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withdrawn,object_id FDA-2022-D-0278-0095,FDA,FDA-2022-D-0278,Action Levels for Lead in Processed Food Intended for Babies and Young Children; Guidance for Industry; Availability; Correction,Notice,Correction,2025-04-21T04:00:00Z,2025,4,,,2025-04-21T13:32:03Z,2025-06786,0,0,0900006486aa43ef FDA-2022-D-0278-0094,FDA,FDA-2022-D-0278,"Petition for Reconsideration from Unleaded Kids, et al.",Other,Petition for Reconsideration,2025-02-21T05:00:00Z,2025,2,2025-02-21T05:00:00Z,,2025-02-21T19:16:02Z,,0,0,090000648693f8dc FDA-2022-D-0278-0082,FDA,FDA-2022-D-0278,Ref 5. Huang et al 2020,Supporting & Related Material,Background Material,2025-01-27T05:00:00Z,2025,1,,,2025-01-27T18:48:12Z,,0,0,090000648690129d FDA-2022-D-0278-0085,FDA,FDA-2022-D-0278,Ref 8. FDA Draft Guidance for Industry,Supporting & Related Material,Background Material,2025-01-27T05:00:00Z,2025,1,,,2025-01-27T18:48:31Z,,0,0,09000064869012a0 FDA-2022-D-0278-0087,FDA,FDA-2022-D-0278,Ref 10. Flannery et al 2020,Supporting & Related Material,Background Material,2025-01-27T05:00:00Z,2025,1,,,2025-01-27T18:48:43Z,,0,0,09000064869012a2 FDA-2022-D-0278-0088,FDA,FDA-2022-D-0278,Ref 11. FDA Closer to Zero,Supporting & Related Material,Background Material,2025-01-27T05:00:00Z,2025,1,,,2025-01-27T18:48:49Z,,0,0,09000064869012a3 FDA-2022-D-0278-0078,FDA,FDA-2022-D-0278,Ref 1. NTP Monograph Health Effects of Low-Level Lead,Supporting & Related Material,Background Material,2025-01-27T05:00:00Z,2025,1,,,2025-01-27T18:47:43Z,,0,0,09000064868f87a8 FDA-2022-D-0278-0091,FDA,FDA-2022-D-0278,Ref 14. FDA Analytical Results for Lead in Food Intended for Babies Young Children FY2021,Supporting & Related Material,Background Material,2025-01-27T05:00:00Z,2025,1,,,2025-01-27T18:49:10Z,,0,0,09000064869012b1 FDA-2022-D-0278-0080,FDA,FDA-2022-D-0278,Ref 3. Kolasinac et al. 2018,Supporting & Related Material,Background Material,2025-01-27T05:00:00Z,2025,1,,,2025-01-27T18:47:56Z,,0,0,09000064868f87aa FDA-2022-D-0278-0081,FDA,FDA-2022-D-0278,Ref 4. OSWER EPA 2014,Supporting & Related Material,Background Material,2025-01-27T05:00:00Z,2025,1,,,2025-01-27T18:48:07Z,,0,0,090000648690129c FDA-2022-D-0278-0092,FDA,FDA-2022-D-0278,Ref 15 FDA Analytical Results for Lead in Processed Food Intended for Babies Young Children FY2023,Supporting & Related Material,Background Material,2025-01-27T05:00:00Z,2025,1,,,2025-01-27T18:49:16Z,,0,0,09000064869012b2 FDA-2022-D-0278-0090,FDA,FDA-2022-D-0278,Ref 13. FDA Survey FY2013-14,Supporting & Related Material,Background Material,2025-01-27T05:00:00Z,2025,1,,,2025-01-27T18:49:05Z,,0,0,09000064869012a5 FDA-2022-D-0278-0089,FDA,FDA-2022-D-0278,Ref 12. FDA Analytical Results for Lead in Food Intended for Babies and Young Children TEP FY2009-FY2024,Supporting & Related Material,Background Material,2025-01-27T05:00:00Z,2025,1,,,2025-01-27T18:48:57Z,,0,0,09000064869012a4 FDA-2022-D-0278-0077,FDA,FDA-2022-D-0278,List of references,Supporting & Related Material,Background Material,2025-01-27T05:00:00Z,2025,1,,,2025-01-27T18:47:36Z,,0,0,09000064868f87a7 FDA-2022-D-0278-0079,FDA,FDA-2022-D-0278,Ref 2. Flannery and Middleton 2022,Supporting & Related Material,Background Material,2025-01-27T05:00:00Z,2025,1,,,2025-01-27T18:47:50Z,,0,0,09000064868f87a9 FDA-2022-D-0278-0093,FDA,FDA-2022-D-0278,Ref 16. Pourrut et al. 2011,Supporting & Related Material,Background Material,2025-01-27T05:00:00Z,2025,1,,,2025-01-27T18:49:26Z,,0,0,09000064869012b3 FDA-2022-D-0278-0083,FDA,FDA-2022-D-0278,Ref 6. Entwistle et al. 2019,Supporting & Related Material,Background Material,2025-01-27T05:00:00Z,2025,1,,,2025-01-27T18:48:18Z,,0,0,090000648690129e FDA-2022-D-0278-0084,FDA,FDA-2022-D-0278,Ref 7. Code of practice for lead contamination in foods (CXC 56-2004),Supporting & Related Material,Background Material,2025-01-27T05:00:00Z,2025,1,,,2025-01-27T18:48:24Z,,0,0,090000648690129f FDA-2022-D-0278-0086,FDA,FDA-2022-D-0278,Ref 9. WHO_TRS_960 2011,Supporting & Related Material,Background Material,2025-01-27T05:00:00Z,2025,1,,,2025-01-27T18:48:37Z,,0,0,09000064869012a1 FDA-2022-D-0278-0075,FDA,FDA-2022-D-0278,Action Levels for Lead in Processed Food Intended for Babies and Young Children; Guidance for Industry; Availability,Notice,Notice of Availability,2025-01-07T05:00:00Z,2025,1,,,2025-01-07T20:36:17Z,2024-31534,0,0,09000064868a3485 FDA-2022-D-0278-0076,FDA,FDA-2022-D-0278,Action Levels for Lead in Processed Food Intended for Babies and Young Children: Guidance for Industry,Other,Guidance,2025-01-07T05:00:00Z,2025,1,2025-01-07T05:00:00Z,,2025-10-30T09:00:24Z,,1,0,09000064868a5613 FDA-2022-D-0278-0061,FDA,FDA-2022-D-0278,Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Reopening of the Comment Period,Notice,Extension of Comment Period,2023-04-06T04:00:00Z,2023,4,2023-04-06T04:00:00Z,,2025-02-07T20:57:23Z,2023-07187,0,0,09000064858f23a0 FDA-2022-D-0278-0036,FDA,FDA-2022-D-0278,Request for Extension from NYS Department of Agriculture and Markets,Other,Request for Extension,2023-03-24T04:00:00Z,2023,3,2023-03-24T04:00:00Z,,2023-03-24T18:07:09Z,,0,0,0900006485825e39 FDA-2022-D-0278-0011,FDA,FDA-2022-D-0278,"Reference 8 - FDA, 2018. Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry. RE Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability",Supporting & Related Material,Background Material,2023-01-25T05:00:00Z,2023,1,,,2023-01-25T20:21:32Z,,0,0,09000064856066bb FDA-2022-D-0278-0006,FDA,FDA-2022-D-0278,"Reference 3 - Kolasinac, S.M., Lekic, S. S., Golijan, J. et al. 2018. Bioaccumulation Process and Health Risk Assessment of Toxic Elements in Tomato Fruit Grown under Zn Nutrition Treatment. Environmental Monitoring and Assessment, 190; 508. 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RE Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2023-01-25T05:00:00Z,2023,1,,,2023-01-25T20:22:04Z,,0,0,09000064856066b8 FDA-2022-D-0278-0012,FDA,FDA-2022-D-0278,"Reference 9 - WHO/FAO Joint Expert Committee on Food Additives, 2011. Evaluation of Certain Contaminants in Food, 73rd Report of the World Health Organization/Food and Agriculture Organization of the United Nations Joint Expert Committee on Food Additives. WHO Technical Report Series 960. RE Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availab",Supporting & Related Material,Background Material,2023-01-25T05:00:00Z,2023,1,,,2023-01-25T20:21:40Z,,0,0,09000064856066bc FDA-2022-D-0278-0017,FDA,FDA-2022-D-0278,"Reference 14 - Pourrut, B., M. Shahid, C. Dumat, P. Winterton, E. Pinelli, 2011. Lead uptake, toxicity, and detoxification in plants. Reviews of Environmental Contamination and Toxicology, 213:113-136. RE Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability",Supporting & Related Material,Background Material,2023-01-25T05:00:00Z,2023,1,,,2023-01-25T20:22:19Z,,0,0,09000064856066c1 FDA-2022-D-0278-0010,FDA,FDA-2022-D-0278,"Reference 7 - Codex Alimentarius, 2021. Revision of the Code of Practice for the Prevention and Reduction of Lead Contamination in Foods. RE Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability",Supporting & Related Material,Background