Welcome to the Department of Pesticide Regulation

   

PESTICIDE REGISTRATION BRANCH

INTAKE THROUGH ARCHIVING: Processing and Routing Packages

December 2003

INTRODUCTION

INTAKE

LOG-IN PROCEDURE
STATUS SHEET AND ASSIGNING CODES
PREFIX CODES
SUFFIX CODES
CHEMICAL CODES
TYPE OF REGISTRATION
SPECIAL ATTENTION FLAGS
FOLDER
STATUS SHEET CORRECTIONS BY REGISTRATION SPECIALIST

INDEXING

LOGGING
CATALOGING
INDEXING THE DATA
ASSIGNING THE SUBMISSION
ADDING TO EXISTING SUBMISSION
DUPLICATE SUBMISSIONS
REPLACEMENT DATA
DATA OWNERSHIP CHANGES

DATE CHANGES

GENERAL
STOP-CLOCK
START-CLOCK
RESUBMISSION WHEN 30-DENY

RETURNS

EVALUATION TRACKING

PACKAGE ORGANIZATION
NEW ACTIVE INGREDIENTS
LOGGING INTO EVALUATION
NON-SUBSTANTIVE CHANGES
ADDITIONAL DATA
SUPPLEMENTAL DATA
WITHDRAWAL OR REMOVAL OF PACKAGE FROM EVALUATION
EVALUATORS' CONCERNS MET
RE-ENTRY BEFORE POSTING
RESUBMISSION DURING POSTING

TRACKING DOCUMENTATION MEMO (Pinky)

LICENSING NEW PRODUCTS

RENEWALS

PROCESSING RENEWALS

VOLUNTARY CANCELLATION MID-YEAR

LABEL REVISIONS TO CODERS

ARCHIVING PACKAGES

INTRODUCTION 

This document describes the handling of registration requests and scientific data from the time of receipt into the Pesticide Registration Branch until archived to the Library.

All incoming submissions with or without data are entered into the mail log by the Intake Technician.

All scientific data enters the registration and evaluation process through the Registration Intake Station and the Registration Indexing Station.

Any data identified during the registration and evaluation process as not cataloged and indexed, must be taken to Indexing for completion of this procedure. The data then continues the registration and evaluation process. Additional data cannot be inserted into data volumes without direct involvement of the Indexer.

All incoming information and data should be accompanied by a cover letter from the company identifying the reason for submission. The information in these letters is very important to the Intake Technician who must ensure correct routing of the package. If the reason for a data submission cannot be determined with assistance of the Registration Specialist, the Intake Technician will contact the submitting company.

This document is to be used in conjunction with the Registration Desk Manual.
 
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INTAKE

LOG-IN PROCEDURE 

All submissions are electronically entered into the mail log database. The log can be accessed through the branch internal home page (http://reggie:8000/cgi-bin/mlog/mrep.pl). The information recorded is:

Date received
Date of the cover letter
Company submitting the data
Product(s) or active ingredient(s)
Number of letters in the package
Number of letters of authorization
Labels
Application form
Application fees
Number of data volumes
Name of Registration Specialist assigned to the package
Other minor items for informational purposes

Each item in the submission is date stamped. Data volumes are stamped only on the first and last pages.

Exceptions which are not logged in or date-stamped: License renewals, RA's (Research Authorizations), County Ag Commissioner mail, scientist's mail, supervisor's/manager's mail.

If the technicians are asked to remove a submission from the Intake station before the procedures are completed, verbal or written instruction from the appropriate Supervisor of Registration is required. 

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STATUS SHEET and ASSIGNING CODES

The Intake Technician determines the type of submission and enters information into the electronic tracking system which generates a status sheet. The status sheet must contain accurate complete information, since this information is used throughout the evaluation process and for the 30 day public posting.

When generating a status sheet, the Intake Technician enters appropriate prefix and suffix codes, chemical code(s), type of registration, EPA Reg. Number, and the assigned Registration Specialist. The electronic tracking system numerically assigns a tracking ID#. The Intake Technician assigns prefix and/or suffix codes which will appear with the tracking ID#.

The tracking ID# assigned to each submission remains the same and stays with the package until a final action is taken (Returned, Registered, Registered Without Notice, Denied, FAL, or Miscellaneous Out).

When one company submits data for another applicant's product, the status sheet must show the correct data owner (company that submitted the data), not the applicant it is being submitted for.

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PREFIX CODES (precedes the tracking ID#)

ABM- AB 2021 Pesticide Contamination Prevention Act data (first time submission only)
ABR - AB 2021 data in response to a review (replacement, rebuttals, additions, and reconsiderations)
ANC- Antimicrobial products submitted concurrently
ANLC- Label amendments to Antimicrobial products submitted concurrently
25B- U.S. EPA exempt pesticide
CA - California Only Registrations
CR - Concurrent allowed by Branch Chief
CRR- Reduced Risk submitted concurrently
D - Devices
EE - Emergency Exemption Requests and Amendments (Section 18)
EPA- Information submitted by U.S.EPA (such as acute toxicology studies)
EUP- Experimental Use Permit Requests and Amendments (Section 5)
FP - First Party Special Local Need (Section 24C)
3P - Third Party Special Local Need (Section 24C)
I - Inerts Project (discontinued)
IR- AB 771 Interim Registration
IR4- IR4 workshare
MC- Microbial or Biochemical active ingredient submitted concurrently
ML - Master Label
MLC- Label amendment to Microbial or Biochemical active ingredient submitted concurrently
PE - All Uses Previously Evaluated
PHC- Public Health products submitted concurrently
PHLC- Label amendments to Public Health products submitted concurrently
RA- Research Authorization
RM - Residue Test Methods
SBC - SB 950 Birth Defects Prevention Act (first time submission only)
SBR - SB 950 Rebuttal or Reconsideration (no data)
SBDR - SB 950 Rebuttal or Reconsideration (with data)
SBRA- SB 950 Risk Assessment (copy of status sheet and cover letter to reevaluation coordinator)
SBMR- SB 950 Additional Data for a requested meeting or for a meeting with Medical Toxicology Branch
SPE - Some Uses Previously Evaluated
V- Volatile Organic Content reevaluation (liquid)
VF- Statements of formula for individual products in VOC reevaluation
VS- Volatile Organic Content reevaluation (solid)
W- Worker Protection Standard

