May 9, 2014

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 Charact erization/Abstract

This information collection program is desi gned to provide the E nvironmental Protection Agency (EPA) with assurances th at the packaging of pesticide pr oducts sold and distributed to the general public in the United States meets st andards set forth by the Agency pursuant to the Federal Insecticide, Fungicide, and Rodenticid e Act (FIFRA). Registra nts must certify to the Agency that the packaging or device meets thes e 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 au thorizes 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 (s ee 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 Sa fety 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 ch ild-resistant packaging. Th e authority for this information collection is pursuant to Section 25 (c)(3) of the FIFRA. Co mpliance regulations are contained in 40 Code of Federal Regu lations (CFR) Part 157 (Attachment B).

2(b). Practical Utility/Users of the Data

EPA reviews a registrant's child-resistant pa ckaging (CRP) certification to determine if there are human safety/health risk concerns. Ex emption requests are reviewed to ascertain if there is a health risk, and if CRP is tec hnically feasible, practi cable, and appropriate.

3. NON DUPLICATION, CONSULTATI ONS, AND OTHER COLLECTION

CRITERIA

3(a). Non duplication

To avoid duplicative testing of packages for pesticidal and no n-pesticidal purposes, EPA's CRP regulations reference th e CPSC packaging standards and protocol testing procedures.p. 2 of 17 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 cer tification of CRP compliance).

3(b). Public Notice Required Pr ior to ICR Submission to OMB

EPA published a notice in the Federal Re gister announcing a 60-day public notice and comment period on the draft ICR (78 FR 59014; September 25, 2013). EPA received no public comment in response to this notice, which is av ailable in the docket for this ICR and can be

accessed at http://www.regulations.gov using the docket identifier EPA-HQ-OPP-2013-0493.

3(c). Consultations

In addition to the public notice that EPA pub lished in the Federal Register concerning the renewal of this ICR, the Agency consulted with stakeholders who actively interact with the Agency through the use of this collection in strument, as required under 5 CFR 1320.8(d)(1). Three companies were selected to respond to ques tions about the information collection and the accuracy of the burden estimates. A record of the consultations (Atta chment C) is available in the

docket for this ICR.

With regard to duplication of data collecte d, one company indicated that their sources of CRP information are the catalog and publications of their packaging suppliers and noted that they obtain their CRP information from either the packaging supplier or the supplier’s website. The EPA notes that, in responding to this inform ation collection, applicants and registrants may submit material and literature, in cluding citations to web pages, from a supplier, provided the information meets the requirements in 40 CFR 157 subpart B. While information might be available from a supplier, the agency would not know that the particular products are used to package registered pesticides unless the responde nt informs the agency. If access to actual raw data is necessary for EPA to reach sound conc lusions, citations to supplier materials, by themselves, will not be deemed adequate to sati sfy agency data requirements. In addition, in accordance with 40 CFR 157.36, registrants mu st retain information supporting CRP certification for as long as the registration of a pesticide product is in effect. While EPA will consider information from a supplier’s website, it is the registrant’s resp onsibility, and not the supplier’s, to retain any required informa tion for the lifetime of the registration.

One company suggested that EPA maintain a li st of packages/closures for which data has been reviewed and accepted so that registrants know whether data is required when certifications are submitted for these packages/closures. EPA does not maintain a separate list of packages/closures for which data has been re viewed and accepted. The agency does provide a list of child resistant packag es on its website, as well as a list of CRP manufacturers ( http://www.epa.gov/opprd001/crp/ ). Packages are designated as child-resistant solely on the

basis of the manufacturers' clai ms. EPA has not reviewed the manu facturers' test data on CRP as a prerequisite for inclusion in the list. The appearance of a pack age in this publication is not intended in any manner to denote approval, certification, or endorsement of the package by the

EPA. However, even if EPA maintained a list su ch as the company propos es, it would not be sufficient to enable a registrant or applicant to claim that a package or pesticide product is CRP compliant without citing previously submitted da ta. An approval of a pesticide product as CRPp. 3 of 17 compliant is based on CRP data submitted by applicants and registrants in support of registration. CRP data is treated like other data submitted to the agency. CRP data is assigned a Master Record Identification Number (MRID) up on submission to the agency. An applicant for CRP certification seeking to re ly on previously reviewed CRP may only do so in accordance with the data compensation provisions of FIFRA s ection 3(c)(1)(F) and the procedures to ensure the protection of data submitters’ rights codified in 40 CFR 152, subpart E.

