Pesticide Labeling Questions & Answers - Distributor Product Labeling

Consistency Questions

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(Note: Contact your Pesticide Product Registration Ombudsman for specific label issues about a single product).

These answers are not intended to create significant new guidance or require any changes to previously accepted labeling. The Agency will contact registrants directly about how to correct problematic labels as appropriate. Changes to EPA accepted labeling will only be required in accordance with standard agency procedures.

7. Distributor Product Labeling

Registrant R and Company A have entered into a supplemental distribution agreement for a pesticide product. May Company A sell the pesticide product exclusively through another distributor, Company B? If so, can the label state "Manufactured for Company A" and "Distributed by Company B"? LC13-0584; 01/15/13

In accordance with 40 CFR 152.132, a registrant, and only the registrant, may sell and distribute its registered pesticide product under another person's name (i.e. the "supplemental distributor" or "subregistrant"). A supplemental distributor may not sell or distribute the registrant's product under another person's name. For the scenario above, in order for the product to be sold or distributed under Company B’s name, Registrant R must enter a supplemental distributor agreement with Company B using EPA Form 8570-5, which must be submitted to EPA prior to distribution.

We are a producer of a registered pesticide. We wish to sell the product in bulk to a refiller (distributor). The distributor then wishes to repackage our product into smaller refillable containers for re-sale. Can we:

use our label but remove our product name from the label
add the distributor name and address and distributor registration number to the label, and
change the storage and disposal language to reflect storage and disposal requirements of a refillable product? (LC10-0369) 08/10/10

You cannot do any of the activities you describe without the consent of the registrant. Even with the consent of the registrants, there are limitations.

In accordance with 40 CFR 152.132, the registrant may enter in a supplemental distributor agreement with another party to distribute a registered product under another person’s name and address instead of or in addition to the registrant’s own. For a supplemental distributor to distribute a pesticide, the registrant must notify EPA and the distributor must complete a Notice of Supplemental Distribution of a Registered Pesticide Product (EPA form 8570-5) signed by both the registrant and the distributor. 40 CFR 152.132 limits what can differ about a distributor product from the registered product. The distributor may only package the registrant’s product if the distributor is the same producer (or under contract in accordance with 40 CFR 152.30) as the producer who produces, packages, and labels the registered product. See 40 CFR 152.132(b). Further, the distributor product may not be repackaged (i.e. it remains in the producer’s unopened container). See 40 CFR 152.132(c).

The label of the supplemental registrant’s product must be the same of the registrant with the exception that: (1) the product name may be different, (2)the name and address of the distributor may appear instead of that of the registrant, (3) the registration number of the registered product must be followed by the distributor’s company number, (4) the establishment number must be that of the final establishment where the product was produced, and (5) specific claims may be deleted provided no other changes are necessary. The registrant must ensure that the EPA-approved labeling of the registered product includes appropriate statements for refillable containers in accordance with 40 CFR 156 Subpart H.

Because you are the producer of the pesticide and the distributor is not, the distributor would not be able to repackage the product into smaller containers even with a supplemental distributor agreement with the registrant. Under a supplemental distributor agreement you may be able to change the product name and the distributor name, address and number. But without a change to the EPA-approved label of the registered product, you cannot change the storage and disposal language.

Can a marketing statement be placed on a label that identifies the retail outlet that is offering the product for sale? If so, what are the parameters of an acceptable statement, and must the statement be submitted as an amendment" (LC10-0329, LC10-0332) 3/11/10

