PESTICIDE REGISTRATION BRANCH
INTAKE THROUGH ARCHIVING: Processing and Routing Packages

December 2011

INTRODUCTION

MAIL/INTAKE

INDEXING

RETURNS

EVALUATION TRACKING

TRACKING DOCUMENTATION MEMO (Pinky)
LICENSING NEW PRODUCTS
RENEWALS & RENEWAL PROCESS
VOLUNTARY CANCELLATION MID-YEAR
CODING
LABEL REVISIONS TO CODERS
ARCHIVING PACKAGES
ARCHIVING UNEVALUATED DATA

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 Registration Resource Center.

All incoming submissions with, or without scientific data enter the registration and evaluation process through the Registration Mail/Intake and Indexing Stations. All incoming submissions are entered into the mail log database by the Mail/Intake Technician and a mail log ID number is generated electronically for each submission.

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 identify the submission type to ensure correct routing of the submission. If the reason for a submission is not clear from the cover letter, the Intake Technician should consult the Regulatory Scientist assigned to the company. If the Regulatory Scientist cannot determine the reason for the submission, the Intake Technician will contact the Lead Intake Analyst.

Any data identified during the registration and evaluation process that has not been cataloged and indexed, must be taken to indexing for completion of this procedure before continuing through the registration process. The data then continues the registration and evaluation process. Additional data cannot be inserted into data volumes without direct involvement of the indexer.

This document is to be used in conjunction with the Registration Desk Manual. The following is an overview of the process that will be discussed throughout this text.

TOP

Mail/Intake
Indexing
Evaluation Tracking
Licensing
Coding
Archiving

MAIL/INTAKE

MAIL–LOG PROCEDURES

The Mail/Intake Technicians electronically enters information regarding all submissions (with the exceptions listed below) into the Pesticide Registration Tracking and Mail Log databases. The list below describes submissions that are neither date stamped or logged. The Mail Log can be accessed through the Registration Branch’s internal homepage at (http://registration/track/intakeindex.cfm): Once all information is entered, the mail tracking system will generate a mail tracking ID number. No submissions are to be removed from the mail/intake area without the verbal or written approval of an appropriate Senior Environmental Scientist.

The following types of submissions are not logged or date stamped by the Mail/Intake Technicians:

For submissions that are logged, the following information is captured and entered into the Pesticide Registration Branch ’s electronic Mail database.

The Mail Technician opens the mail and date stamps all labels, letters, confidential statements of formula (CSF’s), with data volumes being date stamped on the front of the first page and the back of the last page. The mail ID# is written on the front of the application or cover letter.

Application fees submitted for new products (non-renewal) and label amendments are sent to accounting for processing. Each submission must be accompanied by the original application for registration of a new product or amendment of a currently registered product. If no application is submitted, the cover letter may be used in its place. The Mail Technician will write the RS’s initial in the upper right hand corner of the application (or cover letter) to assure the RS gets the original application/cover letter back after processing by accounting. The Mail Technician is to make a copy of the application/cover letter and paper clip the check to the middle of the original application/cover letter, place the copy of the application/cover letter with the submission and give the original application/cover letter with the check attached to the Evaluation Tracking Technician.

If it is a new company not yet assigned to an RS, the Mail Technician will highlight the upper right hand box of the application indicating a new company and route the submission to the Branch Chief who will forward it to the appropriate supervisor for assignment of an RS. If the submission contains numerous data packages, the data will be maintained at the Mail technician’s desk until the application/cover letter portion of the submission is returned by a supervisor.

If the submission’s cover letter refers to a specific tracking ID#, the Mail Technician is to search the Tracking database for the status of that ID#, highlight and indicate status next to ID# (such as return, posted 30 days etc.)

TOP

STATUS SHEET AND ASSIGNING CODES:

When generating a status sheet, the Intake Technician enters the following information into Product Intake tracking system:

The status sheet must contain accurate and complete information, since this information is used throughout the evaluation process and for the notice posting the product for a 30-day public comment period.

The electronic tracking system numerically assigns a tracking ID# which remains the same and stays with the submission until a final action is taken (Return, Registered, Denied, 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.

TOP

PREFIX CODES (precedes the tracking ID#)

AMB–AB2021 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 amendment to a registered Antimicrobial product submitted concurrently 25B–Pesticide Exempt from Registration in CA (and U.S. EPA)
CA – California Only Registrations
CR – Concurrent allowed by Branch Chief
CRR– Reduced Risk submitted concurrently
D – Devices
EE –Emergency Exemption Request and Amendments (FIFRA Section 18)
EPA– Information submitted by U.S.EPA (such as acute toxicology studies)
EUP–Experimental Use Permit Requests and Amendments (FIFRA Section 5)
FP –First Party Special Local Need (FIFRA Section 24C)
3P – Third Party Special Local Need (FIFRA Section 24C)
I – Inerts Project (discontinued)
IR– AB 771 Interim Registration
IR4– IR4 Work share
M – Major new use
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 amendment to Public Health product submitted concurrently
RA– Research Authorization
RM – Residue Test Methods
SBC – SB950 Birth Defects Prevention Act (first time submission only)
SBR – SB950 Rebuttal or Reconsideration (no data)
SBDR – SB950 Rebuttal or Reconsideration (with data)
SBRA– SB950 Risk Assessment (copy of status sheet and cover letter to reevaluation coordinator)
SBMR– SB950 Additional Data for a requested meeting or for a meeting with Medical Toxicology Branch
SPE – Some Uses Previously Evaluated
V–VOC Reformulation
VF– Statements of formula for individual products in VOC reevaluation
VS– Volatile Organic Content reevaluation (solid)
W–Worker Protection Standards

