January 4, 2022
SUPPORTING STATEMENT FOR
AN INFORMATION COLLECTION REQUEST (ICR)
Title: Notice of Arrival of Pesticides and Devices under section 17(c) of FIFRA
EPA ICR No. 0152.13
OMB No. 2070-0020
Docket Number EPA-HQ-OPP-2016-0122
Short Characterization/Abstract
Under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), the Environmental Protection Agency (EPA) regulates the import of pesticides and pesticide devices into the United States. The EPA's definition of pesticides is broad, and includes rodenticides, insecticides, herbicides, fungicides, antimicrobials and certain other substances such as plant growth regulators, pesticide devices used to control pests, including those pesticides imported for research and development purposes (“pesticides”). FIFRA Section 17(c)(1) gives EPA and the United States (U.S.) Department of the Treasury joint responsibility to regulate pesticide imports for compliance with requirements under FIFRA, and vests Treasury with rulemaking authority to carry out these responsibilities. Treasury has delegated its §17(c)(1) functions to U.S. Customs and Border Protection (CBP) in the Department of Homeland Security.
CBP regulations at 19 CFR 12.112 require that an importer or the importer’s agent desiring to import pesticides into the United States shall, prior to arrival of the shipment in the United States, submit a Notice of Arrival (NOA) of Pesticides and Devices on EPA Form 3540-1. In the alternative, the importer or the importer’s agent may file an electronic alternative to the Notice of Arrival, with the filing of the entry documentation, via any CBP-authorized electronic interchange system. Importers and their agents are encouraged to file their EPA NOA information well in advance of their shipment’s arrival at the port of entry to allow time for EPA review, any requests for additional information, and any necessary corrections.
For NOA information submitted in paper form, EPA Form 3540-1 must be submitted prior to arrival to allow for review and signature by the appropriate EPA regional office for the state/territory where the shipment is to arrive and indicate any action to be taken by CBP with respect to the shipment.
The International Trade Data System (ITDS) is the ‘single window’ whereby regulated entities (importers and brokers- referred to as the Trade) can electronically file and process their entry and add agency-specific information for multiple agencies in one location rather than separately with each agency. The Automated Commercial Environment (ACE) implementation supports the ITDS. CBP’s ACE system is a platform that provides a single, centralized access point for the trade community to connect with CBP and its Partner Government Agencies (PGA). ACE is the system of record by which electronic trade transactions are conducted and recorded by CBP". Executive Order 13659, Streamlining the Export/Import Process for America’s Businesses, issued February 19, 2014, aimed to significantly reduce processing and approval times for importers and exporters. In response to E.O. 13659, the CBP transitioned all partner government agencies, including the EPA, to begin using ACE on January 1, 2017. ACE electronically processes the majority of NOAs, significantly reducing the need for manual review and approval by the EPA. Importers can continue to file paper NOAs, and the EPA will continue manual reviews and approvals as necessary.
Respondents subject to this information collection include all importers of pesticides and pesticide devices as defined by FIFRA.
1. Explain the circumstances that make the collection of information necessary. Identify any legal or administrative requirements that necessitate the collection. Attach a copy of the appropriate section of each statute and regulation mandating or authorizing the collection of information.
Under FIFRA, EPA has the authority to regulate the distribution (importation) or sale of registered and unregistered pesticides and pesticide devices into the United States. In order to facilitate compliance with FIFRA, the filing of EPA Form 3540-1 (NOA) is required to notify EPA of the arrival of imported pesticides and pesticide devices. This information collection activity allows EPA and CBP to fulfill their statutory obligation under FIFRA section 17(c) (Attachment A) to notify the EPA prior to the arrival of pesticides and pesticide devices in the United States. A NOA must be submitted for all imported pesticides and pesticide devices, including but not limited to those pesticides that are registered under section 3 of FIFRA and to those that may be transferred, sold, or distributed without registration pursuant to 40 CFR 152.30, such as pesticides for which an Experimental Use Permit has been granted under section 5 of FIFRA, and pesticides for which an Exemption has been granted under sections 18 or 25(b) of FIFRA. This notification allows EPA, prior to arrival, to determine whether imported pesticide devices and registered and unregistered pesticides comply with FIFRA. The information permits EPA to stop suspended, cancelled, misbranded, contaminated, or otherwise violative products from being imported into the United States, track those that do enter, and minimize any adverse human health or environmental impact that might arise from the importation of violative products. If EPA did not collect this information, CBP and EPA would be unable to meet their statutory requirements under FIFRA. The statutory provisions set forth in section 17(c) of the FIFRA, 7 U.S.C. 136o(c), are implemented in the CBP regulations at §§ 12.110 through 12.117 of title 19 of the CFR (19 CFR 12.110–12.117) (Attachment B).
2. Indicate how, by whom, and for what purpose the information is to be used. Except for a new collection, indicate the actual use the agency has made of the information received from the current collection.
The information is used by EPA regional pesticide compliance and enforcement staff, the Office of Enforcement and Compliance Assurance (OECA), and the Office of Pesticide Programs (OPP) to monitor and assure compliance with FIFRA. CBP uses this information to ensure pesticide and pesticide device products admitted to the United States have been reviewed by EPA for compliance. The absence of an accompanying NOA is, under CBP regulations, grounds for refusal of entry into the United States
3. Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and the basis for the decision for adopting this means of collection. Also describe any consideration of using information technology to reduce burden.