In accordance with 40 CFR Section 156.10(c), “An unqualified name and address given on the label shall be considered as the name and address of the producer. If the name of the person for whom the pesticide was produced appears on the label, it must be qualified by appropriate wording such as “Packed for …” “Distributed by … ,” or “Sold by …” to show that the name is not that of the producer.” FIFRA 2(p)(1) defines “label” as “the written, printed, or graphic matter on, or attached to, the pesticide or device or any of its containers or wrappers.” Thus any writing appearing on the pesticide label is considered part of the label that must be approved by EPA and may not be false or misleading. Changes to the label specifying “Packed for….Distributed by…or Sold by…” are not specified in Pesticide Registration Notice (PR) 98-10: Notifications, Non-Notifications and Minor Formulation Amendments and therefore these label changes are considered amendments.
We recently are putting together a label for supplemental distribution. The primary registrant is telling us to avoid using any parentheses on our label (even though theirs has some). Our particular statement where we use parentheses is dosages. We typically state use x to y ppm (a to b gals per 1000 gallons). Where a and b are simply converted values of x and y. Is this wrong? (LC10-0323) 3/11/10

In general, EPA allows the use of parentheses on a label unless: 1) the parentheses are used in such a way that the labeling becomes false and/or misleading or 2) the use of the parentheses causes confusion making the directions for use inadequate to protect human health or the environment. The example you cite where you provide correct ppm information to the user based on the rate on the label would generally be an acceptable use of parentheses on a label.

Please note, however, that the label of a distributor product must be identical to the master label of the parent product, except as provided in 40 CFR 152.132(d). A supplemental distributor may not present statements in parentheses on a label unless the master label of the parent product also contains the same statements in parentheses. Further, the supplemental distributor may not delete statements in parentheses that appear on the parent product's label unless they involve one of the changes allowed in 40 CFR 152.132(d).
40 CFR 152.132(d) says "the label of the distributor product is the same as that of the registered product" ... Does that mean the label must be identical in layout, verbiage, design, etc. or does it mean the information required in 40 CFR 156 (other than excepted in 152.132(d)) must remain unchanged? (LC10-0316) 3/11/10

The supplementally distributed product must bear the same information as the parent product with the exception of the information listed in 40 CFR 152.132(d). Except for the pieces that may change, the wording must be identical. The layout and format of the label of the supplementally distributed product may differ from that of the parent product so long as the change in layout or format doesn’t make the label false or misleading.
Can the registrant of a product whose company name and address appear on the primary label add a second label to the container indicating a distributor company name? Essentially this would avoid the supplemental distribution and subsequent state pesticide registration fees associated with supplemental distribution. (LC09-0298) 3/11/10

Example
Primary Container label
Manufactured for
ABC Company

Secondary Container label
Distributed by or sold by:
XYZ Company

A registrant could add the suggested language you propose as a second label indicating a distributor company name, if the change were reflected on the master label for the product. See 156.10(c). Generally, all information on labeling needs to be approved by EPA in what is collectively referred to as the "master" label. Products can be sold or distributed with a subset of the master labeling provided no changes would be necessary to precautionary statements, use classifications or packaging. To add an alternate distributor name, a registrant could list the standard company name on the master label and include alternates that would be used as appropriate on products depending on how they are distributed. If added as alternative language on the master label, EPA would not treat this scenario as a supplemental distribution as described in 40 CFR 152.132. FIFRA 2(p)(1) defines "label" as "the written, printed, or graphic matter on, or attached to, the pesticide or device or any of its containers or wrappers." Thus any writing appearing on the pesticide is considered part of the label that must be approved by EPA and may not be false or misleading. Adding distributor information to the master label, however, may have no effect on state registration fees, which are governed by state laws.
If a supplemental distributor obtains NSF registration for the distributor product but the basic registrant does not have NSF registration, can the distributor submit a notification to EPA to have the NSF logo added to the distributor label? (LC09-0291) 12/10/09

40 CFR § 152.132 states: “the label of the distributor product is the same as that of the registered product” with listed exceptions. One listed exception is that the distributor may delete specific claims that are found on the basic registrant’s label. Distributors may not add claims that don't appear on the basic registrant's label. EPA considers placement on the label of a third-party certification such as the NSF logo to be a claim, and therefore a distributor may not add it to the distributor label unless it also exists on the label of the basic registrant’s product. For guidance on the use of the NSF label generally, see http://www.epa.gov/oppad001/nsflogo.htm.
Does the Agency allow the use of the GHS corrosive symbol on supplemental distributor labeling without the symbol being on an approved stamped label? (LC09-0192) 8/28/08

