2425ssA01

June 2, 2011

SUPPORTING STATEMENT FOR AN

INFORMATION COLLECTION REQUEST (ICR)

1. IDENTIFICATION OF THE INFORMATION COLLECTION

1(a) Title

Use of Surveys in Developing Improved Labeling for Insect Repellent Products

EPA ICR No.: 2425.01 OMB Control No.: 2070-New

1(b) Short Characterization

The Environmental Protection Agency (EPA or the Agency) intends to initiate a new information collection, a voluntary one-time internet survey for consumer research. The goals of the internet survey are to (1) identify the types of information that users of insect repellents want on the label of an insect repellent product and (2) test four versions of an efficacy mark. This efficacy mark is a graphic that could be placed on the front label of an insect repellent to standardize the presentation of information on how long the insect repellent repels ticks or mosquitoes. For the first efficacy mark viewed, participants would provide information on their understanding of the efficacy mark, just as if they came across the mark on a product label with no prior explanation of what the mark could mean. Participants would rate all of the efficacy marks for understandability and usefulness, and then indicate a preferred choice. EPA would use this information to formulate decisions and policies affecting future labeling of insect repellents. The ultimate goal of this activity is to help the consumer to effectively use information on the label to select the insect repellent product most likely to meet their needs and readily understand label instructions regarding safe product use. One survey would be conducted over the life of the ICR.

The collected information could be used as part of a future analysis conducted as part of potentially revising insect repellent product labels and to create other user-friendly communication and educational materials. By enabling consumers to make better, more informed choices in regard to purchasing and using products intended to protect their health, EPA could more effectively carry out its mandate to protect the public from unreasonable risks to human health.

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 the EPA to register all pesticide products sold in the United States. (See attachment A). EPA uses this registration process to ensure that the products in question will not have unreasonable adverse effects on humans or the environment. As part of this process, EPA examines the ingredients of a pesticide; the amount, frequency and timing of its use; and storage and disposal practices.

EPA’s review of proposed labeling on an insect repellent package or container and the accompanying instructions is a key part of EPA’s pesticide registration process. Under FIFRA section 3(c)(1), a complete copy of the label, along with a statement of all claims made about the product, and any directions for use must be submitted with the registration application. The label of an insect repellent provides critical information about how to apply the repellent, how often to re-apply, and the pests that are repelled.

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 and primarily for agricultural products. However, since that time, 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. As a result, current label requirements may not adequately address the distinction between the needs of consumers and the needs of agricultural sector users.

Without knowledge of consumers’ perceptions and understanding of pesticide label information, EPA cannot judge if the content and design of the label communicates the safety and performance information that consumers desire. More importantly, EPA cannot determine if consumers interpret labeling statements as EPA intended. It is the Agency’s goal that product labels help consumers to understand the products they use, and know how to use them safely. To further this goal, EPA recently conducted ten focus groups to better understand consumer needs and preferences regarding insect repellent product labeling and efficacy marks. The focus group format allowed for in-depth probing and discussion on consumers’ attitudes and perceptions and how consumers use information on an insect repellent label. Feedback from the focus groups allowed EPA to redesign the sample efficacy marks.

These focus groups were conducted in Bethesda, MD; Tampa, FL; Norwalk, CT; and Minneapolis, MN. Four consumer segments were included in the market research: light/infrequent product users, heavy users, parents of young children (less than 10 years old), and general users. A total of 92 participants participated in the focus groups.

Given the limited number of participants, it should be emphasized that the results of a focus group are considered to be qualitative research. A qualitative research methodology seeks to develop directions for future research rather than quantitatively precise or absolute measures. EPA regards the focus groups as an important exploratory component of research on consumer understanding of labels, with findings that can be used to generate hypotheses for further study and decision-making. Though the non-statistical nature of qualitative research means the results cannot be generalized to the general U.S. population, EPA gathered from the focus groups valuable and useful information.