TOP

SUFFIX CODES (follows the tracking ID#) 

E –Additional Data (used alone or with AB, RM, EPA, and SB prefixes)
EA– Additional Data for Adverse Effects Disclosure under FIFRA Section 6(a)(2) or CCR 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 submission currently in evaluation
EU–Unevaluated Data
N –New Active Ingredient. Active ingredient not currently registered in California.
NC –New Concurrent. (Not EPA registered)

TOP

CHEMICAL CODES

Numerical codes are assigned using the chemical dictionary to identify the active ingredient(s) in each product. These chemical codes are unique to an individual ingredient and are different than the chemical code designated by U.S. EPA as a CAS number. Other identifying variables are also collected in the chemical dictionary. Access the chemical dictionary at (http://www.cdpr.ca.gov/docs/chemical/monster2.htm). For New Active Ingredients, the Intake Technician takes the first volume of data to the designated program specialist for a chemical code if one is not already in the system.

TOP

TYPE OF REGISTRATION 

Registration types	Registration codes
New product registration (FIFRA section 3 registration)	3
Product amendment	3A
Sub-registration (Distributor registration)	3S
Experimental Use Permit (FIFRA Section 5 registration)	5
Experimental Use Permit – amendment	5A
Exemption from registration (FIFRA section 18)	18
Exemption from registration – amendment	18A
Special Local Needs registration – First Party (FIFRA 24(c) registration)	24F
Special Local Needs registration – Third Party (FIFRA 24(c) registration)	24T
Special Local Needs registration – amendment	24A
California Only Registration (e.g., adjuvants)	CA
California Only Registration – amendment	CAL
California Only Registration – Exempt from DPR/U.S. EPA registration	25B

Hereafter; section number only refers the type of registration. The type of registration is identified by the Intake Technician and entered on the status sheet.

TOP

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:

"Adjuvant Only" – Active ingredient only found in registered spray adjuvant products.
"See SB950" – There are SB 950 data gaps for the active ingredient, but not necessarily for all uses.
"See AB2021" – 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.
"Reevaluation: See Denise Alder" – The active ingredient is under reevaluation.
"TGA data required for all new liquid AG and STRUCTURAL products (even AB 1011). Must be signed off by Denise Alder" – TGA data are required for one of seven priority active ingredients. They are abamectin, chlorpyrifos, dimethoate, gibberellins, oxyfluorfen, permethrin, and trifluralin. "Attention: 25b?" – This is an active ingredient on CCR section 6147 exempt list.
"Check chem code" – The chemical code needs to be verified.
"Attention No Food Uses" – First food use of active ingredient. Need to check for tolerance and with Medical Toxicology.
"Route to EM" – Active ingredient has possible groundwater and/or surface water concerns.
"Route to FW" – Active ingredient has fish and wildlife concerns.
"EUP Registration Only" – Active ingredient only registered as a Experimental Use Permit
"Structural: Route to Brandi Martin " – This is a structural device product subject to registration.
"Public Report Needed for End-Use Product" – Have not yet completed a public report on active ingredient.
"Fumigant: Route to Anne Downs" – All fumigant products are handled by Anne Downs.
"RCD Review: See Anne Downs" – Active ingredient is in or has completed risk assessment.
"Never Registered" – Active ingredient never present in a pesticide product registered for use in CA.
"No Longer Registered: – Active ingredient present in inactive pesticide products.

Intake Technicians forward all packages with special attention flags to Eileen Mahoney. If the flags also bear another persons name, Eileen will route the package on to that person. After review, Eileen/other staff will forward non data packages to appropriate RS. Packages with data will be forward to Indexer.

TOP

FOLDERS 

The Intake Technician will prepare a colored tracking folder with the computer generated ID tracking number for each appropriate submission, which will remain with the submission until a final action is taken.

Folder Color	Description
Yellow Folder	EA (Adverse Effects)
Green Folder	3 (Section 3) 3S (Section 3 Sub-Registration) CA (California Only) 25B (California Only, Exempt from Registration)
Orange Folder	3A (Section 3 Label Amendment) CAL (California Only Label Amendment)
Light Blue Folder - (Special Local Needs Registration)	24F (First Party) 24T (Third Party) 24A (Amendment)
Red Folder	18 (Section 18’s, Exempt from Registration) 18A (Section 18 Amendment, Exempt from Registration)
Purple Folder	EC (Additional Data in Support of Conditional Registration)
Brown Folder	5 (Section 5, Experimental Use Permits)
Manila Folder	E Data’s (IR-4, ER, ES, EU) Additional Data
Pink Folder	No (Notifications)

Once the submission has been logged and a status sheet prepared, the Intake Technician will put submission without data in the appropriate RS’s mailbox. Submissions with scientific data will be routed to Indexing. Either action results in DPR’s Tracking Database sending the applicant an automatic email informing them that its submission has been routed to either the RS or to Indexing.

TOP

STATUS SHEET CORRECTIONS 

The information on the status sheet is extremely important and is used throughout the evaluation process, including the 30-day public comment period (posting). The information on the status sheet must be accurate and complete.

Upon receipt of the tracking folder, the RS is responsible for making all needed corrections to the status sheet. Corrections are to be made in the following order:

1. Make the changes on the original status sheet.
2. Make a copy of the status sheet with the corrections highlighted and dated.
3. Submit a copy of corrected status sheet to Intake Technician.
4. Corrections to name of applicant, product or chemical the original status sheet is given to intake and after correction are made give the original status sheet to the indexer who will pull the data from the Registration Resource Center and make the necessary corrections on the data volume(s) and in InMagic.