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SUFFIX CODES (follows the tracking ID#) 

E -Additional Data (no time frame) also used with AB, BZ, RM, EPA, and SB codes
EA- Additional Data for Adverse Effects Disclosure under FIFRA Section 6(a)(2) orCCR Section 6210. Also used with SBC Prefix
EC-Additional Data to meet Conditions for Registration
EP-Additional Data Protocol or Pre-Registration Review
ER-Additional Data Reevaluation Response (copy status sheet and cover letter to reevaluation coordinator
ES - Supplemental Data for packages currently in evaluation
M - Major new use
N -New Active Ingredient. Active ingredient not currently registered in California.(Time frame for evaluation of a new active ingredient is 120 days)
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CHEMICAL CODES

Numerical codes are assigned using the chemical dictionary to identify the active ingredient(s). This code is unique to an individual ingredient. Other identifying variables are also collected in the chemical dictionary. Access the chemical dictionary. For New Active Ingredients, the Intake Technician takes the first volume of data to the designated program specialist for a chemical code.
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TYPE OF REGISTRATION 

The type of registration is identified by the Intake Technician and entered on the status sheet.

Terms used for the following types of registrations:

Section 3- Product Registration (3), Subregistration (3S), or Amendment (3A)
Section 5 - EUP Registration (5) or Amendment (5A)
Section 18 - Emergency Exemption Registration (18) or Amendment (18A)
Section 24c - First Party (24F), Third Party (24T), or Amendment (24A)
Section 25(b)-U.S. EPA-exempt, California Only (CA), or Amendment (CAL)
California-Only Registration, such as adjuvants (CA), or Amendment (CAL)

Hereafter the types of registration are referred to by section number only.
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SPECIAL ATTENTION FLAGS

For certain active ingredients, the computer automatically assigns a special attention flag. These attention flags appear after the chemical name on the status sheet. They are as follows:

"See SB 950" - There are SB 950 data gaps for the active ingredient, but not necessarily for all uses.
"See AB 2021" - There are data gaps for the active ingredient, but not necessarily for all uses.
"Suspended" - There are SB 950 data gaps for this active ingredient.
"Attn: Ann Prichard" - This is under Re-evaluation, Risk Assessment, or Other.
"Attn: 25b" - This is a Section 25b exempt product that is seeking registration.
"Attn: Rachel" - Chlorpyrifos or Diazinon product subject to U.S. EPA's Memorandum of Agreement.
"Check chem codes" - The chemical code needs to be verified.
"Attention" - There are concerns about new uses for this active ingredient.
"Attention new food use" -
"Attention route to EMPM" -
"New use EUP only" -
"Structural" - This is a structural device product subject to registration.
"MEBR Alternative" - Contact Ann Prichard.

Forward packages with special attention flags to the designated Supervisor of Registration, who then forwards the package to the Registration Specialist or, if it includes data, to Indexing.
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FOLDER 

A tracking folder with an ID tracking number is prepared and remains with package until a final action is taken. During archiving, the Archiving Technician removes folder and places it into a box in Intake area for recycling.

Status sheet accuracy must be verified by the Registration Specialist. To make corrections, see procedures in section on Status Sheet Corrections.
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STATUS SHEET CORRECTIONS 

The information on the status sheet is extremely important and is used throughout the evaluation process, including the 30 day public posting. The status sheet must contain accurate and complete information.

Errors to the status sheet are corrected by the Registration Specialist by doing the following:

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

The assigned tracking ID# for a submission remains the same and stays with package until final action is taken.

Status sheets cannot be corrected after a final action is taken.
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INDEXING

LOGGING 

All data packages are logged into Indexing manually and on the electronic tracking system. The manual log consists of the tracking ID#, date of receipt from Intake, volume number, and date package leaves Indexing. The electronic log consists of the tracking ID#, applicant name, product name, and location of package.
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CATALOGING

A document (volume) number is assigned to each volume by using the first listed active ingredient on the label. The only exception is a new active ingredient in a product with multiple active ingredients. In this case, the submission is cataloged under the new active ingredient.

The document (volume) number consists of two parts. The first part is a Library reference number assigned to the first ingredient listed on the label; exception outlined above. The second part is numerically assigned (eg. 50221-0001). No document (volume) number is issued unless the data is available for cataloging.
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INDEXING THE DATA

A record number is assigned in numeric sequence to each submitted study. The record for each study is entered into the Pesticide Data Index database - consisting of a tracking ID #, document number, date of study, test type, applicant, product name or active ingredient, performer of the study with report number, and study title. Data which the applicant submits is indexed as belonging to the applicant.

For AB and SB submissions a spreadsheet is completed. This form stays with the package and lists all record numbers, types of studies, test types, and study date.

