August 15, 2013
**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. 1 1 **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 pu

blic 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 ass ociated 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, admi nistered 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 for 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 chi ld

- 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**  **DUPLICATION, 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 20

This 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 Submi ssion to OMB**  In proposing to renew this I CR, EPA will publish a Federal Register Notice and provide a 60

- day public notice and comment period. **3(c). Consultations** In addition to the public notice that EPA will publish in the Federal Register concer ning the renewal of this I CR, the Agency will consult, as required under 5 CFR 1320.8(d)(1), with stakeholders who actively interact with the Agency through the use of this collection instrument. EPA consults with the CPSC on general packaging issues, p roducts 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 gi ven 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. **3(d). Effects of Less Frequent Co llection**  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. 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 re tention 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 withdrawnp. 3 of 20

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 pestic ide 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 often be exceeded in this program. The Agency

solicit s packaging manufacturers t o 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 International 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 Website 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 types of CRP in the marketplace whi ch, 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 Reduction Act regulations. OMB’s re gulations define “information” such that it excludes “samples of products or of any other physical objects” (see 5 CFR 1320.3(h)(2)). Therefore, EPA is not required to estimate the burden associated with submitting these packaging samples. **3(f). Confide ntiality**  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 material for an exemption reques t 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, including responsibilities of EPA employees, phy sical security measures, CBI cop yi ng and destruc tion 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 Control Officer and placed in the Office of Prevention, Pesticides and Toxic Substances paper shredder. **3(g). Sensitive Questions**p. 4 of 20

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 activities. The North American Industrial Classification Sy stem (NAICS) codes for respondents under this ICR include 325320 (Pesticide and other Agricultural Chemical Manufacturing), 424690 (Other Chemical and Allied Products Merchant Wholesalers), and 561710 (Exterminating and Pest Control S ervices). EPA recognizes that while this list may not be comprehensive, it represents a broad spectrum of large and small entities who are engaged in manufacturing pesticide chemicals, wholesale merchandising of pesticide products, or pest management activ ities and who submit CRP applications. **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 options in this section or in section (i)(a) to comply with 40 CFR Part 157:
Certi fy 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 that 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 Pac kages," 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. Les s 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 CFRp. 5 of 20

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 electronic 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 insecticides 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 criteri a 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 registrants 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 the 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; Plan 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.p. 6 of 20

Prepare and submit certification statement. Draft a certification statement citing compliance with CRP requirement s 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 from 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 correspondence 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 reasons 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; Store, file, and maintain data All CRP data submitted to the Agency are referenced by an MRID number in the

registration file jacket for the pesticide product. The Agency maintains a record of all CRP certifications in its generi c 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. At the time of this renewal, OPP is not offering a fully electronic submission option for pesticide registration packages. The Agency is, however, beginning the process of defining requirements for electronic submission of studies as well as other elements of applications and petitions. The Agency has no objection to submission of the CRP information on CD ROM as part of the r egistration 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 most burdensome o f the four response types under this I CR

. EPA only collects data in support of a CRP certification when there are human safety/health risk concerns. 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 isp. 7 of 20

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 req uests b ecause the Agency can ascertain how similar pesticide formulations are packaged. The generic database s ys tem continually tracks all registration actions from the registration

- pending stage through to full registration and until a product is cancel ed. A generic database maintains information on both currentl y registered products and previously registered products, thereb y acting as a registration 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 exact 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 dat a; discretion and innovation with regard to product packaging compatibility

and package selection; and the granting of the size exemptions without requiring an application from the registrant or approval by EPA. EPA also estimated the impact of this I CR on small entities by calculating the annual company burden as a percentage of average annual revenue (see Attachment F)

. EPA estimated the number of small entities that participate under this I CR using information on company revenue and emplo y

ment from Dun and Bradstreet database reported for the year 2010. 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 (see Attachment F). 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 companies which submitted CRP during that period were large and 21 were small (see Attachment F for the list of small entities) , based on infor mation from the Dun and Bradstreet 20 10 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 estimated to be approximately $439 (Table 2, section 6)

