2367-01-icr

August 3, 2009

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.: 2367.01¹

OMB Control No.: 2070-New

1(b) Short Characterization

The Environmental Protection Agency (EPA or the Agency) intends to initiate a new 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 would 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 readily understand label 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 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 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 and use 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. 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 its 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, two of the projects that EPA might pursue during the life of the ICR could be the readability and understandability of insect repellent efficacy claims on a label, and the consumer’s interpretation of the meaning of a “green” logo on a pesticide product label.

Before initiating any formal policy or other regulatory decision-making activities to update label regulations or guidance, the Agency needs basic information about consumer needs and behavior when choosing to use a pesticide product. Such information could be obtained via in-person focus groups. 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 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 consumer behavior, 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:

  • How much of the product to use

  • The pests that the product effectively kills or repels

  • How to apply the product

  • How often to reapply the product

  • Where to apply the product

  • Understand how to store, and dispose of used 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 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 Agency has identified some specific aspects of pesticide labels that could be improved to better inform consumers about use and effectiveness, especially for insect repellents. As such, a possible first use of this ICR may be to collect information in a focus group setting on the public’s understanding of insect repellent labels. 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. Such research often consists of open-ended yet structured discussions or interviews with individuals or 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 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 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 announcing this proposed information collection activity and providing a 60-day public comment period (73 FR 17971, April 2, 2008). The Agency received one comment from the Consumer Specialty Products Association (CSPA). The majority of comments submitted by the CSPA on behalf of the DEET Task Force (DTF) were related to the research EPA might conduct under the ICR once the ICR is approved. The remainder of CSPA comments provided useful suggestions to other planned EPA projects. CSPA’s comments are available as attachment D to this supporting statement, and EPA’s response to the comments is available as attachment E.

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. As indicated previously, the PPDC has formed a workgroup on Comparative Safety Statements or Logos for Pesticide Product Labeling, which will be consulted when EPA designs the focus group(s) that may be formed to get feedback on label issues specific to the statements or logos being considered by that workgroup.

In addition, EPA personnel, with the assistance of those industries with the expertise in consumer marketing and design of focus group discussions about consumer products, will identify the materials and develop the design ofthe focus groups. The overall conclusions (descriptive and summary statistics) of the focus groups will be publicly-available.

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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

The information requested under this voluntary collection does not include questions of a sensitive nature. No personal or private questions will be asked, and no identify information about participants will be collected or retained. EPA will collect only the information necessary to evaluate the proposed labeling statements, i.e., the opinions of the participants. In addition, all responses will remain strictly confidential, and 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 to participate in a focus group.

4(b) Respondent Activities

Focus Groups may involve the following activities:

• Listen to instructions.

• Review material (labels &/or other information) to be discussed.

• Participate in discussions or interviews.

• 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 focus group participants (mail and/or internet address lists of potential focus group members, etc.)

• Conduct focus group; gather information from respondents.

• Review and analyze the information obtained.

• Prepare findings.

• File and store data (information from focus group and analysis), as appropriate.

• Provide an aggregated report of the information obtained and the overall conclusions and results.

• Use the data to inform the design of label statements for consumer pesticide products.

5(b) Collection Procedures

EPA or its contractor will implement the approach prepared for the focus group, including making the necessary logistical arrangements for the focus group, contacting the participants, and gathering the materials for the meeting. EPA will document the discussions and feedback provided by the focus groups primarily by using written transcripts, but may also use a temporary video or tape recordings to facilitate the preparation of such written transcripts. Any recordings will be destroyed after verifying the written transcript and will not be retained.

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 historical respondent information from other consumer research activities, and projected respondent information from the recently approved ICR entitled “Focus Groups as Used by EPA for Economics Projects” (ICR No.2205.01) and the Customer Satisfaction Surveys ICR (No 1711.05), and the Agency’s best professional judgment.

The respondent burden to participate in a single focus group is estimated to be approximately 40 minutes. Each focus group is expected to have up to 12 participants, for an estimated respondent burden of 8 hours for each focus group.

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. The only cost to respondents is their time. To value the respondents’ time, information from the Bureau of Labor Statistics was used. (http://www.bls.gov/opub/ted/2006/sept/wk4/art01.htm) This information indicated that employer costs for June 2006 averaged $7.39 per hour. Wages averaged $17.77 per hour. Thus, the total potential cost for the participants time is estimated to be $25.16 per hour, or $201.28 per focus group (8 hours x $25.16 per hour).

