nitrogen stabilizer products as indicated in 40CFR Part 152.6.
FAC 12803 CCR 6147 CANotice 2000-6

E. ACTIVE INGREDIENTS NOT ALLOWED TO BE REGISTERED IN CALIFORNIA

Certain active ingredients are either not allowed to be registered in California or have most uses cancelled. Examples include the following:

2,4,5-T
CCR 6352

Inorganic mercury compound
CCR 6354

Inorganic arsenic
CCR 6356

Inorganic phosphorous paste
CCR 6358

Ethylene dibromide (EDB)
CCR 6359

Cadmium compounds
CCR 6360

Butyl mercaptan
CCR 6361

1,2-Dichloropropane
CCR 6362

Weed oils as identified by CCR Section 6895

Compound 1080, sodium fluoroacetate
FAC 14061-14063

DDT- or DDE-containing products. Questions about residues in soil should be referred to the Department of Toxic Substances Control. Questions about residues in drinking water should be referred to the Department of Health Services.
CCR 6350

Aerosol or pressurized products containing HCFC (hydrochloro fluorocarbons) or CFC (chloro-fluorocarbons).
PRNotices 93-4, 93-5 memo of 8-17-93

F. EVALUATION AND NOTICE OF DECISION TIME FRAMES

1. California regulations establish the following evaluation time frames for product registration :
CCR 6151

The time frame to complete the evaluation of data submitted for a pesticide containing a new active ingredient or major new use is 120 days.

The time frame to complete the evaluation of data submitted for a pesticide that does not contain a new active ingredient is 60 days.

The time frame to complete the evaluation of additional data requested by the Department is 30 days.

2. When a product exits scientific evaluation, it must be posted within 1 week for a period of 30 days. Products exiting evaluation are posted publically as Notices of Decisions (NODs).
CCR 6255

G. THE INITIAL STEP-WISE PROCESS

1. Intake Process

The Intake Technician receives a registration request and begins the process by doing the following:

Generate a status sheet (also called a Submission Status Record). The status sheet will have information about the product, the applicant, and the type of registration request. A sample copy is in Appendix III-2.

Numerically assign a tracking ID# with the appropriate prefix or suffix to identify the type of submission.

For certain active ingredients, the computer automatically assigns a special attention flag.

Identify new active ingredients by using the procedure in Appendix III-3.
memo of 9-9-96

For microbial products, determine genus, species, subspecies, and strain by using the procedures in Appendix III-4. If unable to make the determination, contact the Registration Specialist.
memo of 10-25-94

Create a folder to facilitate routing. The status sheet and tracking ID# remain with the registration request throughout the process.

If data are submitted with the registration request, forward the entire package to the Indexer. If data aren't submitted, forward the package to the Registration Specialist.

If there is an attention flag on the status sheet, give the entire package to the designated Supervisor of Registration who will then forward the package to the Indexer or to the Registration Specialist.
memos of 8-29-97 7-10-96 5-28-93

The procedures in "Intake through Archiving" guidance document must be followed when processing and tracking any submission. Use it in conjunction with this desk manual. It is available on the branch home page.

2. Indexing Process

If data are submitted with a registration request, the Indexer processes the data by doing the following:

Index the data by entering study information into the data base. This information includes the study title, date of the study, the U.S. EPA test types, and the assigned volume numbers.
memo of 10-28-94

Generate a letter to the data submitter acknowledging receipt of data. The letter includes the assigned tracking ID# and a report of the indexed data, including test types and assigned volume numbers.
memo of 4-4-91

Forward the registration request to the Registration Specialist.

Applicants must submit data in the format outlined in Appendix III-5 "Format Guidelines for All Data Submitted for Pesticide Registration in California" (California Notice 2006-6). Upon receipt of an incorrectly formatted data submission, the PRB will contact the data submitter and inform them that the data will be shredded. DPR will follow-up with a letter notifying the applicant that, with the exception of the data, which were shredded, DPR will maintain the remainder of the submission for nine months. If the applicant resubmits the data, properly bound, DPR will again begin processing the submission. If data submitted to support an application for registration or amendment is not resubmitted within six months, an additional application fee of $750 is required. CA Notice
2006-6

memos of 1-1-99 6-23-93

More detail about indexing the data is in the "Intake through Archiving" guidance document.

3. List of Required Items for Product Applications

The Registration Specialist reviews the status sheet (also called a Submission Status Record) for accuracy and, if needed, makes corrections. It is very important to make corrections! The status sheet is used throughout the evaluation process, including the 30 day posting. It must contain accurate and complete information.

To correct a status sheet, the Registration Specialist will:

Make the changes on the original status sheet.
Make two copies with the corrections highlighted and dated.
Submit one copy to the Intake Technician and, if data was submitted, one to Indexing.

For certain active ingredients, an attention flag with instructions appears on the status sheet. The Registration Specialist follows the instructions. See the "Intake through Archiving" document for a list of Attention Flags.

The Registration Specialist verifies the presence and completeness of the following items which must be submitted by the applicant: CCR 6170

a) Complete Application for Pesticide Registration form (39-030). CCR 6170.1 6170.5

The application form must be filled out and signed. The firm name and address shown on the application must be the same as will appear on the company's license. The address on the label may differ.
CANotice 97-6 and 99-4 memo of 8-31-98

The brand name on the application form must be the same as the name shown on the label and different from the brand names of the company's other products registered in California.
CCR 6152

The percent by weight of the listed ingredients must total 100 percent.

Each active and inert ingredient in the product formulation must be listed. The U.S. EPA Confidential Statement of Formula (CSF) version 2-85 or later, may be submitted in lieu of filling out items 20 through 29 on the DPR form. The CSF must be filled out completely and accurately. If the certified limits are not identified on the CSF, the chemist can calculate the standard certified limits as needed.
memos of 3-24-97 7-30-96 CANotice 96-1

The application form must be signed and dated by an authorized representative. If an agent signs the application form, a letter from the applicant authorizing the agent to act on the applicant's behalf must be on file.
CCR 6157

b) $750 application fee. (effective January 1, 2004)

The application form must show a receipt number (RC#) for the application fee. Exempt from fees are county, state, or federal agencies which sell pesticide at cost.
FAC 12812 CCR 6168

For Interim Registration requests (described in Chapter VII), an additional $5000 fee per registration action is required, unless the request is only for an additional brand name.

Section 5 Experimental Use Permits (EUPs) must be accompanied by the $750 application fee (effective January 1, 2004) and application form.
memo of 8-23-96

c) Proof of federal registration.

A copy of the U.S. EPA stamped, accepted label and a copy of the accompanying U.S. EPA letter is required. U.S. EPA letter(s) and stamped label(s) accepting subsequent label amendments to the original registration can also be used as proof of federal registration.

Proof of federal registration is not available for concurrent submissions until the product is federally registered.

For a subregistration/distributor registration, where the basic company's product is not registered in California, the basic registrant's U.S. EPA-stamped accepted label must be submitted.

California-only registrations, such as spray adjuvants and certain federally-exempted Section 25(b) products, will not need proof of federal registration, since U.S. EPA does not require registration.
FIFRA Sec. 3

d) For subregistrations or distributor registrations, a copy of the U.S. EPA form #8570 "Notice of Supplemental

Distribution of a Registered Pesticide Product" must be submitted. This form ust be completed and signed by both the basic registrant and the distributor, whether or not the basic registrant is registered in California.

e) Six (6) copies of printer's proof of final printed labels.

The labels must be the same as the U.S. EPA approved label and accompanying letter although uses may be deleted. The label must also comply with 40 CFR Part 156, U.S. EPA Registration Standards, REDs, LIPs and PR-Notices on labeling requirements. For specific information, see Chapter II Label Elements and Requirements.

If a company is registering a master label that will not be marketed in California, a final printed or printers proof label is not required as outlined in P/P 2003-1.

The address on the label may differ from the application form and the license.

f) Submission of scientific data.

Data are required to obtain product registration and to amend currently registered products. All data submitted to U.S. EPA by the applicant in support of federal registration of their product are required to be submitted to DPR. The basic data requirements include acute toxicology, product chemistry, residue chemistry if used on a food or feed crop, fish and wildlife if applicable, phytotoxicity if applicable, and efficacy. For specific requirements, see Chapter VI Data Requirements.

In lieu of submitting data, FAC section 12811.5 states that DPR ".may rely upon any evaluations of previously submitted data to determine whether to accept an application for registration of a new pesticide product, an amendment to a registered pesticide product, or to maintain the registration of a pesticide product regardless of the ownership of the data previously evaluated."

Please note the new statute did not change or reduce DPR's data requirements.

Effective January 1, 2006, an applicant for registration of a new pesticide product where the product label specifies uses (including application rate, target pest, etc.) similar to uses previously approved by DPR for another pesticide product(s) containing the same active ingredient, is not required to submit or cite additional data to meet DPR's data requirements.
CCR 6158, 6159

FAC
12811.5

4. Review of the Label

The Registration Specialist reviews the label to determine if it is the same as the U.S. EPA-stamped label and includes any modifications required by U.S. EPA. Deleting uses is allowed on the proposed label.

The Registration Specialist also determines compliance with federal labeling requirements. The required Label Elements are outlined in Chapter II.

5. Registration Specialist Determines Special Features of the Submission

The majority of submissions are for regular product registrations or label revisions. Many, however, have features that require special handling. The Registration Specialist determines whether the registration request contains any of the following special features.

