June 25 , 2010
SUPPORTING STATEMENT FOR AN INFORMATION COLLECTION REQUEST (ICR) 1. IDENTIFICATION OF THE INFORMATION COLLECTION 1(a). Title of the Information Collection Compliance Requirement for Child

- Resistant Packaging OMB No. 2070

- 0052 ; EPA No. 0616. 10 1(b). Short Characterization/Abstract This information collection program is designed to provide the Environmental Protection Agency (EPA) with assurances that the packaging of pesticide products sold and distributed to the general pub lic in the United States meets standards set forth b y the Agency pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Registrants must certify to the Agency that the packaging or device meets these standards. There are no forms asso ciated with this information collection activity

. 2. NEED FOR AND USE OF THE COLLECTION 2(a). Need/Authority for the Collection Section 25(c)(3) of FIFRA authorizes EPA to establish standards for packaging of pesticide products and pesticidal devices to protect children and adults from serious illness or injury resulting from accidental ingestion or contact (see Attachment A). The law requires that these standards are designed to be consistent with those under the Poison Prevention Packaging Act, admin istered b y the Consumer Product Safety Commission (CPSC). Unless a pesticide product qualifies for an exemption, if the product meets certain criteria regarding toxicity and use, it must be sold and distributed in child

- resistant packaging. The authority f or this information collection is pursuant to Section 25(c)(3) of the FIFRA. Compliance regulations are contained in 40 Code of Federal Regulations (CFR) Part 157 (Attachment B). 2(b). Practical Utility/Users of the Data EPA reviews a registrant's chil d

- resistant packaging (CRP) certification to determine if there are human safety/health risk concerns. Exemption requests are reviewed to ascertain if there is a health risk, and if CRP is technically feasible, practicable, and appropriate. 3. NON DUPLICATIO N, CONSULTATIONS, AND OTHER COLLECTION CRITERIA 3(a). Non duplication To avoid duplicative testing of packages for pesticidal and non

- pesticidal purposes, EPA's CRP regulations reference the CPSC packaging standards and protocol testing procedures

.p. 2 of 17

Th is is the only

information collection activity of its kind and the information collected under this activity

is collected only

once per event (e.g., once per certification of CRP compliance). 3(b). Public Notice Required Prior to ICR Submission to OMB In preparing to renew this I CR, EPA published a notice in the Federal Register which provided a 60

- day

public notice and comment period on the draft ICR ( see 75 FR 959 4 ; March 3, 2010). EPA receive d no public comment in response to this notice , which is av ailable in the docket for this ICR and can be accessed at http://www.regulations.gov using the docket indentifier EPA

- HQ

- OPP

- 200 9

- 08 8 7
. 3(c). Consultations EPA consults with the CPSC on general packaging is sues, products under joint jurisdiction (e.g. bleaches and pine oil products), and the regulatory aspect of implementing consumer (child) safety measures in a way that keeps them consistent with those under the Poison Prevention Packaging Act. The Agency also discusses specific packaging issues (for example, determining what can reasonabl y be required or expected in terms of technical and/or economic feasibility) with the CPSC and the packaging industry itself. These consultations occur on an informal "as needed" basis during the process of evaluating exemption requests and certifying to the use of CRP. In the past, when any sort of problem (technical, administrative, or other) arose, or there were suggestions for improvement in the program, the respondent is given ample opportunity to inform the agency

and vice versa. This communication between both parties may take place either in a telephone conversation or in a meeting setting, but not necessarily by a prescribed schedule. During the preparation of this I CR renewal, EPA staff contacted the following representatives of pesticide registrants b y telephone and e

- mail and asked them to comment on the burden and cost estimates in the I CR: 1. John F. Wright , Product & Regulatory Associates, LLC, P. O. Box 1 683, Voorhees, NJ 08043

- 9998, T elephone : 856

- 424

- 1528, E mail : JwrightCH@comcast.net 2. Amy Plato Roberts, Technology Sciences Group, Inc., 712 5 th Street, Suite A, Davis, CA 95616 , Telephone (530) 757

- 1432, E mail : ARoberts@TSGUSA.COM 3. Karen C. Cunningham, Head, Regulatory Affairs L ifecycle Management, Merial Limited , 3239 Satellite Blvd., Duluth, GA 30096, Telephone: 678

- 638

- 3138, Email: karen.cunningham@merial.com 4. Mark Jernigan, Regulatory Affairs Manager, Bio

