April 6, 2012

SUPPORTING STATEMENT ENVIRONMENTAL PROTECTION AGENCY **NOTICE OF ARRIVAL OF PESTICIDES AND DEVICES (EPA Form 3540**  **- 1)**  19 CFR 12.110
- 117 **1. Identification of the Information Collection 1(a) Title of the Information Collection**  TITL E: Notice of Arrival of Pesticides and Devices under section 17(c) of FIFRA
. OMB No. 2070
- 0020 EPA No. 0152 .1 0 **1(b) Short Characterization/Abstract** The U.S. Customs and Border Protection (C ustoms ) regulations at 19 CFR 12.112 require that an importer desiring to import pesticides into the United States shall, prior to the shipment's arrival in the United States, submit a Notice of Arrival (NOA) of Pesticides and Devices (EPA Form 3540
- 1 or Form 3540
- 1) to the U.S. Environmental Protection Agency (EPA o r Agency). EPA will review the form and determine the disposition of the shipment. Upon completing Form 3540
- 1, EPA returns the form to the importer of record (importer) or licensed customs broker (broker) , who must present the form to C ustoms upon arrival of the shipment at the port of entry. This is necessary

to ensure that EPA is notified of the arrival of pesticides and devices as required under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 17(c), and that EPA has the ability to examine such shipments to determine compliance with FIFRA
. Form 3540
- 1 requires the identification and address information of parties involved in the importation of the pesticide or device and information on the identity of the imported p esticide or device shipment. When Form 3540
- 1 is submitted to the EPA region al office having jurisdiction over the state or territory

in which the port of entry is located, EPA enforcement personnel review the form to determine whether the shipment should be released for entry upon arrival , detained for examination , or refused admission into the United States
. The responsible EPA official returns the form to the importer or broker with EPA instructions to C ustom s as to the disposition of the shipment. Upon the arrival of the shipment, the importer or broker presents the completed NOA to the C ustoms District Director at the port of entry . C ustoms compares entry documents for the shipment with the NOA and notifies the EPA regional office of any discrepan cies, which EPA will resolve with the importer or broker . If there are no discrepancies, C ustoms follows instructions regarding release, detention, or refusal. I f there are discrepancies, the shipment may be detained until cleared for release , or retaine d for examination. I f EPA inspects the shipment and it appears from examination of a sample that it is adulterated, misbranded , or otherwise violates the provisions of FIFRA, or is otherwise injurious to health or the environment, the pesticide or device may

be refused admission into the United States. During th is renewal of this information collection, EPA is revising Form 3540
- 1. The revisions clarify

the i nstr uctions for completing the form , amend the required data items , and2

update the terms used on the form to be consistent with those used by Customs
. EPA is also capturing the burden of providing supporting documentation that is currently submitted by most importers to the Agency

on a voluntary

basis
. In practice, EPA has fo und that questions about a shipment can often be resolved if supporting documentation accompanies the Form 3450
- 1 prior to the arrival of the shipment in the United S tates
. Respondents subject to this information collection include all importers of pesticides and devices as defined b y FIFRA. **2. Need for and Use of the Collection 2(a) Need/Authority for the Collection**  This information collection activity allows C ustoms to fulfill its statutory obligation under FIFRA section 17(c) to no tify the EPA of the arrival of pesticides in the United States. An NOA must be submitted for all imported devices and pesticides, including but not limited to those pesticides that are registered under section 3 of the 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 the FIFRA, and pesticides for which an Exemption has been granted under se ction s 18 or 25(b) of FIFRA
. This notification allows EPA to determine whether import ed 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 country , 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 i nformation, C ustoms and EPA would be unable to meet their statutory requirements under FIFRA.**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 Pesticides Programs (OPP) to monitor and assure compliance with FIFRA. C ustoms uses this information to ensure pesticide and device products admitted to the U.S. have been reviewed b y EPA for compliance. The absence of an accomp anyi ng NOA is, under C ustoms regulations, grounds for refusal of entry

into the United States. **3. Non -**  **Duplication, Consultations, and other Criteria. 3(a) Non Duplication**  Some of the information collected on EPA's Notice of Arrival is identical or similar to information collected on Customs ' entry notice form (Form 34 61, OMB Control Number 1651
- 0024 ) or entry

summary fo r

m ( Form 7501 , OMB Control Number 1651
- 0022 )
. In addition, in order to expedite the processing of shipments of pesticides and devices, EPA recommends that3

respondents provide EPA with a cop y of either the entry notice or entry

summary , or other information submitted to C ustoms pursuant to 19 CFR 142.3(5). This supporting documentation allows EPA to validate the information provided on Form 3540
- 1. The information on entry forms is collected electronically via C ustoms ABI/ACS. EPA does not have the ability to electronically receive th is information. Respondents would plan for and gather the information submitted on Form 3450
- 1 as part of customary business practice s . To avoid double counting of burden hours , EPA onl y accounts for the additional time to ent er the information and submit the form. C ustoms entry

