Supporting Statement for an
Information Collection Request (ICR)
Under the Paperwork
Reduction Act (PRA)
Title: |
Standards for Pesticide Containers and Containment |
EPA ICR No.: |
1632.07 |
OMB Control No.: |
2070-0133 |
Docket ID No.: |
EPA-HQ-OPP-2024-0023 |
This is a renewal of a currently approved Information Collection Request (ICR) that covers the information collection activities under the Pesticide Container and Containment Regulations found at 40 CFR Parts 156 and 165. The regulations were finalized August 16, 2006 (71 FR 47330) and amended October 29, 2008 (73 FR 64215). The collection activities and associated burden hours remain the same and the estimated burden and costs have been updated.
This ICR covers the information collection activities associated with the pesticide container design and residue removal requirements and containment structure requirements. With respect to the container design and residue removal requirements, the information collection activities are associated with the requirement that businesses subject to the container regulations (pesticide registrants) and repackaging regulations (pesticide registrants and refillers) maintain records of test data, cleaning procedures, certain data when a container is refilled, and other supporting information. These records are subject to both call-in by EPA and on-site inspection by EPA and its representatives. EPA has not established a regular schedule for the collection of these records, and there is no reporting. With respect to the containment structure requirements, the information collection activities are associated with the requirement that businesses subject to the containment structure regulations maintain records of the: (1) Monthly inspection and maintenance of each containment structure and all stationary bulk containers; (2) Duration over which non-stationary bulk containers holding pesticide and not protected by a secondary containment unit remain at the same location; and (3) Construction date of the containment structure. The businesses subject to the containment structure regulations include agrichemical retailers and refilling establishments, custom blenders and commercial applicators of agricultural pesticides. The records have to be maintained by the owners and operators of such businesses and made available to inspectors to ensure that businesses are in compliance with containment requirements. These inspections are generally conducted by the states, which enforce FIFRA regulations through cooperative agreements with EPA.
The entities affected by the container regulations are different than the entities affected by the containment regulations, so this ICR document provides separate discussions of the primary activities and the related burden estimates for each. Where necessary to distinguish the discussion of these two primary activities within each section of this ICR, the Agency has identified the discussion of the information collection activities associated with the container design and residue removal requirements with this header: “Container,” and the information collection activities related to the containment structure requirements with this header: “Containment.” Where the discussion applies equally to both sets of activities, there is no distinction.
Container
These portions of the ICR cover the information collection activities associated with the container design and residue removal requirements. Specifically, the requirement that businesses subject to the container regulations (pesticide registrants) and repackaging regulations (pesticide registrants and refillers and swimming pool supply companies) maintain records of test data, cleaning procedures, certain data when a container is refilled and other supporting information. These records are subject to both call-in by EPA and on-site inspection by EPA and its representatives. EPA has not established a regular schedule for the collection of these records, and there is no reporting.
Containment
These portions of the ICR cover the information collection activities associated with the containment structure requirements. Specifically, the requirement that businesses subject to the containment structure regulations maintain records of the: 1) monthly inspection and maintenance of each containment structure and all stationary bulk containers; 2) duration over which non-stationary bulk containers holding pesticides and not protected by a secondary containment unit remain at the same location; and 3) construction date of the containment structure. The businesses subject to the containment structure regulations include agrichemical retailers and refilling establishments, custom blenders, and commercial applicators of agricultural pesticides. The records must be maintained by the owners and operators of such businesses. There is no regular schedule for the collection of either of these records, nor does EPA anticipate a call-in of records at some future date. Instead, the records would be available to inspectors to ensure that businesses are in compliance with containment requirements. These inspections are generally conducted by the states, which enforce FIFRA regulations through cooperative agreements with EPA.
Information Collection |
Number of Respondents |
Annual Number of Responses |
Responses per Respondent |
Annual Time Burden (Hours) |
Annual O&M Costs (Dollars) |
Annual Cost Burden (Dollars) |
Recordkeeping Requirements of the Standards for Pesticide Containers and Containment (Total Respondent) |
23,586 |
23,586 |
1 |
180,763 |
$419,875 |
$10,864,047 |
Total Agency |
|
|
|
232 |
|
$20,156 |
The statutory authority for these collection activities are found in sections 3, 8, 19 and 25 of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 7 U.S.C. 136f, 136q and 136w.
The 1988 amendments to FIFRA section 19 significantly expanded and strengthened EPA’s authority in the areas of pesticide storage, disposal and transportation and authorized the administrator, in conjunction with the registration and reregistration of a pesticide, to establish:
data requirements to determine methods of safe storage and disposal of pesticides [FIFRA section 19(a)(1)(A)];
labeling requirements for the storage, transportation and disposal of pesticides, excess pesticides, rinsates, and containers [FIFRA section 19(a)(1)(B)];
pesticide container design standards [FIFRA section 19(e)]; and
pesticide residue removal standards and procedures [FIFRA section 19(f)].
The collection (record keeping) of information covered by this ICR is needed to ensure that EPA’s statutory requirement to develop regulations for pesticide container design and residue removal is implemented. Together with the requirements for containment of large pesticide tanks, the container requirements for design and residue removal are essential to ensure the safe use, reuse and refill of containers as required by FIFRA section 19.
The container design and residue removal regulations are contained in Title 40 of the Code of Federal Regulations (CFR) Parts 156 and 165. The containment structure regulations are contained in 40 CFR Part 165.
EPA or its representative (i.e., the states) will use records that are required to be maintained to verify compliance with the regulations. Although records maintained under the regulations are subject to call-in by EPA, the Agency does not expect to conduct routine call-ins. Instead, the records will be reviewed during routine establishment inspections. These inspections are generally conducted by the states, which enforce FIFRA regulations through cooperative agreements with EPA. In addition, the requirement to keep records should foster regulatory compliance because facilities know they could be inspected and would need to furnish the records. Improved compliance with these regulations will reduce risk to human health and the environment by decreasing the likelihood of pesticide spills from containers and releases from containment structures.