- Lab, Inc ., A Chemtura Company , P
. O

. B ox 98, Atlanta, GA , Telephone: 678

- 502

- 4149, Email: Mark.Jernigan@chemtura.comp. 3 of 17

All four of the above respondent representatives provided feedback to a questionnaire about the collection process and the burden estimates used b y EPA (see Attachment C). As is the case with pesticide registrant companies, the above respondents vary widely in their experience submitting CRP certifications and/or exemptions. Inparticular, since CRP exemptions represent approximately onl y 6 % of all CRP certifications, some companies may have little or no experience submitting CRP exemptions. Th e variability among companies included in this consultation resulted in variable responses with respect to estimates for burden hours for the different types of CRP submissions. One respo ndent agreed with EPA’s burden estimate, and two respondents offered no comment. A fourth respondent, however, believed that the burden estimate for CRP exemptions was too low. Mr. Wright, a representative of a consulting firm whose clients include small entities, proposed that EPA ’s estimate of the burden hours for processing CRP exemptions was too low . EPA selected Mr. Wright to participate in this consultation in part to address the concern of the Office of Management and Budget ( OMB ) regarding the impac t of this information collection on small entities. Mr. Wright also has experience with submitting CRP exemptions. Hence, EPA consider s his comments sufficient to warrant an amendment of the burden estimate for CRP exemptions. The new burden hours for CRP exemptions are given in Table 1 below. EPA is increasing the burden hours for CRP exemptions for large package size from 0 to 1 hour. Previously , EPA had assumed that no time was required because the CRP regulations for size exemptions require no action on the part of registrants. EPA acknowledges that registrants must read the regulations and plan activities, such as reviewing the pesticide label and marketing options, to support the justification for this exemption. EPA is also increasing the burden ho urs for CRP exemptions due to lack of toxicity, packaging, or no residential use from 4 to 8 hours. EPA’s previous estimate of 4 hours was based on the assumption that registrants would require less time to submit a CRP exemption based on lack of toxicity, packaging, or no residential use than to submit a CRP certification with data. Mr. Wright’s comments imply that it requires registrants the same amount of time to complete both of these types of CRP submissions. His comments are consistent with informal c onsultations OPP staff has had with registrants and applicants seeking clarification with regard to their CRP submissions . EPA believes that such informal consultations are beneficial t o both EPA and the applicants. By encouraging communication and exchang e of ideas, such discussions can help in the development of c learer expectations of what must be submitted and of industry burden. W ith respect to the format for CRP submissions , three of the four respondent representatives indicated that the format might be clearer than it currentl y is if a structured form were provided. Currently, there are no forms associated with this I CR. EPA believes this provides registrants with the greatest amount of flexibility to meet the requirements of th e In formation Collec tion. Guidance for CRP submissions is available on

- line (see attachments), or may be obtained by

contacting EPA directl y. 3(d). Effects of Less Frequent Collection The information collection occurs once for each product

- package combination subject by law to the CRP provisions. In the absence of this information collection activity, the burden of proof would be shifted from the registrant to the EPA. Based on enforcement case precedents involving CRP, EPA would need to have specific evidence to make the product

- package case.p. 4 of 17

Consequently , on the basis of the time and cost involved, EPA would find it difficult to fulfill its statutory responsibilities to ensure that pesticides are equipped with protective packages adequate to protect children from accidental illness or injury

. 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. Registrants or applicants of pesticides for which CRP is required must retain the records required under 40 CFR 157.36 for as long as the registration is valid. Registrations are valid unless or until they are either voluntaril y canceled or withdrawn by the registrant or until EPA has cause to suspend or cancel the registration due to an adverse finding b y EPA. Since the average period of marketability of a pesticide ranges from 15 to 30 ye ars, the PRA

- imposed guideline indicating that data, other than health, medical, or tax records need not be retained for more than three years may o ften be exceeded in this program. The Agency

solicit s packaging manufacturers to voluntarily submit samples of CRPs that have passed CRP testing, identify the packaging, its manufacturer, and list the package's classification according to the ASTM Intern ational Standard D3475, "Standard Classification of Child

- Resistant Packages." The Agency will compile and update the information on an ongoing basis on its CRP Website (www.epa.gov/opprd001/crp/) . The Web site include s descriptions and photographs of the package, with each package classified according to the ASTM International D3475 Standard. The CRP Website provide s a service to CRP manufacturers and pesticide registrants by displaying the various type s of CRP in the marketplace which, in turn, should facilitate compliance with the CRP regulations. An Agency request for, and the public’s submission of, these packaging samples is not a collection of information for the purposes of the OMB Paperwork Reduc tion Act regulations. OMB’s regulations define “information” such that it excludes “samples of products or of any other ph ysical objects” (see 5 CFR 1320.3(h)(2)). Therefore, EPA is not required to estimate the burden associated with submitting these pac kaging samples. 3(f). Confidentiality Although submission of confidential information is not required as a part of this information collection, there has been at least one instance where confidential data have been submitted voluntarily

