id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id FDA-2021-N-0471-0422,FDA,FDA-2021-N-0471,Tab C-FRIA-OMB Final Version,Supporting & Related Material,Background Material,2024-11-05T05:00:00Z,2024,11,,,2024-11-05T16:16:54Z,,0,0,09000064867fd9a1 FDA-2021-N-0471-0420,FDA,FDA-2021-N-0471,Tab A-FRIA-OMB Original Version,Supporting & Related Material,Background Material,2024-11-05T05:00:00Z,2024,11,,,2024-11-05T16:16:47Z,,0,0,09000064867fd99d FDA-2021-N-0471-0418,FDA,FDA-2021-N-0471,Tab B-Final Rule-Comparison OMB Original to Final Version,Supporting & Related Material,Background Material,2024-11-05T05:00:00Z,2024,11,,,2024-11-05T16:16:38Z,,0,0,09000064867fd99e FDA-2021-N-0471-0416,FDA,FDA-2021-N-0471,Memorandum to FDA DMS on Agricultural Water Final Rule (Docket No. FDA-2021-N-0471),Supporting & Related Material,Background Material,2024-11-05T05:00:00Z,2024,11,,,2024-11-05T16:16:24Z,,0,0,09000064867fd99b FDA-2021-N-0471-0421,FDA,FDA-2021-N-0471,Tab B-FRIA-Comparison OMB Original to Final Version,Supporting & Related Material,Background Material,2024-11-05T05:00:00Z,2024,11,,,2024-11-05T16:16:51Z,,0,0,09000064867fd99f FDA-2021-N-0471-0417,FDA,FDA-2021-N-0471,Tab A-Final Rule-OMB Original Version,Supporting & Related Material,Background Material,2024-11-05T05:00:00Z,2024,11,,,2024-11-05T16:16:31Z,,0,0,09000064867fd99c FDA-2021-N-0471-0419,FDA,FDA-2021-N-0471,Tab C-Final Rule-OMB Final Version,Supporting & Related Material,Background Material,2024-11-05T05:00:00Z,2024,11,,,2024-11-05T16:16:42Z,,0,0,09000064867fd9a0 FDA-2021-N-0471-0415,FDA,FDA-2021-N-0471,Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals,Notice,Notice of Approval,2024-06-21T04:00:00Z,2024,6,2024-06-21T04:00:00Z,,2024-06-21T13:30:39Z,2024-13638,0,0,09000064865c2a1c FDA-2021-N-0471-0412,FDA,FDA-2021-N-0471,"FRIA Reference 19 - Brown C and Sassi A. Email Communication on the Updated Version of the Outbreaks Database. November 20, 2020",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:20:09Z,,0,0,0900006486541952 FDA-2021-N-0471-0342,FDA,FDA-2021-N-0471,"Reference 39 - California Department of Food and Agriculture and Monterey County Farm Bureau, “California Agricultural Neighbors: Neighbor-to-neighbor best practices to help enhance localized food safety efforts,” June 2022",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:02:17Z,,0,0,0900006486535b6c FDA-2021-N-0471-0349,FDA,FDA-2021-N-0471,"Reference 46 - Chhetri, et al., “Effect of Surrounding Vegetation on Microbial Survival or Die-Off on Watermelon Surface in an Agriculture Setting”",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:03:50Z,,0,0,0900006486535b9b FDA-2021-N-0471-0358,FDA,FDA-2021-N-0471,"Reference 55 - FDA, “FDA Partners with the University of Arizona, Wellton-Mohawk Irrigation and Drainage District, and Yuma Area Leafy Greens Stakeholders to Enhance Food Safety,” September 23, 2019",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:05:31Z,,0,0,0900006486535c03 FDA-2021-N-0471-0388,FDA,FDA-2021-N-0471,"Reference 85 - FDA, “Determining Regulatory Authority for Antimicrobial Substances,” December 14, 2017",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:13:25Z,,0,0,09000064865393f9 FDA-2021-N-0471-0371,FDA,FDA-2021-N-0471,"Reference 68 - Uyttendaele, et al., “Microbial Hazards in Irrigation Water: Standards, Norms, and Testing to Manage Use of Water in Fresh Produce Primary Production”",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:08:28Z,,0,0,090000648653cb66 FDA-2021-N-0471-0383,FDA,FDA-2021-N-0471,"Reference 80 - Murray, et al., “Challenges in the microbiological food safety of fresh produce: Limitations of post-harvest washing and the need for alternative interventions,” Food Quality and Safety 1",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:12:03Z,,0,0,09000064865393dc FDA-2021-N-0471-0390,FDA,FDA-2021-N-0471,"Reference 