While the agency does not maintain a list of packages/closures for which data has been reviewed and accepted, the agency believes there are sufficient avenues for applicants to find the information, if needed. Once a registration is is sued, applicants who wish to identify whether data had been submitted for a particular pestic ide product and its product specific packaging could access the information submitted to the ag ency in support of the registration for the product at the National Pesticide Information Re trieval System (NPIRS), available online at http://state.ceris.purdue.edu/. Applicants may also obtain a copy of any data compliance materials through the Freedom of Information Act, as provided in § 152.119 and consistent with EPA’s information regulations at 40 CFR part 2. Finally, individual CRP suppliers may also have current information regarding whether CRP data has been submitted for a specific package they supply.

With regard to frequency of submission of CRP information, one company noted that they submit certification statements for each regi stration that the contai ner design and closures meet the CRP requirements when the product is distributed and sold. Further, the company reasoned that unless there is good cause such as a change in the formulation or a change in the packaging, they believe additional or new cer tifications for packaging are unnecessary. The agency generally agrees with the company. EPA notes that CRP certification may be required (if the toxicity criteria in 40 CFR 157.22 is met) when a product is registered or if the registration is amended as a result of any modification in th e composition, labeling, or packaging. In addition, certification must be submitted to the agency if the agency determines, in accordance with 40 CFR 157.24(a)(1)(ii), 2(ii), or (b )(4), that a currently register ed product is required to be packaged in child-resistant packaging.

Regarding whether the directi ons for submissions are clear, one company indicated that

directions for the certification statement were adequate and the Application for Pesticide Amendment (EPA Form 8570-1) is adequate and offe rs the registrant more flexibility than a new

form. EPA notes that there is no form associated w ith this information collection and that the

burden for EPA Form 8570-1 is covered under a separate ICR (OMB Control No. 2070-0060). Another company suggested that it would be helpful to have a clearer process for determining if a product is subject to CRP, for example a decisi on-tree. EPA believes that the toxicity criteria for when a product must be sold and distributed in child-resistant packaging are adequately identified in the regulations at 40 CFR 157.22. The t oxicity criteria, as well as information about how to submit CRP information, can be found on EPA’s website at http://www.epa.gov/opprd001/crp/ . Registrants and applicants ma y also contact the agency for additional information if they ar e unsure whether their product meets the toxici ty criteria, or if they need assistance with assembling the submi ssion materials. Two companies suggested that it would be helpful to have an example of the electronic template when submitting test data. The Agency notes that Pesticide Registration Notice 97-9

, entitled “Electronic Submission Of ChildResistant Packaging Test Data For All Pesticides And Child-Resistant Testing Of Prefilled,p. 4 of 17 Nonrefillable Insecticide Bait Stations Not Designed Or Intended To Be Opened Or Activated In A Manner That Exposes The Contents To Human Contact Purpose” contains detailed instructions for submitting CRP data in electronic format. In addition, when the agency does require test data to be submitted in support of a CRP certification, registrant s typically use labs to generate the data and those labs are familiar with the formating requirements.

Regarding whether electronic submission is av ailable, one company suggested that, while submitting data via CD is fine, internet submissi on would be preferable. Electronic submission is already available for some regulatory actions (see http://www.epa.gov/opp00001/regulatin g/registering/submissions/ ). EPA acknowledges, however, that additional opportuni ties for electronic submission would be more efficient for registrants and the agency. While not available fo r this renewal, EPA will continue to explore ways to increase availability of electronic submissions and will amend this ICR to create electronic forms as possible.