CBP amended its regulations at 19 CFR 12.112 to permit the option of filing an electronic alternative to the U.S. EPA NOA paper form (EPA Form 3540-1), with entry documentation, via ACE. CBP and EPA have identified the need to clear up a misunderstanding of the FIFRA NOA requirements; specifically, when the paper and electronic NOA must be received by the EPA, and when CBP must be in receipt of the electronic NOA. ACE information collection has the OMB Control Number 1651-0105. See the associated Information Collection Request for discussion related to this question.
The NOA may still be filed in a paper format with the EPA prior to arrival of the shipment. The completed NOA (form has been completed by the importer or their authorized agent and has been review by EPA) must be filed with CBP at the time of entry.
Under the electronic alternative, the importer or their authorized agent can submit pesticide data required by EPA Form 3540-1 through the PGA Message Set, along with an image of the label that is on the product being imported, through CBP’s ACE’s Document Image System (DIS) for the port of entry where the merchandise will be imported.
Filings for most, but not all, entry types can be accomplished through ACE. For example, Foreign-trade zones (FTZs or “Zone”), known internationally as free-trade zones, are secure areas within the United States that are nonetheless outside the customs territory of the United States (U.S.). Importers importing pesticide merchandise destined to arrive in a FTZ classify the filing as Entry Type 25. ACE does not provide functionality for filing an electronic NOA regarding an arrival in an FTZ, so the importer or their authorized agent must submit a completed paper NOA (Form 3540-1) to the appropriate EPA regional office for the state/territory where the shipment is to arrive in the FTZ. It’s not clear as to when CBP intends to build out the ability to file NOAs electronically in ACE for pesticide merchandise arriving in FTZs.
CBP does not make admissibility determinations for this entry type because the merchandise entering the Zone does not enter Customs territory (entry into the U.S.). However, EPA has an obligation to review pesticide shipment information and make a determination in advance of arrival into the U.S., therefore notifications must be provided to the EPA for the import(s) of pesticides and devices that cross our country’s borders, regardless of whether or not those shipments are ever presented to CBP for entry into U.S. commerce.
4. Describe efforts to identify duplication. Show specifically why any similar information already available cannot be used or modified for use for the purposes described in Item 2 above.
The information collection currently involves a partial duplication if the importer or their authorized agent elects to file a paper NOA (Form 3540-1) instead of filing the NOA electronically in ACE. Much of the identifying information collected on the paper NOA is identical or similar to information collected on CBP’s entry notice form (Form 3461, OMB Control Number 1651-0024).
It is important to note the entry forms are mandatory for CBP purposes (e.g., appraisement, classification, origin, etc.) and must be presented to CBP when a shipment will make entry, which can occur up to 15 days after a pesticide or device arrives in the U.S. The entry forms do not contain all of the information required in an NOA. EPA is obligated to review NOA information for pesticide shipments before entry to determine whether the shipment may properly make entry in the U.S.
As mentioned above, CBP codified the availability of both paper and electronic NOA filing options through an interim final rule published in December 2016. CBP intends to finalize the rule in the near term where the filing an NOA via paper or electrically through ACE will remain as filing options for an importer to meet its FIFRA filing obligations. EPA continues to encourage importers or their authorized brokers to continue or start filing NOAs electronically to facilitate automated review of their electronic NOA filing which expedites release of their goods into the U.S. channels of trade if the data transmitted is complete and valid for ACE to process the filing. However, there are some entry types where an NOA can’t be filed electronically through ACE. For those entry types, a paper NOA must be submitted as explained above. For more information about the ACE system and its functionality, see the information collection activities for the ACE system approved under OMB control number 1651-0105.
Respondents’ use of ACE to file import paperwork electronically enables respondents to electronically populate certain identifying information once in the system and have that information available for pre-population on the electronic NOA. CBP codified the availability of both paper and electronic NOA filing options through an interim final rule on September 30, 2016, (81 FR 67140), making electronic reporting a permanent option for filing. Importers can continue or start filing NOAs electronically to eliminate duplication. This renewal document specifically identifies burdens associated with the current collection activities (Attachment C).
5. If the collection of information impacts small businesses or other small entities, describe any methods used to minimize burden.
The burden of this information collection is minimal and affects all importers. It cannot be reduced and still meet requirements outlined in Section 2(a). The information collection does not disproportionately impact small businesses, because the information requested is gathered during "Customary and Usual Business Practices."
6. Describe the consequence to Federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.
This collection represents the minimum collection frequency possible to comply with statutory requirements, which is that the Agency be notified of the arrival of each shipment into the U.S so that each imported shipment may be evaluated, and if necessary, refused. In addition, if a shipment that should have been refused is allowed entry, the information collection enables the federal government to track the movement and distribution of those shipments within the United States, and to minimize any potential adverse human health or environmental impact that might arise. Collecting this information less frequently or not at all would not only violate a statutory mandate but would hamper mission-critical objectives of EPA and Customs.
7. Explain any special circumstances that would cause an information collection to be conducted in a manner:
requiring respondents to report information to the agency more often than quarterly;
requiring respondents to prepare a written response to a collection of information in fewer than 30 days after receipt of it;
requiring respondents to submit more than an original and two copies of any document;
requiring respondents to retain records, other than health, medical, government contract, grant-in-aid, or tax records, for more than three years;
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;
requiring the use of a statistical data classification that has not been reviewed and approved by OMB;
that includes a pledge of confidentiality that is not supported by authority stablished 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
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 PRA-imposed guideline in 5 CFR 1320.6 that is exceeded in this collection is the recordkeeping retention period. Any record required to be made, kept, and rendered for examination and inspection by CBP under 19 CFR 163.2 shall be kept for 5 years.
