Document ID: EPA-HQ-OPP-2011-0902-0007
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2012-07-20T04:00Z

SUPPORTING STATEMENT FOR AN
                    INFORMATION COLLECTION REQUEST (ICR)  

1.	IDENTIFICATION OF THE INFORMATION COLLECTION

      1(a) Title: Consumer Research through Focus Groups to Develop Improved Labeling for Pesticide Products 

	EPA ICR No.:  2367.02		OMB Control No.:  2070-0175

	1(b) Short Characterization

      The Environmental Protection Agency (EPA or the Agency) intends to renew a voluntary information collection for consumer research involving the use of focus groups to test various versions of pesticide product labels and other informational materials intended for the general public.  The purpose for this research is to identify the consumer's understanding of the information on a pesticide product label.  EPA will use this information to formulate decisions and policies affecting the labeling of pesticide products.  The ultimate goal of this activity is to assure that the consumer can effectively use this information to select the pesticide product most likely to meet their needs, and to assure that the consumer can readily understand label instructions regarding the safe use, handling, storage, and disposal of the product.  The collected information will be used to inform the Agency on the need for and nature of potential revisions to EPA guidance and regulations regarding pesticide product labels and to create other user-friendly consumer information materials.  It is anticipated that multiple focus groups would be conducted over the life of the ICR.

2.  	NEED FOR AND USE OF THE COLLECTION 

	2(a) Need/Authority for the Collection 

      With few exceptions, section 3 of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) requires all pesticides sold or distributed in the United States to be registered by EPA.  (See attachment A).  Pesticide registration is the process through which EPA evaluates the pesticide to ensure that it will not have unreasonable adverse effects on humans, the environment and non-target species.  As part of the registration process, EPA examines the ingredients of a pesticide, the site or crop on which it is proposed to be used, the amount, frequency and timing of its use, and storage and disposal practices.  Pesticides must be registered or exempted by EPA's Office of Pesticide Programs (OPP) before they may be sold or distributed in the United States.  Once registered, a pesticide may not legally be used unless the use is consistent with the approved directions for use on the pesticide's label or labeling.
      
      Under FIFRA section 3(c)(1), a complete copy of the pesticide labeling, along with a statement of all claims made for the pesticide and any directions for pesticide use, must be submitted with the registration application.  Therefore, a key part of EPA's pesticide registration process is EPA's review of the registration applicant's proposed labeling on the pesticide package or container and any accompanying instructions.  The label instructions provide critical information about how to safely handle, use, store, and dispose of the pesticide product to avoid harm to human health and the environment.  Every pesticide product must bear a label containing the information specified by FIFRA as established in EPA's labeling regulations at 40 CFR 156.10 (See attachment B).
      
      EPA's pesticide product labeling requirements were developed in the 1970's primarily for agricultural products.  Since then, the market for FIFRA-regulated consumer products has grown.  FIFRA-regulated consumer products can include sanitizing and disinfecting products, lawn and garden products, and insect repellents.  Today, there is concern that the label requirements in 40 CFR §156.10 and other related guidance may not adequately address the distinction between the needs of consumers and the needs of the agricultural sector.  
      
      The Agency believes that current labeling regulations, guidance, and policies need to be updated to more adequately address consumer needs, which are different from those of the agricultural sector.  While all users need clear, understandable labeling instructions, consumers also have different expectations about the information that they will find on a label.  Just as they compare labels on grocery products, consumers expect to compare pesticide products in order to select the one most appropriate for their needs.  
      
      As part of its Pesticide Program Dialogue Committee (PPDC), formed under the Federal Advisory Committee Act to provide a forum for a diverse group of stakeholders to provide feedback to EPA on various pesticide regulatory, policy, and program implementation issues, EPA recently established a workgroup on Comparative Safety Statements or Logos for Pesticide Product Labeling.   Some producers of pesticide products want to use logos from organizations that certify that the product meets certain criteria, such as EPA's Design for the Environment, Green Seal, or EcoLogo[CM], and use more "factual statements" on the label, essentially what is being termed as "green labeling."

