**Draft 0 9**  **- 1**  **6 -**  **2011 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.: 2367.0**  **2 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 labe ls and other informational materials intended for the general public. The purpose for this research is to identify the consumer’s understanding of the in formation on a pesticide product label

. EPA w ill use this information to formulate decis ions 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 readil y understand l abel instructions regarding the safe use, handling and disposal of the product. The collected information will be used to inform the Agency on the need for and nature of potential revis ions to EPA guidance and regulations regarding pesticide product label s and to create other user

- friendl y 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, s ection 3 of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), requires all pesticides sold or distributed in the United States to be registered b y 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 prop osed 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 before they may be sold or distributed in the United States. Once registered , a pesticide may not legall y 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 cop y 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 reg istration 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**Draft 0 9**  **- 1**  **6 -**  **2011**

information about how to safel y handle and use the pesticide product to avoid harm to human health and the environment. Every pesticide product mus t bear a label containing the information specified b y 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. However, 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 agricultural sector users. The Agency believes that it s labeling regulations , guidance and policies need to be updat ed 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 the y will find on a label. Just as they compare labels on grocery products, consumers expect to compare pesticide products in order to sel e ct the one most appropriate for their needs. As part of its Pesticide Program Dialogue Committee (PPDC) , formed unde r 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 recentl y established a workgroup on Comparative Safety Statements or Lo gos for Pesticide Product Labeling. Some p roducers of pesticide products w ant 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 effectivel y 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 safel y and effectively

. The focus groups conducted during 2010 indicated that consumers of insect repellent products are aware that certain insects carry potentially

deadly diseases and in addition, they want to avoid the itching and pain experienced from bug bites. They want to know how long the protection will last in hours so they will know when to re

apply , and prefer longer acting products so they do not have to re

- appl y as often. Consumers want the information to be clear and concise and in larger print: they do not like s tatements such as long

- lasting as they

find the term to be vague. B efore initiating any

formal poli cy

or other regulatory

decision

- making activities to updat e label regulations or guidance, the Agency needs such information about consumer needs and an und erstanding of their perception of the information on a pesticide product label in a focus group s etting . Testing of existing and/or proposed label statements in realistic situations with ty pical consumers is needed to determine the clarity and understandab ility

of a pesticide product label, and 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**Draft 0 9**  **- 1**  **6 -**  **2011**

information about consumers’ comprehension of the info rmation that is on a pesticide label, and how a consumer uses this information to make their decision to purchase and then safel y 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 th is information collection to inform the develop ment 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 :  L ocate 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 reappl y the product o Where to apply

the product o Understand how to store, and dispose of used products safel y and with minimal effect on the environment  C ompare 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 products 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 collect ed information in a focus group setting on the public’s understanding of ins ect repellent labels , and the potential use of an efficacy mark to identify

the repellent protection time

. Inthe future, o ther 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 way s to explore issues o r 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 survey s to cover a larger population that can also produce**Draft 0 9**  **- 1**  **6 -**  **2011**

s tatistically

significant quantitative data

. Such in

- depth survey s are not a part of the information collection activities covered b y this supporting statement. In addition to generall y i mproving EPA’s understanding about the specific needs for consumer product label s 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 the process for implementing the 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 insect repellent. By

enabling consumers to make better choices in regard to purchasing and using products intended to protect their health, EPA will more effectivel y carry out its mandate to protect the public from unreasonable risks to human health

. **3. NON**  **- DUPLICATION, CONSULTATION**  **S, AND OTHER COLLECTION CRITERIA**  **3(a) Non -** **Duplication** Th is 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 is publish ing a Federal Register (FR) N otice announcing this proposed information coll ection activity and providing a 60

- day public comment period

. **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 Is sues Research and Evaluation Group ( SFIREG )

. In addition, 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.**Draft 0 9**  **- 1**  **6 -**  **2011**

**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 frequentl y 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. Respon dents 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) Confid entiality**  Respondents to this information collection will be private citizens rather than regulated parties, so n o proprietary trade secrets or other proprietary information will be collected. **3(g) Sensitive Questions** Focus group participants voluntarily agree to participate in this research, b y specificall y opting

- in. Participants must actively seek such opportunities by signing

- up and placing their information in the focus group facility database. A minimal amount o f information is collected for that database such name, address (contact information), age, highest level of education completed, emplo ym ent status, household income, ethnicity , and gender. Such information would be collected b y the research companies, as their standard business practices, regardless of whether EPA conducted a survey or not. The research company uses this information to search within their database to locate appropriate particip ants, and then balance the focus groups. Significantl y, 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

– specificall y the Privacy

Act of 1974 (5 U.S.C. 552a), the Hawkins

- Stafford Amendments of 1988 (P.L100

- 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

.**Draft 0 9**  **- 1**  **6 -**  **2011**

**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:  Id entify

the topic for the focus group.  De sign 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.  Id entify 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 anal ys is), 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 . V ideo 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. Ty picall y, focus group participants sign a release form, indicating their consent to be photographed and recorded. (see Attachment C ). **5(c) Small Entity Flexibility**  The focus groups will be designed for participation by individuals , not businesses.**Draft 0 9**  **- 1**  **6 -**  **2011**

