Document ID: EPA-HQ-OPP-2013-0493-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2013-09-25T04:00Z

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. 0616.11

	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 public in the United States meets standards set forth by 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 associated 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, administered by 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 child-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.  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 Submission to OMB
 
 	In proposing to renew this ICR, 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 concerning the renewal of this ICR, 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, 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 reasonably 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.
 
 	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. 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 voluntarily canceled or withdrawn by the registrant or until EPA has cause to suspend or cancel the registration due to an adverse finding by EPA. Since the average period of marketability of a pesticide ranges from 15 to 30 years, 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 solicits 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 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 includes descriptions and photographs of the package, with each package classified according to the ASTM International D3475 Standard.  
 
 	The CRP Website provides a service to CRP manufacturers and pesticide registrants by displaying the various types 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 Reduction Act regulations.  OMB's regulations 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). 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 material 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 Information Manual.
 
 	This manual contains instructions relative to all contact with confidential documents, including responsibilities of EPA employees, physical security measures, 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 internally or on contract), and division internal procedures.
 
 	The manual dictates that all CBI must be marked or flagged as such, only 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 by a Document Control 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 activities. The North American Industrial Classification System (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 Services). 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 activities 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:
 
 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 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 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 94 percent of pesticide registrants choose to certify that their pesticide product packaging meets the effectiveness, compatibility, and durability standards at 40 CFR 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 human safety/health risk concerns.  If data is needed, EPA requests that registrants submit data electronically to expedite data analysis. 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 effectively 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 for 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 by 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 by the toxicity criteria are not indicative of risk to humans, or that CRP is not technically feasible, practicable, or appropriate. Each request for an exemption is unique, and the data necessary to support an exemption are unique. Less than 3 percent of pesticide registrants choose this option with the CRP program. 
 
 		(ii)  Respondent Activities
 
 	In order to comply 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.
 
 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 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 generic database. 

 	5(b). Collection Methodology and Management
 
 	Respondents to this ICR 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 registration package.
 
 	For CRP certifications with data, EPA requests that responses are submitted electronically to expedite data analysis. See Attachment D for guidance on electronic data submission. CRP certifications with data are the most burdensome of the four response types under this ICR.
 
 	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 type 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 type 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 because the Agency can ascertain how similar pesticide formulations are packaged.

 	The generic database system continually tracks all registration actions from the registration-pending stage through to full registration and until a product is canceled. A generic database maintains information on both currently registered products and previously registered products, thereby acting as a registration action historical file. Additionally, the CRP compliance certification hard copy 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 data; 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 ICR 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 ICR using information on company revenue and employment 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 ICR (see Attachment F). Child Resistant Packaging applications were submitted to the Agency by 49 parent firms between 2006 and 2009.  EPA determined 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 information from the Dun and Bradstreet 2010 database. EPA was unable to size one company.  

	The table below presents the total and average revenue and employment 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 evenly 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 0.03% 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 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 application 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 Burden
 
 	In calculating the respondent burden, EPA estimates that registrants will submit 685 responses to this information collection activity annually during this renewal ICR.  The number of responses is based on the number of products in FY2010, FY2011, and FY2012 with Child-Resistant Packaging (CRP) requirements. During this three year period, approximately 486 CRP applications were submitted annually. The expected decrease from 1,165 to 685 is largely associated with the implementation of the EPA's Registration Review program, which was mandated by the Food Quality Protection Act and requires the Agency to periodically reevaluate pesticides to make sure that as changes occur, products in the marketplace can still be used safely. 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 is expecting an increase in CRP applications 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. This estimate is based on an average response time across all response types (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 types is based on the number of each type of CRP submission received annually. 
 
 	EPA's estimates of respondent burden do not include any burden at management levels.  Responses to this information collection activity are generally 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 types, each CRP action requires an estimated 5.7 hours 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 copy 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 type 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 technical labor time in order to determine the product is subject to the CRP regulations (meets toxicity criteria, residential use); identify the type 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 1 hour of technical time and 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 ICR (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 comply 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
TOTAL
                                      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
 
 
 Costs associated with this burden are estimated in the next section.
 	