forms cannot substitute for the submission of EPA's notice of arrival because the entry

forms are not required to be completed prior to the arrival of the shipment and hence do not meet the requirements of FIFRA 17 (c). Entry may be made up to 15 day s after a pesticide or device arrives in the U.S. and the entry forms does not contain al l of the information required in a notice of arrival. The information in a notice of arrival is necessary for EPA to determine the disposition of a shipment upon its arrival in the U.S. As discussed in Section 5(b) , EPA is currently participating in the ACE/ITDS project. When ACE becomes fully functional, it will allow for the electronic collection of the information in the N o tice of Arrival
. EPA is currentl y undertaking rulemaking to facilitate the electronic submission of Notice of Arrival information
. **3(b) Public Notice Required Prior to ICR Submission to OMB** Pursuant to 5 CFR 1320.8(d), EPA published a Federal Register (FR) Notice on Wednesday , December 14, 2011 (76 FR 77817) announcing the proposed renewal of this information collection activity and provided a 60
- day

public comment period. The Agency received three comments on this I CR renewal. The comments are available in the docket for this action, and are summarize below, along with EPA’s responses, which are also available in the docket. Two commenters, CropLife America and the Chemical Producers and Distributors Association requested that EPA allow for a 45
- day extension of the public comment p eriod from February 13 to March 29, 2012
. The FR N otice sought public comment on the renewal of three ICRs (OMB Control No.’s 2070

–0032, 2070

–0020, and 2070

–0060) that are currentl y approved under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq .). The approval for two ICRs (OMB Control No.’s 2070
- 0032 and 2070
- 0060) is currentl y scheduled to expire on July 31, 2012, and the approval for this IC R (OMB Control No. 2070
- 0020) is currently scheduled to expire on August 31, 2012. The agency carefull y c onsidered these requests to extend the comment period. However, the timeframe s established under the PRA to renew ICRs before they expire are such that EPA was unable to allow for an extension of the comment period. EPA’s response to the request for an extension is also available in the docket for this action. Baye r CropSciences (Bayer) also submitted comments to the public docket. Regarding4

the clarity of instructions on EPA Form 3540
- 1, Bayer provided several comments. Bayer commented that EPA’s definition of brand name (block 6) could be confusing because a pesticide can be relabled and may bear multiple alternate brand names for the same registration
. EPA agrees with the need for clarification. EPA will revise the instructions for block from “Brand name of the product as it appears on the label under which the pesticide or device is sold or distributed” to “Brand name of the product as it appears on the product label at the time of import.” Baye r believes that the active ingredients and percentage of each (block 7 ) can be redundant because this registration information can often be found online at publically avai la ble websites. EPA must rely

on the information provided by the importer at the time of importation
. P ublically

available websites may

not accuratel y describe registration information for products in the shipment upon importation and are not used to validate the active ingredients and percentages of each
. EPA is recommending that this information be pro vided on EPA Form 3540
- 1 because the agency has found in practice that it needs to validate the formulation of imported pesticides. The actual active ingredients and percentages of each in the actual shipment of an imported pesticide may

vary from the percentages as registered with EPA
. EPA needs to ensure that the variation is within the certified limits for the pesticide product. In addition, EPA notes that, on occasion, the incorrect EPA registration number has been provided on EPA Form 3540
- 1 ; in such cases, EPA may

not rely on the EPA registration number to identify the active ingredients or percentages of each
. Baye r commented that EPA should harmonize its definition of the country of origin with Customs definition. In addition, Bayer believes that EPA’s requires that the country of origin provid ed on the form match the EPA Producer E stablishment number (block 5), and hence is redundant, since country

of origin is captured in the EPA Producer E st ablishment Number
. The definition of the country

of ori gin provided b y EPA is harmonized with Custom s definition. Under 19 CFR 134.1(b), Customs definition of country of origin states in part “ Country of origin means the country

of manufacture, production, or growth of any article of foreign origin entering the U.S. ” EPA’s definition for the country of origin reads “ The country of manufacture, production, or formulation of the pesticide or device of foreign ori gin entering the United States.” The EPA Producer Establ ishment Number and the c ountry of origin do not have the same definition. On the product label, the EPA Producer Establishment Number is the final establishment where the product was produced prior to shipment to the U.S. The country of origin represents the country where the product was first produced. Thus, the country of origin may be, but is not necessarily captured by , the EPA Producer Establishment Number
. Baye r noted that it can provide entry numbers for shipments (block 14) , but the presence of this field a s a required element of EPA F orm 3540
- 1 creates certain challenges in timing of submission to EPA
. Bayer also noted that some research and development compounds are shipped in such small quantities that they qualify for customs free entry