Correction can be made to a status sheet after a final action has been taken.

PROCEDURES FOR COMPANY REASSIGNMENTS BETWEEN REGULATORY ENVIRONMENTAL SCIENTISTS

The Senior Environmental Scientist will:

1. Reassign the company and provide Pat and Elaine with an email of the company name, firm number and new RS.
2. Within one day of reassignment, instruct the current RS to take all packages submitted by the company (that are to be given to the new RS) to Pat for assignment to the new RS.

Intake Analyst will:

1. Make changes to the electronic workload report.
2. Correct status sheet for all current packages.
3. Distribute corrected packages to the new RS.
4. Provide intake technicians with company reassignment list.
5. Update list when needed

License Analyst will:

1. Change the company database to reflect new RS

TOP

INDEXING

LOG IN 

All data submitted for product registration to the Department is routed through the Registration Branch and recorded both manually and electronically and housed in the Registration Resource Center (RRC).

The manual indexing log consists of the following:

TOP

CATALOGING

A document (volume) number is assigned to each data volume by referencing the first active ingredient listed on the label. The only exceptions are products that contain both new active ingredients and currently registered active ingredients. In this case, the submission is cataloged under the new active ingredient. The numbers are assigned through the In Magic database. After the next available number is retrieved, a new record is created in the InMagic database. The new InMagic record consists of the following:

Document number	Tracking ID number
Applicant	Product
EPA number	Volume content
Page count of volumes	Inventory status

The document (volume) number consists of two parts. The first part is a Resource Center 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.

TOP 

INDEXING

The Indexer is responsible for indexing the data. If a submission is unbound or bound incorrectly it will not be indexed. The Indexer is responsible for contacting the applicant and providing the applicant with an opportunity to resubmit data properly bound. If the applicant does not resend the data properly bound within a three week timeframe the package will be returned and the Data held by the lead Indexer. If the data are not resubmitted the submission will be shredded. A record number is assigned in numeric order to each study submitted. The record number is automatically assigned to each study in the Pesticide Data Index database. The information entered is as follows:

Chemical Code	Document number
Tracking ID#	EPA #
Study Date	Sponsor and /or originator #
Test types	Applicant
Product	Study title
Performing Lab with Study and Report #

For AB or SB submissions a spreadsheet is completed by the Indexer. A copy of the spreadsheet will be routed to the Regulatory Scientist in the appropriate folder and will list the following information:

Record numbers	Report Type
Test types	Study date & organism
Chemical	Tracking ID#
Applicant

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) application for (product)" is included in the study title during indexing.

The Indexer generates an electronic letter and Detail Summary report that are sent via email to the data submitter. A copy of the Detail Summary Report is bound into the front of the first volume of the submission to be used as an index. The Indexer will make a copy of the Detail Summary Report as part of the submission in the folder. Do not remove this report from the submission.

The detailed summary report contains the following:

Applicant name	Product name
EPA registration number	Test Types
Record numbers	Tracking ID number
Volume number	Study title

TOP

DISTRIBUTING THE SUBMISSION

Note: All data submitted with a submission will be routed to the Registration Resource Center.

Once the submission has completed indexing, it is distributed as follows:

ADDING TO EXISTING SUBMISSION

Any data or information being added to an existing submission must first be date stamped and logged in by the Intake Technician who will than forward to the Indexer. This includes data or information that was mailed, hand-carried, faxed or emailed. Indexer will pull data from the RRC or retrieve it from staff person it is checked out to and add new data.

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

DUPLICATE SUBMISSION

There are two situations where this can occur.

–  If duplicate data is submitted, the RS notifies the Indexer to remove it from the indexing system. The duplicate data is then shredded.

–  If a new tracking ID number is assigned to a submission that was actually part of an existing submission, the newer ID number is taken out of the tracking system as a duplicate. The indexer will change all data volumes to reflect the new number and InMagic system.

REPLACEMENT DATA

The RS must take replacement data hand-carried, faxed or emailed to Intake to be logged in. Indexing will catalog and index and route to the RRC.

DATA OWNERSHIP CHANGES

The RS must give a copy of the U.S. EPA data ownership change document to the RRC.

TOP

UNEVALUATED DATA

Any data received that hasn’t gone through the evaluation process is considered unevaluated data. There are two main situations where this can occur.

–  A return that has data in the RRC ready for shedding but determined by the RS supervisor to be retained (see instructions under Return section).

–  Data submitted for a submission posted 30 days to Deny and all the deficiencies were not met, and the submission will be posted Final to Deny (see instructions under Resubmission-Data Received During Posting 30 Days to Deny).

RETURNS

RETURNING A DEFICIENT SUBMISSION.

If a submission is deficient and cannot be processed further, a letter is written describing deficiencies and mailed to the applicant and the submission sent to the Intake Technician: The submission is assembled in the following manner:

The RS will:

The Senior Environmental Scientist will:

The Intake Technician will:

1. Take final action by entering tracking ID# and date of the return letter into electronic tracking database this removes the tracking ID# from the system and RS workload report.
2. File the submission on return shelf and generates a weekly electronic return log and route to the Registration Resource Center.