For containers, EPA will use the records of test data and other information collected or submitted under the pesticide container design and residue removal regulations to assess compliance with the regulations and to evaluate their effectiveness.
The data will be used by the Registration Division, the Antimicrobial Division, and the Biopesticides and Pollution Prevention Division of OPP, as well as the Office of Compliance and the Office of Civil Enforcement in EPA’s Office of Enforcement and Compliance Assurance. The specific users within the divisions include chemists, economists, and product and project managers. The data may also be used by EPA Regions and state enforcement officials.
For containment, the records of the inspection and maintenance of containment structures and stationary bulk agricultural pesticide containers will assist EPA, states or political subdivisions duly designated by EPA to assess the integrity of bulk containers and containment structures.
Records documenting the duration over which a pesticide remains in a bulk container not protected by secondary containment at the same location will allow EPA or its representatives to determine whether the bulk container has exceeded the 30-day residence criterion which triggers requirements for secondary containment of stationary bulk containers.
Records of the construction date of the secondary containment structure will allow EPA or its representatives to determine whether the structure must comply with the standards for existing structures or for new structures (according to the definitions of existing and new in the final rule).
EPA expects to receive and review waiver requests for new products as they are submitted. The correspondence may be submitted in printed or electronic format, including e-mail, according to the respondent’s preference. EPA will receive and manage these waiver requests in accordance with its existing and standard procedures for the receipt and management of information submitted to it under the pesticide laws.
Duplication is not an issue because these records are generally unique to the requirements of the federal pesticide law (FIFRA) and to specific pesticide products. EPA is the primary Federal Agency that regulates pesticide chemicals, pesticide containers and disposal. To the extent that companies may already retain these records as part of its management practices, any potential duplication will facilitate their compliance with the regulation. Therefore, there is no duplication of effort.
In addition, EPA maintains files on all pesticide chemicals, as well as correspondence and information/data submitted. These files are referenced to determine whether the necessary data are already on hand, thereby eliminating duplicative data requests. The list of data submitters that EPA publishes enables the industry to act cooperatively in the development and/or use of data. Further, EPA allows cost-sharing agreements among manufacturers of specific pesticide chemicals in order to minimize the duplication of laboratory tests conducted for this program.
Small entities are generally subject to the same requirements as large entities. The information to be recorded is straightforward and can be maintained by facilities in the manner they see fit, as long as the records are available for review during routine establishment inspections by EPA or the states. The notifications and waiver requests involve the use of existing forms and processes, which reflect the consideration of small entity flexibility in their establishment. No new forms are being established for these regulations.
There is no collection activity. Records are generated when certain activities take place, such as repackaging pesticide into a refillable container or inspecting a containment structure, and, if necessary, information will be collected periodically without a set schedule for compliance assurance.
For containers: EPA is requiring that the information described above be retained by registrants or refillers for more than three years so that risks presented by pesticide containers can be thoroughly evaluated. Most container designs and many refillable containers are in use for more than three years. Further, even when a design is discontinued, containers of that design type may remain on the market for a number of years. Therefore, if EPA is to be able to thoroughly evaluate risks presented by pesticide containers it requires access to information on these containers designs and containers for as long as they remain in commerce.
For
containment: EPA requires
retention of records documenting the age of the containment facility
because the standards for structures built before promulgation of the
containment rule differ slightly from the standards for structures
built after promulgation of the rule. The two sets of standards
apply to “existing” and “new” containment
structures, terms which are defined in the rule. EPA is
requiring that the records be retained for a period in excess of that
proposed by PRA guidelines because containment structures are
typically in use for much longer than three years.
a) requiring respondents to report information to the agency more often than quarterly;
b) requiring respondents to prepare a written response to a collection of information in fewer than 30 days after receipt of it;
c) requiring respondents to submit more than an original and two copies of any document;
d) requiring respondents to retain records, other than health, medical, government contract, grant-in-aid, or tax records, for more than three years;
e) in connection with a statistical survey, that is not designed to produce valid and reliable results that can be generalized to the universe of study;
f) requiring the use of a statistical data classification that has not been reviewed and approved by OMB;
g) that includes a pledge of confidentiality that is not supported by authority established in statute or regulation, that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or
h) requiring respondents to submit proprietary trade secrets, or other confidential information unless the agency can demonstrate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law.
The only guideline established under the Paperwork Reduction Act (PRA) that may be exceeded in this collection is the time period for retaining records. The PRA guidelines specify that an Agency must provide justification when requiring data other than health, medical or tax records be retained for more than three years. This is discussed below.
Regarding containers the following time periods for retaining records under the container design and residue removal regulations exceed the three-year guideline for record retention established under the PRA:
) for nonrefillable containers, the registrant must maintain the required records for as long as the nonrefillable container is used with the pesticide product and for three years thereafter;
) for refillable containers, each registrant who distributes or sells a pesticide product to a refiller for repackaging into refillable containers and each registrant who distributes or sells a pesticide product in refillable containers must maintain the required records for the current operating year and for three years thereafter;
) for refillable containers, each refiller must maintain the required informational records for the current operating year and for three years thereafter. Information about actual repackaging must be recorded and kept for three years.
EPA is requiring that the information
described above be retained by registrants or refillers for more than
three years so that risks presented by pesticide containers can be
thoroughly evaluated. Most container designs and many refillable
containers are in use for more than three years. Further, even when a
design is discontinued, containers of that design type may remain on
the market for a number of years. Therefore, if EPA is to be able to
thoroughly evaluate risks presented by pesticide containers it
requires access to information on these containers designs and
containers for as long as they remain in commerce.
Containment
Regarding containment, the only guideline established under the PRA that is exceeded is the time period for retaining records relating to the construction date of the secondary containment structure. The regulations require that records documenting the construction date of the containment structure be retained as long as the containment structure is in use, and for three years thereafter. EPA requires retention of records documenting the age of the containment facility because the standards for structures built before promulgation of the containment rule differ slightly from the standards for structures built after promulgation of the rule. The two sets of standards apply to “existing” and “new” containment structures, terms which are defined in the rule. EPA is requiring that the records be retained for a period in excess of that proposed by PRA guidelines because containment structures are typically in use for much longer than three years.
