United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2016_register executive 2018-02-02 article Notices D09002ee1c7f67b07 D09002ee1c7f67b9f United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency 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. 81 FR 11572 https://www.govinfo.gov/app/details/FR-2016-03-04/2016-04712 2016-04712 fr04mr16-83 4164-01-P Docket No. FDA-2016-N-0321 https://www.govinfo.gov/app/details/FR-2016-03-04/2016-04712 https://www.govinfo.gov/content/pkg/FR-2016-03-04/html/2016-04712.htm https://www.govinfo.gov/content/pkg/FR-2016-03-04/pdf/2016-04712.pdf 3 p. 11572 11574 81 FR 11572 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; Federal Register Vol. 81, Issue NOTICE 2016-04712 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2016-05-03 Docket No. FDA-2016-N-0321 4164-01-P 2016-04712 Notice; request for comments and for scientific data and information.

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.

Submit either electronic or written comments and scientific data and information by May 3, 2016. Jane Van Doren, Center for Food Safety and Applied Nutrition (HFS-005), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2927. Requests for Information: Risk Assessment of Foodborne Illness Associated With Pathogens From Produce Grown in Fields Amended With Untreated Biological Soil Amendments of Animal Origin , http://www.fda.gov/downloads/Food/FoodScienceResearch/RiskSafetyAssessment/UCM470780.pdf http://www.fda.gov/regulatoryinformation/dockets/default.htm http://www.regulations.gov Vol. 81, no. 43 Office of the Federal Register, National Archives and Records Administration 2016-03-04 continuing daily deposited born digital 263 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-03-04 P0b002ee19834aea4 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr04mr16 https://www.govinfo.gov/app/details/FR-2016-03-04 https://www.govinfo.gov/content/pkg/FR-2016-03-04/pdf/FR-2016-03-04.pdf https://www.govinfo.gov/content/pkg/FR-2016-03-04/xml/FR-2016-03-04.xml fdlp 11407 11658 DGPO 2018-02-02 2024-06-02 FR-2016-03-04 machine generated eng FR FR-2016-03-04 81 43