Frequently Asked Questions on the Container and Containment Labeling Requirements
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.) The answers reflect the container and containment regulations as published in 2006 and amended in 2008 and 2010.
Questions on this page involve:
- Scope of products that must comply
- technical products or manufacturing use products (MUPs)
- antimicrobial products
- plant-protection products
- Scope of containers that must comply
- aerosols & other inherently non-refillable containers
- ISO tanks, tank cars, and compressed gas cylinders
- fiber drums
- Language requirements
- Products packaged in multiple container types
- Handling residential and non-residential uses
- Container cleaning instructions
- Replacing storage and disposal label language
- Replacing container disposal label language
- Batch code number
- Process for Making Label Changes
- Submitting label changes
- Alternate residue removal language
- Storage and disposal statements
- Approved labels and notification submission response
- Label Deadline
- Labels and Subregistrants
- Changes to the regulations
- Container Requirements
- Containment Requirements
Scope of products that must comply
- Do technical products or manufacturing use products (MUPs) have to comply with the container and containment labeling requirements? Aren’t technical products exempt from the container and containment rule?
- Do antimicrobial products have to comply with the container and containment labeling requirements? Aren’t antimicrobials exempt from the container and containment rule?
- As plant-protection products, do plant-growth regulators have to comply with the container and containment labeling requirements in the 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.
Yes, antimicrobial 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.
Yes, plant growth regulators have to comply with the container and containment labeling requirements. These are not the plant-incorporated protectants specifically mentioned as exempt in 40 CFR § 156.140.
Scope of containers that must comply
- Do the labels of products packaged in aerosol cans & other inherently nonrefillable containers still have to say “Nonrefillable container. Do not reuse or refill this container.”?
- Do tank cars, International Standards Organization (ISO) tanks, and compressed gas cylinders have to bear any of the statements required by the container and containment labeling requirements? (Note: the question is answered separately, below, for tank cars [5(A)], ISO tanks [5(B)], and compressed gas cylinders [5(C)].
- Do tank cars have to bear any of the statements required by the container and containment labeling requirements, specifically the refillable container type statement or residue removal language for cleaning the containers prior to final disposal?
- Do the labels on International Standards Organization (ISO) tanks have to bear any of the statements required by the container and containment labeling requirements, specifically the refillable container type statement or residue removal language for cleaning the containers prior to final disposal?
- Do the labels of compressed gas cylinders have to bear any of the statements required by the container and containment labeling requirements, specifically the refillable container type statement or residue removal language for cleaning the containers prior to final disposal?
- Are fiber drums with plastic bag liners considered “rigid”?
No. The 2008 amendments to the container and containment regulations exempt certain container types, including aerosol cans, from the identification of container type and reuse statements in 40 CFR §§ 156.140(a)(1) and (a)(2). The container types that are exempt from these statements are listed in 40 CFR § 156.140(a)(5).
The labels of containers listed in §156.140(a)(5) are not exempt, however, from the recycle/recondition statement or batch code requirement in 40 CFR § 156.140(a)(3) and (a)(4). Additionally, the labels of these containers are not exempt from the requirement to have residue removal instructions (40 CFR § 156.146) unless the product is exempted by 40 CFR §156.144; that is, unless the product is for household/residential use, a pesticidal article, a gas or distributed or sold only in a transport vehicle. However, registrants may request a modification to or exemption from the requirements for a recycle/recondition statement, batch code or residue removal instructions (40 CFR §§ 156.140(c) and 156.144(d)).
No. The 2008 amendments exempt transport vehicles, such as tank cars, from the requirements to have a container type statement and instructions for residue removal prior to final disposal. Therefore, the labels of pesticide products that are distributed or sold only in transport vehicles are not required to have the “refillable container” statement in 40 CFR § 156.140(b) or the refillable container residue removal statement required by 40 CFR § 156.156. An example of this situation is when a registrant delivers a pesticide product directly to an end user’s bulk tank from a transport vehicle. Further, pesticide products that are distributed or sold in transport vehicles and are subsequently packaged into other containers for further distribution or sale would have to bear the container-related label statements that are required for the containers in which they are ultimately distributed or sold. An example of this situation is when a registrant delivers a pesticide product to a refiller's bulk tank from a transport vehicle and the refiller repackages the product into minibulks for distribution or sale to end users. In this case, the label would have to bear the “refillable container” statement in 40 CFR § 156.140(b) and a refillable container residue removal statement required by 40 CFR § 156.156 for the minibulk containers.