87 - FDA, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water: Supplement to the Finding of No Significant Impact,” July 1, 2022",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:13:58Z,,0,0,09000064865393fb FDA-2021-N-0471-0374,FDA,FDA-2021-N-0471,"Reference 71 - Muirhead, R. W., R. J. Davies-Colley, A. M. Donnison, et al., “Faecal Bacteria Yields in Artificial Flood Events: Quantifying In-Stream Stores.” Water Research 38 (2004)",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:09:13Z,,0,0,090000648653cb69 FDA-2021-N-0471-0326,FDA,FDA-2021-N-0471,"Reference 23 - FDA, “Investigation Report: Factors Potentially Contributing to the Contamination of Red Onions Implicated in the Summer 2020 Outbreak of Salmonella Newport,” May 13, 2021",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T13:55:41Z,,0,0,090000648653601a FDA-2021-N-0471-0308,FDA,FDA-2021-N-0471,"Reference 5 - Draper, et al., ""Microbial Survey of Pennsylvania Surface Water Used for Irrigating Produce Crops""",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T13:37:54Z,,0,0,0900006486531fcb FDA-2021-N-0471-0317,FDA,FDA-2021-N-0471,"Reference 14 - Antaki, et al., “Low Concentration of Salmonella enterica and Generic Escherichia coli in Farm Ponds and Irrigation Distribution Systems Used for Mixed Produce Production in Southern Georgia”",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T13:43:25Z,,0,0,090000648653204c FDA-2021-N-0471-0398,FDA,FDA-2021-N-0471,"FRIA Reference 5 - FDA, Requirements for Additional Traceability Records for Certain Foods Final Regulatory Impact Analysis (FRIA). 2022",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:16:17Z,,0,0,0900006486541944 FDA-2021-N-0471-0401,FDA,FDA-2021-N-0471,"FRIA Reference 8 - FDA, Analysis of Economic Impacts - Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption (FRIA). 2015",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:17:07Z,,0,0,0900006486541947 FDA-2021-N-0471-0337,FDA,FDA-2021-N-0471,"Reference 34 - Interagency Food Safety Analytics Collaboration, “Foodborne Illness Source Attribution Estimates for 2020 for Salmonella, Escherichia coli O157, and Listeria monocytogenes Using Multi-Year, Outbreak Surveillance Data,” November 2022",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:01:04Z,,0,0,0900006486535b35 FDA-2021-N-0471-0367,FDA,FDA-2021-N-0471,"Reference 64 - Crawford, Baloch, and Gerrity, “Environmental Assessment: Non-O157 Shiga Toxin-Producing E. coli (STEC): Findings and Potential Preventive Control Strategies,” December 2010",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:07:29Z,,0,0,0900006486535c3f FDA-2021-N-0471-0391,FDA,FDA-2021-N-0471,"Reference 88 - FDA, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water, Preliminary Regulatory Impact Analysis, Initial Regulatory Flexibility Analysis, Unfunded Mandates Reform Act Analysis,” 2021",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:14:08Z,,0,0,09000064865393fc FDA-2021-N-0471-0356,FDA,FDA-2021-N-0471,"Reference 53 - FDA, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water: Supplement to the Finding of No Significant Impact,” April 22, 2024",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:05:11Z,,0,0,0900006486535bea FDA-2021-N-0471-0325,FDA,FDA-2021-N-0471,"Reference 22 - FDA, “Factors Potentially Contributing to the Contamination of Leafy Greens Implicated in the Fall 2020 Outbreak of E. coli O157:H7,” April 6, 2021",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T13:55:31Z,,0,0,0900006486535dc0 FDA-2021-N-0471-0408,FDA,FDA-2021-N-0471,FRIA Reference 15 - Consumer Federation of America. Foodborne Illness: Another Way the Poor Pay More. 2020,Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:19:19Z,,0,0,090000648654194e FDA-2021-N-0471-0314,FDA,FDA-2021-N-0471,"Reference 11 - Partyka, et al., “Spatiotemporal Variability