RECEIPT OF A RETURNED SUBMISSION

Based on the initial return date, if all items have been received according to the return letter no additional fees are required. If submission received has only part of required items stated in the return letter it is returned again. When returning a submission more than once the original return date is used to base the six months from and determine if additional fees are needed. The submission is processed in the following manner:

The Intake Technician will:

1. Pull return from return shelf
2. Determine if additional fees are required by checking original date of return letter to the new information received date. If new information is received passed the six month time frame complete money memo to RS.
3. Pull return from electronic database by selecting Intake Routing menu than select pull option.
4. Select Product Intake menu to create new ID#. At menu screen enter mail ID# and prior ID# all other information is already retrieved, just enter new arrival date.
5. Attach new information and status sheet on top of the returned information inside the folder. Attach new ID# sticker over old ID# on the folder
6. If previously returned status sheet listed data or new data is submitted forward submission(s) to the Indexer and note prior ID # that had data. If previous and new submission contains no data forward to the RS.

The Indexers will:

1. For all submissions which were previously returned and which have data (new or old) change records to reflect the new ID#, for data already housed in the RRC line out the old ID# and add new ID# to the volume(s) and update InMagic.
2. Route submission to RS.

SHREDDING RETURNS SHELVED OVER SIX MONTHS

If the applicant fails to submit the required documents within the six month time frame or pick up the returned submission, the following procedures will be followed.

The Return Technician will:

1. Prepare two shred lists one for RS and one list for the Intake Technician to track all ID numbers being shredded.
2. The RS will review the list and check the box next to those packages that should be shredded. The RS will return the list to the Return Technician within 5 business days from receipt.
3. Return Technician will route any submission containing data identified for shredding to the RS’s supervisor for review. The supervisor will decide which data should be shredded and which data should be retained.
4. Input the appropriate information into the electronic tracking system and shred the paperwork. All data determined by supervisors to be shredded will be routed to the Indexer who will pull data from the RRC and shredded.
5. Data determined by the supervisors to be retained, will be pulled from the RRC by the Indexer and given a separate ID# with an EU (unevaluated data) suffix.

The Indexer will:

1. Ensure that all data volumes are present.
2. Remove the volume number(s) from the system by deleting record numbers from Pesticide Data Index Database. A corresponding list will be emailed to the Resource Technician for removal from the InMagic database.
3. Shred the data.

TOP

EVALUATION TRACKING

PACKAGE ORGANIZATION

Packages requiring scientific evaluation should be prepared by the RS, and forwarded to the Evaluation Tracking Technician in the following manner:

The RS will:

1. Clip to outside of tracking folder Original status sheet/route sheet (back-to-back copy, for RS binder) with evaluation stations checked and highlighted. Evaluators’ comments and recommendations will be recorded on this copy. One copy of the proposed product label with the ID# written in the upper right-hand corner, (With the exception of submissions for additional data E, EC, EA, resubmission or a Section 18). This becomes part of the Materials Entering Evaluation (MEE) list and is forwarded to PREC committee members.
2. Clip to inside of folder A copy status sheet/route sheet with all evaluation stations indicated. All pertinent information including proposed label and U.S. EPA documentation.

NOTE:
See section on new active ingredients for routing.
See section on non-substantive changes for routing.

TOP

LOGGING INTO/ROUTING THROUGH EVALUATION

The Evaluation Tracking Technician will:

1. Log the ID# and check routing stations into the Pesticide Registration Tracking database.
2. Attach a colored tag to the package indicating the type of registration.(listed below). Tag includes RS initials, received date and ID#
3. Place the copy of status sheet/route sheet located outside the tracking folder into the RS binder. This binder is used to record the evaluator’s comments as the submission enters and exits each station.
4. Retain the label copy clipped to the outside of the tracking folder (with ID# on it) for the mid-week report called Materials Entering Evaluation (MEE Report). This list is forwarded to members of the Pesticide Registration and Evaluation Committee (PREC).
5. On the copy of the status sheet/ route sheet that remains with the tracking folder, record the date submission enters the first evaluation station and route to that station. Repeat the step each time the submission is routed to another evaluation station.
6. Upon return of submission from an evaluation station, record the date it was completed, evaluators comments and decision on copy of the status sheet in RS binder. Do this for each station.
7. Attach the original evaluator’s memo (there will be three copies) to the tracking folder, attach one copy to the status sheet in the RS binder, place one copy in the appropriate RS mailbox.

Submissions should be delivered to evaluation stations on a daily bases.

The list below identifies the different color tags and folders associated with different types of registrations.

TOP

NEW ACTIVE INGREDIENTS - SPECIAL INSTRUCTIONS

Submissions of pesticide products containing active ingredients not found in any currently registered pesticide product in California are identified by the Intake Technician as “New Active Ingredients” (new ai’s).

The evaluation routing process for new active ingredients is not the same as for non-new active ingredient submissions. New active ingredient submissions are routed simultaneously to each evaluation station (Status sheet/route sheet, application form, label, correspondence, and Detail Summary Report from indexing). A copy of the evaluation submission is also maintained in the new AI evaluation tracking station binders. The documents are filed alphabetically by company and then by tracking ID#.

The new active ingredient Program Specialist will prepare the submission for evaluation by assembling the submission in the following order:

1. Status Sheet/route sheet with the evaluation stations highlighted
2. Application
3. Label
4. All other pertinent information such as U.S. EPA documentation
5. Correspondence
6. Detail Summary Report
7. MSDS
8. Make extra copy of submission for reference volume in Pesticide Resource Center

An extra copy of the above information is maintained in a reference volume in the Registration Resource Center for evaluation scientists to review, if necessary.