Yes. While ISO tanks are used in the transportation of materials, they are not vehicles and therefore do not meet EPA’s definition of transport vehicle in 40 CFR §§ 156.3 and 165.3, which is “a cargo-carrying vehicle such as an automobile, van, tractor, truck, semitrailer, tank car or rail car used for the transportation of cargo by any mode.” The Agency understands ISO tanks to be considered refillable containers, as defined in 40 CFR § 165.3. Therefore, the labels on ISO tanks would have to include a refillable container type statement from 40 CFR 156.140(b), such as “Refillable Container. Refill this container with [common chemical name] only. Do not reuse this container for any other purpose.” and residue removal instructions for cleaning the container prior to final disposal as required by 40 CFR § 156.156. However, registrants may request a modification to or exemption from both of these requirements (40 CFR §§ 156.140(c) and 156.144(d)).
Yes. The labels of compressed gas cylinders must bear a “container type” statement required by § 156.140 but are not required to bear residue removal instructions. The 2008 amendments exempt products that are gaseous at atmospheric temperature and pressure from the residue removal requirements for both nonrefillable containers and refillable containers (40 CFR §156.144(e)). Compressed gas cylinders that are refillable containers (defined in 40 CFR § 165.3) must include on the label a refillable container type statement from 40 CFR 156.140(b), such as “Refillable Container. Refill this container with [common chemical name] only. Do not reuse this container for any other purpose.” However, registrants may request a modification to or exemption from this requirement (40 CFR §§ 156.140(c)).
No. For the purposes of the container and containment regulations, fiber drums with plastic bag liners are not "rigid" containers because the immediate container that the pesticide itself is in contact with is the flexible bag liner. Therefore, these types of containers containing a solid dilutable pesticide would not need to bear the triple rinse statements from 40 CFR § 156.146, provided that they are not refillable containers, as defined in 40 CFR § 165.3.
However, please note that if these containers are intended to be refilled for sale or distribution, then they would need to bear residue removal language appropriate for refillable containers, per 40 CFR § 156.156. Existing container disposal statements from PR Notice 83-3 likely would fulfill this requirement.
- What does “rigid” mean?
- What does “dilutable” mean?
- What does “refillable” mean?
- What about household products with instructions for refilling, such as spray bottles? Are these considered refillable containers?
- What does “suspension concentrate” mean?
By rigid containers, EPA means containers that have definite retained shape and form and that are self-supporting. Examples of rigid containers are plastic jugs and metal containers. A more detailed description of rigid container can be found in EPA's response to comments document for the 2006 final rule, which is in the docket for the pesticide container and containment rule. (Go to http://www.regulations.gov, docket identification number EPA-HQ-OPP-2005-0327, document EPA-HQ-OPP-2005-0327-0021, pages 100-101.)
Dilutable means that the pesticide product’s labeling allows or requires the pesticide product to be mixed with a liquid diluent prior to application or use. This definition appears in 40 CFR §§ 156.3 and 165.3, as well as in the nonrefillable container residue removal standard in 40 CFR § 165.25(f)(1).
“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 nonrefillable container) and implements its decision by labeling the container appropriately. This decision also would impact packaging design, packaging material, and distribution and marketing plans.
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 language about reuse in 40 CFR § 156.140(a)(2)(iii). If this alternate language is not appropriate for the product, the registrant can suggest modifications to the reuse statements or request an exemption from the reuse statement according to 40 CFR § 156.140(c).
Suspension concentrate is defined in 40 CFR § 165.3 as a stable suspension of solid particulate active ingredients in a liquid intended for dilution with water before use. In the original 2006 rule, EPA had used the term “flowable concentrate”, with much the same definition. In the 2008 amendments, the Agency replaced the term “flowable concentrate” with “suspension concentrate” because it more accurately describes the formulation type intended. Suspension concentrate is defined in 40 CFR § 165.3 as a stable suspension of solid particulate active ingredients in a liquid intended for dilution with water before use.