in Microbial Quality of Western US Agricultural Water Supplies: A Multistate Study”",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T13:42:24Z,,0,0,0900006486532026 FDA-2021-N-0471-0359,FDA,FDA-2021-N-0471,"Reference 56 - FDA, “FDA Partners with the California Department of Food and Agriculture, Western Center for Food Safety, and California Agricultural Stakeholders to Enhance Food Safety,” November 19, 2020",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:05:40Z,,0,0,0900006486535c04 FDA-2021-N-0471-0384,FDA,FDA-2021-N-0471,"Reference 81 - Olaimat and Holley, “Factors Influencing the Microbial Safety of Fresh Produce: A Review”",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:12:33Z,,0,0,09000064865393dd FDA-2021-N-0471-0310,FDA,FDA-2021-N-0471,"Reference 7 - Havelaar, et al., “Evaluating the U.S. Food Safety Modernization Act Produce Safety Rule Standard for Microbial Quality of Agricultural Water for Growing Produce”",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T13:38:30Z,,0,0,0900006486531fd1 FDA-2021-N-0471-0311,FDA,FDA-2021-N-0471,"Reference 8 - Lothrop, et al., ""Optimal strategies for monitoring irrigation water quality""",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T13:38:39Z,,0,0,090000648653201f FDA-2021-N-0471-0315,FDA,FDA-2021-N-0471,"Reference 12 - Harris, et al., “Impact of storm runoff on Salmonella and Escherichia coli prevalence in irrigation ponds of fresh produce farms in southern Georgia”",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T13:42:38Z,,0,0,0900006486532027 FDA-2021-N-0471-0335,FDA,FDA-2021-N-0471,"Reference 32 - Howell, Coyne, and Cornelius, ""Fecal Bacteria in Agricultural Waters of the Bluegrass Region of Kentucky""",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:00:36Z,,0,0,0900006486535adb FDA-2021-N-0471-0341,FDA,FDA-2021-N-0471,"Reference 38 - Monterey County Farm Bureau, “California Agricultural Neighbors,” 2022",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:02:07Z,,0,0,0900006486535b39 FDA-2021-N-0471-0344,FDA,FDA-2021-N-0471,"Reference 41 - Rothrock, et al., “Pastured Poultry Production in the United States: Strategies to Balance System Sustainability and Environmental Impact”",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:02:36Z,,0,0,0900006486535b73 FDA-2021-N-0471-0346,FDA,FDA-2021-N-0471,"Reference 43 - Jay-Russell, “What is the Risk From Wild Animals in Food-Borne Pathogen Contamination of Plants?”",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:02:55Z,,0,0,0900006486535b75 FDA-2021-N-0471-0347,FDA,FDA-2021-N-0471,"Reference 44 - FDA, “FDA and USDA announce key step to advance collaborative efforts to streamline produce safety requirements for farmers,” June 5, 2018",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:03:06Z,,0,0,0900006486535b98 FDA-2021-N-0471-0350,FDA,FDA-2021-N-0471,"Reference 47 - Chhetri, et al., “Attachment Strength and On-Farm Die-Off Rate of Escherichia coli on Watermelon Surfaces”",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:03:59Z,,0,0,0900006486535b9d FDA-2021-N-0471-0351,FDA,FDA-2021-N-0471,"Reference 48 - Weller, D. L., J. Kovac, S. Roof, et al., “Survival of Escherichia coli on Lettuce under Field Conditions Encountered in the Northeastern United States”",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:04:09Z,,0,0,0900006486535ba0 FDA-2021-N-0471-0355,FDA,FDA-2021-N-0471,"Reference 52 - FDA, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water: Finding of No Significant Impact,” November 9, 2021",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:04:47Z,,0,0,0900006486535be9 FDA-2021-N-0471-0360,FDA,FDA-2021-N-0471,"Reference 57 - California Food Emergency Response Team, “Investigation of an Escherichia coli O157:H7 Outbreak Associated with Dole Pre-Packaged Spinach,” March 21, 