Document ID: EPA-HQ-OPP-2009-0887-0004
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-09-07T04:00Z

SEQ CHAPTER \h \r 1 SUPPORTING STATEMENT FOR

AN INFORMATION COLLECTION REQUEST (ICR)

1.	IDENTIFICATION OF THE INFORMATION COLLECTION

	

	1(a). Title of the Information Collection

	Compliance Requirement for Child-Resistant Packaging

	OMB No. 2070-0052; EPA No. 0616.10

	1(b). Short Characterization/Abstract

	This information collection program is designed to provide the
Environmental Protection Agency (EPA) with assurances that the packaging
of pesticide products sold and distributed to the general 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.

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 preparing to renew this ICR, EPA published a notice in the Federal
Register which provided a 60-day public notice and comment period on the
draft ICR (see 75 FR 9594; March 3, 2010). EPA received no public
comment in response to this notice, which is available in the docket for
this ICR and can be accessed at   HYPERLINK "http://www.regulations.gov"
 http://www.regulations.gov  using the docket indentifier
EPA-HQ-OPP-2009-0887.  

	3(c). Consultations

	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.

	During the preparation of this ICR renewal, EPA staff contacted the
following representatives of pesticide registrants by telephone and
e-mail and asked them to comment on the burden and cost estimates in the
ICR:

1. John F. Wright, Product & Regulatory Associates, LLC, P. O. Box 1683,
Voorhees, NJ 08043-9998, Telephone: 856-424-1528, Email:
JwrightCH@comcast.net 

2. Amy Plato Roberts, Technology Sciences Group, Inc., 712 5th Street,
Suite A, Davis, CA 95616, Telephone (530) 757-1432, Email:
ARoberts@TSGUSA.COM

3. Karen C. Cunningham, Head, Regulatory Affairs Lifecycle Management,
Merial Limited, 3239 Satellite Blvd., Duluth, GA 30096, Telephone:
678-638-3138, Email: karen.cunningham@merial.com

4. Mark Jernigan, Regulatory Affairs Manager, Bio-Lab, Inc., A Chemtura
Company, P.O. Box 98, Atlanta, GA, Telephone: 678-502-4149, Email:
Mark.Jernigan@chemtura.com

All four of the above respondent representatives provided feedback to a
questionnaire about the collection process and the burden estimates used
by EPA (see Attachment C).  As is the case with pesticide registrant
companies, the above respondents vary widely in their experience
submitting CRP certifications and/or exemptions. In particular, since
CRP exemptions represent approximately only 6% of all CRP
certifications, some companies may have little or no experience
submitting CRP exemptions. The variability among companies included in
this consultation resulted in variable responses with respect to
estimates for burden hours for the different types of CRP submissions.
One respondent agreed with EPA’s burden estimate, and two respondents
offered no comment. A fourth respondent, however, believed that the
burden estimate for CRP exemptions was too low. Mr. Wright, a
representative of a consulting firm whose clients include small
entities, proposed that EPA’s estimate of the burden hours for
processing CRP exemptions was too low. EPA selected Mr. Wright to
participate in this consultation in part to address the concern of the
Office of Management and Budget (OMB) regarding the impact of this
information collection on small entities. Mr. Wright also has experience
with submitting CRP exemptions. Hence, EPA considers his comments
sufficient to warrant an amendment of the burden estimate for CRP
exemptions. 

The new burden hours for CRP exemptions are given in Table 1 below.  EPA
is increasing the burden hours for CRP exemptions for large package size
from 0 to 1 hour. Previously, EPA had assumed that no time was required
because the CRP regulations for size exemptions require no action on the
part of registrants. EPA acknowledges that registrants must read the
regulations and plan activities, such as reviewing the pesticide label
and marketing options, to support the justification for this exemption.
EPA is also increasing the burden hours for CRP exemptions due to lack
of toxicity, packaging, or no residential use from 4 to 8 hours. EPA’s
previous estimate of 4 hours was based on the assumption that
registrants would require less time to submit a CRP exemption based on
lack of toxicity, packaging, or no residential use than to submit a CRP
certification with data. Mr. Wright’s comments imply that it requires
registrants the same amount of time to complete both of these types of
CRP submissions. His comments are consistent with informal consultations
OPP staff has had with registrants and applicants seeking clarification
with regard to their CRP submissions. EPA believes that such informal
consultations are beneficial to both EPA and the applicants. By
encouraging communication and exchange of ideas, such discussions can
help in the development of clearer expectations of what must be
submitted and of industry burden. 