If, as a separate submission, one company submits data for another applicant's product, the status sheet must show the correct data owner (company that submitted the data), not the applicant it is submitted for. The statement: "submitted to support ( company's ) application for ( product )" is included in the study title during indexing.

The Indexer generates a letter and a Detail Summary Report which are sent to the data submitter.

The Detail Summary Report contains the following information:

· The applicant name
· The product name
· EPA registration number
· Test types
· Record numbers
· Tracking ID number
· Volume number
· Study title

A copy of the Detail Summary Report is bound into first volume of submission as an index. Do not remove this report from package.
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ASSIGNING THE SUBMISSION

Note: Large sets of data may have only the first volume given to the Registration Specialist. The Indexer sends remaining volumes to be housed in the Library.

Product registrations, label amendments, additional data unspecified, additional data to meet conditions, and EUPs are given to the Registration Specialist assigned to the company.

New active ingredients products are given to the designated Registration Specialist.

New active ingredient microbials and biochemicals are given to the designated Registration Specialist.

Section 18s and Section 24(c)s are given to the designated Registration Specialist.

Adverse Effects Disclosures (EA suffix) are given to the designated Registration Specialist.
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ADDING TO AN EXISTING SUBMISSION

Any data or information being added to an existing submission must first be logged in by Intake. This includes data or information that was mailed, hand-carried, faxed, or emailed. Data must be forwarded to the Indexer.

For specific instructions on adding data to a package that is in an evaluation station, see section on Evaluation Tracking - Supplemental Data (ES).

DUPLICATE SUBMISSIONS

There are two situations where this can occur.

- If duplicate data is submitted, the registration specialist gives it to the Indexer for removal from the indexing system. The duplicate data is then shredded.

- If a new tracking ID number is assigned to a submission which should have been made part of an existing submission, the newer ID number is taken out of the tracking system as a duplicate.

REPLACEMENT DATA

The Registration Specialist must take replacement data to Intake, if not already logged in, and then to Indexing for inclusion in a volume. This includes data that was mailed, hand-carried, faxed, or emailed.

DATA OWNERSHIP CHANGES

The Registration Specialist must give a copy of the U.S. EPA data ownership change document to the Librarian.
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DATE CHANGES

The Target Date can only be changed if any one of the following four situations occurs. Note that only the target date can be changed, not the original received date.

RECEIVED DATA/INFORMATION PRIOR TO RETURN OR ENTERING EVALUATION

The target date can be changed if data or information is received and added to a submission prior to the submission being returned or prior to it entering evaluation.
If the Intake Technician identifies new incoming data or information as belonging to an existing submission, the Intake Technician changes the date on original submission by retrieving package from Registration Specialist. Change the target date based 60 or 120 days as appropriate. Submission is given to Registration Specialist, unless scientific data was submitted. If data was submitted, Intake Technician gives the package to Indexing.

If the Intake Technician did not initially identify incoming data or information as belonging to an existing submission, the Registration Specialist must take the submission to the Intake Technician. The Intake Technician makes the above target date change using the Deficiency-Response (formerly PRA-7) letter that is prepared by the Registration Specialist.

If original submission is associated with an application fee, the Registration Specialist will:

a) Submit copy of revised status sheet showing new target date to Intake Technician.

b) Send Deficiency-Response letter (formerly known as PRA-7) to applicant. This letter tells applicant that although the submission could have been returned, new data or information was received allowing it to continue in the process.

c) Submit copy of Deficiency-Response letter to Intake Technician. The Intake Technician may request to see original package.

If submission is not associated with an application fee, the Registration Specialist will:

Obtain Supervisor of Registration initials on revised status sheet showing the new target date. Give a copy of this to the Intake Technician. The Intake Technician may request to see original package.


It is the Registration Specialist's responsibility to provide correct information to the Intake Technician on all items pertaining to a submission.

STOPPING CLOCK DURING SCIENTIFIC EVALUATION PROCESS

If submission has entered scientific evaluation process, and is associated with an application fee, the clock can be stopped temporarily, but only if all of the following occur:

a) The submission is associated with an application fee and;
b) The submission is currently in evaluation process and;
c) There is an approaching target date on the submission and;
d) The submission is not yet posted for 30 day comment period and;
e) There is a negative recommendation from an evaluator and;
f) There is at least one remaining evaluation station.


The Registration Specialist will:

a) Send stop-clock letter Deficiency-During-Evaluation (formerly known as PRA 1-2) to the applicant.
b) Give copy of Deficiency-During-Evaluation letter to Evaluation Tracking Technician.


The Evaluation Tracking Technician then will:

a) Verify the Deficiency letter information by checking tracking system to confirm that submission is currently in evaluation and has at least one review remaining.
b) Place date from Deficiency letter into Specific Status Record field, which then assigns SC code.

From this point, the "stopped clock" status carries forward with the submission as evaluation continues and until the clock is re-started.

While clock is stopped on a submission:

All actions to register the product are excluded (not allowed). This is done by a check of the rule base built into the tracking system.

The "stopped clock" status carries forward with the submission as evaluation continues.

When the evaluation process is completed, and the clock was not restarted, the only allowable actions are to Propose-to-Deny or Final-Deny.

To allow registration, the clock must be re-started. See next section for instructions.

It is the Registration Specialist's responsibility to provide correct information to the Intake Technician on all items pertaining to a submission.

The Registration Specialist's weekly workload listing will list "stopped clock" submissions separately and will treat them as though they are in a separate process.
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STARTING CLOCK AFTER STOPPED CLOCK

A new target date is assigned to original submission if applicant responds to stop-clock Deficiency letter by sending in required data/information while submission is still in evaluation.