2007",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:05:50Z,,0,0,0900006486535c09 FDA-2021-N-0471-0322,FDA,FDA-2021-N-0471,"Reference 19 - Gerrity, “Memorandum to the File on the Environmental Assessment; Yuma 2018 E. coli O157:H7 Outbreak Associated with Romaine Lettuce.” October 24, 2018",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T13:45:37Z,,0,0,0900006486532060 FDA-2021-N-0471-0333,FDA,FDA-2021-N-0471,"Reference 30 - Cooley, et al., ""Incidence and Tracking of Escherichia coli O157:H7 in a Major Produce Production Region in California""",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T13:59:06Z,,0,0,0900006486535ad9 FDA-2021-N-0471-0331,FDA,FDA-2021-N-0471,"Reference 28 - Gauthier, F., and F. Archibald, ""The Ecology of ""Fecal Indicator"" Bacteria Commonly Found in Pulp and Paper Mill Water Systems""",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T13:58:48Z,,0,0,090000648653624a FDA-2021-N-0471-0352,FDA,FDA-2021-N-0471,"Reference 49 - Belias, et al., “Effect of Weather on the Die-Off of Escherichia coli and Attenuated Salmonella enterica Serovar Typhimurium on Preharvest Leafy Greens following Irrigation with Contaminated Water”",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:04:19Z,,0,0,0900006486535ba1 FDA-2021-N-0471-0381,FDA,FDA-2021-N-0471,"Reference 78 - FDA, “Equivalent Testing Methodology for Agricultural Water,” 2024",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:10:39Z,,0,0,09000064865393da FDA-2021-N-0471-0386,FDA,FDA-2021-N-0471,"Reference 83 - FDA, “FDA Updates Protocol for the Development and Registration of Treatments for Preharvest Agricultural Water,” January 6, 2023",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:13:06Z,,0,0,09000064865393df FDA-2021-N-0471-0402,FDA,FDA-2021-N-0471,"FRIA Reference 9 - EPA, 2012 Recreational Water Quality Criteria. 2012",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:17:23Z,,0,0,0900006486541948 FDA-2021-N-0471-0407,FDA,FDA-2021-N-0471,"FRIA Reference 14 - McCrickard, Crim, Kim, Bowen, Disparities in severe shigellosis among adults—Foodborne diseases active surveillance network, 2002-2014. 2018",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:19:08Z,,0,0,090000648654194d FDA-2021-N-0471-0410,FDA,FDA-2021-N-0471,"FRIA Reference 17 - Hadler, et al., Relationship Between Census Tract-Level Poverty and Domestically Acquired Salmonella Incidence: Analysis of Foodborne Diseases Active Surveillance Network Data, 2010-2016. 2020",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:19:43Z,,0,0,0900006486541950 FDA-2021-N-0471-0364,FDA,FDA-2021-N-0471,"Reference 61 - Assar, et al., “Memorandum to the File--Addendum to the September 16, 2014 Memo on the Review of Microbial Decay Constants Reported in Field Trials of Contaminated Produce,” October 30, 2015",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2025-02-09T08:24:30Z,,0,0,0900006486535c3c FDA-2021-N-0471-0320,FDA,FDA-2021-N-0471,"Reference 17 - FDA, “Qualitative Assessment of Risk to Public Health from On-Farm Contamination of Produce,” 2015",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T13:44:16Z,,0,0,090000648653204f FDA-2021-N-0471-0312,FDA,FDA-2021-N-0471,"Reference 9 - Goh, et al., ""Occurrence of microbial indicators, pathogenic bacteria and viruses in tropical surface waters subject to contrasting land use""",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T13:39:46Z,,0,0,0900006486532024 FDA-2021-N-0471-0318,FDA,FDA-2021-N-0471,"Reference 15 - Truitt, et al., “Microbial Quality of Agricultural Water Used in Produce Preharvest Production on the Eastern Shore of Virginia”",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T13:43:36Z,,0,0,090000648653204d FDA-2021-N-0471-0340,FDA,FDA-2021-N-0471,"Reference 37 - EPA, “Summary of the Clean Water Act,” 2022",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:01:46Z,,0,0,0900006486535b38 