supporting statement A Focus Groups for Lm at Retail.03202019

SUPPORTING STATEMENT JUSTIFICATION FOR

STAKEHOLDER INPUT ON FEDERAL OUTREACH TO CONTROL LISTERIA MONOCYTOGENES AT RETAIL

1. Circumstances Making Collection Of Information Necessary:

This is a request for a new information collection on outreach efforts related to retail best practices to control Listeria monocytogenes (Lm) in retail delicatessens

The Food Safety and Inspection Service (FSIS) has been delegated the authority to exercise the functions of the Secretary as provided in the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (EPIA) (21 U.S.C. 1031 et seq.). These statutes mandate that FSIS protect the public by ensuring that meat, poultry, and egg products are safe, wholesome, unadulterated, and properly labeled and packaged.

FSIS intends to collect information from stakeholders from industry, State and public health and agriculture departments with responsibilities for retail food safety, local health departments, and grocers to gather information on FSIS outreach efforts related to retail best practices to control Listeria monocytogenes (Lm) in retail delicatessens. The purpose of this information collection is to enhance Federal outreach and interagency coordination to control Lm at retail.

2. How, By Whom and Purpose Information Is To Be Used:

The following is a discussion of the information collection activities.

To gather feedback to enhance Federal outreach and interagency coordination to control Lm at retail, FSIS, in collaboration with the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), will conduct focus groups with a sample of stakeholders from industry, state and local public health and agriculture departments, and retail delicatessens. In the focus groups, a sample of stakeholders will be invited to provide input on the awareness and usefulness of existing outreach materials and tools related to best practices for controlling Lm in delicatessens, how they currently receive this type of information (e.g., from FSIS, FDA, CDC, State Health department, Cooperative Extension), and how those channels of communication could be improved.

The Interagency Retail Lm Work Group (FSIS, FDA and CDC) is collaborating and has identified specific criteria for participants in each of the 30 focus groups. Key leadership personnel from FSIS, FDA and CDC are working with officials from the Association for Food and Drug Officials (AFDO), Association of State and Territorial Health Officials (ASTHO), American Frozen Food Institute (AFFI), Federal Marketing Institute (FMI), National Grocers Association (NGA), National Environmental Health Association (NEHA), National Association of County and City Health Officials (NACCHO), and National Association of State Departments of Agriculture (NASDA) to identify appropriate participants. Each association was selected based on the role of their member, which aligns with the criteria for the focus groups. Please see the attachment “Focus Group Background Plan” for a list of the respondent types and the recruitment criteria. Once the appropriate participants are identified, FSIS will send a letter confirming their participation. FSIS's Office of Planning, Analysis, and Risk Management will facilitate the groups using the online platform, Adobe Connect, which allows users to connect via computer and phone to the group. This will eliminate the need for travel by the participants. There will be a total of 30 focus groups, approximately 6-8 participants per focus group, with each session lasting approximately 1.5 hours.

In the focus groups, the participants will be invited to provide input on the awareness and usefulness of existing outreach materials and tools related to best practices for controlling Lm in delicatessens, how they currently receive this type of information (e.g., from FSIS, FDA, CDC, State Health department, Cooperative Extension), and how those channels of communication could be improved.

FSIS's Office of Planning, Analysis, and Risk Management will analyze and summarize the data, and provide it to the interagency team (FSIS, FDA, and CDC) for further consideration to enhance Federal outreach and interagency coordination to control Lm at retail. This feedback will help FSIS, FDA and CDC better understand the information needs of State public health and agriculture departments with retail food safety responsibilities, local health departments, and retail delicatessens, how these stakeholders currently get information used to guide retail food safety efforts, and provide feedback on the usefulness and practicality of current FSIS outreach (e.g., tools and communication) to support control of Lm in retail delicatessens. The feedback collected from participants may also include practical recommendations for improving Federal communications and outreach efforts to support the control of Lm at retail moving forward.

3. Use Of Improved Information Technology:

To provide information to interpret the study findings, the focus groups will be digitally recorded, and the audio-recordings will be transcribed. No electronic copies of the questions will be provided to the participants before the focus group discussions.

4. Efforts To Identify Duplication:

FSIS has determined that this information collection will not duplicate any other information collections. There is no other available information that can be used or modified.

5. Methods To Minimize Burden On Small Business Entities:

Data requested of small businesses will be the same as for large ones. FSIS estimates that 80 small businesses will participate in the focus group studies.