Focus group participants want clearer, more concise statements on the labels of the insect repellents they buy. Currently, consumers seem to have a difficult time comparing products when considering a purchase, largely because there are no standards for the type, placement, or format of information on the label. Consumers are looking for a consistent standard of measurement for evaluating the efficacy and safety of personal insect repellents. However, instead of standard information, claims on current insect repellent labels are widely variable, confusing, and not always easy to read or understand. Vague, general, or unsubstantiated claims such as “long-lasting protection” or “effective dependable protection” and wordy claims do not provide consumers with specific information, in a user-friendly format that could guide consumers to choose the best insect repellents for their needs.

The results of the focus groups indicate that consumers primarily want insect repellent labels to communicate:

• the specific number of hours of efficacy for the product,

• the specific insects or other pests the product repels, and

• the precise percentage of active ingredient in the product.

These data must be presented in a sizeable, clear font and placed on the front of the package. They also would like manufacturers to use visuals that are eye appealing and relevant to the situations in which they use insect repellents. Therefore, it is critical for any revised labeling system to include these specific data points and criteria in an easy-to-read format on the front of the package.

The exploratory research gained via the focus groups provided EPA with key information on consumer needs from insect repellent labels. To build on this information, a consumer survey is needed to fully understand and quantify consumers’ perceptions. The information collected will allow EPA to more completely understand consumers’ reasons for choosing personal insect repellents, their comprehension of label information, and their use of this information to make a purchasing decision and take safety precautions. The information collected will provide support for the Agency’s policy and regulatory activities in advising label language, designing label metrics, and revising labeling regulations and policies.

Today, there is an increasing trend of asking the public for their views and perceptions, in order to discover and understand the public’s needs and wants, and to access the public’s expertise and knowledge. This is evidenced by several recent surveys conducted by agencies of the Federal government, after approval by OMB, to understand consumer perceptions.

• The Federal Trade Commission conducted an internet survey to examine consumer perception of environmental marketing claims (such as “eco-friendly” or “green”). The survey was part of the Commission’s regulatory review of the Guides for the Use of Environmental Marketing Claims (“Green Guides” or “Guides”). (OMB Control No. 3084-0152)

• EPA’s Office of Air and Radiation conducted internet survey research for developing the fuel economy labels that are posted on window stickers of all new light duty cars and trucks sold in the U.S. This survey was aimed at addressing the increasing market penetration of advanced technology vehicles, in particular plug-in hybrid electric vehicles and electric vehicles, which will require new label metrics and presentation to effectively convey information to consumers. (OMB Control No: 2060-0643)

• The Food and Drug Administration's (FDA) Center for Tobacco Products conducted internet research to evaluate the relative efficacy of various graphic images depicting the risks of cigarette smoking in influencing consumers' attitudes, beliefs, perceptions, and intended behaviors related to cigarette smoking. The information collected will inform FDA’s efforts to implement the mandatory graphic warnings required by the Tobacco Control Act. (OMB Control No: 0910-0668)

Similarly the information from EPA/Office of Pesticide Program’s one time survey on labeling for insect repellent products could be used in the future to update the Agency’s pesticide labeling regulations and policies to more adequately address consumer needs. While both agricultural users and personal consumers need clear, understandable labeling instructions, consumers have different expectations about and less experience with the information on pesticide labels. Just as they compare labels on grocery products, consumers expect to be able to compare pesticide products and select the one most appropriate to their needs.

2(b) Practical Utility/Users of the Data

The Agency will use the information collected as part of an analysis to develop future policy and/or regulatory efforts intended to clarify risk reduction and efficacy information to consumers via a label. Any new policy developed would 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

  • Which pests the product effectively kills or repels

  • How to apply the product

  • How often to reapply the product

  • Where to apply the product

  • 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 pesticide product risks through the registration process. The existing labels on consumer pesticide products adequately convey some information to the public. However, EPA believes that improvements are possible, and has identified areas where improvement is needed. The ten focus groups discussed earlier have provided qualitative data that provides a foundation for further research on proposed label improvements for insect repellents. Though this in-depth qualitative data is very important to the research process, it cannot be expanded to support statistical constructs, or to make large-scale assumptions about the population. Instead, responses from focus groups can be used to develop questions for a survey.