- How should a product that is packaged in multiple container types and/or sizes comply with the container and containment labeling requirements in 40 CFR § 156.140 - § 156.159 and described in PR Notice 2007-4 (16 pp, 163k, About PDF)?
- How should a product that has both residential uses and non-residential uses be handled?
- If registrants choose the phrase "Clean container promptly after emptying" from 40 CFR § 156.146(a)(1), are triple rinse instructions still required?
- Does the label language required by the container and containment regulations and repeated in PR Notice 2007-4 (16 pp, 163k, About PDF) replace the "pesticide storage" and "pesticide disposal" language in the "Storage and Disposal" section of a pesticide label?
- Does the label language required by the container and containment regulations and repeated in PR Notice 2007-4 (16 pp, 163k, About PDF) replace the existing “container disposal” language?
- 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?
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 Product Manager or the Notification Team and approved if acceptable.
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.
Yes, per the requirements in § 156.146(b) and as described in 40 CFR § 156.146(a).
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. Labels must address both issues.
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 Chapter 13 of the Label Review Manual (PDF) (30 pp, 817.19k, About PDF) provides additional recommendations on how to incorporate the required language into existing storage and disposal statements. The version of the Storage and Disposal Chapter (Chapter 13) to the Label Review Manual posted in October 2008 on www.epa.gov/pesticides addresses the 2006 Container and Containment rule, but does not reflect the 2008 amendments. EPA intends to revise this chapter again to reflect the 2008 amendments.
The batch code, or other identifying 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.
Process for Making Label Changes
- Can registrants submit their label changes by notification?
- 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?
- Can registrants make other changes to their storage and disposal statements at the same time that they respond to PR Notice 2007-4 (16 pp, 163k, About PDF)?
- 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 (16 pp, 163k, About PDF)?
- When should a registrant submit an amended label that includes the new container-related instructions to EPA for review?
- Are subregistrants allowed to continue to use their current stock (deplete their stock and when ordering new labels, make the change then), as with the changes to the first aid statements a number of years ago?
The Agency published PR Notice 2007-4 (16 pp, 163k, About PDF) 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.
Yes, registrants can submit alternate residue removal language as an amendment for review by the Product Manager. 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).
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, then yes, additional changes can be made. As with any amendment, please note all label changes in the submission package.
If your EPA stamped, approved label already complies with the container and containment labeling requirements in 40 CFR part 156 subpart H, then no further action is needed.
Since the second quarter of 2010, EPA has been strongly encouraging pesticide registrants to immediately submit any remaining revised labels as soon as possible and definitely prior to the previous deadline of August 16, 2010. Any further delay in clear and complete label modification requests will make it difficult for EPA and States to carry out their label review activities by the new compliance deadline of August 16, 2011.
No, subregistrants may not use current labels after August 16, 2011 (based on the October 8, 2010 final rule). This situation is different from the first aid statements because the container-containment regulations include a specific compliance date for the new container-related requirements in 40 CFR156.140 - §156.156. The deadline of August 16, 2011, in 40 CFR156.159 applies to products sold by supplemental distributors (subregistrants) because they are being sold under the registrant's EPA registration. The regulations on supplemental distribution in 40 CFR 152.132 state that "the registrant may distribute or sell his registered product under another person's name and address instead of (or in addition to) his own. Such distribution and sale is termed 'supplemental distribution' and the product is referred to as a 'distributor product.' The distributor is considered an agent of the registrant…and both the registrant and the distributor may be held liable for violations pertaining to the distributor product."
In addition, if the registrant revises the label to comply with the new container-related instructions before the compliance date, the distributor products must also comply before the compliance date. 40 CFR 152.132 establishes certain conditions for supplemental distribution, including that the label of the distributor product is the same as that of the registered product with a few exceptions. However, different storage and disposal instructions are not one of the exceptions in 40 CFR152.132(d). When the registrant revises the label to change the storage and disposal instructions, the label of the distributor products must be changed at the same time.