into the United States, and therefore no entry

number would be needed. Making this field required under these circumstances could create an unresolvable data gap in the form. EPA recommends that all5

applicable blocks on the NOA form be completed when submitting the form to EPA. The entry number is the primary

date element that allows EPA to identify and communicate with Customs about a spec ific shipment. E PA will consider incomplete forms and resolve data gaps on a case
by
- case basis. Baye r believes that all data contained on EPA Form 3540
- 1 should be considered confidential and covered by confidentiality

provisions of FIFRA with the exceptions of the information provided in blocks 4,5, 6 & 7. EPA notes that all the information provided on the form , with the exception of that in blocks 4, 5, 6, &7, may be claimed as CBI by

respondents , and if claimed as such, would be covered b y the confi dentiality provisions of FIFRA. EPA needs to know what information the respondent is claim ing as CBI. EPA believes that the current requirement to indicate clearl y in block 16 what information is to be considered CBI provides respondents with flexibility in making CBI claims. Baye r asked EPA to clarify whether the EPA Est ablishment Number is required for movement of unregistered pesticides between establishments operated b y different producers. EPA agrees with the need for clarification. EPA will revise the instructions for block 17 from:

“ **Location of Goods for Examination after Importation** : Enter the phys ical address of the location of goods for examination after importation. In the case of unregistered pesticides products imported between estab lishments operated by the same producer, enter the EPA establishment number for importing registered establishment.” to: “ **Location of Goods for Examination after Importation** : Enter the phys ical address of the location of goods for examination after importation. In the case of unregistered pesticides products imported between establishments operated b y the same or different producer(s), enter the EPA establishment number for i mporting registered establishment.” Baye r asked EPA to give consideration to capital investm ents made to comply with the notice of arrival requirement, and should include information considering potential impacts on commerce and business as a result of delay s in shipment from resolving issues arising in the NOA process. EPA Form 3540
- 1 is available as a pdf document, and can be completed, printed, and stored using office technology and technology sy stems that are required for the routine and usual functi oning of a company
. Inaddition, this ICR renewal does not require new capital investments to acquire and install new sy stems. With regards to impacts on commerce and business as a result of delay s in shipment from resolving issues arising in the NOA revi ew process, EPA acknowledges that these are real costs associated with the regulation of the importation of pesticides. EPA makes every effort to resolve issues in a timely and efficient manner. Costs incurred during the review process, however, are not part of the burden of collecting, generating, or providing information that is the subject of this I CR.6

Baye r also noted that, in its experience, the submission of supportin g information along with the EPA Form 3540
- 1 is not voluntary . Bayer noted that documentation requests for supporting information are inconsistent between EPA regions, are time consuming and can lead to addition al delay s or issues with the notice of arrival review process for reasons unrelated to the notice of arrival or human health and safety. Bayer would ask that if such practices are to be normal that they

not be given a “voluntary” designation but rather be officially incorporated and standardized as part of the notice of arrival process. Although §17(c) provides authority for the U.S. Government to require companies to provide information that is necessary to ensure that a pesticide shipment is in compliance with FIFRA, consistent with the purposes of the Paperwork Reduction Act, information should only be requested when needed. Su pporting information is needed in some cases and not others. Th e recommendation to provide the supp orting information with EPA Form 3540
- 1 prior to arrival is based on EPA’s experience that importers have learned that suppl yi ng supporting information exp e dites the notice of arrival review process. The decision to request supporting information for an imported pesticide, if the information not provided voluntarily by the importer, is made on a case
- by
- case basis b y the regional office, depending on the uni que circumstances of surrounding the importation of the pesticide product. If an importer believes that it is more efficient to routinely submit supporting information, that company may incorporate such submission into its standard business operations without necessity

of a Government requirement. **3(c) Consultations** As part of preparation of this I CR renewal, EPA co ntacted representatives from importers and brokers seekin g feedback on the notice of arrival information reporting requirements and processes , as well as an assessment of the burden estim ates associated with this information collection
. The list of companies that participated in the consultation process, and a summary of the consultations is prov ided in the docket for this action. Regarding clarity of instructions, two representatives, Baye r and Sy ngenta, asked EPA to clarify the instructions for submitting EPA Form 3540
- 1 and for completing blocks on the form designated as self

