April 25, 1994

Notice To: Manufacturers, Producers, Formulators, and Registrants of Pesticide Products

Attention: Persons Responsible for Federal Registration and Reregistration of Pesticide Products

Subject: Withdrawal of PR Notice 91-8

Effective immediately, EPA is withdrawing PR Notice 91-8, entitled "Revised Policy To Provide Applicants Other Than Basic Manufacturers An Opportunity To Submit Generic Data and Receive Data Compensation For It." That notice requested the use of a generic label statement on manufacturing use products (MPs) to effect this policy. Persons who have complied with PR Notice 91- 8 may retain such statements or may delete them from product labeling, at their discretion.

1. Background
2. Agency Action
3. Data Compensation Rights Of Persons Who Develop Data
4. Registrant Action
5. Effective Date
6. Additional Information

1. Background

   In the mid-1980s, the Agency developed a policy for Manufacturing Use Product (MP) labeling that uses supported by the MP registrant should appear on the label and that reformulation for other uses should be prohibited. During pesticide reregistration many MP registrants have elected not to develop data in support of some label uses of their products, especially the minor uses. In accordance with Agency policy, these uses must be removed from MP product labeling.

   Certain grower groups and end-use formulators have decided to fill the void themselves by submitting generic data to support the registration or reregistration of those minor uses. However, the Agency's policy for MP labeling could have the unintended consequence of denying these user groups and formulators compensation from other formulators for this data as provided under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Section 3(c)(1)(F). Because the Agency's MP labeling policy prohibits an unsupported use from appearing on an MP label, these user groups and formulators must provide the data they intend to generate to an MP registrant in order to ensure that an MP can be reformulated lawfully for the minor uses that the data support. Once the MP is supported for such uses, however, other formulators using the MP may claim the formulator's exemption for those uses, thereby denying compensation to the user groups or formulators that developed the data. Therefore, several end-use registrants and user groups requested that the Agency establish a mechanism to ensure that the data compensation rights of grower groups and formulators generating minor use data are retained.

   PR Notice 91-8 was the Agency's attempt to ensure compensation for data developed by grower groups or formulators by requesting MP registrants to include an additional generic labeling statement that permits reformulation of their products for uses other than those specifically listed on the MP label and supported by the MP registrant, provided the formulator supports such uses. This statement preserves the data compensation rights of grower groups or end-use formulators because the labeling statement would effectively prevent other formulators that did not develop data from claiming the formulator's exemption for specific uses supported by user groups or end-use formulators.

   These same end-use registrants and user groups have now advised the Agency that MP registrants should not be required to adopt the generic labeling statement set forth in PR Notice 91-8. These groups have joined with the representatives of MP registrants in advising the Agency that MP registrants should be able to control the uses made of their products by controlling the MP label. They indicated that the user groups and end-use formulators must work in cooperation with the MP registrants before developing the necessary data to sustain a use which the MP registrant no longer intends to support. These groups, have, however, asked that the Agency affirm that the formulators, c

2. Agency Action

   Because representatives of grower groups and end-use formulators who requested PR Notice 91-8 believe that the Agency should not require MP registrants to adopt the label statements set forth in the Notice, the Agency sees no reason to continue the policy. Accordingly, the Agency withdraws PR Notice 91-8 and will not require MP registrants to incorporate the generic labeling statement set forth in PR Notice 91-8.

3. Data Compensation Rights Of Persons Who Develop Data

   Although EPA is withdrawing PR Notice 91-8, it is not abandoning the principles underlying the notice. EPA affirms that data developers who develop generic or use-specific data in support of registration or reregistration of a product are entitled to the same data compensation rights as MP registrants that develop such data. They may request that they be identified on the Agency's Data Submitters List, as wanting data compensation from registrants who use their data in support of registration. The request to be added to the Data Submitters List should include the name of the active ingredient, data for which compensation is required, and their firm's name and address. Submit such requests to Ms. Sherada Hobgood at the address under VI below.

4. Registrant Action

   MP registrants who have complied with PR Notice 91-8 may continue to use the label statement set forth in the notice, or may delete it at their discretion. No notification is required solely for this purpose.

   Any MP registrants wishing to do so may add one of the following statements to an MP label under "Directions for Use" to permit the reformulation of their product for a specific use or all additional uses supported by a formulator or user group. Furthermore, provided no other labeling changes are made, no notification to the Agency is required.

   Note: This notice does not alter the Agency's basic labeling policy that MP registrants include a specific list on the label of those uses for which the MP may be reformulated.

   1. "This product may be used to formulate products for specific use(s) not listed on the MP label if the formulator, user group, or grower has complied with U. S. EPA data submission requirements regarding the support of such use(s)."
   
   
   2. "This product may be used to formulate products for any additional uses not listed on the MP label if the formulator, user group, or grower has complied with U. S. EPA data submission requirements regarding the support of such uses."

5. Effective Date

   Effective immediately PR Notice 91-8 is withdrawn.




6. Additional Information

   For further information please contact:

   Rosalind L. Gross
   Registration Support Branch
   Registration Division (7505-W),
   EPA
   401 M Street, SW
   Washington, DC 20460
   (703) 308-8354

    

   Stephen L. Johnson,
   
   Acting Director Registration Division (7505-C)

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