Quantitative data, which is provided by large surveys, is required to discover the statistical significance of any observations about consumers’ attitudes. It can also refine information gathered from the focus groups, and correct misperceptions resulting from the necessarily limited population comprising the focus groups. Therefore, to develop insect repellent labels that are the clearest and most effective for the largest number of people, a national survey should be carried out in addition to the focus groups already conducted. This ICR would be used to conduct an internet survey involving a group of 3,000 respondents that, statistically, would more closely resemble the U.S. population. An internet survey was chosen over phone interview techniques, so that graphics can be included within the questions. The survey questions would be derived from the responses and discussions of the focus groups concerning the efficacy marks reviewed by the focus group participants. Thus, the information collected through the survey will help the Agency to determine if an efficacy mark would be useful on an insect repellent product, and if there is a preference for one of the efficacy marks offered in the survey.

The information collected through the survey is expected to assist EPA in designing insect repellent pesticide product labels that provide the consumer with clear information. This will aid consumers in the safe and informed use of pesticides. EPA would use the data to determine what aspects of consumer pesticide product labels need to be improved and then establish the process for such improvements. Once the information from the survey 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

To date, the Agency is unaware of any survey that has been conducted concerning the usefulness and understandability of insect repellent labels, particularly with regards to efficacy. However, in 1996, the Agency launched a voluntary project the Consumer Labeling Initiative (CLI) (Federal Register on March 22, 1996 (61 FR 12011)(FRL-4956-8). The purpose of the project was to "…ensure that consumers have and understand the information they need in order to make responsible product choices based on their own needs and values, and to use chosen products safely as directed..” The CLI surveys were voluntarily undertaken and funded by industry and trade association Partners of CLI. The CLI partners conducted surveys concerning the labels of certain kinds of pesticide products used by consumers in and around their homes. However, none of the CLI surveys concerned insect repellent pesticide products, which are distinctly different than other pesticide products, since the insect repellent is deliberately applied to human skin. Additionally, the CLI did not address difficulties in comparing or selecting products based on label information. Instead, the CLI focused on improving ways to communicate information about a product’s hazards, first aid, storage, disposal, or providing manufacturer contact information. For additional information see http://www.epa.gov/pesticides/regulating/labels/consumer-labeling.htm.

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

Pursuant to 5 CFR 1320.8(d), EPA has published a Federal Register (FR) notice announcing this proposed information collection activity and a 60-day public comment period (February 18, 2011; 76 FR 9574). The Agency has established a public docket for this proposal, which can be accessed at http://www.regulations.gov using the docket identifier EPA-HQ-OPP-2010-1085. EPA received one comment, which is addressed in Attachment G .

3(c) Consultations

Consultations with the general public have not been conducted since EPA was not able to readily identify potential respondents. Since these surveys would be conducted with a specific subset (those adults who purchase insect repellents) of the general public interested in participating in an online survey, there are no established, organized entities with whom EPA has a purposeful relationship. However, EPA personnel, with the assistance of a consultant with the expertise in consumer marketing and survey design, will develop the instruments for the surveys and focus groups. The overall conclusions (descriptive and summary statistics) of the survey will be publicly-available.

During the 60-day comment period for this ICR, EPA specifically requested that insect repellent registrants and any others who have conducted focus groups or surveys concerning insect repellent labels share that information with EPA. EPA received no data in response to that request.

Additionally, EPA believes that there could be, in the future, another opportunity for collecting information on the efficacy marker that purchasers of insect repellents would like on the product label. If the regulations in 40 CFR 156.10 are proposed for revisions to include the use of an efficacy marker, then there would be a comment period of 90 days or longer associated with that proposed rule. As part of the public comment period, EPA is considering to have a website available so members of the general public can “vote” on the efficacy marker that they prefer.