- explanatory . Fo r this ICR Renewal, EPA has clarified the instructions for submitting the form and for completing all data elements. In addition, Bayer asked EPA to provide direction on EPA Form 3540
- 1 regarding what should be done if the shipment is delayed or there i s a carrier change after the form has been filed and approved (and therefore the entry date or shipper is incorrect). Bayer also asked whether direction could be placed on the form as to how much advance notice EPA would like a form received by . If the in formation on EPA Form 3540
- 1 changes after it has been submitted and approved, EPA recommends that the importer contact the Region having jurisdiction of the state/territory

of the port of entry

where the shipment will arrive. Further, EPA recommends that the importer submit the form prior to the arrival of the pesticide or device at the port of entry
. EPA leaves the exact tim ing of the submission of the notice of arrival to the importer’s discretion. Sy

ngenta asked for clarification on net quantities and units of measure requirements.7

Due to the variety of packaging, EPA provides importers with discretion when reporting net quantities and units of measures. On the revised Form 3540
- 1, EPA provided clarification that the net weight is the net weight as identified on the product label of the pesticide or device on the immediate container, not including the wrapper or other packaging materials. Regarding the fre quency

of submission and the review process, Sy ngenta noted that EPA will not grant blanket notice of arrivals for multiple shipments arriving in defined period of time. EPA is not contemplating granting blanket notices at this time. Bayer noted that some Regions require justification of CBI claims, which can take several weeks to resolve. EPA notes that d uring review of a notice of arrival , EPA regional staff may on occasion raise a question regarding confidentiality

claims, but the Agency

does not delay

approval of a shipment based on such claims. Regarding the burd en estimates, the respondent re pres entatives provided a range of estimates for the burden hours required to complete EPA Form 3540
- 1. The estimates provided range from 0.18 hrs to 3.85 hrs. For this ICR renewal, EPA increased the burden from .3 hrs to .43 hrs per response, on average, as di scussion in section 6(f) below. This change in burden hours per response is a result of changes to the data items on Form 3450
- 1, and well as an accounting of the burden of voluntarily submitting certain information. EPA’s estimate of the burden hours rep resents an average. Some respondents will spend less t ime and others more time than the estimated average. EPA appreciates the comments provided during the consultation period. These communications permit an exchange of issues, problems and solutions on many issues. **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 United States. **3(e) General Guid elines**  The only PRA
- imposed guide line 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 Customs under 19 CFR 163.2 shall be kept for 5 years .8

**3(f) Confidentiality** If information on Form 3540
- 1 is declared sensitive or confidential, it cannot be released to the public. Certain information on Form 3540
- 1 (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 Confidential Business Information (CBI). Other information ( EPA Registration Number and Producer Establishment Number, the brand name of product, and active ingredients and percentages o f each) may not be claimed as CBI pursuant to FIFRA section 7(d) and labeling requirements for pesticides/devices at 40 CFR § 156.10. Confidential data submitted to EPA is handled in accordance with the provisions of the FIFRA CBI security manual. Th is m anual contains instructions to physical security measures; CBI cop yi ng 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 b y a Document Co ntrol Officer. **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 Clas**  **sification System (NAICS) Codes.** Respondents to this information collection are pesticide importers, which includes many ty pes of business entities ranging from Commercial and Institutional Building Construction (NAICS 236220) to Pesticide and Other Agricultural Chemical Manufacturing (NA ICS 325300) and even Public Administration: Executive Offices (NAICS 921110). Other business and institutions that import pesticides include Agriculture, Forestry , Fishing and Hunting (Sector 11), Wholesale Trade, (Sector 42). The majority of responses c ome from businesses that fall under NAI CS 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, devices are the same, except where indicated below.9

**a. Currently approved data items.**  All data in this I CR that is recorded and reported is required b y FIFRA Sections 3, 7, and 17, and 19 CFR Part 12. Provide notification of:  name and complete address of broker or agent (19 CFR 12.112)  name and complete address of importer or consignee (19 CFR 12.112)  name and address of shipper (19 CFR 12.112)  EPA registration number (19 CFR 12.111 and FIFRA Sec. 3)  EPA producer establishment number (19 CFR 12.112 and FIFRA Sec. 7)  brand name of product (19 CFR 12.112 and FIFRA Sec. 17(c))  active ingredients and percentage of each (19 CFR 12.112 and FIFRA Sec.17(c))  unit size, quantity, and total net weight (19 CFR 12.112 and FIFRA Sec. 17(c))  country

of origin (19 CFR 12.112)  port of entry , entry

number, entry date (19 CFR 12.113)  carrier (19 CFR 12.113)  location of good for examination after importation (19 CFR 12.115) **b. Revisions**  **to the data items** EPA is revising the following minor changes to the data items on E PA Form 3540
- 1 under this information collection:  Requiring the complete address of the carrier (19 CFR 12.113). Currentl y, only the name is required.  Adding the email and phone numbers to the address information required f or the importer , broker, shipper, carrier, and consignee (19 CFR 12.112)
. The c omplete address will be defined to include the physical address, telephone number (including cellular or mobile telephone), and email address.  Changing the entry

