IDENTICAL PRODUCT REGISTRATIONS
A. INTRODUCTION TO IDENTICAL PRODUCT REGISTRATIONS
B. SUBREGISTRATION / DISTRIBUTOR REGISTRATIONS
E. COMPANY NAME CHANGE WITH A CHANGE IN OWNERSHIP
F. COMPANY NAME CHANGE WITHOUT CHANGE IN OWNERSHIP
G. IDENTICAL PRODUCTS WITH DIFFERENT USEPA REG. NO's
Appendix V-1 Product Ownership or Company Name Change Form
Appendix V-2 Affidavit of No Change in Ownership Form
Chapter V
IDENTICAL PRODUCT REGISTRATIONS
A product which is identical to a currently registered product may be registered without scientific evaluation, submission of data, or posting for public comment, if certain criteria are met.
The labels must be identical (although uses may be deleted).
The formulations must be identical.
The appropriate documentation and letters of authorization must be submitted.
Identical product registrations involve the issuance of a license (Certificate of Registration) and can be any of the following:
"Currently registered" includes products last registered within one year.
If during review of an identical product a deficiency in the basic registrant's label or formulation is identified, the basic registrant should be notified.
Inert ingredients are kept confidential to the basic registrant.
For all products registered as identical to a currently registered product, the Licensing Technician will take the tracking ID# out of the system by taking a final action of "Register Without Notice". To issue the product license, see Chapter III.
Some minor differences to a currently registered product still allow the product to be registered as identical. This includes changes which would have been processed as a Nonsubstantive Change, FAL (File as Latest), or Notification for the basic product.
The formulation can still be considered identical if the only difference is:
- Addition of a fragrance or dye.
- Addition of .01% or less of the bittering agent Bitrex (denatonium benzoate).
- Compliance with U.S. EPA mandates such as PR-Notices, REDs, or LIPs.The label can still be considered identical if the only difference in the label is:
- Change to water soluble packaging (WSP)
- Compliance with U.S. EPA mandates such as PR-Notices, REDs, LIPs.
- Storage and disposal statements appropriate to the container type or size.
If the currently registered product (or last registered within one year) is registered conditionally or is a time-limited registration, the identical product must also be registered conditionally with the same time frames. See Chapter III-K Conditional Registrations for procedures.
B. SUBREGISTRATION/DISTRIBUTOR REGISTRATION
U.S. EPA supplemental registration (subregistration) permits a distributor of a U.S. EPA registered pesticide product to market that product under the distributor's brand name. The product must have the same formulation, label, and packaging as the currently registered product.
In California, before a subregistration/distributor product can be sold or used, a license must be obtained.
U.S. EPA requires only that a Notice of Supplemental Distribution of a Registered Pesticide Product (Form# 8570-5), signed and dated by both the basic registrant and the distributor, be mailed to the U.S. EPA. The U.S. EPA then allows the distributor to release the product with the distributor's brand name, firm name and address, and distributor firm number.
If a basic registrant's product is currently registered in California (or another subregistration of the same basic registrant), a subregistrant/distributor can be registered as an identical product. A listing of subregistrants of the same basic product is available on the branch home page. The term "Currently registered" in California also includes products last registered within one year.
The following items are required to register a subregistration/distributor registration:
1. An Application for Registration form which shows the identical formulation to the currently registered product. The inert ingredients might not be known to the subregistrant, but must be on file or submitted to DPR. Inert ingredients are kept confidential to the basic registrant of the product.
2. $750 application fee. (Effective January 1, 2004)
3. Six copies of printer's proof or final printed labels which are identical to the currently registered product's label in California.
The label must comply with U.S. EPA PR-Notices, LIPs, Registration Standards, REDs, and other label requirements. It is permissible to delete uses and sites.
The product name, firm name and address, and, in some cases, the EPA Establishment No. will differ from the basic registrant's.
