Pesticide Labeling Questions & Answers - Packaging
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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)
- In the labeling of pesticide products:
Say two or more products are sold together in a cardboard tray.
The tray does not qualify is an "outside container" because only the bottom portion of the pesticide label is covered.
Would ALL covered language (such as claims and other non-mandatory language) need to be duplicated on the tray, or only the EPA required language (i.e. ingredients, disinfectant claims, cautionary text, etc.)? LC13-0652; 08/27/13
40 CFR 156.10(a)(4) requires that the label appear on or be securely attached to the immediate container of the pesticide product. If the immediate container is enclosed within a wrapper or outside container through which the label cannot be clearly read, the label must also be securely attached to such outside wrapper or container, if it is a part of the package as customarily distributed or sold. While marketing claims and other non-mandatory language (e.g. a warranty statement) generally must be approved by EPA before being included on a label, a registrant may choose where and when to include them so long as their presence or absence does not cause the label to be false or misleading or otherwise misbranded as defined in FIFRA sec. 2(q). In short, these non-mandatory label elements do not have to be duplicated on the tray.
- Recently went to buy some rat poison and the store had broke up the bulk 8 packages and are selling them as individual packs even though it says not intended to be sold individually. They are sealed in their individual packs from the original bulk pack. Are there consequences of doing so? LC12-0583; 12/18/12
Selling and distributing a pesticide in package sizes that have not been approved by EPA or with labeling that does not conform with the EPA-accepted labeling may be a violation of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Violations of FIFRA can lead to civil or criminal penalties. For more detail, see EPA's FIFRA Enforcement Response Policy, which is available at http://www.epa.gov/compliance/resources/policies/civil/fifra/fifra-erp1209.pdf/
- If you buy a product from a company and repackage it to smaller quantities for resale, how do you use the parent company's label with your company name? Does it have to be subregistered and if so, how? LC12-0539; 07/15/12
There are a number of ways a company may repackage a registrant's product. A company may enter into a supplemental distribution agreement with the registrant to sell or distribute the registrant's product according to the conditions found in 40 CFR § 152.132. The distributor product would bear the supplemental registrant's company name with the appropriate qualifiers (see 40 CFR § 156.10(c)).
A second alternative would be for the registrant to amend their registration by adding an alternate brand and container size for the product your company wishes to sell if they do not already sell the product in that container size. Again, the label could bear your company's name and address with the appropriate qualifiers as described in 40 CFR § 156.10(c).
The third alternative would be for your company to register your own product as a 100% repack of the first registrant's product. If you choose that option contact the ombudsperson of the relevant registering division (http://www.epa.gov/pesticides/regulating/contacts.htm) in OPP for more information on the process for registering a pesticide as a 100% repack.
- If a product is packaged in a small size that involves an outer box, with the Front Panel requirements, and a pouch inside the box with the full directions for use on a folded up insert label, is that acceptable. Does any other language besides the required Front Panel statements have to be on the outer box (provided the full label is on the inner insert)? LC12-0521; 05/11/12
A pesticide product label must appear on or be securely attached to the immediate pesticide product in accordance with 40 CFR 156.10(a)(4) and, if the product has an outer container through which the label cannot be clearly read, the label must also be securely attached to the outer container. 40 CFR 156.10(a) lists the contents of a pesticide label. Each piece of information listed in 40 CFR 156.10(a) must appear on the label unless there is a specific provision allowing it to appear elsewhere. For example, 40 CFR 156.10(i)(1)(ii) allows the directions for use to "appear on printed or graphic matter which accompanies the pesticide provided that: (A) If required by the Agency, such printed or graphic matter is securely attached to each package of the pesticide, or placed within the outside wrapper or bag; (B) The label bears a reference to the directions for use in accompanying leaflets or circulars, such as 'See directions in the enclosed circular;' and (C) The Administrator determines that it is not necessary for such directions to appear on the label." Certain label elements must appear on the front panel, for example, the signal word and child hazard warning in accordance with 40 CFR 156.60(a). But including just the items required to be on the front panel on the outer container may not be sufficient. For example, in some cases, the first aid statement may not be required on the front panel. See 40 CFR 156.68(d). But the first aid statement must always appear on the label as opposed to solely on an insert.
- Could you provide information that would define the allowable use period of refillable containers. Is this based on years of use (a specified number), or determined by individually testing each container prior to refilling (failure of container would end use period)? LC11-0487; 12/29/11
There is no maximum lifetime (specified number of years) for refillable containers in EPA's pesticide container regulations. Under EPA's regulations, refillable containers can be used as long as they continue to pass the visual inspection required before each refill by EPA's regulations (40 CFR 165.70(f)) and any leakproofness test and periodic inspections specified in the Department of Transportation (DOT) requirements that EPA incorporated into the refillable container regulations in 40 CFR 165.45(a) & (b). In addition, refillers should look carefully at their repackaging contracts with the pesticide registrants because those contracts may specify maximum life spans for certain types of containers.
- What information is required on the outside of a shipping container for pesticide products. The shipping container will have a number of labeled retail pesticide products inside. (LC10-0345; 7/21/10)
40 CFR 156.10(a)(4)(i) states that: “The label shall appear on or be securely attached to the immediate container of the pesticide product.” The regulations go on further to state: “If the immediate container is enclosed within a wrapper or outside container through which the label cannot be clearly read, the label must also be securely attached to such outside wrapper or container, if it is a part of the package as customarily distributed or sold.”
