![[logo] US EPA](http://www.epa.gov/epafiles/images/logo_epaseal.gif){kind=logo}
Label Review Manual
Chapter 18: Unique Product Labeling
Table of Contents
Chapters:
- Purpose of Manual
- What is a Pesticide?
- General Labeling Requirements
- Types of Label Reviews
- Ingredient Statement
- Use Classification
- Precautionary Labeling
- Environmental Hazards
- Physical or Chemical Hazards
- Worker Protection Labeling
- Directions for Use
- Labeling Claims
- Storage and Disposal
- Identification Numbers
- Company Name and Address
- Graphic & Symbols on Labels
- Content/Net Weight Statement
- Unique Product Labeling
- The Consumer Labeling Initiative and Pesticide Labels
I. Introduction
Certain specialty products pose a challenge to meeting the regulatory labeling requirements. Package size, shape, and composition often dictate unorthodox approaches to attaching the necessary information. While many labeling provisions of 40 CFR 156.10 are mandatory, other provisions provide the flexibility necessary to address challenging specialty products. The following examples have been accepted by the Agency and may be used as models for new and novel products that may be developed in the future. Label reviewers must address each product on a case-by-case basis, and determine whether the labeling meets applicable legal requirements.
II. Multi-Packs/Co-Packs
- A Registered Pesticide Packaged with a Non-Pesticide. A registered
pesticide product, in one container, may be packaged with a non-pesticide
component, such as an adjuvant, in a separate container (which is to be
added to the pesticide during mixing). These two containers, combined
in one package, may be sold as a single unit only if the adjuvant is referred
to in the Directions for Use on the label.
- The two containers are distributed and sold as a single retail unit, and together comprise the pesticide product. (See 40 CFR 152.3 and FIFRA 2(u) defining pesticide to include a “mixture of substances”). If the two components are bound together with a shrink-wrap sleeve or in a box, the full panel of the pesticidal component must be visible through the wrapping, or the label must be duplicated and attached to, or printed on, the outermost container.
- The regulation at 40 CFR 152.3(t) states that the "pesticide product" includes the package intended to be distributed or sold. EPA has jurisdiction over the packaging and labeling of any "non-pesticide" which is part of the package. This means that the Agency reviews and accepts or disapproves of the non-pesticide that is packaged with the pesticide. The reviewer examines the non-pesticide labeling to determine whether it contains any language that conflicts with the pesticide label, but the reviewer does not actually stamp the non-pesticide label. An example of such a non-pesticide would be an activator (such as potassium permanganate) which accompanies a pesticide (sodium bromide). EPA reviews the labels for both products, but stamps only the accepted pesticide label, noting any problems or changes needed for the non-pesticide label.
- Two or More Pesticides Packaged Together. Two or more pesticide products
may be packaged in separate containers but sold together as a single
unit and intended to be tank mixed just before application. [FIFRA 2(u)]
- Each container must bear, or be accompanied by, full labeling, and the full labels of both containers must be visible. If the outermost packaging obscures any part of the labeling of the pesticides, the full labels must be duplicated and attached to the outermost container. [40 CFR 156.10(a)(4)(i)]
- Policies regarding the labeling for multi-packs and co-packs are being clarified by the Agency. Registrants should contact the Registration Division for additional information before submitting registrations or amendments that feature multi-packs or co-packs.
III. Small Containers
- Some containers are too small to contain all required label text. In such cases, it is permissible to have text located on accompanying pamphlets which are considered labeling. The Agency historically required certain information to appear on the label of small containers: ingredient statement, signal word, skull and crossbones (when required), child hazard warning, EPA Registration Number and EPA Establishment Number, the phrase "RESTRICTED USE PESTICIDE" (if so classified), and a reference statement to any accompanying pamphlets. Outer boxes, bubble packs, accordion-pleated attached labels, and plastic self-sealing envelopes containing additional labeling have been accepted.
- Whatever the approach, it is important to stress that ALL labeling must accompany the product at point of sale, and that the immediate container must bear a statement referring the user to the location of any additional labeling which is securely affixed to the container. All of this labeling must be reviewed and accepted. Registrants are encouraged to consult with the Agency about special labeling needs.
IV. Soluble Packets
- An increasingly popular means of packaging dry pesticides is the water-soluble packet. For some chemicals, EPA has required water-soluble packaging to reduce exposure of mixer-loaders to dust, vapor, or liquid pesticides. This method of packaging, however, presents problems in labeling. Since the immediate container is the film, a strict application of the regulations would require front panel text to be printed on the film itself. Although recent technological advances have made such printing possible, most standard printing techniques and inks are not compatible with the polyvinyl alcohol films. In order to accommodate this desirable method of packaging, the Agency has accepted other labeling approaches. See PR Notice 94-8 for complete information.
