Chapter IV
LABEL OR FORMULATION CHANGES

A. INTRODUCTION TO LABEL OR FORMULATION CHANGES

B. TYPES OF PROCEDURES FOR LABEL CHANGES OR FORMULA CHANGES

1. Label Amendments (Formula Changes or Changes Requiring Conditional Registration) Requiring Data and Possibly Requiring Scientific Evaluation

2. Non-Substantive Changes

3. File As Latest (FAL) Minor Changes to the Label or Formula

4. DPR Notification Process for Certain Minor Changes

5. FIFRA 2ee Statements

Appendix IV-1 First Aid - Statement of Practical Treatment Form
Appendix IV-2 DPR Notification Form

Chapter IV

LABEL OR FORMULATION CHANGES

A. INTRODUCTION TO LABEL OR FORMULA CHANGES

This section contains instructions for label changes and for formula revisions to currently registered products including the following:

• Label amendments requiring data and possibly scientific evaluation.

• Non-substantive changes.

• Minor changes processed as a "File as Latest" (FAL).

• Minor changes processed through the DPR Notification process.

• Minor changes not requiring notification to DPR.

Note: Due to the passage of AB 1011, the Department may rely upon the evaluations of previously submitted data, regardless of data ownership, to support amendments to pesticide products (use sites, pests, precautionary language, etc). We no longer require a letter of authorization. If a letter of authorization is submitted, it should be included with the package sent to the Label Resource Center, but is no longer considered a legal document. It will be treated as correspondence.

The Registration Specialist will:

• Compare the submitted label or formula revision to the currently registered label or formula.
  
  
• Highlight the revisions, if the applicant has not done so.
  
  
• Determine if the label or formula change should be processed as a File as Latest (FAL), a non-substantive change, or as a label amendment requiring data. If data are required, the next step is to determine if any of the amendments were previously approved on another pesticide product or if the amendment is unique. Review the cover letter submitted by the applicant and follow the steps listed below:

  - If the applicant has identified a "previously approved product" (or products), the registration specialist will obtain a copy of the cited product(s) label(s) and the csf(s) where applicable.

  - If the applicant has not identified a "previously approved product(s)," the registration specialist will attempt to identify one or more previously approved products containing the same a.i.(s) and bearing the same or similar uses as the proposed label amendment.
  
  Compare the proposed amended label (and/or csf where applicable) with the previously approved product label(s) (and/or csfs) and determine whether the proposed amendment was "previously approved."
  
  If the specialist needs assistance in making this determination, they should consult with a scientist from the relevant review station(s).

  - If all amendments were previously approved by DPR, add a "PE"* prefix to the hard copy of the status sheet. Make a copy of the amended status sheet (sign and date the change) and place in the intake technician's box.

  - If some of the amendments were previously approved by DPR, add an "SPE"* prefix to the hard copy of the status sheet. Make a copy of the amended status sheet (sign and date the change) and place in the intake technician's box.

  - If the applicant submitted or referenced data to support the non-previously approved amendment(s), fill out the tracking sheet and route the submission to the appropriate evaluation station(s). The specialist must identify all non-approved amendments either on the tracking sheet or by highlighting the novel uses on the proposed product label so that the evaluation scientist understands what needs to be evaluated. A copy of the applicant's cover letter should also be included.
  
  Note: the document numbers listed on the tracking sheet are intended to be a reference point for the evaluator. The evaluator may choose to reference any data on file with the Department to support the amendments. The documentation should not identify the brand name(s) or EPA Reg. No.(s) of the previously approved product(s).
  
  If the specialist finds that none of the proposed amendment(s) were previously approved by DPR, no prefix will be added to the ID#. If the applicant submitted or referenced data to support the amendment, the specialist will fill out the tracking sheet and route the package to the appropriate evaluation station(s). The specialist must identify all changes, either on the tracking sheet or by highlighting the proposed product label so that the evaluation scientist understands what needs to be evaluated. A copy of the applicant's cover letter should be included.
  
  If the applicant did not submit or reference data to support all non-previously approved amendments, and the registration specialist cannot locate any data on file that could be referenced, the submission should be returned. Please see the return section in "Intake through Archiving."