40 CFR 152.132(d) requires that "the label of the distributor product is the same as that of the registered product" with certain listed exceptions such as the product name, registration number and establishment number. Inclusion of additional symbols or graphics on a distributor label is not one of the exceptions. Thus the basic registrant would have to add the GHS corrosive symbol to their label first before a distributor could use it.
A pesticide dealer copies mixing directions from a product label, puts them on a sticker, and puts the sticker on the products he sells. He also puts a sticker with his business address on the containers. Does either sticker misbrand the products? (LC08-0232) 2/26/09
Both activities are unlawful presuming the dealer is not acting with the permission of the registrant and in accordance with various regulatory requirements. FIFRA § 12(a)(2)(A) states that it is unlawful “to detach, alter, deface, or destroy, in whole or in part, any labeling required [under FIFRA].” Putting the copied mixing directions on another product is considered labeling and must be done in a registered establishment and in accordance with the registration of the product to which the sticker is added. If the product getting stickered doesn’t include the sticker information as part of its approved labeling, the product would be misbranded.
Pesticide/fertilizer labels in certain states must have a label attached to the package, which includes an acceptable internet statement (e.g. "Information regarding the contents and levels of metals in this product is available on the internet at: http://www.aapfco.org/metals.htm.) Is it legal for a supplemental distributor to add the internet statement on their supplemental distributor fertilizer/pesticide product labels when the master EPA label does not have this statement? (LC08-0197) 10/30/08

The label of a distributor product must be identical to the master label of the parent product, except as provided in 40 CFR 152.132(d). A supplemental distributor may not add statements such as that proposed in the question unless the master label of the parent product is amended to include the statement
If a registered pesticide label is distributed in both the USA and in another country does the Agency allow both the USA Distributor Company's Division Name & address and the International Distributor Company's Division Name and address on the same supplemental label? (LC08-0193)

40 CFR 156.10(a)(1)(ii) requires that the name and address of the producer, registrant, or person for whom produced appear on the label. Further 40 CFR 156.10(c) requires that if the producer is not the company listed in the name and address on the label, the name and address must be qualified by a phrase such as “Distributed by,” “Produced for,” or “Sold by” to show that the name appearing on the label is not that of the producer. So long as the qualification is not false or misleading, the international distributor’s name and address may be added to the label if it is properly qualified by a phrase such as “Distributed Internationally by” or “International Distributor:”. See FIFRA sec. 2(q)(1)(A).
In a situation where a registrant voluntarily cancels a registration, the registrant generally has 18 months to continue to sell product in channels of trade. When a basic registrant terminates a supplemental registration, does the sub-registrant (the supplemental distributor) have the same 18-month period to sell product? (LC08-0156) 3/20/08
EPA interprets 40 CFR 152.130(c) 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 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).
Must a subregistrant use the warranty statement that is on the Basic Registration label? The subregistrant wants to substitute its own warranty statement. (LC08-136) 12/13/07
40 CFR § 152.132(c) generally limits that changes that can be made between a registrant’s label and a supplemental distributor’s label to the name of the product, the name and address of the distributor, the registration and establishment numbers and a deletion of claims on the distributor product. However, because warranty statements are not required by EPA to be on pesticide labels, the Agency will allow supplemental distributors to use their own warranty statements so long as such a change to the labeling is allowed by contract between the registrant and the distributor and the substitute warranty statement is not false or misleading. See FIFRA Compliance Program Policy No. 3.2 (May 10, 1982). Any revised warranty statement on a distributor's label cannot expand upon, either explicitly or implicitly, the uses allowed on the registrant's label and cannot conflict with the claims stated on the label. For help in developing an acceptable warranty statement, see the guidance available at http://www.epa.gov/pesticides/regulating/labels/pdf/warranty.pdf (11 pp, 60K, About PDF)
We are a supplemental distributor registrant for a product. One of our customers would like to buy our subregistered product, but they would like to have their name and logo on the packaging. Can we label the product with our customer's name, address and logo on the front panel, qualified by "Sold by"; and still put our name, address, Reg. No., and Est. No. on the back panel, qualified by "Distributed by"? (LC08-0131) 1/31/08