8. If applicable, provide a copy and identify the date and page number of publication in the Federal Register of the agency's notice, required by 5 CFR 1320.8(d), soliciting comments on the information collection prior to submission to OMB. Summarize public comments received in response to that notice and describe actions taken by the agency in response to these comments. Specifically address comments received on cost and hour burden.
Describe efforts to consult with persons outside the agency to obtain their views on the availability of data, frequency of collection, the clarity of instructions and recordkeeping, disclosure, or reporting format (if any), and on the data elements to be recorded, disclosed, or reported.
Consultation with representatives of those from whom information is to be obtained or those who must compile records should occur at least once every 3 years - even if the collection of information activity is the same as in prior periods. There may be circumstances that may preclude consultation in a specific situation. These circumstances should be explained.
Prior to submission to OMB, this ICR was made available to the public for comment through a Federal Register notice. The public had 60 days to provide comments. EPA did not receive any comments in response to the previously provided public review opportunity issued in the Federal Register on May 8, 2020 (85 FR 27413). With this submission, EPA is providing an additional 30 days for public review.
In addition to the public notice that EPA published in the Federal Register concerning the extension of this ICR, the Agency consulted with stakeholders who actively interact with the Agency through the use of this data collection. EPA staff contacted five relevant stakeholders and received responses from one of them. EPA asked for their assessment of the regulatory burden and cost estimates expressed by the Agency in this ICR, the clarity of instructions for respondents, the method and frequency of collection, etc.
The Agency only received a few comments from the Household and Chemical Products Association. The stakeholder agreed with the appropriate guidance however stated there was a lack of central written guidance on importing small-scale samples for research purposes. EPA responds that chemicals that are imported for pesticide R&D uses, i.e., the chemical is intended for use in the R&D context to prevent, destroy or mitigate any pest, for use as a plant regulator, defoliant, or desiccant, or as a nitrogen stabilizer, are pesticides as defined by FIFRA and must be imported with an EPA NOA. This would include, for example, any R&D chemical the manufacturer, registrant, or importer intends to use or knows will be used for the purpose of gathering information in support of a pesticide’s registration, and any R&D chemical that has been issued an experimental use permit (EUP) by the EPA’s Office of Pesticide Programs. Whether registered or unregistered, all R&D pesticides must comply with all pesticide import requirements, including submission of an NOA, production establishment registration and reporting requirements, and all applicable labeling requirements.
The stakeholder commented on how some clients do not yet have a customs broker to facilitate this. Without a customs broker they do not have access to ACE and information must be supplied minimally via email to the appropriate Region or via hard copy mailing. EPA responds that importers have two options for filing an EPA NOA (paper or electronic) to CBP. They are the following: (1) using a knowledgeable customs broker who has the software to file the EPA NOA through ACE or (2) purchase software and self-file the EPA NOA through ACE after learning what and how to file using the software. Resources for finding a customs broker can be found at https://www.ncbfaa.org.
The stakeholder also commented that the estimates underestimate the burden. EPA responds that EPA’s estimate of the time required per NOA is an average based on all respondents. Some respondents will spend less time and others more time than the estimated average. EPA does not assume that a company has regulatory staff dedicated to complying with the NOA requirements. Rather, EPA assumes personnel familiar with the company’s importation processes will complete a NOA. EPA also assumes that the activities would require personnel with a technical level of experience to identify, locate, and compile the information, although companies may choose to assign these activities to clerical personnel.
The full consultation is included in (Attachment D).
9. Explain any decision to provide any payment or gift to respondents, other than remuneration of contractors or grantees.
Not applicable.
10. Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statute, regulation, or agency policy. If the collection requires a systems of records notice (SORN) or privacy impact assessment (PIA), those should be cited and described here.
Confidential data submitted to EPA is handled in accordance with the provisions of the FIFRA Confidential Business Information (CBI) security manual. This manual contains instructions to physical security measures; CBI copying and destruction procedures; transfer of CBI materials within EPA to contractors or to other government offices; computer security; CBI typing procedures; and internal office procedures. The manual dictates that all CBI must be marked or flagged as such, only authorized Agency personnel may be permitted access to CBI, all CBI must be kept in secure (double-locked) areas, and all CBI marked for destruction must be cleared by a Document Control Officer.
If information in the NOA is claimed as confidential, it cannot be released to the public except in accordance with EPA confidentiality regulations at 40 CFR part 2, subpart B. Certain information in NOAs (e.g., names and complete addresses, along with unit size, quantity, total net weight, country of origin, port of entry, entry number, and anticipated entry date) may be claimed as FIFRA CBI.
However, other information presented in an NOA may not be protected as confidential pursuant to FIFRA section 7(d), labeling requirements for pesticides/devices at 40 CFR 156.10, and misbranding provisions in FIFRA section 2(q), specifically:
EPA Registration Number.
EPA Establishment Number.
Brand name of product.
Active ingredients and percentages of each.
11. Provide additional justification for any questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private. This justification should include the reasons why the agency considers the questions necessary, the specific uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.
Not applicable. No information of a sensitive or private nature is requested in the information collection activity.
12. Provide estimates of the hour burden of the collection of information. The statement should:
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.
Respondents to this information collection are pesticide importers, which includes many types of business entities ranging from Commercial and Institutional Building Construction (NAICS 236220) to Pesticide and Other Agricultural Chemical Manufacturing (NAICS 325300) and even Public Administration: Executive Offices (NAICS 921110). Other industries and institutions that import pesticides include Agriculture, Forestry, Fishing and Hunting (Sector 11), Wholesale Trade, (Sector 42). The majority of responses come from businesses that fall under NAICS code 325300.
