REGULATORY ACTIONS AFTER THE PRODUCT IS REGISTERED
B. RENEWAL OF PRODUCT REGISTRATION
1. Procedures for Renewal
2. Late Renewal
3. Nonrenewal of Product Registration
4. Lapsed Registration
C. RE-REGISTERING AN INACTIVATED PRODUCT
D. EXTENDING A CONDITIONAL REGISTRATION
E. CHANGING A CONDITIONAL REGISTRATION TO A FULL REGISTRATION
H. RISK ASSESSMENTS
I. DATA CALL-INS
1. SB950 Birth Defects Prevention Act
2. AB2021 Pesticide Contamination Prevention Act
Appendix IX-1 Voluntary Cancellation Form
Appendix IX-2 SB950 Exemption and Waiver Criteria
Appendix IX-3 SB950 Waiver and Exemption Procedures
Chapter IX
REGULATORY ACTIONS AFTER THE PRODUCT IS REGISTERED
Registrants must, on a quarterly basis, pay an assessment per dollar sales on each registered pesticide product sold in California.
Exempted from this requirement are
- manufacturing-use only products
- products sold at cost by government agencies.
If another person, not the registrant, is the first person to sell the pesticide in California, they are subject to payment of mill assessment.
B. RENEWAL OF PRODUCT REGISTRATION
A pesticide product certificate of registration (license) expires on December 31st of each year.
Approximately October 15 of each year, each registrant is mailed a list of their currently registered pesticide products.
The registrant will:
A product will not be renewed if the registrant has not complied with the conditions of its time-limited registration.
DPR prepares a final renewal notice for all renewed products. This is posted for public comment.
Initiating the Renewal Process
The Licensing Technician sends each registrant an Application for Renewal, listing the company's registered products. With the renewal request, DPR sends a letter outlining general requirements for renewal.
Applicant Sends in Renewal Form
With each renewal request, the registrant must submit the following:
When a pesticide registration is renewed without reevaluation, DPR makes a written finding that information was not received necessitating reevaluation. Notice of the proposed decision to renew registration is posted for 30-day public comment period.
An Emergency Registration cannot be renewed for more than one year.
Data not previously submitted by the company should be sent and processed separately from the renewal request. See "Intake through Archiving" document for processing these 'additional data' packages.
Processing the Renewal Request
Applications for Renewal that are complete are processed by the Licensing Technician and forwarded to the Information Systems Branch for coding.
If only an address change is made on the renewal request, the Licensing Technician will make the change to the license and to the computer data base. This is confirmed with the designated Program Specialist. If the address change includes an agent's name, first verify this with the registration specialist.
The Licensing Technician routes any of the following to the Registration Specialist:
The Registration Specialist will:
- Initial the Application for Renewal and give to the Licensing Technician.
- Forward the progress report to the Label Resource Center with a note that it is to be filed in the product file.
- Forward a copy of the report with the route sheet and instructions to the appropriate Evaluation Scientist.
If the Application for Renewal shows a change in a firm name, product name, additional brand name, or new registration number, the Registration Specialist informs the registrant that they must apply for registration. The Registration Specialist requests a new application form, label, and supporting documents.
The Registration Specialist may correct the Application for Renewal to show only those products to be renewed, initial the correction initial the application, and forward it to the Licensing Technician.
Products which are still registered as Intrastate (California-only) registrations can be renewed only if a Section 3 request is pending at U.S. EPA or, if already registered with U.S. EPA, is in the DPR evaluation process and has not been denied registration.
After the records are updated, the Licensing Technician issues the Certificate of Registration listing the registrant's products registered for the current year. The Licensing group checks them for accuracy, distributes copies, and mails the original to the registrant.
| If a registrant does not return the Application of Renewal within one calendar month after expiration of the Certificate of Registration, a pentalty of $150 per product is charged. | P/P 2006-4 |
If a registrant does not return the Application of Renewal within one calendar year after expiration of the Certificate of Registration, the company's products will be inactivated.
A request for late renewal or reinstatement of a pesticide product's registration must be accompanied by a $750 renewal fee, and $150 late fee for each product. The Licensing Technician will issue a Supplemental License, listing the product brand name, EPA Reg. No. (with the same alpha code), and the date of renewal. Licensing will also change the database to list the product as "active." The lapse in registration will be reflected by the date of the Supplemental License. However, it will not show in DPR's database. If the product was inactivated by DPR, Licensing will send a copy of DPR's letter and Supplemental License renewing the product(s) registration(s) to Mill Assessment.