FDA-2021-N-0471-0343,FDA,FDA-2021-N-0471,"Reference 40 - Alegbeleye, Singleton, and Sant’Ana, “Sources and Contamination Routes of Microbial Pathogens to Fresh Produce During Field Cultivation: A Review”",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:02:27Z,,0,0,0900006486535b72 FDA-2021-N-0471-0348,FDA,FDA-2021-N-0471,"Reference 45 - FDA, “The FDA Concludes Voluntary Pilot Program to Evaluate Alignment of Third-Party Food Safety Standards with FSMA Rules,” October 30, 2023",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:03:40Z,,0,0,0900006486535b9a FDA-2021-N-0471-0379,FDA,FDA-2021-N-0471,"Reference 76 - EPA, “Report on the 2nd Five-Year Review of EPA’s Recreational Water Quality Criteria,” May 2023",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:10:01Z,,0,0,09000064865393d8 FDA-2021-N-0471-0375,FDA,FDA-2021-N-0471,"Reference 72 - Bach and Delaquis, “The Origin and Spread of Human Pathogens in Fruit Production Systems,” Microbial Safety of Fresh Produce",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:09:22Z,,0,0,090000648653cb6a FDA-2021-N-0471-0324,FDA,FDA-2021-N-0471,"Reference 21 - 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",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T13:55:20Z,,0,0,0900006486535dbe FDA-2021-N-0471-0323,FDA,FDA-2021-N-0471,"Reference 20 - 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",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T13:45:49Z,,0,0,0900006486532061 FDA-2021-N-0471-0336,FDA,FDA-2021-N-0471,"Reference 33 - 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",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:00:46Z,,0,0,0900006486535adc FDA-2021-N-0471-0368,FDA,FDA-2021-N-0471,"Reference 65 - World Health Organization and United Nations Environmental Programs. WHO Guidelines for the Safe Use of Wastewater, Excreta and Greywater. Geneva, Switzerland: WHO Press, 2006",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:07:42Z,,0,0,0900006486535ca3 FDA-2021-N-0471-0380,FDA,FDA-2021-N-0471,"Reference 77 - EPA, “Fact Sheet: Report on the 2nd Five-Year Review of EPA’s Recreational Water Quality Criteria,” May 2023",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:10:10Z,,0,0,09000064865393d9 FDA-2021-N-0471-0387,FDA,FDA-2021-N-0471,"Reference 84 - USDA National Organic Program, “Guidance: The Use of Chlorine Materials in Organic Production and Handling,” July 22, 2011",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:13:14Z,,0,0,09000064865393e0 FDA-2021-N-0471-0389,FDA,FDA-2021-N-0471,"Reference 86 - FDA, “FDA-State Produce Safety Implementation Cooperative Agreement Program,” July 4, 2022",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:13:49Z,,0,0,09000064865393fa FDA-2021-N-0471-0395,FDA,FDA-2021-N-0471,"FRIA Reference 2 - ERS, USDA, Before Implementation of the Food Safety Modernization Act's Produce Rule: A Survey of U.S. Produce Growers, 2018",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:15:10Z,,0,0,0900006486539400 FDA-2021-N-0471-0372,FDA,FDA-2021-N-0471,"Reference 69 - Gerba, “The Role of Water and Water Testing in Produce Safety,” Microbial Safety of Fresh Produce",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:08:55Z,,0,0,090000648653cb67 FDA-2021-N-0471-0378,FDA,FDA-2021-N-0471,"Reference 75 - Ravaliya, et al., “Memorandum to the File--Review of Water Quality Standards in Development of Proposed Microbial Standard in § 112.44(c) of the Proposed Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” September 16, 2014",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:09:52Z,,0,0,09000064865393d7 FDA-2021-N-0471-0369,FDA,FDA-2021-N-0471,"Reference 66 - Stine S. W., I. Song, C. Y. Choi et al., “Application of Microbial Risk Assessment to the Development of Standards for Enteric Pathogens in Water Used to Irrigate Fresh