40 CFR 152.132(d) requires that the labeling of the distributor product be the same as that of the registered product with the following exceptions:

(1) The product name of the distributor product may be different (but may not be misleading);
(2) The name and address of the of the distributor may appear instead of that of the registrant;
(3)The registration number of the registered product must be followed by a dash, followed by the distributor’s company number (obtainable from the Agency upon request);
(4) The establishment number must be that of the final establishment at which the product was produced; and
(5) Specific claims may be deleted, provided that no other changes are necessary.

These exceptions do not allow for the supplemental distributor to put a customer’s information on the label. However, the supplemental distributor could incorporate the customer’s name into the product name (e.g. X’s insecticide) so long as the new product name is not misleading and the registrant allows the subregistrant to make such a change under any applicable contracts between the registrant and subregistrant.
Our company imports a commodity chemical from outside the US into a public warehouse. One end-use of the chemical is as an EPA-registered pesticide. The quantity of this chemical that we currently have in stock at the public warehouse is not labeled. When we receive an order for the EPA-registered pesticide, the warehouse labels packages of the product with the registrant’s label and ships it to the customer. The registrant provides the necessary labels for the warehouse to affix to each package. Do we as the distributor need to be registered in order to direct our third-party public warehouse (physically in possession of the product) to affix the labels on the registrant's behalf? Or does the warehouse need to be registered, or both? ( LC07-0120)

The person doing the labeling must be doing so under the instruction of the registrant but does not have to be registered. In contrast, the warehouse where the labeling is taking place must be registered as a pesticide producing establishment since labeling is defined as production of a pesticide and all pesticide production must take place in a registered establishment. See 40 CFR Part 167. The establishment number of the warehouse where the labeling is taking place must appear on the label of the product. 40 CFR 156.10(a)(1)(v). You may obtain an establishment registration for the warehouse by contacting the EPA Regional office which has jurisdiction over the state where the warehouse is located. For more information on the establishment registration process and reporting obligations see: http://www.epa.gov/Compliance/monitoring/programs/fifra/establishments.html.
Is it acceptable for a Supplemental Distribution of a Registered Pesticide Product form to have two distributor product names listed in the box (e.g. XXX Algae Relief and Algae Pond Relief)? In the past, each distributor product has had its own form. (LC07-0105)

In accordance with 40 CFR 152.132(a) each distributor must complete a signed Notice of Supplemental Distribution of a Registered Pesticide Product (EPA form 8570-5), however, the form can contain more then one brand name. So, it is possible for a distributor to list two product names on the form. The names would have to be for the same registered product and be submitted by the same distributor.
My questions are in regard to a combo product, a fertilizer with a pesticide on it. When sub-registering a product, and the Primary label mentions "spreader settings" on the label, is it a requirement for the sub-registered label, to carry this same statement about what the settings should be, or is it permissible to include a general statement of contacting the spreader manufacture for up to date settings for the product, due to the large amount of spreaders and possible changes, and also since "spreader settings" is not a FIFRA or 40 CFR label requirement? (LC07-0086)

A distributor label under Supplemental Distribution must be the same as that of the registered product except for a limited set of exceptions, 40 CFR 152.132(d). Directions for Use are not excepted and must be identical to those of the registered product. Therefore, the “spreader settings” of the parent registered product must be used on the Distributor label, being a part of the Directions for Use. If the distributor label included any additional text not included on the registered product label, it would not be the same as the registered label, and thus in violation of the regulations.
May distributor labels differ from EPA-accepted labels? (LC07-0089)

