Attachment E_Instructions for Submitting a Notice of Supplemental Distribution

Attachment E_Instructions_Submitting a Notice of Supplemental Distribution.pdf

Notice of Supplemental Distribution of a Registered Pesticide Product

Attachment E_Instructions for Submitting a Notice of Supplemental Distribution

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Chapter 9 -

Pesticide Registration Manual:
Chapter 9 - Supplemental Distribution of a
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Supplemental Distribution of a Registered Pesticide
Requirements for Approval of Supplemental Distribution
Cancellation of a Distributor Product
Where to Submit All Communications Concerning a
Supplemental Registration of a Distributor Product
Where to Request a Company Number
Where to Request an Establishment Registration
Contacts for More Information
References Cited in Chapter 9

Supplemental Distribution of a Registered
Pesticide
According to 40 CFR 152.132 (PDF) (1 pp, 131.94 k About PDF) ,
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 is termed
“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 of the 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 of another 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 of a currently federally registered pesticide product.
They are a duplication of the basic registered product and must
reflect any changes in formulation or labeling made to the basic
registered product within the same timeframe imposed on that
product.
If the 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 152.132(e) (PDF) (1 pp, 131.94 k
About PDF) ).

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Table of Contents
       Introduction
1. Requirements for Pesticide
Registration and Registrant
Obligations
2. Registering a Pesticide
Product
3. Additional Considerations for
Biopesticide Products
4. Additional Considerations for
Antimicrobial Products
5. Registration Fees
6. Amending a Registered
Pesticide Product
7. Notifications and Minor
Formulation Amendments
8. Inert Ingredients
9. Supplemental Distribution of
a Registered Pesticide
10. Data Compensation
Requirements
11. Tolerance Petitions
12. Applying for an Experimental
Use Permit
13. Devices
14. How to Obtain an EPA
Company or Establishment
Number and Change of
Address of Contact
Information
15. Submitting Data and
Confidential Business
Information
16. Transfer of Product
Registrations and Data
Rights
17. State Regulatory Authority
18. Other Federal or State
Agency Requirements
19. How to Obtain Publications
20. Forms and How to Obtain
Them
21. Directions for Submitting
Applications and Contacting
EPA
Appendices
Appendix A: Guidance
Documents
Appendix B: Examples of
Registrant Documents
Appendix C: Pesticide Forms
Overview Table
Appendix D: Examples of

Pesticide Registration Manual: Chapter 9 - Supplemental Distribution of a Registered Pesticide | Pesticides | US EPA
If the basic registered product is transferred to another
company, supplemental distributorships do not transfer
with the section 3 registration. Registrants must notify
all supplemental distributors of the transferred product
of the transfer agreement.
If the new registrant wishes to continue any
supplemental distributorship or add new ones, the
registrant must fill out a new “Notice of Supplemental
Distribution of a Registered Product” Form 8570-5
(PDF) (2 pp, 505k) .
Top of page

Requirements for Approval of
Supplemental Distribution
The following conditions must be met before EPA will permit
supplemental distribution of a federally registered pesticide
product:
The registrant of the 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, 505k) , Notice
of Supplemental Registration of Distributor) in triplicate
signed by both the registrant of the basic registered
product and the second party (“the distributor”).  Refer
to 40 CFR 152.132(a) (PDF) (1 pp, 131.94 k About PDF) .
The application form must include the following
information:
the name and address of the registrant of the
basic registered product and the registration
number of the federally registered product; and
the name and address of the distributor, the
distributor's company number, and the name of
the distributor product. If EPA has not already
assigned the distributor a 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.
The distributor product is produced, packaged, and
labeled in a registered establishment operated by the
same producer (or under contract with 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 of the basic registered
product, with the following exceptions:
 
the product name of the distributor's product may
be different from that of the registrant's, but it
may not be misleading (40 CFR 152.132(d)(1)
(PDF) (1 pp, 131.94 k About PDF) );

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Completed Forms

Pesticide Registration Manual: Chapter 9 - Supplemental Distribution of a Registered Pesticide | Pesticides | US EPA
the name and address of the distributor's
company may appear instead of the 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 of the basic
registered product must be followed by a hyphen,
followed by the distributor's company number
(e.g., if the registration number of the
registrant's product is EPA Reg. No. 99999988888, and the distributor's company number is
777777, then the distributor's number appearing
on the label should be EPA Reg. No. 99999988888-777777) (40 CFR 152.132(d)(3) (PDF) (1
pp, 131.94 k About PDF) );
the establishment number on the label must be
that of the 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 k About PDF) );
and
any specific claims on the registrant's label, such
as the sites of application or pests to be
controlled, may be omitted from the distributor's
product label provided that no changes are
necessary in any of the precautionary or other
labeling of the 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 additions to the registrant’s
basic product label (i.e., add claims, additional sites, or pests).
Top of page

Cancellation of a Distributor Product
When a registrant enters into a relationship with a supplement
distributor, for each product involved, the registrant must
submit to the Agency a statement signed by both registrant and
supplemental distributor that lists the names and addresses of
both parties, the distributor’s company number, any additional
brand names to be used, and the registration number of the
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.
If a 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 under that registration
number are also canceled and that the registrant is responsible
for notifying all distributors of the terms and conditions of
cancellation. A 6(f) voluntary cancellation request can be
submitted via letter on company letterhead.
In addition to instances when a basic registration is voluntarily
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

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Pesticide Registration Manual: Chapter 9 - Supplemental Distribution of a Registered Pesticide | Pesticides | US EPA
the basic registration remains but the distributor product is
canceled. There are also times when the registrant and/or
distributor wants to remove a brand name from a distributor
product while keeping both the basic and distributor
registrations active. The Agency requests that these types of
notifications be provided by letter. To assure efficient
processing, when notifying the Agency of the end of a
supplemental distributor relationship, the following should be
included in the subject line and body of the request letter:
“Notification of Termination of Supplemental Distributor
Agreement,” then add the PRODUCT NUMBER including the
distributor company number for which the relationship has
ended.
When notifying the Agency of changes to the brand name of a
supplemental distributor product, the following should be
included in the subject line and body of the 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 interprets 40 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 of the effective date of termination of the subject
supplemental registration. Sale or distribution of any quantities
of the affected distributor product produced after the effective
date of termination would be considered illegal under FIFRA. It
is important to note that while EPA regulations and policy may
permit such distribution or sale of existing stocks for 18 months
following termination of the 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 distributor are 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 limits the existing stocks period.
The ability for the supplemental distributor to sell and distribute
is linked to the liability of the basic registrant. If the
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 of the relationship. After the relationship between
basic registrant and supplemental distributor is officially and
totally terminated (either by the passing of 18 months after the
basic registrant notified the Agency of the end of the
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.
Top of page

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Pesticide Registration Manual: Chapter 9 - Supplemental Distribution of a Registered Pesticide | Pesticides | US EPA

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

Where to 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 at
the 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
Top of page

Where to Request an 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.
Top of page

Contacts for More Information
For further information, please contact Barbara Purnell
(purnell.barbara@epa.gov) or by calling 703-305-5780.
Top of page

References Cited in Chapter 9
Refer to Chapter 19 for information on the sources of these
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 (PDF) (2 pp, 505k) - Notice of Supplemental

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Pesticide Registration Manual: Chapter 9 - Supplemental Distribution of a Registered Pesticide | Pesticides | US EPA
Registration of Distributors
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