       6(b). Estimating Respondent Costs
 
 	Consistent with recent ICR 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 publicly-available data to provide more accurate estimates and allow easy replication of the calculations.
 
 	Methodology:	The methodology uses data on each sector and labor type for an Unloaded wage rate (hourly wage rate), and calculates the Loaded wage rate (unloaded wage rate + benefits), and the Fully loaded wage rate (loaded wage rate + overhead).  Fully loaded wage rates are used to calculate the Agency's staffing costs.  
 
 	Unloaded Wage Rate:  Wages are estimated for labor types (management, technical, and clerical) within applicable sectors. The Agency uses average wage data for the relevant sectors available in the National Industry-Specific Occupational Employment and Wage Estimates from the Bureau of Labor Statistics (BLS) at http://www.bls.gov/oes/current/oes_nat.htm.  
 
 	Sectors: The specific North American Industry Classification System (NAICS) code and website for each sector is included in that sector's wage rate table.  Within each sector, the wage data are provided by Standard Occupational Classification (SOC).  The SOC system is used by Federal statistical agencies to classify workers into occupational categories for the purpose of collecting, calculating, or disseminating data (see http://www.bls.gov/oes/current/oes_stru.htm ).  
 
 	Loaded Wage Rate: Unless stated otherwise, all benefits represent 44% 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 44% is not applicable, the applicable percentage will be stated.
 
 	Fully Loaded Wage Rate: We multiply the loaded wage rate by 50% (EPA guidelines 20-70%) to get overhead costs.  Attachment E contains worksheets providing the breakout of these costs.  Costs are indexed to 2012 data.  
 
 	To derive the labor rates for this ICR, 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 $62.58 and $37.33 per hour, respectively.  These labor rates are fully 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 by dividing the total technical burden hours (3,912 in Table 1) across all four CRP response types by the total number of responses (685). The total clerical burden hours per response is similarly computed. These are then broken down among the various collection activities in Table 2 according to the same proportions 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
                                    $26.21 
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 
Review submission
                                     0.57
                                     0.00
                                     0.57
                                    $35.74 
Store, submit, file, or maintain data
                                     0.00
                                     0.54
                                     0.54
                                    $20.29 
                                     TOTAL
                                      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 year
                                 Annual Totals
                                                                   Burden (hrs)
                                                                      Costs ($)

                                                                   Burden (hrs)
                                                                       Cost ($)
                                                                            7.9
                                                                            439
                                                                            685
                                                                          5,401
                                                                        300,715
Totals may not sum due to rounding
 Annual Burden: 7.9 Hours per Response x 685 Responses = 5,401 Burden Hours
 Annual Cost:  $439 per Response x 685 responses = $300,715
 
                                           	
 	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 type 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
                                     66.5
                                      532
                                      0.9
                                       7
                                      539
TOTAL
                                      685
                                      n/a
                                    19,140
                                      n/a
                                      672
                                    19,812
 	
 
 ANNUAL AGENCY BURDEN = 19,140 (technical burden) + 672 (clerical burden) = 19,812
 
 TOTAL HRS/AGENCY ACTION = 19,812/685 = 28.9 hrs
  
 	Table 5 presents Agency burden hours and costs by collection activity averaged across all CRP response types. The average Agency burden per CRP response is estimated at approximately 28.9 hours at a cost of $2,230.87 per response. 
 
 	
 Table 5.	AVERAGE AGENCY BURDEN/COST ESTIMATES PER RESPONSE
 
 
BURDEN HOURS 
                                     TOTAL
                             COLLECTION ACTIVITIES
                                  Mgmt. $/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
                                     26.4
                                       0
                                     26.4
                                  $2,064.64 
Store, file, or maintain data
                                       0
                                       0
                                      0.9
                                      0.9
                                    $40.15 
TOTAL
                                       0
                                     28.0
                                      0.9
                                     28.9
                                  $2,230.87 
 
 Table 6 presents the total annual agency burden and cost.

