Pesticide Labeling Questions & Answers - Notifications
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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
- Antimicrobial Claims
- 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)
- We have an EPA-stamped draft label that makes no mention of a label booklet. In order to accommodate a smaller container, it will be necessary to move some language to a securely attached label booklet. The statement on the center panel of the stamped draft label reads: "See side panel for first aid and additional precautionary statements." This statement would be changed to: "See attached label booklet for first aid, precautionary, storage and disposal statements and use directions." Can these changes be made by notification or will the use of a securely attached label booklet and reference to it require filing a label amendment? LC10-0391; 5/19/11
PR Notice 98-10 (10 pp, 52K, About PDF) discusses what labeling changes may be accomplished through notification or non-notification pursuant to 40 CFR 152.46. Generally, reformatting of labeling can be done through non-notification. Section IV.E includes the following about redesigning labels through non-notification: "A label format change that does not modify approved label text and is consistent with the format requirements of 40 CFR 156.10 and Agency policy. These may include, among other things, changes in color, type size or style, use of space, configuration or placement of label elements." But the change you describe -- changing the reference statement to point users to a booklet rather than a side panel -- changes approved label text and therefore is not a redesign of the label format that may be accomplished through non-notification. Because the Agency has not provided elsewhere that this change may be accomplished through notification, it must be submitted as an amendment to registration under 40 CFR 152.44.
If a registrant wants to amend their label to reflect a change in storage temperature as outlined in an MSDS, e.g. for a biolarvicide product, can this change be made through the notification process? LC10-0375; 08/28/10
Storage temperature is not a data requirement generally imposed by the Agency, however, a manufacturer may include specific storage instructions which are developed on an individual basis to ensure the efficacy of the product. For example, certain microbial products may simply state "refrigerate," while others (if necessary) will list a specific temperature range at which the product should be stored. There is no standard because each microbial is unique and presents different storage issues.
When storage instructions, such as a specific storage temperature, are included on a pesticide label, they are considered part of the directions for use. According to Pesticide Registration (PR) Notice 98-10, Notification, Non-Notifications and Minor Formulation Amendments, only limited changes to the directions for use may be made by notification (see section II.M.). Other changes to the directions for use including changes to storage and disposal directions may not be made though the notification process (see section II.N.3). Therefore, a label change to reflect a change in the storage temperature (physical/chemical property) of a product must be submitted as an amendment.
If the storage temperature is not specifically mentioned on the label and instead only appears on the MSDS, it may be changed on the MSDS without amendment or notification. EPA considers an MSDS to be labeling when it accompanies a pesticide product, but EPA does not review or approve the MSDS. The MSDS must, however, not conflict with the labeling EPA has approved for the pesticide product as that could make the pesticide product misbranded
Can insecticide or fungicide groups based on IRAC (Insecticide Resistance Action Committee) or FRAC (Fungicide Resistance Action Committee) classifications be added to a label via notification or does the label need to be updated via the amendment process? (LC09-0279; 8.13.09)
IRAC and FRAC classifications refer to mode or target site of action groupings used in pesticide resistance management advisory statements. See PR Notice 2001-5 for more information. While pesticide resistance management statements are generally not required at this time, the Agency considers pesticide resistance management important. EPA encourages registrants to include both the resistance management statements and the mode/target site of action classification on product labels whenever submitting new or revised labeling to the Agency. In order to make it easy for registrants, the Agency allows the addition of resistance management statements and the mode/target site of action classification to be added to product labels by notification provided that registrant use either the wording provided in PR Notice 2001-5 or registrants use similar wording based on the attributes described in section VI of PR Notice 2001-5.
Following up on LC06-0059, can a registrant add the phrase "Produced for" to their label without notifying EPA (as a non-notification - per PRN 98-10)? (LC08-0194)
PR Notice 98-10 section IV.D, changes in name and address, indicates that non-notification would be appropriate for changes in the name and address of a registrant provided these comply with other regulatory requirements. As described in 40 CFR 156.10(c), use of qualifiers such as "produced for" are considered as part of the name and address element of a label. Use of the qualifier “Produced for” in connection with the name and address can be done via non-notification.
- PR Notice 98-10 indicates that a registrant would be able to add state required analysis of fertilizer components. We have recently been told by multiple registrants of dual (pesticide/fertilizer) products that EPA is not accepting notifications for these items. Could you please indicate which PR Notice supersedes PR Notice 98-10 in this instance. (LC07-0091)
In accordance with section IV. C., "Revision, Addition or Deletion of Non-FIFRA Related Label Elements" of PRN 98-10, state-required analysis of the fertilizer component of a pesticide product can be added to a label without amendment or notification. Although PR Notice 2000-5 does supersede sections of PR Notice 98-10, it does not supersede section IV.,C., pertaining to your question and therefore 98-10 reflects the most current guidance.
- Can language required by states be added via notifications? Does PR
Notice 20-5 (Guidance for Mandatory and Advisory Labeling Statements)
supersede PR Notice 98-10 (Notifications, Non- Notifications and Minor
Formulation Amendments)? If an amendment is necessary, what is the typical
turn around time for review of the amended label?
Under FIFRA section 24(b), states cannot require labeling different from the federally-approved label. However, states can regulate sale and use in their state. Registrants may choose to amend their label to conform to state restrictions. These amendments would have to be reviewed by the agency. The amendment could fall under various time line categories, although most would fall within the fast-track category which has a 90-day turnaround.
PR Notice 2000-5 does not supersede PR notice 98-10 in total. PR notice 2000-5 does affect one portion of PR 98-10: registrants may no longer add or change advisory labeling statements by Notification.