. Assuming that CRP submissions are evenl y distributed across small and large companies, an average firm would submit approximately 14 CRP applications per year , assuming 50 companies are responsible for the 685 (see Table 1, section 6) CRP submissions in a given year . This would result in an average annual company burden of $ 6,146 , or 0.0 3 % of small firm ’s annual revenue , on average .p. 8 of 20 **Total Number**  **of Firms**  **T otal 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 Firms 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 Schedule** CRP certification is usually conducted only

when a registrant notifies EPA by applicati on of their intention to change packaging, 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 THE COLLECTION**  **6(a). Estimating Respondent Burd en**  In calculating the respondent burden, EPA estimates that registrants will submit 685 responses to this information collection activity annually during this renewal I CR

. The number of responses is based on the number of products in FY20 10 , FY20 11 , and FY20 12 with Child

Resistant Packaging (CRP) requirements. During this three year period, approximately 486 CRP applications were submitted annuall y. The expected de crease from 1,165 to 685 is largely associated with the implementation of the EPA’s Registration Re view program, which was mandated b y the Food Quality Protection Act and requires the Agency to periodicall y reevaluate pesticides to make sure that as change s occur, products in the marketplace can still be used safel y . The registration reviews completed under the program during FY2010

- 2012 did not result in an expected increase in the number products requiring CRP for that period

. The EPA is using the higher number of 685 because the agency i s expecting an increase in CRP applicati ons for certain products containing pesticide chemicals that will no longer be under exclusive use data protection

. 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. EPA estimates that the average burden associated with this information collection activity is approximately 7.9 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

1 Based on Table 1, the avg. technical burden across all response types is approx. 5.7 hrs. per response (3,912 ÷ 685) and the avg. clerical burden across all response types is approx. 2.2 hrs. per response (1,489 ÷ 685). For the purposes of estimating resp ondent burden and cost (see Table 2), EPA assumes that the average burden is 7.9 hrs. per response (5.7 technical hrs. + 2.2 clerical hrs.).p. 9 of 20

of CRP submission received annuall y. EPA’s estimates of respondent burden do not include any burden at management levels. 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 s upport. Averaged across the four CRP ty pes , each CRP action require s an estimated 5.7 hour s of technical time and 2

. 2 hours of clerical time, which is broken down as follows (see Table 2) :

 0.76 technical hours 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;  2.28 technical hours to create/prepare the information;  2.09 technical hours to review submission for accuracy and appropriateness (process, compile, complete document);  1 .6 clerical hours to format submission and prepare information;  0.57 technical hours to review and sign the appropriate documents; and,  0.6 clerical hours 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 212 31 CRP certification with data 453 66 Exempt

– large package size 12 2 Exempt

– lack of toxicity, packaging, no residential use, lower product toxicity 8 1
Total 685 100 The burden estimates by

response type are summarized in Table 1. 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 ty pe of CRP 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 require 8 hours of techni cal 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 requirep. 10 of 20

1 hour of technical time and no clerical time bec ause 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, lower product toxicity

) require 8 technical hours and 3 clerical hours to prepare their submission indicating why CRP is not required and/or CRP is not possible. The total estimated respondent burden to compl y with this information collection activity is 5,401 burden hours/year . **Table 1.** RESPONDENT BURDEN BY RESPONSE TYPE **Type of Response No. of**  **Responses Technical Burden**  **Clerical Burden Aggregate**  **Burden Hours Per**  **Response Total**  **Hours Per Response**  **Total** CRP certification without data 212 1 212 0.5 106 318 CRP certification with data 453 8 3624 3 1359 4,983 Exempt from CRP due to large package size 12 1 12 0 0 12 Exempt from CRP due to lack of toxicity, packaging, no residential use, lower product toxicity 8 8 64 3 24 88
TO TAL 685 NA 3,912 NA 1,489 5,401 ANNUAL RESPONDENT BURDEN = 3,912 (technical burden) + 1,489 (clerical burden) = 5,401 hrs TOTAL HRS/RESPONDENT ACTION = 5,401 /685 = 7.9 hrs
C osts associated with this burden are estimated in the next section. **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 consistent 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 wag e rate), and calculates 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.p. 11 of 20