Produce”",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:08:09Z,,0,0,090000648653cb64 FDA-2021-N-0471-0330,FDA,FDA-2021-N-0471,"Reference 27 - Carrillo, M., E. Estrada, and T. C. Hazen, ""Survival and Enumeration of the Fecal Indicators Bifidobacterium adolescentis and E. coli in a Tropical Rain Forest Watershed""",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T13:58:40Z,,0,0,0900006486536248 FDA-2021-N-0471-0396,FDA,FDA-2021-N-0471,"FRIA Reference 3 - Biemiller, Brown, and Lasher, “Memorandum to the File—Agricultural Water Proposed Rule Expert Elicitation,” November 8, 2021",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:15:30Z,,0,0,0900006486539401 FDA-2021-N-0471-0403,FDA,FDA-2021-N-0471,"FRIA Reference 10 - U.S. Bureau of Labor Statistics, May 2022 National Occupational Employment and Wage Estimates United States, Farmers, Ranchers, and Other Agricultural Managers. 2023",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:17:43Z,,0,0,0900006486541949 FDA-2021-N-0471-0414,FDA,FDA-2021-N-0471,"FRIA Reference 21 - Scallan et al., Foodborne illness acquired in the United States—major pathogens",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:20:46Z,,0,0,0900006486541954 FDA-2021-N-0471-0413,FDA,FDA-2021-N-0471,"FRIA Reference 20 - Centers for Disease Control and Prevention, National Outbreak Reporting System (NORS). 2020",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:20:35Z,,0,0,0900006486541953 FDA-2021-N-0471-0362,FDA,FDA-2021-N-0471,"Reference 59 - FDA, “Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables,” October 1998",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:06:21Z,,0,0,0900006486535c39 FDA-2021-N-0471-0365,FDA,FDA-2021-N-0471,"Reference 62 - FDA, “Investigation Report: Factors Potentially Contributing to the Contamination of Packaged Leafy Greens Implicated in the Outbreak of Salmonella Typhimurium During the Summer of 2021,” 2022",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:06:54Z,,0,0,0900006486535c3d FDA-2021-N-0471-0392,FDA,FDA-2021-N-0471,"Reference 89 - Astill, et al., “Before Implementation of the Food Safety Modernization Act’s Produce Rule: A Survey of U.S. Produce Growers,” 2018",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:14:16Z,,0,0,09000064865393fd FDA-2021-N-0471-0376,FDA,FDA-2021-N-0471,"Reference 73 - Tallon, et al., “Microbial Indicators of Faecal Contamination in Water: A Current Perspective,” Water, Air, & Soil Pollution 166",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:09:33Z,,0,0,090000648653cb6b FDA-2021-N-0471-0329,FDA,FDA-2021-N-0471,"Reference 26 - FDA, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water, Final Regulatory Impact Analysis, Final Regulatory Flexibility Analysis, Unfunded Mandates Reform Act Analysis,” 2024",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T13:58:31Z,,0,0,0900006486536020 FDA-2021-N-0471-0328,FDA,FDA-2021-N-0471,"Reference 25 - FDA, “FDA Releases Spanish and English Paper-Based Versions of the Agricultural Water Assessment Builder Tool,” August 11, 2022",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T13:58:20Z,,0,0,090000648653601e FDA-2021-N-0471-0327,FDA,FDA-2021-N-0471,"Reference 24 - FDA, “FDA Launches Agricultural Water Assessment Builder to Help Farms Understand Agricultural Water Proposed Rule Requirements,” March 21, 2022",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T13:55:53Z,,0,0,090000648653601c FDA-2021-N-0471-0305,FDA,FDA-2021-N-0471,"Reference 2 - FDA, “FDA Considering Simplifying Agricultural Water Standards,” 2017",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T13:37:18Z,,0,0,0900006486531ba3 FDA-2021-N-0471-0306,FDA,FDA-2021-N-0471,"Reference 3 - Collaborative Food Safety Forum, “Agricultural Water Standards and Testing Protocols: Summary,” November 11, 2017",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T13:37:32Z,,0,0,0900006486531fc9 FDA-2021-N-0471-0373,FDA,FDA-2021-N-0471,"Reference 70 - Codex Alimentarius Commission, “Code of Hygienic Practice for Fresh Fruits and Vegetables, CXC 53-2003,” 2017",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:09:04Z,,0,0,090000648653cb68 FDA-2021-N-0471-0400,FDA,FDA-2021-N-0471,"FRIA Reference 7 - U.S. Department of Health and Human Services, Guidelines for Regulatory Impact Analyses. 