Have the proposed use sites, pests, etc. been approved for another product with the same active ingredient(s) or is the product identical to one currently registered or recently inactivated? Identical products must have identical formulas and label claims with some minor differences allowed.

Examples may include additional brand names, changes in ownership, changes in brand names, and subregistrations/distributor registrations.

If the proposed product label specifies uses previously approved by DPR for one or more pesticide products containing the same active ingredient(s), or the product is identical to another product currently registered or inactivated after 1996, the proposed product would not require scientific evaluation or the 30 day public comment period.

Does the label or formula change require the submission and review of data? See Chapter IV for procedures.

Can the label or formula change be processed as a Non-Substantive change or as a "File As Latest" (FAL)? See Chapter IV for procedures.

Are there any special label requirements? See Chapter II on Label Elements.

Is an attention flag with instructions on the status sheet? Flags can indicate Interim registration, suspended products, or a requirement for special mitigating language on a label. Follow the instructions on the status sheet.
memo of 8-29-97

Is this registration request submitted concurrently with U.S. EPA submission? The applicant's cover letter will indicate that the product is not yet federally registered. The following product types may be submitted concurrently to DPR and U.S. EPA as allowed by Ca Notice to Registrants 2005-10 and 2002-5.

- All new active ingredient products.
- All new microbial products.
- All new biochemical products.
- Antimicrobial products which meet criteria in Appendix III-9.
- New or amended "public health pesticides" meeting criteria in Appx. III-9.
- Section 5 Experimental Use Permits (EUPs)

- Products designated by the Branch Chief.
CANotice 2005-10

Is the request for a microbial or biochemical product? If so, the request is processed by the designated registration specialist. New microbial or biochemical products may be submitted concurrently to DPR and U.S. EPA.

The Registration Specialists must provide the Tracking Coordinator with copies of all letters regarding registration, denial, or return of microbial or biochemical products.

See Chapter VIII for microbial and biochemical product data requirements.
CANotice 98-8

memo of 8-30-95

Is the product exempted under California law and regulation FAC 12803 and CCR 6147 (similar to FIFRA Section 25b)? See Chapter VII.

Does the product contain a new active ingredient? If so, the application must be accompanied by chronic toxicology data, medical management data and, for agricultural uses, the groundwater protection data, in addition to the basic data requirements. See Chapter VI Data Requirements.

New active ingredient products are processed by the designated New Active Ingredient Registration Specialist(s) with the exception of spray adjuvants. All spray adjuvants, including those containing new active ingredients, are handled by the designated Registration Specialist assigned to the applying company.

Is the request for a major new use? A major new use is a use pattern different from currently registered use patterns and for which there is increased public or worker exposure or increased environmental exposure. See Chapter VI Data requirements.

An example is the addition of indoor use, which must be accompanied by exposure data pertinent to the new use pattern.

Is this for use in or around the home? If the active ingredient is not currently registered for home use, indoor exposure data may be required. See Chapter VI on Data Requirements.

Is this the first agricultural use of the active ingredient? The application must be accompanied by AB2021 groundwater protection data (unless submitted as an Interim Registration request).

See Chapter VI on Data Requirements and check with the designated Registration Specialist to identify any existing AB2021 data gaps.

Is this a request for Interim Registration allowed by FAC Sections 13161 through 13170? See Chapter VII for procedures and criteria.

Is this a request for an Emergency Registration allowed by California law FAC Section 12833? See Chapter VII.

Is the requested use for a crop grown for seed, where no residue tolerance has been established? Residue chemistry data are not required if the criteria in Ca Notice 96-7 are met.

Is this an antifouling paint containing tributyltin compounds (TBT)? See Chapter X.

Is this an antifouling paint containing copper oxide? Efficacy and non-target organism reviews are not needed if all of the following criteria are met:

- The sole active ingredient is copper oxide within the range of 38% to 51%.
- The use instructions are limited to standard roller, brush, or spray application methods.
- A letter of authorization from Amercian Chemet Corporation is received.
memo of 9-26-96

Is this a chlorinated isocyanurate for use in pools, spas, or hot tubs, which conforms to the requirements in Appendix III-6? If so, the product is registered (or the label amendment accepted) without scientific evaluation.
memo of 10-4-96

Is this product in compliance with the U.S. EPA's 1986 "Guidance for the Reregistration of Pesticide Products Containing Sodium and Calcium Hypochlorite Salts as the Active Ingredient"? The product does not need to be routed into the scientific evaluation process, with three exceptions - conditioning live oysters, toilet bowl sanitizers, or Hubbard and immersion tank uses. These must be routed for Microbiology-Antimicrobial review.
memo of 11-17-95

Is this a 100% sodium carbonate or 100% sodium bicarbonate product which meets the label criteria outlined in Appendix III-7? Acute toxicology data may not be required.
memo of 3-6-92

Is the product a bacteriostatic water filter? If so, send the applicant a copy of Appendix III-10.

Is the product for medical waste treatment? If so, send the applicant a copy of Appendix III-11.

Is the product a lepidopteran pheromone as defined in P/P 99-3? Only chemistry and efficacy data are required. The submission is routed only to these two scientific evaluation stations.
Is this a device for structural pest control of wood-destroying organisms? If so, process according to Ca Notice to Registrants 2000-7.
Does the label include a Spanish translation? Follow instructions in P/P 2002-3.
Is it a request for review of a master label only? Follow instructions in P/P 2003-1.
P/P 99-3

FAC 15300

6. Verification of Completeness

The Registration Specialist verifies the completeness of the registration request and determines whether

1) The registration request can be completed by the Registration Specialist without scientific evaluation.

or

2) The registration request is deficient and can be returned to applicant.

or

3) The registration request can enter the scientific evaluation process.

Note: Before a package is processed further, any corrections to the status sheet must be given to the Intake Technician.

7. Registration Specialist Processes Packages Not Requiring Scientific Evaluation

The following types of submissions can be processed by the Registration Specialist without scientific evaluation:

Products with previously approved uses. Effective January 1, 2006, an applicant for registration of a new pesticide product where the product label specifies uses (including application rate, target pest, etc.) similar to uses previously approved by DPR for another pesticide product(s) containing the same active ingredient, is not required to submit or cite additional data to meet DPR's data requirements.
FAC 12811.5

Identical Products. The registration request is for a product identical to a current registration. See Chapter V for details.

Nonsubstantive changes to the label or the formula. The Registration Specialist routes nonsubstantive change requests through the Tracking Coordinator to the Program Supervisor for a determination. See Chapter IV for criteria and procedures.

File-as-Latest (FAL) label or formula revisions. The label or formula revisions are minor and can be processed by the Registration Specialist. See Chapter IV for criteria and procedures.

Sodium and Calcium Hypochlorite products. The product in compliance with the U.S. EPA's 1986 "Guidance for the Reregistration of Pesticide Products Containing Sodium and Calcium Hypochlorite Salts as the Active Ingredient." The three exceptions are uses for conditioning live oysters, toilet bowl sanitizers, or Hubbard and immersion tank uses. The exceptions must be routed for Microbiology review.
memo of 11-17-95

Chlorinated isocyanurate products used in pools, spas, or hot tubs, which conform to the requirements in Appendix III-6.
memo of 10-4-96

First Aid (SOPT) revision. For labels with new revised First Aid - Statement of Practical Treatment (SOPT), the Registration Specialist determines if it is correct. The determination is based on 40CFR, PR-Notices, Registration Standards, U.S. EPA REDs, California regulations, and the Consumer Product Safety Commission (CPSC), but mainly by U.S. EPA PR-Notice 2001-1. Use the form in Appendix IV-1 for First Aid - SOPT statements which cannot be determined by the Registration Specialist.
memo of 6-11-98

8. Return to Applicant, Incomplete Submission

If any of the required items listed in the preceding sections are lacking, incomplete, or are otherwise unacceptable, the registration request shouldn't be processed further and should be returned to the applicant.

The registration request is returned using the following steps.

The Registration Specialist will:

Prepare a return letter to the applicant. The letter identifies all apparent deficiencies.
Make a copy of only the first page of the original application form or, if a label amendment copy of the label. This copy will be sent to the applicant along with the return letter. This ensures that certain business information such as inert ingredients listed on the back page remain confidential.
Route the letter, with the copy of the first page of the application form, and the registration request to their supervisor.
Make a copy of the letter for the "return package."
memo 10-01-90

The Supervisor of Registration will:

Review and surname the letter.
Route the letter, copy of the first page of the application form, and the registration package to the designated Technician for distribution.

The designated Technician will:

Enter the tracking ID number and date of return letter in the tracking system.
Mail original letter with copy of first page of application to applicant.
Give the surname copy of letter to the Registration Specialist.
Attach copy of letter to data package and place in the "return package" cabinet.
Enter date from cover letter into the return section on application form.
memos of 6-11-91 7-15-91

If the applicant provides only some, but not all, of the missing items, the application is still incomplete. The Registration Specialist again returns the registration request using the appropriate letter. The applicant may provide the missing items within the time indicated from the date of the first return letter without an additional fee.

More detail about tracking and processing returned packages is in the "Intake through Archiving" document.

H. PREPARING DATA PACKAGE FOR SCIENTIFIC EVALUATION

If the registration (or label amendment) request is complete and requires scientific evaluation - as determined in previous sections of this chapter - the Registration Specialist prepares the package for scientific evaluation.

The Registration Specialist reviews the label, determines the data requirements, and verifies that all required data are present with the package or are referenced in the Library.

Use Chapter VI to determine data requirements for most product. Use Appendix III-1 "Selecting Evaluation Review Stations."