Label changes must be submitted to, and found acceptable by DPR before the labels are released for sale. Minor changes submitted through the DPR Notification Process are directed to the designated Technician.

Note: If U.S. EPA assigns a new EPA Reg. No. due to a formulation change, it is considered a new product. Follow the procedures in Chapter V and if applicable, Chapter III.

Use Chapter II to determine any special label elements.
The most current DPR approved label or formula becomes the latest registered label or formula. It is permissible to have an alternate formula or alternate label (for example supplemental labeling) in the Label Resource Center product files.

The most current DPR approved label or formula becomes the latest registered label or formula. It is permissable to have an alternate formula or alternate label in the Label Resource Center product files.

B. TYPES OF PROCEDURES FOR LABEL OR FORMULA CHANGES

1. Label Amendments (or Formula Changes) Requiring Data and Possibly, Scientific Evaluation

Some label or formula changes require the submission of data. If the amendment(s) has not been previously approved by DPR on one or more pesticide product labels, scientific evaluation may be required. Examples of label amendments requiring data, include, but are not limited to:

• Addition of a crop or a use site.
• Addition of indoor use.
• Adding the first agricultural use for the active ingredient.
• Adding pests or types of pests not already on the label.
• Reducing the signal word or the precautionary statements.

A $100 application fee, regardless of whether the registrant submits data or the amendment is submitted into evaluation, must accompany label amendments or formula revisions that require scientific data. This includes subregistrants who submit label amendments to include label language that has already been approved on the basic's California label.

If U.S. EPA requires the applicant to submit an application for amended registration, they will stamp the accepted label and include an accompanying letter. The registrant is required to submit this label and letter to California when amending their product label. For a change in formulation, U.S. EPA will only send a letter of acceptance to the company. This letter must be submitted to California for a formulation change.

DPR requires the applicant to send a copy of the U.S. EPA approval, 6 copies of final or printer's proof labels, and any required data. In lieu of submitting data, an applicant may reference appropriate data previously submitted to DPR, regardless of ownership, or a pesticide product(s) previously approved by DPR that would be subject to some or all of the same data requirements. Applicants are directed to highlight label changes and provide a detailed description in their cover letter. See Chapter VI on Data Requirements and Chapter III on Selecting Evaluation Review Stations.

For formulation changes:

• If the percent of active ingredient stated on the label is decreased and the rate of application not adjusted accordingly, the specialist should follow the steps listed above to determine if the package needs to be routed to the appropriate Evaluation Scientist to determine if the product is still efficacious.
  
  
• If the percent of active ingredient stated on the label is increased and the rate of application not adjusted accordingly, there are a number of areas to consider. The applicant should submit a justification for increasing the amount of active ingredient. The increase in active ingredient may require phytotoxicity or toxicology data. The reg. specialist should follow the steps listed above to determine if the package needs to be routed to an Evaluation Scientist

When the label amendment or formula revision is found acceptable, the Registration Specialist will:

• Write a letter to the company accepting the label amendment or formula change. The correct and full company name must be on the letter. If a formula revision, identify in the subject line the date the CSF was signed by the approving official or the date of the application if the company submitted a Product Formulation Sheet. Do not include a copy of the CSF or Product Formulation Sheet. The Department does not allow the release of the original or printed copies of these documents, even if requested by the basic registrant. Print an envelope with the appropriate company information on it. If there are more than 7 pages to be sent out, you must use an 8 1/2" by 11" or 6" by 9" envelope. Preparation of this is the responsibility of the Registration Specialist.
  
  
• Stamp three labels for distribution to the product file, coding, and the company. The Registration Specialist may retain an additional copy for their file.

• For the product file, clip together the yellow surname copy of DPR letter (to be placed on top) and stamped label. Write "product file" on the upper right corner of the letter and the label.

• For cover letter file, staple a copy of the DPR letter to the company and the cover letter submitted by the applicant. Write "cover letter file" on the upper right hand corner of the letter copy.

• Record the tracking ID # on the weekly action log. If the amendment went through scientific evaluation, record in the proposed to register or proposed to deny column; whichever is appropriate. If the amendment required data, but didn't require scientific evaluation, record in the "Amendment w/o Notice" column.