With regard to EPA’s burden estimate, tw o stakeholders provided no comment on EPA’s estimate of the respondent burden hours. One comp any indicated that the split between technical and clerical time in the respondent burden may be different than EPA’s estimate. In particular, the company commented that 2 hours of technical time and no clerical time are needed to submit

CRP certification without da ta rather than EPA’s estimation of 1 hr of technical time and 0.5 hrs of clerical time. In addition, the company comm ented that only 6 hours of technical time and no clerical time are required to submit CRP certificati on with data rather than EPA’s estimate of 8

hrs of technical time and 3 hours of clerical time.

The Agency notes that that its estimates ar e aggregated averages; some stakeholders may take more time to respond to the information co llection, and others less. In addition, EPA expects that there may be variability among respondents with regard to how ac tivities undertaken to respond to this information collection are distribu ted between technical and clerical staff. As a result of the company’s comments, EPA will increase the agency’s burden estimate for technical

time for CRP certifications without data to 1.5 hrs, leaving the cler ical burden at 0.5 hrs, for a

total of 2hrs. This new estimate of total burden is consistent with the company’s estimate of 2 hrs to submit CRP certification without data, while accounting for variability among respondents of how response time is distributed between technical and clerical staff. EPA is not reducing its burden estimate for CRP with data, but will keep the conservative estimate of 8hrs of technical

time and 3 hrs of clerical time.

EPA consults with the CPSC on genera l packaging issues, products under joint jurisdiction (e.g. bleaches and pi ne oil products), and the regula tory aspect of implementing consumer (child) safety measures in a way th at 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 c onsultations occur on an informal "as needed" basis during the process of eval uating exemption requests and certi fying to the use of CRP. In the past, when any sort of problem (technical, ad ministrative, or other) arose, or there were suggestions for improvement in the program, the respondent is given ample opportunity top. 5 of 17 inform the agency and vice versa. This communication between both parties may take place either in a telephone conversation or in a mee ting 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 en sure that pesticides are equipped with protective packages adequate to protect children fr om accidental illness or injury.

3(e). General Guidelines

The only PRA-imposed guideline in 5 CFR 1320.6 that is exc eeded in this collection is the recordkeeping retention peri od. 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 susp end or cancel the registration due to an adverse finding by EPA. Since the average period of market ability 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 manufacturer s to voluntarily submit samples of CRPs that have passed CRP testing, identify the pack aging, its manufacturer, and list the package's classification according to the ASTM Internatio nal 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 pest icide registrants by displaying the various types of CRP in the ma rketplace which, in tu rn, 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 phy sical 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 confid ential information is not re quired as a part of thisp. 6 of 17 information collection, there has been at least one instance where confid ential data have been submitted voluntarily as supporting material for an exemption request from CRP compliance requirements.

When any trade secret or Confidential Busi ness Information (CBI) is provided to EPA, such information is protected from disclosure un der section 10 of FIFRA. Data submitted to EPA is handled strictly in accorda nce with the provisions of the FIFRA Confidential Business

Information Manual. This manual contains instruc tions relative to all contact with confidential documents, including responsibilities of EPA employees, physical secu rity 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 dict ates that all CBI must be marked or flagged as such, only authori zed 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 place d 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 collecti on activity represent entities involved in manufacturing of pesticide chemicals, wholesal e merchandising of pesticide products, or pest management activities. The North American Indus trial Classification System (NAICS) codes for respondents under this ICR in clude 325320 (Pesticide and othe r Agricultural Chemical Manufacturing), 424690 (Other Chemical and Alli ed Products Merchant Wholesalers), and 561710 (Exterminating and Pest Cont rol 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 w ho 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 CF R 157, or request an exemption to the requirement.