The data requirements for spray adjuvants are found in Chapter VII.

The data requirements for microbial and biochemical (biopesticides) products are found in Chapter VIII.

Note: If the applicant does not believe a required study is applicable to their specific product and use patterns, the applicant can request the data be waived and must provide reasons for the waiver request. If U.S. EPA data waivers were granted, include this documentation when entering the package into evaluation.

A subregistration/distributor registration request is placed into scientific evaluation if the basic registrant's product is not currently registered in California and the use sites, pests, etc. have not been previously evaluated by DPR for a product containing the same active ingredient.

1. Arrangement and Content of Package Entering Scientific Evaluation

The Registration Specialist ensures that the data package entering the evaluation process contains the following.

A cover letter.
The status sheet with correct information.
The route sheet with the evaluation stations selected and any special instructions to the evaluators. See sample in Appendix III-8.
Two printed labels for the product.

Write the status sheet ID "Tracking Number" on the top right hand corner of one of these labels.

For label amendments, applicants are instructed to highlight or identify all changes to labels or applications. If the applicant did not highlight the label, the Registration Specialist will do this. The highlighted copy is submitted into the scientific evaluation process.

The second copy of the label is forwarded by the Tracking Coordinator in a report to the PREC committee members.

Copy of the complete Application for Registration Form 39-030. Attach the U.S. EPA Confidential Statement of Formula (CSF) if available. The U.S. EPA CSF may be submitted by the applicant in lieu of filling out items 20 through 29 on the DPR application form. If only a label revision is requested. this form is not needed.
Data submitted by the applicant with the registration request.

If the product contains a new active ingredient, the data are not routed with the package, but are stored in the library with the reference volume. The reference volume contains the cover letter, copy of the application form, U.S. EPA stamped label (unless a concurrent submission), MSDS, copy of route sheet, and any other correspondence.

The volume numbers for referenced data specifically listed in the instructions for each evaluation station on the route sheet.
A FIFRA Confidential Business Information card (big red card stapled to the back of all brown folders).
If data waiver requests were submitted, include this documentation when entering the package into evaluation.
If the request is for full registration of a product previously reviewed as a Section 5 EUP, the Registration Specialist attaches a copy of the Chemist's original evaluation and the Data Index Report.

2. Selecting Evaluation Review Stations

The Registration Specialist indicates the appropriate review stations on the route sheet, depending on the type of product, use patterns, and the claims being made on the proposed label.

Use Appendix III-1 "Evaluation Station Responsibilities and Purpose of Review" to determine the appropriate scientific evaluation station. This includes new products as well as label amendments and formula revisions.

Generally, a data package will be routed to Chemistry, Medical Toxicology, and Worker Health and Safety, and the appropriate Efficacy review station.

For new active ingredients, major new uses, or certain use patterns, the package may also need to be routed to Medical Management, Fish and Wildlife, Plant Physiology, or Microbiology.

Submit the registration request package to the Tracking Coordinator (or for new active ingredients,the designated Tracking Coordinator) to be routed and tracked through the scientific evaluation process.

DPR review stations are as follows:

Pesticide Registration Branch

Chemistry

Microbiology - Antimicrobials

Microbiology - Microbials

Pest Detection and Disease Prevention

Fish and Wildlife

Plant Physiology

Medical Toxicology Branch

Worker Health and Safety Branch

Worker Safety

Medical Management of Poisoning

Environmental Monitoring Branch

The evaluation scientists will:

Determine if submitted or referenced data are acceptable and support registration.
Determine if any required data are not submitted.
Determine if additional testing is needed.
Determine if data supports the label signal word and precautionary statements, protective clothing statements, worker or public reentry intervals, environmental hazard statements, statement of practical treatment, preharvest intervals, use directions, and efficacy claims.
Determine if there is evidence of an adverse effect or a potential adverse effect.
Determine if potential hazards are mitigated by the label.

I. ENTERING THE SCIENTIFIC EVALUATION PROCESS

1. Tracking and Routing of the Data Package

The Registration Specialist has indicated the appropriate evaluation stations on the route sheet and has entered the registration request into scientific evaluation.

From this point, routing of registration request packages is handled by the Tracking Coordinator (or for new active ingredients, the designated Tracking Coordinator) as the package enters and exits each evaluation review station. The Tracking Coordinator records the information in the Registration Specialist's binder and enters the information into the electronic tracking system data base.

If deficiencies are noted during scientific evaluation, the Registration Specialist sends the applicant a stop-clock letter. To comply with the Permit Reform Act which requires written notification of decisions, this interim decision process is used. Details about stop-clock and start-clock actions are in the "Intake through Archiving" document.

If the product is a new active ingredient, the designated Registration Specialist will give a copy of the following items to the designated Tracking Coordinator:

- Status sheet and label
- Detail Summary Report
- First page of application form
- U.S. EPA stamped label, unless concurrent submission
- MSDS, if available

The designated Tracking Coordinator gives these copies to the CDFA Chemistry Lab, who will contact the designated Registration Specialist if more information is needed.

Remember to use the Intake through Archiving document to track and process submissions. This is available on the branch home page.

2. Early Release of an Evaluation Report

The evaluation reports, previously named evaluation memos, may be released to the applicant, data holder, or other authorized party. This may be done without a written request while the registration application is still in the evaluation process, and before any letters listed below have been sent.

Before early release of an evaluation report, complete the following steps:

1. Read the evaluation report for any trade secret or protected information such as manufacturing process or inert ingredient identification. Although this type of information is not expected to appear in the report, the Registration Specialist should still closely examine it for information which should not be released.

When the registrant, applicant, or authorized party is not the data holder, it may be necessary to block out any trade secret or confidential business information. For assistance in making this determination, contact the Supervisor of Registration.

2. Write "preliminary release" across the top of the first and last page of each evaluation report.

3. Submitting Back into an Evaluation Station During Scientific Review

Data packages that exit an evaluation station, but are still in the evaluation process, occasionally need to be submitted back into an evaluation station. This is based on receipt of new or corrected information or data.

The Registration Specialist fills out the re-entry section on the route sheet. Use the "Intake through Archiving" document for details of the procedure.

Note: If the registration request has exited scientific evaluation, but has not been posted for 30 day public comment, see section J in this chapter on Re-entry.

Note: If the registration request has already been posted for 30-day public comment, see section L in this chapter on Resubmission for review of new data or information.

4. Withdrawing the Submission from Evaluation Process.

If the applicant requests withdrawal of an application after the data package has entered evaluation, the Registration Specialist will:

- Submit a Tracking Documentation Memo (pinky).
- Post the action Final-to-Deny, with the reason stated on the action log "application withdrawn by applicant." Follow procedures for denials.
- Use the appropriate fom letter and state the reason for denial as "application withdrawn by the applicant".

If the Registration Specialist (not the applicant) requests withdrawal of an application after the package has entered evaluation, the Specialist will:

- Submit a Tracking Documentation Memo (pinky).

- Post the action Propose-to-Register or Propose-to-Deny, as appropriate.

J. EXIT SCIENTIFIC EVALUATION - DECISION TO REGISTER, REGISTER CONDITIONALLY, OR DENY

When the scientific evaluation is completed, the route sheet is signed by the Program Supervisor - indicating whether the registration should be approved or denied.

The Tracking Coordinator then gives the package to the Registration Specialist.

The Registration Specialist will:

Review the scientists' evaluation reports and the Program Supervisor's recommendation.
Communicate any data deficiencies, unmitigated hazards, possible adverse effects, recommendations for conditional registration, or recommendation for risk assessment to the applicant.
If final printed or printer's proof labels have not been received, notify the applicant that labels must be submitted and found acceptable before registration is granted.
If conditional registration is recommended by any evaluators, follow procedures in section K Conditional Registration Option in this chapter.
If an adverse effect disclosed by data pertains to any other currently registered products, contact the Reevaluation Coordinator. See Chapter IX on Reevaluations for instructions.
Begin the 30-day public comment period by placing the tracking ID# on the weekly action log given to the designated Tracking Coordinator. The designated Tracking Coordinator prepares the 30-day public comment notice. The data package is held by the Registration Specialist until this 30-day period is complete.

Evaluator's Concerns Met, Due to New Information

If during, or before, the 30-day public posting period an evaluator's concerns are met by submission of a revised label or a corrected application, the package is not submitted back into evaluation. Instead, the Registration Specialist will:

- Submit a Tracking Documentation Memo (pinky) describing the action and signed by their Supervisor of Registration.
- Give a copy to the Evaluator and give the package to Program Supervisor of Evaluation.
- Give the package to the Tracking Coordinator.

A Proposed Decision to Register

If all evaluators find the data/information acceptable, the proposed decision to register is posted for the 30-day public comment period. The proposed decision to register means the following:

The data support registration.

Label mitigates any hazards or possible adverse effects.

No additional data or information are required to support full registration (or Conditional registration has been recommended by the evaluator.)

Concurrent submissions: If the submission is concurrent with submission to U.S. EPA, the proposed decision to register may be posted 30 days for comment. However, the Registration Specialist must verify receipt of the U.S. EPA-stamped label and accompanying letter and must compare the final U.S. EPA label to the proposed label for any changes before final registration. Significant changes may mean that the package must be resubmitted to the applicable evaluation stations. Concurrent submissions which complete scientific evaluation may be held by the Registration Specialist for up to six months until U.S. EPA registration is granted.

A Proposed Decision to Register when there is a Recommendation to Deny.