The New AI Tracking Technician will:

1. Make copies of the submission for each designated evaluation station and retain the original for the Program Specialist binder to record comments and concerns.
2. Enter ID# and routing station(s) information in the Pesticide Registration Tracking database using http://registration/track/intakeindex and choosing Routing and Tracking Actions screen.
3. Attach a pink tag with ID# date received and Program Specialist initials on it to the folder.
4. Deliver submission to designated scientific stations.

Upon each evaluation station completions

The New AI Tracking Technician will:

1. Enter evaluator’s decision in Pesticide Registration Tacking database using http://registration/track/intakeindex and choosing New AI Decision screen.
2. Remove tag and any paperwork from the status sheet/route sheet and evaluators memo. Place status sheet/route sheet and memo in the Program Specialist binder. Shred any confidential paperwork and recycle remaining paperwork.
3. Route copy of memos, one to the Program Specialist, one copy remains with submission in Specialist binder, original route to Resource Center for ai reference volume.
4. Route binder copy with all the evaluation packets (status sheet/route sheet, evaluator’s memos) using http://registration/track/intakeindex choosing Routing, Tracking Actions screen to the EPM I for signature.
5. Record EPM I decision in Pesticide Registration Tracking database using http://registration/track/intakeindex choosing Routing, Tracking Actions screen, enter decisions and route package to Program Specialist.

Note:  If decision is “do not register” or conditional from any of the evaluation stations, a copy of the memo is routed to the EMP I & II.

NONSUBSTANTIVE CHANGES - SPECIAL INSTRUCTIONS

Certain label and formula changes do not require data or scientific review, but cannot be processed as a “File as Latest” submission. These are processed as Non-substantive changes.

The RS will:

1. Submit submission in tracking folder to Evaluation Tracking Technician
2. The original status sheet with correct information
3. The route sheet with evaluation station selected and any special instructions for designated Environmental Program Manager I (EPMI)
4. Check and highlight the non-substantive change box
5. The proposed label or if applicable, proposed confidential statement of formula (CSF)
6. Copy of U.S. EPA stamped approved label or CSF.

The Evaluation Tracking Technician will:

1. Enter the information into the Registration Tracking database.
2. Forward the submission to the designated Staff ES for microbiology, and the Senior ES for chemistry

The Staff/Senior Environmental Scientist will:

1. Review the amendment and determine whether the change is in fact nonsubstantive.
2. Note decision on status sheet and initial and date.
3. Return submission to Evaluation Tracking.

Environmental Program Manager I (EPMI):

1. Determine if the submission can be approved as a non-substantive change, without further scientific evaluation
2. Sign off and return to the Evaluation Tracking Technician

If the submission is not approved as a non-substantive change, the Evaluation Tracking Technician will return the submission to the RS and they will determine if the submission should be returned or submitted for scientific evaluation.

ADDITIONAL DATA – VARIOUS E SUFFIXES

Upon completing the evaluation process, and receiving the signature of the designated EPMI, “E” submissions (with exception of ES and EU) will be “Miscellaneous Out” by the RS on their weekly action log and archived.

See special instruction below for Supplemental Data (ES).

Data submissions with an 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, must be processed in a timely manner.

All data will be housed in the Registration Resource Center.

TOP

SUPPLEMENTAL DATA SUBMITTED WHILE A PACKAGE IS IN EVALUATION – ES Suffix

Note: All Supplemental Data submitted to the Department (ES suffix) Must be Processed and routed by the Intake and Evaluation Tracking Technician. There are No Exceptions.

When data are received for a submission currently in an evaluation station, but not yet posted for the 30 days comment period, it is assigned an ES suffix and referred to as “Supplemental Data.” The Intake Technician notes this on the front of the original status sheet and includes the tracking ID# of the original package. The package is forwarded by the Intake Technician to the Indexer who will processes the data and route it to the Registration Resource Center, forward a copy of the Detailed Summary Report and status sheet/route sheet to the Evaluation Routing Technician

The Evaluation Tracking Technician will:

Locate the original submission

1. Add the new volume number(s) to original status sheet and to the RS binder copy. Staple a copy of the original status sheet to the ES status sheet and place in the ES file.
2. Contact the RS for instructions on routing to the appropriate evaluation station(s).
3. “Miscellaneous Out” the ES number in the Tracking database.

If, in rare instances, an ES submission 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 submission, the Evaluation Tracking Technician changes the ES suffix to an E suffix and takes submission to the Indexer. The Indexer gives the corrected submission to the RS and routes data to the RRC.

This includes all ongoing and New Active Ingredient submissions.

TOP

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. The company requests a withdrawal of the submission before the evaluation is complete.
2. The RS determines a need to remove the submission before the evaluation is completed.

RS will:

1. Post final to deny on action log with comment at bottom stating the company requested withdrawal.

Posting Technician will:

1. Add ID number and comment to the posting.

EVALUATORS' CONCERNS MET (WITHOUT FURTHER EVALUATION)

If an evaluator’s concerns are met either before or after the 30-day public posting period, but before a final action is taken.

The RS can address the concerns by doing the following:

1. Prepare pinky describing how evaluator’s concerns were met. This document must be signed by a supervisor. Make two copies of the pinky. The original is attached to the RS Action Log which is filed in a binder containing all Tracking Documentation Memos. Both copies remain with the package.
2. Forward the submission to the designated Environmental Program Manager I for recommendation/signature on the status sheet/route sheet.
3. Forward the submission to the Evaluation Tracking Technician.

Note: In lieu of the above, the RS can submit the submission back into evaluation for approval.