as supporting m aterial for an exemption request from CRP compliance requirements. When any

trade secret or Confidential Business Information (CBI) is provided to EPA, such information is protected from disclosure under section 10 of FIFRA. Data submitted to EPA is handled strictly

in accordance with the provisions of the FIFRA Confidential Business In formation Manual. This manual contains instructions relative to all contact with confidential documents,p. 5 of 17

including responsibilities of EPA employees, phy sical security me asures, CBI copying and destruction procedures, transfer of CBI materials within the EPA, to contractors or other government offices, computer security, CBI typing procedures (documents to be typed internall y or on contract), and division internal procedures. The manual dictates that all CBI must be marked or flagged as such, onl y authorized EPA personnel may

be permitted access to CBI, and CBI must be kept in secure (double locked) areas. Additionally , CBI for destruction must be cleared b y a Document Co ntrol Officer and placed in the Office of Prevention, Pesticides and Toxic Substances paper shredder. 3(g). Sensitive Questions No information of a sensitive or private nature is requested in this information collection activity

. 4. THE RESPONDENTS AND THE INFORMATION REQUESTED 4(a). Respondents/NAICS Codes Respondents to this information collection activity represent entities involved in manufacturing of pesticide chemicals, wholesale merchandising of pesticide products, or pest management activi ties. The following North American Industrial Classification System (NAICS) codes account for over 80% of respondents: NAI CS 2

- Digit Code Category Description
32 Chemical M anufacturing manufacturers of chemicals used in pesticide products 42 Who lesale Trade wholesale merchandisers of pesticide products 56 Administrative and Support

and Waste Management and Remediation Services establishments performing routine support activities related to pest management

.
4(b). Information Requested Pesticide registrants subject to the regulations are required to certify to the Agency

that the packaging for the pesticide product meets the standards of 40 CFR 157, or request an exemption to the requirement.

(i) Data items, including record keeping requirements The respondent certification letter must exercise one of the following information optionsp. 6 of 17

in this section or in section (i)(a) to comply with 40 CFR Part 157: Certify to CRP by letter to Agency The name, and EPA registration number of the product to which the certification

applies, the Certification statement, the registrant’s name and address, the date, and the name, title and signature of the company officer making the certification. The Certification statement must contain a statement th at the pesticide product complies with 40 CFR 157.32. A description of the packaging used and the ASTM International Standard D3475, "Standard Classification of Child

Resistant Packages," designation is requested (not required). Product does not meet Toxicity Criteria Submit toxicity data that indicate a specific product's minimal toxicity, or

reformulate to a less toxic product and assert that the CRP regulations do not apply. Less than 2 percent of pesticide registrants choose this option for complying with the CRP program. Product is not for Residential Use Revise product labeling so that CRP regulations do not apply, i.e., specifying

non -residential use areas, or eliminate residential use. The registrant is required to send EPA a copy of the revised labeling. Less than 2 percent of pesticide registrants use this option. Approximately 9 4 percent of pesticide registrants choose to certify that their pesticide product packaging meets the effectiveness, compatibility, and durability standards at 40 C FR 157.32. Registrants who certify are required to maintain data to corroborate the certification for the duration of the pesticide's registration as required by 40 CFR 157.36. Of those registrants who do certify , approximately 27 % may also be required to submit additional data because of hum an safety/health risk concerns. If data is needed, EPA requests that registrants submit data electronically

to expedite data anal ys is. Pesticide Regulation (PR) Notice 97

- 9 describes the benefits and requirements of el ectronic data submission (see Attachment D ).

(i)(a) Exemptions from CRP Currently , registrants have several options by which they

may be exempted from CRP requirements. These options include: (1) Package the product in a large size so that CRP regulations do not apply. Exercising this option effectivel y eliminates sales to the general public. It is based on the concept that certain bulk size pesticide packages are intended for commercial use even in residential areas (i.e., exterminator

- use inse cticides and contract lawn care products). These package sizes are specified in 40 CFR 157.24 (a)(2). The pesticide registrant is not required to seek a formal exemption fo r this option, and less than 3 percent of registrants use this option. However, CRP may be required for products packaged in a size exceeding those outlined in exemption criteria at 40 CFR 157.24(a)(2) if it is determined b y the EPA that the product is distributed or sold to the general public. As such, EPA expects that some of these regi strants will no longer meet the criteria for the exemption. (2) Registrants may

also assert that an exemption to CRP is warranted because the hazards indicated b y the toxicity criteria are not indicative of risk to humans, or that CRP is not technicall y feasible, practicable, or appropriate. Each request for an exemption is unique, and thep. 7 of 17

data necessary

to support an exemption are unique. L ess than 3 percent of pesticide registrants choose this option with the CRP program.