	With respect to the format for CRP submissions, three of the four
respondent representatives indicated that the format might be clearer
than it currently is if a structured form were provided. Currently,
there are no forms associated with this ICR. EPA believes this provides
registrants with the greatest amount of flexibility to meet the
requirements of the Information Collection. Guidance for CRP submissions
is available on-line (see attachments), or may be obtained by contacting
EPA directly.

	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 (  HYPERLINK
"http://www.epa.gov/opprd001/crp/"  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
following North American Industrial Classification System (NAICS) codes
account for over 80% of respondents: 

NAICS 2-Digit Code	

Category	

Description

32	

Chemical Manufacturing	

manufacturers of chemicals used in pesticide products

42	

Wholesale Trade	

wholesale merchandisers of pesticide products

56	

Administrative and Support and Waste Management and Remediation Services

establishments performing routine support activities related to pest
management.

	4(b). Information Requested

	

	Pesticide registrants subject to the regulations are required to
certify to the Agency that the packaging for the pesticide product meets
the standards of 40 CFR 157, or request an exemption to the requirement.

		(i)  Data items, including record keeping requirements

	The respondent certification letter must exercise one of the following
information 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.  Although EPA is
working to allow electronic submission of registration packages, they
are currently submitted by mail.  The Agency has no objection to
submission of the CRP information on CD ROM as part of the registration
package.

	For CRP certifications with data, EPA requests that responses are
submitted electronically to expedite data 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,
comprising about 25 percent of all responses and nearly 67 percent of
the total estimated burden.

	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.	

	During the last ICR approval process, OMB was concerned about the
impact of this information collection on small entities. The ICR was
conditionally cleared by OMB with the request that EPA provide the
number of small entities that are respondents. In order to respond to
this request from OMB, EPA used information on company revenue and
employment from the Dun and Bradstreet database. 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).  

	To estimate the number of small entities that participate under this
ICR, EPA assumed the majority of respondents are individual companies
with a NAICS code 325320 (Pesticide and Other Agricultural Chemical
Manufacturing). Currently, the number of companies in the Dun and
Bradstreet 2010 database using this code is 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 (see Attachment
F for the list of small entities), based on information from the Dun and
Bradstreet 2009 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 approximately $224. 
Assuming that CRP submissions are evenly distributed across small and
large companies, an average firm would submit approximately 23 CRP
applications per year, assuming 50 companies are responsible for the
1,165 CRP submissions in a given year.  This would result in an average
annual company burden of $5,152, or 0.02% of small firm’s annual
revenue, on average.

 	Total Number of Firms	Total Revenue

($)	Total Employee Size	Average Revenue1

($)	Average Employment1

	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 1,165 responses to this information collection activity
annually during this renewal ICR.  The number of responses is based on
the number of products in FY2007, FY2008, and FY2009 with
Child-Resistant Packaging (CRP) requirements. During this three year
period, approximately 703 CRP applications were submitted annually. The
expected increase in the number of CRP submissions from 703 to 1,165 is
largely associated with the implementation of the EPA’s Registration
Review program. Through the Registration Review program, which was
mandated by the Food Quality Protection Act, the Agency periodically
reevaluates pesticides to make sure that as change occurs, products in
the marketplace can still be used safely. 