Unloaded Wage Rate: Wages are estim ated 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 (BLS) 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 wage 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 4 4 % 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 4 4 % 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. Attachment E contain s worksheets providing the breakout of these costs. Costs are indexed to 20 12 data. To derive the labor rates 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 technical and clerical rates are estimated at $6 2

. 58 and $ 37 .33 per hour, respectively . These labor rates are full y loaded and include benefits and overhead costs. Table 2 presents respondent burden hours and cost by collection activity averaged across all four CRP response types. For example, the total per- response technical burden hours is 5.7 hrs, which is obtained b y dividing the total technical burden hours (3,912 in Table 1 ) across all four CRP response ty

pes by the total number of responses (685). The total clerical burden hours per response is si milarly

computed. These are then broken down among the various collection activities in Table 2 according to the same proportion s used in the previous ICR renewal , using from industry

consultation. The total average cost of the estimated burden per respondent to comply with CRP requirements is approximately $ 438.52 per response. Using the Agency ’s burden estimate and the fully

- loaded labor rates, the Agency estimates total applicant costs to be approximately

$ 300,385 per year . There are no capital expenditures associated with this information collection activity

. **Table 2.** RESPONDENT BURDEN/COST ESTIMATES PER RESPONSE COLLECTION ACTIVITIES **Burden Hours TOTAL**  **Technical, $65.58 /hr.**  **Clerical,**

**$37.33/hr. Burden**  **Hours Cost** 
Read instructions 0.34 0.00 0.34 $21.44 Plan activities 0.42 0.00 0.42 $26.21p. 12 of 20

Create information including electronic format of data 2.28 0.00 2.28 $142.95 Process, compile, and complete written compliance document 2.09 1.63 3.72 $191.90 Revie w submission 0.57 0.00 0.57 $35.74 Store, submit, file, or maintain data 0.00 0.54 0.54 $20.29

TO TAL 5.7 2.2 7.9 $438.52 Table 3 presents the total annual respondent burden and cost. **Table 3**

**– Total Annual Respondent Burden/Cost**  Per Submission Estimates Total Submissions Expected each ye ar Annual Totals Burden (hrs) Costs ($) Burden (hrs) Cost ($) 7.9 439 685 5,401 300,715 Totals may not sum due to rounding Annual B urden : 7.9 Hours p er Response x 685 Response s = 5,4 0 1 Burden Hours Annual C ost : $ 439 per Response x 685 response s = $ 300, 71 5 **6(c). Estimating Agency Burden and Cost** The Agency burden and costs are shown in Table 4

. The Agency burden hours for the entire CRP process will increase from 14.8 hours to 28.9 hours per response. Although there has been a decrease in the total number of CRP submissions to the Agency , there has been a net shift from less

- burdensome to more

- burdensome ty pe responses (e.g., increased percentage of registrants electing to certify to the CRP requirements with data). As a result, there is an overall increase in the average Agency burden per response.
**Table 4**  **.** 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 data 212 2.3 488 1 212 700 CRP certification with data 453 40 18,120 1 453 18,573 Exempt from CRP due to large package size (registrant meets size requirement, no action needed) 12 0 0 0 0 0
Exempt from CRP due to lack of toxicity, packaging, no residential use, lower product toxicity 8 6 6.5 5 32 0.9 7 5 39

TO TAL 685 n/a 19,1 40 n/a 67 2 19, 812p. 13 of 20

ANNUAL AGENCY BURDEN = 19,140 (technical burden) + 67 2 (clerical burden) = 19, 812 TOTAL HRS/AGENCY ACT ION = 19, 812 /685 = 2 8.9 hrs Table 5 presents Agency

burden hours and costs by collection activity

averaged across all CRP response ty

pes. The average Agency burden per CRP response is estimated at approximately 2 8.9 hours at a cost of $2 ,2 30