(ii) Respondent Activities In order to compl y with the CRP regulations, registrants must engage in the following activities:
Read instructions Review requirements of FIFRA section 25 (c)(3) and 40 CFR Part 157, including its reference to 16 CFR 1700.15(b) and 16 CFR 1700.20; P lan activities Decide under which option to comply with CRP compliance requirements or whether an exemption will be requested; Create information Compile necessary data regarding compliance or exemption from CRP requirements; Review data for reliability and appropriateness Review performance testing data to ensure that it will support CRP certification and identify the ASTM International Standard D3475, “Standard Classification of Child

- Resistant Packages,” for the package. Prepare and submit certification statement. Draft a certification statement citing compliance with CRP requirements and include a description of the package, or explain why the product is not subject to CRP, or request an exemption from CRP compliance requirements and compile/cite any supporting data as necessary. Submit information to EPA. Store, file, and maintain data Maintain any data and information sent to EPA to certify CRP compliance, support a determination as to why product is not subject to CRP, or justify an exemption fr om CRP.

5. THE INFORMATION COLLECTED - AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT 5(a). Agency Activities Upon receipt of a certification letter, EPA performs the following activities:
Review correspondence Review corresp ondence for completeness. Incomplete/incorrect certifications are

returned to registrants; Evaluate data and advise registrant Evaluate data submitted and determine whether the registrant has met the CRP

requirements, has sufficiently substantiated reas ons for not being subject to CRP (e.g. reformulate to a less toxic product) or decide whether or not to grant an exemption. Advise registrant of decision;p. 8 of 17

Store, file, and maintain data All CRP data submitted to the Agency are referenced by an MRID numbe r in the

registration file jacket for the pesticide product. The Agency maintains a record of all CRP certifications in its generic database. 5(b). Collection Methodology and Management Respondents to this I CR submit the information as part of their larger package for registration of a pesticide product. Although EPA is working to allow electronic submission of registration packages, they are currentl y submitted by mail. The Agency

has no objection to submission of the CRP information on CD ROM as part of the registration package. For CRP certifications with data, EPA requests that responses are submitted electronically

to expedite data anal ys is. See Attachment D for guidance on electronic data submission. CRP certifications with data are the mo st burdensome of the four response types under this I CR, comprising about 2 5 percent of all responses and nearl y 67 percent of the total estimated burden. EPA only collects data in support of a CRP certification when there are human safety/health risk co ncerns. EPA requires that registrants maintain data in support of their certifications of the child

- resistance of the product's packaging or devices. At the time of CRP certification we are requesting that the registrant identify the typ e of packaging used . This data is a part of their recordkeeping requirements (under 40 CFR 157.36). This additional piece of data may enable the Agency

to contact all pesticide registrants using a particular ty pe of CRP should a generic problem with the CRP become evident (e .g. trigger sprayers that are no longer considered CRP). It will also facilitate the review of CRP exemption requests b ecause the Agency can ascertain how similar pesticide formulations are packaged. The generic database s ys tem continually tracks all re gistration actions from the registration

- pending stage through to full registration and until a product is canceled. A generic database maintains information on both currentl y registered products and previously registered products, thereb y acting as a regi stration action historical file. Additionally, the CRP compliance certification hard cop y correspondence letters are filed in the pesticide product registration jacket

. 5(c). Small Entity Flexibility The incorporation of alternative methods to verify that the package meets the requirements of 40 CFR 157.32 have allowed manufacturers to use extrapolation schemes, available child

- resistant protocol test data, and supporting documentation without spending the time and money

to develop the data on their exa ct package. The burden and cost to industry also is minimized by : the reference of the CPSC effectiveness standards and protocol test procedures that preclude duplicative testing for pesticidal and non

- pesticidal purposes, and also allow for the use of CRP developed for non

- pesticidal purposes; the use of packaging manufacturer's data rather than product

- specific data; discretion and innovation with regard to product packaging compatibility

and package selection; and the granting of the size exemptions with out requiring an application from the registrant or approval by EPA.p. 9 of 17

During the last IC R approval process , OMB was concerned about the impact of this information collection on small entities. The I CR was conditionally cleared by

OMB with the request that EPA provide the number of small entities that are respondents. In order to respond to this request from OMB, EPA used information on company revenue and employ ment from the Dun and Bradstreet database