      However, without knowledge concerning the consumer's perspective and interpretation of the information on the label, EPA cannot judge if the proposed content and design of the label is effectively conveying useful safety and performance information to the consumer.  It is the Agency's goal that consumer labels enhance the consumer's understanding of and ability to use products safely and effectively.  For example, focus groups conducted during 2010 indicated that in addition to wanting to avoid the pain and itching associated with insect bites, consumers of insect repellent products use repellents because they are aware that certain insects carry potentially deadly diseases and want to reduce the risk of contracting these diseases. They want to know what insects are repelled, and they want to know how long those insects will be repelled in hours so they will know how often to re-apply. Consumers want information on the label to be clear, concise, and in larger print, and they do not like vague statements such as "long-lasting."
      
      Before initiating any formal policy or other regulatory decision-making activities to update label regulations or guidance, the Agency needs such information about consumer needs and an understanding of consumer perceptions of the information on a pesticide product label in a focus group setting. Testing of existing and/or proposed label statements in realistic situations with typical consumers is needed to determine the clarity and understandability of a pesticide product label, and to determine what these label statements are likely to communicate to consumers.  This information collection will allow EPA to gather, via a focus group setting, the necessary information about consumers' comprehension of the information that is on a pesticide label, and how a consumer uses this information to make their decision to purchase and then safely handle the product.  This information will also inform and provide support for revisions to the Agency's policy, guidance, and regulatory activities related to pesticide label language and design label metrics.

	2(b) Practical Utility/Users of the Data
      
      The Agency will use this information collection to inform the development of future pesticide labeling related policy, guidance, and/or regulatory efforts to provide consistent, meaningful, and transparent risk reduction and efficacy information to the public.  The goal of any new or revised policy, guidance, or regulatory provision developed as a result of these efforts would be to improve consumer pesticide product labels and other supporting consumer materials. The Agency believes that any user of a consumer-oriented pesticide product should be able to:
      * Locate on the label information such as:
            o How much of the product to use
            o The pests that the product effectively kills or repels
            o How to apply the product
            o How often to reapply the product
            o Where to apply the product
            o Understand how to store and dispose of products safely and with minimal effect on the environment
      * Compare products intended for similar uses. 

      EPA evaluates and controls potential product risks through the registration process described in 2(a) above, which includes the approval of the product's label and accompanying information.  Although the existing labels on consumer pesticide products may adequately convey information to the public, EPA believes that improvements are possible.  
      
      The first use of this ICR collected information in a focus group setting on the public's understanding of insect repellent labels, and the potential use of an efficacy mark to identify the product's repellency time.  In the future, other focus groups may be used to gather information about the public's understanding of labels used for other categories of consumer products, or on general proposals related to label design or other materials for consumers.
      
      The focus groups will provide valuable qualitative information that can be used to gain insights into some consumer reactions, as well as ways to explore issues or structure future focus groups, or otherwise word the questions used in the focus groups.  Focus group research consists of open-ended, yet structured discussions with small groups of individuals, and therefore can provide in-depth information about the topic discussed in that focus group.  
      
      While EPA anticipates that focus group research would yield helpful information, the information obtained from small groups may not necessarily be extrapolated or generalized to the general public.  In order to obtain a more robust understanding of consumers' use of pesticide products and label comprehension, the Agency may also use the information obtained from the focus groups to develop more in-depth surveys to cover a larger population that can also produce statistically significant quantitative data.  Such in-depth surveys are not a part of the information collection activities covered by this supporting statement.
      
      In addition to generally improving EPA's understanding about the specific needs for consumer product labels and labeling in terms of design and content, EPA will use the data collected through the focus groups to determine what aspects of EPA's policy, guidance, or regulations need to be improved, identify potential improvements, and then set about a process for implementing those improvements.  
      
      Once the information from the focus groups has been translated into label revisions, consumers will be able to make better decisions about whether to purchase and use a given pesticide or insect repellent product.  By enabling consumers to make better choices in regard to purchasing and using products intended to protect their health, EPA will more effectively carry out its mandate to protect the public from unreasonable risks to human health.

3.	NON-DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA 

	3(a) Non-Duplication 

      This information collection activity is specific to the needs of the federal pesticide law that is administered by EPA, thereby negating the need for this or similar data by other federal agencies or any other office within EPA.  