If the Intake Technician identifies new incoming data or information as response to a stop-clock Deficiency letter, they give the new submission an ES suffix and forward it to Indexing. The Intake Technician changes the date on the original submission in the tracking system, which removes the stop-clock SC designation.

If the Intake Technician did not identify incoming data or information as response to a stop-clock Deficiency letter, the Registration Specialist must take new data/information to Intake Technician. The Intake Technician then makes the date change and processes the submission as indicated above.

To start the clock, the Intake Technician will:

a) Enter new receipt date which will calculate a new target date. This restarts the clock.
b) Clear tracking system database field that was set to "SC." The history of the submission while the clock was stopped is preserved by the status records.

If applicant did not submit all required items in Deficiency-During-Evaluation letter by the time submission exits evaluation, the Registration Specialist posts action 30-to-Deny.

It is the Registration Specialist's responsibility to provide correct information to the Intake Technician on all items pertaining to a submission.

Note: ES packages do not automatically cause a date change. This must be done by the Intake Technician.
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RESUBMISSION AFTER OR DURING 30-DAY POSTING

If data or information is received during 30-to-Deny posting, the Intake Technician identifies this and retrieves original submission from Registration Specialist. The Intake Technician gives submission to the Registration Specialist. If scientific data was submitted, the Intake Technician forwards submission to Indexing.

If the submission is then resubmitted into evaluation, Evaluation Tracking Technician changes the target date.

Note: The Registration Specialist cannot, on their own, add to or subtract data volumes from a submission, but must take new data/information to Intake who then forwards it to Indexing as needed.

Reminder: If, as a separate submission, one company submits data for another applicant's product, the status sheet must show the correct data owner (company that submitted the data), not the applicant it is submitted for. The statement: "submitted to support (company's) application for (product)" is included in the study title during indexing.
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RETURNS

Process for returning a deficient submission.

If a submission is deficient and cannot be registered and cannot be entered into scientific evaluation, the submission should be returned to applicant in the following manner:

1. Registration Specialist assembles the return package (application form, data, correspondence, etc.), writes a Return letter describing deficiencies, and gives the signed letter and package to their Supervisor of Registration for surname signature. Note: If multiple volumes were housed in the library, they remain there until Return package is shredded or enters evaluation.

2. Supervisor of Registration places letter and package in Return basket.

3. Return Technician will:

a. Enter information into electronic tracking system by both the tracking ID# and the date of return letter.
b. Highlight the tracking ID# on the data volume to indicate removal from system. Once the ID# is removed from system, it cannot be reused.
c. File the submission on the Return shelf.

If applicant does not reapply within nine months or pick up their returned submission.

If after nine months applicant does not re-apply, the submission is shredded.

The Intake Technician will:

1. Prepare a shred list and give it to the Registration Specialist.
2. Before shredding a submission containing data, take it to the Supervisor of Registration, who then gives it back with approval to shred.
3. Give submission to the Indexer, who ensures that all volumes are present, then removes volume number(s) from the system by deleting record numbers from all Library records.
4. Shred the submission.

If the Registration Specialist, with supervisor's approval, needs to retain a data volume, the data is separated and given a separate ID# as additional data.

If the data is to be evaluated, it is given an E suffix and routed to the appropriate scientific evaluation station. The remaining paperwork is shredded.

If the data is to be archived as "unevaluated," it is given an EU suffix. The remaining paperwork is shredded. A Tracking Documentation Memo must be prepared.

Response to a returned submission is received.

If applicant responds to the return letter within nine months, the original package is pulled from the return file and a new tracking ID# is assigned. Based on this initial return date, another application fee may be needed when the applicant resubmits the application.

All incoming submissions which were previously returned and which have data (new or old) are routed to the Indexer. The Indexer changes the records to reflect the new ID# and routes the submission to the Registration Specialist.
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EVALUATION TRACKING

PACKAGE ORGANIZATION

Registration Specialist prepares submission for scientific evaluation by organizing it as follows:

1. Clip to outside of folder

Copy of status sheet/route sheet (back-to-back copy) for Registration Specialist's binder, with evaluation stations indicated. Evaluators' comments and recommendations will later be recorded on this copy.

Extra copy of proposed label, with ID# written on it. This becomes part of the Materials Entering Evaluation (MEE) list and is forwarded to PREC committee members. There is no extra copy of label if the submission is additional data, a resubmission, or a Sec. 18.

2. Put inside folder

Status sheet and route sheet with all evaluation stations indicated.

All other pertinent information including proposed label, U.S. EPA documentation, and letters of authorization.

3. Data submitted with the package that is cataloged with the same ID# as on status sheet. Collect volumes to be routed before forwarding submission to Evaluation Tracking Technician.

Data volumes that are only referenced are not routed into evaluation. The evaluator checks needed volumes out of the Library and returns them when finished.

Data volumes that are part of a very large submission remain in the library and are not routed into evaluation, although the first volume may be routed. Registration Specialist notes this on route sheet. The evaluator checks needed volumes out of the Library and returns them when finished.

For new active ingredients, see New Active Ingredients section.

Registration Specialist gives submission to the Evaluation Tracking Technician for processing.

For non-substantive changes, see Non-Substantive Changes section.
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NEW ACTIVE INGREDIENTS - special instructions

Submissions for products containing active ingredients not currently registered in California are identified by Intake as New Active Ingredients and are given a 120 day target date.