. The Dun and Bradstreet database is a comprehensive so urce of financial information on entities, including firm locations, sales, number of employees, and primary business classifications under North American Industrial Classification Sy stem code (NAICS). To estimate the number of small entities that participate under this ICR, EPA assumed the majority

of respondents are individual companies with a NAICS code 325320 (Pesticide and Other Agricultural Chemical Manufacturing). Currently , the number of companies in the Dun and Bradstreet 2010 database using th is code is 892. EPA was able to determine the size of 882 of these individual companies

. T he parent company of the 10 remaining un - sized companies did not report enough sales or employee data to allow a proper anal ys is based on the SBA size classifications . Of the sized firms, 26.3% (232) are large firms or are subsidiaries of large firms, and 73.7% (650) are small firms or subsidiaries of small firms. C urrently , 1733 companies are listed in EPA’s registration tracking database discussed in section 5(b). As suming that the distribution of large and small firms is independent of NAICS code, EPA estimates that there are 456 (26.3% of 1733) large firms and 1277 (73.7 % of 1733) small firms that are potential respondents to this I CR. EPA also estimated the imp act of this I CR on small entities by calculating the annual company burden as a percentage of average annual revenue. Child Resistant Packaging applications were submitted to the Agency by 49 parent firms between 2006 and 2009

. E PA determine d that 27 of the submitting companies were large and 21 were small (see Attachment F for the list of small entities) , based on information from the Dun and Bradstreet 2009 database

. EPA was una

ble to size one company. The table below presents the total and average revenue and employ

ment for small companies, large companies, and all companies combined. As shown below in Section 6, the burden cost per CRP submission is approximately $2 24 . Assuming that CRP submissions are evenly distributed across small and large compani es, an average firm would submit approximately 2 3 CRP applications per year , assuming 50 companies are responsible for the 1,165 CRP submissions in a given year . This would result in an average annual company burden of $5 ,152 , or 0.02% of small firm ’s annual revenue , on average .

Total Number of Firms Total Revenue

($) Total

Employee Size Average

Revenue 1 ($) Average

Employment 1 Small Firms 21 414,668,000 1,737 23,037,111 73 Large Firms 27 312,730,280,167 598,975 12,028,087,699 23,031 All Firm s 48 313,144,948,167 600,712 7,116,930,640 13,639 1 Only based on firms that report sales on D&B.

5(d). Collection Schedulep. 10 of 17

CRP certification is usually conducted only

when a registrant notifies EPA by applicati on of their intention to change packag ing, enter the residential market, or otherwise become subject to CRP regulations. Therefore, for each registered pesticide product, this is a one

- time submission unless labeled product use or package design changes. 6. ESTIMATING THE BURDEN AND COST OF T HE COLLECTION 6(a). Estimating Respondent Burden In calculating the respondent burden, EPA estimates that registrants will submit 1,1 65 responses to this information collection activity annually during this renewal I CR

. The number of responses is base d on the number of products in FY2007, FY2008, and FY2009 with Child

Resistant Packagi ng (CRP) requirements . During this three year period, approximately 703 CRP applications were submitted annuall y. The expected increase in the number of CRP submissions f rom 703 to 1,165 is largely associated with the implementation of the EPA’s Registration Review program. Through the Registration Review program, which was mandated by the Food Quality Protection Act, the Agency periodicall y reevaluates pesticides to make sure that as change occurs, products in the marketplace can still be used safel y. EPA estimates that the average burden associated with this information collection activity is approximately 4 .2 hours per response. 1 This estimate is based on an average response time across all response typ es (i.e. CRP certifications, CRP certifications with data, CRP exemption explanation based on large package size, and CRP exemption explanation based on a lack of toxicity, packaging issues, eliminating residential use, lower product toxicity). The number of respondents expected for each of the various response ty pes is based on the number of each typ e of CRP submission received annuall y. EPA’s estimates of respondent burden do not include any burden at management leve ls. Responses to this information collection activity are generall y handled, without management time, by the technical personnel such as the regulatory affairs person and packaging personnel with some clerical support. Averaged across the four CRP ty pes , each CRP action require s an estimated 3.0 hour s of technical time and 1. 2 of hours clerical time, which is broken down as follows:

 2 4 technical minutes to ascertain whether the product is subject to the CRP regulations (meets toxicity

criteria, residential use) and to decide whether to submit a CRP certification, data, be exempt from regulations due to large size or other criteria;  7 2 technical minutes to create/prepare the information;  6 6 technical minutes to review submission for accuracy and appropri ateness (process, compile, complete document);  5 4 clerical minutes to format submission and prepare information;

