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Frequently Asked Questions on the Container and Containment Labeling Requirements

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This web page contains answers to questions that the Agency has received from stakeholders on the container and containment labeling requirements and Pesticide Registration Notice 2007-4 (Labeling Revisions Required by the Final Rule "Pesticide Management and Disposal; Standards for Pesticide Containers and Containment.)

Questions on this page involve:

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Scope of products that must comply

  1. Do technical products or manufacturing use products (MUPs) have to comply with the container and containment labeling requirements? Aren't't technical products exempt from the August 2006 container and containment rule?

    Yes, technical products and MUPs have to comply with the container and containment labeling requirements. Technical products and MUPs are exempt from the container and containment regulations in 40 CFR part 165, but not from the labeling requirements in 40 CFR part 156 subpart H.

  2. Do antimicrobial products have to comply with the container and containment labeling requirements? Aren't't antimicrobials exempt from the August 2006 container and containment rule?

    Yes, antimicrobials products have to comply with the container and containment labeling requirements. Some antimicrobials are exempt from some portions of the container and containment regulations in 40 CFR part 165, but not from the labeling requirements in 40 CFR part 156 subpart H.

  3. As plant-protection products, do plant-growth regulators have to comply with the container and containment labeling requirements in the August 2006 container and containment rule?

    Yes, plant growth regulators have to comply with the container and containment labeling requirements. These are not the plant-incorporated protectants specifically exempted in 40 CFR § 156.140

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Scope of containers that must comply


  1. Do products packaged in aerosols and other inherently non-refillable containers still have to say "Non refillable container. Do not reuse or refill this container."? Yes. Currently the regulations do not allow for exemptions from the identification of container type requirements in 40 CFR § 156.140 for any container.

    Yes. Currently the regulations do not allow for exemptions from the identification of container type requirements in 40 CFR § 156.140 for any container.

    However, the Agency has proposed amendments to the container and containment regulations to exempt some inherently non-refillable container types from the identification of container type requirements and to allow the Agency to grant waivers and exemptions from these requirements for other container types on a case-by-case basis (73-FR-3305). See FAQ #22 for additional information on proposed changes to the container and containment regulations in 40 CFR part 156 subpart H and part 165.

  2. Do International Standards Organization (ISO) tanks, tank cars, and compressed gas cylinders have to bear residue removal language for cleaning the containers prior to final disposal?

    The Agency recommends that registrants who package their pesticide products in tank cars, ISO tanks, and compressed gas cylinders request waivers of the residue removal requirements in 40 CFR § 156.156, as allowed by 40 CFR § 156.144(d). The Agency assumes that these types of containers would be considered refillable containers, as defined in 40 CFR § 165.3.

    In addition, the Agency has proposed amendments to the container and containment regulations that, among other things, will exempt labels from bearing residue removal instructions applicable to transport vehicles (e.g., tank cars, ISO tanks) and compressed gas cylinders (73-FR-3305). See FAQ #22 for additional information on proposed changes to the container and containment regulations in 40 CFR part 156 subpart H and part 165.

  3. Are fiber drums with plastic bag liners considered "rigid"?

    No. For the purposes of the container and containment regulations, the Agency is not considering fiber drums with plastic bag liners to be "rigid" containers. The immediate container that the pesticide itself is in contact with is the flexible bag liner. Therefore, these types of non refillable containers containing a solid dilutable pesticide would not need to bear the triple rinse statements from 40 CFR § 156.146.

    However, please note that if these containers are refillable, then they would need to bear residue removal language appropriate for that type of container, per 40 CFR § 156.156. Existing container disposal statements from PR Notice 83-3 likely would fulfill this requirement.

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Definitions


  1. What does "rigid" mean?

    By rigid containers, EPA means containers that have definite retained shape and form and that are self-supporting. This is described in more detail in EPA's response to comments document in the docket for the final pesticide container and containment rule. Examples of rigid containers are plastic jugs and metal containers.

  2. What does "dilutable" mean?

    Dilutable means that the pesticide product's labeling allows or requires it to be mixed with a liquid diluent prior to application or use. This definition is incorporated in the non refillable container residue removal standard in 40 CFR § 165.25(f)(1). The Agency intends to make this definition more prominent through proposed amendments to 40 CFR section § 165.3 (see FAQ #22)

  3. What does "refillable" mean?

    "Refillable container" means a container that is intended to be filled with pesticide more than once for sale or distribution. The registrant determines whether a container is intended to be refilled for sale or distribution (in which case it is a refillable container) or if it is not intended to be refilled for sale or distribution (in which case it is a non refillable container) and implements its decision by labeling the container appropriately. This decision also would impact packaging design, packaging material, and distribution and marketing plans.

  4. What about household products with instructions for refilling, such as spray bottles? Are these considered refillable containers?

    No. Since these products are intended to be filled with pesticide more than once for use, but not for sale or distribution, these are not subject to the refillable container requirements of the container and containment regulations. For these types of products, the Agency provided alternate container type language in 40 CFR § 156.140(a)(2)(iii).

  5. What does "flowable concentrate" mean?

    Flowable concentrate is defined in 40 CFR section § 165.3 as a stable suspension of active ingredients in a liquid intended for dilution with water before use. The Agency is proposing amendments to replace the term "flowable concentrate" with "suspension concentrate," retaining the same definition. While the Agency used the term "flowable concentrate" in the regulations, we understand "suspension concentrate" will more accurately describe the formulation type intended.

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Language requirements


  1. How should a product that is packaged in multiple container types and/or sizes comply with the container and containment labeling requirements in the August 2006 final rule and described in PR Notice 2007-4?