When the submission is given to the designated Evaluation Tracking Technician, the Registration Specialist also routes a copy of the application, label, U.S. EPA documentation, status sheet, route sheet, MSDS's and any other pertinent information to the Library to form a reference volume.

The reference volume is kept in the Library for use by evaluation scientists.

For food use labels, the Registration Specialist must notify the designated Evaluation Tracking Technician to submit a copy of the status sheet, summary report, first page of application form, U.S. EPA stamped label, and MSDS to the CDFA Center for Analytical Chemistry.

The evaluation routing process for new active ingredients is not exactly the same as for other registration requests. Instead, each evaluation station simultaneously receives a copy of the evaluation routing package (status sheet/route sheet, application form, label, correspondence, and Detail Summary Report from Indexing.) A copy of the evaluation routing package is also maintained at the evaluation tracking station in binders filed by company and then by tracking ID#. A pink tag (new active ingredient) and an identifier tag are attached. All data are housed in the library for reference, as are original evaluation reports.
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LOGGING INTO EVALUATION

The designated Evaluation Tracking Technician will:

1. Enter ID# and indicated routing stations into the tracking system.

2. Attach a color tag to the package. Use a different color for each type of registration. The tag shows received date, the Registration Specialist's initials, and tracking ID#.

New Product - dark green
Label Amendments - light green
Section 5 - yellow
New Active Ingredient - pink
Section 18 - red
Section 24c - light blue
Additional Data - white
Data for a Conditional - purple
Adverse Effects - tan/gold


3. Into the folder place the single-sided copy of status sheet/route sheet, the application form, U.S. EPA stamped label as needed, letter(s) of authorization, and proposed label.

4. Place the back-to-back copy of status sheet/route sheet into Registration Specialist's binder. Record each subsequent evaluation station and evaluator's comments on this copy, as package enters and exits each station.

5. Retain the label copy with ID# on it for the mid-week report called Materials Entering Evaluation (MEE Report). This is forwarded to members of the Pesticide Registration and Evaluation Committee (PREC).

6. On route sheet, record the date package enters first Evaluation Station. Record each subsequent evaluation station as package enters each one. This copy remains with the package as it is routed.

7. Deliver the packages to the evaluation stations daily.
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NONSUBSTANTIVE CHANGES - special instructions for routing

Some label or formula changes do not require data or scientific review, but cannot be processed as an FAL. These are processed as Non-Substantive changes.

Registration Specialist submits package with following items to Evaluation Tracking Technician:

- Status sheet with correct information.
- Route sheet with evaluation station selected and any special instructions for designated Program Supervisor. Check the Non-Substantive Change box and highlight.
- Proposed label copy or, if applicable, proposed formula.
- Copy of U.S. EPA stamped approved label or formula CSF.

Evaluation Tracking Technician will:

- Enter the information into the tracking system.
- Forward the submission to the designated Program Supervisor.

Designated Program Supervisor will:

- Determine if submission can be approved as Non-substantive change, without further scientific evaluation.
- Give submission to Evaluation Tracking Technician.

If submission is not approved as a Non-substantive change, the Registration Specialist determines if submission should be returned or if it should be submitted into scientific evaluation process.

ADDITIONAL DATA - various E Suffixes

Additional data submitted by a company is given a tracking ID# with an E suffix. Prefixes may also be included with tracking ID# depending on purpose of the additional data submission:

EC is additional data submitted to meet Conditions placed on a currently registered product.
EA is additional data submitted to comply with Adverse Effects disclosure requirement.
ES is additional data submitted as Supplemental to a package currently in scientific evaluation.
EU is unevaluated data that is being Archived
E is additional data not in any of the above categories.

See special instructions below for Supplemental Data (ES).

Upon completion of evaluation and signature by Program Supervisor, "E" packages (with exception of ES and EU) will be "Miscellaneous Out" by the Registration Specialist on their weekly action log and archived to the library.

Data packages with E suffix are not subject to any mandated time frames. However, EC packages are submitted to meet conditions placed on a currently registered product and, therefore, should be processed in a timely manner.
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SUPPLEMENTAL DATA submitted while a package is in evaluation - ES Suffix

When data is received from the applicant for a registration request currently in an evaluation station, and not yet posted for 30 day comment, it is assigned an ES suffix and referred to as "supplemental data." The Intake Technician notes this on front of status sheet and includes tracking ID# of the original package. The Indexer processes the data and gives it to Evaluation Tracking Technician.

The Evaluation Tracking Technician will:

  • Contact Registration Specialist for instruction on routing to appropriate evaluation stations
  • Miscellaneous Out the ES number
  • Locate original package
  • Add new volume numbers to original status sheet and to the copy. Staple the copy to the ES status sheet and place in the ES file.
  • On the data volume, line through the ES tracking ID#

If, in rare instances, an ES package is joined to a submission after it exits evaluation, but before a final action is taken, the Evaluation Tracking Technician follows the above steps.

If ES data is not to be joined with a package, the Evaluation Tracking Technician changes the ES suffix to an E suffix and takes package to the Indexer. The Indexer gives the corrected package to the Registration Specialist.

Note: All Supplemental Data (ES suffix) Go Through Evaluation Tracking Technician. There are No Exceptions.
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WITHDRAWAL OR REMOVAL OF PACKAGE FROM EVALUATION

Withdrawing or removing a submission from scientific evaluation requires a Tracking Documentation Memo (pinky). This can occur for two reasons.

1. Company requests withdrawal of the submission before evaluation is complete.
2. Registration Specialist determined a need to remove submission before evaluation is completed.

