Pesticide Labeling Questions & Answers - Supplemental Labeling (NOT distributor products)
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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. These answers are primarily based on federal law, regulations and policies implemented by EPA. States, tribes, territories, and other federal agencies may have additional requirements relevant to their jurisdictions.
- Advertising Claims
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- Contract Manufacture
- Use Sites
- Definitions of Terms
- Distributor Product Labeling
- Exception to Use in a Manner Not Permitted (FIFRA Sec 2ee)
- Existing Stocks
- General Labeling
- Labeling from Web Sites
- Multiple Products Packaged Together
- NAFTA Labeling
- Pesticide Exemption (FIFRA 25B)
- Pictures and Logos
- Repacked Products
- Service Containers
- Subject to FIFRA
- Superlative Terms
- Supplemental Labeling (NOT distributor products)
- Can a registrant add an expiration date to a supplemental label if there is not an EPA-accepted and stamped supplemental label that also has the expiration date? LC11-426; 7/7/11
No, the registrant cannot add an expiration date without EPA's approval. With the exemption of limited changes EPA has allowed changes to be made through notification or non-notification, all labeling changes must be approved by EPA. Supplemental labels are part of the labeling for a registered product and therefore must be reviewed and accepted by EPA before any amendments to that label are allowed (see 40 CFR 152.44(a) for more information). However, the Agency would like all supplemental labeling to have expiration dates and highly encourages registrant to add expiration dates using the amendment process.
- A registrant recently received approval from EPA to add a use to their label. We recently approved the full section 3 label after our review. The registrant sent an e-mail to their local distributors with a pdf copy of the label, stating that this label may now be distributed to users who need the new use. When we informed the registrant that this was not allowed because the label on the container must be followed, they stated that no other state had such a requirement and they had never been required to produce a supplemental label for the new use. Is it an acceptable practice for the registrant to distribute a new Section 3 label to users who already have the product? LC11-400; 5/19/11
The practice you describe is likely not acceptable for two reasons. First, relabeling a pesticide product, including causing new labeling to accompany it that was not included when the pesticide was released for shipment, is considered production under 40 CFR 167.3. The establishment where the relabeling takes place must be registered in accordance with 40 CFR 167.20. If the local distributors that were instructed to hand out the new label are not registered establishments, the production would be occurring unlawfully. This is true whether the local distributors are handing out a full section 3 label or whether they are handing out an approved supplemental label that would newly accompany the pesticide since its last production step. See also, LC07-0126.
Second, when a new section 3 label is distributed with a pesticide product that has the old section 3 label attached, it is possible that inconsistencies between the two labels will make the product misbranded. For example, if a change is made that does more than simply add to what was on the old label (e.g. adding a use or adding application equipment), the differences between the two labels could lead the labeling as a whole to be misleading and therefore misbranded under FIFRA 2(q)(1)(A). It is unlawful to sell or distribute a misbranded pesticide. FIFRA 12(a)(1)(E). Generally, when OPP staff review labels that add a new use, they evaluate and approve the label as a whole new label unless it specifies that part will be used as a supplemental label at which point it would be evaluated in conjunction with the old label. Because of this, OPP would not have determined that the new label as described in the question could be used in conjunction with the old label. Therefore OPP’s approval of the new label would not be an indication that use of both labels at the same time is acceptable.
- A pesticide dealer wants to add a sticker with his company name and contact information for re-ordering purposes to large drums of pesticides he sells. Since large drums are typically the shipping container and have DOT, shipping or other non-pesticide labels attached, could he do this through a simple agreement with the registrant avoiding the need for supplemental distribution requirements. LC10-0370; 1/6/11
If the drums are the package in which the pesticide is intended to be distributed or sold to the end-user, then adding a sticker of any kind would be altering the label, which without permission of the registrant is unlawful. See FIFRA 12(a)(2)(A). If done with the permission of the registrant, adding a sticker would be considered "production" under 40 CFR 167.3, which includes such actions as “…to package, repackage, label, relabel or otherwise change the container of any pesticide or device.” "Production" must occur in a registered establishment and must be reported in accordance with section 7 of FIFRA and its implementing regulations in 40 CFR Part 167. In addition to these requirements, if the dealer and registrant are not acting under a supplemental distributor agreement, the master label approved by EPA must include the information provided in the sticker. If the dealer is a supplemental distributor, 40 CFR 152.132(d)(2) allows the distributor product label to include the distributor name and address instead of that of the registrant. This replacement would not need to be included in the master label approved by EPA.
We have a current registration for a pesticide product. The label contains language which uses "may be used to treat..." in several places. In order to eliminate any ambiguity we wish to introduce directive language. Can this be effected by use of Supplemental Labeling? (LC08-0163; 5/15/08)
Supplemental labeling in connection with section 3 of FIFRA is a term that the Agency uses to describe labeling which includes new approved uses and other information which have been accepted for a product since the last accepted Master label. Supplemental labeling introducing directive language is inappropriate because the basic directions for use of the product are being modified. This would lead to inconsistencies between the container label and the supplemental label, which are not allowed. Such a change must be made by label amendment and must be incorporated into the standard labeling rather than through a supplemental label. The Mandatory and Advisory Statements PR Notice (2000-5) provides guidance for improving the clarity of labeling statements. The PR Notice states that adding or modifying mandatory or advisory labeling statements for currently registered products must be made by submitting an application for amended registration.Voluntary changes such as proposed can be phased-in in various ways. After the revised label is approved, the fastest way to get the new label in the marketplace would be to resticker product at registered establishments. Alternatively, registrants generally have 18 months after the approval of revisions to distribute or sell product under the previously approved labeling. See 40 CFR 152.130(c). This means you would have 18 months before which the newly approved label would be required to be on products you sell or distribute. Product with previously approved labeling may generally be sold by people other than the registrant until all such products are sold.