. 87 per response.
**Table 5**  **.** AVERAGE AGENCY BURDEN/COST ESTIMATES PER RESPONSE **BURDEN HOURS TOTAL**  COLLECTION ACTIVITIES **Mgm t. $/hr**  **Tech. $/hr Clerical $/hr**  **Burden Hours**  **Costs $ 120.60**  **$ 78.24 $ 44.61**  Read correspondence 0 1.6 0 1.6 $126.08 Execute activities including data review and certifications for large size non - liquid pool chemicals 0 2 6.4 0 2 6

. 4 $2 ,064 .64 Store, file, or maintain data 0 0 0.9 0.9 $4 0. 1 5 TO TAL 0 2 8.0 0 .9 28.9 $2, 2 30

. 87 Table 6 presents the total annual agency burden and cost.
**Table 6**

**– Total Annual Agency Burden/Cost**  Per Submission Estimates Total Submissions Expected each ye ar Totals Burden (hrs) Costs ($) Burden (hrs) Cost ($) 28.9 $2,230 685 19, 812 1,528,145 Totals may not sum due to rounding Annual Burden = 2 8. 9 hours per response x 685 responses = 19, 812 Annual Cost = $2,2 30 per resp onse x 685 responses = $1,52 8 , 145
**6(d). Bottom Line Burden Hours and Cost Table** Hours Costs Respondent Burden/Cost Estimates 5,4 0 1 $ 300, 71 5 Agency Burden/Cost Estimates 19, 812 $ 1, 52 8 , 1 45 **6(e). Reasons for Change i**  **n Burden** The number of responses is expected to de crease fro m 1,165 in the last I CR approval to 685

. The decrease is due to EPA’s revised expectations regarding the number of CRPp. 14 of 20

applications that will be submitted to the agency

. The average burden hours per response increased f rom 4. 2 hours to 7.9 hours per submission

. While the average burden hour s per response has increased, the burden estimate remains the same for CRP certifications. The change in the average burden hours per response is due to a change in the distribution of responses among the four response typ es, resulting in a significant net shift from less

- b urdensome (CRP certifications without data) to more
- burdensome (CRP certifications with data) ty pe responses. This increase is partially due to the expiration of the exclusive use period for certain pesticide chemicals since the last ICR renewal and regis trants 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 estimated total respondent burden is expected to increase from 4,893 hours to 5,4 0 1 hours , or 5 0 8 hours . Although the estimated total number of responses for the current ICR renewal is expected to be significantl y less than the last I CR approval, the shift from less

burdensome to more - burdensome ty pe responses has resulted in a net increase in the estimated total respondent burden. The estimated burden increase represents an adjustment. **6(f). Burden Statement** The total annual respondent burden for the collection of information contained in this ICR is estimated to be 5,4 0 1 hours. The average "respondent" (certifier) burden for the Compliance Requirement for the CRP regulations is estimated to be 7.9 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 CRP certific ation or submission. “Burden” is defined in 5 CFR 1320.3(b). The Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information subject to the PRA unless it display s a currently

valid OMB control number. OMB co ntrol numbers for certain regulations in Title 40, after initial display in the Federal Register, are listed in 40 CFR part 9 and may appear on the information collection instrument as applicable, i.e., form or instructions, and in the Federal Register. The Agency

has established a public docket for this I CR under Docket ID No. EPA

- HQ

OPP

- 2013

- 0493, which is available for online viewing at www.regulations.gov , or in person viewing at the EPA Docket Center

- Public Reading Room, EPA West Building, in Rm. S

- 3334, 1301 Constitution Avenue, NW, Washington, DC. This docket facility is open from 8:30 a.m. to 4:30 p.m., Monday

through Friday , excluding federal holiday s. The docket telephone number is (202) 566

- 1744. You may submit comments regarding the Agency's need for this information, the accuracy

of the provided burden estimates and any suggested methods for minimizing respondent burden, including the use of automated collection techniques.p. 15 of 20

Comments may

be submi tted to EPA electronically through http://www.regulations.gov or by mail addressed to Director, Collection Strategies Division, U.S. Environmental Protection Agency (2822T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. Include Docket ID No. EPA