1 Based on Table 1, the avg. technical burden across all response types is approx. 3.0 hrs. per response (3,496 ÷ 1,165) and the avg. clerical burden across all response types is approx. 1.2 hrs. per response (1,398 ÷ 1,165). For the purposes of estimating respondent burden and cost (see Table 2), EPA assumes that the average burden is 4.2 hrs. per response (3.0 technical hrs. + 1.2 clerical hrs.).p. 11 of 17

 18 technical minutes to review and sign the appropriate documents; and,  18 clerical minutes to mail the submission, file the respondent cop y and CRP documentation

Type of Response Number of Responses Percent of Total CRP certification without data 798 68 CRP certification with data 296 25 Exempt

– large package size 34 3 Exempt

– lack of toxicity, packaging, no residential use, lower product toxicity 37 3 Respondents submitting CRP certifications without data require 1 hour of technical labor time in order to determine whether the product is subject to the CRP regulations (meets toxicity criteria, residential use) , identify the typ e of C RP used, and prepare the CRP certification. An additional 30 minutes clerical time is required to complete the CRP certification submission to the Agency

and file the supporting CRP information. Respondents submitting CRP certifications with data requi re 8 hours of technical labor time in order to determine the product is subject to the CRP regulations (meets toxicity criteria, residential use); identify

the ty pe of CRP used; prepare the CRP certification; gather the supporting CRP data; and 3 hours of clerical time to prepare the CRP data package, complete the CRP certification submission to the Agency , and file the supporting CRP data. Respondents that are exempt from CRP requirements based on large package size require one hour of technical time an d no clerical time because the CRP regulations require little action on the part of the respondent . Respondents that are exempt from CRP requirements for the reasons described in Section 4(b) of this I CR ( lack of toxicity , packaging, no residential use, lo wer product toxicity) require 8 technical hours and 3 clerical hours to prepare their submission indicating wh y CRP is not required and/or CRP is not possible. These burden estimates b y response type are summarized in Table 1. The total estimated respon dent burden to compl y with this information collection activity is 4, 89 3 burden hours/year ( 4. 2 hours per respondent x 1,1 65 respondents) at a cost of $ 261 , 237

. This cost estimate is illustrated in Table 2. Table 1. ANNUAL RESPONDENT BURDEN BY RESPONSE T YPE Type of Response No. of Responses Technical Burden Clerical Burden Aggregate Burden Hours Per Event Total Hours Per

Event Total
CRP certification 798 1.0 798 0.5 399 1,197 CRP certification with data 296 8.0 2,368 3.0 888 3,256p. 12 of 17

Exempt from CRP due to large package size 34 1 .0 34 0.0 0 34 Exempt from CRP due to lack of toxicity, packaging, no residential use, lower product toxicity 37 8 .0 296 3. 0 111 407

TO TAL 1,1 65 NA 3, 496 NA 1,3 98 4, 89 3 6(b). Estimating Respondent Costs Consistent with recent I CR renewals, OPP is using labor cost estimates from Agency economists with respect to wages, benefits and overhead for all labor categories for affected industries, state government, and EPA employees. This approach uses a transparent and consis tent methodology

employing publicl y- available data to provide more accurate estimates and allow eas y replication of the calculations. Methodology : The methodology uses data on each sector and labor ty pe for an Unloaded wage rate (hourl y wage rate), and c alculates the Loaded wage rate (unloaded wage rate + benefits), and the Fully loaded wage rate (loaded wage rate + overhead). Fully loaded wage rates are used to calculate the Agency ’s staffing 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 Statistics (B LS) at 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 wag e rate table. 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 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 43% of unloaded wage rates, based on benefits for all civilian non

- farm workers, from http://www.bls.gov/news.release/ecec.t01.htm . However, if other sectors are listed for which 43% is not applicable; the applicable percentage will be stated. Fully L oaded Wage Rate: We multiply the loaded wage rate b y 50% (EPA guidelines 20

- 70%) to get overhead costs. Attachments F and F.1 contain worksheets providing the breakout of these costs. Costs are indexed to 2008 data. To derive the labor rate s for this I CR, Agency economists estimated the wages for the management, technical, and clerical labor categories using the methodology cited above. The respondent costs for this renewal for managerial, technical and clerical rates are estimated at $109. 82, $60.39 and $35.89 per hour, respectivel y. These labor rates are fully loaded andp. 13 of 17

include benefits and overhead costs. Table 2 presents respondent burden hours and cost by collection activity averaged across all four CRP response types. The total ave rage cost of the estimated burden per respondent to comply with CRP requirements is approximately $ 224 per response. Using the Agency ’s burden estimate and the full y- loaded labor rates, the Agency estimates total applicant costs to be approximately

$ 261 , 2 3 7 per year . There are no capital expenditures associated with this information collection activity