The data items that must be submitted for registered pesticides, unregistered pesticides, and pesticide devices are the same, except where indicated below.
Filing an EPA signed paper NOA requires software to file in ACE. Information on how to apply for a secure ACE portal account can be found on CBP’s webpage at https://www.cbp.gov/trade/automated/getting-started/portal-applying.
For further information on filing the paper EPA NOA, please see the filing tips sheet at https://www.cbp.gov/document/publications/ace-tips-filing-epa-pesticides. [Important Note: CBP is urging importers to file an image of the signed paper EPA NOA via DIS in ACE rather than filing on paper with the shipment]
EPA reviews and evaluates NOA information submitted in paper form and may request additional information in order to make a determination of whether to approve the shipment or not. Under the electronic alternative, EPA responds to notifications from ACE for electronic NOA filings that have failed the ACE automated checks. In addition, EPA routinely monitors and conducts compliance reviews of electronic NOA filings for pesticide shipments that have passed the initial checks in ACE and released from CBP custody. Under both filing options, a completed NOA (electronic or paper) for a pesticide shipment must be submitted to CBP for entry.
Under FIFRA, EPA has the authority to regulate the distribution (importation) or sale of registered and unregistered pesticides and pesticide devices into the United States All data in this ICR that is recorded and reported is required in order to fulfill EPA and CBP’s obligation under FIFRA 17(c). Below, Table 1 provides listing of data items required by FIFRA (along with citations to collect data) and recommended changes for most to provide clarity. No new data elements are being introduced in Table 1.
Table 1 – Required 3540-1 Form Parts and Boxes, Authority, and Clarifying Changes to Currently Approved Form Parts, Boxes, and Instructions
The “label is the law” and EPA ensures pesticides are in compliance with the EPA-approved label and pesticide devices are compliant with regulations. OMB approved the use of ACE DIS to collect the label image. Under the current ICR, submission of the label is a mandatory requirement when filing electronically in ACE. A copy of the on-product label that is affixed to the imported pesticide device and pesticide product as part of the standard NOA package. The label allows EPA to verify compliance with FIFRA labeling requirements and may help to resolve issues with a shipment. The label also communicates information that may help Customs Officers take appropriate precautionary measures when handling these shipments at the port. This recommendation is accounting for current practice and can be provided through paper or electronic filing.
In addition to the required data items identified in section 4(b)(i)(a), EPA recommends the following data items continue to be included with submission of an NOA under this information collection. Submission of this information is voluntary.
When importing an unregistered pesticide, provide the CAS No. or Pesticide Chemical (PC) code for the active ingredients in Box 7. The CAS No. and PC code is a unique identifier of the chemical ingredient or substance. Brokers and importers sometimes provide CAS # or PC code because it is faster and more reliable than the chemical name. If the chemical name of the active ingredient for an unregistered pesticide is unknown, it can delay the NOA approval processing.
Any additional information, including the intended use and a description of why the product is being imported into the United States (Box 18 on EPA Form 3540-1 (Attachment E) or information in the remarks (Box 19 on EPA Form 3540-1). EPA recommends that importers of unregistered pesticides provide this information to help expedite EPA’s review of the NOA. Electronic filers will be able to provide this information through ACE.
Supporting documentation, such as safety data sheets (SDS), Customs forms 7501 or 3461 other information submitted to Customs pursuant to 19 CFR 142.3(5), that may assist EPA in evaluating the shipment. The Customs entry forms allow EPA to verify that the information submitted on an NOA is accurate. The SDS provides EPA inspectors with information about the proper handling of the shipment when an inspection is required. This recommendation is accounting for current practice and can be provided through paper or electronic filing.
Read instructions
Plan activities - Customary and Usual Business Practice
Gather information
Enter information on Form 3540-1 or its Customs-authorized electronic equivalent and submit the information, including the label, to EPA prior to arrival of pesticide or pesticide device product
Respond to questions if further inquiries are made by EPA
If using the paper Form 3540-1, after it is reviewed and signed by EPA, provide to Customs
Plan and review information for accuracy
Store, file, and maintain the information
The Customary and Usual Business Practice, during the course of normal and prudent business operations, a respondent would plan activities for this information collection, arrange for the collection, review the information for accuracy, and arrange to maintain or store the information detailed under 4(b) above. The information to be kept is generally information that prudent businesses would maintain.
Estimating the Burden and Cost of the Collection.
Estimating Respondent Burden
In calculating the respondent burden, EPA estimates that, on average, importers will submit over 92,133 responses (81,549 for electronic and 10,584 for paper) to this information collection annually during this renewal ICR. This estimate is based on a projected decrease in the number of paper NOAs EPA receives for manual review. We expect the number of paper NOAs to decrease. At the same time, the number of electronic responses is expected to increase for a total increase annually. For the last renewal, EPA estimated the annual number of responses at 38,000. These at the time were entirely paper responses. The decrease for paper NOA responses is primarily due to a respondent’s choice to file an electronic alternative to the NOA, with their entry documentation, via a CBP-authorized electronic interchange system. The ACE system, implemented in January 2017, is the platform for respondents to electronically provide their responses to CBP and EPA (as well as other agencies). Although ACE does initially identify commodities where responding may be required, respondents are independently responsible for determining whether they have any FIFRA obligations or obligations under any other Federal Law. Approximately 10,600 paper NOAs and 81,500 electronic NOAs were received on average over the past three years from 2017-2019.