Pursuant to 5 CFR 1320.8(d), EPA published a notice in the Federal Register on April 22, 2024 (89 FR 29323; FRL-11670-01-OCSPP), announcing the planned renewal of this information collection activity, soliciting public comment on specific aspects of the ICR and providing a 60-day public comment period.
The EPA also consulted four stakeholders, specifically asking them for their assessment of the regulatory burden estimates expressed by the Agency in this ICR (Attachment A). One stakeholder provided responses. The stakeholders consulted were:
Bayer CropScience
Corteva Agriscience
J.R. Simplot Company
Wilbur-Ellis Company
Of those consulted, EPA received comments from Corteva Agriscience, which agreed with the labor rates, estimated burden, and the current approach of collecting information by request and/or onsite inspection. The commenter also agreed that the information covered in the ICR is not available from any public source and that it is not collected by another entity. Substantive comments, comments of a broader regulatory nature, and the Agency’s responses to those comments are summarized below. The Agency thanks all commenters for their comments and has considered them in developing this ICR.
Stakeholder Comment: Corteva commented that the American Agronomic Stewardship Alliance (AASA) inspections provide a reference opportunity for container and containment status at the time of the audit for those refiller locations that participate. Corteva also mentioned that CropLife America provides refillable container cleaning and compliance/educational materials.
Agency Response: EPA agrees that the AASA inspections provide useful information to the refilling facilities. EPA thanks both AASA and CropLife America for developing and sharing educational materials.
Stakeholder Comment: Corteva supports the development of a consistent format for both container and containment compliance record keeping requirements. They mention that there is a containment inspection form example online provided by the MN Dept of Agriculture.
Corteva also supports electronic record keeping efforts as an option for both refillers and for registrants with the explanation that electronic record keeping may provide improved data consistency and may support compliance efforts with reminders for needed activity or other helpful information. Corteva adds that electronic records may also be easier to provide during an inspection or for a data call-in.
Agency Response: EPA believes that providing flexibility in the format of the records is important to allow the regulated community to develop a record keeping approach that works best for them and their systems. If EPA mandated a format, it could make electronic recordkeeping more difficult if a company’s software and applications did not conform to the mandated format. A different recordkeeping approach is likely needed for large companies compared to smaller companies that do not have many pesticide registrations or do not refill many refillable containers each year. EPA continues to believe that it is more important for the required information to recorded and available when requested rather than be recorded in a specific format.
Stakeholder Comment: Corteva commented that registrants may incur a small capital cost for computer hardware and software needed for compliance, similar to the small capital cost assumed for agricultural pesticide refillers. Corteva commented that this compliance would likely not be a separate expense but part of other business activity.
Agency Response: Based on the explanation that the computer hardware and software would likely be a part of other business activity, EPA is not adding an annual capital cost for registrants.
This question is not applicable to this ICR.
In some cases, the nonrefillable container records may contain confidential business information (CBI) as defined in FIFRA, but the other records do not contain CBI. If registrants submit CBI, such information is protected from disclosure under FIFRA Section 10. CBI data submitted to the EPA is handled strictly in accordance with the provisions of the FIFRA Confidential Business Information Security Manual.
Since EPA does not anticipate a collection or call-in of the retained records covered by this ICR, the information in those records would not leave the possession of the affected businesses.
No information of a sensitive or private nature is requested in conjunction with these information collection activities, and these information collection activities comply with the provisions of the Privacy Act of 1974 and OMB Circular A-108, as amended, “Responsibilities for the Maintenance of Records about Individuals by Federal Agencies.
Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated. Unless directed to do so, agencies should not conduct special surveys to obtain information on which to base hour burden estimates. Consultation with a sample (fewer than 10) of potential respondents is desirable. If the hour burden on respondents is expected to vary widely because of differences in activity, size, or complexity, show the range of estimated hour burden, and explain the reasons for the variance. Generally, estimates should not include burden hours for customary and usual business practices.
If this request for approval covers more than one form, provide separate hour burden estimates for each form and aggregate the hour burdens.
Provide estimates of annualized cost to respondents for the hour burdens for collections of information, identifying and using appropriate wage rate categories. The cost of contracting out or paying outside parties for information collection activities should not be included here. Instead, this cost should be included under ‘Annual Cost to Federal Government’.
The regulated community affected by the container design and residue removal regulations includes businesses that formulate pesticide products or repackage pesticide products into refillable pesticide containers. The affected businesses are pesticide registrants, classified as North American Industry Classification System (NAICS) code 325320 - Pesticide and Other Agricultural Chemical Manufacturing, NAICS code 422910 - Farm Supplies Wholesalers, and Swimming Pool Applicators, classified under 3 different NAICS codes shown in the table below.
The regulated community affected by the
containment regulations includes facilities that utilize one or more
stationary bulk agricultural pesticide containers, mobile bulk
agricultural pesticide containers that remain in one location for at
least 30 consecutive days, and containment pads for agrichemical
pesticide dispensing areas. The majority of such facilities are
classified in the farm supplies industry under one NAICS code, 422910
- Farm Supplies Wholesalers. NAICS 422910 includes both farm supply
dealers and fertilizer dealers, (frequently referred to as
agrichemical facilities or businesses), as well as other
establishments engaged in the distribution of animal feeds,
fertilizers, agricultural chemicals, pesticides, seeds and other farm
supplies, except grains. Agricultural (aerial and ground) commercial
applicators are also affected by the rule. Most of these industries
are classified under NAICS 115112 - Soil Preparation, Planting and
Cultivating. A number of agricultural services such as cultivation,
pollination, detasseling of corn, hoeing, and pruning are included
under this NAICS code.