• Clip together the individual sections listed above (company, product file, coding, cover letter) and submit to your supervisor. Do not include the brown folder.

For Amendments Requiring Conditional Registration:

If a registrant makes an amendment to a label that warrants the revision of a product license to reflect a conditional registration, the specialist will prepare the following:

1. A letter to the company using the label amendment form letter, a copy of the conditional evaluation memo, and an addressed envelope. The letter must be modified to indicate that the product will be conditionally registered, specify the conditions and time frames, and include a cc to Licensing.

2 A yellow surname copy for the file.

3. A copy of the form letter with the word "licensing" written in the upper right hand corner, and a copy of the conditional evaluation memo attached. This letter will indicate to Licensing that a new conditional license needs to be produced. The letter, license, and evaluation memo will eventually be placed into the Conditional Binder.

4 A copy of the form letter with the specialist's last name written in the upper right hand corner.

5. If necessary, a copy of the form letter with "coding" written in the upper right hand corner. Licensing will generate the license (4 copies) and return the package to the specialist. The specialist will then prepare and submit the package to their Supervisor for sign off.

The surname copy received by the Label Resource Center will be placed in the product file and the word "conditional" written in red on the front, top portion of the application.

2. Non-substantive Changes

Some formula changes do not require data or scientific review, but cannot be processed as an FAL. These are processed as non-substantive changes. The following are examples of non-substantive changes:

• Minor revision or restatement of an ingredient on the CSF.
• Moving an ingredient listed as active to inert on the CSF.
• Change of percentage of active ingredient to the nominal concentration on the CSF.

The Registration Specialist submits the package to the Evaluation Tracking Technician who forwards it to the designated Program Supervisor. The Program Supervisor determines if the request can be considered nonsubstantive and can be approved without further evaluation.

• If the formula change is confirmed to be non-substantive, the Registration Specialist completes the approval by approving the change in formula). The registration action is not posted for the 30-day public comment period.
  
  
• If the change is determined to be substantive, the Registration Specialist will process the request as listed above in the Label Amendments (or Formula Changes) Requiring Data, and possibly, Scientific Evaluation section. If the amendment went through scientific evaluation, record in the proposed to register or proposed to deny column; whichever is appropriate. If the amendment required data, but didn't require scientific evaluation, record in the "Amendment w/o Notice" column. If the applicant did not submit or reference data to support substantive non-previously approved changes, and the registration specialist cannot locate any data on file that could be referenced, the submission should be returned. See return procedures in "Intake through Archiving."

When the non-substantive formula revision is found acceptable, the Registration Specialist will:

• Write a letter to the company accepting the formula change. Identify in the subject line the date the CSF was stamp accepted by U.S. EPA or the date of the application, if the company submitted a Product Formulation Sheet. Do not include a copy of the CSF or product formulation sheet. The Department does not allow the release of the original or printed copies of these documents, even if requested by the basic company. Print an envelope with the appropriate company information on it.
  
  
• For the product file, clip together the yellow surname copy of DPR letter, the new confidential statement(s) of formula or product formulation sheet(s) and any U.S. EPA documentation if submitted, in that order. Write "product file" on the upper right corner of the CSF and the letter.

• For cover letter file, staple a copy of the DPR letter to the company and the cover letter submitted by the applicant. Write "cover letter file" on the upper right hand corner of the letter and label copy.

• Record the tracking ID # on the weekly action log under "Nonsubstantive Change and FAL" column.

3. File as Latest (FAL)

Some label or formula changes are minor and can be processed by the Registration Specialist without scientific evaluation. The following label changes are examples of FALs:

• Compliance with a U.S. EPA PR-Notice or a Label Improvement Program (LIP), Red's, Registration Standards, or U.S. EPA Worker Protection Standard (WPS), without any other changes.

• Standardized Spanish label statements such as "PRECAUCION (caution), AVISO (warning), PELIGRO (danger); Si Usted no entiende la etiqueta, busque a alguien para que se la explique a Usted en detalle (If you do not understand this label, find someone to explain it to you in detail)." If a company chooses to translate the label, follow the instructions in P/P 2002-3.

• Certain formulation changes, such as the addition of .01% or less of Bitrex (denatonium benzoate) bittering agent.

