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Federal Register / Vol. 86, No. 231 / Monday, December 6, 2021 / Proposed Rules
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www.regulations.gov. References without asterisks are not on public display at https www.regulations.gov because they have copyright restriction.
Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. FDA
has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time.
1. FDA, FDA Considering Simplifying Agricultural Water Standards, 2017.
Available at: http wayback.archiveit.org/org-1137/20180908124905/https
www.fda.gov/Food/GuidanceRegulation/
FSMA/ucm546089.htm.
2. Collaborative Food Safety Forum, Agricultural Water Standards and Testing Protocols: Summary, November 11, 2017.
3. Wall, G., D. Clements, C. Fisk, et al., Meeting Report: Key Outcomes from a Collaborative Summit on Agricultural Water Standards for Fresh Produce.
Comprehensive Reviews in Food Science and Food Safety 18, no. 3 2019: 723
737.
4. Assar, S., Memorandum to the File Summary of Stakeholder Questions and Feedback on the Agricultural Water Requirements for Produce Other than Sprouts Received During Educational Farm Visits in 2018. October 5, 2021, FDA.
5. Comment from California Walnut Commission, posted December 5, 2017, to Docket No. FDA2017N5094.
Available at https www.regulations.gov, Comment ID FDA2017N50940007.
6. Comment from Western Agricultural Processors Association, dated December 6, 2017, to Docket No. FDA2017N
5094. Available at https
www.regulations.gov, Comment ID FDA
2017N50940014.
7. Comment from California Farm Bureau Federation, dated December 7, 2017, to Docket No. FDA2017N5094.
Available at https www.regulations.gov, Comment ID FDA2017N50940015.
8. Comment from Western Agricultural Processors Association, dated December 6, 2017, to Docket No. FDA2017N
5094. Available at https
www.regulations.gov, Comment ID FDA
2017N50940017.
9. Comment from Produce Marketing Association et al., dated February 5, 2018, to Docket No. FDA2017N5094.
Available at https www.regulations.gov, Comment ID FDA2017N50940043.
10. Comment from California Farm Bureau Federation, dated February 5, 2018, to Docket No. FDA2017N5094.
Available at https www.regulations.gov, Comment ID FDA2017N50940070.
11. FDA, Qualitative Assessment of Risk to Public Health from On-Farm Contamination of Produce, 2015.
Available at: https www.fda.gov/media/
116766/download.
12. FDA, Environmental Assessment of Factors Potentially Contributing to the
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Contamination of Romaine Lettuce Implicated in a Multi-State Outbreak of E. coli O157:H7, November 1, 2018.
Available at: https www.fda.gov/food/
outbreaks-foodborne-illness/
environmental-assessment-factorspotentially-contributing-contaminationromaine-lettuce-implicated.
13. Gerrity, K., Memorandum to the File on the Environmental Assessment; Yuma 2018 E. coli O157:H7 Outbreak Associated with Romaine Lettuce.
October 24, 2018. FDA. Available at:
https www.fda.gov/media/117512/
download.
14. FDA, Letter to State Agriculture Officials and the Leafy Greens Industry Concerning the Environmental Assessment, November 1, 2018.
Available at: https www.fda.gov/media/
117511/download.
15. FDA, Investigation Summary: Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in the Fall 2018 Multi-State Outbreak of E. coli O157:H7, February 13, 2019. Available at: https
www.fda.gov/food/outbreaks-foodborneillness/investigation-summary-factorspotentially-contributing-contaminationromaine-lettuce-implicated-fall.
16. FDA, Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in the Three Outbreaks of E.
coli O157:H7 During the Fall of 2019, May 21, 2020. Available at: https
www.fda.gov/food/outbreaks-foodborneillness/factors-potentially-contributingcontamination-romaine-lettuceimplicated-three-outbreaks-e-coli.
17. FDA, Factors Potentially Contributing to the Contamination of Leafy Greens Implicated in the Fall 2020 Outbreak of E. coli O157:H7, April 6, 2021.