Table 1. Potentially Affected Entities Under Container Regulations
Category |
NAICS codes |
Examples of potentially affected entities |
Pesticide and other agricultural chemical manufacturing |
325320 |
Pesticide registrants and businesses who formulate pesticide products or pesticide formulation intermediates. |
Farm Supply Wholesalers |
422910 |
All agricultural pesticide refillers whose principal business is retail sale of agricultural pesticides. |
Other services to buildings & dwellings All other miscellaneous store retailers (except tobacco stores) All other special trade contractors |
561790 453998
235990 |
Swimming pool applicators. |
Independent commercial applicators |
115112 |
Businesses that apply pesticides for compensation (by aerial and/or ground application) and that are not affiliated with agrichemical dealers. |
In order to comply with the container design and residue removal requirements, respondents must undertake a number of recordkeeping activities (see tables below) for as long as the product is used and for three years after that. There are no reporting requirements for these regulations. However, the required records must be furnished and made available for inspection and copying upon request of EPA or its designee. In addition, registrants must inform EPA by notification of the label changes made to comply with the requirements of 40 CFR part 156.
Table 2. Recordkeeping Requirements for Nonrefillable and Refillable Containers
|
Recordkeeping |
Nonrefillable Containers |
For as long as a nonrefillable container is used for the product and for 3 years thereafter:
|
Repackaging |
(a) These “informational” records must be kept for the current operating year and for three years after that (see the table below which identifies which businesses (registrants and/or refillers)) must comply:
(b) Each time a registrant or refiller repackages pesticide product into a refillable container for distribution or sale, the following records must be generated and maintained for at least three years after the date of repackaging:
As shown in the following table, antimicrobial products used in swimming pools and closely-related sites do not have to comply with these section (b) repackaging requirements. |
Table 3. Recordkeeping Requirements in the Repackaging Regulations
Product-Specific Record
|
Registrants who d/s directly in refillables 1 |
Registrants who d/s to refillers for repackaging into refillables 1 |
Refillers who aren’t registrants |
||
Swim pool products 2 |
All other products |
All products |
Swim pool products 2 |
All other products |
|
Informational Records |
|||||
Contract to repackage |
No |
No |
Yes |
Yes |
Yes |
Refilling residue removal procedure |
Yes |
Yes |
Yes |
Yes |
Yes |
Description of acceptable containers |
Yes |
Yes |
Yes |
Yes |
Yes |
Repackaging Records |
|||||
EPA registration # d/s in the container |
No |
Yes |
No |
No |
Yes |
Date of the repackaging |
No |
Yes |
No |
No |
Yes |
Serial # of the container |
No |
Yes |
No |
No |
Yes |
(1) “d/s” = distribute or sell.
(2) Swim pool products = antimicrobial products used in swimming pools and closely related sites, that are subject to the pesticide container-related regulations.
Registrants may request waivers from or modifications to the nonrefillable container standards and to some of the refillable container standards. There are no forms associated with this record keeping.
Table 4. Recordkeeping Requirements in the Containment Regulations
(a) Records of inspection and maintenance for each containment structure and for each stationary bulk container and its appurtenances must be kept for 3 years and must include the following information: (1) name of the person conducting the inspection or maintenance; (2) date the inspection or maintenance was conducted; (3) conditions noted; and (4) specific maintenance performed. |
(b) Records for any non-stationary dry or liquid bulk container that holds pesticide but is not protected by a secondary containment unit meeting the regulations must be kept for 3 years. Records on non-stationary bulk containers must include the time period that the container remains at the same location. |
(c) Records of the construction date of the containment structure must be kept for as long as the pesticide containment structure is in use, and for 3 years afterwards. |
There are no forms associated with this record keeping.
Table 5. Registrant Activities for Nonrefillable Containers
Respondent Paperwork Activity |
Description |
1. Read instructions |
Read container regulations. |
2. Plan activities |
- Determine whether your products are subject to the container requirements, and if so which ones. - Determine what subset of the DOT regulations your products are subject to. - Develop plan to comply. |
3. Gather information |
- Determine if the containers holding your products dispense properly and have standard closures. - Develop residue removal data for dilutable pesticides in rigid containers. - Prepare waiver request (if desired). |
4. Record information |
- Develop and maintain a recordkeeping system of test data and documentation for container/formulation combinations. - Submit waiver request. |
5. Store/maintain data |
File and maintain copies of all container records for as long as the container is used and for 3 years afterwards. |
The burden hours and the associated cost of registrant activities for nonrefillable containers are provided in Table 12.
Table 6. Registrant Activities for Refillable Containers
Respondent Paperwork Activity |
Description |
1. Read instructions |
Read container regulations. |
2. Plan activities |
- Determine what standards your refillable containers must meet. - Develop plan to comply. |
3. Gather information |
- Determine if your refillable containers meet the specified DOT regulations. - Develop or obtain records for pesticides that are not DOT hazardous materials and are distributed in refillable containers that document compliance with (at a minimum) DOT Packing Group III standards - Determine if your refillable containers are marked with a serial number and have a one-way valve or tamper-evident device on each opening. |
4. Store/maintain data |
File and maintain copies of records documenting compliance with DOT regulations for pesticides that are not DOT hazardous materials and are sold or distributed in refillable containers. |
Table 7. Registrant Activities for Distributing to Refillers for Repackaging
Respondent Paperwork Activity |
Description |
1. Read instructions |
Read container regulations. |
2. Plan activities |
Develop plan to comply. |
3. Record information |
- Develop a recordkeeping system for contracts with refillers. - Develop residue removal procedures. - Develop a written list of acceptable containers. |
4. Store/maintain data |
Maintain records of contracts with refillers and “informational” records for current operating year and for 3 years afterwards. |
The burden hours and the associated cost of registrant activities for refillable containers are combined in in Tables 13.
Table 8. Registrant Activities for Repackaging Directly into Refillable Containers
Respondent Paperwork Activity |
Description |
1. Read instructions |
Read container regulations. |
2. Plan activities |
Develop plan to comply. |
3. Gather information |
Gather labeling, written residue removal procedures and description of acceptable containers at each producing establishment that fills refillable containers |
4. Record information |
- Record specified information each time product is repackaged. - Record date and other information for any required leakproofness tests every 2.5 years (for pesticides that are not DOT hazardous materials) |
5. Enforce & monitor |
Inspect and relabel containers. |
6. Store/maintain data |
- File and maintain copies of all “informational” container records for the current operating year and for 3 years afterwards. - File and maintain copies of any required leakproofness tests until the next leakproofness test in 2.5 years - File and maintain copies of all repackaging records for 3 years (all products other than swimming pool chemicals). |
The burden hours and the associated cost of registrant activities for repackaging into refillable containers are provided in Table 14.