(i) Data items, including reco rd keeping requirements

The respondent certific ation letter must exercise one of the following information options in this section or in section (i)( a) to comply with 40 CFR Part 157:p. 7 of 17 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 theASTM International Standard D3475, "Standard Classification of ChildResistant 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 pestic ide 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 labeli ng. Less than 2 percent of pesticide registrants use this option.

The majority of pesticide registrants c hoose to certify that their pesticide product packaging meets the effectiveness, compatib ility, and durability standards at 40 CFR 157.32. Registrants who certify are require d to maintain data to corroborate the certification for the duration of the pesticide's registration as required by 40 CFR 157.36. EPA may also request registrants who certify to submit additional data b ecause of human safety/health risk concerns. If data is needed, EPA requests that registrants submit data electronical ly to expedite data analysis. Pesticide Regulation (PR) Notice 97-9 describes th e 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 la rge size so that CRP regula tions do not apply. Exercising this option effectively eliminates sales to the general public. It is ba sed on the concept that certain bulk size pesticide packages are intended for commercial use even in residential areas (i.e., exterminator-use insecticid es 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 percen t 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 distri buted 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 cr iteria 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.p. 8 of 17 (ii) Respondent Activities

In order to comply with the CRP regulati ons, registrants must engage in the following

activities:

Read instructions Review requirements of FIFRA sec tion 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-Resist ant 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 sen t 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 wh ether the registrant has met the CRP requirements, has sufficiently substantiate d 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 pesticid e product. The Agency maintains a record of all CRP certifications in its generic database.p. 9 of 17 5(b). Collection Methodology and Management

Respondents to this ICR submit the informa tion as part of their larger package for registration of a pesticid e product. At the time of this renewal, OPP is not offering a fully electronic submission option for pesticide regi stration packages. The Agency is, however, beginning the process of defining requirements for electronic s ubmission 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 guidanc e on electronic data

submission. CRP certifications with data are th e 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. EP A requires that registrants main tain data in support of their

certifications of the child-resist ance 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 re gistrants using a particular type of CRP should a generic problem with the CRP become eviden t (e.g. trigger sprayers that are no longer considered CRP). It will also facilitate th e review of CRP exemption requests because the Agency can ascertain how similar pe sticide 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 regi stration action historical file. Additionally, the CRP compliance certification hard copy corresponde nce letters are file d 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 manuf acturers to use extrapolation schemes, available child-resistant protoc ol test data, and supporting docu mentation 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 effec tiveness standards and prot ocol test procedures that preclude duplicative testing fo r pesticidal and non-pesticidal pu rposes, 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 gr anting of the size exemp tions without requiring an application from the regist rant 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 estimatedp. 10 of 17 the number of small entities that participat e under this ICR using information on company revenue and employment from Dun and Bradstr eet database reported for the year 2010. EPA estimated that there are 456 (26.3% of 1733) la rge firms and 1277 (73.7 % of 1733) small firms that are potential respondents to this ICR (s ee 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 subm itted 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 wa s 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 $448 (Table 2, section 6). Assuming that CRP submissions are evenly distri buted 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 $6,272, 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 ch ange packaging, enter the residential market, or otherwise become subject to CRP regulations. Therefore, for each regi stered pesticide product, this is a one-time submission unless the labeled product use or the 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 annua lly during this renewal ICR. The number of responses is based on the number of products in FY2010, FY2011, and FY2012 with ChildResistant Packaging (CRP) requirements. During this three year period, approximately 486 CRP applications were submitted annually. The exp ected decrease from 1,165, estimated during the previous ICR renewal, to 486 is largely asso ciated with the implementation of the EPA’s Registration Review program, which was manda ted by the Food Quality Protection Act and requires the Agency to periodically reevaluate pesticides to make sure that as changes occur,p. 11 of 17 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 incr ease in the number products requiring CRP for that period. The EPA is usi ng the higher number of 685 rather than 486 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 be required to provide their own CRP test data, which will

have to be reviewed for huma n safety/health risk concerns.