. Table 2. ANNUAL RESPONDENT BURDEN/COST ESTIMATES

COLLECTION ACTIVITIES Burden Hours TOTAL Tech. $ 6 0.39 /hr. Clerical

$ 35.89 /hr. Burden

Hours Cost
Re ad instructions 0. 18 0.0 0 0.18 $10.57 Plan activities 0.2 2 0.0 0 0.2 2 $1 3

. 29 Create information including electronic format of data 1.2 0 0.0 0 1.2 0 $7 2

. 47 Process, compile, and complete written compliance document 1.1 0 0.9 0 1.9 0 $9 8

. 73 Revie w submiss ion 0. 30 0.0 0 0.4 0 $ 18.12 Store, submit, file, or maintain data 0.0 0 0.3 0 0.3 0 $1 0

. 77

TO TAL 3.0 0 1.2 0 4.2 0 $22 3

. 94 T otals may not sum due to rounding. ANNUAL BURDEN: 4. 2 Hours Per Response x 1,1 65 Response s = 4, 89 3 Burden Hours ANNUAL C OSTS :

(a) Technical : 3.0 hours x $ 6 0

. 39 x 1, 165 response s = $ 211, 063. 05 (b) Clerical : 1. 2 hours x $ 3 5
. 89 x 1,1 65 response s = $ 50,174 .22 Total = $ 261, 237. 27 6(c). Estimating Agency Burden and Cost The Agency

burden hours for the entire CRP process will de crease from 18 .9 hours to 1 4

. 8 hours per response. There has been an in crease in the number of CRP submissions to the Agency . However, the majority of new submissions are for CRP c ertification without data , which is the least resource intensive activity for EPA . As a result, there is an overall decrease in the average Agency

burden per response. Annual burden to the Agency is estimated at 1 7 , 263 burden hours at a cost of $ 1, 20 2 , 339

.p. 14 of 17

Despite the larger increase in applicatio ns for CRP Certification without data, the main portion of the burden hours is still expected t o result from the evaluation of those CRP Certifications submitted with data related to human safety/health risk concerns, and assessing some of the more complex options for compliance (e.g. requesting an exemption). Table 3. ANNUAL AGENCY BURDEN BY RESPONSE TYPE
Action No. of Respondents Technical Burden Clerical Burden Aggregate Burden Hrs Per Event Total Hrs Per Event Total
CRP certification without d ata 798 2.3 1,835 1.0 798 2,633 CRP certification with data 296 40.0 11,840 1.0 296 12,136 Exempt from CRP due to large package size (registrant meets size requirement, no action needed) 34 0.0 0 .0 0.0 0 .0 0 .0

Exempt from CRP due to lack of toxicity, pa ckaging, no residential use, lower product toxicity 37 66.5 2,461 0.9 33 2,494

TO TAL 1,165 n/a 16,136 n/a 1,127 17,263 AGENCY BURDEN = 1 6 , 136 (technical burden) + 1, 127 (clerical burden) = 1 7 , 263 TOTAL HRS/AGENCY ACT ION = 1 7 , 263 ÷ 1,1 65 = 14.8 hrs T able 4 presents Agency

burden hours and costs by collection activity

averaged across all CRP response ty

pes. The average cost to the agency of receiving a CRP submission is 14.8 hours and $1,03 2

. Table 4. ANNUAL AGENCY BURDEN/COST ESTIMATES

COLLECTION ACTIVITIES BURDEN HOURS (per respondent) TOTAL Mgmt. $ 107.56 /hr Tech.

$ 71 . 58 /hr Clerical

$4 1 . 2 1 /hr. Burden

Hours Costs Read correspondence 0.00 0.8 0.0 0.8 $ 57
. 26 Execute activities including data review and certifications for large size non

- liquid po ol chemicals 0.00 1 3

. 1 0.0 13.1 $9 37.70

. Store, file, or maintain data 0.00 0.0 0.9 0

. 9 $37.09 TO TAL 0.00 13. 9 0.9 14. 8 $1,03 2.0 5 T otals may not sum due to rounding.p. 15 of 17

ANNUAL BURDEN: The average Agency burden per CRP response is estimated at approximate ly

1 4.8 hours, costing $ 1,03 2 per response ($ 1,20 2 , 339 ÷ 1, 165 ).
ANNUAL COSTS :

(a) Technical: 13. 9 hours x $ 71.58 x 1,1 65 re sponses = $ 1,15 9 , 130.73 (b) Clerical: 0.9 hours x $ 41.21 x 1, 165 res ponses = $ 4 3 , 208.69 Total = $1, 20 2,339.42
6(d). Bottom Line Burden Hours and Cost Table Hours Costs Respondent Burden/Cost Estimates 4, 89 3 $261,2 37 Agency Burden/Cost Estimates 1 7 , 263 $1, 20 2 , 339
6(e). Reasons for Change In Burden The number of responses has increas ed fro m 703 in the last I CR approval to 1,1 65