 
Table 6  -  Total Annual Agency Burden/Cost 
                           Per Submission Estimates
                                                              Total Submissions
                                                             Expected each year
                                    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 = 28.9 hours per response x 685 responses = 19,812
 Annual Cost = $2,230 per response x 685 responses = $1,528,145
 
 
 
 	6(d). Bottom Line Burden Hours and Cost Table
 
 
 Hours
 Costs
 Respondent Burden/Cost Estimates 
                                     5,401
                                    $300,715
 Agency Burden/Cost Estimates
                                     19,812
                                   $1,528,145

  
 	6(e). Reasons for Change in Burden
 
 	The number of responses is expected to decrease from 1,165 in the last ICR approval to 685. The decrease is due to EPA's revised expectations regarding the number of CRP applications that will be submitted to the agency. 
 
 	The average burden hours per response increased from 4.2 hours to 7.9 hours per submission. While the average burden hours 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 types, resulting in a significant net shift from less-burdensome (CRP certifications without data) to more-burdensome (CRP certifications with data)  type responses. This increase is partially due to the expiration of the exclusive use period for certain pesticide chemicals since the last ICR renewal and 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 estimated total respondent burden is expected to increase from 4,893 hours to 5,401 hours, or 508 hours. Although the estimated total number of responses for the current ICR renewal is expected to be significantly less than the last ICR approval, the shift from less-burdensome to more-burdensome type 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 5,401 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 certification 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 displays a currently valid OMB control number. OMB control 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 ICR 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 holidays.  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.  

	Comments may be submitted 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.

                    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-2013-0493 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 PESTICIDES AND DEVICES  -  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 Human Contact  -  available at  http://www.epa.gov/PR_Notices/pr97-9.html 
 
       Attachment E: Worksheet for Estimating OPP ICR Wage Rates for Industry and EPA Labor Costs
       
       Attachment F: Calculations 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
       
       
       
       
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                              
                                 Attachment E
                                       
            Work Sheets used to Calculate Registrant Labor Costs  
This attachment is available as part of the electronic docket EPA-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 Hourly 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 Hourly 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*Lo
                                                                        $39.25 
                                                                        $20.86 
                                                                         $12.44
Fully Loaded 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
     NAICS 325300 - Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing
     Standard Occupational Codes:   
       Management:   11-0000, Management Occupations  
       Technical:        19-0000, Life, Physical, 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.

                                       
                                       
     Work Sheets used to Calculate EPA and Federal Government Labor Costs
This attachment is available as part of the electronic docket EPA-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 Hourly 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 Hourly 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*Lo
                                                                        $40.20 
                                                                        $26.08 
                                                                        $14.87 
Fully Loaded 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
     NAICS  999100 -  Federal Executive Branch
     Standard Occupational Codes:   
       Management:   11-0000, Management Occupations  
       Technical:        19-0000, Life, Physical, 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.

 
 
 
 
 
 
 
 
 
                                  Attachment F
                                       	
       Calculations Regarding Small Entities that Participate in this ICR
                                        
 EPA estimated the number of small entities that participate under this ICR using information on company revenue and employment 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 System code (NAICS). EPA 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 analysis 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 ICR 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.  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 NAICS code, annual sales, employment, US Small Business Administration (SBA) small business definition, and SBA size threshold. EPA was unable to size one company.  

 
 Table F.1
 Parent Company
 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
                                     1,000
 Gil Manufacturing Inc
                                     453998
                                   1,100,000
                                       11
                                       R
                                   6,000,000
 Haco Group Inc
                                     423610
                                    250,000
                                       2
                                       E
                                      100
 McLaughlin Gormley King Company
                                     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 employment 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 System Codes" available online at: http://www.sba.gov/idc/groups/public/documents/sba_homepage/serv_sstd_tablepdf.pdf
 
Table F.2 below presents the total and average revenue and employment 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 evenly 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 0.03% 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.