date to anticipated entry

d ate (19 CFR 12.113)  Adding the recommendation that respondents importing a n unregistered pesticide provide additional information, including the intended use and a description of why the product is being imported into the United States, in the remarks. Pro viding this information voluntarily

on Form 3540
- 1 will expedite EPA’s review of the N otice of Arrival.  Adding the recommendation that respondents of registered pesticides list the active ingredients and percentage of each. Most respondents already voluntarily provide this information. This addition is accounting for current practice.  Adding the recommendation that respondents include supporting documentation, including a product label, material safety data sheets, Customs forms 7501 or 3461 other informati on submitted to Customs pursuant to 19 CFR 142.3(5). Most10 respondents already voluntarily submit supporting documentation as part of a NOA review package that includes Form 3540
- 1
. This addition is accounting for current practice. **(ii) Respondent Activi ties** 

 Read instructions on reverse side of Form 3540
- 1  Plan activities
- CBP  Gather information
- CBP  Enter information on Form 3540
- 1and submit to EPA prior to arrival of pesticide or device product  Respond to questions if further inquires are made by EPA  Submit Form 3540
- 1 , after it is reviewed and signed by EPA, to Customs and Border Protection  Plan and review information for accuracy
- CBP  Store, file, and maintain the information
- CBP C BP means ” Customary

and Usual Business Practice ; " d uring 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 In formation to be kept is generall y information that prudent businesses would maintai n. **5. The Information Collected -**  **Agency Activities, Collection Methodology, and Information Management** 
. **5(a) Agency Activities** EPA regional personnel review Form 3540
- 1 for accuracy and completeness of the submitted information and maintain 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 re quire additional follow
- up in order to determin e the disposition of the pesticide or device shipment. EPA regional personnel also work with Customs agents at the port of entry to resolve discrepancies between information submitted on Form 3540
- 1 and Custo ms entry documents. **5(b) Collection Methodology and Management** The information collected is produced b y all importers as part of Custo mary and Usual Business Practice, as described above. This collection request concerns the entry and submission of this information using the Form 3540
- 1.11

In addition to the revisions of the data items discussed in 4(b), EPA is proposing the f ollowing changes to Form 3540
- 1 to improve the information collected and review process for importers: 1. Change “Broker” to “Licensed Broker” in Block 1 and “Importer” to “Importer of Record” in Block 2. EPA is also remov ing the term “Agent” in Blocks 1, 19 and 20. These changes will improve the form’s consistency with the terminology used by Customs
. 2. In clude in th e Instructions for completing Form 3540
- 1 a recommendation to the importer to voluntarily provide all information , including supporting documentation, at the time of submission of Form 3540
- 1 to EPA prior to the arrival of the shipment in the United States in order to expedite the revie w of the pesticide or device shipment. 3. In clude in the instructions for the Remarks in Block 18 a reminder that respondents can voluntaril y submit additional information. P esticides or devices without an EPA registration numb er often require consultation between the EPA reviewer and the respondent and many respondents are not aware they can submit additional information. 4. C larify

the instructions for Blocks 3, 4, 5, 6, 7, 11, 13, 16 and 17. EPA has closely follow ed EPA and C ustoms regulatory provisions in proposing these changes. 5. Add instructions for Blocks 1, 2, 8, 9, 10, 12, 14, 15, and 18 . The added instructions primarily provide information for those respondents not familiar with importing pesticides and devices , and clarify the information that is need ed for those who are familiar with import requirements
. EPA has closely follow ed EPA and C ustoms regulatory

provisions in proposing these changes
. The currently

approved version and revised version s of EPA Form 34501
- 1 are included in the docket for this action. Inaddition, EPA revised the instructions based on comments received during the first comment period. The final revised version is also in the docket. NOA information is entered once onto Form 3450
- 1 , signed, and submitted to EPA. Form 3450
- 1 i s reviewed by EPA , and, if approved, s i gned by the EPA reviewer. The form is then returned to the importer for submission as a shipping document to accompany the shipment upon its arrival at the U.S. port of entry
. Customs inspectors compare Form 3540
- 1 with entry documents for the shipment of pesticides or de vices and notify the Administrator of any discrepancies. EPA is currentl y participating in an interagency initiative known as the International Trade Dat a S ys tem (ITDS). The goal of ITDS is to make the Federal government’s compliance monitoring of international trade less burdensome and more efficient b y integrating and automating the government
- wide collection, use, and dissemination of international trade data. Under the ITDS concept, agencies harmonize their data requirements with Customs , thereby eliminating redundancies and minor definitional differences.12