If the proposed decision is to register when there is a recommendation to deny, the Registration Specialist must obtain approval from the Branch Chief. The Registration Specialist will:

- Attach a registration Tracking Documentation Memo (pinkie) describing the rationale supporting the proposed action signed by the Branch Chief.

- Give a copy to the Evaluator and to the Program Supervisor of Evaluation.

- Give the package to the Tracking Coordinator.

For instruction on completing the registration process, see Final Decision section in this chapter.

A Proposed Decision to Deny Registration

If any evaluator finds the data/information does not support registration, the proposed decision to deny registration is posted for the 30 day public comment period.

The proposed decision to deny means any or all of the following:

The evaluator has stated that submitted data indicate a potential hazard not mitigated by the label.
Label claims are not supported by information/data submitted.
Required data was not submitted.

The Registration Specialist sends a letter to the applicant which includes:

- Reasons for denial.
- Specific information, data, or description of documentation required to complete the deficient application.
- A copy of the Evaluation Report may be included.

For instruction on completing the denial process, see Final Decision section in this chapter.

If data or information is submitted during the 30 day comment period, the Registration Specialist processes the package as a Resubmission as described in Section L-2.

Note: Packages exiting the scientific evaluation process with a negative recommendation can be re-entered or resubmitted. If the recommendation is still negative, the package is not routed to the Program Supervisor. The Tracking Coordinator enters the exit date on the route sheet and sends the package directly to the Registration Specialist.

K. CONDITIONAL REGISTRATION OPTION

IIf during the scientific evaluation process, DPR's scientific staff find that an applicant submitted sufficient data to make a registration decision, but additional data are needed for full registration, the scientist can recommend that the product be conditionally registered. California Code of Regulations (CCR) section 6200 allows the director to waive certain data requirements for a period reasonably sufficient, not to exceed a maximum of three years, for the generation and submission of the required data.

Conditional registrations may only be granted if certain data required under California laws and regulations are found to be acceptable, but insufficient by our scientific staff. The fact that a product may be conditionally registered with the U.S. Environmental Protection Agency is not grounds for conditional registration in California. .

Conditional registration can be granted only if the following data are submitted and found acceptable. A more complete list is in CCR Section 6200.

Acute oral LD50 data on the product.
Acute dermal LD50 data on the product.
Acute LC50 data on products which produce respirable aerosols or gases.
Primary eye irritation data on the product.
Primary skin (dermal) irritation data on the product.
Medical management data.
Foliar and soil residue data as specified in Section 6181 and 6182 of CCR, sufficient to establish safe reentry level or interval, when human contact is likely to occur.
Analytical methods to determine residues of each active ingredient and each toxic metabolite resulting from the active ingredient for which a U.S. EPA tolerance has been established. Test methods must allow determination of residues in or on plant tissue, soil, and water.
Preliminary efficacy data indicating the effectiveness for the proposed use.
Groundwater protection data (as required by the Pesticide Contamination Prevention Act, (AB2021 data), for the first agricultural use of an active ingredient, unless Interim Registration is requested.
The mandatory health effects data as required by the Birth Defects Prevention Act, (SB950) new active ingredients. DPR may waive one or more of the studies after consulting with OEHHA.

The Registration Specialist will:

Post the decision to conditionally register the product for the 30-day comment period.
Contact the applicant for agreement to the conditions.
Send a letter to the applicant listing the conditions, the time frames, and the requirement within 30 days for a written agreement to the conditions.
If the agreement is received, the product can be registered conditionally, after the 30-day posting period.
If the agreement is not received, the decision to deny registration is posted 30 days for comment. Denial is finalized after the posting period.
New Products (for label amendments see Chapter IV)

After posting the product for public comment, and upon receipt of written agreement from the applicant agreeing to conduct the required data, the specialist will prepare the following:

1. Prepare a form letter to the company, identifying each of the conditions and timeframe(s) for submission. Attaching copies of Evaluation Reports is not a substitute for listing the conditions and timeframes in the letter. E-mail the draft letter to Licensing. Licensing will prepare the final letter.

2. Write "Conditional" in red ink on the top, middle portion of the first page of the application.

3. Make a copy of the conditional evaluation memo(s), prepare and submit the package to Licensing. For information on how to prepare a package for Licensing, please see Chapter 3 of the Desk Manual.

4. The Licensing Technician will prepare 6 copies of the conditional letter:

1 original copy for the company
1 surname copy for the product file
1 copy for coding
1 copy for the company licensing binder
1 copy for the Conditional Binder
1 copy for the specialist
The Conditional Binder is located on the shelf with the other Licensing binders. It contains a copy of the letter, license, and conditional evaluation memo(s) and is filed in order by the specialist's last name.

Once the Licensing Technician prepares the letters and licenses, the technician will give the package back to the specialist for sign off. The package will now contain an additional copy of the letter, license, and a copy of the evaluation memo(s).

Following receipt of the package, the specialist will review and sign the letter, and submit the entire package to their Supervisor for sign off.

Yearly Assignments
In early October of each year, each specialist will review the Conditional Binder to see if there are any outstanding conditional registrations that will expire before December 31st of that year. The specialist will contact all companies with outstanding conditions, to determine if the deadline can be met. Time frames may be extended no more than 3 years. The specialist should consult with the Evaluation Scientist who recommended the conditional registration, to determine if an extension is warranted. If the Evaluation Scientist feels that an extension of time should be granted, request a reasonable time frame for completion of the studies. Consult with your Supervisor before extending the time for the conditional registration.

If the time frame cannot be met, the company should be informed that their product would not be renewed for the upcoming year. They should be advised to line out the product on their renewal form before submitting it to the Department.

If an extension is granted, the specialist is to prepare the appropriate letter to the registrant indicating that we have extended the time frame for completing the required data. Include the new target date and a cc to Licensing.

A conditional registration is converted to a full registration upon acceptance of the required data. See Chapter IX on Changing a Conditional Registration to a Full Registration.

L. 30-DAY PUBLIC COMMENT PERIOD REQUIREMENT

1. Requirement to Post for Public Comment

All new pesticide products and amendments to currently registered pesticide products that enter scientific evaluation must go through the posting process. The public comment period is a component of the pesticide registration process CEQA equivalency. The purpose of the 30 day notice is to allow for public review and comment. The Registration Branch responds to all public comments before a final decision. See P/P

2007-2

California Code of Regulations (CCR) section 6253 requires that each proposed decision relating to product registration and renewal, and each decision to begin reevaluation be posted by the Department, as well as at each commissioner's office, and in each District office for 30 days public review and comment. CCR section 6253 also requires DPR to send a copy of such notices to any person who requests it in writing, and to the public agencies specified under CCR Section 6252.

During the 30-day public comment period on a "30 to Register" posting, specialists may gather and prepare the appropriate registration documents for submission to Licensing. However, specialists may not give the prepared registration package to Licensing until: 1) the day after the 30-day posting period ends and; 2) DPR responds to any comments received during the comment period on that product. If DPR receives a comment(s) on a product during the 30-day posting period, the specialist will be informed immediately.

2. Resubmission into Evaluation during the 30-day Public Comment Period

During the 30-day (to deny) public comment period, the applicant may submit additional data to meet deficiencies identified during the evaluation.

If this occurs, the Registration Specialist takes the new data/information and the original status sheet to the Intake Technician. When possible, the Intake Technician will retrieve the package when the new data/information is first received. The new data/information is not given a new tracking ID# or a new status sheet. The Intake Technician takes the package with the newly submitted data to Indexing. The Indexer catalogs and indexes the information and gives the entire package back to the Registration Specialist.

If the new data or information meets all deficiencies listed in the propose-to-deny letter:

The Registration Specialist gives the package to the Tracking Coordinator, with the evaluation stations indicated.
The Tracking Coordinator enters new receipt date, generating a new target date. This is based on 60 days (120 days for new active ingredients and major new uses).

If the new data or information doesn't meet all deficiencies listed in propose-to-deny letter:

The decision to deny registration stays in effect until the end of the original 30-day comment period. At the end of that comment period, the Registration Specialist takes the Final Deny action and states in the letter that the additional information/data sent in during the posting period is unacceptable.
The Registration Specialist archives the submission including unevaluated data, according to instructions in the "Intake through Archiving" document.

M. FINAL DECISION

After the 30-day public comment period, a final action to register or to deny is taken.

1. Process for Registering the Product

If the recommendations support registration, the Registration Specialist verifies that all required items have been received and will:

Verify that final printed, or printer's proof labels were submitted and acceptable. (If the submission is only for a master label, follow instructions in P/P 2003-1.)
Compare the proposed label to the printed label, if submitted after scientific evaluation. Significant changes mean that the company must submit corrected final labels or the package must be sent to the applicable evaluation stations.
If the submission was concurrent with U.S. EPA review, verify receipt of the U.S. EPA stamped approved label and accompanying letter. Compare the final U.S. EPA label to the proposed label for any changes.

Significant changes mean that the package must be sent to the applicable evaluation station.

If data are required to support the changes, post the registration request for the 30 days to deny comment period.

If all items are submitted and acceptable, the product can be licensed. Assemble the items following procedures in the section in this chapter on Issuing a Product License.
Mark the evaluation route sheet "Registered" and sign the route sheet.
Give the data package, original evaluation memos, status sheet, and route sheet to the Archiving Technician, who processes them and sends them to the library. For more detail on archiving a package, see "Intake through Archiving document."
Record the tracking ID# as Final to Register on the weekly action log.