If the pesticide product is customarily removed from the shipping container prior to being distributed or sold to the end user, the shipping container does not have to bear the full product label. If the shipping container is the unit which is customarily distributed or sold to the user the shipping container must bear the full product label. While the regulations do not require specific labeling for shipping containers, the Agency recommends that the shipping container be labeled with enough information for emergency personnel to be able to identify the material in the shipping container in the event of an accident or spill. Be advised that DOT may require labeling of the shipping container depending on the characteristics of the material being shipped.
- A registrant holds a registration on a place-pack style product, a product that contains multiple individual use items that are not intended for individual sale and are packaged into various larger offerings. Must the individual place-pack items bear the identical language to the outer container or is it acceptable to use a "shortened" version? If a retailer were to then attempt to sell the place-pack items individually, who would be held responsible? Would it be acceptable for a supplemental distributor to use the full label text on the individual place-pack items to protect against liability in the event a retailer split them up (even though the Basic is using the shortened version on their individual items)? (LC08-0208; 2/26/09)
Individual items in a place-pack-style product may bear the full label or an abbreviated label. If the individual items bear a full label, they may be sold individually provided the amount contained in the place-pack is sufficient to control the pest for which it is intended. If the individual items bear an abbreviated label, they must refer to further directions on the outer container and bear a statement prohibiting individual sale. Sale of individual place-packs with abbreviated labeling is a violation of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) because they would not contain all required label language and therefore would be misbranded. See FIFRA secs. 2(q) and 12(a)(1)(E). If the basic registrant markets individual place-packs of a product with both full and abbreviated labels, the sub-registrant may market his place-pack products with either label. With the basic registrant’s permission, a supplemental distributor may put the full label on individual place-packs even when the basic registrant labels their individual place-pack products with an abbreviated label only. If a retailer sells individual place-pack items that bear a partial label he would be in violation of section 12(a)(1)(E) of FIFRA for selling or distributing a misbranded pesticide. Sale of individual, fully labeled place-pack items in units that are not sufficient to control the pests by either a retailer or a supplemental registrant could be a violation of FIFRA sec. 12(a)(1)(E) if the label doesn't sufficiently indicate that the individual place-pack item will not control a pest on its own.
- At a bulk terminal where a blank net contents and blank EPA Est. No. are printed onto a laminated label, would it be acceptable to place stickers with appropriate information beneath the blank portions of the preprinted label? The lamination makes it difficult for terminals to write in the information with permanent marker and it often fades once in the field. (LC08-0233; 1/28/2009)
It would be acceptable to place stickers with the appropriate net contents and establishment number on the label, provided the stickers, like the label itself, are securely attached to the label and can reasonably be expected to remain affixed during the foreseeable conditions and period of use. See 40 CFR part 156.10(a)(4). Such stickering must occur at a registered establishment and be recorded per the requirements of 40 CFR Part 167.
Where can I find a list of EPA-approved inks for Water Soluble Packaging (WSP)? (LC08-0206; 9/22/08)
There is no specific list of approved inks for water soluble packaging (WSP). For a listing of inert ingredients permitted for use in nonfood use pesticide products refer to the Agency web site http://www.epa.gov/opprd001/inerts/inert_nonfooduse.pdf. For a listing of inert ingredients permitted for use in food use pesticide products refer to the tolerance exemptions listed in 40 CFR 180 beginning with 40 CFR 180.910 (available at http://www.access.gpo.gov/nara/cfr/waisidx_07/40cfr180_07.html).
- Is Draft PR Notice 2002-X in effect? Section IV. B. 2 of Chapter 12 of the Label Review Manual seems to be in conflict with PR 2002-X, regarding use of superlative terms in product brand names. Can a term like, "Super" or "Ultra" be used in a product brand name without qualifying it with the term "Brand"?; are the other disclaimers in PR 2002-X required at this time? (LC07-0124; 11/1/07)
PR Notice 2002-X is only a draft PR Notice, and is not in effect at this time. Section 12(a)(1)(e) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) makes unlawful the sale or distribution of any pesticide which is misbranded. "Misbranded" is defined, in part, in FIFRA 2(q)(1)(A) as bearing "any statement ... which is false or misleading in any particular." You should rely on the Agency regulations concerning false or misleading claims [40 CFR 156.10(a)(5) and 40 CFR 156.10(b)(2)]. In particular, 40 CFR 156.10(a)(5)(iv) lists "a false or misleading comparison with other pesticides or devices" as an example of a claim that may constitute misbranding. Additional guidance on this issue is limited to the Label Review Manual. The descriptors "Super" or "Ultra" may be found to be misleading on a case-by-case basis, if EPA determines that these terms in context imply unwarranted claims of heightened efficacy. We suggest that you speak to the Product Manager assigned to your pesticide to discuss whether these terms are acceptable for your product.
PR Notice 94-8 on Water Soluble Packaging (WSP) at II.4 states "Labeling of an individual WSP unit is optional if the WSP is integrally sealed in an outer container that bears appropriate labeling." Would you please clarify if this applies when more than one (i.e., 2 - 4) WSP packets are placed in one sealed outer container that bears appropriate labeling. (LC07-0096)
If the directions for use on the outer container require that all WSP units inside be used at the same time, labeling of the individual WSP units is optional. If the units may be used separately, the minimum labeling on each unit should be in accordance with PR Notice 94-8 so that each unit would be labeled in the event it becomes separated from the outer container. PR Notice 94-8 lists the following elements for labeling inner WSP units: product name, statement of active ingredients, signal word, skull and cross bones if required, Keep out of reach of children statement, EPA registration number, restricted use statement if so classified and a referral statement to the main label.