. The increase in the expected number of responses is driven primaril y by the expe cted influx of CRP submissions as sociated with the implementatio n of the Registration R eview program

. In addition, the exclusive use period for certain pesticid e chemicals is expiring. Registrants with products using these chemicals will now be required to provide their own CRP test data, which will have to be reviewed for human safety/health risk concerns. The average total burden hours per respondent decreased f rom 4.94 hours to 4. 2 hours per submission

. While the average burden estimate for CRP exemptions has increased, the burden estimate remained the same for CRP certifications and certifications with data, which together represent 94% of all submissions. Furthermore, the distribution of responses among the four response types has changed, resulting in a significant net shift from more

- burdensome to less

burdensome type responses. In particular, EPA expects to receive a larger percentage of CRP certifications without data during this ICR renewal than during the previous I CR. The estimated annual burden under the last I CR approval was 3 , 473 hours. Under this renewal I CR, the annual burden is estimated to be 4 , 89 3 hours. This in crease is due to the increase in the expected number of responses. The estimated burden increase represents an adjustment

. 6(f). Burden Statement The total annual respondent burden for the collection of information contained in thisp. 16 of 17

ICR is estimated t o be 4 , 89 3 hours. The average "respondent" (certifier) burden for the Compliance Requirement for the CRP regulations is estimated to be 4. 2 hours per submission of data necessary

to support a claim that product is not subject to CRP, should be exempt from CRP, or CRP certification, including time for: reading relevant federal legislation and regulations; conducting performance testing on closures and/or devices; reviewing test data; prepare submission or CRP certification; and recordkeeping regarding the C RP certification or submission. As defined b y the PRA and 5 CFR 1320.3(b), “burden” means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency . Thi s includes the time needed to review instructions; develop, acquire, install, and utilize technology and sy stems for the purpose of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing info rmation; adjust the existing ways to comply with an y previously

applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and tran smit or otherwise disclose the information. An 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 OMB control numbers for EPA’s regulatio ns in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable. To facilitate public comment on the Agency's need for this information, the accurac y of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public for this I CR under Docket ID No. EPA

- HQ

- OPP

- 200 9

- 08 8 7 . All documents in the docket are listed in the docket index. Although listed in the index, some information may not be publicly

available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as cop yri ghted material, is not pla ced on the Internet and will be publicly available only

in hard copy form. Publicly

available docket materials are available either in the electronic docket at http://www.regulations.gov , or, if onl y available i n hard cop y, at the OPP Regulatory Public Docket in Rm. S

- 4400, One Potomac Yard (South Building), 2777 S. Cry stal Drive, Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday , excluding legal hol iday s. The Docket telephone number is (703) 305

- 5805. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Please inc lude the EPA Docket ID No. EPA

- HQ

- OPP

- 200 9

- 08 8 7 and OMB Control No. 2070

- 0 05 2 in any correspondence.p. 17 of 17 Attachments to the Supporting Statement All of the attachments listed below can be found in the docket for this ICR (unless otherwise noted); accessible electronically through www.Regulations.gov . On the main page, select Advanced Search from the menu bar at the top and select Docket Search

. Enter the Docket ID Number, EPA

- HQ

- OPP

- 2009

- 088 7 in the Docket ID field. Click on the Submit button . From the results page, you will be able to link to the docket view or directly open select documents found in the docket

. Attachment A: Section 25 (c)(3) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

– als o available at http://www.epa.gov/opprd001/crp/ Attachment B: 40 CFR Part 157

- PACKAGING REQUIREMENTS FOR PESTI CIDES AND DEVI CES

– also available at http://www.access.gpo.gov/nara/cfr/waisidx_03/40cfr157_03.html Attachment C : Record of Consultations Between the U.S. Environmental Protection Agency and Respondents to the Information Collection Request: “Compliance Requirem ent for Child - Resistant Packaging” Attachment D : Pesticide Registration Notice 97 - 9

- Electronic Submission of Child

- resistant Packaging Test Data for All Pesticides and Child

- resistant Testing of Prefilled, Nonrefillable Insecticide Bait Stations Not D esigned or Intended To Be Opened or Activated in a Manner That Exposes the Contents to Human Contact

– also available at http://www.epa.gov/opppmsd1/PR_Notices/pr97

- 9.html Attachment E : Worksheet f or Estimating OPP ICR Wage Rates for Industry, State and EPA Labor Costs Attachment F: Classification and List of Small Entities