• New or revised First Aid - Statement of Practical Treatment, which complies with current standards, especially U.S. EPA PR-Notice 2001-1. If the First Aid statements does not appear to comply, forward the form in Appendix IV-1 to the Worker Health and Safety Branch, Medical Management reviewer.
  
  
• Addition of a pest similar to one already on the label (except antimicrobial products which must be processed as a label amendment).
  
  
• Changes involving similar use patterns or pests. New Registration Specialists should consult with their lead Specialist or Supervisor to determine if a changed use pattern or pest is similar to use patterns or pests already on the label.

If acceptable as an FAL, the Registration Specialist will:

• Write a letter to the company accepting the label amendment or formula change. The correct and full company name must be on the letter. If a formula revision, identify in the subject line the date the CSF was signed by the approving official or the date of the application if the company submitted a Product Formulation Sheet. Do not include a copy of the CSF or Product Formulation Sheet. The Department does not allow the release of the original or printed copies of these documents, even if requested by the basic registrant. Print an envelope with the appropriate company information on it. If there are more than 7 pages to be sent out, you must use an 8 1/2" by 11" or 6" by 9" envelope. This is the responsibility of the Registration Specialist.

• Stamp three labels for distribution to the product file, coding, and the company. The Registration Specialist may retain an additional copy for their file.

• For the product file, clip together the yellow surname copy of DPR letter (to be placed on top) and stamped label. Write "product file" on the upper right corner of the label and the letter. For a formula revision, include the new confidential statement of formula(s).

• For cover letter file, staple a copy of the DPR letter to the company and the cover letter submitted by the applicant. Write "cover letter file" on the upper right hand corner of the letter copy.
  
  
• For coding, staple a copy of the DPR letter to the company, the stamp-accepted label with the changed portions highlighted, and a copy of the status sheet, in that order. Write "coding" on the upper right corner of the letter and label copy.

  Note: Certain specific label revisions and certain formula revisions do not need to be sent to Coding. P/P 2000-1 outlines the criteria for those that do not have to be sent to Coding.

• Record the tracking ID # on the weekly action log in the "Nonsubstantive Change and FAL" column.
  
  
• Clip together the individual sections listed above (company, product file, cover letter, coding) and submit to your supervisor. Do not include the brown folder.

4. DPR Notification Process

Certain label changes or a change in source of active ingredient may be done by the registrant using the DPR Notification Form in Appendix IV-2 and following the criteria for the DPR Notification Process in Ca Notice 2002-1. These types of changes are processed by the designated Technician and do not require data or scientific evaluation or written approval.

Before the registrant can release the revised product for sale in California, the revised label or if a formula change, the revised application or CSF, must be received by DPR.

The registrant sends the DPR Notification Form and three revised labels or, if a change in source of active ingredient, the revised application or CSF, to the designated Technician.

The designated Technician will review the submission for compliance with the notification criteria.

If the submission is in compliance, the label is filed as the latest label.

If the submission is not in compliance, the request is returned to the applicant. If the Registration Specialist can address the issue, the request is forwarded to the Registration Specialist.

Note: There are some changes that can be made by notification to U.S. EPA, but must be submitted for review to DPR. An example is a change on the label of the name or address of the registrant. Conversely, U.S. EPA may require that a registrant submit an application for amended registration for revisions that DPR would allow by notification. In most cases U.S. EPA notifies the registrant and states its reason for requiring an application for amended registration in lieu of a notification.

The following minor changes can be submitted as a DPR Notification in California:

• Label and formula revisions outlined in Ca Notice 2002-1. Also use this notice to determine which revisions are considered non-notification in California.
  
  
• Resistance management statements as outlined in USEPA PR Notice 2001-5.

5. FIFRA Section 2(ee) Statements

Printed statements produced by a company in accordance with FIFRA Section 2(ee) are not required by DPR, nor are they a part of the label acceptance process, including the Notification process. If a registrant chooses to submit printed claims allowed by FIFRA Section 2(ee), shred the submission and inform the company that such information need not be submitted to DPR. Examples of 2(ee) acceptable statements are outlined in U.S. EPA's Label Review Manual.