The Tracking Technician will:

1. If posted 30 days to deny, route the submission as a resubmission (so posting action can be taken) See instructions on resubmission below.
2. Retain one copy of the “pinky” for the RS binder copy, input the necessary information into the database and return the entire submission to the RS.

TOP

RESUBMISSION AFTER OR DURING 30-DAY POSTING:

If data or information is received during 30-day-posting the Intake Technician identifies this and retrieves original submission from the RS.

For information only, submission goes back to the RS. If data is submitted the Intake Technician will route the data and submission to the Indexing Technician.

Indexing Technician will:

1. Will catalog and index the new data, add the new volume number(s) to the original status sheet.
2. Return the submission with a Detailed Summary Report of the new data to the RS.
3. Route the data to the RRC.

Note: The RS cannot add to or subtract data volumes from a submission. This can only be done in Indexing.

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 submitting the data) not the applicant it is submitted for. The statement: “submitted to support (company) application for (product)” is included in the study title during indexing.

RE-ENTRY OF SUBMISSION INTO EVALUATION BEFORE POSTED FOR 30 DAYS

RS can submit a submission back into an evaluation as needed. This occurs when the submission has exited the evaluation process, but is not yet posted for 30 days comment. A “Pinky” is not needed.

This process is different from a Resubmission that occurs during the 30 to Deny public comment period.

RESUBMISSION – DATA RECEIVED DURING POSTING 30 DAYS TO DENY

Data received for a submission posted 30 Days to Deny is not given a tracking ID# or a status sheet. Instead, the Intake Technician retrieves the submission from the RS and forwards it along with the newly submitted data to the Indexer.

The Indexer will:

1. Catalog and index the new data, add the new volume number(s) to the original status sheet.
2. Return the submission with a Detailed Summary Report of the new data to the RS.
3. Route the data to the RRC.

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

The RS will:

1. Take the original submission with the new information to the Evaluation Tracking Technician, with the evaluation station(s) indicated and the new volumes of data noted on the status sheet.

The Evaluation Tracking Technician will:

1. Enter new receipt date generating a new target date.
2. Route submission to the appropriate evaluation station(s).

If the new data or information doesn’t meet all deficiencies listed in proposed to deny letter, the following steps are taken:

The RS will:

1. Take the Final Deny action
2. For data submitted, inform the Intake Technician to add EU suffix and prior ID to the newly received unevaluated data to the tracking database and give Indexing a copy of corrected status sheet for newly received unevaluated data.
3. Prepare submission for archiving and prepare a Tracking Documentation Memo (pinky) signed off by their supervisor.

Indexing will:

1. Change record information in InMagic

In most cases new data is assigned a new volume number. If a correction or additions to an existing study are inserted into an existing volume, the Indexer flags with a sticky note the inserted data for easy identification by the evaluator. The Indexer may receive the corrections and additions from either the RS or the Intake Technician.

TOP

TRACKING DOCUMENTATION MEMO (Pinky)

Tracking Documentation Memos (pinkies) allow support staff to take an action in the database that is in conflict with established policies and procedures. The memo must be signed by a Senior Environmental Scientist (supervisor) or the Branch Chief depending upon the action being requested, indicating to the support staff member that the action has been approved. The form is available online in the Z drive (under Computer/templates/REG Forms/wordtemplates/Tracking_Doc_MemO_Pinky on "dprhq01eros").

The following situations require a Tracking Documentation Memo:

1. An evaluator’s requirements are met due to receipt of new information and the submission does not have to go back to the evaluator for verifications.
2. Applicant requests withdrawal of a submission after it has entered evaluation. The RS posts the submission Final to Deny. On the posting, state reason for denial as “application withdrawn by applicant”.
3. Submission is withdrawn from scientific evaluation process before the process was completed, for reasons other than “withdrawn by applicant”, state reason.
4. The submission received a negative recommendation from an Evaluation Scientist’s, but the package is listed on action log as proposed for registration. Additional information or data may or may not have been received. THE BRANCH CHIEF MUST SIGN OFF.
5. Scientific evaluation is not yet completed, but submission is being posted for the 30 days public comment period. THE BRANCH CHIEF MUST SIGN OFF.
6. Certain unevaluated data will be archived. Confirm this with the Environmental Program Manager I. (See section on Archiving Unevaluated Data)

The RS will:

1. Prepare a Tracking Documentation memo (pinky). Complete each section, including a concise description of the action being taken and the reason. Send the draft as an email attachment to their Senior Environmental Scientist (supervisor).
2. Print the approved draft on pink paper for signature by the Senior Environmental Scientist
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, two copies and the submission to the Evaluation Tracking Technician. The designated Environmental Program Manager I signs off on the recommendation line of the route sheet. If it involves both a positing decision and scientific evaluation, give the original pinky to the Tracking coordinator (posting) and give the copies along with the submission to the Evaluation Tracking Technician.

