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,. Chapter 9 - Supplemental Distribution of a Registered Pesticide 

# Pesticide Registration Manual: Chapter 9 - Supplemental Distribution ofa Re 1stered Pesticide
You will need the free Adobe Readertoview some ofthe files on this page. See EPA's PDF page to learn more. Current as ofAugust 2010 In this Chapter:

• Supplemental Distribution ofa Registered Pesticide • Requirements for Approval ofSupplemental Distribution • Cancellation of a Distributor Product • Where to Submit All Communications Concerning a Supplemental Registration ofa Distributor Product • Where to Reguest a Company Number • Where to Reguest an Establishment Registration • Contacts for More Information • References Cited in Chapter 9 1.
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17. 18. 19. 20. 21. Registration Manual Table of Contents Introduction Requirements for Pesticide Registration and Registrant Obligations Registering a Pesticide Product Additional Considerations for Biopesticide Products Additional Considerations forAntimicrobial Products Registration Fees Amending a Registered Pesticide Product Notificationsand Minor Formulation Amendments Inert Ingredients Supplemental Distribution ofa Registered Pesticide Data Compensation Requirements Tolerance Petitions Applying for an Experimental Use Permit Devices How to Obtain an EPA Company or Establishment Numberand Change of Address ofContact Information Submitting Data and Confidential Business Information Transfer ofProduct Registrations and Data Rights State Regulatory Authority Other Federal orState Agency Requirements How to Obtain Publications Forms and How to Obtain Them Directionsfor Submitting Applications and Contacting EPA Appendices

• Appendix A: Guidance Documents • Appendix B: Examples of

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### Supplemental Distribution ofa Registered Pesticide Registrant Documents • Appendix C: Pesticide Forms OverviewTable • Appendix D: Examples of Completed Forms

According to 40 CFR 152.132 (PDF) (1 pp, 131.94 k About POE), registrants may distribute or sell their registered product under another company's name and address instead of (or in addition to) their own. Such distribution and sale istermed "supplemental distribution" and the product is referred to as a "supplemental registration" or "distributor product."The distributor, also known as a "subregistrant," is considered an agent ofthe registrant, and both the registrant and the distributor may be held liable for violations pertaining to the distributor product. Detailed information on the supplemental distribution or supplemental registration ofanother federally registered product can be found in 40 CFR 152.132 (PDF) (1 pp, 131.94 k About PDF). 

### Important Note: Supplemental registrations are only an extension ofa currently federally registered pesticide product. They are a duplication ofthe basic registered product and must reflect any changes in formulation or labeling made to the basic registered productwithin the same timeframe imposed on that product.

• Ifthe basic registered product is canceled, the supplemental registration is automatically canceled effective on the same date as the basic registered product, and existing stocks must be sold in the same time period (40 CFR 152.132Ce) (PDF) (1 pp, 131.94 k

### Ab.n.ut EQE)). • Ifthe basic registered product is transferred to another company, supplemental distributorships do nottransfer with the section 3 registration. Registrants must notify all supplemental distributors ofthe transferred product ofthe transfer agreement. • Ifthe new registrant wishes to continue any supplemental distributorship or add new ones, the registrant mustfill out a new"Notice ofSupplemental Distribution ofa Registered Product" Form 8570-5 (PDF) (2 pp, SOSk). 

### Requirementsfor Approval ofSupplemental Distribution The following conditions must be met before EPA will permit supplemental distribution ofa federally registered pesticide product:

• The registrant ofthe federally registered product for which a second party wishes to obtain supplemental registration must have submitted to the Agency a statement (EPA Form 8570-5 (PDF) (2 pp, SOSk), Notice ofSupplemental Registration of Distributor) in triplicate signed by both the registrant ofthe basic registered product and the second party ("the distributor"). Refer to 40 CFR 152.132(a) (PDF) (1 pp, 131.94 k About POE). The application form must include the following information:
• the name and address ofthe registrant ofthe basic registered product and the registration number ofthe federally registered product; and • the name and address ofthe distributor, the distributor's company number, and the name ofthe distributor product. If EPA has not already assigned the distributora company number, one will be assigned upon written request. Refer to Chapter 21 for the address. Applications that are incomplete or that contain errors will be returned with a checklist explaining the reason for rejection or disapproval.

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3of5 • The distributor product is produced, packaged, and labeled in a registered establishment operated by the same producer (or under contractwith basic producer according to 40 CFR 152.30) who produces, packages, and labels the basic registered product (40 CFR 152.132(b) (PDF) (1 pp, 131.94 k About PDF)). • The distributor product may not be repackaged. It must remain in the basic registrant's or producer's original, unopened container. Refer to Chapter 14, which explains how to obtain an establishment registration. • The labeling associated with the distributor product must be the same as that ofthe basic registered product, with the following exceptions:
• the product name ofthe distributor's product may be differentfrom that ofthe registrant's, but it may not be misleading (40 CFR 152.132(d){1) (PDF) (1 pp, 131.94 k About PDF)); • the name and address ofthe distributor's company may appear instead ofthe registrant's name and address (a phrase such as "Distributed by

..." must be used) (40 CFR 152.132(d)(2) (PDF) (1 pp, 131.94 k About PDF), and 40 CFR 156.10(c) (PDF) (6 pp, 162.65 k About PDF)); • the EPA registration number ofthe basic registered product must be followed by a hyphen, followed by the distributor's company number (e.g., ifthe registration number ofthe registrant's product is EPA Reg. No. 999999-88888, and the distributor's company number is 777777, then the distributor's number appearing on the label should be EPA Reg. No. 999999-88888-777777) (40 CFR 152.132(d)(3) (PDF) (1 pp, 131.94 k About PDF)); • the establishment number on the label must be that ofthe final establishment at which the basic registered product was produced, which includes packaging and/or repackaging for sale {40 CFR 152.132(d)(4) (PDF) (1 pp, 131.94 kAbout PDF)); and • any specific claims on the registrant's label, such as the sites ofapplication or pests to be controlled, may be omitted from the distributor's product label provided that no changes are necessary in any ofthe precautionary or other labeling ofthe basic registered product (40 CFR 152.132(d)(5) (PDF) (1 pp, 131.94 k About PDF)). 