- The most widely used packaging is a tear-open foil envelope containing each soluble packet; the foil envelope bears the required labeling. This foil envelope method has the added benefit of protecting the soluble packet from moisture which could cause shelf-life problems. Another acceptable method is a muffin-pan type of package where each packet is enclosed in a depression with a tear-off top that seals each chamber. The tear-off top bears the required labeling.
- A vital consideration in dealing with soluble packets is how to reduce the likelihood of the user removing unlabeled packets from labeled containers long before use and then forgetting what they are. Because laundry detergents and dry bleaches are also manufactured in soluble packets, there is the possibility that pesticides could be mistaken as these products. The Agency believes that simply packaging a quantity of unlabeled soluble packets in an outer container where they could be easily separated from the accompanying labeling does not meet the FIFRA registration standard. EACH packet must either bear identifying labeling on the film itself (where feasible) or on packaging immediately enclosing that packet. PR Notice 94-8 describes in more detail the concerns the Agency has with pesticide products containing water-soluble packaging (See Chapter 10 for reduced Personal Protective Equipment for water-soluble packaging products subject to the Worker Protection Standard.)
V. Bulk Containers
Agricultural pesticides are often sold by dealers out of bulk tanks and pumped directly into spray rigs or truck-mounted tanks brought to the dealer by the farmer or applicator. This method of sale has the advantage of reducing the number of empty pesticide containers and the attendant disposal problems. In such cases, the dealer is obligated to deliver the full label to the purchaser at the time of sale. Such labels are supplied to the dealer by the registrant. Often registrants are using smaller containers in the field filled with products from these bulk containers which are called “Refillable Containers”. The label reviewer must ensure that the label language does not preclude the reuse of the container.
VI. Foreign Language Labeling
- Foreign language text, in addition to the full English text, is permitted in part or its entirety on the product so long as it is a true and accurate translation of the English text. (See PR Notice 98-10) A registrant may provide bilingual labeling on any product without notification. However, if it is submitted, the Office of Pesticide Programs (OPP) currently does not review the translation for accuracy or stamp/approve it. If the foreign text is inaccurate or goes beyond the reviewed and accepted English labeling, the Office of Enforcement and Compliance Assurance may take enforcement action. Products marketed in Puerto Rico can be labeled in English only or in English and Spanish.
- Some registrants have requested that they be allowed to translate
just the signal word and the statement used on the labels of products
falling under the scope of the Worker Protection Standard (WPS) in cases
where they know that their product users are not fluent in English. This
is allowed by OPP. In cases where they are translating into Spanish, the
Spanish signal word for toxicity category I products is "PELIGRO"
and for toxicity category II products is "AVISO." The statement
that appears on toxicity category I and II WPS products is as follows:
"Si usted no entiende la etiqueta, busque a alguien para que se la explique a usted en detalle. (If you do not understand the label, find someone to explain it to you in detail.)"
VII. Pesticides Used to Treat Seeds
- Pesticides bearing directions for seed treatment (as opposed to drill-box, planter-box, and slurry treatments done by the farmer immediately before planting) are required to have either a dye in the formulation unless there is a tolerance for residue of the pesticide. [40 CFR153.155(a).] Products intended and labeled for use only by commercial seed treaters need not have dyes if the labeling clearly advises the user to add an EPA approved dye with the pesticide during the seed treatment process. [40 CFR 153.155(b)(1).]
- Below are EPA policy statements regarding seed treatment label statements about the use of the treated seed for food, feed, or oil. See Criteria and Policy Notice 2170.1. For certain products, the Agency has found these statements to be required in light of incidents involving use of treated seed for food/feed purposes.
- For Commercial Seed Treatment Products
Treated seed must not be used for or mixed with food or animal feed, or processed for oil. Seed commercially treated with a pesticide must be labeled as follows: “Treated Seed. Do not use for food, feed or oil.”
- For Hopper-Box Use Products, that is, if the product is intended
for direct use on seed at planting time:
- “Do not use treated seed for food or feed purposes or process for oil. Treat only those seeds needed for immediate use, minimizing the interval between treatment and planting. Do not store excess treated seeds beyond planting time.”
- Dye used to color the treated seed must be an EPA approved dye. Refer to 40 CFR 153.155(c).
