Surveillance Sampling Outreach

APPENDIX A

SURVEILLANCE SAMPLING OUTREACH QUESTIONNAIRE

Generic FDA Rapid Response Surveys

OMB No. 0910-0500

Expiration Date: 09/30/2020

Listeria monocytogenes and E. coli in Bagged Salad

Hello. Thank you for agreeing to meet with us today to work on the prevention of possible future foodborne illnesses. We will ask you a series of questions to determine how the FDA and industry can help prevent foodborne illnesses. The Food Safety Modernization Act is based on preventing problems before they happen, rather than solely responding to outbreaks of foodborne illness. However, in order to develop prevention-based systems, we need data and other information to help identify hazards that must be addressed and minimized before they happen. That is why we are meeting with you today to help us to identify patterns that may help predict and prevent future contamination by disease-causing bacteria.

FDA is meeting with several industry representatives to gather feedback on upcoming sampling assignments. The questions asked will be reviewed by FDA staff, followed up, and communicated to your industry when the information collection has been completed.

There are two hazard/commodity pairs that FDA intends to investigate, and the questions for each pair are listed below. Your moderator will ask you questions in your area of expertise, and collect your answers during the session.

Thank you for agreeing to participate in this most worthwhile effort.

The two hazard/commodity pairs are:

1. Listeria monocytogenes and E. coli in Bagged Salad

2. Norovirus and Hepatitis A in Frozen Berries

The first questionnaire deals with listeria monocytogenes, salmonella, and E. coli in Bagged Salad.

Questionnaire 1 - Listeria monocytogenes and E. coli in Bagged Salad

1. Overall, are you satisfied with the way the U.S. FDA performed the external outreach for the upcoming future sampling plans?

2. Before this call have you heard of the sampling activities conducted by the U.S. FDA?

3. Where did you hear, read or see information about the sampling activities?

4. Based on the information we shared with you today related to proposed future sampling plans, please provide your recommendations on how to increase efficiency of the sample collection (for both industry and regulators).

5. Based on the information we shared with you today related to proposed future sampling plans, please provide your input on any anticipated challenges with sample collection for this particular assignment and/or commodities.

6. Based on the information we shared with you today related to proposed future sampling plans, please provide your input on existing sampling information or research related to these commodities (including academia, industry, state sampling) that we could take into account to make the upcoming sampling assignments more effective and efficient.

7. Based on the information we shared with you today related to proposed future sampling plans and your current knowledge of the industry, please provide feedback on additional factors that we should take into account when reviewing the results of this assignment (e.g. domestic/import, country/state, season, variety).

8. Based on the information we shared with you today related to proposed future sampling plans, please provide feedback on any food safety initiatives or industry practices specific to these commodities (e.g. marketing order).

9. Based on your current knowledge of the industry, please provide input on additional groups/organizations that you are aware of that we should include in this survey and for future outreach.

To see the stakeholder lists developed for purposes of this outreach, please see Appendix B.

Norovirus and Hepatitis A in Frozen Berries

Hello. Thank you for agreeing to meet with us today to work on the prevention of possible future foodborne illnesses. We will ask you a series of questions to determine how the FDA and industry can help prevent foodborne illnesses. The Food Safety Modernization Act is based on preventing problems before they happen, rather than solely responding to outbreaks of foodborne illness. However, in order to develop prevention-based systems, we need data and other information to help identify hazards that must be addressed and minimized before they happen. That is why we are meeting with you today to help us to identify patterns that may help predict and prevent future contamination by disease-causing bacteria.

FDA is meeting with several industry representatives to gather feedback on upcoming sampling assignments. The questions asked will be reviewed by FDA staff, followed up, and communicated to your industry when the information collection has been completed.

There are two hazard/commodity pairs that FDA intends to investigate, and the questions for each pair are listed below. Your moderator will ask you questions in your area of expertise, and collect your answers during the session.

Thank you for agreeing to participate in this most worthwhile effort.

The two hazard/commodity pairs are:

1. Listeria monocytogenes, Salmonella, and E. coli in Bagged Salad

2. Norovirus and Hepatitis A in Frozen Berries

Questionnaire 2 - Norovirus and Hepatitis A in Frozen Berries

1. Overall, are you satisfied with the way the U.S. FDA performed the external outreach for the upcoming future sampling plans?

2. Before this call have you heard of the sampling activities conducted by the U.S. FDA?

3. Where did you hear, read or see information about the sampling activities?

4. Based on the information we shared with you today related to proposed future sampling plans, please provide your recommendations on how to increase efficiency of the sample collection (for both industry and regulators).

5. Based on the information we shared with you today related to proposed future sampling plans, please provide your input on any anticipated challenges with sample collection for this particular assignment and/or commodities.

6. Based on the information we shared with you today related to proposed future sampling plans, please provide your input on existing sampling information or research related to these commodities (including academia, industry, state sampling) that we could take into account to make the upcoming sampling assignments more effective and efficient.

7. Based on the information we shared with you today related to proposed future sampling plans and your current knowledge of the industry, please provide feedback on additional factors that we should take into account when reviewing the results of this assignment (e.g. domestic/import, country/state, season, variety).

8. Based on the information we shared with you today related to proposed future sampling plans, please provide feedback on any food safety initiatives or industry practices specific to these commodities (e.g. marketing order).

9. Based on your current knowledge of the industry, please provide input on additional groups/organizations that you are aware of that we should include in this survey and for future outreach.

To see the stakeholder lists developed for purposes of this outreach, please see Appendix B.