6. Consequences If Information Were Collected Less Frequently:

FSIS does not currently obtain data of this type and scope from this population.

7. Circumstances That Would Cause The Information Collection To Be Conducted In A Different Manner:

• requiring respondents to report informa­tion to the agency more often than quarterly;

• requiring respondents to prepare a writ­ten response to a collection of infor­ma­tion in fewer than 30 days after receipt of it;

• requiring respondents to submit more than an original and two copies of any docu­ment;

• requiring respondents to retain re­cords, other than health, medical, governm­ent contract, grant-in-aid, or tax records for more than three years;

• in connection with a statisti­cal sur­vey, that is not de­signed to produce valid and reli­able results that can be general­ized to the uni­verse of study;

• requiring the use of a statis­tical data classi­fication that has not been re­vie­wed and approved by OMB;

• that includes a pledge of confiden­tiali­ty that is not supported by au­thority estab­lished in statute or regu­la­tion, that is not sup­ported by dis­closure and data security policies that are consistent with the pledge, or which unneces­sarily impedes shar­ing of data with other agencies for com­patible confiden­tial use; or

• requiring respondents to submit propri­etary trade secret, or other confidential information unless the agency can demon­strate that it has instituted procedures to protect the information's confidentiality to the extent permit­ted by law.

The information collection activities in this submission are consistent with the guidelines in 5 CFR 1320.6.

8. Consultation With Persons Outside The Agency:

In accordance with the Paperwork Reduction Act, FSIS published a 60-day notice, Notice of Request for a New Information Collection (Stakeholder Input on Federal Outreach to Control Listeria Monocytogenes at Retail) on November 20, 2018, (83 FR 58525). The Agency received no relevant comments. FSIS also contacted John Luker (518-457-5382; Association of Food and Drug Officials), Abraham Kulungara (571-527-3154; Association of State and Territorial Health Officials), Haley Oliver (765-491-4775, Purdue University/Cooperative Extension), and Donald Schaffner (848-932-5411, Rutgers University) to request input on the Agency’s burden estimate. All four individuals agreed with the Agency’s burden estimate of 90 minutes to participate in a focus group. Therefore, the Agency is making no change to the estimated time for completion.

 

9. Payment or Gifts to Respondents:

Respondents will not receive any gifts or payments.

10. Confidentiality Provided To Respondents:

No assurances other than routine protection provided under the Freedom of Information Act have been provided to respondents.

11. Questions Of A Sensitive Nature:

The applicants are not asked to furnish any information of a sensitive nature.

12. Estimate of Burden

The total burden estimate associated with this information collection is 240 hours. The total number of respondents is 240.

The Agency estimates that 240 focus group participants will respond 1 time annually, taking 105 minutes each, to supply the information regarding FSIS outreach efforts related to retail best practices to control Listeria monocytogenes (Lm) in retail delicatessens for a total of 420 hours.

Listeria monocytogenes at retail focus groups

Type of Establish- Ment	No. of Respon-dents	No. of Responses per Respondent	Total Annual Responses	Time for Response in Mins.	Total Annual Time in Hours
Stakeholders	240	1	1	105	420

The cost to the respondents is estimated at $78.73 annually. The Agency estimates that it will cost respondents $44.99 an hour, including fringe benefits, in fulfilling these paperwork requirements. Respondents will spend an annual total of 1.75 hours and $78.73. The hourly rate for the respondents was attained from the Department of Labor Bureau of Labor and Statistics wage data, May, 2017.

13. Capital and Start-up Cost and Subsequent Maintenance

There are no capital and start-up costs and subsequent maintenance burdens.

14. Annual Cost To Federal Government:

The cost to the Federal Government for these information collection requirements is $79,632.30 annually. The costs arise primarily from the time spent by FSIS staff developing and administering the focus group questions, as well as analyzing and reporting the data. The Agency estimates a cost of $44.99 per hour, including fringe benefits, for the FSIS staff.

15. Reasons For Changes In Burden:

This is a new information collection.

16. Tabulation, Analyses And Publication Plans:

FSIS will present the results to public health partners, such as local, state, and federal agency employees.

17. OMB Approval Number Display:

FSIS will display the OMB approval number on the focus group questions and any documents shared relating to this data collection.

18. Exceptions to the Certification:

There are no exceptions to the certification.

Page 6