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Notice of Request for a New Information Collection: In-Home Food Safety Behaviors and Consumer Education: Annual Observational Study

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Food Safety and Inspection Service, USDA.


Notice and request for comments.


In accordance with the Paperwork Reduction Act of 1995 and Office of Management and Budget (OMB) regulations, the Food Safety and Inspection Service (FSIS) is announcing its intention to collect information in the form of observational studies to inform the development of food safety communication products and to evaluate public health education and communication activities.


Submit comments on or before February 21, 2017.


FSIS invites interested persons to submit comments on this information collection. Comments may be submitted by one of the following methods:

  • Federal eRulemaking Portal: This Web site provides the ability to type short comments directly into the comment field on this Web page or attach a file for lengthier comments. Go to Follow the on-line instructions at that site for submitting comments.
  • Mail, including CD-ROMs, etc.: Send to Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, Docket Clerk, Patriots Plaza 3, 1400 Independence Avenue SW., Mailstop 3782, Room 8-163A, Washington, DC 20250-3700.
  • Hand- or courier-delivered submittals: Deliver to Patriots Plaza 3, 355 E Street SW., Room 8-163A, Washington, DC 20250-3700.

Instructions: All items submitted by mail or electronic mail must include the Agency name and docket number FSIS-2016-0036. Comments received in response to this docket will be made available for public inspection and posted without change, including any personal information, to

Docket: For access to background documents or comments received, go to the FSIS Docket Room at Patriots Plaza 3, 355 E Street SW., Room 8-164, Washington, DC 20250-3700 between 8:00 a.m. and 4:30 p.m., Monday through Friday.

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Gina Kouba, Office of Policy and Program Development, Food Safety and Inspection Service, USDA, 1400 Independence Avenue SW., Room 6065, South Building, Washington, DC 20250-3700; (202) 720-5627.

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Title: In-Home Food Safety Behaviors and Consumer Education: Annual Observational Study.

Type of Request: New information collection.

Abstract: FSIS has been delegated the authority to exercise the functions of the Secretary of Agriculture (7 CFR 2.18, 2.53) as specified in the Federal Meat Inspection Act and the Poultry Products Inspection Act (21 U.S.C. 453 et seq., 601 et seq.). FSIS protects the public by verifying that meat and poultry products are wholesome, not adulterated, and properly marked, labeled, and packaged.

The U.S. Department of Agriculture's Food Safety and Inspection Service's Office of Public Affairs and Consumer Education (USDA, FSIS, OPACE) ensures that all segments of the farm-to-table chain receive valuable food safety information. The consumer education programs developed by OPACE's Food Safety Education Staff inform the public on how to safely handle, prepare, and store meat, poultry, and processed egg products to minimize incidence of foodborne illness.

OPACE strives to continuously increase consumer awareness of recommended food safety practices with the intent to improve food-handling behaviors at home. OPACE shares its messages through The Food Safe Families campaign (a cooperative effort of USDA, Food and Drug Administration, and Centers for Disease Control and Prevention); other advertising; social media; AskKaren (an online database of frequently asked food safety questions); the FSIS Web site; the Meat and Poultry Hotline; publications; and events. These messages are focused on the four core food safety behaviors: Clean, separate, cook, and chill.

To test new consumer messaging and tailor existing messaging, FSIS can help ensure that it is effectively communicating with the public and working to improve consumer food safety practices. This behavioral research will provide insight into the effect FSIS consumer outreach campaigns have on consumers' food safety behaviors. The results of this research will be used to enhance messaging and accompanying materials to improve their food safety behavior. Additionally, this research will provide useful information for tracking progress toward the goals outlined in the FSIS Fiscal Years 2017-2021 Strategic Plan.

To inform the development of food safety communication products and to evaluate public health education and communication activities, FSIS is requesting approval for a new information collection to conduct observational studies using an experimental design. Previous research suggests that self-reported data (e.g., surveys) on consumers' food safety practices are unreliable, thus observational studies are a preferred approach for collecting information on consumers' actual food safety practices. These observational studies will help FSIS assess adherence to the four recommended food safety behaviors of clean, separate, cook, and chill, and to determine whether food safety messaging focused on those behaviors affects consumer food safety handling behaviors and whether consumers introduce cross-contamination during food preparation. For this 3-year study, FSIS plans to conduct an observational study each year and to focus on a different behavior, food and food preparation task, and food safety communication product each year. The initial study will examine participants' use of a food thermometer to determine if meat and poultry products are cooked to the proper temperatures. FSIS may decide to continue to conduct these studies annually, and if so, will request a renewal to extend the expiration date for the information collection request.

FSIS has contracted with RTI International to conduct the observational studies. The observational studies will be conducted in North Carolina State University's test kitchen. Participants will be recruited using convenience sampling, and recruited participants will reflect the demographics of the U.S. population with regard to race, ethnicity, age, education, income, and household size. Using a fully randomized experimental design, participants will be assigned to a treatment or control group. Treatment participants will receive food safety messaging prior to the study, while control participants will receive messaging unrelated to food safety. Participants will be given ingredients and asked to prepare a meal consisting of ready to eat products and meat or Start Printed Page 92773poultry products. Prior to meal preparation, the meat/poultry product will be inoculated with a harmless tracer bacterium or virus to assess the extent of cross-contamination. Researchers will video-record meal preparation. Trained researchers will subsequently view the videos and use a coding rubric to assess adherence to recommended practices and notational analysis to assess recorded actions and their frequency.