TOP

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.
The RS will “See Desk manual for Instructions”:

The Licensing Technician will:

1. Prepare the appropriate registration letter for the RS signature. If the product is being registered conditionally, the RS 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 product(s). Make 4 copies (5 if conditionally registered) and a yellow surname copy. The original will be sent to the company, the yellow surname copy will be sent with the package to the product file, one copy will be distributed to coding, one copy will be placed with the cover letter, one copy will be placed in the Licensing Conditional Binder (if applicable), and one copy will be sent to the RS.
2. Verify that there is an original RC# on the application form and that the application fee has been processed. The RC# can be recorded on the application only by the licensing Technician. For an “interim” registration, verify that the $5000 fee is paid.
3. Prepare the Certificate of Registration (license). The license expires on December 31. For an “Emergency Section 18” registration, the expiration is one year from the date of issue
4. For Master Labels the product name should be preceded by the words Master Label and the alpha code will be ML. For example, the license and letter will read (Master Label-Deer Away, EPA Reg. No. 223-23-ML) on the license will look like: Master Label-product name. On the letter it will look like: (Master Label-Deer Away 223-23-ML)
5. For a company name change, issue a new license to supersede the old name. Write the old firm name on the license in the licensing binder with the words “Amended,” the date of issuance, and the company name change to . . .
6. Reinstatement of a product is only allowed after one calendar year and requires $750 registration fee and an additional $150. After a year it must be submitted as a new product.
7. Assemble the package to be sent to the specialist in the following order:
   • –Original letter
   • –Original license
   • –Yellow surname copy of the letter
   • –Coding documents (already prepared by RS) with a copy of the company letter on top and stapled together
   • –Product file documents (already prepared by RS)
   • –Cover letter document(s) (prepared by RS) with a copy of the company letter on top and stapled together.
   • –A copy of the company letter to be sent to the specialist
   • –A copy of the company letter to be placed in the Conditional Binder
   • –A copy of the product license to be placed in the Conditional Binder
   • –Place package in the RS mailbox

Once the package has been signed off by the supervisor and placed in the licensing in-box, the Licensing Technician will complete the following:

1. 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.
2. Forward a copy of the license, the yellow surname copy of the letter, and the documents marked “product file” to the Label Resource Center.
3. Forward the documents marked “coding” to the coders with a copy of the DPR cover letter.
4. Place a copy of the license, cover letter, and conditional evaluation report(s) (provided by the RS) in the Conditional Binder.
5. Forward a copy of the cover letter marked “cover letter file” to the designated Office Technician for filing.
6. Place a copy of the license in the appropriate company binder.
7. 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.”

TOP

RENEWALS & RENEWAL PROCESS

A pesticide product’s Certificate of Registration (license) expires on December 31st of each year. The Licensing Technician processes all renewals.

In mid October of each year, the Licensing Technician mails each registrant an Application for Renewal form that lists each of the registrants currently registered pesticide products.

The registrant is required to:

1. Line out the names of any products they do not wish to renew the registration of for the following year.
2. 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 that sell the product at cost.
3. Submit a report on the status of any conditional registrations (send to RS). A product will not be renewed if the registrant has not complied with the conditions placed on a product’s registration.

If any of the following occur, the Licensing Technician routes the information to the RS.

1. The application for renewal shows a change in firm name, altered brand name, altered registration number, or additional brand name.
2. The renewal form is accompanied by an annual progress report in accordance with a conditional registration.
3. Regulatory action against the product is being taken by DPR.

Once the records are verified by the RS and returned to the Licensing Technician a Certificate of Registration will be issued listing the products registered for the current year. The Licensing Technician verifies the certificate for accuracy, distributes copy to the licensing binder, and mails the original to the registrant.

Penalties for late Renewal
If the registrant’s Application for Renewal is not postmarked within one calendar month after expiration of the Certificate of Registration (license), a penalty of $150 per product is charged.

Exception: A penalty is not collected if the Application for Renewal is accompanied by an affidavit that no business was done during the period of non-registration.

Non-Renewal of Product Registration
Non-renewal of a product registration can occur for any of the following reasons.

1. The applicant deletes a product(s) from their Application for 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 registration.
4. The product is no longer U.S. EPA registered. Generally DPR allows a product to remain registered for two years past the lapse in federal registration, unless registration is specifically prohibited by cancellation/suspension.
5. DPR regulatory action, such as cancellation.

VOLUNTARY CANCELLATION MID-YEAR

A company may request to voluntarily cancel the registration of one or more of its pesticide products during the calendar year (prior to the renewal period).

The registrant must send a written request to the Licensing Technician or the RS using DPR’s Voluntary Cancellation Form, which can be found on-line at http://www.cdpr.ca.gov/doc/regforms/cancel/volcance.pfd. The written request must include a waiver of their right to a hearing or it cannot be processed. It can be mailed, emailed or faxed, followed by a hard copy.

If received by the RS, it’s forwarded to the Licensing Technician with instructions to issue a Supplemental Certificate of Registration (license) showing deletion of the product(s).

The Licensing Technician will:

1. Prepare an amended Certificate of Registration deleting the product(s). If the registrant does not request a specific cancellation date, the date of the request letter is used.
2. Prepare the appropriate license letter.
3. Give the documents to the RS for signature and surname by Senior Environmental Scientist (supervisor), who will forward the documents to the Licensing Technician.
4. Update the label file database to indicate “voluntary cancellation” as the reason for inactivation.
5. Line out the brand name and registration number on the main Certificate of Registration (license) and write, “ Amended, voluntary cancellation”, and date of issuance.
6. Forward the Supplemental Certificate of Registration (license) and other information to the Label Resource Center.
7. Forward a copy of the Supplemental Certificate of Registration (license) to the Enforcement Branch.

CODING

All new pesticide products must be routed to the Coding Technicians for entry into the Product Label Database, which is used by DPR’s Enforcement Branch, County Agricultural Commissioners, and the general public.

The RS will:

Route copy of cover letter, status sheet, application to include CSF, memorandum of registraton on blue paper, and label to the coders.