Changes to the Regulations
- What changes were made to the container and containment labeling requirements by the 2010 amendments?
- What changes were made to the container and containment labeling requirements by the final 2008 amendments?
- Extended the labeling compliance date from August 17, 2009 to August 17, 2010; (Note this was revised by the 2010 amendments.)
- Changed the phrase “sold or distributed” to “released for shipment” where it is used in association with compliance dates;
- Provided for exceptions to some of the container-type labeling requirements for some specific nonrefillable types of containers;
- Allowed EPA to grant waivers of the container-type label requirements for other refillable and nonrefillable containers on a case-by-case basis;
- Provided for exceptions to the requirement for residue removal instructions for some specific types of containers; and
- Corrected minor errors, including typographical errors.
- When were the changes made final?
- What does “released for shipment” mean?
In an October 8, 2010 Federal Register Notice, EPA announced a final rule that extended the compliance date for pesticide storage and disposal label statements, from December 16, 2010 to Aug. 16, 2011. In an earlier action on June 15, 2010, the Agency extended the compliance date from August 16, 2010 to December 16, 2010.
The following are some of the changes EPA made by amending the container and containment regulations:
The Agency published a Federal Register notice on October 29, 2008 - Standards for Pesticide Containers and Containment
The definition of “released for shipment” in 40 CFR § 152.3 is: “…A product becomes released for shipment when the producer has packaged and labeled it in the manner in which it will be sold, or has stored it in an area where finished products are ordinarily held for shipment. Products stored in an area where products are ordinarily held for shipment, but which are not intended to be released for shipment must be physically separated and marked as not yet released for shipment. Once a product becomes released for shipment, the product remains in the condition of being released for shipment until subsequent activities, such as relabeling or repackaging, constitute production.”
- How much material can go back through a valve for it to be considered a one-way valve?
- Does a pump that is integrally attached to the container count as an opening on the container that requires a one-way valve or tamper-evident device?
Answer: The regulations (40 CFR165.3) define a one-way valve as a valve that is designed and constructed to allow virtually unrestricted flow in one direction and no flow in the opposite direction, thus allowing the withdrawal of material from, but not the introduction of material into, a container. EPA recognizes that there could be a small amount of seepage of material before the one-way valve would engage against any back flow and that deliberate efforts to damage a one-way valve could cause it to fail. EPA is not planning to quantify the maximum amount of seepage that could pass through the valve for it to meet the regulatory definition. Instead, the design of the one-way valve should be consistent with the intent of this requirement, which is to prevent any person other than the refiller from placing material into the container.
Yes. Where the design of a portable refillable pesticide container (typically a large container) includes an integral pump, the pump is considered to be an opening on the container. The refillable container regulations (40 CFR165.45(e)) require that each opening of a portable pesticide container for liquid materials (except for DOT cylinders) other than a vent must have a one-way valve, a tamper-evident device, or both. The regulations provide that the one-way valve may be located in a device or system separate from the container if the device or system is the only reasonably foreseeable way to withdraw pesticide from the container.
The requirement for one-way valves and tamper-evident devices is intended to give refillers reasonable indication about whether substances other than the pesticide product for which the containers are labeled may have been introduced into the containers. Therefore, if there is a practical way for a person to introduce material into the container through the pump, then the container would not comply with this requirement, and the pump would need to be fitted with a tamper-evident device and/or a one-way valve to prevent someone from introducing material through the pump into the container.
- Can a facility use a portable pad to comply with the requirement for a containment pad?
- construction materials (40 CFR Section (§)165.85(a));
- general design (§165.85(b));
- capacity (§165.85(c));
- operations, inspection and maintenance (§165.90); and
- recordkeeping (§165.95).
- As an example, a new portable containment pad would have to comply with the standards for construction materials (§165.85(a)); general design (§165.85(b)); capacity (§165.85(c)(3) and (4)); specific design of containment pads (§165.85(e)); operations, inspection, and maintenance (§165.90); and recordkeeping (§165.95). Some of the key requirements are whether the containment pad:
- Is constructed of a rigid material capable of withstanding the full hydrostatic head, load and impact of any pesticides, precipitation, other substances, equipment and appurtenances placed within the structure (§165.85(a)(1)).