IT DS is the organizational framework for Customs and more than 40 participating government agen cies to integrate import requirements into a modernized, upgraded Automated Commercial Environment (A CE ) , which is being designed by Customs to process imports and exports. EPA is currently working with Customs to integrate into the ACE sy stem the Agency ’s six import regulatory

programs, including the current process for notification of arrival of pesticides and devices. In the future, EPA anticipates that most importers will submit the notice of arrival electro nically

in the ACE sy stem , and that the notice of arrival process will be done electronically

and almost instantaneously among importers, EPA, and Customs for most shipments of pesticides or devices
. **5(c) Small Entity Flexibility** The burden of this info rmation 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 Notice of Arrival submission is required on each occasion that a pesticide or 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 importers will submit 28,000 responses to this information collection annually during this renewal ICR. This estimate is based on a projected increase in the number of NOAs EPA receives
. For the last renewal, EPA estimated the annual number of responses at 25,000. In2010, EPA received 27,000 NOAs and EPA projects that the Agency will receive 28,000 NOAs in 2011. EPA estimates that the average burden associated with this information collection activity is approximately

0.43 hours (26 minutes) per response. This average is based on the average estimated response time for registered pesticides, unregistered pesticides , and devices
. Be cause 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 ty pes. The number of respondents expected for each response typ es is based on the number of each type of response , exhibited in Table 1
.13

**Table 1: Number of Responses by Type Type of Response**  **Number of Responses Percent of Total**  Registered Pesticides and Devices 19,600 70 Unregistered Pesticides 8,400 30 As discussed above, importers must submit EPA Form 3450
- 1 prior to the arrival in the United States of a shipment of a pesticide or device. In estimating the burden per response, EPA assumes that all importers will voluntarily submit supporting documents to EPA with Form 3450
- 1. In addition, for unregistered pesticides, EPA assumes importers will voluntarily provide information regarding the intended use of the product, as well as a description of why the product is being imported. EPA estimates it will take respondents submitting a N OA for a registered pesticide or device product 0.4 hours to read the instructions, complete the form, and submit the form to EPA and Customs, for a total of 7,840 hours annuall y. Respondents submitting a NOA for unregistered pesticides will require 0.5 hours for these activities, or 4 ,200 hours annuall y. The annual burden hours per response type are found by multiplying the annual number of responses per response ty

pe time the burden per response. The paperwork burden estimates represent the average 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 12,040 hours annuall y . **6 (b) Estimating**  **Respondent Costs**  The methodology

for calculating the wage rates in this renewal of the IC R has been updated to be consistent with the method for wage calculati on for all ICRs managed b y the Office of Pesticide Programs (OPP). The wage estimates are based on 2010 wage data. The calculation of the wage rate uses base wage data for each sector and labor ty pe for an Unloaded wage rate (hourl y wage rate) and calcul ates the Loaded wage rate (unloaded wage rate + benefits) and the Fully loaded wage rate (loaded wage rate + overhead) based on that data. Full y loaded wage rates are used to calculate respondent and Agency costs. Unloaded Wage Rate: Wages are estimated for labor ty pes (management, technical, and clerical) within applicable sectors. The Agency uses average wage data for the relevant sectors available in the National Industry
- Specific Occupational Employ ment and Wage Estimates from the Bureau of Labor St atistics (BLS) (see http://www.bls.gov/oes/current/oes_nat.htm ). Sectors: The specific North American Industry Classification Sy stem (NAICS) code and website for each sector is included in that sector’s wage rate table in Attachment D. Within each sector, the wage data are provided by Standard Occupational Classification (SOC) . The SOC sy stem is used by

federal statistical agencies to classify workers into occupational categories for14

the purpose of collecting, calculating, or disseminating data (see http://www.bls.gov/o es/current/oes_stru.htm ). Loaded W

age Rate : Unless stated otherwise, all benefits represent 44% of unloaded wage rates, based on average rate of benefits for all civilian non
- farm workers (see htt p://www.bls.gov/news.release/ecec.t01.htm ). Fully Loaded W

age Rate: OPP multiplies the loaded wage rate b y 50% (EPA guidelines 20
- 70%) to get overhead costs. Since the majority of NOAs are submitt ed b y firms in NAI CS code 325300 (Pesticide and Other A gricultural Chemical Manufacturing), hourly wage rates for this sector were used to calculate respondent burden. The full y loaded hourly wage rates for management, technical, and clerical occupations for NAI CS 32 5300 are $120.28, $60.85, and $37.11, respe ctivel y. See Attachment D for labor wage calculations. Table 2 shows the estimated respondent burden and cost for submitting EPA Form 3540
- 1 and supporting documents for registered pesticide and devices
. For these products , EPA estimates the burden per response to be 0.4 hours. The total annual burden for registered pesticides is estimate to be 7,840 burden hours, at a cost of $446,142. The total management, technical, and clerical hours are multiplied times the annual number of responses and b y the full y loaded wage rates to get total annual respondent costs
. **Table 2**  **: Annual**  **Respondent Burden and Cost: Registered Pesticides and Devices**  **Collection Activities Managem**  **ent (hours)**  **Technical**