Following food preparation, trained surface sample collectors will take surface swab samples from multiple sites within the test kitchen. The swabs will be plated at a laboratory to determine presence of the tracer bacterium or virus and concentration of the tracer if any is present. The presence of this tracer will indicate that cross-contamination occurred during food preparation. The level of cross-contamination will be compared across the sampling sites to determine the highest risk areas. Kitchen surfaces, appliances, and other potentially contaminated sites will be cleaned and sanitized after each participant in order to ensure that any bacterial samples collected were from the participant's behaviors.

Participants will be asked to complete an interview after the observation to collect additional information on food handling practices and what they would do in particular situations when practices could not be observed. Certain relevant food handling practices are unable to be observed during the course of the in-person study; therefore, participants will be asked to provide information on these practices.

Statistical analysis will be conducted comparing the differences in handling behavior scores between the treatment and control groups for the four food handling behaviors. A comparative analysis will also be conducted on the samples collected from the designated kitchen sites and food samples to determine whether levels of cross-contamination differed between the two groups, as well as to identify the kitchen sites with the highest levels of contamination. This information will help to determine whether the food safety communication products tested in the experimental study affect consumer food handling behavior and thus help OPACE refine existing materials or inform the development of new food safety communication products. Improving consumer food safety practices in the home may help to minimize incidence of foodborne illness.

Estimate of Burden: Each year of the 3-year study, it is expected that 833 individuals will complete the web-based screener and it is assumed that 625 will be eligible and subsequently contacted by phone to schedule an appointment for the observation study. Of these, it is assumed that 500 will agree to take part in the study and schedule an appointment, and of these, it is assumed that 400 will show up and complete the observation study and interview. Each web-screening is expected to take 8 minutes (0.133 hour) and each phone call to schedule an appointment is expected to take 7 minutes (0.116 hour). Taking part in the observation study appointment will take a total of 120 minutes (2 hours): 15 minutes (0.25 hours) to obtain informed consent and provide exposure to the messaging, 90 minutes (1.5 hours) for the meal preparation/observation, and 15 minutes (0.25 hours) for the post-observation interview. For each iteration of the study, the estimated annual reporting burden is 983.289 hours, which is the sum of the burden estimates for each component of the study (including the burden for consumers who initially completed the web-based survey but do not agree to participate or do not show up for the observation study). For a 3-year study the estimated total number of individuals to be screened is 2,499 (833 each year) and the estimated total number of individuals to complete the observation study is 1,200 (400 each year). The estimated total burden for the 3-year study is 2,949.867 hours (983.289 *3).

Estimated Annual Reporting Burden for Each Iteration of the Observational Study

Study componentEstimated number of respondentsAnnual frequency per responseTotal annual responsesHours per responseTotal hours
Web-based screening questionnaire83318330.133 (8 min.)110.789
Appointment phone script, confirmation email, reminder phone script62516250.116 (7 min.)72.5
Consent Form and Messaging40014000.25 (15 min.)100.0
Food Preparation Task/Observation40014001.5 (90 min.)600.0
Post-observation interview40014000.25 (15 min.)100.0

Respondents: Consumers.

Estimated Number of Respondents: 2,499.

Estimated Number of Annual Responses per Respondent: 1.

Estimated Total Burden on Respondents: 2,949.867 hours.

Copies of this information collection assessment can be obtained from Gina Kouba, Office of Policy and Program Development, Food Safety and Inspection Service, USDA, 1400 Independence SW., Room 6077, South Building, Washington, DC 20250, (202) 690-6510.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of FSIS's functions, including whether the information will have practical utility; (b) the accuracy of FSIS's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques, or other forms of information technology. Comments may be sent to both FSIS, at the addresses provided above, and the Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget, Washington, DC 20253.

Responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.Start Printed Page 92774

Additional Public Notification

Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this Federal Register publication on-line through the FSIS Web page located at:​federal-register.

FSIS also will make copies of this publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to our constituents and stakeholders. The Update is available on the FSIS Web page. Through the Web page, FSIS is able to provide information to a much broader, more diverse audience. In addition, FSIS offers an email subscription service which provides automatic and customized access to selected food safety news and information. This service is available at:​subscribe. Options range from recalls to export information, regulations, directives, and notices. Customers can add or delete subscriptions themselves, and have the option to password protect their accounts.

USDA Non-Discrimination Statement

No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.

How To File a Complaint of Discrimination

To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at​sites/​default/​files/​docs/​2012/​Complain_​combined_​6_​8_​12.pdf, or write a letter signed by you or your authorized representative.

Send your completed complaint form or letter to USDA by mail, fax, or email:

Mail: U.S. Department of Agriculture, Director, Office of Adjudication, 1400 Independence Avenue SW., Washington, DC 20250-9410, Fax: (202) 690-7442, Email:

Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.), should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).

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Done at Washington, DC, on December 15, 2016.

Alfred V. Almanza,

Acting Administrator.

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[FR Doc. 2016-30599 Filed 12-19-16; 8:45 am]