2. Process for Denial of Product Registration

If the recommendations do not support registration, the Registration Specialist will:

Verify that the lacking or deficient items have not been submitted.
Write a letter to the applicant notifying them that registration denial is final.
Stamp the first page of the original Application form "Denied."
Staple together the final denial letter (placed on top), a copy of the denied application, a copy of the propose-to-deny letter listing the deficiencies, the U.S. EPA documents, the original letter of authorization, and copies of the evaluation memos and a label. These are stapled together, marked "Denial File," and given to the Label Resource Center.
Mark the route sheet "Denied" with the date and signature.
Give the data package, status sheet, and route sheet to the Archiving Technician, who processes them and sends them to the library. Use the "Intake through Archiving" document for instructions on archiving a package.
Record the tracking ID# number as Final to Deny on the weekly action log.

After a final denial action has been taken as described below, the applicant may reapply for registration by submitting:

- A new Application for Registration.
- Another $750 application fee.
- All the data or information identified as lacking in the previous submission.

Note: If the product contains a new active ingredient and is final denied because U.S. EPA did not approve the product registration before our comment period ended, the registrant has 18 months to submit the U.S. EPA stamp-accepted label (once approved) to DPR without having to resubmit any documentation or the $750 application fee. They should however, provide a cover letter with the original tracking ID number, explaining their actions

N. ISSUING A PRODUCT LICENSE (CERTIFICATE OF REGISTRATION)

Once the 30-day posting period is up and the product is ready to be registered (licensed), the following steps are taken. Also refer to the "Intake through Archiving" document for more detail.

The Registration Specialist will:

Initial the Application for Registration form and write the EPA Reg. No. with correct alpha code, and tracking ID# in the upper right-hand corner. The first registration of an EPA Reg. No. in California is given the alpha code AA. The alpha code for an additional brand name is the next one in sequence: ZA, ZB, ZC, etc.

Assigning special numbers: If there is no U.S. EPA-assigned firm number, the Registration Specialist will assign a firm number using the California Firm Numbers Assignment binder in the Licensing area.

If a product number is not assigned by U.S. EPA, such as for an adjuvant, a stand-alone 24(c), or a product exempted from registration by U.S. EPA Section 25(b) which the company chooses to register, the Registration Specialist will use the same binder to assign a product number.

Upon issuance, adjuvants are assigned a 50000 California Registration Number (Ca. Reg. No.) that immediately follows the company number and precedes the alpha code AA
(ex. 123-50001-AA). In general, additional brand names for registered adjuvants should be given a unique product number rather than a new alpha code. However, should a special circumstance arise, a new alpha code may be assigned. If you feel you have a special circumstance, you should speak to your supervisor.

For a Section 24(c) with no federal Section 3 registration, a 50000 product number is assigned in numerical sequence.

For a Section 25(b)-exempt product which is not U.S. EPA registered, but the company chooses to register in California, a 30000 product number is assigned in numerical sequence.

When issuing an EUP, the Registration Specialist will assign a number in the following way: Firm number - 55000 (the last digits are assigned from the USEPA-assigned EUP number) - EX.

For a Section 24(c), an SLN number will also have to be assigned using the SLN Number Assignment binder. Include the SLN number along with the assigned product number on the stamped, accepted label and on the cover letter. Use the instructions in Chapter VII for preparing and distributing the SLN paperwork.

Stamp three labels for distribution to the product file, coding, and the company and fill in the appropriate information. The Registration Specialist may retain an additional copy for their file.
For a conditional registration prepare the appropriate form letter listing the conditions. It may be emailed to the Licensing Technician in advance.
For an Interim Registration, prepare the appropriate form letter listing the conditions. It may be emailed to the Licensing Technician in advance.

Assemble for Product File

Assemble and clip together the following items for the product file in the Label Resource Center (in this order):
a) Original application form including the product characterization information and statement(s) of formula. Write "product file" in the upper right hand corner of the application.Verify that there is an RC# on the form.

b) U.S. EPA stamped label and accompanying letter. For a company name change only or for an additional brand name, a copy of the registrant's notification to U.S. EPA, if there is no letter from U.S. EPA.

c) Copy of the U.S. EPA form # 8570-5, if the product is a subregistration/distributor registration.

d) Affidavit of no change in ownership, if applicable.

e) Memorandum of Registration, if being registered as an identical product. See Chapter V.

f) For Conditional Registrations, see Chapter 3, Section K.
A copy of the stamped, approved printer's proof or final printed label. This should be placed behind the product file documents but not clipped to them. It will be tagged and placed in the back of the product file in the Label Resource Center.

Assemble for the Registrant:

a) Copy of the stamped, approved label designated "company" in the upper right hand corner. This is sent to the company with the letter of registration and the license.

b) Prepare the conditional letter, if applicable and send an electronic copy to licensing (include a short description to licensing in your email regarding the product and the action you are taking).

Assemble for Coding:

Assemble and clip together the following items for coding (in this order):

a) Copy of the application form designated "coding" in the upper right-hand corner of the application. Attach a copy of any accompanying application forms or statements of formula.

b) Copy of the stamped, approved label.

c) Status sheet with all corrections made.

Assemble for Cover Letter File

Include the cover letter submitted by the applicant. Write "cover letter file" on the upper right hand corner of the letter copy.

Clip together the individual sections listed above (product file, registrant, coding, cover letter - in that order) and place in the correct basket in licensing. Include the brown folder if the tracking ID# will be removed from the tracking system by the licensing technician (examples include company ownership change, new products that did not enter scientific evaluation, company name change). It should be clipped to the bottom of the package. Do not include the brown folder for all other actions (such as new products that were sent to evaluation).

Once the specialist receives his or her copy of the letter back from licensing, affirming that the license has been sent to the registrant, the specialist must place the product ID# on their action log to be posted "Final to Register." Do not place the product ID# on the action log before this letter has been received. Pursuant to CCR section 6255, each product must be posted "Final to Register" within one week of the issuance of the product's license. Issuance has not occured until the product license has been sent out by the Registration Branch.

The Licensing Technician will:

Verify that there is an RC# on the form and the appropriate fee is submitted.
Prepare the appropriate registration letter for the Registration Specialist's signature, unless the Registration Specialist has already done so. For company name changes or firm number changes, include a statement in the letter about any conditionally registered or other time-limited products.
Prepare the license (certificate of registration). The license expires December 31.
For an Emergency Registration (FAC 12833), the license is issued with a one year expiration date.
For Conditional Registration, see Chapter 3, Section K
For an Interim registration, the Licensing Technician prepares a separate license and renewal form.
For a company name change, issue a new license to supersede the old name license. The old firm name license is marked "Amended" in the company's license files.
Mail the letter, the license, and a copy of the stamped accepted label to the company. All subsequent registration actions are mailed to the address on the license, in accordance with Ca Notice 97-6.
Forward a copy of the license (Certificate of Registration), the yellow surname copy of the registration letter, and the product file documents listed above to the Label Resource Center for filing.
Route the documents designated "Coding" and "Cover letter."
If the product is being registered as an identical product, remove the tracking ID # from the system as a "Registered Without Notice."

The Label Resource Center will:

Create a product file for the materials received from the Licensing Technician.
Place the license in the company's license file.
For company name changes, relabel files with the new firm name, staple the new application to the old application form in each file, and place a card in the file under the old firm name with a cross-reference to the new firm name.

Information about each registered product can also be accessed through DPR's internet home page (www.cdpr.ca.gov).

Product label amendments and/or formula revisions must be submitted to DPR as outlined in Chapter IV.

Appendix III-1

EVALUATION STATION RESPONSIBILITIES and PURPOSE OF REVIEW

This section identifies the scientific evaluation stations and their areas of responsibility in reviewing a pesticide registration request. See Chapter VI which provides in-depth guidance on data required for the various registration types and product types.

Medical Toxicology Branch - Reviews toxicology data pertaining to human effects

A. Route the following to the Medical Toxicology Branch:

All new products containing new active ingredients (exceptions listed below).
All new product registration requests for review of acute toxicology studies.
All new active ingredient products for review of chronic toxicology data.
Any submitted chronic toxicology studies.
Label amendments to decrease the signal word or precautionary statements.
Registration Branch identification of a potential unmitigated risk.
New use substantially different from other similar currently registered products.
Dog palatability studies for home use metaldehyde products.
Section 18 or Section 24(c) requests for products not registered in California.

B. Do not route the following to the Medical Toxicology Branch:

Applications that do not contain toxicology studies or that contain only partial data, summaries, material safety data sheets or reference book citations. These are considered incomplete, cannot enter the scientific evaluation process, and will be returned to the applicant with a list of the required data.
Spray adjuvants, non-agricultural antimicrobials, manufacturing-use
only products, rodenticides in bait boxes or bait block form, non-topical home use
repellents, DEET-containing products that comply with the current registration
standard, pet dips and shampoos if label includes requirement to wear gloves, and
home garden diazinon or chlorpyrifos products which are in compliance with
current standard language.
Section 18s and 24(c)s issued from existing registrations.
Upgrade of signal word to "Danger" with appropriate accompanying precautionary statements for Category I products from 40CFR.
100% sodium bicarbonate products for use in swimming pools used to increase alkalinity. Label must have the signal word "Caution" and the statement "Keep out of reach of children." Place copy of Appendix III-6 in the package.
100% sodium carbonate products for use in swimming pools to increase alkalinity. Label must have the statement "Caution Irritant. Harmful if swallowed" in accordance with the Hazardous Substance Labeling Guide of the Consumer Product Safety Commisision (CPSC).
Chlorinated isocyanurates which conform to the requirements in Appendix III-6.
Lepidopteran pheromones which conform to the requirements in P/P 99-3.
Products with the active ingredient moved to inert ingredient.
Addition of similar non-food use pattern.