EPA estimates that the average burden associ ated with this information collection activity is approximately 8.04 hours per response. 1 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 residentia l use, lower product toxicity). The number of respondents expected for each of the various resp onse 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 activit y 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 5.87 hours of technical time and 2.17 hour s of clerical time, which is broken down as follows (see Table 2):

 0.78 technical hours to ascertain whether the pr oduct is subject to the CRP regulations (meets toxicity criteria, residential use) and to decide whether to submit a CRP certification, data, be exempt from regulati ons due to large size or other criteria;

 2.35 technical hours to create/pr epare the information;

 2.15 technical hours to review submission fo r accuracy and appropr iateness (process, compile, complete document);

 1.63 clerical hours to format submi ssion and prepare information;

 0.59 technical hours to review and si gn the appropriate documents; and,

 0.54 clerical hours to mail the submissi on, 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

1 Based on Table 1, the avg. technical burden across all response types is approx. 5.87 hrs. per response (4,018 ÷ 685) and the avg. clerical burden across a ll response types is approx. 2.17 hrs. per response (1,489 ÷ 685). For the purposes of estimating respondent burden and cost ( see Table 2), EPA assumes that the average burden is 8.04 hrs. per respon se (5.87 technical hrs. + 2.17 clerical hrs.).p. 12 of 17 The burden estimates by response type are summarized in Table 1 below. Respondents submitting CRP certifications withou t data require 1.5 hours of tec hnical labor time in order to determine whether the product is subject to th e CRP regulations (meet s 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 Agenc y, and file the supporting CRP data.

Respondents that are exempt from CRP require ments based on large package size require

1 hour of technical time and no clerical time becau se 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 tec hnical 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 comp ly with this information collection activity is 5,507 burden hours/year.

Table 1. RESPONDENT BURDEN BY RESPONSE TYPE

Type of Response No. of Responses Technical Burden Clerica l Burden Total Burden

Hours Per Response Total Hours Per Response Total

CRP certification

without data 212 1.5 318 0.5 106 424

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 4,018 NA 1,489 5,507

ANNUAL RESPONDENT BURDEN = 4,018 (technica l burden) + 1,489 (clerical burden) = 5,507 hrs

TOTAL HRS/RESPONDENT ACTION = 5,507/685 = 8.04 hrsp. 13 of 17 Costs associated with this burden ar e 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 + overh ead). Fully loaded wage

rates are used to calculate th e 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 Indus try-Specific Occupational Employm ent and Wage Estimates from the Bureau of Labor Statistics (BLS) at ht tp://www.bls.gov/oes/current/oes_nat.htm.

Sectors: The specific North American Indus try 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 Cl assification (SOC). The SOC system is used by Federal statistical agencies to classify worker s into occupational categor ies for the purpose of collecting, calculating, or dissemi nating 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. Howe ver, if other sectors are listed for which 44% is not applicable, the appli cable percentage will be stated.

Fully Loaded Wage Rate: We multiply the loaded wage rate by 50% (EPA guidelines 20- 70%) to get overhead costs. Atta chment E contains worksheets pr oviding 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 cate gories using the methodolog y 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 a nd costs by collection activity averaged across all four CRP response types. For example, the total per-response tech nical burden hours is 5.87 hrs, which is obtained by dividing the total t echnical burden hours (5,057 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 ar e then broken down among the various collectionp. 14 of 17 activities in Table 2 according to the same proporti ons used in the previous ICR renewal, using input from industry consultation. The total aver age cost of the estimated burden per respondent to comply with CRP requirements is approxi mately $448.20 per response. Using the Agency’s burden estimate and the fully-loaded labor rates, the Agency estimates to tal respondent costs to be approximately $306,880 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 0.35 0.00 0.35 $22.02

Plan activities 0.43 0.00 0.43 $26.92

Create information including electronic format of data 2.35 0.00 2.35 $146.82

Process, compile, and complete written compliance document 2.15 1.63 3.78 $195.45

Review submission 0.59 0.00 0.59 $36.70
Store, submit, file, or maintain data 0.00 0.54 0.54 $20.29

TOTAL 5.87 2.17 8.04 $448.20
Totals may not sum due to rounding.