The label must bear the registration number of the U.S. EPA registered product with the distributor's firm number as a suffix to the registration number.
|
Example: 00000-00000-00000 |
||
| 00000 - | 00000 - | 00000 |
| Basic Registrant's | Product | Distributor's |
| Firm Number | Number | Firm Number |
Special attention must be given to a subregistrant's label so that the basic registrant's agricultural or industrial label has not been inappropriately used. For example, the renaming of an agricultural use label to imply home use is not acceptable.
4. A copy of the basic registrant's U.S. EPA stamped label and accompanying letter.
If a copy of the U.S. EPA stamped label and accompanying letter is not sent in by the applicant, make a copy from the currently registered product's file.
5. A copy of the U.S. EPA Notice of Supplemental Distribution of a Registered Pesticide Product (Form #8570-5) signed and dated by both the primary registrant and the distributor/subregistrant must be submitted. This form is required whether or not the basic registrant is registered in California.
To issue the product license, follow the steps in Chapter III, Section N.
The term "subregistration" and "distributor registration" are used synonymously and refer to products which are registered and sold under the distributor's name, address, and brand name. The term "supplemental registration" is sometimes used.
If the basic registrant's product is not registered in California and there is no other currently registered subregistration, the product must undergo the same scientific evaluation process as a new product, including the 30 day public comment period. Since the basic product is not registered in California, the subregistration/distributor label is compared to the basic registrant's U.S. EPA stamped label.
If the product is an antimicrobial product, also see the Introduction section of this chapter.
Note: Once a product is registered as a subregistration/distributor registration and the basic registrant's product undergoes an ownership change, the subregistrant/distributor registrant must reapply for registration.
A pesticide product may be registered under more than one brand name.
The same brand name cannot be registered for products (within the same company) of different chemical composition, or different physical condition sufficient to affect its pesticidal properties.
A brand name cannot be false or misleading.
For additional brand names, the following are required:
1. An Application for Registration form which shows the identical formulation to the currently registered product.
2. $750 application fee. (Effective January 1, 2004)
3. Six copies of printer's proof or final printed labels which are identical to the currently registered product's label in California. It is permissable to delete uses or sites.
The label must comply with U.S. EPA PR-Notices, LIPs, Registration Standards, REDs, and other label requirements. It is permissible to delete uses and sites.
4. A copy of the registrant's letter notifying U.S. EPA of the additional brand name or U.S. EPA's letter accepting the additional name.
If a copy of the U.S. EPA stamped label and accompanying letter is not sent in by the applicant, make a copy from the currently registered product's file.
The next alpha code is assigned.
To issue a product license, follow the steps in Chapter III, Section N.
For a change in product ownership the following are required:
1. An Application for Registration form which shows the identical formulation to the currently registered product.
2. $750 application fee. (Effective January 1, 2004)
3. Six copies of printer's proof or final printed labels which are identical to the currently registered product's label in California. The product name, firm name, and address may differ.
The label must comply with U.S. EPA PR-Notices, LIPs, Registration Standards, REDs, and other label requirements. It is permissible to delete uses and sites.
4. A copy of the U.S. EPA documentation acknowledging the ownership change and showing any assignment of a new firm number or product number.
A copy of any U.S. EPA documentation acknowledging a change in ownership of data or a letter from the previous owner specifying change in ownership of data they have on file in California pertaining to the transferred products, if applicable. Remember to give a copy of this letter to the Library.
If a copy of the U.S. EPA stamped label and accompanying letter is not sent in by the applicant, make a copy from the currently registered product's file.
If the product is an antimicrobial product, see the Introduction section of this chapter.
To issue the product license, follow the steps in Chapter III, Section N. The registration specialist will prepare the form Memorandum of Registration (Product Ownership or Company Name Change) in Appendix V-1.
E. COMPANY NAME CHANGE WITH CHANGE IN OWNERSHIP
A certificate of registration cannot be transferred if there is a change of business ownership. A new application and fee are necessary.