- Is made of materials compatible with the pesticides stored, where compatible means able to withstand anticipated exposure to stored or transferred substances and still provide containment of those same or other substances within the containment area (§165.85(a)(3)).
- Has a volume of at least 750 gallons or 100% of the largest pesticide container or pesticide-holding equipment used on the pad, whichever is smaller (§165.85(c)(3) and (4)).
- Allows for removal and recovery of spilled, leaked, or discharged material and rainfall, such as by a manually activated pump (§165.85(e)(3)).
- Has its surface sloped toward an area where liquids can be collected for removal (§165.85(e)(4)).
- The containment regulations (§165.85(d) and §165.87(d)) require stationary containers of liquid pesticides that are protected by a secondary containment unit to be anchored or elevated to prevent flotation in the event that the secondary containment unit fills with liquid. How high do the tanks need to be elevated?
- Would a tank be considered anchored if it always holds enough pesticide so it would not float if the secondary containment unit fills with liquid?
(This reflects an evolution of the Agency’s understanding of portable structures (PDF) (1 pp, 40 KB, About PDF) relative to the discussion in the preamble to the final rule (71 FR 47396).)
Yes, a facility can use a portable structure to comply with the federal pesticide containment regulations, as long as the portable structure meets all of the requirements for new structures. These requirements include standards for:
In addition, the portable structure would have to comply with the specific design requirements for containment pads in §165.85(e), secondary containment of liquid pesticides in §165.85(d), or secondary containment of dry pesticides §165.85(f).
These requirements would prevent a person from using only a flexible tarp as a pad because it would not be rigid, would not have the minimum volume, and would not allow for removal and recovery of liquids. These requirements would also prevent a person from using a baby pool as a pad because it is unlikely to be compatible with the pesticides or to meet the minimum volume requirement. However, it is possible that a portable structure that is specifically designed for chemical containment could meet these standards in addition to the other containment requirements cited above.
This requirement is a performance standard. The tanks must be anchored or elevated (or anchored and elevated) so the tank does not float if the secondary containment unit becomes filled with liquid. Whether or not a tank would float in that situation depends on a number of factors, including how the tank is secured, the weight of the tank, the weight of the pesticide in the tank, the volume of the tank that would be submerged if the secondary containment was full, and the density of the liquid that fills the secondary containment unit.
One way to comply with this requirement is to elevate (and secure) the tanks so the bottom of the tank is above the top of the secondary containment wall. Another way to comply is to anchor the tanks with bolts or cables that are strong enough to prevent the tank from floating if the secondary containment unit filled with liquid. For more information about mechanically anchoring a tank, see pages 29-33 of the MidWest Plan Service document Designing Facilities for Pesticide and Fertilizer Containment, MWPS-37 or pages 35-39 of Wisconsin Minimum Design and Construction Standards for Concrete Mixing and Loading Pads and Secondary Containment Structures.
In addition, a facility could ensure that the tank always holds enough pesticide so it is heavy enough that it would not float if the secondary containment unit filled with liquid. (See next question for more details.)
Lastly, a facility could use a combination of these approaches – elevating the tank above the floor but not higher than the wall, anchoring with bolts or cables, and/or ensuring that the tank always has a certain amount of pesticide in it – as long as the performance standard of preventing flotation if the secondary containment fills with liquid is met.
Please note that the goal of the performance standard is to prevent flotation in the event that the secondary containment unit fills with liquid, but not necessarily to prevent the tanks from moving in a catastrophic event, such as a flood or tornado, where the forces on the tanks are stronger than the buoyant forces in a full secondary containment unit.
Yes, a facility could ensure that the tank always holds enough pesticide so it is heavy enough that it would not float if the secondary containment unit filled with liquid. EPA considers this a form of anchoring because it would meet the performance standard of preventing flotation if the secondary containment unit filled with liquid. If a facility chooses to anchor a tank in this way, the level of pesticide in the tank must always be at or above the required volume, and the facility should have documentation of the buoyant force calculations that support the required minimum volume. Click here for more details about the buoyant force calculations to support a minimum volume. (PDF) (4 pp, 98.4 KB, About PDF)