Material,2023-01-25T05:00:00Z,2023,1,,,2023-01-25T20:21:25Z,,0,0,09000064856066ba FDA-2022-D-0278-0003,FDA,FDA-2022-D-0278,List of references RE Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability,Supporting & Related Material,Background Material,2023-01-25T05:00:00Z,2023,1,,,2023-01-25T20:20:29Z,,0,0,0900006485606687 FDA-2022-D-0278-0009,FDA,FDA-2022-D-0278,"Reference 6 - Entwistle, J. A., Amaibi, P. M., Dean, J. R., et al., 2019. An Apple a Day? Assessing Gardeners' Lead Exposure in Urban Agriculture Sites to Improve the Derivation of Soil Assessment Criteria. Environmental International, 122; 130-141. RE Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability",Supporting & Related Material,Background Material,2023-01-25T05:00:00Z,2023,1,,,2023-01-25T20:21:17Z,,0,0,09000064856066ad FDA-2022-D-0278-0008,FDA,FDA-2022-D-0278,"Reference 5 - Huang, F., Zhou H., Gu, J., et al. 2020. Differences in Absorption of Cadmium and Lead Among Fourteen Sweet Potato Cultivars and Health Risk Assessment. Ecotoxicology and Environmental Safety, 203; 111012. RE Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability",Supporting & Related Material,Background Material,2023-01-25T05:00:00Z,2023,1,,,2023-01-25T20:21:09Z,,0,0,09000064856066b0 FDA-2022-D-0278-0005,FDA,FDA-2022-D-0278,"Reference 2 - Flannery, B.M., K. B. Middleton., 2022. Updated Interim Reference Levels for Dietary Lead to Support FDA’s Closer to Zero Action Plan. Reg. Toxicol. Pharmacol., 133. RE Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability",Supporting & Related Material,Background Material,2023-01-25T05:00:00Z,2023,1,,,2023-01-25T20:20:46Z,,0,0,090000648560668d FDA-2022-D-0278-0016,FDA,FDA-2022-D-0278,"Reference 13 - FDA Survey FY 2021. Analytical Results for Lead in Food Intended for Babies and Young Children, FY2021. RE Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability",Supporting & Related Material,Background Material,2023-01-25T05:00:00Z,2023,1,,,2023-01-25T20:22:11Z,,0,0,09000064856066c0 FDA-2022-D-0278-0004,FDA,FDA-2022-D-0278,"Reference 1 - HHS, National Toxicology Program, 2012. NTP Monograph on Health Effects of Low-Level Lead. RE Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability",Supporting & Related Material,Background Material,2023-01-25T05:00:00Z,2023,1,,,2023-01-25T20:20:37Z,,0,0,090000648560668a FDA-2022-D-0278-0013,FDA,FDA-2022-D-0278,"Reference 10 - FDA, 2021. Closer to Zero: Action Plan for Baby Foods. RE Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability",Supporting & Related Material,Background Material,2023-01-25T05:00:00Z,2023,1,,,2023-01-25T20:21:48Z,,0,0,09000064856066b7 FDA-2022-D-0278-0007,FDA,FDA-2022-D-0278,"Reference 4 - Office of Solid Waste and Emergency Response, U.S. Environmental Protection Agency, 2014. Technical Review Workgroup Recommendations Regarding Gardening and Reducing Exposure to Lead-Contaminated Soils. RE Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability",Supporting & Related Material,Background Material,2023-01-25T05:00:00Z,2023,1,,,2023-01-25T20:21:01Z,,0,0,0900006485606697 FDA-2022-D-0278-0014,FDA,FDA-2022-D-0278,"Reference 11 - FDA, 2022. Analytical Results for Lead in Food Intended for Babies and Young Children Sampled under the FDA’s Toxic Elements in Food and Foodware and Radionuclides in Food – Import and Domestic Compliance Program, FY 2008 to FY 2021. RE Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability",Supporting & Related Material,Background Material,2023-01-25T05:00:00Z,2023,1,,,2023-01-25T20:21:56Z,,0,0,09000064856066bf