	EPA estimates that the average burden associated with this information
collection activity is approximately 4.2 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 3.0 hours of technical time and 1.2 of
hours clerical time, which is broken down as follows:

24 technical minutes to ascertain whether the product is subject to the
CRP regulations (meets toxicity criteria, residential use) and to decide
whether to submit a CRP certification, data, be exempt from regulations
due to large size or other criteria;

72 technical minutes to create/prepare the information; 

66 technical minutes to review submission for accuracy and
appropriateness (process, compile, complete document); 

54 clerical minutes to format submission and prepare information; 

18 technical minutes to review and sign the appropriate documents; and,

18 clerical minutes to mail the submission, file the respondent copy and
CRP documentation

Type of Response	Number of Responses	Percent of Total

CRP certification without data	798	68

CRP certification with data	296	25

Exempt – large package size	34	3

Exempt – lack of toxicity, packaging, no residential use, lower
product toxicity	37	3

	Respondents submitting CRP certifications without data require 1 hour
of technical labor time in order to determine whether the product is
subject to the CRP regulations (meets toxicity criteria, residential
use), identify the 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 one 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.  These
burden estimates by response type are summarized in Table 1.

	The total estimated respondent burden to comply with this information
collection activity is 4,893 burden hours/year (4.2 hours per respondent
x 1,165 respondents) at a cost of $261,237.  This cost estimate is
illustrated in Table 2.

Table 1.	ANNUAL RESPONDENT BURDEN BY RESPONSE TYPE

Type of Response	No. of Responses	Technical Burden 	Clerical Burden
Aggregate Burden

Hours Per Event	Total	Hours Per Event	Total

	CRP certification	798	1.0	798	0.5	399	1,197

CRP certification with data	296	8.0	2,368	3.0	888	3,256

Exempt from CRP due to large package size	34	1.0	34	0.0	0	34

Exempt from CRP due to lack of toxicity, packaging, no residential use,
lower product toxicity	37	8.0	296	3.0	111	407

TOTAL	1,165	NA	3,496	NA	1,398	4,893

	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   HYPERLINK
"http://www.bls.gov/oes/current/oes_nat.htm" 
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   HYPERLINK "http://www.bls.gov/oes/current/oes_stru.htm" 
http://www.bls.gov/oes/current/oes_stru.htm  ).  

	Loaded Wage Rate: Unless stated otherwise, all benefits represent 43%
of unloaded wage rates, based on benefits for all civilian non-farm
workers, from   HYPERLINK "http://www.bls.gov/news.release/ecec.t01.htm"
 http://www.bls.gov/news.release/ecec.t01.htm . However, if other
sectors are listed for which 43% is not applicable; the applicable
percentage will be stated.

	Fully Loaded Wage Rate: We multiply the loaded wage rate by 50% (EPA
guidelines 20-70%) to get overhead costs.  Attachments F and F.1 contain
worksheets providing the breakout of these costs.  Costs are indexed to
2008 data.  

	To derive the labor 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
managerial, technical and clerical rates are estimated at $109.82,
$60.39 and $35.89 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. The total average
cost of the estimated burden per respondent to comply with CRP
requirements is approximately $224 per response. Using the Agency’s
burden estimate and the fully-loaded labor rates, the Agency estimates
total applicant costs to be approximately $261,237 per year. There are
no capital expenditures associated with this information collection
activity.

Table 2.	ANNUAL RESPONDENT BURDEN/COST ESTIMATES

COLLECTION ACTIVITIES	Burden Hours	TOTAL

	Tech. 

$60.39/hr.	Clerical 

$35.89/hr.	Burden

Hours	Cost

Read instructions	0.18	0.00	0.18	$10.57 

Plan activities	0.22	0.00	0.22	$13.29 

Create information including electronic format of data	1.20	0.00	1.20
$72.47 

Process, compile, and complete written compliance document	1.10	0.90
1.90	$98.73 

Review submission	0.30	0.00	0.40	$18.12 

Store, submit, file, or maintain data	0.00	0.30	0.30	$10.77 

TOTAL	3.00	1.20	4.20	$223.94 

Totals may not sum due to rounding.