Since EPA anticipates conducting up to 10 focus groups each year under this ICR, the total annual respondent burden is estimated to be 80 hours (8 hours per focus group x 10 focus groups), and the respondent costs are estimated to be $2,012.80 ($201.28 per focus group x 10 focus groups).

6(b) Estimating Agency Burden and Costs

Total Agency burden and costs will depend on the costs necessary to develop and conduct the individual focus group, and then to analyze the data gathered and prepare the report that will be made publicly available for that focus group. This may also include costs such as hiring contractors to develop and conduct the focus groups; travel to focus group cities for both agency and contractor personnel, and renting meeting space. Agency personnel would evaluate and then determine how to use the information collected to improve consumer pesticide product labels, as well as related policies, guidance or regulations. Lower costs or efficiencies in the design and conduct of the focus groups would eventually occur by subsequent use of the same or similar approaches for future 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 Bureau of Labor Statistics (BLS) at http://www.bls.gov/oes/current/oes_nat.htm.

Sectors: The specific North American Industry Classification System (NAICS) code and website for each sector is included in that sector’s wage rate table (see Attachment F). 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% 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 Loaded Wage Rate: We multiply the loaded wage rate by 50% (EPA guidelines 20-70%) to get overhead costs.

The estimated Agency burden for one focus group is 43.3 hours and the estimated cost for one focus group of $4,845, which includes an estimated $2,000 for contractor costs and $2,845 for EPA administrative costs (See Table 1). Attachment C contains a worksheet providing the breakout of these costs. Costs are indexed to 2006 data.

The total annual Agency burden for conducting up to 10 focus groups a year is estimated to be 433 hours (43.3 hours for one focus group x 10 focus groups) and cost $48,450 ($4,845 cost 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. $101.16/hr	Tech. $66.88/hr	Contractor	EPA Hours	EPA Cost
Develop focus groups materials	0	13.3	$2000.00 per focus group	13.3	$892.00
Conduct focus groups	0	3.3		3.3	$223.00
Review data	0	1.7		1.7	$111.00
Analyze results	0.3	6.7		7	$480.00
Store and maintain results	0	3.3		3.3	$113.00
Prepare findings	0.7	10		10.7	$736.00
TOTAL	1.7	41.6	$2,000.00	43.3	$2,845.00

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)		Annual # Events	Total Annual
	Burden Hrs.	Costs		Burden Hrs.	Costs
Respondent	8	$201.28	10	80	$2,012.28
EPA	43.3	$4,845.00		433	$48,450.00

6(d) Reason for Change in Burden

This is a new information collection activity, and therefore there are no changes in burden from a previously approved ICR.. This new information collection activity represents a program change in EPA’s overall Information Collection Budget.

6(e) Burden Statement

The total annual respondent burden is estimated to be 80 hours at a cost of $2,012.80, assuming a total of 10 focus groups are conducted annually. The per respondent burden is estimated to by 40 minutes per focus group. 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 responding to survey questions or 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-2008-0156, 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), 2777 S. Crystal Drive, Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 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-2008-0156 and OMB control number 2070-TBD 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-2008-0156. These attachments are available for online viewing at www.regulations.gov or otherwise accessed as described in the sections below.

Attachment A: 7 U.S.C. 136a - FIFRA Section 3:- This attachment is available as part of the Docket EPA-HQ-OPP-2008-0156 or can be accessed via the internet at: http://www4.law.cornell.edu/uscode/7/usc_sec_07_00000136---a000-.html

Attachment B: 40CFR 156.10: This attachment is available as part of the Docket EPA-HQ-OPP-2008-0156 or can be accessed via the internet at: http://www.access.gpo.gov/nara/cfr/waisidx_07/40cfrv23_07.html

Attachment C: Agency Labor Cost Worksheet 2006 Data: This attachment is available only as part of Docket EPA-HQ-OPP-2008-0156.

Attachment D: Comment Submitted in Response to Federal Register Notice (73 FR 17971, April 2, 2008): This attachment is available only as part of Docket EPA-HQ-OPP-2008-0156.

Attachment E: Agency Response to Attachment D: This attachment is available only as part of Docket EPA-HQ-OPP-2008-0156.

1 This ICR was originally submitted to OMB on May 14, 2009 under EPA ICR No. 2297.01. EPA withdrew the ICR at OMB’s request to address consumer research through focus groups and consumer research through surveys separately. EPA is merely submitting the revised ICR covering consumer research through focus groups to OMB under a newly assigned EPA ICR number (ICR No. 2367.01).

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