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 ($) Burden (hrs) Cost ($)
8.04 448 685 5,507 306,880
Totals may not sum due to rounding Annual Burden: 8.04 Hours per Response x 685 Responses = 5,507 Burden Hours Annual Cost: $448 per Response x 685 responses = $306,880

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 respons e. Although there has

been a decrease in the total number of CRP submi ssions to the Agency, there has been a net shift

from less-burdensome to more-burdensome t ype responses (e.g., incr eased 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 18,573p. 15 of 17 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 AC TION = 19,812/685 = 28.9 hrs

Table 5 presents Agency burden hours and cost s 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/C OST 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 5,507 $306,880

Agency Burden/Cost Estimates 19,812 $1,528,145p. 16 of 17 6(e). Reasons for Change in Burden

The estimated total respondent burden is expected to increase by 614 hours from 4,893 for the previous ICR renewal hours to 5,507 hours for this renewal. The increase in burden is a result of a number of factors. First, the es timated average burden hours per response increased from 4.20 hours to 8.04 hours per submission. The av erage burden per response is an average over all response types. Based on comments received during cons ultations with stakeholders, EPA increased the burden estimate per response fo r CRP certifications that do not require data. Second, there has been a change in the distributio n of responses among the four response types. The number of responses annually is expected to decrease from 1,165 in the last ICR approval to 685. Although the estimated number of responses for the current ICR renewal is expected to be significantly less than the last ICR approval, th ere is a 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 th e exclusive use period for certain pesticide chemicals; registrants with products using these chemicals will be required to provide their own CRP test data, which will have to be reviewed for human sa fety/health risk concerns.

6(f). Burden Statement

The total annual respondent burden for the collection of in formation contained in this ICR is estimated to be 5,507 hours. The av erage "respondent" (certif ier) burden for the Compliance Requirement for the CRP regulations is estimated to be 8.04 hours per submission of data necessary to support a claim that produc t is not subject to CRP, should be exempt from CRP, or CRP certification, including time for: reading relevant fe deral legislation and regulations; conducting performance testing on closures and/or de vices; reviewing test data; preparing submission or CRP certif ication; and recordkeeping rega rding 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 appli cable, i.e., form or instructions, and in the Federal Register.

The Agency has established a public docke t for this ICR under Docket ID No. EPA-HQOPP-2013-0493, which is available for online vi ewing at www.regulations.gov, or in person viewing at the EPA Docket Center-Public R eading 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 regardi ng 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 elect ronically through http://www.regulations.gov or by mail addressed to Director , Collection Strategies Division, U.S. Environmental Protectionp. 17 of 17 Agency (2822T), 1200 Pennsylvania Ave., NW, Wa shington, D.C. 20460. Include Docket ID No. EPA-HQ-OPP-2013-0493 and OMB control number 2070-0052 in any correspondence.

7. ATTACHMENTS

All of the attachments listed below can be found in the docket for this ICR (unless otherwise noted); accessible electronically through http://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) – also available at http://www.gpo.gov/fdsys/pkg/USCODE2012-title7/pdf/USCODE-2012-title7 -chap6-subchapII-sec136w.pdf

Attachment B: 40 CFR Part 157 - PACKAGING REQUIREMENTS FOR

PESTICIDES AND DEVICES – also available at http://www.gpo.gov/fdsys/pkg/CFR2003-title40-vol21/pdf/CFR- 2003-title40-vol21-part157.pdf

Attachment C: Record of Consultations

Attachment D: Pesticide Registration Notice 97-9

- Electronic Submission of Childresistant Packaging Test Data for All Pesticid es 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 Sma ll Entities that Participate in this ICR

Attachment G: Display Related to OMB Control #2070-0052 - Listings of Related Regulations in 40 CFR 9.1