A pentalty is not collected if the Application for Renewal is accompanied by an affidavit that no business was done during the period of nonregistration.
3. Nonrenewal of Product Registration
Nonrenewal of a product registration can occur for any of the following reasons:
1. The applicant deletes products from their Application of Renewal.
or
2. The applicant has not submitted the appropriate renewal fees.
or
3. The applicant has not submitted data required by conditions placed on the product at time of registration. This includes data or information required for any time-limited registrations.
or
4. DPR cannot renew a product due to regulatory action, such as cancellation.
In any of the above cases, the Registration Specialist will:
Voluntary Cancellation
A registrant may request voluntary cancellation mid-year by doing the following:
The registrant may use the "Request for Voluntary Cancellation" form in Appendix IX-1. By signing the form, the registrant waives their right to a hearing.
The written request or form may be submitted by fax, followed by a hard copy.
If no specific date of cancellation is requested by the registrant, the date of the request letter is used.
- Update label file database (Teale or Oracle) showing "voluntary cancellation" as the reason for inactivation.
- Line out the brand name and registration number on the main Certificate of Registration.
- Forward the Supplemental Certificate of Registration and other information to the Label Resource Center.
- Forward a copy of Supplemental Certificate of Registration to the Enforcement Branch.
The Label Resource Center will:
In all of the above cases, the registrant cannot sell the product from the time the registration lapses. A dealer who is in possession of the product with a lapsed registration may sell it for two years. The end user may use the product indefinitely, unless there is a suspension or cancellation of use.
C. RE-REGISTERING AN INACTIVATED PRODUCT
After the one year time period, a registrant can no longer "renew" or "reinstate" a product
's registration. The registrant must apply to "register" a product again by submitting a new application
for registration form, $750 application fee, any other necessary documentation, and supporting data, if applicable.
If the product was inactivated after 1996, the specialist can locate the inactive file, and the registrant made
no substantive changes to the product formulation or label, or the product label specifies uses previously approved
by DPR for one or more pesticide products containing the same active ingredients, then under AB 1011, no scientific
evaluation would be needed. If the product was inactivated prior 1996 and DPR has not previously approved the proposed
label claims, supporting data may be required.
The specialist will assign the product a different alpha code. By assigning a different alpha code, the lapse in
the product's registration will be reflected in the DPR database for enforcement and mill assessment purposes.
D. EXTENDING A CONDITIONAL REGISTRATION
As discussed in Chapter 3, subdivision K, the director may waive specific data requirements for a period reasonably
sufficient, not to exceed three years, for the generation and submission of the required data. Upon registration,
the time frame for submission of data is indicated in the letter to the applicant. If the conditional registration
extends over January 1 of any year, each registrant is required to submit an annual progress report at renewal
time for each item of the waived data.
If a registrant submits an extension of time to submit the required data, the Registration Specialist will:
If an extension is to be granted, the registration specialist will:
E. CHANGING A CONDITIONAL REGISTRATION TO A FULL REGISTRATION
When the registrant submits the required data in support of full registration for the conditionally registered
product, the Registration Specialist will:
No target date is assigned on the status sheet.
If the submission is incomplete or incorrect, the Registration Specialist will notify the registrant, in writing, of the deficiencies.
If an extension is requested by the registrant, the Registration Specialist will:
To determine the validity of the extension request, the Registration Specialist consults with the Evaluation Scientist who recommended the conditional registration and with the Evaluation Program Supervisor. When appropriate, the Evaluation Scientist will suggest a reasonable time extension to complete the studies.
If the registrant has not attempted to fulfill the requirements, and the time frame for submission of data has elapsed, the Registration Specialist will:
If during the registration process, or anytime after registration, the registrant (or applicant) has evidence of an adverse effect or risk to human health or the environment, the registrant (or applicant) must immediately submit the information to DPR. This information includes, but is not limited to that required by federal law FIFRA Section 6(a)(2).
Registrants were requested in Ca Notice 92-5 to identify adverse effects disclosures in their cover letter with a citation referring to FAC Section 12825.5 or to CCR Section 6210.
If there is reason to believe that use or continued use of the pesticide constitutes an immediate substantial danger to persons or to the environment, the director may, after notice to the registrant, suspend the registration pending a hearing and final decision.
Procedure for Adverse Effects Disclosure
The Intake Technician will:
The Library will:
If the submission is related to SB950, the Library forwards the submission to the Medical Toxicology Branch. The Library gives copies of the status sheet, spreadsheet, and cover letter to the designated adverse effects disclosure Registration Specialist and to the designated SB950 Registration Specialist.