### Important Note: The distributor, also known as a "subregistrant," may not make additionsto the registrant's basic product label (i.e., add claims, additional sites, or pests).


### Cancellation ofa Distributor Product When a registrant enters into a relationship with a supplement distributor, for each product involved, the registrant mustsubmit to the Agency a statement signed by both registrant and supplemental distributorthat liststhe names and addresses of both parties, the distributor's company number, any additional brand namesto be used, and the registration number ofthe product {40 CFR 152.132(a) (PDF) (1 pp, 131.94 k About PDF)). Providing a complete Form 8570-5 (PDF) (2 pp, 505k) fulfills this requirement. Just as the registrant's product ("the basic registration") may have alternate brand names, a Supplemental (Distributor) Product can have multiple names associated with a product. Ifa registrant voluntarily cancels its basic product registration, 40 CFR 152.132(e) (PDF) (1 pp, 131.94 k About PDF) states all distributor products distributed or sold underthat registration number are also canceled and that the registrant is responsible for notifying all distributorsof the terms and conditions ofcancellation. A 6(f) voluntary cancellation request can be submitted via letter on company letterhead. In addition to instances when a basic registration isvoluntarily canceled, and therefore all distributor products are canceled, the registrant may wish to notify the Agency that a supplemental distributor relationship has ended. In this situation the basic registration remains but the distributor product is canceled. There are also times when the registrant and/or distributorwantsto remove a brand name from a distributor product while keeping both the

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4of5 basic and distributor registrations active. The Agency requests thatthese types of notifications be provided by Jetter. To assure efficient processing, when notifying the Agency ofthe end ofa supplemental distributor relationship, the following should be included in the subject line and body ofthe request letter: "Notification ofTermination ofSupplemental DistributorAgreement," then add the PRODUCT NUMBER including the distributor company numberfor which the relationship has ended. When notifying the Agency ofchanges to the brand name ofa supplemental distributor product, the following should be included in the subject line and body ofthe request letter: "Notification of [Removal and/or Change] of Distributor Product Name,"then add the PRODUCT NAME you would like removed or changed. Please note, when a basic registrant terminates a supplemental registration, EPA interprets40 CFR 152.130(c) (PDF) (2 pp, 135.03 k About PDF) to generally permit a supplemental distributor 18 months to sell and distribute existing stocks after the basic registrant terminates the supplemental registration. In this context, the supplemental registrant's existing stocks are only those affected pesticide products that have been released for shipment as ofthe effective date oftermination ofthe subject supplemental registration. Sale or distribution ofany quantitiesof the affected distributor product produced after the effective date oftermination would be considered illegal under FIFRA. It is importantto note that while EPA regulations and policy may permitsuch distribution or sale ofexisting stocks for 18 months following termination ofthe supplemental distribution, the contractual arrangement between the basic registrant and the supplemental distributor may contain terms that further limit or preclude sale and distribution by the supplemental distributor (although such contractual arrangements would be enforceable through the courts, and not by EPA). The registrant and supplemental distributorare equally liable for any violations that occur during the 18 months during which the existing supplemental product can 

### be sold, unless a contractual arrangement between the two limitsthe existing stocks period. The ability for the supplemental distributorto sell and distribute is linked to the liabilit'\ofthe basic registrant. Ifthe supplemental distributor is legally selling and distributing, the basic registrant is still liable for any violations. The basic registrant would not, however, be liable for any violations stemming from distributor product that is produced after the termination ofthe relationship. After the relationship between basic registrant and supplemental distributor is officially and totally terminated (either by the passing of 18 months afterthe basic registrant notified the Agency ofthe end ofthe relationship or by a contract that finally ends the relationship earlier by disallowing existing stocks), the basic registrant is no longer liable for any violations that occur based on the distributor's product.


### Whereto SubmitAll Communications Concerning a Supplemental Registration ofa Distributor Product The registrant ofthe basic registered product should submit the completed application and any requests or notificationsto: U.S. Environmental Protection Agency Document Processing Desk (DIST) Office of Pesticide Programs- 7504P 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460-0001

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### Whereto Request a Company Number To obtain an EPA assigned company number (PDF) {4 pp, 118k), submit a written request to the Office of Pesticide Programs atthe following address and as described in Chapter 14: U.S. Environmental Protection Agency Document Processing Desk (NEWCO) Office of Pesticide Programs- 7504P 1200 Pennsylvania Avenue, N.W. Washington, D.C. 20460-0001


### Whereto Requestan Establishment Registration Information on how and where to register an establishment (pesticide product producing facility) may be found on the Pesticide Establishment Registration and Reporting Web page and Chapter 14.


### Contactsfor More Information For further information, please contact Barbara Purnell (purnell.barbara@epa.gov) or by calling 703-305-5780.


### References Cited in Chapter 9 Refer to Chapter 19 for information on the sources ofthese documents. Code of Federal Regulation. Title 40

• Part 152
- Pesticide registration and classification procedures • Part 156
- Labeling requirements for pesticides and devices EPA Form 8570-5 CPDFl (2 pp, SOSk)

- Notice of Supplemental Registration of Distributors

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