Table 9. Refiller (non-registrant) Activities for Repackaging
Respondent Paperwork Activity |
Description |
1. Read instructions |
Read container regulations. |
2. Plan activities |
Determine what repackaging requirements you must comply with and plan compliance. |
3. Gather information |
Gather labeling, written residue removal procedures and description of acceptable containers. |
4. Record information |
- Develop and maintain a recordkeeping system for contracts with registrants who allow you to repackage their pesticide for distribution and sale and all required container information, which includes the contracts, residue removal procedures and descriptions of acceptable containers. - Record specified information each time product is repackaged. - Record date and other information for any required leakproofness tests every 2.5 years (for pesticides that are not DOT hazardous materials) |
5. Enforce & monitor |
Inspect and relabel containers. |
6. Store/maintain data |
- File and maintain copies of all “informational” container records for the current operating year and for 3 years afterwards. - File and maintain copies of any required leakproofness tests until the next leakproofness test in 2.5 years - Record and maintain repackaging records for 3 years. |
The burden hours and the associated cost of refiller activities are provided in Table 15.
Table 10. Swimming Pool Supply Company Activities for Repackaging
Respondent Paperwork Activity |
Description |
1. Read instructions |
Read container regulations. |
2. Plan activities |
Determine what repackaging requirements you must comply with and plan compliance. |
3. Gather information |
Gather labeling, written residue removal procedures and description of acceptable containers. |
4. Record information |
Develop and maintain a recordkeeping system for contracts with registrants who allow you to repackage their pesticide for distribution and sale and all required container information. (No repackaging recordkeeping is required.) |
5. Enforce & monitor |
Inspect and relabel containers. |
6. Store/maintain data |
File and maintain copies of “informational” container records for the current operating year and for 3 years afterwards. (No repackaging recordkeeping is required.) |
The burden hours and the associated cost of swimming pool supply company activities are provided in Table 16.
Respondent Activities for Labeling Requirements
All registrants are required to comply with the labeling requirements, and the Agency allowed label changes to be submitted by notification. Because the deadline for compliance with the container labeling requirements was August 16, 2011, there will not be any new notifications associated with these requirements. The required container instructions will be included in newly submitted labels, covered under the ICR for the registration of pesticides under FIFRA section 3.
Table 11. Respondent Activities for Regulated Entities for Containment
Respondent Paperwork Activity |
Description |
1. Read instructions |
Read containment regulations. |
2. Plan activities |
Plan activities
|
3. Record information |
- Inspect and maintain each containment structure and each stationary bulk container and its appurtenances monthly. Record the following information: (1) name of the person conducting the inspection or maintenance; (2) date the inspection or maintenance was conducted; (3) conditions noted; (4) specific maintenance performed. - Inspect and maintain each non-stationary bulk container and record the time period that it remains at the same location in the facility. |
4. Store/maintain data |
- File and maintain copies of all inspection and maintenance records for 3 years. - File and maintain data on time-in-location for all non-stationary bulk containers which are not protected by secondary containment for 3 years. - File and maintain documents proving the construction date of the facility (to demonstrate whether it is subject to the standards for new or existing structures) for as long as the structure is in use and for 3 years afterwards. |
The burden on the regulated community considered in this analysis is the administrative burden associated with the time spent to record and maintain the necessary records. There is no requirement to submit the records to the Agency. The burden also includes a review of the applicable requirements and a determination of how the regulations affect the respondent, which were expected to occur in the first year of compliance with the regulations, but that may occur when new pesticides are registered and as a periodic review of compliance.
The ICR estimates all recordkeeping and reporting burden and costs associated with the regulations. An analysis is provided below for each of the three regulated industries for the pesticide container regulations.
The labor rates used in the analysis are the standard rates used in EPA ICRs and include both fringe benefits and overhead. This ICR will use wage rates for an administrative labor category and a professional labor category. The most current 2022 BLS wage rates for registrants are $57.74 for the administrative labor category and $153.45 for managerial labor.
Snapshot of Burden Hours and Costs for this ICR – Combined Container and Containment Regulations
The total combined bottom line burden for both the container design and residue removal regulations and the containment structure regulations are discussed in this section. The estimated total number of potential respondents is 23,586 which includes the sum of 1,804 registrants, 16,795 agricultural pesticide refillers, 322 swimming pool supply companies, and 4,665 facilities requiring pesticide containment structures. The estimated total respondent annual burden hours is 180,763 hours (162,103 for the container regulations and 18,660 for the containment regulations). The estimated total respondent annual costs are $10,864,047, which includes an estimated burden cost of $9,786,618 for container regulations and an estimated cost of $1,077,428 for containment regulations for maintenance and operational costs.
There are three separate sets of paperwork burden activities for pesticide registrants. Tables 12, 13, and 14 describe the estimated burden and costs associated with these activities.
For nonrefillable containers, the burden is associated with creating records documenting that new formulations and containers meet the requirements and submitting waiver requests. As with any change in labeling or registration requirements, a certain number of waiver requests is to be expected, and processing waivers is an ongoing activity. The Agency estimates that if a registrant wishes to submit an application for a waiver from some of the requirements of the rule, professional labor will be used. The burden for the application of a waiver is estimated to be the same in each year, which is likely an overestimate. It is estimated that one percent of pesticide registrants may apply for a waiver. To simplify the analysis, the burden and costs estimated for the application of a waiver are applied to the nonrefillable container burden and cost estimates (registrants can apply for a waiver for a subset of both nonrefillable and refillable requirements).
It is estimated that each respondent will spend three hours on the paperwork activities associated with new formulations and new nonrefillable containers (Table 12).1 At a cost of $57.74 per hour for the administrative labor, the cost, per respondent, is estimated to be $173. In addition, it is estimated that 1% of the respondents will spend an additional four hours preparing and processing waivers. At costs of $153.45per hour for the professional labor associated with this activity, the cost per respondent is estimated to be $614.