The registration specialist will put instructions on the route sheet to the Medical Toxicology reviewer to include a worker safety review for specific WHS issues . In many cases, the regular Medical Toxicology evaluation will be combined with the specified review for worker safety.

Chemistry - Reviews chemistry and certain efficacy data

A. Route the following to the chemistry evaluation station:

New product registrations. (except microbials)
New active ingredient registrations. These are reviewed for product chemistry data and, if on food or feed, for residue chemistry. Microbials are not routed here unless directed by the Microbiologist-Microbials.
Label amendments which add use on a food or feed crop.
Section 18 emergency exemption requests.
New or amended spray adjuvants such as crop oils, spreader-stickers, and drift controls for review of efficaacy data.
Residue chemistry data submitted to support new or continued registration on a food or feed crop (limited).
Products with the first agricultural use of the active ingredient.
Environmental fate AB2021 data for agricultural uses.
Environmental fate data for algaecides and slimicides that are to be released into waterways, disinfection for greenhouse and nursery use, aquatic algaecides, antifouling agents, and termiticides.
Section 5 Experimental Use Permits EUPs (except microbials). The chemistry station evaluates only the EUP-required data listed in 40CFR part 158 and any environmental fate AB2021-type data that are submitted. They will not evaluate any other submitted data such as residue data for crops not listed on the EUP, storage stability data, or other product chemistry studies not required for the EUP. Review of these types of data is deferred until the Section 3 submission is received.
Sanitizer products used on food contact surfaces for verification of Title 21 clearances.
Antifouling paints or coatings containing tributyltin (TBT) for review of release rate data.

B. Do not route the following to the Chemistry evaluation station:

Biocides for home and garden indoor use.
Products used only in animal houses, dairies, or other animal husbandry/premises uses.
Products used only in institutional or indoor use sites (PCO-applied products around structures, gardens, and ornamental interior scapes).
Microbial products, unless directed by the Microbiologist-Microbials.

Worker Health and Safety - Reviews human exposure

Note: Supervisors must sign off on the route slip before the product can be routed to Worker Health and Safety.

A. Route the following to the Worker Health and Safety review station:

All Section 18's.
Data such as dermal absorption, worker or user exposure, and dislodgable residue on all types of products.
New products and amendments which are flagged on the status sheet as a result of a
completed Risk Assessment or mitigation document.
Any product specifically requested by Worker Health and Safety, Registration, or Medical Toxicology branches.
New products and amendments including 24(c)s which have one, or more, of the following:
- Fumigant use

- Specialized application methods such as fogging machines and pool or packing house injector systems

- Self-contained breathing apparatus (SCBA) or supplied air respirators

- Worker or workplace monitoring requirement

- Reduction of Personal Protective Equipment (PPE) or engineering controls

- Reduction of Restricted Entry Intervals (REI) or similar type exposure restrictions

B. Do not route the following to the Worker Health and Safety evaluation station:

New active ingredients which are the following.
1. Spray adjuvants.
2. Non-agricultural antimicrobials.
3. Manufacturing use only products.
4. Industrial use only products.
5. Rodenticides in bait boxes or bait block form.
New Category I, II, III, IV products for agricultural or home use which are the following.
1. Non-topical home use repellents.
2. DEET-containing products that comply with the Registration Standard.
3. Pet dips and shampoos (the label must include the requirement to wear gloves.
4. Home garden diazinon/chlorpyrifos products which are in compliance with current standard language.
5. Rodenticides in bait boxes or bait block form.
6. Spray adjuvants
Labels with new or revised First Aid - Statement of Practical Treatment (SOPT) that complies with 40CFR, PR-Notices, U.S. EPA Registration Standards, REDs, regulations, CPSC, and currently acceptable standard requirements, especially U.S. EPA PR-Notice 2002-1. This is determined by the Registration Specialist.
Labels revised to comply with a U.S. EPA mandate such as the Worker Protection Standard (WPS).
Lepidopteran pheromones which conform to the requirements in P/P 99-3.

The registration specialist will continue to verify that U.S. EPA Worker Protection Standard (WPS) statements are present on products labels subject to WPS. The registration specialist will continue to determine if the First Aid statement on a label complies with current standards based on 40CFR, PR-Notices, and other currently acceptable standard requirements. If the registration specialist cannot make this determination, they should confer with their supervisor.

Pest and Disease Protection - Reviews efficacy

A. Route the following to the Pest and Disease Protection evaluation station:

All new product registration requests or applicable label amendment requests for insecticides, fungicides, nematicides, pheromones, and snail and slug or other molluscides used on plants, crops, animals and structures (except fungicides on structural materials).
All new products for flea and tick control on humans and domestic animals including birds, and data for lice control on domestic animals including birds.
All new products for use on stored product pests (pantry pests) and storage diseases (mold, mildew, and rots).
Label amendments to add any of the above uses.
Wood preservatives to control termites, and other wood destroying insects.
Submissions containing data such comparison tests, application methods, and effects on beneficial and non-target organisms.
All new structural pest control devices for wood-destroying organisms.

B. Do not route the following to the Pest and Disease Protection evaluation station:

Fungicides on structural materials.
Wood preservatives that control rots and molds. These are reviewed by the microbiology evaluation station.

Plant Physiology -Reviews efficacy and phytotoxicity

Route the following to the Plant Physiology evaluation station:

All new product registration requests or applicable label amendments for herbicides, plant growth regulators, defoliants, and desiccants. These are reviewed for efficacy claims and for phytotoxicity.
Phytotoxicity data for any pesticide, including plant growth regulators and spray adjuvants, applied to desirable plants such as crops, ornamentals, turf, lawns, and forests.
Efficacy data for algaecides on lakes, ponds, and other outdoor uses.
Drift studies for phytotoxicity due to off-site movement.
Studies showing effects on non-target aquatic plants.

Fish and Wildlife - Reviews fish & wildlife hazards and efficacy

A. Route the following to the Fish and Wildlife evaluation station:

All new products (except adjuvants) or label amendments for products that are likely to come into contact with fish and wildlife and pollinating bees (outdoors) under the label use and under normal use conditions.
All new products or label amendments for for products used on agricultural sites, including golf courses and recreation areas, and forestry sites.
Algaecides which may be released into bays, rivers, streams, and fish-bearing waters. An example is use in cooling towers (except recirculating towers) drained into bays before new water and product are replaced.
Antifouling boat paints. These products are evaluated for efficacy as well as fish or other aquatic organism toxicity. See exception below for products not requiring fish and wildlife review.
Repellents such as animal and bird repellents, intended to be nonlethal, used on crops or structures. These products are evaluated for efficacy as well as fish and wildlife hazard.
Rodenticides, avicides, and other vertebrate control products. These products are evaluated for efficacy as well as fish and wildlife hazard.

B. The following do not require review by the Fish and Wildlife evaluation station:

Spray adjuvants.
Most household or home and garden or structural pesticides (other than rodenticides and avicides).
Products labeled for manufacturing-use only.
Antifouling paints with copper oxide as sole active ingredient, within the range of 38% to 51%, have an acceptable data base for efficacy and non-target organism effects. No further data or evaluation are needed for these products if a letter of authorization from American Chemet is provided and if labeling is limited to standard roller, brush, or spray application methods.
Label amendments to add the standard wording "Do not apply directly to water, to areas where surface water is present, or to intertidal areas below the mean high water mark."
Algaecides intended for recirculating (do not drain) cooling towers.
Lepidopteran pheromones which conform to the requirements in P/P 99-3.

Microbiology - Antimicrobials Reviews efficacy of all antimicrobial products, including amendments.

A. Route the following to the Microbiology-Antimicrobials evaluation station:

Disinfectants and sanitizers (nonagricultural and agricultural setting).
Wood preservatives for rot, molds, and mildew caused by microorganisms.
Industrial preservatives.
Industrial biocides.
Swimming pool disinfectants, algaecides, and water modifiers.
Other water disinfectants.
Confirmatory study data for products registered as identical but with a different EPA Est. No. or products with formulation changes.
Antimicrobial precursors.

B. Do not route the following to the Microbiology-Antimicrobials evaluation station:

Sodium and calcium hypochlorite products which comply with specific labeling and % of active ingredient outlined in USEPA's 1986 "Guidance for the Reregistration of Pesticide Products Containing Sodium and Calcium Hypochlorite Salts as the Active Ingredient." Exceptions are products labeled for Hubbard and immersion tanks, conditioning live oysters, or toilet bowl sanitizers. The exceptions require submission and evaluation of efficacy data prior to registration.
Chlorinated isocyanurates for pools, spas, and hot tubs which conform to Appendix III-6 do not require scientific evaluation.

Microbiology - Microbials Reviews chemistry of microbials and biochemicals.

- Route all microbial or biochemical products. These are reviewed for chemistry and, in some cases, efficacy.

- Route revisions to formulas for microbial or biochemical products.

Endangered Species Program in the Pest Management and Licensing Branch

The Endangered Species evaluation station reviews the following for endangered species impact:

Section 18 requests.
Product registrations and label amendments as determined by the Registration Specialist.

Environmental Monitoring Branch - reviews environmental impact of certain uses

Route the following to the Environmental Monitoring Branch:

Environmental adverse effects disclosures.
Upon request for environmental fate review.
VOC data.
Toxic air contaminant data (AB1807).
All products applied to water, including new products, label amentments, Section 24(c)s, or Section 18s, with or without data.
All products requesting use on rice, including new products, label amendments, Section 24(c)s, or Section 18s, with or without data.