EVALUATORS' CONCERNS MET (WITHOUT FURTHER EVALUATION)

If an evaluator's concerns are met before a final action is taken, the Registration Specialist can address the concern by doing the following:

1. Prepare Tracking Documentation Memo (pinky) descibing how evaluator's concerns were met.
2. Take submission along with the pinky to their Supervisor of Registration for signature.
3. Then take submission and pinky with supervisor's signature to designated Program Supervisor who makes necessary changes to status sheet/route sheet, changing that evaluation station's decision box and changing the final decision.
4. Make two copies of pinky.
5. Give one copy of pinky to the scientific Evaluator.
6. Take the package, the original pinky, and the two copies of the pinky, to the designated Tracking Technician, who makes necessary changes to the tracking data base and to the binder copy.

Note: In lieu of the above, the Registration Specialist can submit the package back into evaluation for approval.
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RE-ENTRY OF PACKAGE INTO EVALUATION BEFORE POSTED FOR 30 DAYS

The Registration Specialist can re-enter a package back into an evaluation station as needed. This occurs when the package has exited the evaluation process, but is not yet posted for 30 day public comment. A Tracking Documentation Memo (pinky) is not needed. If new data/information was submitted, follow instructions in the section on Date Changes.

This process is different from a Resubmission which occurs during the 30-to-Deny posting.

RESUBMISSIONS - DATA RECEIVED DURING POSTING 30 DAYS TO DENY

Data received for a submission posted 30-to-Deny is not given a tracking ID# or a status sheet. Instead, the Intake Technician retrieves the submission from Registration Specialist and takes it along with the newly submitted data to Indexing. The Indexer catalogs and indexes the information and gives entire package back to the Registration Specialist.

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

1. The Registration Specialist takes the submission and the new information to the designated Evaluation Tracking Technician. Indicate the evaluation station(s).
2. The Evaluation Tracking Technician enters new receipt date generating a new target date. The new target date is based on 60 days (120 days for new active ingredients and major new uses). The package is resubmitted to the appropriate evaluation station.

If new data or information doesn't meet all deficiencies listed in propose-to-deny letter, the above do not occur. Instead, the following steps are taken.

1. The Registration Specialist takes the Final Deny action.

2. The Registration Specialist archives the submission including the newly received unevaluated data. The Registration Specialist prepares a Tracking Documentation Memo (pinky) and notifies the Archiving Technician that the new data will not be evaluated.

3. The Archiving Technician then stamps the data "unevaluated" with initials and date.

In most cases new data is assigned a new volume number. If corrections or additions to an existing study are inserted into an existing volume, the Indexer flags the inserted data for easy identification by the evaluator.
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TRACKING DOCUMENTATION MEMO (Pinky)

The tracking system is organized so that only certain actions follow other actions. In rare cases, it is necessary to take a different action than the one that would follow in the system. To do this, a Tracking Documentation Memo (pinky) must be prepared.

The following are situations which require a Tracking Documentation Memo (pinky).

  • An evaluator's requirements are met due to receipt of new information - and the package does not have to go back to the evaluator for verification. Remember to also give a copy to the Evaluator and a copy to the Evaluation Program Supervisor.
  • The action to register/approve is without scientific evaluation because the request for this registration action was already evaluated under a previous ID# number, and the registration was not completed at that time. An example is a concurrent submission that did not previously receive U.S. EPA registration. Indicate this on the pinky.
  • Product will be Registered Without Notice, but it also had a partial evaluation as a Non-substantive Change or as a Label Amendment. Give the original pinky to the designated Evaluation Technician (posting) and a copy to the Licensing Technician.
  • Applicant requests withdrawal of a submission after it has entered evaluation. The Registration Specialist posts the submission Final to Deny. On the posting, state reason for denial as "application withdrawn by applicant."
  • Withdrawal of submission from scientific evaluation process before the process was completed, for reason other than "by applicant."
  • The Evaluator's recommendation will not be followed and the posting is contrary to the recommendation. No new information or data was received. The Branch Chief must sign this. Remember to also give a copy to the Evaluator and a copy to Evaluation Program Supervisor.
  • Scientific evaluation is not yet completed, but submission is being posted for 30 day public comment. The Branch Chief must sign this.
  • Certain unevaluated data will be archived. Confirm this with the Supervisor of Registration.

The Registration Specialist will:

1. Prepare a Tracking Documentation Memo (pinky) using the form found online in the Varlet section. Complete each section, including a concise description of the action being taken and the reason. Send the draft as an email attachment to their Supervisor of Registration for review and any necessary editing before it is printed.

2. Print the approved draft on pink paper for signature by the Supervisor of Registration. (Note: the Branch Chief must sign it if an Evaluator's recommendation is not being followed and no new information was received. The Branch Chief must also sign for early posting before scientific evaluation is complete.)

3. If it involves posting a decision for public comment, give original signed pinky (along with the action log) to the Tracking Coordinator (posting). If it involves scientific evaluation, give original signed pinky and two copies and the package to the Evaluation Tracking Technician. The designated Program Supervisor then signs the recommendation line on the route sheet. If it involves both a posting decision and scientific evaluation, give the original pinky to the Tracking Coordinator (posting) and give the copies along with the package to the Evaluation Tracking Technician.

4. If the pinky pertains to an Evaluator's recommendation, also give a copy to the Evaluator and a copy to the Evaluation Program Supervisor.

5. If it involves a Register Without Notice action, give the original and a copy to the Licensing Technician.
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LICENSING NEW PRODUCTS

After a product is approved for registration, a Certificate of Registration (license) is issued to the registrant. Each license expires on December 31 each year and is subject to renewal.