In estimating the burden per response, EPA assumes that all importers will include a copy of the product label as part of current practice and will voluntarily submit other supporting documents to EPA as part of the NOA. In addition, EPA assumes importers of unregistered pesticides will voluntarily provide information regarding the intended use of the product, as well as a description of why the product is being imported. Therefore, all potential burden (both required and recommended/voluntary information) for both registered and unregistered pesticide imports has been accounted for in these burden estimates and may represent a slight overestimation of actual paperwork burden.
On average, the burden associated with this information collection activity is approximately 0.43 hours (26 minutes) per response. This estimate is based on an average response time across all response types. The response time includes an estimated average of 4 minutes of managerial time, 9 minutes of technical time and 13 minutes of clerical time, which is broken down approximately as follows:
4 managerial and technical minutes to read and hear any instructions.
4 minutes of technical and clerical time to gather information, including the label or supporting information.
5 managerial and technical minutes to process, compile and review information.
5 technical and clerical minutes to complete the form and attach the label.
4 clerical minutes to mail the form.
4 clerical minutes to file the form and supporting information.
Because EPA recommends that importers of unregistered pesticides voluntarily supply information about the intended use and an explanation of why the product is being imported, the responses types have been divided into two types, registered and unregistered. In addition, the NOAs have been divided based on the submission method, paper or electronic. It is expected that electronic NOAs will take less time than paper submissions over time, but for this renewal, they are assumed to take the same amount of time. The number of respondents expected annually for each response type is exhibited in Table 2.
Table 2: Estimated Average Annual Number of Responses, by Type
Type of Response |
Number of Responses |
Percent of Total (%) |
Burden (Hours) per Response |
Paper |
10,584 |
11% |
|
Registered Pesticides and Pesticidal Devices |
6,754 |
64% |
0.4 |
Unregistered Pesticides |
3,830 |
36% |
0.5 |
Electronic |
81,549 |
89% |
|
Registered Pesticides and Pesticidal Devices |
45,108 |
55% |
0.4 |
Unregistered Pesticides |
36,441 |
45% |
0.5 |
Total |
92,133 |
100% |
|
Registered Pesticides and Pesticidal Devices |
51,863 |
56% |
0.4 |
Unregistered Pesticides |
40,270 |
44% |
0.5 |
EPA estimates it will take respondents submitting a NOA for a registered pesticide or pesticidal device product 0.40 hours (i.e., 24 minutes) per response to read instructions, complete form, and submit information to EPA and Customs, for a total of 20,745 hours annually. Respondents submitting a NOA for unregistered pesticides will require 0.50 hours (i.e., 30 minutes) for these activities, or 20,135 hours annually. The annual burden hours per response type are found by multiplying the annual number of responses for each response type (as shown in Table 2), times the estimated burden per response for that type. The paperwork burden estimates represent the average burden and costs. Some respondents will spend less time and others more time than the average estimated. The total estimated respondent burden to comply with this information collection is 40,880 hours annually.
Since the option to file NOAs electronically is relatively new to many importers, the burden estimates in this renewal assumes that companies will submit the NOA using paper Form 3450-1, which EPA believes overestimates the burden to submit a NOA electronically. Over time, EPA expects that the burden to file NOAs will decrease as electronic NOA filings become a part of standard business practice. These burden reductions will be reevaluated as the ACE system is fully implemented and will be reflected in future renewals of this ICR once EPA has data on the frequency of electronic and paper filings and the time required to complete each type of NOA.
Estimating Respondent Costs
The methodology for calculating the wage rates in this renewal of the ICR has been updated to be consistent with the method for wage calculation for all ICRs managed by the Office of Pesticide Programs (OPP). The current wage estimates are based on latest wage data, 2019 data accessed online in 2019. The calculation of the wage rates (Attachment F) use base wage data for each sector and labor type for an Unloaded wage rate (hourly wage rate) and calculates the Loaded wage rate (unloaded wage rate + benefits) and the Fully loaded wage rate (loaded wage rate + overhead) based on that data. Fully loaded wage rates are used to calculate respondent and Agency costs.
Unloaded Wage Rate: Wages are estimated for labor types (management, technical, and clerical) within applicable sectors. The Agency uses average wage data for the relevant sectors available in the National Industry-Specific Occupational Employment and Wage Estimates from the Bureau of Labor Statistics (BLS) (see http://www.bls.gov/oes/current/oes_nat.htm).
Sectors: The specific North American Industry Classification System (NAICS) code and website for each sector is included in that sector’s wage rate table in Attachment F. Within each sector, the wage data are provided by Standard Occupational Classification (SOC). The SOC system is used by federal statistical agencies to classify workers into occupational categories for the purpose of collecting, calculating, or disseminating data (see http://www.bls.gov/oes/current/oes_stru.htm)
Loaded Wage Rate: Unless stated otherwise, all benefits represent 46% of unloaded wage rates, based on average rate of benefits for all civilian non-farm workers (see http://www.bls.gov/news.release/ecec.t01.htm).
Fully Loaded Wage Rate: OPP multiplies the loaded wage rate by 50% (EPA guidelines 20-70%) to get overhead costs. Since the majority of NOAs are submitted by firms in NAICS code 325300 (Pesticide and Other Agricultural Chemical Manufacturing), hourly wage rates for this sector were used to calculate respondent burden. The fully loaded hourly wage rates for management, technical, and clerical occupations for NAICS 325300 are $144, $75, and $48, respectively. See Attachment F for labor wage calculations.
Table 3 shows the estimated respondent burden and cost for submitting a NOA, including a label and other supporting documents, for registered pesticide and pesticidal devices. For these products, EPA estimates the burden per response to be 0.40 hours.
