October 2, 2020
SUPPORTING STATEMENT FOR
AN INFORMATION COLLECTION REQUEST (ICR)
1. Identification of the Information Collection
1(a) Title of the Information Collection
Notice of Arrival of Pesticides and Devices under section 17(c) of FIFRA.
OMB No. 2070-0020 EPA No. 0152.13
1(b) 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 have been signed 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.
2. Need for and Use of the Collection
2(a) Need/Authority for the Collection
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 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(b) Practical Utility/Users of the Data
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. Non-Duplication, Consultations, and other Criteria.
3(a) Non-Duplication
The information collection currently involves a partial duplication if filing with a paper NOA. Much of the identifying information collected on a paper NOA is identical or similar to information collected on CBP’s entry notice form (Form 3461, OMB Control Number 1651-0024).
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).
3(b) Public Notice Required Prior to ICR Submission to OMB
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.
3(c) Consultations
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 Steven Bennett. This stakeholder is a representative 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).
3(d) Effects of less frequent collection
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.
3(e) General Guidelines
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.
3(f) Confidentiality
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.
3(g) Sensitive Questions
Not applicable. No information of a sensitive or private nature is requested in the information collection activity.
4. The Respondents and Information Collected
4(a) Respondents/North American Industry Classification System (NAICS) Codes.
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.
4(b) Information Requested
(i) Data items, including record keeping requirements
The data items that must be submitted for registered pesticides, unregistered pesticides, and pesticide devices are the same, except where indicated below.
Required data items.
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
Data Item Required – A Copy of the On-Product Label
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 Document Information System (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.
c. Continue Voluntary Data Items
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.
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.
(ii) Respondent Activities
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.
5. The Information Collected - Agency Activities, Collection Methodology, and Information Management.
5(a) Agency Activities
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.
5(b) Collection Methodology and Management
The information collected is produced by all importers as part of Customary and Usual Business Practice, as described above. This collection request concerns the entry and submission of this information using either EPA Form 3540-1 (Attachment E) or its CBP-authorized electronic equivalent. The currently approved version of EPA Form 3540-1 is included in the docket for this action.
Electronic NOA information can be submitted in ACE or by submitting EPA Form 3540-1 signed by the importer and then mailed, along with a paper copy of the on-product label (or final printed label) and any other supporting documentation required in order for EPA to determine the import is compliant,, to the appropriate EPA region. The form is reviewed and signed by the EPA reviewer and then returned to the importer where they have the option to file an image of the EPA-signed Form 3540-1 in the ACE Document Image System (DIS) or file by sending with the shipment.
Under the electronic alternative, importers or the importer’s agent can submit pesticide data required by EPA Form 3540-1 by typing into screens in their software, transmitting the information (what is referred to as the Partner Government Agency (PGA) Message Set), and uploading an image of the on-product label that is on the product being imported, to ACE’s Document Image System (DIS). ACE then completes a series of automatic checks to determine if there are problems with the information submitted and will issue electronic notifications to the importer. A successful filing through the PGA Message Set will trigger a “may proceed” message to the entry filing whose status is updated in ACE and is sent to the filer Filings that do not pass the initial checks will receive a “reject” or “hold intact” notification. EPA may review and provide feedback directly to the importer. The filer would need to correct the filing and resubmit in order to receive an “accept” and “may proceed.” Barring any other admissibility issue, CBP will release the shipment upon receiving a “may proceed.” ACE does not allow corrections ten days after CBP “release” which may correspond to the date of arrival.
5(c) Small Entity Flexibility
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."
5(d) Collection Schedule
A NOA submission is required on each occasion that a pesticide or pesticide device shipment arrives for entry in the United States.
6. Estimating the Burden and Cost of the Collection.
6(a) 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.
6(b) 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. |
|
The estimated total annual burden for registered pesticides and pesticidal devices is shown in Table 4. The total annual burden is estimated to be 20,745 burden hours, at a cost of $1,370,120. The burden and cost per response is multiplied by the number of responses to get total annual respondent burden and cost, respectively.
Table 4: Total Annual Respondent Burden and Cost: Registered Pesticides and Pesticidal Devices
Information Collection |
Burden Per Response (hours) |
Cost Per Response |
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 |
$1,370,120 |
Table 5 shows the estimated respondent burden and cost for submitting a NOA, including a label, supporting documents, and intended use information, for unregistered pesticides. For these responses, EPA estimates the burden per response to be 0.50 hours.
Table 5: Respondent Burden and Cost per Response: Unregistered Pesticides
Collection Activities
|
Management (hours)1 |
Technical (hours)1 |
Clerical (hours)1 |
Total (hour) |
Cost ($) |
$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. The total annual burden for unregistered pesticides and pesticidal devices is estimated to be 20,135 hours, at a cost of $1,383,402.
Table 6: Total Annual Respondent Burden and Cost: Unregistered Pesticides
Information Collection |
Burden Per Response (hours) |
Cost Per Response |
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 |
(ii) 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.
6(c) Estimating Agency Burden
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 |
6(d) Estimating Agency 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 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 |
6(e) Bottom Line Burden Hours and Cost
(i) Respondent Burden
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 |
(ii) 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 |
(iii) Bottom Line Burden and Cost
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 |
6(f) Reasons for Change in 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.
6(g) Burden Statement
The total annual respondent burden for this collection of information is estimated to be 40,880 hours. The annual respondent burden for the collection of information associated with the submission of a NOA is, on average, 0.44 hours per submission. This estimate includes the time for reviewing instructions, maintaining the data needed, and completing and reviewing the collection of information. The Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
The Agency has established a public docket for this ICR under Docket ID No. EPA-HQ-OPP-2016-0122, which is available for online viewing at www.regulations.gov. The OPP Docket telephone number is (703) 305-5805.
You may submit comments regarding the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden, including the use of automated collection techniques. Submit your comments, referencing Docket ID No. EPA-HQ-OPP-2016-0122 and OMB Control No. 2070-0020, to (1) EPA online using www.regulations.gov, and (2) OMB by mail to: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW, Washington, DC 20503.
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. |
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Attachment B: |
19 CFR 12.110-117. Available online at the US Government Publishing Office’s Electronic CFR Website.
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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 |
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Attachment D:
Attachment E:
Attachment F:
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Summary of Consultations (TBA)
EPA Form 3540-1 (Paper Form)
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 | 2021-01-11 |