{"abstract":"The Food and Drug Administration (FDA or we) is requesting scientific data, information, and comments that would assist the Agency in its plan to develop a risk assessment for produce grown in fields or other growing areas amended with untreated biological soil amendments of animal origin (including raw manure). The risk assessment will evaluate and, if feasible, quantify the risk of human illness associated with consumption of produce grown in fields or other growing areas amended with untreated biological soil amendments of animal origin that are potentially contaminated with enteric pathogens, such as Escherichia coli O157:H7 or Salmonella. The risk assessment also will evaluate the impact of certain interventions, such as use of a time interval between application of the soil amendment and crop harvest, on the predicted risk. The risk assessment is intended to inform policy decisions with regard to produce safety.","action":"Notice; request for comments and for scientific data and information.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2016/03/04/2016-04712.html","cfr_references":[],"citation":"81 FR 11572","comment_url":null,"comments_close_on":"2016-05-03","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments and scientific data and information by May 3, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-N-0321"],"dockets":[{"supporting_documents":[{"title":"Reference 1 Final Qualitative Assessment of Risk to Public Health from On-Farm Contamination of Produce re Risk Assessment of Foodborne Illness Associated with Pathogens from Produce Grown in Fields Amended with Untreated Biological Soil Amendments of Ani","document_id":"FDA-2016-N-0321-0002"}],"agency_name":null,"documents":[{"comment_count":25,"comment_start_date":"2016-03-04","updated_at":"2023-03-01T03:42:40.810-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2016-N-0321-0001","allow_late_comments":null,"id":"FDA-2016-N-0321-0001","comment_end_date":"2016-05-04","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":1,"id":"FDA-2016-N-0321","title":"Risk Assessment of Foodborne Illness Associated with Pathogens from Produce Grown in Fields Amended with Untreated Biological Soil Amendments of Animal Origin"}],"document_number":"2016-04712","effective_on":null,"end_page":11574,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/03/04/2016-04712.xml","html_url":"https://www.federalregister.gov/documents/2016/03/04/2016-04712/risk-assessment-of-foodborne-illness-associated-with-pathogens-from-produce-grown-in-fields-amended","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-04712?publication_date=2016-03-04","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-03-04/2016-04712/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":2766,"last_updated":"2026-07-27 02:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-03-04/pdf/2016-04712.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-04712.pdf?1457012751","publication_date":"2016-03-04","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/03/04/2016-04712.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 1 Final Qualitative Assessment of Risk to Public Health from On-Farm Contamination of Produce re Risk Assessment of Foodborne Illness Associated with Pathogens from Produce Grown in Fields Amended with Untreated Biological Soil Amendments of Ani","document_id":"FDA-2016-N-0321-0002"}],"comments_count":25,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-N-0321","supporting_documents_count":1,"docket_id":"FDA-2016-N-0321","document_id":"FDA-2016-N-0321-0001","regulation_id_number":null,"title":"Risk Assessment of Foodborne Illness Associated with Pathogens from Produce Grown in Fields Amended with Untreated Biological Soil Amendments of Animal Origin","checked_regulationsdotgov_at":"2023-03-01T08:42:39Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":11572,"subtype":null,"title":"Risk Assessment of Foodborne Illness Associated With Pathogens From Produce Grown in Fields Amended With Untreated Biological Soil Amendments of Animal Origin; Request for Scientific Data, Information, and Comments","toc_doc":"Risk Assessment of Foodborne Illness Associated With Pathogens From Produce Grown in Fields Amended With Untreated Biological Soil Amendments of Animal Origin","toc_subject":"Requests for Information:","topics":[],"type":"Notice","volume":81}