40 CFR 152.132(d) requires that "the label of the distributor product is the same as that of the registered product" with certain listed exceptions such as the product name, registration number and establishment number. In addition, claims may be deleted for the distributor label provided no other changes are necessary (40 CFR 152.132(d)(5)).
In situations where a product is produced by a contract manufacturer as well as the registrant, could the registrant preface his name and address on the label with the term "produced for" regardless of whether he is the producer or the contract manufacturer is the producer of the pesticide? (LC06 -0059)
A registrant may qualify his name and address with the term "produced for" regardless of who is the producer of the product. The registrant may also qualify his name and address with the terms "Sold by" or "Distributed by," which are equally acceptable. See, generally, 40 CFR 156.10(c).
Can a product label list the distributor's name and address on the packaging label in the absence of the distributor's company number appended to the product registration number? The product is not "sub-registered" to the distributor, but is an alternate brand name, with the ABN including the distributor's name. (LC06-0052)

A product label may list a distributor's name and address on the label without the distributor's company number appended to the product registration number. If the distributor is not the producer of the pesticide, the distributor's name and address must be qualified as required in 40 CFR part 156.10(c).
Is it a violation of FIFRA if the literature accompanying a supplemental distributor label lists more microorganisms than those listed on the distributor label even if the organisms listed in the literature are also listed on the EPA-approved master label? (LC06-0035)

No, it would not be a violation of FIFRA. With some exceptions, not relevant here, 40 CFR 152.132(d) requires that the label of the distributor product be the same as that of the registered product. The term "label" is defined as "the written, printed, or graphic matter on, or attached to, the pesticide or device or any of its containers or wrappers." FIFRA sec. 2(p)(1). The more expansive term "labeling" is defined as "all labels and all other written, printed or graphic material." that accompanies a pesticide or device at any time or to which reference is made on the label or in literature accompanying the pesticide or device. FIFRA sec. 2(p)(2). As long as the EPA-approved master label for the registered product lists these pests, the supplemental distributor can market its product with those approved uses, claims, etc.
A company is proposing to distribute a pesticide product which currently has an EPA registration number. On the front of the label, they would like to indicate their brand and on the back of the label, they would like to indicate a "Distributed by" notation with the address of the distributor. First, can they do this without reregistering the product? Second, does a distributor number need to be included and if so, how does a distributor become registered (and is it a per-product registration)? (LC07-6-0007)
The distribution or sale of a registered product under a distributor's name and address is called "supplemental distribution." The requirements for supplemental distribution are set out in 40 CFR 152.132. The product can be distributed as a distributor product without a separate FIFRA section 3 registration. The distributor would need to be a registered company with their own company number - that company number would be used on all their distributor products. Their EPA Registration number on the distributor products would look something like this: EPA Reg. No. xxx-xxx-xxx or [parent company, number]-[product number]-[distributor company number]. The company numbers may be acquired through the nearest EPA regional office, or by written request to OPP. The Label Review Manual provides a more detailed explanation of supplemental distribution process in Chapter 14-1, Section III.
If a distributor sells a pesticide with another registrants name and EPA information on the container, can that distributor apply a tag or label stating:

Sold By:
XYZ Distributors
Anywhere, USA

This information would only be used to identify where the consumer may have purchased the product. An example might be a garden center selling "Round-Up" Weed Killer and applying a small sticker to the side of the container with his name and phone number on it. (LC06-0024)
A distributor may not place a tag or sticker to a product as this is considered labeling and the product would be considered misbranded.
Can a box of twelve pesticides be shipped by a formulator to a private-label distributor unlabeled? EPA-approved private labels are affixed by the distributor upon receipt? Would the box need to be relabeled? (LC06-27)
A formulator may ship unlabeled pesticides to a private label distributor provided the pesticides are transferred to a registered establishment and the conditions of 40 CFR Part 152.30(b) are met. The private label distributor may label the products under a contract manufacturing agreement with the registrant of the pesticide product. The container the unlabeled pesticides are shipped in must bear the label of the registered product.

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