Activity |
Ensuring that New Formulations and Containers Comply (All Registrants) |
Preparing and Processing Waiver Requests (1% of Registrants) |
||
Burden Hours (per Year) |
Costs ($ per Year) |
Burden Hours (per Year) |
Costs ($ per Year) |
|
Administrative ($57.74/Hr) |
Professional ($153.45/Hr) |
|||
1. Read instructions |
0 |
0 |
0.5 |
$77 |
2. Plan activities |
0 |
0 |
0.5 |
$77 |
3. Gather information |
1 |
$58 |
2 |
$307 |
4. Record information |
1 |
$58 |
0.5 |
$77 |
5. Store/maintain data |
1 |
$58 |
0.5 |
$77 |
Total Burden |
3 |
173 |
4 |
$614 |
Administrative labor costs $57.74/hour, professional labor costs $143.29/hour.
The total annual paperwork burden across all respondents, assuming that 1,8042 registrants will be affected by the requirement, is 5,484 hours (Table 12), with a total annual cost estimated to be $323,562.
(3 hours per registrant X 1,804 registrants) + (4 hours per registrant X (1,804 registrants X 1% of registrants)) = 5,412 hours + 72 hours = 5,484 hours per year
(3 hours per registrant X $57.74/hour X 1,804 registrants) + (4 hours per registrant X $153.45/hour X (1,804 registrant X 1% of registrants)) = $312,489 + $11,073 = $323,562
For the paperwork burden activities associated with distributing pesticide to refillers for repackaging into refillable containers, it is estimated that 3 hours will be spent per registrant respondent (Table 13). These burden estimates include both the activities associated with refillable containers and for registrants distributing pesticides to refillers for repackaging. At a cost of $57.74 per hour for the administrative labor, the estimated cost now that the contracts are in place, assuming three hours of time spent on information collection, per respondent, is estimated to be $173.22. The total annual paperwork burden across all respondents, assuming that 1,804 registrants will be affected by the requirement, is 5,412 hours (Table 13).
Activity |
Burden Hours (per Year) |
Costs ($ per Year) ($57.74 per hour)
|
|
Administrative |
Total Hours |
||
1. Read instructions |
0 |
0 |
0 |
2. Plan activities |
0 |
0 |
0 |
3. Gather and record information |
1.75 |
1.75 |
$101 |
4. Store/maintain data |
1.25 |
1.25 |
$72 |
Total Burden |
3 |
3 |
$173 |
3 hours per registrant X 1,804 registrants = 5,412 hours per year
3 hours per registrant X $57.74/hour X 1,804 registrants = $312,489
It is estimated that 8 administrative hours, at a cost of $57.74 per hour will be spent by each registrant for the paperwork activities associated with repackaging directly into refillable containers (Table 14). The total annual paperwork burden across all respondents, assuming that 1,804 registrants will be affected by the requirement, is 14,432 hours (Table 14).
Activity |
Burden Hours (per Year) |
Costs ($ per Year) ($57.74 per hour) |
|
Administrative |
Total Hours |
||
1. Read instructions |
0.5 |
0.5 |
$29 |
2. Plan activities |
0.5 |
0.5 |
$29 |
2. Gather Information |
1 |
1 |
$58 |
3. Record information |
1.5 |
1.5 |
$87 |
4. Enforce & Monitor |
4 |
4 |
$231 |
5. Store/maintain data |
0.5 |
0.5 |
$29 |
Total Burden |
8 |
8 |
$462 |
8 hours per registrant3 X 1,804 facilities = 14,432 hours per year
8 hours per registrant X $57.74/hour X 1,804 facilities = $833,304
The estimated annual burden per pesticide registrant respondent associated with nonrefillable pesticide container record keeping activities is 3 hours per year, although 1% of registrants have an additional 4 hours of burden associated with preparing and processing waiver requests (See Table 12). The estimated annual burden per registrant associated with distributing pesticides to refillers for repackaging and distributing pesticide directly in refillable containers is 3 hours per year and 8 per year (Tables 13 and 14), respectively. Based on an estimated 1,804 pesticide registrants affected by the requirement per year, the total annual burden is estimated to be 25,328 hours per year. (See Tables 12, 13 and 14).
5,484 + 5,412 + 14,432 = 25,328 hours per year
The estimated annual cost per pesticide registrant respondent associated with nonrefillable pesticide containers record keeping activities is $173 per year (Table 12). In addition, for the estimated 1% of respondents that will spend an additional four hours of professional time preparing and processing waivers, the cost is $614 per hour (Table 12). The estimated annual cost per registrant associated with refillable containers and repackaging is $173 and $462, respectively (Tables 13 and 14). Based on an estimated 1,804 pesticide registrants affected by the requirement per year, the total annual cost is estimated to be $1,469,355.
The paperwork burden activities that affect agricultural pesticide refillers are associated with the repackaging of agricultural pesticides directly into refillable containers. It is estimated that 8 hours will be spent per year for the paperwork activities associated with repackaging agricultural pesticides directly into refillable containers (Table 15).
Activity |
Burden Hours (per Year) |
Costs ($ per Year) ($57.74 per hour) |
|
Administrative |
Total Hours |
||
1. Read instructions |
0.5 |
0.5 |
$29 |
2. Plan activities |
0.5 |
0.5 |
$29 |
3. Gather Information |
1 |
1 |
$58 |
4. Record information |
1.5 |
1.5 |
$87 |
5. Enforce and Monitor |
4 |
4 |
$231 |
6. Store/maintain data |
0.5 |
0.5 |
$29 |
Total Burden |
8 |
8 |
$462 * |
* There are also annual capital costs of $25 per year for each refiller.