**(hours) Clerical** 

**(hours) Total** 

**hours Cost**  $120 $61 $37 Read or hear any instructions 784 523 0 1,307 $ 126,104 Plan activities 0 0 0 0 $

- Create information 0 0 0 0 $

- Gather information 0 0 0 0 $

- Process, compile, review information for accuracy 261 1,045 0 1,307 $ 95,042 Com plete written forms 0 1,307 1,307 2,613 $ 128,006 Record, disclose, or display information 0 0 1,307 1,307 $ 48,495 Store, file, or maintain information 0 0 1,307 1,307 $ 48,495 **TOTAL BURDEN 1,045**  **2,875 3,920**  **7,840 $ 446,142** 15 1 Hourly wages rates are fully

loaded wage rates based on NAICS 325300
- Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing from U.S. Dept. of Labor, Bureau of Labor Statistics, May 2010. See Attachment C for wage calculations. 2 Totals m ay

not sum due to rounding. Table 3 shows the estimated respondent burden and cost for submitting EPA Form 3540
- 1 , supporting documents , and intended use information for unregistered pesticides
. For these responses , EPA estimates the burden per response to be 0. 5 hours. The total annual burden for unregistered pesticides and devices is estimate to be 4 ,2 0 0 burden hours, at a cost of $ 2 39 , 004
. **Table 3: Annual**  **Respondent Burden and Cost: Unregistered Pesticides**  **Collection Activities Managem**  **ent (hours)**  **T echnical** 

**(hours) Clerical** 

**(hours) Total** 

**hours Cost**  $120 $61 $37 Read or hear any instructions 420 280 0 700 $ 67,555 Plan activities 0 0 0 0 $

- Create information 0 0 0 0 $

- Gather information 0 0 0 0 $

- Process, compile, review information for accuracy 140 560 0 700 $ 50,915 Com plete written forms 0 1, 5 40 700 2 , 24 0 $ 68 ,575 Record, disclose, or display information 0 0 70 0 70 0 $ 2 5 , 979 Store, file, or maintain information 0 0 700 700 0 $ 2 5 , 979 **TOTAL BURDEN 560**  **1,540 ,**  **2,10 0**  **4,2 0**  **0 $ 2**  **39 ,**  **004** 1 Hourly wages rates are fully

loaded wage rates based on NAICS 325300
- Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing from U.S. Dept. of Labor, Bureau of Labor Statistics, May

2010. See Attachment C for wage calculations. 2 Totals may

not sum due to rounding. **(ii) Estimating Capital and Operations and Maintenance Costs**
. Not applicable.16

**(iii) Capital Start -**  **up vs. Operating and Maintenance Costs** Not applicable. **6(c) Estimating Agency Burden and Cost** EPA estimates that in total 8.0 FTEs across EPA regional offices are allocated for processing data submitted under this information collection
. The estimated number of federal government FTEs n eeded to process and review EPA Form 3450
- 1 on an annual basis was increased from the pr evious estimate of 3.57 to 8.0 . The number of EPA FTEs was estimated at 8.0 based on input from EPA regional offices. The increase reflects more accurate estimates of the federal government burden for processing NOAs. The annual salary

for a federal employee at the GS
- 13, Step 1 level ($71,674) is used as the base wage; no adjustment for locality is made because employees that process NOA forms work in several different localities. After adjusting the salary to account for the cost of benefits and overhead, the full y l oaded annual rate is $154,386; calculations are shown in Attachment D. Table 3 sh ows the total cost of federal government labor for processing NOA forms. At a full y loaded annual wage rate of $154,386 per year, the total annual cost of 8.0 FTEs to the federal g overnment is approximately $1.24 million. **Table 3. Federal Government (Agency) Labor Costs Data Category**  **Value** Fully L oaded Annual Rate ($/year per FTE) * $ 154,386 Total EPA FTEs 8.00 **Total Federal Government Labor Costs**  **$ 1,235 ,**  **086** * For calculation of Fully L oaded Annual Rate from base salary , see Attachment C 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 $60,947. Adjusting for inflation using the Consumer Price Index, the direct cost of processing NOA forms for this I CR renewal is estimated at $62,390. 1 Updating the number to account for the increase in NOAs, the value for this renewal is $70,482. Table 4 combines the labor costs and direct costs to the federal government of processing Notice of Arrival forms. The total cost is approximately $1. 3 million per year, assuming an average of 28,000 Notice of Arrival forms are processed each ye ar.
1 Inflation rate based on Consumer Price Index, All Urban Consumers, U.S. City Average, Series ID: CUSR0000SA0; change from June 2008 to June 2011.17