**5(d) Collection Schedule**  EPA anticipates conducting up to 10 focus groups each ye ar, over the next three ye ars. **6 .**  **ESTIMATING THE BURDEN AND COST OF THE COLLECTION 6(a)**  **Estimatin g 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, f or a series of 10 focus groups, conducted using the same materials, the estimated respondent burden is 200 hours. Serving on a focus group means the respondent merel y answers the questions and participates in the discussions

. There are no capital expenditures , or operation and maintenance costs associated with this information collection activity

. T o value the respondents’ time, infor mation from the Bureau of Labor Statistics released on June 8, 2011, was used. (http://www.bls.gov/news.release/ecec.nr0.htm) 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 $ 60 1.40 per focus group ( 20 hours x $ 30.07 per hour)

. The annual cost for a series of 10 focus groups is $6014.00. EPA notes, that actuall y, 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

pay ment is $75 per participant for 2 hours. This is part of the contractor costs. **6(b) Estimating Agency Burd**  **en and Costs**  Total Agency burden and costs will depend on the costs necessary to develop and conduct the focus group s , and then to anal yz e the data gathered and prepare the report that will be made publicl y available for that focus group

. This also include s 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

. C osts for agency managerial and agency technical staff were determined using the following methodology : Methodology : The methodology uses data on each sector and labor ty pe for an Unloaded wage rate (hourl y wage rate ), and calculates the Loaded wage rate (unloaded wage rate + benefits ),**Draft 0 9**  **- 1**  **6 -**  **2011**

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 l abor ty pes (management, technical, and clerical ) within applicable sectors. The Agency uses average wage data for the relevant sectors available in the National Industry

- Specific Occupational Employ ment and Wage Estimates from the Bureau of Labor Statistics (BLS) at http://www.bls.gov/oes/current/oes_nat.htm

. Sectors: The specific North American Industry Classification Sy stem (NA ICS) 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 Classif ication (SOC). The SOC sy stem is used by Federal statistical agencies to classify workers into occupational categories for the purpose of collecting, calculating, or disseminating data ( see http://www.bls.gov/oes/current/oes_stru.htm ). Loaded Wage Rate: Unless stated otherwise, all benefits represent 43% 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% is not applicable; the applicable percentage will be stated. Fully L oaded Wage Rate: We multiply the loaded wage rate by

50% (EPA guidelines 20

- 70%) to get ov erhead costs. Costs are indexed to 20 09 data. 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 total annual Agency burden for conducting a series of 10 focus groups is estimated to be 433 hours (43.3 hours for one focus group x 10 focus groups) and cost $4 8,450 ($4,845 cost for one focus group x 10 focus groups ). **T ABLE**  **1 :**  **Estimated Annual**  **Agency Burden Costs Estimates for**  **a S eries of Tens**  **Focus Group**  **s**
Collection

Activities Burden Hours Total Mgmt. $1 12.42/hr Tech.

$ 74.51 /hr Contractor EPA Hours EPA

Cost Develop focus groups materials 6 120 $ 8 5 ,000 .0 0 per series of 10 focus groups (includes payments to participants) 120 $ 9 615.72 Conduct focus groups 4 8 12 $ 1045.76 Review data 0 60 60 $ 4470.60 Analyze results 0 70 70 $ 5215.70 Store and maintain results 0 5 5 $ 372.55 Prepare findings 1 2 75 $ 6937.29**Draft 0 9**  **- 1**  **6 -**  **2011**
TO TAL 22 338 $85 ,000 .0 0 360 $ 27,657.62 **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**  **Burd en**  **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 $ 6014.00 EPA 36 $2765.76 360 $ 27,657.62 **6( d**  **) Reason for Change in Burden**  The total annual respondent burden from the previously approved ICR were 381.34 hours at a cost of $9,594.35. The burden in the previously approved ICR is based on the Agency ’s use of estimates that were based on a similar I CR. This ICR renewal i s base d on the actual costs of conducting a series of 10 focus groups in 2010. This I CR will decrease the burden hours to 200 hours at a cost of $6014.00 . This change is an adjustment. **6( e** **) Burden Statement**  The total annual respondent burden is estimated to be 20 0 hours at a cost of $ 6014.00 , 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 b y 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 currentl y 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 IC R 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 Regulatory Public Docket in Rm. S

- 4400, One Potomac Yard (South Building), 277 7 S. Cry stal Drive, Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday

through Friday , excluding legal holiday s. The docket telephone number is (703) 305

- 5805. You may

submit comments regarding the Agency's need for this inform ation, the accuracy o f 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 (2822 T ), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460

. You can also send**Draft 0 9**  **- 1**  **6 -**  **2011**

comments to the Office of Information and Regulatory Affairs, Office of Man agement and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA. In clude docket ID No. EPA

- HQ

- O PP
- 2011

- 0902 and OMB control number 2 070

- 0175 in any correspondence but do not submit information under this collection to these addresses.**Draft 0 9**  **- 1**  **6 -**  **2011**

**ATTACHMENTS TO THE SUPPORTING STATEMENT** Attachments to the supporting statement are available in the public docket established for this Information C ollection Request (ICR) under the docket identification number **EPA -**  **HQ -**  **OPP**   ** 200** **8 -**  **0 156**  . These attachments are available for online viewing at www.regulations.gov unless otherwise accessed as described in the section s 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 :**  **Generic Release Form for Focus Group Participants**