	3(b) Public Notice Required Prior to ICR Submission to OMB 

	Pursuant to 5 CFR 1320.8(d), EPA published a Federal Register (FR) Notice (76 FR 76399, December 7, 2011) announcing this proposed information collection activity and provided a 60-day public comment period.  The Agency established a public docket for this proposal, which can be accessed at http://www.regulations.gov using the docket identifier EPA-HQ-OPP-2011-0902.  The Agency did not receive any comments during the comment period. As a result, the Agency did not make any changes to the burden projections in this ICR, and has made only non-substantive changes to this ICR. 
        
	3(c) Consultations

      The Agency's efforts to improve consumer pesticide product labels is based on various discussions with different stakeholders and regulated entities that occurred as part of the programs ongoing consultations over the years.  Examples of organizations for potential consultation could include:
         * State agricultural agencies
         * The PPDC workgroup on Comparative Safety Statements or Logos for Pesticide Product Labeling
         * The State-FIFRA Issues Research and Evaluation Group (SFIREG).  

      The focus groups used to test various versions of pesticide product labels and other informational material would be conducted with members of the general public, so there are no established, organized entities with whom EPA has a purposeful relationship.  Since EPA was not able to readily identify potential respondents, consultations with the general public have not been conducted.  However, EPA personnel, with the assistance of a contractor from industries with the expertise in consumer marketing and design of focus group discussions about consumer products, will identify the materials and develop the design of the focus groups.  The overall conclusions (descriptive and summary statistics) of the focus groups will be publicly-available. 
>
	3(d) Effects of Less Frequent Collection
	
	Each focus group will be a one-time collection exercise for the enrolled participants, so the effect of conducting the information collection activity less frequently would be to not conduct it at all. 

	3(e) Compliance with General OMB Guidelines

This collection of information will be collected in accordance with all OMB guidelines under 5 CFR 1320.6.  Respondents will be asked to participate in the consumer research activities only once and their participation will be voluntary. There will be no need for participants to maintain records or submit proprietary trade secrets or other information.  

	3(f) Confidentiality 

	Respondents to this information collection will be private citizens rather than regulated parties, so no proprietary trade secrets or other proprietary information will be collected.

	3(g) Sensitive Questions 

      Focus group participants voluntarily agree to participate in this research by specifically opting-in.  Participants must actively seek such opportunities by signing-up and placing their information in the focus group facility database.  A minimal amount of information is collected for that database, such as name, address (contact information), age, highest level of education completed, employment status, household income, ethnicity, and gender.  Such information would be collected by the research company as part of their standard business practice, regardless of whether EPA conducted a survey or not.  The research company uses this information to search within their database to locate appropriate participants, and then balance the focus groups.  Significantly, EPA does not collect or retain this information.  EPA retains only the opinions of the participants.  EPA will guarantee all participants that their responses will not be attributed to any individual.  Consumer research conducted will fully conform to federal regulations  -  specifically the Privacy Act of 1974 (5 U.S.C. 552a), the Hawkins-Stafford Amendments of 1988 (P.L 100-297), and the Computer Security Act of 1987.  

	3(h) Electronic Reporting. 

	There will be no direct electronic submission scheme for this collection.  

4.	THE RESPONDENTS AND THE INFORMATION REQUESTED 

	4(a) Respondents

	Potential respondents to this information collection will include members of the general public that volunteer (opt-in) to participate in a focus group. 
	
      4(b) Respondent Activities

      Focus Groups may involve the following activities:
      * Listen to instructions.
      * Review handouts (labels and/or other information) being discussed.
      * Participate in discussions
      * Complete forms, if applicable

5.	AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT

	5(a)	Agency Activities

	EPA or its contractor will perform the following activities:
      * Identify the topic for the focus group.
      * Design the approach for conducting the focus group (agenda, discussion points, presentation materials). 
      * Internal EPA review and approval of discussion topics and the design of the approach. 
      * Identify and then screen focus group participants (recruited from the focus group facility database).
      * Conduct focus group.
      * Review and analyze the information obtained.
      * Provide an aggregated report of the information obtained and the overall conclusions and results.
      * File and store data (information from focus group and analysis), as appropriate.
      * Use the data to inform the design of label statements for consumer pesticide products and/or prepare questions for a national survey.