The designated Registration Specialist will:
Write a letter to the registrant after the scientific evaluation summarizing the results of the evalution.
If an adverse effect exists, forward the submission to the Reevaluation Coordinator, who will write to the registrant.
For submissions related to SB950, the Medical Toxicology Branch prioritizes the active ingredient for risk assessment. The criteria for Risk Assessment are listed in a later section of this chapter.
- If the submission contains data, archive the entire package to the Library. Keep a copy of the letter to the registrant at the workstation.
- If the submission does not contain data, archive only a copy of the status sheet and evaluator's comments to the Library. Keep the remaining information and documents for 2 years at the workstation.
California law requires DPR to continuously evaluate registered pesticides. DPR established the reevaluation process to implement this requirement. A number of factors may result in a registered pesticide product or group of products being reevaluated:
Public or worker health hazard.
Environmental contamination.
Residue over tolerance.
Fish or wildlife hazard.
Lack of efficacy.
Undesirable phytotoxicity.
Hazardous packaging.
Inadequate labeling.
Disruption of the implementation or conduct of pest management.
Other information suggesting a significant adverse effect.
A reevaluation may be triggered by ongoing DPR registration reviews or by State and county pesticide use surveillance and illness investigations, pesticide residue sample analyses, environmental monitoring activities, and information submitted by other State or federal agencies, or other sources.
Receipt of a request for reevaluation
Upon receipt of a request for reevaluation along with the basis and supporting data, the Reevaluation Coordinator routes the request to all Branch Chiefs, Assistant Directors, Chief Deputy Director, and the Director for concurrence. If the Director decides to reevaluate, the Reevaluation Coordinator identifies the products involved in reevaluation and identifies the Registration Specialists whose registrants have products involved in the reevaluation.
1. The Reevaluation Coordinator prepares a "Notice of Proposed Decision to Reevaluate Pesticide Products" and prepares the individual letters to registrants whose products are to be reevaluated. The Notice is signed by the Registration Branch Chief and routed for surname to the Assistant Director. The date the notice is signed is the initiation date of the reevaluation. A copy of the registrant letter is sent to the appropriate Registration Specialist for that company.
2. The Reevaluation Coordinator prepares a reference binder of reevaluation information. The binder includes:
All correspondence and memoranda regarding the reevaluation.
Copies of letters notifying registrants of the reevaluation.
Copy of "Notice of Proposed Decision Concerning Reevaluation of Pesticide Products."
Concurrence form and all information relative to the basis of the reevaluation.
Copies of labels (unless too numerous to be practical).
During the reevaluation of a pesticide, data relevant to the focus of the reevaluation may be required. A reasonable time, not to exceed two years, is allowed for the development and submission of data.
3. The Reevaluation Coordinator informs appropriate Branch Chiefs that the reevaluation has been initiated and requests a list of data and/or information, if any, to be required from the registrant. If the decision is to require additional data, the Reevaluation Coordinator prepares letters notifying registrants of the data requirements. Copies of the letters are routed to the appropriate Registration Specialists. At this point, the reevaluation enters an inactive phase until the data are received.
Other ongoing registration actions proceed independent of the reevaluation, but are included in consideration of the reevaluation.
Processing data submitted during reevaluation
Once the data are received, the Intake Technician prepares a status sheet (the ID number will have ER as a suffix) and routes the data to the library for indexing. After indexing, the data are routed to the appropriate Registration Specialist. The Registration Specialist identifies the appropriate evaluator of the data and submits the package into the scientific evaluation process. Upon completion of the reviews, the Evaluation Tracking Technician gives the data package to the Registration Specialist. The Registration Specialist writes a letter to the registrant identifying the results of the review, with a copy routed to the Reevaluation Coordinator.
Conclusion of the reevaluation
When the issues that caused the reevaluation to be initiated have been resolved, the Reevaluation Coordinator prepares a summary and recommendation for review by the Branch Chief. The Registration Branch Chief forwards copies to the other Branch Chiefs, Legal Counsel, and if appropriate, to the PREC for comment. The Registration Branch Chief then makes the decision to modify, restrict, suspend, cancel, or continue registration.
There are several possible outcomes of a reevaluation. The data may demonstrate that the issue is resolved and that no significant adverse effect will occur. DPR may determined that there is a need to adopt mitigation measures; or DPR may determine that the adverse effect cannot be mitigated in which case the pesticide product(s) must be suspended or canceled.