- HQ

- OPP

- 2013

- 0493 and OMB control number 2070

- 0052 in any correspondence.p. 16 of 20 **Attachments to the Supporting Statement** All of the attachments listed below can be found in the docket fo r 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

- 20 13

- 0 493 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)** 

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

- PACKAGING REQUIREMENTS FOR PESTI CIDES AND DEVI CES

– available at http://www.access.gpo.gov/nara/cfr/waisidx_03/40cfr157_03.html **Attachment C :**  **Reserved for Record of Consultations**  **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 Designed or Intended To Be Opened or Activated in a Manner That Exposes the Contents to Hu man Contact

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

- 9.html **Attachment E :**  **Worksheet f**  **or Estimating OPP ICR Wage Rates for Industry and**  **EPA Labor Costs Attachment F:**  **Calculation s**  **Regarding Small Entities that Participate in this ICR**  **Attachment G**  **: Reserved for**  **Display Related to OMB Control #2070 -**  **0052 -**  **Listings of Related Regulations in 40 CFR 9.1** p. 17 of 20 **Attachment E Work Sheets used to Calculate Registrant**  **Labor Costs** This attachment is available as part of the electronic docket **EP A**  **- HQ**  **- OPP**  **- 2013**  **- 0493**  and is part of the ICR’s Supporting Statement. **NAICS: 325300 Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing**  Labor Category : Formula Managerial Technical Clerical Unloaded Hourl y Rate 1 = W $54.34 $28.88 $17.23 Benefits Percentage 2 Lb = B/W 44% 44% 44% Benefits per hour B = W*Lb $24.15 $12.84 $7.66 Loaded Hourl y Rate Wb = W + B = W(1+Lb) $78.49 $41.72 $24.89 Overhead Percentage 3 Lo = OH/Wb 50% 50% 50% Overhead per hour OH = Wb*L o $39.25 $20.86 $12.44 Fully L oaded Hourly Rate Wf = Wb + OH = W + B + OH $117.74 $62.58 $37.33

1. Data Source: BLS http://www.bls.gov/oes/current/naics4_325300.htm May 2012 data NAI CS 325300

- Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing Standard Occupational Codes: Management: 11

- 0000, Management Occupations Technical: 19

- 0000, Life, Phy sical, and Social Science Occupations Clerical: 43

- 0000, Office and Administrative Support Occupations 2. Fringe benefits/wage per hour. 3. U. S. Environmental Protection Agency , EPA Air Pollution Control Cost Manual, Sixth Edition , EPA

- 452

- 02

- 001, January 2002, pg. 2

- 34. The loading for indirect costs is within the range of 20

- 70% of the load labor rate (wage + benefits) suggested in EPA guidance.p. 18 of 20

**Work Sheets used to Calculate EPA and Federal Government Labor Costs**  This attachment is available as part of the electronic docket **EP A**  **- HQ**  **- OPP**  **- 2013**  **- 0493**  and is part of the ICR’s Supporting Statement
**NAICS: 999100 Federal Executive Branch**  Labor Category : Formula Managerial Technical Clerical Unloaded Hourl y Rate 1 = W $55.66 $36.11 $20.59 Benefits Percentage 2 Lb = B/W 44% 44% 44% Benefits per hour B = W*Lb $24.74 $16.05 $9.15 Loaded Hourl y Rate Wb = W + B = W(1+Lb) $80.40 $52.16 $29.74 Overhead Percentage 3 Lo = OH/Wb 50% 50% 50% Overhead per hour OH = Wb*L o $40.20 $26.08 $14.87 Fully L oaded Hourly Rate Wf = Wb + OH = W + B + OH $120.60 $78.24 $44.61

1. Data Source: BLS http://www.bls.gov/oes/current/naics4_999100.htm May 2012 data NAI CS 999100

- Federal Executive Branch Standard Occupational Codes: Management: 11

- 0000, Management O ccupations Technical: 19

- 0000, Life, Phy sical, and Social Science Occupations Clerical: 43

- 0000, Office and Administrative Support Occupations 2. Fringe benefits/wage per hour. 3. U. S. Environmental Protection Agency , EPA Air Pollution Control Cost Manual, Sixth Edition , EPA