Table 3: Respondent Burden and Cost per Response: Registered Pesticides and Pesticidal Devices
Collection Activities
|
Management (hours)1 |
Technical (hours)1 |
Clerical (hours)1 |
Total (hours)
|
Cost ($)
|
|
$143.80/hr |
$75.21/hr |
$47.95/hr |
||||
Read or hear any instructions |
0.01 |
0.05 |
- |
0.06 |
5.20 |
|
Plan activities |
- |
- |
- |
- |
0.00 |
|
Create information |
- |
- |
- |
- |
0.00 |
|
Gather information, including label and supporting information (both mandatory and recommended/voluntary information) |
- |
0.02 |
0.03 |
0.05 |
2.94 |
|
Process, compile, review information for accuracy |
0.02 |
0.05 |
- |
0.07 |
6.64 |
|
Complete written forms |
- |
0.04 |
0.04 |
0.08 |
4.93 |
|
Record, disclose, or display information |
- |
- |
0.07 |
0.07 |
3.36 |
|
Store, file, or maintain information |
- |
- |
0.07 |
0.07 |
3.36 |
|
TOTAL BURDEN2 |
0.03 |
0.16 |
0.21 |
0.40 |
$26.42 |
|
1 Hourly wages rates are fully loaded wage rates based on NAICS 325300 - Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing from U.S. Department of Labor, Bureau of Labor Statistics, 2019 data, Accessed June 2019. See Attachment F for wage calculations. 2 Totals may not sum due to rounding. |
|
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The estimated total annual burden for registered pesticides and pesticidal devices is shown in Table 4. As was stated above and as is shown in Table 3, the burden hours per response is estimated to be about 0.40 hours. The burden cost per response for registered pesticides and pesticidal devices is $26.42 and the total number of responses per year is 51,863. The burden and cost per response is multiplied by the number of responses to get total annual respondent burden and cost, respectively. Thus, the total annual burden is estimated to be 20,745 burden hours and the total annual burden cost that is associated with these hours is expected to be $1,370,120 as is presented in Table 4.
Table 4: Total Annual Respondent Burden and Cost: Registered Pesticides and Pesticidal Devices
Information Collection |
Burden Per Response (hours) |
Cost Per Response1 |
Responses Per Year |
Annual Burden (hours) |
Total Costs |
Notice of Arrival for Registered Devices (paper) |
0.40 |
$26.42 |
6,754 |
2,702 |
$178,433 |
Notice of Arrival for Registered Pesticides and Devices (electronic) |
0.40 |
$26.42 |
45,108 |
28,043 |
$1,191,687 |
Total |
0.40 |
$26.42 |
51,863 |
20,745 |
$1,370,120 |
1 Cost per Response is from Table 3 above.
Table 5 shows the estimated respondent burden and cost for submitting a NOA, including a label, supporting documents, and intended use information, for unregistered pesticides. For these responses, EPA estimates the burden per response to be 0.50 hours.
Table 5: Respondent Burden and Cost per Response: Unregistered Pesticides
Collection Activities
|
Management (hours)1 |
Technical (hours)1 |
Clerical (hours)1 |
Total (hour) |
Cost ($) |
$143.80/hr |
$75.21/hr |
$47.95/hr |
|||
Read or hear any instructions |
0.02 |
0.05 |
- |
0.07 |
6.64 |
Plan activities |
- |
- |
- |
- |
0.00 |
Create information |
- |
- |
- |
- |
0.00 |
Gather information, including label and supporting information |
- |
0.03 |
0.04 |
0.07 |
4.17 |
Process, compile, review information for accuracy |
0.02 |
0.05 |
- |
0.07 |
6.64 |
Complete written forms |
- |
0.04 |
0.04 |
0.08 |
4.93 |
Record, disclose, or display information |
- |
0.07 |
0.07 |
0.14 |
8.62 |
Store, file, or maintain information |
- |
- |
0.07 |
0.07 |
3.36 |
TOTAL BURDEN2 |
0.04 |
0.24 |
0.22 |
0.50 |
$34.35 |
1 Hourly wages rate are fully loaded wage rates based on NAICS 325300 - Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing from U.S. Department. of Labor, Bureau of Labor Statistics, 2019 data, Accessed June 2019. See Attachment F for wage calculations.
2 Totals may not sum due to rounding.
The estimated total annual burden for unregistered pesticides is shown in Table 6. As was stated above and as is shown in Table 5, the burden hours per response for unregistered pesticides is estimated to be about 0.50 hours. The burden cost per response for unregistered pesticides is $34.35 and the total number of responses per year is 40,270. The burden and cost per response is multiplied by the number of responses to get total annual respondent burden and cost, respectively. Thus, the total annual burden is estimated to be 20,135 burden hours and the total annual burden cost that is associated with these hours is expected to be $1,383,402 as is presented in Table 6.
Table 6: Total Annual Respondent Burden and Cost: Unregistered Pesticides
Information Collection |
Burden Per Response (hours) |
Cost Per Response1 |
Responses Per Year |
Annual Burden (hours) |
Total Costs |
Notice of Arrival for Unregistered Pesticides (paper) |
0.50 |
$34.35 |
3,830 |
1,915 |
$131,566 |
Notice of Arrival for Unregistered Pesticides (electronic) |
0.50 |
$34.35 |
36,441 |
18,220 |
$1,251,836 |
Total |
0.50 |
$34.35 |
40,270 |
20,135 |
$1,383,402 |
1 Cost per Response is from Table 5 above.
Other Costs
EPA acknowledges that delays of shipments resulting from resolution of issues arising in the NOA process may result in real costs incurred by the importer. While these costs are not part of the paperwork burden associated with this information collection activity, EPA is providing an estimate of costs that may arise. During the last renewal cycle (EPA ICR No. 0152.13), EPA consulted with three respondents and asked them to estimate the costs associated with delays due to resolving issues arising in the NOA review process. The respondents provided estimates that include storage (e.g., for courier sample and ocean containers), and container demurrage, as follows:
Table 7: Other Costs
Other Costs1 |
Estimated cost per day |
Storage |
$330 |
Container Demurrage |
$100+ |
The prices from the previous ICR were updated using the Consumer Price Index (CPI). Inflation rate based on CPI, All Urban Consumers, United States City Average, Series ID: CUSR0000SA0; change from June 2011 to June 2015.