	5(b)	Collection Procedures

	EPA's contractor will implement the approach prepared for the focus group, including making the necessary logistical arrangements for the focus group and contacting the participants.  Both video and tape recordings will be used to document the discussions.  Given the fixed position of the camera and recording equipment, identification of specific individuals would be challenging.  The contractor will also prepare written transcripts.  Video or tape recording "clips" may be used in briefing materials, but the "clips" will be maintained under Agency control and would not be distributed or used for publication purposes.  
	
      5(c)	Small Entity Flexibility

	The focus groups will be designed for participation by individuals, not businesses.  

	5(d)	Collection Schedule

	EPA anticipates conducting up to 10 focus groups each year, over the next three years.  
 6.	ESTIMATING THE BURDEN AND COST OF THE COLLECTION 

	6(a)	Estimating Respondent Burden and Cost

	To estimate the paperwork burden hours and costs, and the potential number of respondents, EPA used the information obtained during the focus groups conducted during 2010. 

      The per respondent burden to participate in a single focus group is estimated to be approximately 2 hours.  Each focus group would have 8 to 12 participants, or an average of 10 participants for each focus group.   This is an estimated respondent burden of 20 hours for each focus group.  The industry standard is to use the same or similar materials to conduct a series of focus groups.  Therefore, for a series of 10 focus groups, conducted using the same materials, the estimated annual respondent burden is 200 hours.

      Serving on a focus group means the respondent merely answers the questions and participates in the discussions.  There are no capital expenditures, or operation and maintenance costs associated with this information collection activity.  To value the respondents' time, information from the Bureau of Labor Statistics (BLS) released on June 8, 2011, was used (http://www.bls.gov/news.release/archives/ecec_06082011.pdf).  Wages averaged $20.91 per hour.  Benefits averaged $9.15. Thus, the total potential cost for the participants' time is estimated to be $30.07 per hour.  The cost of 10 focus group participants, two hours each, is $601.40 per focus group (20 hours x $30.07 per hour).  The annual cost for a series of 10 focus groups is $6,014.00. 
      
      EPA notes that focus group participants are paid.  This is an industry standard to acknowledge the use of the participant's time, as well as driving and parking expenses.  A customary payment is $75 per participant for 2 hours.  This is part of the contractor costs.
      
	6(b)	Estimating Agency Burden and Costs
 
      Total Agency burden and costs will depend on the costs necessary to develop and conduct the focus groups, and then to analyze the data gathered and prepare the report that will be made publicly available for that focus group. This also includes costs such as hiring contractors to develop materials and conduct the focus groups, travel to focus group cities for both agency and contractor personnel, and renting meeting space. Agency personnel would determine how to use the information collected to improve consumer pesticide product labels, as well as related policies, guidance, or regulations.  The same or similar materials and approaches are used for a series of 10 focus groups.  
      
      Costs for agency managerial and agency technical staff were determined using the following methodology:  

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 BLS at http://www.bls.gov/oes/current/oes_nat.htm.  

Sectors: The specific North American Industry Classification System (NAICS) code and website for each sector is included in that sector's wage rate table .  Within each sector, the wage data are provided by Standard Occupational Classification (SOC).  The SOC system is used by Federal statistical agencies to classify workers into occupational categories for the purpose of collecting, calculating, or disseminating data (see http://www.bls.gov/oes/current/oes_stru.htm).  

Loaded Wage Rate: Unless stated otherwise, all benefits represent 43.6% of unloaded wage rates, based on benefits for all civilian non-farm workers, from http://www.bls.gov/news.release/ecec.t01.htm. However, if other sectors are listed for which 43.6% 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.  Costs are indexed to 2009 data (See Attachment C).  

      The industry standard is to use the same or similar materials to conduct a series of focus groups.  Therefore, the estimated annual Agency burden is for a series of 10 focus groups, conducted using the same materials. 
      
      The estimated Agency burden for one focus group is 36 hours and the estimated cost for one focus group of $11,266, which includes an estimated $8,500 for contractor costs and $2,766 for EPA administrative costs (See Table 1).  

      The total annual Agency burden for conducting a series of 10 focus groups is estimated to be 360 hours (36 hours for one focus group x 10 focus groups) and cost $112,657.60 ($2,765.76 plus $8,500 for one focus group x 10 focus groups).