- 452

- 02

- 001, January 2002, pg. 2

- 34. The loading for indirect costs is within the range of 20

- 70% of the load labor rate (wage + benefits) suggested in EPA guidance.p. 19 of 20 **Attachment F Calculations Regarding**  **Small Entities that Participate in this ICR**  EPA estimated the number of small entities that participate under this I CR using information on company revenue and employ ment from Dun and Bradstreet database reported for the year 2010. The Dun and Bradstreet database is a comprehensive source 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). E PA assumed the majority of respondents are individual companies with a NAICS code 325320 (Pesticide and Other Agricultural Chemical Manufacturing). The number of companies in the Dun and Bradstreet 2010 database using this code was 892. EPA was able to determine the size of 882 of these individual companies. The 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. Currently , 1733 companies are listed in EPA’s registration tracking database discussed in section 5(b). Assuming 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 ICR. EPA also estimated the impact of this I CR on small entitie s 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. EPA determined that 27 of the submitting companies were large and 21 were small based on information from the Dun and Bradstreet 2010 database. Table F.1 exhibits list of small entities that submitted CRP applications between 2006 and 2009. Companies are listed at the parent level. The table includes company NAIC S code, annual sales, employ ment, US Small Business Administration (SBA) small business definition, and SBA size threshold. EPA was unable to size one company.
Table F.1
**Parent Com pany**  **NAICS Code**  **Annual**

**Sales ($) Employees**  **SBA Definition**  **1 SBA Size** 

**Threshold 1**  Alden

- Leeds, Inc. 325998 75 E 500 American Vanguard Corporation 325320 237,538,000 320 E 500 Aqua Tri 424690 2,000,000 24 E 100 Biosensory Insect Control 561710 130,000 3 R 6,000,000 Bonide Products, Inc. 325998 35,700,000 200 E 500 Bug Stompers Inc 561710 200,000 3 R 6,000,000 Clarke Mosquito Control Products, Inc.

- 325320 35,000,000 40 E 500 Control Solutions, Inc. 325320 50 E 500 Db Square LLC 561990 100,000 2 R 6,000,000 Envirosafe Technologies, Inc. 334112 2,200,000 18 E 1,000p. 20 of 20

Gil Manufacturing Inc 453998 1,100,000 11 R 6,000,000 Haco Group Inc 423610 250,000 2 E 100 McLaughlin Gormley King Com pany 325320 1,000,000 90 E 500 Pbi/Gordon Corporation 325320 300 E 500 Pic Corporation (inc) 325320 5,400,000 30 E 500 Porpoise Pool & Patio, Inc. 533110 1,000,000 280 R 6,000,000 Share Corporation 325612 16,900,000 172 E 500 Southeast Laboratories, Inc. 335314 250,000 3 E 750 Spurrier Chemical Companies, Inc. 325199 20,900,000 67 E 1,000 Vertex Chemical Corp 325188 52,000,000 45 E 1,000 Vetsource, Inc. 423390 3,000,000 2 E 100 1. An “E” indicates that the SBA small business definition is based on employ ment and an “R” indicates that the SBA small business definition is based on revenue from annual sales. Definitions and SBA size thresholds are based on the US Small Business Administration’s 2008 “Table of Small Business Size Standards Matched to North American Industry Classification Sy stem Codes” available online at: http://www.sb a.gov/idc/groups/public/documents/sba_homepage/serv_sstd_tablepdf.pdf Table F.2 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 estimated to be approximately $439 (Table 2, section 6). Assuming that CRP submissions are evenl y distributed across small and large companies, an average firm would submit approximately

14 CRP applications per year, assuming 50 companie s are responsible for the 685 (see Table 1, section 6) CRP submissions in a given year. This would result in an average annual company burden of $6,146, or 0.03% of small firm’s annual revenue, on average. Table F.2 **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 Firms 48**  **313,144,948,167 600,712**  **7,116,930,640 13,639**  1 Only based on firms that report sales on D&B.