2016",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:16:57Z,,0,0,0900006486541946 FDA-2021-N-0471-0404,FDA,FDA-2021-N-0471,"FRIA Reference 11 - U.S. Bureau of Labor Statistics, May 2022 National Occupational Employment and Wage Estimates United States, First-Line Supervisors of Farming, Fishing, and Forestry Workers. 2023",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:17:53Z,,0,0,090000648654194a FDA-2021-N-0471-0409,FDA,FDA-2021-N-0471,"FRIA Reference 16 - Quinlan, Foodborne Illness Incidence Rates and Food Safety Risks for Populations of Low Socioeconomic Status and Minority Race/Ethnicity: A Review of the Literature. 2013",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:19:32Z,,0,0,090000648654194f FDA-2021-N-0471-0339,FDA,FDA-2021-N-0471,"Reference 36 - Berger, et al., “Fresh Fruit and Vegetables as Vehicles for the Transmission of Human Pathogens”",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:01:33Z,,0,0,0900006486535b37 FDA-2021-N-0471-0354,FDA,FDA-2021-N-0471,"Reference 51 - FDA, “Environmental Assessment for the Proposed Rule: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water,” November 9, 2021",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:04:38Z,,0,0,0900006486535be6 FDA-2021-N-0471-0382,FDA,FDA-2021-N-0471,"Reference 79 - Jung, Jang, and Matthews, “Effect of the Food Production Chain from Farm Practices to Vegetable Processing on Outbreak Incidence”",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:10:49Z,,0,0,09000064865393db FDA-2021-N-0471-0385,FDA,FDA-2021-N-0471,"Reference 82 - Blackburn, “Memorandum: Revised Protocol Review for Reg. No. 94151PA7; DP Barcode: 455973; Submission #: 1044629,” April 29, 2020",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:12:58Z,,0,0,09000064865393de FDA-2021-N-0471-0397,FDA,FDA-2021-N-0471,"FRIA Reference 4 - Roerink, Produce Closes Out the Year on a High note, Setting New Records, 2022",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:16:07Z,,0,0,0900006486539402 FDA-2021-N-0471-0411,FDA,FDA-2021-N-0471,"FRIA Reference 18 - U.S. Small Business Administration, Table of Small Business Size Standards Matched to North American Industry Classification System Codes. 2022",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:19:54Z,,0,0,0900006486541951 FDA-2021-N-0471-0366,FDA,FDA-2021-N-0471,"Reference 63 - FDA, “Lettuce: FDA Investigation Summary--Multistate Outbreak of E. coli O157:H7 Illnesses Linked to Ready-to-Eat Salads,” December 11, 2013",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:07:20Z,,0,0,0900006486535c3e FDA-2021-N-0471-0319,FDA,FDA-2021-N-0471,"Reference 16 - Lee, et al., “Evaluation of Grower-Friendly, Science-Based Sampling Approaches for the Detection of Salmonella in Ponds Used for Irrigation of Fresh Produce”",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T13:43:49Z,,0,0,090000648653204e FDA-2021-N-0471-0332,FDA,FDA-2021-N-0471,"Reference 29 - McElhany and Pillai, ""Prevalence and Fate of Gut-Associated Human Pathogens in the Environment""",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2025-02-10T02:16:03Z,,0,0,0900006486535ad8 FDA-2021-N-0471-0353,FDA,FDA-2021-N-0471,"Reference 50 - FDA, “Final Environmental Impact Statement for the Proposed Rule: Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” October 2015",Supporting & Related Material,Background Material,2024-05-06T04:00:00Z,2024,5,,,2024-05-06T14:04:28Z,,0,0,0900006486535be5