- Please explain the conflict between the responses to LC08-0140 and LC07-0126 regarding the Agency’s position on requiring supplemental labeling to be stamped “approved.”(LC08-0165; 5-15-08)
LC07-0126 deals with use of a supplemental label prior to that use being placed on a product label and put in distribution. Question LC08-0140 discusses taking a use off of a label in production and placing it on a supplemental label. In question LC07-0126 we assumed all appropriate labeling from the product label would be placed on the supplemental labeling and this labeling had been reviewed and found approved. In reviewing question LC08-0140 we decided that because the use may be tied to the product label by many different restrictions (human precautions, environmental precautions, use etc) there is too much of a chance for conflicting information on the product label and supplemental label, therefore, the Agency needs to review and stamp the supplemental labeling. This same thought process should apply to question LC07-0126. Any supplemental labeling should be approved by the Agency. We will be revising the answer to LC07-0126 to reflect and refer to LC08-0140.
Can a registrant pull new uses/directions for use, etc. from an EPA "accepted" master label in order to produce a supplemental label or must a supplemental label be approved by EPA in order for the registrant to produce a supplemental final product label? LC08-0140, 1/10/08
Supplemental labeling (not to be confused with supplemental distribution under 40 CFR 152.132) is a term used by the Agency to describe labeling which includes newly approved uses, or other changes such as reduced/increased pre harvest intervals which have been added since the last accepted Master label. These are partial labels distributed with the product by the registrant or distributors. Since these are partial labels, they must bear a statement referring the user to the product label for complete directions, precautions and a statement that the labeling must be in the possession of the user. Both the product label and the supplemental labeling are required to safely and effectively apply the product for its supplemental use. See the Label Review Manual (LRM), Chapter 3 paragraph IV. D. (http://www.epa.gov/oppfead1/labeling/lrm/chap-03.htm).
The supplemental labeling must be submitted and stamped “accepted” by the Agency. The Agency requires that these labels bear the following information:
Misuse statement: "It is a violation of Federal law to use this product in a manner inconsistent with its labeling."
The labeling must be in possession of the user at the time of application.
Read the label affixed to the container for [pesticide X] before applying.
Use of [pesticide X] according to this labeling is subject to the use precautions and limitations imposed by the label affixed to the container for [pesticide X].
EPA Registration Number
Restricted Use Statement (if required)
Normally, supplemental labeling will be incorporated into the affixed label at the next printing of the product label (final printed label) or within 18 months, whichever comes first. However, there are circumstances when this might not be done, for example if the directions for use on the supplemental labeling are subject to continual, frequent change, e.g., California aerial application county restrictions can change every six months or so. In that case, a supplemental label will likely be replaced with a new supplemental label before it must be incorporated into the affixed label. Note that just like other labels, supplemental labels must be accepted prior to distribution.
Because supplemental labels are intended to add to the existing label and not conflict with the existing label, taking a registered use off of an existing label to make it a supplemental label would not be acceptable. If a registered use was "taken off" the existing label to be put on a supplemental label, it would still appear on the existing containers until the next printing and a supplemental label with the use would cause confusion.
If a company wanted to segregate uses that are currently on an affixed label, it would be permissible for a company to take a use(s) from a master label and place it on segregated product label that would be marketed separately with the segregated use directions on the affixed label. See 40 CFR 152.130(b). This is often referred to as Sub or Split label (see LRM Chapter 3, paragraph IV). That label would not be a “supplemental label” but a stand-alone product label under the existing registration and must comply with all applicable EPA label requirements.
- When EPA approves a label amendment to add a new use to an existing label, and the label version that EPA stamps as "Approved" is the complete Section 3 label (including the new use), the registrant will sometimes prepare a Supplemental Label to extend the new use to customers who might otherwise have access only to containers that are not labeled with the newly approved use. What is EPA’s stance on this type of Supplemental Labeling? Is the Supplemental label already considered to be “EPA approved” based on the fact that the wording is directly extracted from the EPA Stamped Label, or, must the Supplemental Label be separately “stamped” (or approved) by EPA? LC07-0126: 11-8-07
First, as clarification, the term "supplemental label" as used by the questioner does not relate to supplemental distribution under 40 CFR 152.132. A supplemental label, in the context used by the questioner, generally has been required to contain certain labeling elements including, at minimum:
Misuse statement: "It is a violation of Federal law to use this product in a manner inconsistent with its labeling."
Statements such as:
“The labeling must be in possession of the user at the time of application.”
“Read the label affixed to the container for [pesticide X] before applying.”
“Use of [pesticide X] according to this labeling is subject to the use precautions and limitations imposed by the label affixed to the container for [pesticide X].”
EPA Registration Number
Restricted Use Statement (if applicable)
Because it is important to assure that any necessary labeling elements are provided and that the supplemental labeling does not conflict with the container label, the Agency will review supplemental labeling and stamp approval. The supplemental labeling may then be used in connection with the registered product that is labeled with previously approved labeling.Please note that adding the supplemental labeling to an already produced product (whether by affixing the supplemental label to the container or by causing the label to accompany the product) is considered production and must be done in a registered establishment. Handing out supplemental labeling at a dealership, unless it is a registered establishment, is not acceptable. The label on the container and the labeling that accompany the product are the labeling that must be followed; therefore, the approved supplemental label must accompany the product and be in the hands of the user at time of application.