- For seed treatment products that may be under the scope of WPS depending
on the type of treatment please add the following:
“Seed treatment on agricultural establishment in hopper-box, planted box, or other seed-treatment application at or immediately before planting is within the scope of WPS, while commercial treatment of seeds is not within the scope.”
VIII. Child-Attracting Packaging ("Attractive Nuisance")
From time to time, registrants package pesticides in containers attractive to children. Bait-type pesticides for rodents and roaches have been marketed in little doll houses, fire trucks, and other toy-like dispensers or containers that look like food containers, e.g., a milk-carton shape. The Agency has not found these types of packages to be acceptable. It may be difficult for the reviewer to determine the package style when the final printed label is only a printer's proof and is not usually given a final review. However, certain types of products amenable to such unacceptable packaging should be checked and if any doubt or suspicion arises, the applicant should be required to submit the intended packaging before the product is registered. The Agency can require child-resistant packaging when the toxicity criteria and use criteria are met. See 40 CFR 157.22.
IX. Secondary Containers
- There are limited cases (e.g., custom blenders at 40 CFR 167.3) where
users of concentrated products dilute and then use/store the product in
a separate unmarked container (secondary container). Although the Agency
does not require labels on secondary containers, it will allow registrants
to provide labels to users for secondary containers that are used to apply
or temporarily store end-use pesticides as long as the labels that accompany
the secondary container are "not inconsistent" with the EPA
approved label and the label includes the following information:
- Product name;
- EPA registration number;
- Name and percentage of active ingredient, followed by the phrase "The product in this container is diluted as directed on the pesticide product label."
- Signal word and precautionary statements from the registered label unless the registrant has acute toxicity data supporting a lesser precautionary statements for the diluted product; and
- The statement: "Follow the directions for use on the
pesticide label when applying this product."
(Note to reviewer : There are also secondary containers which are not diluted, but are filled from a large container to be used/stored in the field. These may need less or additional label information. Contact your product manager or the for guidance.)
- "Not inconsistent" means that the registrant has met the above conditions and that the secondary labeling has no other statements which directly conflict with the approved pesticide label.
- Registrants are not required to submit secondary labels for review by the Agency; however, if the secondary label is inconsistent with the EPA approved label, the Agency will consider the product misbranded. This guidance does not apply to hand-held containers used by structural pest control operators.
X. Child-Resistant Packaging
- Child-Resistant Packaging (CRP) is defined as packaging that is designed or constructed to be significantly difficult for children under 5 years of age to open or obtain a harmful amount of the substance contained therein in a reasonable time and that it not be difficult for normal adults to use properly. See 40 CFR 157.21(b)
- If the pesticide is subject to CRP regulations the registrant must certify (40 CFR 157.34) to the Agency that the pesticide as packaged meets the standards set forth in the regulations (40 CFR 157.32). These standards are Child-Resistant Effectiveness (85% before demonstration, 80% after demonstration, 42-51 months of age), Senior Adult-Use Effectiveness (90% 50-70 yrs old), product packaging compatibility, and product-packaging durability (for its lifetime the product as packaged must continue to meet the effectiveness and compatibility standards). An example of the proper CRP certification language is found in PR Notice 96-2. Additionally, a registrant must maintain adequate records to substantiate the CRP certification for the life of the pesticide registration. The Agency has exempted some products from CRP (i.e., prefilled, nonrefillable ant and roach insecticide bait stations not designed or intended to be opened or activated in a manner that exposes the contents to human contact). This exemption set out in the Federal Register is discussed in PR Notice 97-9.
- Any changes in CRP will require an amendment of the pesticide registration (40 CFR 152.44) and a new CRP certification, including its designation using the American Society for Testing Materials (ASTM) standard D3475-95 “Standard Classification of Child-Resistant Packages,” should accompany the amendment. Agency approval is required before any packaging change can occur. CRP changes are not notifications.
- A pesticide product may be exempt from the CRP requirements if it is classified for restricted use, if a package is a large size as defined in (40 CFR 157.24 (a)(2)), if the pesticide is not toxic, or if an exemption is based on technical factors that preclude using the product. In the last two cases, the exemption must be approved by the Agency before the exemption can occur.
XI. Attached Label Booklets
OPP’s preference is that the precautionary information be placed on the outside of the booklet and that, if necessary, the Directions for Use be placed on the inside. However, reviewers need to keep in mind what information would be left on the container if the booklet was detached, lost, or damaged.