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3(d) Consequences of Not Conducting the Collection of Information

Without the survey, it will be extremely difficult to determine how modifying various presentations of efficacy information on insect repellent labels will impact consumers’ choices and use of these products. The Agency will only be able to understand the consumer’s perspective on efficacy marks from a general qualitative perspective based on the remarks of 92 consumers. Without the quantitative, statistically-based information, the Agency will not be able to determine if an efficacy mark would improve the presentation of information on insect repellent labels, and if the marks favored by focus group participants are understandable by a broader group of people; EPA therefore could not propose revisions to the labeling regulations in 40 CFR 156.10.

3(e) Compliance with General OMB Guidelines

This collection of information will be conducted in accordance with all OMB guidelines under 5 CFR 1320.6. The contractor will ensure a stratified sample of the population across consumer groups broadly representing the characteristics of U.S. noninstitutionalized respondents 18 years and older, relative to the most recent Census Bureau Current Population Survey.

EPA acknowledges that survey participants would be limited to participants with access to a computer and that such participants tend to be persons who have self-selected by expressing an interest in consumer research. Having considered the costs and benefits of various data collection methods, EPA has concluded that the most efficient way to collect data to meet the research objectives within a feasible budget is to use an internet survey panel provider. One of the weaknesses of internet surveys is that such surveys cannot be considered representative of the US population as a whole. One of the sources of error for internet surveys is the lack of internet access: not everyone in the U.S. is online. According to the U.S. Census Bureau 2010 Statistical Abstract, 85 percent of U.S. adults, or 71 percent of U.S. households, have an internet connection (2008 statistics (Table 1120 – Internet Access and Usage (2008)). [http://www.census.gov/compendia/statab/cats/information_communications/internet_publishing_and_broadcasting_and_internet_usage.htm]

Though access to the internet through wired or wireless devices is increasing, 15 to 30 percent of adults would not be able to self-select to participate in this survey. Additionally, “internet access tends to be positively associated with income and education and negatively associated with age (younger people are more likely to be online than older people). Some demographic groups are also less likely to be online (e.g., blacks, Hispanics, and undocumented immigrants)” (AAPOR, pages 9 and 52). Methods to address these issues are discussed in Section B.

Because the primary focus of the study is to understand the perceptions of adults who purchase and use insect repellent products, using a broad sample of individuals at least 18 years of age will provide sufficient information to determine if the labeling regulations need to be changed, and information on the changes needed. Part B of this Supporting Statement has further detail about survey methodology.

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. EPA will collect only the information necessary to evaluate the proposed efficacy marks.

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. EPA will collect only the information necessary to evaluate the proposed labeling statements. All responses will remain strictly confidential, and EPA will guarantee to all survey participants that their responses will remain private. However, the overall conclusions of the research will be publicly available. 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. The survey will be conducted via the internet.

4. THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a) Respondents

Potential respondents affected by these voluntary collection activities will be adults (those over 18) who purchase and use insect repellent products.

4(b) Respondent Activities

Surveys may involve the following activities:

• Read instructions

• Complete questionnaire

• Return/submit questionnaire

5. AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT

5(a) Agency Activities

EPA or its contractor will perform the following activities:

• Develop survey design;

• Refine survey questions based on the questions derived from the focus groups

• Assemble data sources (internet address lists, etc.)

• Pretest the survey

• Internal EPA review and approval of survey

• Submit specific survey design, including collection methodology, sample size, incentive plans, and summary of focus group results, to OMB for clearance under the PRA

• Disseminate survey to respondents

• Gather information from respondents

• Review and analyze the information obtained

• Prepare findings of the overall conclusions and results

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

5(b) Collection Procedures

The survey is voluntary and will be designed to be completed by individuals and/or households, not small businesses. An advantage of collecting information via an internet survey is the flexibility that such a collection offers the respondent. For example, such surveys can be completed at the convenience of the respondent, in privacy. There is no need to arrange times for interviews, disclose information to an interviewer, or return a paper form by mail.