When a product is ready to be licensed, the following steps are taken.

Registration Specialist will:

1. Initial the Application for Registration form and write 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 alpha code AA. The alpha code for an additional brand name is the next one in sequence: ZA, ZB, etc. This is verified by checking the online data base.

2. Assign special number, if needed.

If there is no U.S. EPA-assigned firm number, the Intake Technician assigns a firm number using the California Firm/Product Number Assignment binder. This is done when submission is first received.

If there is no U.S. EPA-assigned product number, such as for an adjuvant or for a stand-alone 24c product or for a U.S. EPA 25b-exempt product which the company chooses to register in California, the Registration Specialist uses the California Firm/Product Number Assignment binder to assign a product number. The binder is in Intake area. This is done when the product is to be posted 30-to-Register.

For an adjuvant, a 50000 product number is assigned in numerical sequence.

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

For a Section 25b-exempt product that the company chooses to register in California, a 30000 product number is assigned in numerical sequence.

For a Section 5 EUP, the number is assigned in the following way: Firm number-55000-EX. The last digits of the 55000 portion is from the U.S. EPA assigned EUP number.

For a Section 24c, an SLN number is assigned using the SLN Number Assignment binder in the Label Resource Center. Include the SLN number along with the assigned product number on the stamped, accepted label and on the cover letter.

3. Assemble the documents as follows:

Stamp three labels "acceptable" and fill in the appropriate information.

For a conditional registration or for an interim registration, prepare appropriate letter listing the conditions. The letter may be emailed to the Licensing Technician in advance.

Assemble for Product File -

a) Original application form designated "product file" in the top right corner.
b) Accompanying applications or statements of formula.
c) U.S. EPA documentation of product or company name change, number change, or data ownership change, if applicable.
d) For company name change only or for additional brand name, a copy of the registrant's notification to U.S. EPA, if there is no U.S. EPA letter.
e) U.S. EPA stamped label and accompanying letter.
f) Letter(s) of Authorization.
g) Copy of the stamped, approved printer's proof or final printed label.
h) Memorandum of Registration for product being registered as identical to another product.
i) For subregistration/distributor registration, copy of U.S. EPA form #8570-5.
j) Affidavit of no change in ownership, if applicable.

Assemble for Coding -

a) Copy of application form designated "coding." Attach copy of accompanying statement of formula.
b) Copy of stamped, approved label.
c) Status sheet.
d) See P/P 2000-1 for examples of revisions that do not need to be sent to coding.

Assemble for Registrant -

a) Copy of stamped, approved label designated "company." This is sent to the company with the Certificate of Registration (license).
b) The Conditional letter, if applicable.


4. Give the documents to the Licensing Technician.

The Licensing Technician will:

1. Prepare the appropriate registration letter for the Registration Specialist's signature. If the product is being registered conditionally, the Registration Specialist will have already prepared the letter. For company name changes or firm number changes, remember to include a statement about any conditionally registered or time-limited products.

2. Verify that there is an original RC# on the application form and that the application fee is submitted. The RC# can be placed on a document only by the Licensing Technician. For an "interim" registration, verify that the additional $5000 fee is paid.

3. Prepare the Certificate of Registration (license). The license expires on December 31. For an "emergency" registration, the expiration is one year from the date of issue.

4. For a company name change, issue a new license to supersede the old name license. Mark the old firm name license "Amended" in the license binder files.

5. 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.

6. Forward a copy of the license, the yellow surname copy of the letter, and the documents marked "product file" to the Label Resource Center.

7. Forward the documents marked "coding" to the Coders with a copy of the DPR cover letter.

8. If the product is being registered as an identical product, such as a company name change, remove the tracking ID# from the system as "Registered Without Notice."
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RENEWALS

PROCESSING RENEWALS

A pesticide product Certificate of Registration (license) expires on December 31st of each year.

Approximately November 1 of each year, the Licensing Technician mails each registrant a list of their currently registered pesticide products on the Application for Renewal form.

The Registrant will:

  • Line out the names of any products they wish to discontinue
  • Sign and return the renewal request with renewal fees. The renewal fee is $750 per product. Exempt from fees are county, state, or federal agencies which sell the product at cost.
  • Submit any data required for renewal of a product. A product will not be renewed if the registrant has not complied with the conditions placed on a product's registration.

An Emergency Registration cannot be renewed for more than one year.

Applications for Renewal that are complete are processed by the Licensing Technician.

Address changes indicated on the renewal request are verified by the designated Program Specialist before the Licensing Technician makes the change to the license and in the data base.

If any of the following occur on the renewal request, the Licensing Technician routes the information to the Registration Specialist:

1. The application for renewal shows a change in firm name, altered brand name, altered registration number, or additional brand name.
2. Scientific data is received .
3. Data or information for an adverse effects disclosure is received.
4. The annual progress report in accordance with a conditional registration is received.
5. Regulatory action against the product is being taken by DPR.
6. The registration is an Emergency 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.

Penalties for Late Renewal

If the registrant's Application of Renewal is not postmarked within one calendar month after expiration of the Certificate of Registration (license), a penalty of $150 per product is charged. For 2004, an additional month will be given.

A penalty is not collected if the Application for Renewal is accompanied by an affidavit that no business was done during the period of nonregistration.

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.
2. The applicant has not submitted the appropriate renewal fees.
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.
4. The product is no longer U.S. EPA registered. Generally DPR allows a registration to be renewed for two years past U.S. EPA lapse of registration, unless specifically prohibited by cancellation/suspension.
5. DPR cannot renew a product due to regulatory action, such as cancellation.
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VOLUNTARY CANCELLATION MID-YEAR

A company may request voluntary cancellation during the calendar year, even before the renewal period.