The Coding Technicians will extract the following information for inclusion into the Product Label database:

1. Registration Number
2. Registration Type
3. Signal Word
4. Formulation
5. Application Method
6. Pesticide Type
7. Health Hazard
8. Environmental Hazard
9. Target Pest
10. Special Instructions
11. Chemical Information
12. Site Information

All completed coding packages for new pesticide products are to be returned to Coding Analyst . Coding Analyst will pull all packages with a blue or green AB 1011 Memorandum of Registration and forward to Indexing Analyst. Indexing Analyst will check to see if product is for ag, structural or turf use, look up product numbers (AKA prodno) used to register main product. Search TGA table for main product and enter the supporting product(s) prodno.

TOP

LABEL REVISIONS SENT TO CODERS

Certain types of label revisions or amendments to currently registered pesticide product must also be sent to Coders for entry into the Product Label database.

The RS will send:

1. Copy of the DPR cover letter.
2. Copy of the label with only the revisions that pertain to coding highlighted (If the label is not highlighted correctly, coders are to return the label to the Lead SSA for Intake).
3. Copy of the status sheet
4. For formula revisions, 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

Once a final action is taken, all registration requests (and additional data submissions) must be archived to the Resource Center. The RS must take the final action on their weekly action log prior to archiving and the submission must be archived promptly following the final action. The RS prepares the package as outlined below and gives it to the Archiving Technician who forwards it to the Registration Resource Center.

All submissions undergoing scientific evaluation (including non-substantive changes) are archived to the Registration Resource Center. These include submissions with or without data.

The RS will:

1. Take a final action on the submission
2. Assemble all relevant documents (outlined in the Desk Manual) – clipped and rubber.
   1. Original copy of the status sheet and route sheet with the evaluator’s reviews and the recommendation of the Environmental Program Manager I.
   2. The scientists’ evaluation reports in reverse chronological order. Include the Medical Toxicology evaluation worksheets with the toxicology memos.
   3. A 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 information pertaining directly to the data submission.
3. Route the submission to the Archiving Technician.

A submission without data will consist of:

1. The status sheet/route sheet with evaluators’ reviews and Environmental Program Manager I recommendation.
2. The evaluation reports.

Note:  The Archiving Technician and the Registration Resource Center staff no longer accept any other paperwork, such as labels or company correspondence. The RS may keep the remaining items for their files.

The Archiving Technician will:

1. Remove submission from folder and remove any tags.
2. Pull RS binder copies from file located in room 3-10. Verify the information on the status sheet/route sheet and match with the original status sheet/route sheet.
3. Assemble the binder copies of the scientists’ evaluation reports; in reverse chronological order with the status sheet/route sheet on top, (these will be filed in completed binders housed in the Registration Resource Center.)
4. Take the archive action in the tracking system (.http://dprweb/cfdocs/apps/track/intakeindex.cfm)
5. Generate an archiving list (At the Registration home page choose Tracking System Report, Packages Archived to Resource Center (select date range, this would be date of last report to current date.)
6. Cart the packages and archive list to Registration Resource Center.

The Resource Center Staff will:

1. Make sure there are two complete sets of documents (evaluation reports, status sheet/route sheet, data if applicable) one original and one copy.
2. Pull and insert the original documents into the first data volume listed on the status sheet.
3. Insert the copy of original documents into the completed binders.

One set of data to support multiple products:

When one set of data was used to support the registration for multiple products with multiple tracking ID numbers, the Registration Resource Center staff will insert the appropriate documents, including the original status sheets and memos (evaluation reports) for each tracking ID number, into the first volume of data listed on the status sheet. The Resource Center staff also ensures that each product with a tracking ID number has a complete set of relevant documents to file in the completed binders.

ARCHIVING UNEVALUATED DATA

The following are special situations where unevaluated data can be archived to the Resource Center. In some cases a pinky is prepared as indicated in the Tracking Documentation Memo (pinky) section.

Pinky Required

1. Only some of the requested data in a Proposed Deny letter was received before the Final Deny action was taken and the data will not be evaluated at this time. The signed pinky are given to the Intake Technician who will create a new status sheet with “EU” suffix, “Miscellaneous Out” the ID#, stamp data “unevaluated”, initial and date. Forward a copy of the status sheet to indexers to correct records in InMagic and on data volumes in the RRC.
2. A return package is being shredded, but in rare cases the scientific data will be archived. The signed pinky are given to the Intake Technician. The remaining paperwork is shredded. The data are given a separate ID#, with “EU” suffix. The Intake Technician will “Miscellaneous Out” the ID#, stamp the data “unevaluated” and initials and date. Then route the new status sheet to Indexers to fix the records and InMagic and on data volumes in the RRC.
3. Additional data is received that is not associated with a registration request and scientist determines it will not undergo the scientific evaluation at this time. The RS provides the Intake Technician a signed pinky who gives the submission a ID# with “EU” suffix and takes the “Miscellaneous Out” action, stamp data “unevaluated” initial and date. The Intake Technician than routes the submission to the Indexer to fix the InMagic records and add new ID# to data in RRC.

No Pinky Required

1. Application for registration or amendment, which is accompanied by data, and RS, determines that all product label claims were previously approved (AB1011). Upon receipt of a submission with Previously Evaluated “PE” prefix.
   
   The RS will:
   1. Notify Intake Technician to create a status sheet with an EU suffix.
      
      
   The Intake Technician will:
   1. Go into Chemical Intake screen
   2. Enter mail log # from original status sheet
   3. Choose EU suffix
   4. Enter original ID # to the product name
   5. Enter chem. Code(s)
   6. Insert
      DO NOT CHANGE ANY DATES