5(c) Small Entity Flexibility

The surveys will be designed to be completed by individuals and/or households, not small businesses.

5(d) Collection Schedule

One survey will be conducted.

6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION

6(a) Estimating Respondent Burden

To estimate the paperwork burden hours and costs, and the potential number of respondents, EPA used historical respondent information from other surveys. Table 1 below describes the respondent burden hours and costs.

TABLE 1. Total Respondent Burden and Cost Estimates for One-Time Survey

Testing Instruments	Estimated Number of Respondents	Estimated Response Time (min) per Respondent	Estimated Respondent Time (hours)	Estimated Respondent Costs ($20.90/hr)
Totals for One-Time Survey	3000	15	750	$15675

Little is required of a survey respondent. The respondent reads the instructions, answers the questions, and then submits the survey.

There are no capital expenditures, or operation and maintenance costs associated with this information collection activity. The only cost to respondents is their time. However, to value the respondents’ time, information from the Bureau of Labor Statistics was used. This information indicated that for June 2010 wages averaged $20.90 per hour. Thus, the approximate value of the respondents’ response time of 15 minutes is $5.23.

6(b) Estimating Agency Burden

Total costs will depend on the costs necessary to develop, pre-test, conduct, and follow-up the survey. EPA will incur costs such as hiring contractors to develop and conduct the survey. Agency personnel would evaluate and then determine how to use the information collected to revise insect repellent labels. Costs for agency managerial and agency technical staff were determined using the methodology below. Costs are indexed to 2006 data.

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 respondent 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 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.

TABLE 2. Estimated Annual Agency Burden Costs Estimates for a Survey

Collection Activities	Totals
	Mgmt. $112.36/hr	Tech. $74.47/hr	EPA Hours	EPA Cost
Develop survey questions	0	33.3	33.3	$2,480
Obtain approval	0.7	3.3	4	$324
Conduct survey	0	13.3	13.3	$990
Review data	0	13.3	13.3	$990
Analyze results	0.3	13.3	13.7	$1,024
Store and maintain results	0	3.3	3.3	$246
Prepare findings	0.7	10	10.7	$823
TOTAL	1.7	89.8	91.6	$6,878

Contractor Costs: approximately $55,000.00

TABLE 4. Estimated Annual Respondent and Agency Burden Hours and Cost

	Hours	Cost
Respondents
Respondent Total for One-Time Survey	750	$15,675
Agency
Agency Total for One-Time Survey	91.6	$6,878
Agency Contractor Costs	---	$55,000

6(e) Reason for Change in Burden

This is a new information collection activity, and therefore there are no changes in burden other than the beyond the new estimates provided herein. The total annual respondent burden for this ICR is estimated to be750 hours. This is a program change.

6(f) Burden Statement

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. 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-2010-1085, 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-2010-1085 and OMB control number 2070-new 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-2010-1085. 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 can be accessed via the internet at: http://www4.law.cornell.edu/uscode/7/usc_sec_07_00000136---a000-.html

Attachment B: 40 CFR 156.10: This attachment can be accessed via the internet at: http://www.access.gpo.gov/nara/cfr/waisidx_07/40cfrv23_07.html

Attachment C: Part B - Survey Methodology - This attachment is part of the docket EPA-HQ-OPP-2010-1085 at regulations.gov.

Attachment D: Consumer Efficacy Mark Questionnaire. Prepared by Shugoll Research (draft – 05-23-2011). This attachment is part of the docket EPA-HQ-OPP-2010-1085 at regulations.gov.

Attachment E: Focus Group Report. Prepared by Shugoll Research (09-21-2010). This attachment is part of the docket EPA-HQ-OPP-2010-1085 at regulations.gov.

Attachment F: Short Presentation of Focus Group Report. Prepared by Shugoll Research. This attachment is part of the docket EPA-HQ-OPP-2010-1085 at regulations.gov.

Attachment G: EPA’s Response to Comments Document. This attachment is part of the docket EPA-HQ-OPP-2010-1085 at regulations.gov.

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