The estimated annual burden per agricultural pesticide refiller associated with record keeping activities is 8 hours per year. Based on an estimated 16,795 agricultural pesticide refillers affected by the requirements per year, the total annual burden is estimated to be 134,360 hours per year. The estimated annual cost per agricultural pesticide refiller associated with record keeping is $462. Assuming it takes an agricultural pesticide refiller 8 hours to refill, with a labor cost of $57.74 per refiller, the estimated total annual cost associated with the burden is $7,757,946 per year (See Table 15).
8 hours per refiller X 16,795 refillers = 134,360 hours
8 hours per refiller X $57.74/hour X 16,795 refillers = $7,757,946
$25 per refillers X 16,795 refillers = $419,875
The paperwork activities that affect swimming pool supply companies are associated with repackaging antimicrobial pesticides into refillable containers. It is estimated that 7.5 hours will be spent per year for the paperwork activities associated with refillable containers (Table 16).
Activity |
Burden Hours (per Year) |
Costs ($ per Year) ($57.74 per hour) |
||
Administrative |
Total Hours |
|||
1. Read instructions |
0.5 |
0.5 |
$29 |
|
2. Plan activities |
0.5 |
0.5 |
$29 |
|
3. Gather Information |
1 |
1 |
$58 |
|
4. Record information |
1 |
1 |
$58 |
|
5. Enforce and Monitor |
4 |
4 |
$231 |
|
6. Store/maintain data |
0.5 |
0.5 |
$29 |
|
Total Burden |
7.5 |
7.5 |
$433 |
Based on an estimated 322 swimming pool supply companies affected by the requirements per year, the total annual burden is estimated to be 2,415 hours per year. At a cost of $57.74 per hour for the administrative labor, the estimated cost per respondent is $433 per year (Table 16). Assuming 322 swimming pool supply companies, the estimated total annual cost per year is $139,442.
7.5 hours per company x 322 companies = 2,415 hours
7.5 hours per company X $57.74/hour X 322 companies = $139,442
The bottom-line estimates for the container regulations represent the total annual burden and costs estimates per year. Table 17 provides the total estimated annualized burden and costs for respondents, as well as the total estimated annualized burden and costs for the Agency. The burden estimate is based on Agency activities associated with reading instructions, planning activities, gather and recording information, and storing and maintaining data, etc.
Table 17. Annual Bottom Line Burden and Costs for Container Regulations
Respondent/Collection Activity |
Annual Burden |
|
|
Hours |
Cost |
Registrants |
|
|
Nonrefillable containers |
5,484 |
$323,562 |
Refillable containers |
5,412 |
$312,489 |
Repackaging into refillable containers |
14,432 |
$833,304 |
Registrants Subtotal |
25,328 |
$1,469,355 |
Agricultural Refillers |
134,360 |
$7,757,946* |
Swimming Pool Suppliers |
2,415 |
$139,442 |
Total Annual Burden, Containers |
162,103 |
$9,366,743 |
* There are also total annual capital costs of $419,875.
Facilities are required to inspect containment structures and to maintain records of inspection and maintenance. The main on-going activities include inspecting facilities monthly and recording the required information, which is estimated to take an average of 15 minutes per month, or three hours a year. The activity associated with storing and maintaining this information and the records of the age of the containment structure and any large mobile containers (if applicable) is estimated to take an average of five minutes per month, or one hour per year, for a total burden of 4 hours per year (see Table. 18). Record-keeping is associated with an administrative labor category which is associated with an average rate of $57.74 per hour.
Activity |
Burden Hours (per Year) |
Costs ($ per Year) ($57.74 per hour) |
|
Administrative |
Total Hours |
||
1. Read instructions |
0 |
0 |
0 |
2. Plan activities |
0 |
0 |
0 |
3. Record information |
3 |
3 |
$173 |
4. Monitor & enforce |
1 |
1 |
$58 |
Total Burden |
4 |
4 |
$231 |
At a cost of $57.74 per hour for administrative labor, the estimated cost per year for four hours of time spent on the information collection, per respondent, is $231. The total annual paperwork burden across all respondents, assuming that 4,6654 facilities will be affected by the requirement, is 18,660 hours per year. Based on an estimated 4,665 facilities affected by the requirement per year, the total annual cost is estimated to be $1,077,428 per year.
4 hours per facility x 4,665 facilities = 18,660 hours
4 hours X $47.78/hour X 4,665 facilities = $1,077,428
These figures represent the total industry burden and cost for the paperwork activities under the containment structures regulations.
The cost estimate should be split into two components: (a) a total capital and start-up cost component (annualized over its expected useful life) and (b) a total operation and maintenance and purchase of services component. The estimates should take into account costs associated with generating, maintaining, and disclosing or providing the information. Include descriptions of methods used to estimate major cost factors including system and technology acquisition, expected useful life of capital equipment, the discount rate(s), and the time period over which costs will be incurred. Capital and start-up costs include, among other items, preparations for collecting information such as purchasing computers and software; monitoring, sampling, drilling and testing equipment; and record storage facilities.
If cost estimates are expected to vary widely, agencies should present ranges of cost burdens and explain the reasons for the variance. The cost of purchasing or contracting out information collections services should be a part of this cost burden estimate. In developing cost burden estimates, agencies may consult with a sample of respondents (fewer than 10), utilize the 60-day pre-OMB submission public comment process and use existing economic or regulatory impact analysis associated with the rulemaking containing the information collection, as appropriate.
Generally, estimates should not include purchases of equipment or services, or portions thereof, made: (1) prior to October 1, 1995, (2) to achieve regulatory compliance with requirements not associated with the information collection, (3) for reasons other than to provide information or keep records for the government, or (4) as part of customary and usual business or private practices.
In addition to the burden hours and associated costs presented in Section 12, there is an annual capital cost of $25 per agricultural pesticide refillers, or $419,875 for the assumed 16,795 agricultural pesticide refillers.