During the last renewal cycle, one respondent also mentioned air freight charges, but provided no cost information. On average, it takes from one to five days to resolve an issue related to an NOA. EPA has not attempted to confirm these delay cost estimates. In many instances, if the importer submits the paper NOA prior to the arrival of shipment at the port of entry or files the NOA electronically with the filing of the entry documentation via any Customs-authorized electronic data interchange system, issues can be resolved quickly with no associated costs incurred.
EPA estimates that delays occur for less than 5% of all NOAs submitted to EPA and that as few as 1% to 3% of shipments are held at the port annually due to resolving issues associated with the NOA review. In many instances, if the importer has submitted a NOA prior to the arrival of shipment at the port of entry, issues can be resolved quickly and there is a little likelihood that delays, and associated costs will be incurred. For electronic filings through ACE, the majority are processed automatically which results in fewer delays. This is the key advantage of filing electronically.
The total annual respondent burden hours for this ICR are estimated at 40,880 hours. The total annual respondent cost for this ICR is estimated to be $2.75 million.
Table 11: Total Annual Respondent Burden and Costs
Information Collection |
Responses Per Year |
Burden Per Response (hours) |
Annual Burden (hours) |
Total Costs |
Notice of Arrival for Registered Pesticides and Pesticidal Devices |
51,863 |
0.40 |
20,745 |
$1,370,120 |
Notice of Arrival for Unregistered Pesticides |
40,270 |
0.50 |
20,135 |
$1,383,402 |
Total |
92,133 |
0.44 |
40,880 |
$2,753,522 |
13. Provide an estimate for the total annual cost burden to respondents or record keepers resulting from the collection of information. (Do not include the cost of any hour burden already reflected on the burden worksheet).
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.
There are no operational and maintenance cost associated with this collection.
14. Provide estimates of annualized costs to the Federal government. Also, provide a description of the method used to estimate cost, which should include quantification of hours, operational expenses (such as equipment, overhead, printing, and support staff), and any other expense that would not have been incurred without this collection of information. Agencies may also aggregate cost estimates from Items 12, 13, and 14 in a single table.
EPA regional personnel review the submitted information for accuracy and completeness and maintains files of the NOA for inspection and targeting. If all information is complete and accurate, the Agency reviewer signs and returns the form to the importer. An incomplete NOA may require additional follow-up in order to determine the disposition of the pesticide or pesticide device shipment. EPA regional personnel also work with Customs agents at the port of entry to resolve discrepancies between information submitted in a NOA and Customs entry documents. An incomplete, or incorrectly categorized NOA may also result in a review of the product. EPA headquarters and regional personnel participate in the pesticide device determination work group, formed in 2017, to increase consistency on Agency device determinations. The work group meets weekly and addresses device questions, including those from NOAs. The workgroup evaluates whether an import is a pesticide device, a pesticide or is a product unregulated by EPA. If the import is a pesticide device, the work group may evaluate the function and uses of the device which may include current label claims and changes needed to allow the import of the device.
EPA estimates that, in total, 9 EPA FTEs are allocated for processing data submitted under this information collection. The estimated number of federal government FTEs (full time equivalents) needed to process and review NOAs on an annual basis was decreased from the previous estimate of 10 to 9. To estimate the Agency burden hours for this ICR, the number of FTEs, 9, was multiplied by the number of workday hours in a year, 2,080 hours (52 weeks multiplied by 40hrs/week), to get a total of 16,640 Agency burden hours.
Table 8: Agency Burden Estimate
|
Total Burden |
FTEs (full time equivalents) |
9 FTEs |
Workday hours per FTE |
2,080 hours |
Total Workday Hours Annually |
18,720 hours |
The methodology for calculating the wage rates in this renewal of the ICR has been updated to be consistent with the method for wage calculation for all ICRs managed by the Office of Pesticide Programs (OPP). The previous ICR used the 2016 annual salary for a federal employee at the GS-13, Step 1 level ($77,272 annually, or $37/hr, $82/hr when fully loaded). This ICR uses the fully loaded hourly (flh) wage rate for technical staff in the federal government ($78,681 annually, or $40/hr, $87/hr when fully loaded) to represent the wage rates for relevant Agency staff for 2020.
The current wage estimates are based on the most recent 2019 BLS wage data, accessed online in 2019. The calculation of the wage rate uses base wage data for each sector and labor type for an Unloaded wage rate (hourly wage rate) and calculates the Loaded wage rate (unloaded wage rate + benefits) and the Fully loaded wage rate (loaded wage rate + overhead) based on that data.
Fully Loaded Wage Rate: OPP multiplies the loaded wage rate by 50% (EPA guidelines 20-70%) to get overhead costs. NAICS code 999100 for the Federal Government was used to calculate hourly wage rates for the Agency. The fully loaded hourly wage rates for management, technical, and clerical occupations for NAICS 999100 are $132, $87, and $49, respectively. See Attachment F for labor wage calculations.
