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 2004_register executive 2010-09-23 article Part IV Rules and Regulations D09002ee1c8126069 D09002ee1c8126123 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) is issuing a final regulation that requires the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States. Such records are to allow for the identification of the immediate previous sources and immediate subsequent recipients of food. The final rule implements the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), and is necessary to help address credible threats of serious adverse health consequences or death to humans or animals. The requirement to establish and maintain records is one of several tools that will help improve FDA's ability to respond to, and further contain, threats of serious adverse health consequences or death to humans or animals from accidental or deliberate contamination of food. In the event of an outbreak of foodborne illness, such information will help FDA and other authorities determine the source and cause of the event. In addition, the information will improve FDA's ability to quickly notify the consumers and/or facilities that might be affected by the outbreak. 69 FR 71562 https://www.govinfo.gov/app/details/FR-2004-12-09/04-26929 04-26929 fr09de04-25 RIN 0910-AC39 4160-01-S Docket No. 2002N-0277 https://www.govinfo.gov/app/details/FR-2004-12-09/04-26929 https://www.govinfo.gov/content/pkg/FR-2004-12-09/html/04-26929.htm https://www.govinfo.gov/content/pkg/FR-2004-12-09/pdf/04-26929.pdf 94 p. 71562 71655 69 FR 71562 Title 21 Part 1 21 CFR Part 1 Title 21 Part 11 21 CFR Part 11 RIN 0910-AC39 Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Federal Register Vol. 69, Issue RULE 04-26929 IV DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2005-02-07 Docket No. 2002N-0277 4160-01-S 04-26929 Final rule.

The Food and Drug Administration (FDA) is issuing a final regulation that requires the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States. Such records are to allow for the identification of the immediate previous sources and immediate subsequent recipients of food. The final rule implements the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), and is necessary to help address credible threats of serious adverse health consequences or death to humans or animals. The requirement to establish and maintain records is one of several tools that will help improve FDA's ability to respond to, and further contain, threats of serious adverse health consequences or death to humans or animals from accidental or deliberate contamination of food. In the event of an outbreak of foodborne illness, such information will help FDA and other authorities determine the source and cause of the event. In addition, the information will improve FDA's ability to quickly notify the consumers and/or facilities that might be affected by the outbreak.

Effective Date: This final rule is effective February 7, 2005. Nega Beru, Center for Food Safety and Applied Nutrition (HFS-305), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1400. Public Health Security and Bioterrorism Preparedness and Response Act of 2002; implementation: Food for human or animal consumption Manufacturing, processing, packing, transportation, distribution, etc.; records establishment and maintenance, http://factfinder.census.gov/servlet/DatasetMainPageServlet http://ssrn.com/abstract=379270 http://www.archives.upenn.edu/urc/rates04.html http://www.cdc.gov/ncidod/diseases/index.htm http://www.census.gov/epcd/cbp/view/cbpview.html http://www.census.gov/epcd/naics02/def/ND488510.HTM http://www.census.gov/epcd/nonemployer/index.html http://www.census.gov/statab/www/part3.html#income http://www.cfsan.fda.gov/˜dms/fsbttraz.html http://www.cfsan.fda.gov/˜mow/intro.html http://www.dsa.org/research/numbers.htm#DISTTYPE http://www.fda.gov/oc/bioterrorism/bioact.html http://www.memag.com/ http://www.nmworld.com/pages/Countries/USA/index.html http://www.sba.gov/size/indextableofsize.html http://www.transtats.bts.gov Vol. 69, no. 236 Office of the Federal Register, National Archives and Records Administration 2004-12-09 continuing daily deposited born digital 360 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2004-12-09 P0b002ee1809714ff 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr09de04 https://www.govinfo.gov/app/details/FR-2004-12-09 https://www.govinfo.gov/content/pkg/FR-2004-12-09/pdf/FR-2004-12-09.pdf https://www.govinfo.gov/content/pkg/FR-2004-12-09/xml/FR-2004-12-09.xml fdlp 71339 71689 DGPO 2010-09-23 2024-06-06 FR-2004-12-09 machine generated eng FR FR-2004-12-09 69 236