The registrant must send a written request to the Licensing Technician or to the Registration Specialist, preferably using DPR's Voluntary Cancellation Form. The written request must include a waiver of their right to a hearing or it cannot be processed. It can be mailed - or faxed, followed by a hard copy.

If received by the Registration Specialist, the Registration Specialist gives the registrant's written request to the Licensing Technician, with instructions to issue a Supplemental Certificate of Registration (license) showing deletion of the product.

The Licensing Technician will:

1. Prepare an amended Certificate of Registration deleting the product. If no specific date of cancellation is requested by the registrant, the date of the request letter is used.
2. Prepare the appropriate License letter.
3. Give the documents to the Registration Specialist for signature and surname by Supervisor of Registration, who will give the documents back to the Licensing Technician.
4. Update label file database showing "voluntary cancellation" as the reason for inactivation.
5. Line out the brand name and registration number on the main Certificate of Registration (license).
6. Forward the Supplemental Certificate of Registration (license) and other information to the Label Resource Center.
7. Forward a copy of Supplemental Certificate of Registration (license) to the Enforcement Branch.
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LABEL REVISIONS SENT TO CODERS

Label revisions or amendments are sent to the Coders for entry into the data base. The items designated "Coding" are:

1. Copy of the DPR cover letter.
2. Copy of the label with only the revisions highlighted.
3. Copy of the status sheet
4. For formula revisions, a copy of the application form containing the statement of formula.

See Policy/Procedure 2000-1 for examples of amendments and revisions that do not need to be sent to the Coders.


ARCHIVING PACKAGES

Registration requests (and additional data submissions) must be archived to the Library after a final action is taken. The Registration Specialist prepares the package as outlined below and gives it to the Archiving Technician who forwards it to the Indexer. All relevant documents and data are sent together.

A final action on the weekly action log must be taken prior to archiving -
the submission must be archived promptly following the final action.

All volumes listed on the status sheet must accompany the data package unless pre-arranged with the Indexer. There are no exceptions.

All submissions which undergo scientific evaluation (including non-substantive changes) are archived to the Library. This includes packages with data as well as "no-data" packages.

The Registration Specialist will:

1. Take a final action on the submission.

2. Assemble all relevant documents - clipped and rubber banded to the outside of the first numbered volume.

a. Original copy of the status sheet and route sheet with the evaluator's reviews and the recommendation of the Program Supervisor.
b. The scientists' evaluation reports in reverse chronological order. Include the Medical Toxicology evaluation worksheets with the toxicology memos.
c. One copy each of label, application form (and Confidential Statement of Formula, if available), and U.S. EPA correspondence. Do not include any general correspondence unless it includes data or information pertaining directly to the data package.
d. The submitted data. (required)

3. Route the package to the Archiving Technician.

The "no-data" packages being archived consist only of 1. The status sheet/route sheet with evaluators' reviews and Program Supervisor's recommendation and 2. The evaluation reports. Note that the Evaluation Tracking Technician and Indexing staff no longer accept any other paperwork, such as labels or company correspondence. The Registration Specialist may keep the remaining items for their files.

The Archiving Technician will:

1. Remove package from brown folder and remove tags from package.
2. Pull the Registration Specialist's binder copies. Verify the information on the status sheet/route sheet and match with the original status sheet/route sheet.
3. Verify that the ID tracking number(s) and document numbers(s) on all data volumes match status sheet.
4. Assemble the binder copies of the scientists' evaluation reports, in reverse chronological order with the status sheet/route sheet on top. Clip to original information. For packages with data, clip both original and binder copy to outside of first volume of data, then with rubber band.
5. Take the archive action on the tracking system.
6. Route to Indexer for processing.

The Indexer will:

1. Make sure there are two complete sets of documents - one original and one copy.

2. Insert the original relevant documents into the data volume listed first on the status sheet.

Multiple products: When there is only one set of data supporting registration requests for multiple products with multiple tracking ID numbers, the Indexer will insert a complete package, including original status sheet and memos (evaluation reports) for each number, into the first volume of data listed on the status sheet. The Indexer also ensures that each product with a tracking ID number has a complete set of relevant documents to file in the completed binders.

3. Give the data volumes and the copies to the Library for shelving and filing.

If data volume is needed before archiving is complete.

When a rush is needed for a volume that has been submitted for archiving, the person requesting the volume notifies the Archiving Technician that there is a rush. The Archiving Technician takes a final archive action and processes the paperwork. The Indexer finishes the paperwork and notifies the person requesting the volume that archiving is complete and that the volume can be checked out of the library.

Unevaluated data which is selected to be archived.

The following are special situations where unevaluated data can be archived to the Library. In each case, a pinky is prepared as indicated in the Tracking Documentation Memo (pinky) section.

1. Only some of the requested data in a Propose to Deny letter was received before the Final Deny action was taken and the data will not be evaluated at this time.

2. A Return package is being shredded, but in rare cases the scientific data will be archived. The data is given a separate ID# with EU suffix. The remaining paperwork is shredded. The Intake Technician will "Miscellaneous Out" the ID# and give the package to the Indexer.

3. Additional data is received that is not associated with a registration request and will not undergo scientific evaluation at this time. The package and the pinky are given to the Intake Technician who gives the ID# an EU suffix and takes the Miscellaneous-Out action. The Intake Technician gives the package to Indexing to complete the archiving.
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