Table 9 shows the total cost of federal government labor for processing NOA forms. At a fully loaded annual wage rate of $181,454 per FTE annually, the total annual cost of 9 FTEs to the federal government is approximately $1.63 million.
Table 9: Federal Government (Agency) Labor Costs
Data Category |
Value |
Fully Loaded Annual Rate ($/year per FTE) * |
$181,454 |
Total EPA FTEs |
9 |
Total Federal Government Labor Costs |
$1,633,088 |
* For calculation of Fully Loaded Annual Rate from base salary, see Attachment F |
|
In addition to labor costs, there are direct costs of printing instructions and reporting forms. In the previous ICR renewal, this cost was estimated at $76,352 for 38,000 paper NOAs. In this renewal cycle there were roughly 10,600 paper NOAs, so the cost is estimated to be $21,948.
With electronic NOAs, EPA estimates an additional $5,000 in annual operations and maintenance costs to the federal government. These costs are associated with the electronic NOA reference file that will be sent from the Pesticide Registration Information System to Customs via EPA’s Central Data Exchange and received in ACE. There will be cost reductions from switching to electronic NOAs in the form of reduced printing costs and review time, e.g. reduction in direct costs like printing. These cost reductions will be estimated as the ACE system is implemented and will be reflected in future updates of this ICR.
Table 10 combines the labor costs and direct costs to the federal government of processing Notice of Arrival forms. The total cost is approximately $1.47 million per year, assuming an average of about 92,133 NOAs filings (both paper and electronic) are processed each year.
Table 10: Total Annual Agency Costs
Data Category |
Costs |
Total Federal Government Labor Costs |
$1,633,088 |
Total Federal Government Direct Costs |
$21,948 |
Total Federal Government Operations and Maintenance Costs |
$5,000 |
TOTAL AGENCY COSTS |
$1,655,037 |
Agency Burden
The total annual agency burden for this ICR is estimated to be 9 FTEs. With direct costs, this would result in a total annual agency cost of $1.47 million.
Table 12: Total Annual Agency Burden and Costs
Information Collection |
Responses Per Year |
Annual Burden (hours) |
Total Costs (Labor plus Direct & O&M) |
Notice of Arrival |
92,133 |
18,720 |
$1,655,037 |
Table 13: Bottom Line Burden Hours and Cost
|
TOTAL |
|
Hours |
Costs |
|
Respondent Burden Estimate |
40,880 |
$2,753,522 |
Agency Burden Estimate |
18,720 |
$1,655,037 |
15. Explain the reasons for any program changes or adjustments reported on the burden worksheet (in hour or cost burden.)
There is an increase of 24,540 hours in the total estimated respondent burden compared with the currently approved ICR burden. This increase is a result of an increase in the annual number of NOAs submitted. The new electronic system for submitting NOA filings, ACE, has contributed to the increase in the number of NOAs. The annual number of NOAs submitted to EPA increased from 38,000 for the previous ICR renewal to 92,133 for this ICR renewal. The average burden hours per response increased slightly from the previous ICR renewal of 0.43 hours to the current 0.44 per response. This estimate of burden hours per response takes into account past changes to the data items on the NOA, as well as an accounting of the burden of submitting certain information voluntarily or as part of current practice. Specifically, this burden estimate accounts for the burdens related to providing a copy of the label as well as complete contact information, including a telephone number and email addresses, for the shipper, importer of record, licensed broker, carrier and ultimate consignee when supplying name and address information. In addition, EPA is accounting for the burden of voluntarily providing supporting documentation for registered and unregistered pesticides, active ingredients and percentage of each for registered pesticides, as well as intended use information for unregistered pesticides.
Labor costs for respondents and the Agency increased as a result of changes in the wage rates made to reflect current wage rates.
EPA expects that the burden hours and costs to file NOAs may decrease as electronic NOAs become a part of standard business practice. These cost reductions will be reflected in future updates of this ICR once EPA has data on the time it takes to complete electronic filings received by the Agency.
16. For collections of information whose results will be published, outline plans for tabulation and publication. Address any complex analytical techniques that will be used. Provide the time schedule for the entire project, including beginning and ending dates of the collection of information, completion of report, publication dates, and other actions.
Not applicable.
17. If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons that display would be inappropriate.
Not applicable
18.Explain each exception to the topics of the certification statement identified in “Certification for Paperwork Reduction Act Submissions.”
EPA does not request an exception to the certification of this information collection.
ATTACHMENTS TO THE SUPPORTING STATEMENT
Attachments to the supporting statement are available in the public docket established for this ICR under docket identification number EPA-HQ-OPP-2016-0122. These attachments are available for online viewing at http://www.regulations.gov/ or otherwise accessed as described in section 6(f) of the supporting statement.
Attachment A: |
7 U.S.C. 136o - Section 17 of the Federal Insecticide, Fungicide, and Rodenticide Act. Available online at the US Government Publishing Office’s website. |
|
|
Attachment B: |
19 CFR 12.110-117. Available online at the US Government Publishing Office’s Electronic CFR Website.
|
Attachment C: |
Emergency Processing Request for Information Collected in the ITDS Pilot for Pesticide Notice of Arrival (OMB Control No. 2070-0020; EPA ICR No. 0152.11). Available online at http://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201606-2070-002 |
Attachment D: |
Summary of Consultations |
Attachment E |
EPA Form 3540-1 (Paper Form) |
Attachment F |
Work Sheets used to Calculate Labor Costs |
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Hernandez, Connie |
| File Modified | 0000-00-00 |
| File Created | 2022-04-01 |