    Each pesticide product must bear storage and disposal statements appropriate for its container. The registrant may submit separate labels for each container type and/or size, or may submit a single label with alternative storage and disposal statements. A label submitted for EPA review that bears alternative statements must indicate the circumstances in which each statement would appear on a final container label. For example, a registrant could provide that circumstance information in italics or brackets. The proposed labels will be reviewed by the appropriate EPA staff person (Product Manager, Notification Team. or Regulatory Action Leader) and approved if acceptable.

  2. How should a product that has both residential uses and non-residential uses be handled?

    For products with both household and non-household uses, the registrant must include both sets of storage and disposal statements on the label submitted to the Agency for approval. The registrant should indicate on the submitted label the circumstances in which each statement would appear on a final printed label.

  3. If registrants choose the phrase "Clean container promptly after emptying" from 40 CFR § 156.146(a)(1), are triple rinse instructions still required?

    Yes, per the requirements in § 156.146(b) and as described in 40 CFR § 156.146(a).

  4. Does the label language required by the container and containment regulations and repeated in PR Notice 2007-4 replace the "pesticide storage" and "pesticide disposal" language in the "Storage and Disposal" section of a pesticide label?

    No. The language required by the container and containment regulations, while part of the storage and disposal section, is "container disposal" (or container management) language and independent of the "pesticide storage" and "pesticide disposal" language. Storage and disposal label language must address all of these topics.

  5. Does the label language required by the container and containment regulations and repeated in PR Notice 2007-4 replace the existing "container disposal" language?

    Generally, no. The language required by the container and containment regulations adds to the statements currently on the pesticide label. However, in many cases, it would make sense to work the required language into the existing container disposal section. For example, "Triple rinse (or equivalent)." may appear on many product labels. This can easily be incorporated into one of the statements required by 40 CFR § 156.146(a), such as "Triple rinse container (or equivalent) promptly after emptying."

    In addition, please note that a revised Storage and Disposal Chapter (Chapter 13) to the Label Review Manual should be released shortly, and EPA anticipates that this new chapter will provide additional recommendations on how to incorporate the required language into existing storage and disposal statements.

  6. Does the batch code number required by the container and containment regulations in 40 CFR § 156.140(a)(4) need to appear on the product itself, or can it appear on the outermost layer of a shipping container?

    The batch code can be placed on the label or on the immediate container itself, but it must appear on each individual container. It may not appear only on overwrap or a secondary container such as a cardboard box that could be separated from the container and thrown away.

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Process for Making Label Changes


  1. Can registrants submit their label changes by notification?

    The Agency published PR Notice 2007-4 in October 2007 to explain the circumstances in which registrants may make the required label changes by notification. EPA expects that registrants will be able to make the required label changes by notification for most registered products.

  2. Can registrants submit alternate residue removal language for different container sizes or other containers not addressed by the regulatory language? How should the alternate language be submitted?

    Yes, registrants can submit alternate residue removal language as an amendment for review by the Product Manager (or Regulatory Action Leader). A label submitted for EPA review that bears alternative statements must indicate the circumstances in which each statement would appear on a final container label. This would be considered a fast-track amendment. In addition, this application would not be subject to registration service fees under the Pesticide Registration Improvement Act (PRIA).

  3. Can registrants make other changes to their storage and disposal statements at the same time that they respond to PR Notice 2007-4?

    If a registrant is responding to PR Notice 2007-4 by notification, then no. The Agency is requesting that no other changes be made to the storage and disposal sections of product labels, or other label language, in notifications submitted in response PR Notice 2007-4. The Agency is requesting this for ease of processing the 2007-4 notification submissions.

    However, if a registrant is responding to PR Notice 2007-4 by submitting an amendment to the Product Manager or Regulatory Action Leader, then yes, additional changes can be made. As with any amendment, please note all label changes in the submission package.

  4. If an EPA-stamped, -approved product label already complies with the container and containment requirements, does the Agency still need a notification submission in response to PR Notice 2007-4?

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Pending Changes to the Regulations


  1. What changes are being proposed to the container and containment labeling requirements?

    EPA has proposed amendments to the container and containment regulations to make the following changes:

    • Extend the labeling compliance date from August 17, 2009, to August 17, 2010;
    • Change the phrase "sold or distributed" to "released for shipment" where it is used in association with all compliance dates;
    • Provide for exceptions to the container-type labeling requirements for some specific non refillable packages;
    • Allow EPA to grant waivers of certain label requirements for other refillable and non refillable containers on a case-by-case basis; and
    • Correct minor errors, including typographical errors.


  2. When does the Agency expect to finalize these changes?

    The Agency published a Federal Register notice proposing these changes on June 11, 2008 (73-FR-3305) and is requesting public comment (docket number EPA-HQ-OPP-2005-0327). The Agency expects to publish a final rule in the fall of 2008. These changes will not take effect until a final rule is published.

  3. What does "released for shipment" mean?

    The Agency has proposed a definition of "released for shipment" in the amendments to the container and containment rule. The Agency is asking for comments on this proposed definition, so if you have additional questions or comments, please submit them to the docket for that rulemaking (see FAQ #23).

    EPA has proposed the following definition:

    "A product is released for shipment when the producer has packaged and labeled it in the manner in which it will be shipped, or has stored it in an area where finished products are ordinarily held for shipment. An individual product is only released for shipment once, except where subsequent events constitute production (e.g., relabeling, repackaging)."

    This proposed definition is consistent with EPA's previously published definitions of "released for shipment;" the most recent of these appears in PR Notice 93-11, Supplement C (August 13, 1993), and in a 1984 proposed rule (49 FR 37916, September 26, 1984). The first sentence is essentially that of the 1984 proposed rule, which focuses on actions manifesting the producer's intent to introduce a product into commerce. The second sentence would make it clear that products already in the channels of trade are all "released for shipment," and that relabeled or reworked products must be released a second time.

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