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 2018-02-07 article Part IV Rules and Regulations D09002ee1c7f62310 D09002ee1c7f623fe 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 issuing this final rule to require domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to address hazards that may be introduced with the intention to cause wide scale public health harm. These food facilities are required to conduct a vulnerability assessment to identify significant vulnerabilities and actionable process steps and implement mitigation strategies to significantly minimize or prevent significant vulnerabilities identified at actionable process steps in a food operation. FDA is issuing these requirements as part of our implementation of the FDA Food Safety Modernization Act (FSMA). 81 FR 34166 https://www.govinfo.gov/app/details/FR-2016-05-27/2016-12373 2016-12373 fr27my16-14 RIN 0910-AG63 4164-01-P Docket No. FDA-2013-N-1425 https://www.govinfo.gov/app/details/FR-2016-05-27/2016-12373 https://www.govinfo.gov/content/pkg/FR-2016-05-27/html/2016-12373.htm https://www.govinfo.gov/content/pkg/FR-2016-05-27/pdf/2016-12373.pdf Administrative Practice and Procedure Computer Technology Reporting and Recordkeeping Requirements Food Packaging Foods 58 p. 34166 34223 81 FR 34166 Title 21 Part 11 21 CFR Part 11 Title 21 Part 121 21 CFR Part 121 RIN 0910-AG63 Mitigation Strategies To Protect Food Against Intentional Adulteration; Federal Register Vol. 81, Issue RULE 2016-12373 IV DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2016-07-26 Docket No. FDA-2013-N-1425 4164-01-P 2016-12373 Final rule.

The Food and Drug Administration (FDA or we) is issuing this final rule to require domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to address hazards that may be introduced with the intention to cause wide scale public health harm. These food facilities are required to conduct a vulnerability assessment to identify significant vulnerabilities and actionable process steps and implement mitigation strategies to significantly minimize or prevent significant vulnerabilities identified at actionable process steps in a food operation. FDA is issuing these requirements as part of our implementation of the FDA Food Safety Modernization Act (FSMA).

This rule is effective July 26, 2016. See section VIII for compliance dates. Ryan Newkirk, Center for Food Safety and Applied Nutrition (HFS-005), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-3712, email: Ryan.Newkirk@fda.hhs.gov. Administrative Practice and Procedure Computer Technology Reporting and Recordkeeping Requirements Food Packaging Foods Mitigation Strategies to Protect Food Against Intentional Adulteration , Ryan.Newkirk@fda.hhs.gov http://www.algemeiner.com/2014/11/28/isis-calls-for-poisoning-and-running-down-westerners/# http://www.centerforfoodsafety.org/files/fsma-remedy-order_52466.pdf http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm378628 http://www.fda.gov/food/guidanceregulation/fsma/ucm459719.htm http://www.fda.gov/fooddefense http://www.foodsafetymagazine.com/enewsletter/food-defense-in-the-age-of-domestic-terrorism/ http://www.ifscertification.com/images/ifs_standards/ifs6/IFS_Food_V6_en.pdf http://www.japantimes.co.jp/news/2014/01/26/national/crime-legal/toxins-tie-suspect-to-poisonings/#.VvBCLnn2ZD9 http://www.mygfsi.com/images/mygfsi/gfsifiles/information-kit/GFSI_Guidance_Document.pdf http://www.news.com.au/world/toshiki-abe-arrested-for-poisoning-frozen-in-japan/story-fndir2ev-1226810502913 http://www.regulations.gov http://www.reuters.com/article/us-boston-bombings-trial-idUSKBN0MJ0Z620150323 https://www.washingtonpost.com/world/string-of-paris-terrorist-attacks-leaves-over-120-dead/2015/11/14/066df55c-8a73-11e5-bd91-d385b244482f_story.html news.com Vol. 81, no. 103 Office of the Federal Register, National Archives and Records Administration 2016-05-27 continuing daily deposited born digital 669 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-05-27 P0b002ee198595d0e 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr27my16 https://www.govinfo.gov/app/details/FR-2016-05-27 https://www.govinfo.gov/content/pkg/FR-2016-05-27/pdf/FR-2016-05-27.pdf https://www.govinfo.gov/content/pkg/FR-2016-05-27/xml/FR-2016-05-27.xml fdlp 33581 34240 DGPO 2018-02-07 2024-06-01 FR-2016-05-27 machine generated eng FR FR-2016-05-27 81 103