ANNUAL BURDEN:        4.2 Hours Per Response  x 1,165 Responses    = 
4,893 Burden Hours

ANNUAL COSTS:

		(a) Technical: 3.0 hours x $60.39 x 1,165 responses = 	$211,063.05

		(b) Clerical:    1.2 hours x $35.89 x 1,165 responses = 	$  50,174.22

	Total      =     	$261,237.27

	6(c). Estimating Agency Burden and Cost

	The Agency burden hours for the entire CRP process will decrease from
18.9 hours to 14.8 hours per response.  There has been an increase in
the number of CRP submissions to the Agency.  However, the majority of
new submissions are for CRP certification without data, which is the
least resource intensive activity for EPA. As a result, there is an
overall decrease in the average Agency burden per response.

  

	Annual burden to the Agency is estimated at 17,263 burden hours at a
cost of $1,202,339.  Despite the larger increase in applications for CRP
Certification without data, the main portion of the burden hours is
still expected to result from the evaluation of those CRP Certifications
submitted with data related to human safety/health risk concerns, and
assessing some of the more complex options for compliance (e.g.
requesting an exemption). 

Table 3.	ANNUAL AGENCY BURDEN BY RESPONSE TYPE	

Action	No. of Respondents	Technical Burden 	Clerical Burden	Aggregate
Burden

Hrs Per Event	Total	Hrs Per Event	Total

	CRP certification without data	798	2.3	1,835	1.0	798	2,633

CRP certification with data	296	40.0	11,840	1.0	296	12,136

Exempt from CRP due to large package size (registrant meets size
requirement, no action needed)	34	0.0	0.0	0.0	0.0	0.0

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

TOTAL	1,165	n/a	16,136	n/a	1,127	17,263

Agency Burden = 16,136 (technical burden) + 1,127 (clerical burden) =
17,263

Total hrs/Agency Action = 17,263 ÷ 1,165 = 14.8 hrs

 

	Table 4 presents Agency burden hours and costs by collection activity
averaged across all CRP response types. The average cost to the agency
of receiving a CRP submission is 14.8 hours and $1,032.

	

Table 4.	ANNUAL AGENCY BURDEN/COST ESTIMATES

COLLECTION ACTIVITIES	BURDEN HOURS (per respondent)	TOTAL

	Mgmt. $107.56/hr	Tech. $71.58/hr	Clerical

$41.21/hr.	Burden

Hours	Costs

Read correspondence	0.00	0.8	0.0	0.8	$57.26

Execute activities including data review and certifications for large
size non-liquid pool chemicals	0.00	13.1	0.0	13.1	$937.70.

Store, file, or maintain data	0.00	0.0	0.9	0.9	$37.09

TOTAL	0.00	13.9	0.9	14.8	$1,032.05

Totals may not sum due to rounding.

ANNUAL BURDEN: The average Agency burden per CRP response is estimated
at approximately 14.8 hours, costing $1,032 per response ($1,202,339 ÷
1,165). 

ANNUAL COSTS:

		(a) Technical:    13.9 hours x $71.58 x 1,165 responses = 
$1,159,130.73

		(b) Clerical:       0.9 hours x $41.21 x 1,165 responses   =	 $   
43,208.69  

       Total    =  	$1,202,339.42

	6(d). Bottom Line Burden Hours and Cost Table

	Hours	Costs

Respondent Burden/Cost Estimates 	4,893	$261,237

Agency Burden/Cost Estimates	17,263	$1,202,339

 

	6(e). Reasons for Change In Burden

	The number of responses has increased from 703 in the last ICR approval
to 1,165.  The increase in the expected number of responses is driven
primarily by the expected influx of CRP submissions associated with the
implementation of the Registration Review program. In addition, the
exclusive use period for certain pesticide chemicals is expiring.
Registrants with products using these chemicals will now be required to
provide their own CRP test data, which will have to be reviewed for
human safety/health risk concerns. 

	The average total burden hours per respondent decreased from 4.94 hours
to 4.2 hours per submission. While the average burden estimate for CRP
exemptions has increased, the burden estimate remained the same for CRP
certifications and certifications with data, which together represent
94% of all submissions. Furthermore, the distribution of responses among
the four response types has changed, resulting in a significant net
shift from more-burdensome to less-burdensome type responses. In
particular, EPA expects to receive a larger percentage of CRP
certifications without data during this ICR renewal than during the
previous ICR. The estimated annual burden under the last ICR approval
was 3,473 hours. Under this renewal ICR, the annual burden is estimated
to be 4,893 hours. This increase is due to the increase in the expected
number of responses. The estimated burden increase represents an
adjustment. 