TABLE 1: Estimated Annual Agency Burden Costs Estimates for One Focus Group
                                       
                                       
                                  Collection
                                  Activities
                                       
                                 Burden Hours
                                       
                                     Total
                                       
                                       
                                     Mgmt.
                                  $112.42/hr
                                       
                                     Tech.
                                   $74.51/hr
                                       
                                  Contractor
                                       
                                   EPA Hours
                                      EPA
                                     Cost
Develop focus groups materials
                                      0.6
                                      12
                                       
                                       
                                       
                                   $8,500.00
                                per focus group
                              (includes payments
                               to participants)
                                     12.6
                                    $961.57
Conduct focus groups
                                      0.4
                                      0.8
                                       
                                      1.2
                                    $104.58
Review data
                                       0
                                       6
                                       
                                       6
                                    $447.06
Analyze results
                                       0
                                       7
                                       
                                       7
                                    $521.57
Store and maintain results
                                       0
                                      0.5
                                       
                                      0.5
                                    $37.26
Prepare findings
                                      1.2
                                      7.5
                                       
                                      8.7
                                    $693.73
                                     TOTAL
                                      2.2
                                     33.8
                                   $8,500.00
                                      36
                                   $2,765.76

      6(c) 	Bottom Line Burden Hours and Cost 

	The total annual burden hours and costs for this ICR are presented in Table 2.
 
 TABLE 2.  Estimated Annual Respondent and Agency Burden Hours and Cost

                            Per Event (Focus Group)
                           10 Focus Groups per Year
                                 Total Annual

                                  Burden Hrs.
                                     Costs
                                       
                                  Burden Hrs.
                                     Costs
Respondent
                                      20
                                    $601.40
                                      10
                                      200
                                   $6,014.00
EPA
                                      36
                                  $11,265.76
                                       
                                      360
                                  $112,657.60
   
	6(d)	Reason for Change in Burden

	The total annual respondent burden from the previously approved ICR was 80 hours at a cost of $2,012.80.  The burden in the previously approved ICR is based on the Agency's use of estimates that were based on a similar ICR.  This ICR renewal is based on the actual costs of conducting a series of 10 focus groups in 2010.  This ICR will increase the burden hours to 200 hours at a cost of $6,014.00.  This change is an adjustment.   

	6(e)	Burden Statement
      
      The total annual respondent burden is estimated to be 200 hours at a cost of $6,014.00, for a series of 10 focus groups.  The per respondent burden is 2 hours.  According to the PRA, "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.  For this collection, it is the time participating in a focus group.  The 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 number will appear on the information collection instrument as applicable, i.e., form or instructions.       

      The Agency has established a public docket for this ICR under Docket ID No. EPA-HQ-OPP-2011-0902, which is available for online viewing at www.regulations.gov, or in person viewing at the OPP Docket in the EPA Docket Center, EPA West, Rm. 3334, 1200 Pennsylvania Ave, NW, Washington DC.  This docket facility is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.  The OPP Docket telephone number is (703) 305-5805.  
      
      You may submit comments regarding the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques.  Comments may be submitted to EPA electronically through http://www.regulations.gov or by mail addressed to Director, Collection Strategies Division, U.S. Environmental Protection Agency (2822T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460.  You can also send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA.  Include docket ID No. EPA-HQ-OPP-2011-0902 and OMB Control No. 2070-0175 in any correspondence but do not submit information under this collection to these addresses.

                    ATTACHMENTS TO THE SUPPORTING STATEMENT

Attachments to the supporting statement are available in the public docket established for this Information Collection Request (ICR) under the docket identification number EPA-HQ-OPP-2011-0902.  These attachments are available for online viewing at http://www.regulations.gov unless otherwise accessed as described in the sections below.  
Attachment A:  7 U.S.C. 136a - FIFRA Section 3:- This attachment can be accessed via the internet at: http://www.law.cornell.edu/uscode/7/136a.html 
Attachment B:  40 CFR 156.10:  Labeling Requirements:  This attachment can be accessed via the internet at: http://edocket.access.gpo.gov/cfr_2007/julqtr/pdf/40cfr156.10.pdf 
                                       
Attachment C: Work Sheet used to Calculate EPA and Federal Government Labor Costs