Available at: https www.fda.gov/food/
outbreaks-foodborne-illness/factorspotentially-contributing-contaminationleafy-greens-implicated-fall-2020outbreak-e-coli.
18. FDA, Investigation Report: Factors Potentially Contributing to the Contamination of Red Onions Implicated in the Summer 2020 Outbreak of Salmonella Newport, May 13, 2021.
Available at: https www.fda.gov/food/
foodborne-pathogens/factors-potentiallycontributing-contamination-red-onionsimplicated-summer-2020-outbreaksalmonella.
19. California Food Emergency Response Team, Investigation of an Escherichia coli O157:H7 Outbreak Associated with Dole Pre-Packaged Spinach, March 21, 2007. Available at: https
www.marlerblog.com/files/2013/02/
2006_Spinach_Report_Final_01.pdf.
20. Jay, M.T., M. Cooley, D. Carychao, et al., Escherichia coli O157:H7 in Feral Swine Near Spinach Fields and Cattle, Central California Coast. Emerging Infectious Diseases 13, no. 12 2007:
19081911.
21. California Food Emergency Response Team, Investigation of the Taco Johns Escherichia coli O157:H7 Outbreak Associated with Iceberg Lettuce, February 15, 2008.

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22. Behravesh, C.B., R.K. Mody, J. Jungk, et al., 2008 Outbreak of Salmonella Saintpaul Infections Associated with Raw Produce. The New England Journal of Medicine 364, no. 10 2011: 918927.
23. Greene, S.K., E.R. Daly, E.A. Talbot, et al., Recurrent Multistate Outbreak of Salmonella Newport Associated with Tomatoes from Contaminated Fields, 2005. Epidemiology & Infection 136, no.
2 2008: 157165.
24. Batz, M.B., L.C. Richardson, M.C.
Bazaco, et al., A Recency-Weighted Statistical Modeling Approach to Attribute Illnesses caused by 4 Pathogens to Food Sources Using Outbreak Data, United States. Emerging Infectious Diseases 27, no. 1 2021: 214222.
25. Interagency Food Safety Analytics Collaboration, Foodborne Illness Source Attribution Estimates for 2019 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter Using Multi-Year Outbreak Surveillance Data, October 2021. Available at: https www.cdc.gov/
foodsafety/ifsac/pdf/P19-2019-reportTriAgency-508.pdf?utm_
medium=email&utm_
source=govdelivery.
26. Richardson, L.C., M.C. Bazaco, C.C.
Parker, et al., An Updated Scheme for Categorizing Foods Implicated in Foodborne Disease Outbreaks: A TriAgency Collaboration. Foodborne Pathogens and Disease 14, no. 12 2017:
701710.
27. FDA Food Traceability Workgroup, Memorandum for the RecordFood Traceability List for Requirements for Additional Traceability Records for Certain Foods Proposed Rule 2020.
August 12, 2020. Available at: https
www.fda.gov/media/142283/download.
28. FDA Food Traceability Workgroup, Memorandum for the Record Designation of the Food Traceability List Using the Risk-Ranking Model for Food Tracing 2020 version. September 2, 2020. Available at: https www.fda.gov/
media/142282/download.
29. FDA, Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs:
Guidance for Industry, January 2018.
Available at: https www.fda.gov/
regulatory-information/search-fdaguidance-documents/guidance-industrypolicy-regarding-certain-entities-subjectcurrent-good-manufacturing-practiceand.
30. USDA National Organic Program, Guidance: The Use of Chlorine Materials in Organic Production and Handling, July 22, 2011. Available at:
https www.ams.usda.gov/sites/default/
files/media/5026.pdf.
31. Western Growers, Appendix A: Ag Water System Assessments and Remediation Guidelines, December 12, 2019. Available at: https lgmaassets.sfo2.digitaloceanspaces.com/
downloads/Appendix_A.pdf.
32. FDA, Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards
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