The Reevaluation Coordinator prepares the "Notice of Final Decision Concerning the Reevaluation of Pesticide Products" and the individual letters to registrants informing them of the reevaluation final decision. The Registration Branch Chief signs the final Notice, and routes it for surname to the Assistant Director, Chief Deputy Director, and the Director. The reevaluation is concluded on the date the notice is signed. A copy of the registrant letter is given to the appropriate Registration Specialist for each company.
Semiannual Report
A publically available semiannual report is prepared describing the status of pesticides under reevaluation, or for which factual or scientific information was received, but no reevaluation was initiated.
Upon registration of a new active ingredient product, the active ingredient is prioritized for risk assessment. Risk assessment of currently registered active ingredients can be triggered by a number of different factors, including the identification of potential adverse effects. Risk assessments are generally related to chronic human health effects. Risk assessment prioritization is determined by the Adverse Effects Advisory Panel. The Adverse Effects Panel is made up of representatives from the Medical Toxicology Branch (Med. Tox.), the Worker Health and Safety Branch (WHS), and the Office of Environmental Health Hazard Assessment (OEHHA).
Risk assessments are conducted by MT and WHS. The Registration Branch is responsible for data distribution and communication with registrants. For any data submitted relating to risk assessment, Intake prepares a status sheet using the prefix SBRA. Intake routes the data to the library for indexing. After indexing, the library routes the data directly to Med.Tox. Copies of the status sheet are given to the SB 950 coordinator and the risk assessment coordinator. Med.Tox. marks on the status sheet if the data package needs to be routed to WHS and then returns the data package to the evaluation clerk. Med.Tox. routes copies of the status sheets and review memos to the SB950 coordinator, who in turn gives them to the risk assessment coordinator. The risk assessment coordinator passes on the results of the review of the data to the registrant, with copies to the SB950 coordinator.
The risk assessment coordinator is responsible for notifying registrants at six different stages in the risk assessment/mitigation process. Notices are sent when:
1. DPR first prioritizes a pesticide active ingredient for risk assessment.
2. DPR initiates the risk assessment process on a specific active ingredient.
3. DPR determines the endpoints of toxicological significance for a specific active ingredient.
4. DPR completes final drafts of the Risk Characterization and Exposure Assessment documents for a specific active ingredient.
5. DPR completes the final Risk Characterization and Exposure Documents for a specific active ingredient. If no mitigation measures are needed the process ends. If mitigation measures are needed, the notice provides registrants with an opportunity to propose risk mitigation measures.
6. DPR completes the final Risk Mitigation/Risk Management documents.
Data call-ins occur for products which are already registered. These are usually initiated through legislation and become part of law. These data call-ins differ from the reevaluation process which is initiated by DPR and is more fully described in the section on Reevaluation in this chapter.
1. Birth Defects Prevention Act (known as SB950)
This is a data call-in for a set of 10 or 11 chronic toxicology studies on all currently registered products registered as of January 1, 1984. New active ingredients registered after that date also require submission of a complete set of the chronic toxicology studies.
Spray adjuvants are not subject to the SB950 requirements. Antimicrobial products can follow the U.S. EPA tier testing. Microbial and biochemical products can follow the U.S. EPA tier testing.
Exemptions, Deferrals, and Waivers
Registrants may request exemptions from the SB950 data requirements by complying with Section 13127 of the Food and Agriculture Code. A data waiver request (which differs from an exemption request) may also be granted upon determination by the Medical Toxicology and the Worker Safety Branch, with communication through the Registration Branch. SB950 exemption or waiver requests are processed according to Appendix IX-2 and IX-3.
Failure to comply with SB950 requirements has resulted in issuance of suspension notices. Suspension means that the product may remain registered, but that the registrant can not sell the product in California. If a suspension cannot be lifted, a cancellation may follow.
The data call-in process for the first 200 priority active ingredients has been completed. The data call-in
and suspension process continues for the remaining active ingredients.
2. Pesticide Contamination Prevention Act (known as AB2021)
This is a data call-in for environmental fate (groundwater protection) data on all agricultural use active ingredients registered as of January 1, 1987. The data requirements are outlined in Chapter VI and in Section 13143 of the Food and Agriculture Code. New active ingredients require submission of these data prior to registration, unless requested as an Interim Registration.
Use of some active ingredients have been restricted as a result of the data call-in, requiring restricted materials permits and special reporting of sales and use.