	6(f). Burden Statement

	The total annual respondent burden for the collection of information
contained in this ICR is estimated to be 4,893 hours. The average
"respondent" (certifier) burden for the Compliance Requirement for the
CRP regulations is estimated to be 4.2 hours per submission of data
necessary to support a claim that product is not subject to CRP, should
be exempt from CRP, or CRP certification, including time for:  reading
relevant federal legislation and regulations; conducting performance
testing on closures and/or devices; reviewing test data; prepare
submission or CRP certification; and recordkeeping regarding the CRP
certification or submission. 

As defined by the PRA and 5 CFR 1320.3(b), “burden” means the total
time, effort, or financial resources expended by persons to generate,
maintain, retain, or disclose or provide information to or for a Federal
agency. This includes the time needed to review instructions; develop,
acquire, install, and utilize technology and systems for the purpose of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements; train personnel to be able to respond to
a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the
information. 

An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number. The OMB control numbers for EPA’s
regulations in title 40 of the CFR, after appearing in the Federal
Register, are listed in 40 CFR part 9, and included on the related
collection instrument or form, if applicable. 

To facilitate public comment on the Agency's need for this information,
the accuracy of the provided burden estimates, and any suggested methods
for minimizing respondent burden, including the use of automated
collection techniques, EPA has established a public for this ICR under
Docket ID No. EPA-HQ-OPP-2009-0887.  All documents in the docket are
listed in the docket index. Although listed in the index, some
information may not be publicly available, e.g., CBI or other
information whose disclosure is restricted by statute.  Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form.  Publicly
available docket materials are available either in the electronic docket
at   HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov
, or, if only available in hard copy, at the OPP Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal
Drive, Arlington, VA. The hours of operation of this Docket Facility are
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The Docket telephone number is (703) 305-5805.

Also, you can send comments to the Office of Information and Regulatory
Affairs, Office of Management and Budget, 725 17th Street, NW,
Washington, DC 20503, Attention: Desk Officer for EPA.  Please include
the EPA Docket ID No. EPA-HQ-OPP-2009-0887 and OMB Control No. 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  
HYPERLINK "http://www.Regulations.gov"  www.Regulations.gov . On the
main page, select Advanced Search from the menu bar at the top and
select Docket Search. Enter the Docket ID Number, EPA-HQ-OPP-2009-0887
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   HYPERLINK
"http://www.epa.gov/opprd001/crp/"  http://www.epa.gov/opprd001/crp/  

 

Attachment B:	40 CFR Part 157 - PACKAGING REQUIREMENTS FOR PESTICIDES
AND DEVICES – also available at    HYPERLINK
"http://www.access.gpo.gov/nara/cfr/waisidx_03/40cfr157_03.html" 
http://www.access.gpo.gov/nara/cfr/waisidx_03/40cfr157_03.html 

	 

Attachment C:	Record of Consultations Between the U.S. Environmental
Protection Agency and Respondents to the Information Collection Request:
“Compliance Requirement for Child-Resistant Packaging” 

 Attachment D:	Pesticide Registration Notice 97-9 - Electronic
Submission of Child-resistant Packaging Test Data for All Pesticides and
Child-resistant Testing of Prefilled, Nonrefillable Insecticide Bait
Stations Not Designed or Intended To Be Opened or Activated in a Manner
That Exposes the Contents to Human Contact – also available at   
HYPERLINK "http://www.epa.gov/opppmsd1/PR_Notices/pr97-9.html" 
http://www.epa.gov/opppmsd1/PR_Notices/pr97-9.html  

Attachment E:	Worksheet for Estimating OPP ICR Wage Rates for Industry,
State and EPA Labor Costs

Attachment F:	Classification and List of Small Entities

 

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

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June 25, 2010