Pest Management and Licensing Branch - evaluates certain pest management problems

Route the following to the Pest Management and Licensing Branch

Interim Registration requests for review of the Pest Management System portion.

The following products are not defined as pesticides or are adequately regulated by another agency and, therefore, do not require registration by U.S. EPA or DPR.	FIFRA 25b 40CFR 152.20 memo of 11-19-87
Fish drugs. The CDFA Commodities and Regulatory Services Branch regulates commercial aquaculture drugs.
Contact lens solutions. These are defined as medical devices and are regulated by FDA.
Macroorganisms such as insect predators, nematodes, and macroscopic parasites.	40CFR 158.65
Any product intended to be used solely for medicinal or cosmetic use on humans or on commercial feed as stated in FAC 12801.	FAC 12801 40CFR 152.20
Pediculicides (lice control) products on humans (on the body) are defined as a human drug and are regulated by FDA.	40CFR 152.20 memo of 12-15-94 PRNotice 94-6
Deodorizers, deodorants, and cleansers, unless pesticidal claims are made.	CCR 6205 40CFR 152.5, 152.10
Livestock or animal drugs as determined in 40CFR 152.3. These are regulated by CDFA Agricultural Commodities & Regulatory Services Branch.
Ozone generators. These are defined as devices.
Chlorine generators. These are defined as devices.
Devices as defined by FIFRA Section 2(h) , with the exception of those sold for structural pest control of wood-destroying organisms. See FAC 15300 and California Notice to Registrants 2000-7.	40CFR 152.500
Natural cedar. The label cannot claim use against ticks or claims to retard mildew. The exemption does not include cedar oil.	40CFR 152.25
Treated articles. These are treated with a U.S. EPA-registered pesticide (usually antimicrobial), but do not make claims beyond protection of the article itself. Treated lumber is an example.	40CFR 152.25
Preservatives for biological specimens.	40CFR 152.25
Liquid chemical sterilants (including products with subordinate disinfectant claims) used on critical or semi critical devices. To be exempt, the product must be no longer defined federally as a pesticide, have premarket clearance from FDA, and not include ethylene oxide as an active ingredient. See 40CFR Part 152.	FAC 12809 CCR 6146 CANotice 98-5 memo of 2-22-95
Attractants or pheromones used solely for survey or detection purposes and which are not used with a pesticide.	40CFR 152.25, 152.10
Substances intended to inactivate, inhibit growth of, or destroy fungi, bacteria, or virus in or on living man or other animals.	40CFR 152.20, 152.5, 152.8
Substances used to inhibit the growth of, inactivate or destroy bacteria, viruses or fungi in or on processed food, beverages, or pharmaceuticals including cosmetics.	40CFR 152.5, 152.25
Bacteriostatic water filters designated by U.S. EPA as devices. These are considered on a case-by-case basis by DPR.	memo of 2-19-97
Fertilizer products not containing a pesticide. These are regulated by CDFA's Agricultural Commodities and Regulatory Services Branch.. If a product is both a fertilizer product and a pesticide product, the registrant must apply to DPR for registration as a pesticide. They must also submit the product to CDFA. However, we are not involved in that process.	40CFR 152.8
An individual's personal use of a substance to control their residence or garden pests, provided no treated food or feed commodity is sold or distributed or fed to animals that are sold or distributed for human consumption.	CCR 6301
Exempted products described by FAC 12803 and CCR 6147. These include food-grade type products. California's exemption is similar to, but not identical to, U.S. EPA's Section 25(b) and 40CFR 152.25. Some nitrogen stabilizer products as indicated in 40CFR Part 152.6.	FAC 12803 CCR 6147 CANotice 2000-6

2,4,5-T	CCR 6352
Inorganic mercury compound	CCR 6354
Inorganic arsenic	CCR 6356
Inorganic phosphorous paste	CCR 6358
Ethylene dibromide (EDB)	CCR 6359
Cadmium compounds	CCR 6360
Butyl mercaptan	CCR 6361
1,2-Dichloropropane	CCR 6362
Weed oils as identified by CCR Section 6895
Compound 1080, sodium fluoroacetate	FAC 14061-14063
DDT- or DDE-containing products. Questions about residues in soil should be referred to the Department of Toxic Substances Control. Questions about residues in drinking water should be referred to the Department of Health Services.	CCR 6350
Aerosol or pressurized products containing HCFC (hydrochloro fluorocarbons) or CFC (chloro-fluorocarbons).	PRNotices 93-4, 93-5 memo of 8-17-93

Generate a status sheet (also called a Submission Status Record). The status sheet will have information about the product, the applicant, and the type of registration request. A sample copy is in Appendix III-2.
Numerically assign a tracking ID# with the appropriate prefix or suffix to identify the type of submission.
For certain active ingredients, the computer automatically assigns a special attention flag.
Identify new active ingredients by using the procedure in Appendix III-3.	memo of 9-9-96
For microbial products, determine genus, species, subspecies, and strain by using the procedures in Appendix III-4. If unable to make the determination, contact the Registration Specialist.	memo of 10-25-94
Create a folder to facilitate routing. The status sheet and tracking ID# remain with the registration request throughout the process.
If data are submitted with the registration request, forward the entire package to the Indexer. If data aren't submitted, forward the package to the Registration Specialist.
If there is an attention flag on the status sheet, give the entire package to the designated Supervisor of Registration who will then forward the package to the Indexer or to the Registration Specialist.	memos of 8-29-97 7-10-96 5-28-93

Index the data by entering study information into the data base. This information includes the study title, date of the study, the U.S. EPA test types, and the assigned volume numbers.	memo of 10-28-94
Generate a letter to the data submitter acknowledging receipt of data. The letter includes the assigned tracking ID# and a report of the indexed data, including test types and assigned volume numbers.	memo of 4-4-91
Forward the registration request to the Registration Specialist.
Applicants must submit data in the format outlined in Appendix III-5 "Format Guidelines for All Data Submitted for Pesticide Registration in California" (California Notice 2006-6). Upon receipt of an incorrectly formatted data submission, the PRB will contact the data submitter and inform them that the data will be shredded. DPR will follow-up with a letter notifying the applicant that, with the exception of the data, which were shredded, DPR will maintain the remainder of the submission for nine months. If the applicant resubmits the data, properly bound, DPR will again begin processing the submission. If data submitted to support an application for registration or amendment is not resubmitted within six months, an additional application fee of $750 is required.	CA Notice 2006-6 memos of 1-1-99 6-23-93

The Registration Specialist verifies the presence and completeness of the following items which must be submitted by the applicant:	CCR 6170
a) Complete Application for Pesticide Registration form (39-030).	CCR 6170.1 6170.5
The application form must be filled out and signed. The firm name and address shown on the application must be the same as will appear on the company's license. The address on the label may differ.	CANotice 97-6 and 99-4 memo of 8-31-98
The brand name on the application form must be the same as the name shown on the label and different from the brand names of the company's other products registered in California.	CCR 6152
The percent by weight of the listed ingredients must total 100 percent.
Each active and inert ingredient in the product formulation must be listed. The U.S. EPA Confidential Statement of Formula (CSF) version 2-85 or later, may be submitted in lieu of filling out items 20 through 29 on the DPR form. The CSF must be filled out completely and accurately. If the certified limits are not identified on the CSF, the chemist can calculate the standard certified limits as needed.	memos of 3-24-97 7-30-96 CANotice 96-1
The application form must be signed and dated by an authorized representative. If an agent signs the application form, a letter from the applicant authorizing the agent to act on the applicant's behalf must be on file.	CCR 6157
b) $750 application fee. (effective January 1, 2004) The application form must show a receipt number (RC#) for the application fee. Exempt from fees are county, state, or federal agencies which sell pesticide at cost.	FAC 12812 CCR 6168
For Interim Registration requests (described in Chapter VII), an additional $5000 fee per registration action is required, unless the request is only for an additional brand name. Section 5 Experimental Use Permits (EUPs) must be accompanied by the $750 application fee (effective January 1, 2004) and application form.	memo of 8-23-96
c) Proof of federal registration. A copy of the U.S. EPA stamped, accepted label and a copy of the accompanying U.S. EPA letter is required. U.S. EPA letter(s) and stamped label(s) accepting subsequent label amendments to the original registration can also be used as proof of federal registration. Proof of federal registration is not available for concurrent submissions until the product is federally registered. For a subregistration/distributor registration, where the basic company's product is not registered in California, the basic registrant's U.S. EPA-stamped accepted label must be submitted. California-only registrations, such as spray adjuvants and certain federally-exempted Section 25(b) products, will not need proof of federal registration, since U.S. EPA does not require registration.	FIFRA Sec. 3
d) For subregistrations or distributor registrations, a copy of the U.S. EPA form #8570 "Notice of Supplemental Distribution of a Registered Pesticide Product" must be submitted. This form ust be completed and signed by both the basic registrant and the distributor, whether or not the basic registrant is registered in California.
e) Six (6) copies of printer's proof of final printed labels. The labels must be the same as the U.S. EPA approved label and accompanying letter although uses may be deleted. The label must also comply with 40 CFR Part 156, U.S. EPA Registration Standards, REDs, LIPs and PR-Notices on labeling requirements. For specific information, see Chapter II Label Elements and Requirements. If a company is registering a master label that will not be marketed in California, a final printed or printers proof label is not required as outlined in P/P 2003-1. The address on the label may differ from the application form and the license.
f) Submission of scientific data. Data are required to obtain product registration and to amend currently registered products. All data submitted to U.S. EPA by the applicant in support of federal registration of their product are required to be submitted to DPR. The basic data requirements include acute toxicology, product chemistry, residue chemistry if used on a food or feed crop, fish and wildlife if applicable, phytotoxicity if applicable, and efficacy. For specific requirements, see Chapter VI Data Requirements. In lieu of submitting data, FAC section 12811.5 states that DPR ".may rely upon any evaluations of previously submitted data to determine whether to accept an application for registration of a new pesticide product, an amendment to a registered pesticide product, or to maintain the registration of a pesticide product regardless of the ownership of the data previously evaluated." Please note the new statute did not change or reduce DPR's data requirements. Effective January 1, 2006, an applicant for registration of a new pesticide product where the product label specifies uses (including application rate, target pest, etc.) similar to uses previously approved by DPR for another pesticide product(s) containing the same active ingredient, is not required to submit or cite additional data to meet DPR's data requirements.	CCR 6158, 6159 FAC 12811.5