For a company name change with a change in ownership the following are required:
1. An Application for Registration form which shows the identical formulation to the currently registered product.
2. $750 application fee. (Effective January 1, 2004)
3. Six (6) copies of printer's proof or final printed labels of each product label (identical to the currently registered label) currently available showing the new firm name. Labels showing the new firm name for the remaining products are to be submitted within one year.
The label must comply with U.S. EPA PR-Notices, LIPs, Registration Standards, REDs, and other label requirements. It is permissible to delete uses and sites.
4. A copy of U.S. EPA documentation acknowledging the company name and ownership change and, if applicable, data ownership change. Remember to give a copy of the data ownership letter to the Library.
After the product is licensed, the Label Resource Center will relabel files with the new firm name, staple the new application to the old application, and place a card in the label files under the old firm name with a cross-reference to the new firm name.
If both the old company name and the new company name remain active for the same product with the same firm number, an (01) designation is added to the license by the Licensing Technician. A new alpha code is assigned when this occurs. However, if the old product is inactivated when the new product is licensed, a new alpha code is not assigned. [Licenses for firm numbers with multiple company names are tracked manually.]
For a company name change, issue a new license to supersede the old name license. The license with the old firm name is then marked "Amended" in the license binder files.
To issue the product license, follow the steps in Chapter III, Section N. The registration specialist will prepare the form Memorandum of Registration (Product Ownership or Company Name Change) in Appendix V-1. If the product is an antimicrobial product, see the Introduction section of this chapter.
F. COMPANY NAME CHANGE WITHOUT A CHANGE IN OWNERSHIP
A change of the name of a registrant may be made without additional fee by submission of the following:
1. An Application for Registration form which shows the identical formulation to the currently registered product.
2. Six (6) copies of printer's proof or final printed labels of each product label currently available showing the new firm name. Labels showing the new firm name for the remaining products are to be submitted within one year.
The label must comply with U.S. EPA PR-Notices, LIPs, Registration Standards, REDs, and other label requirements. It is permissible to delete uses and sites.
3. U.S. EPA documentation acknowledging the new firm name or a copy of the registrant's notification to U.S. EPA of their new name.
4. Affidavit of no change in ownership. (Appendix V-2)
To issue the product license, follow the steps in Chapter III, Section N. The registration specialist will prepare the form Memorandum of Registration (Product Ownership or Company Name Change) in Appendix V-1. The new license supersedes the old name license. The license with the old firm name is then marked "Amended" in the license binder files.
If both the old company name and the new company name remain active for the same product with the same firm number, an (01) designation is added to the license by the Licensing Technician. A new alpha code is not assigned.
After the product is licensed, the Label Resource Center will relabel files with the new firm name, staple the new application to the old application form in each file, and place a card in the label files under the old firm name with a cross-reference to the new firm name.
G. IDENTICAL TO ANOTHER CURRENTLY REGISTERED PRODUCT OF AN UNRELATED
COMPANY.
A product may be registered as identical to another currently registered product, even if the current product is registered to a company unrelated to the applicant. This may be done by submission of the following:
1. An Application for Registration form which shows the identical formulation to the currently registered product.
2. $750 application fee. (Effective January 1, 2004)
3. Six copies of printer's proof or final printed labels which are identical to the currently registered product's label in California.
The label must comply with U.S. EPA PR-Notices, LIPs, Registration Standards, REDs, and other label requirements. It is permissible to delete uses and sites.
4. If applicable, a copy of U.S. EPA documentation acknowledging data ownership change. Remember to give a copy of this letter to the Library.
5. A letter of authorization from the currently registered company. If any other companies' data were used to support registration of the currently registered product, letter(s) of authorization from the data owner(s) only are required.
To issue the product license, follow the steps in Chapter III, Section N.
Diazinon products are an example. Nearly every diazinon label that is submitted is identical to an existing diazinon product held by a specific company.
If the product is an antimicrobial product, see the Introduction section of this chapter.