**Table 4. Total Agency**  **Costs Data Category**  **Value** Total Federal Government L abor Costs $ 1,23 5,086 Total Federal Government Direct Costs $ 70,482 **TOTAL AGENCY COSTS**  **$ 1,305,568 6(**  **d ) Bottom Line Burden Hours and Cost**  **(i) Respondent Burden** The total annual respondent burden hours for this ICR are estimated at 1 2 , 04 0 hours. The total annual respondent cost for this ICR is estimated to be $ 6 8 5 , 146
. **Table 5. 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 Devices 19,600 0. 4 7,840 $ 446,142 Notice of Arrival for Unregistered Pesticides 8,400 0.5 4,200 $2 39 , 004 **Total Annual Respondent Burden 12,040**  **$68 5**  **, 146** 
**(ii) Agency Burden**  The total annual agency

burden for this IC R is estimated to be 8.0 FTEs
. With direct costs, this would result in a total annual agency cost of $1,305,568
. **Table 6. Total Annual Agency Burden and Costs** In formation Collection Responses Per Year Annual Burden

(FTEs) Total

Costs (L abor plus Direct) **Notice of Arrival 28,000**  **8.0 $1,305,568** 
**(iii) Bottom Line Burden and Cost** 18

**Table 7**  **. Bottom Line Burden Hours and Cost**  TOTAL Hours /FTEs Costs Respondent Burden Estimate 1 2 , 0 4 0 Hours $6 8 5 , 146 Agency Burden Estimate 8.0 FTEs $ 1,305,568 **6(f) Reasons for Change in Burden** There is an increase of 4 , 54 0 hours in the total estimated respondent burden compared with th e currentl y approved IC R burden
. This increase is a result of an increase in the annual number o f NOAs submitt ed and an increase in the burden hours per response. The annual number of NOAs submitted to EPA increased from 25,000 for the previous I CR renewal to 28,000 for this I CR renewal
. The average burden hours per response will change from 0.3 hours for the previous IC R renewal to 0.4 3 hours for this I CR renewal. This change in burden hours per response is a result of changes to the data items on Form 3450
- 1, and well as an accounting of the burden of voluntarily submitting certain information
. Specificall y, this burden estimate accounts for the new burdens relat ed to providing information for the telephone numbers and email addresses of the shipper, importer of record, licensed broker, and ultimate consignee when supplying name and address information , and that the complete address, including telephone and email address, of the carrier be provided. In addition, EPA is accounting for the burden of voluntarily

providing s upporting documentation for registered and unregistered pesticides, active ingredients and percentage of each for registered pesticides, as well as intended use information for unregistered pesticides
. The annual burden increase represents an adjustment. Labor costs for respondents and the Agency increased as a result of changes in the wage rates made to: a) reflect current wage rates an d b) to make the methodology for calculating wage rates consistent with other OPP I CRs. The new wage estimates incorporated higher estimates for benefits and overhead than were used in the past. **6(g) Burden Statement** The total annual public respondent burden for this collection of information is estimated to be 12 , 0 4 0 hours. The annual respondent burden for the collection of information associated with the submission o f EPA Form 3450
- 1 is, on average, 0.4 3 hours per submission. This es timate 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 un less it displays a currently

valid OMB control number. The Agency

has established a public docket for this I CR under Docket ID No. EPA
- HQ
OPP
- 20 11
- 0843 , which is available for online viewing at www.regulations.gov, or in person viewing at the OPP Regulatory Public Docket in Rm. S
- 4400, One Potomac Yard (South19

Building), 2777 S. Cry stal Drive, Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday

through Friday , excluding legal holiday s. The docket telepho ne 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 te chniques. Submit your comments, referencing Docket ID No. EPA
- HQ
- OPP
- 2011
- 0843 and OMB Control No. 2070
- 002 0 , to (1) EPA online using www.regulations.gov (our preferred method), or b y mail to: Public In formation and Records Integrity Branch (PIRIB), Mail C ode: 7502P, Office of Pesticide Programs (OPP), Environmental Protection Agency , 1200 Penns ylvania Ave., NW, Washington, DC 20460, 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 20503.20 **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 -**  **2011 -**  **0 843**  . These attachments are available for online viewing at 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 House of Representatives’ US Code website **Attachment B: 19**  **CFR 1**  **2.110 -**  **117.** Available online at the National Archives and

Records Administration’s Electronic CFR Website **Attachment C**  : **Work Sheets used to Calculate Labor Costs**  **Attachment D: Summary or Consultations**  **Attachment E: EPA Form 3540**  **- 1** 21