5. Registration Specialist Determines Special Features of the Submission The majority of submissions are for regular product registrations or label revisions. Many, however, have features that require special handling. The Registration Specialist determines whether the registration request contains any of the following special features.
Have the proposed use sites, pests, etc. been approved for another product with the same active ingredient(s) or is the product identical to one currently registered or recently inactivated? Identical products must have identical formulas and label claims with some minor differences allowed. Examples may include additional brand names, changes in ownership, changes in brand names, and subregistrations/distributor registrations. If the proposed product label specifies uses previously approved by DPR for one or more pesticide products containing the same active ingredient(s), or the product is identical to another product currently registered or inactivated after 1996, the proposed product would not require scientific evaluation or the 30 day public comment period.
Does the label or formula change require the submission and review of data? See Chapter IV for procedures. Can the label or formula change be processed as a Non-Substantive change or as a "File As Latest" (FAL)? See Chapter IV for procedures.
Are there any special label requirements? See Chapter II on Label Elements.
Is an attention flag with instructions on the status sheet? Flags can indicate Interim registration, suspended products, or a requirement for special mitigating language on a label. Follow the instructions on the status sheet.	memo of 8-29-97
Is this registration request submitted concurrently with U.S. EPA submission? The applicant's cover letter will indicate that the product is not yet federally registered. The following product types may be submitted concurrently to DPR and U.S. EPA as allowed by Ca Notice to Registrants 2005-10 and 2002-5. - All new active ingredient products. - All new microbial products. - All new biochemical products. - Antimicrobial products which meet criteria in Appendix III-9. - New or amended "public health pesticides" meeting criteria in Appx. III-9. - Section 5 Experimental Use Permits (EUPs) - Products designated by the Branch Chief.	CANotice 2005-10
Is the request for a microbial or biochemical product? If so, the request is processed by the designated registration specialist. New microbial or biochemical products may be submitted concurrently to DPR and U.S. EPA. The Registration Specialists must provide the Tracking Coordinator with copies of all letters regarding registration, denial, or return of microbial or biochemical products. See Chapter VIII for microbial and biochemical product data requirements.	CANotice 98-8 memo of 8-30-95
Is the product exempted under California law and regulation FAC 12803 and CCR 6147 (similar to FIFRA Section 25b)? See Chapter VII.
Does the product contain a new active ingredient? If so, the application must be accompanied by chronic toxicology data, medical management data and, for agricultural uses, the groundwater protection data, in addition to the basic data requirements. See Chapter VI Data Requirements. New active ingredient products are processed by the designated New Active Ingredient Registration Specialist(s) with the exception of spray adjuvants. All spray adjuvants, including those containing new active ingredients, are handled by the designated Registration Specialist assigned to the applying company.
Is the request for a major new use? A major new use is a use pattern different from currently registered use patterns and for which there is increased public or worker exposure or increased environmental exposure. See Chapter VI Data requirements. An example is the addition of indoor use, which must be accompanied by exposure data pertinent to the new use pattern.
Is this for use in or around the home? If the active ingredient is not currently registered for home use, indoor exposure data may be required. See Chapter VI on Data Requirements.
Is this the first agricultural use of the active ingredient? The application must be accompanied by AB2021 groundwater protection data (unless submitted as an Interim Registration request). See Chapter VI on Data Requirements and check with the designated Registration Specialist to identify any existing AB2021 data gaps.
Is this a request for Interim Registration allowed by FAC Sections 13161 through 13170? See Chapter VII for procedures and criteria.
Is this a request for an Emergency Registration allowed by California law FAC Section 12833? See Chapter VII.
Is the requested use for a crop grown for seed, where no residue tolerance has been established? Residue chemistry data are not required if the criteria in Ca Notice 96-7 are met.
Is this an antifouling paint containing tributyltin compounds (TBT)? See Chapter X.
Is this an antifouling paint containing copper oxide? Efficacy and non-target organism reviews are not needed if all of the following criteria are met: - The sole active ingredient is copper oxide within the range of 38% to 51%. - The use instructions are limited to standard roller, brush, or spray application methods. - A letter of authorization from Amercian Chemet Corporation is received.	memo of 9-26-96
Is this a chlorinated isocyanurate for use in pools, spas, or hot tubs, which conforms to the requirements in Appendix III-6? If so, the product is registered (or the label amendment accepted) without scientific evaluation.	memo of 10-4-96
Is this product in compliance with the U.S. EPA's 1986 "Guidance for the Reregistration of Pesticide Products Containing Sodium and Calcium Hypochlorite Salts as the Active Ingredient"? The product does not need to be routed into the scientific evaluation process, with three exceptions - conditioning live oysters, toilet bowl sanitizers, or Hubbard and immersion tank uses. These must be routed for Microbiology-Antimicrobial review.	memo of 11-17-95
Is this a 100% sodium carbonate or 100% sodium bicarbonate product which meets the label criteria outlined in Appendix III-7? Acute toxicology data may not be required.	memo of 3-6-92
Is the product a bacteriostatic water filter? If so, send the applicant a copy of Appendix III-10.
Is the product for medical waste treatment? If so, send the applicant a copy of Appendix III-11.
Is the product a lepidopteran pheromone as defined in P/P 99-3? Only chemistry and efficacy data are required. The submission is routed only to these two scientific evaluation stations. Is this a device for structural pest control of wood-destroying organisms? If so, process according to Ca Notice to Registrants 2000-7. Does the label include a Spanish translation? Follow instructions in P/P 2002-3. Is it a request for review of a master label only? Follow instructions in P/P 2003-1.	P/P 99-3 FAC 15300

Products with previously approved uses. Effective January 1, 2006, an applicant for registration of a new pesticide product where the product label specifies uses (including application rate, target pest, etc.) similar to uses previously approved by DPR for another pesticide product(s) containing the same active ingredient, is not required to submit or cite additional data to meet DPR's data requirements.	FAC 12811.5
Identical Products. The registration request is for a product identical to a current registration. See Chapter V for details.
Nonsubstantive changes to the label or the formula. The Registration Specialist routes nonsubstantive change requests through the Tracking Coordinator to the Program Supervisor for a determination. See Chapter IV for criteria and procedures.
File-as-Latest (FAL) label or formula revisions. The label or formula revisions are minor and can be processed by the Registration Specialist. See Chapter IV for criteria and procedures.
Sodium and Calcium Hypochlorite products. The product in compliance with the U.S. EPA's 1986 "Guidance for the Reregistration of Pesticide Products Containing Sodium and Calcium Hypochlorite Salts as the Active Ingredient." The three exceptions are uses for conditioning live oysters, toilet bowl sanitizers, or Hubbard and immersion tank uses. The exceptions must be routed for Microbiology review.	memo of 11-17-95
Chlorinated isocyanurate products used in pools, spas, or hot tubs, which conform to the requirements in Appendix III-6.	memo of 10-4-96
First Aid (SOPT) revision. For labels with new revised First Aid - Statement of Practical Treatment (SOPT), the Registration Specialist determines if it is correct. The determination is based on 40CFR, PR-Notices, Registration Standards, U.S. EPA REDs, California regulations, and the Consumer Product Safety Commission (CPSC), but mainly by U.S. EPA PR-Notice 2001-1. Use the form in Appendix IV-1 for First Aid - SOPT statements which cannot be determined by the Registration Specialist.	memo of 6-11-98

All new pesticide products and amendments to currently registered pesticide products that enter scientific evaluation must go through the posting process. The public comment period is a component of the pesticide registration process CEQA equivalency. The purpose of the 30 day notice is to allow for public review and comment. The Registration Branch responds to all public comments before a final decision.	See P/P 2007-2
California Code of Regulations (CCR) section 6253 requires that each proposed decision relating to product registration and renewal, and each decision to begin reevaluation be posted by the Department, as well as at each commissioner's office, and in each District office for 30 days public review and comment. CCR section 6253 also requires DPR to send a copy of such notices to any person who requests it in writing, and to the public agencies specified under CCR Section 6252.
During the 30-day public comment period on a "30 to Register" posting, specialists may gather and prepare the appropriate registration documents for submission to Licensing. However, specialists may not give the prepared registration package to Licensing until: 1) the day after the 30-day posting period ends and; 2) DPR responds to any comments received during the comment period on that product. If DPR receives a comment(s) on a product during the 30-day posting period, the specialist will be informed immediately.