Capital costs are included based on registrant comments. In the previous version of this ICR, two registrant respondents generally agreed with assumptions about capital costs, while the two refiller respondents indicated missing capital costs. One of these respondents suggested that capital costs occur as a result of recordkeeping tracking supplies. The other refiller respondent said that the cost of installing barcodes onto refillable and non-refillable containers and electronic scanners should be included into the capital costs. These comments represent different ways for refillers to comply with the recordkeeping requirements for refillers – paper recordkeeping forms and electronic barcode scanners – and show that facilities implement the recordkeeping requirements in different ways. The previous capital cost was $20 per agricultural pesticide refillers, and was inflation adjusted to $25 for this version of this ICR. A registrant commenter on this version of the ICR said that registrants may also incur a small cost for computer hardware and software and added that it would likely not be a separate expense but part of other business activity. Based on the explanation that the computer hardware and software would likely be a part of other business activity, EPA is not adding an annual capital cost for registrants.
EPA does not anticipate collecting or calling-in the records retained to comply with the container regulations. The data maintained by registrants, refillers and swimming pool applicators will be available for review by EPA or its designee to ensure compliance with the regulations and in the event that a problem arises with a particular type of container. However, EPA anticipates that there may be waiver requests from some or all of the container design and residue removal requirements.
Table 19. EPA Activities - Containers
Agency Activity |
Description |
1. Receive Waiver Requests and Inquiries |
There are approximately 19,000 pesticide products registered by EPA, and waiver requests may be submitted for some products. Submissions will have to be screened for confidentiality and protected accordingly. |
2. Plan activities |
RD will coordinate with the other divisions who make registration decisions (AD and BPPD) to respond to waiver requests. Records of waivers will be maintained as usual by the registering divisions, and possibly in an additional database unique to container issues. |
3. Record information |
EPA will use existing databases to store and track incoming information. |
4. Complete paperwork |
RD and the other registering divisions will coordinate to prepare responses to waiver requests stating approval/disapproval with comments. |
5. Monitor DOT regulatory actions and publish FRNs |
RD will have to monitor FR Notices issued by DOT to determine if the DOT regulations referred to in the container rule have been changed, and if so, must publish an EPA FR notice informing the regulated community of any changes. |
6. Store/maintain data |
Store, file, and maintain copies of waiver requests and responses/ authorizations. |
EPA does not anticipate collecting or calling-in the records retained to comply with the container regulations. The data maintained by registrants, refillers and swimming pool applicators will be available for review by EPA or its designee to ensure compliance with the regulations and in the event that a problem arises with a particular type of container. However, EPA anticipates that, as with most registration requirements and label amendments, there may be waiver requests from some of the container requirements. There are no regular burden impacts to EPA in the containment regulations. Agency labor rates are based on Office of Personnel Management salary tables for federal employees and include benefits and overhead costs, as well as locality pay for the Washington, DC-Baltimore area. For management, the wage rate is $153 per hour; for technical workers, the wage rate is $95; for clerical workers, the wage rate is $53. Estimates for the Agency's burden and costs are provided below.
COLLECTION ACTIVITIES |
BURDEN HOURS (per year) |
COSTS |
||||||
Management |
Technical $95/hr. |
Clerical $53/hr. |
Total Hours |
Total Costs |
||||
1) Receive notifications, waiver requests and inquiries |
2 |
90 |
10 |
102 |
$9,412 |
|||
2) Plan activities |
5 |
20 |
5 |
30 |
$2,895 |
|||
3) Record information |
0 |
20 |
10 |
30 |
$2,440 |
|||
4) Complete paperwork |
0 |
30 |
15 |
45 |
$3,660 |
|||
5) Monitor DOT regulatory actions and publish FRNs |
0 |
10 |
5 |
15 |
$1,220 |
|||
6) Store/maintain data |
0 |
0 |
10 |
10 |
$530 |
|||
TOTAL BURDEN |
7 |
170 |
55 |
232 |
$20,156 |
|||
(a) Management - 7 hours X $153 |
= |
$1,071 |
|
|
||||
(b) Technical - 170 hours x $95 |
= |
$16,150 |
|
|
||||
(c) Clerical - 55 hours x $53 |
= |
$2,915 |
|
|
||||
TOTAL |
|
$20,156 |
|
|
There is no change in the number of burden hours as there are no programmatic updates or changes for this ICR. The change in costs for the regulated community is $1,830,391. The increase in costs is based on BLS wage rate adjustments. There is also an increase in capital costs of $83,975 as a result of an increase in costs for agricultural pesticide refiller. These are adjustments.
This question is not applicable. The activity is conducted only as needed by EPA or state inspections or upon the determination of the respondent. There is no set schedule for the collection of this information.
This question not applicable to this ICR.
EPA does not request an exception to the certification of this information collection.
You can also provide comments to the Office of Information and Regulatory Affairs, Office of Management and Budget via https://www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function.
All comments received by EPA will be included in the docket without change, including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.
The attachments listed below can also be found in the docket for this ICR. The docket for this ICR is accessible electronically through https://www.regulations.gov using Docket ID Number: EPA-HQ-OPP-2024-0023.
Attachment |
Description |
A |
Consultation |
Display Related to OMB Control #2070-0133 – Listings of Related Regulations in 40 CFR 9.1
EPA (2006). Economic Analysis of the Bulk Pesticide Container Design and Residue Removal Standards
EPA (2006). Economic Analysis of the Bulk Pesticide Containment Structures Final Regulation
EPA. (2006). Pesticide Management and Disposal; Standards for Pesticide Containers and Containment; Final Rule (August 16, 2006)
FIFRA Sections 3, 8, 19 and 25.
1 The amount of time estimated for these activities depends on the size of the facility. For this analysis, since there are relatively more small pesticide registrants and agricultural pesticide refillers potentially impacted by the regulations than large registrant and agricultural pesticide refillers, estimates of burden are based on small facilities.
2Estimate of the number of pesticide registrants estimated to be impacted by the rulemaking. See the Economic Analysis of the Pesticide Container Design and Residue Removal Standards.
3 This requirement actually applies to each producing establishment, and here assumes that the average registrant has one facility that refills containers.
4 Estimate of the number of bulk pesticide containment facilities estimated to be impacted by the rulemaking. See the Economic Analysis of the Bulk Pesticide Containment Structures.
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Author | Terry Green |
File Modified | 0000-00-00 |
File Created | 2025-01-16 |