,,ii #aafth ,,congress #ast ,session ,s4 #aiie ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,june #bf1 #bjai,mr4 ,durbin 7for himself1 ,mr4 ,blumenthal1 ,mrs4 ,feinstein1 and ,mrs4 ,gillibrand7 introduced the following bill2 which was read twice and referred to the ,committee on ,agriculture1 ,nutrition1 and ,forestry ,a ,,bill ,to establish the ,food ,safety ,administration to protect the public health by preventing foodborne illness1 ensuring the safety of food1 improving research on contaminants leading to foodborne illness and the chronic health outcomes associated with foodborne illnesses1 improving the surveillance of foodborne pathogens 7including foodborne pathogens identified as antibiotic resistant71 and improving security of food from intentional contamination1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,safe ,food ,act of #bjai4 7b7 ,table of contents ,the table of contents of this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4,sec4 #b4 ,findings2 purposes4,sec4 #c4 ,definitions4,title ,i--,establishment of ,food ,safety ,administration,sec4 #aja4 ,establishment of ,food ,safety ,administration4,sec4 #ajb4 ,consolidation of separate food safety and inspection services and agencies4,sec4 #ajc4 ,additional duties of the ,administration4,title ,,ii--,administration of food safety program,sec4 #bja4 ,administration of national program4,sec4 #bjb4 ,registration of food facilities4,sec4 #bjc4 ,preventive process controls to reduce adulteration of food4,sec4 #bjd4 ,performance standards for contaminants in food4,sec4 #bje4 ,inspections of food facilities4,sec4 #bjf4 ,food production establishments4,sec4 #bjg4 ,federal and ,state cooperation4,sec4 #bjh4 ,foreign supplier verification program4,sec4 #bji4 ,imports4,sec4 #baj4 ,traceback4,sec4 #baa4 ,food safety technology4,title ,,iii--,research and education,sec4 #cja4 ,public health assessment system4,sec4 #cjb4 ,public education and advisory system4,sec4 #cjc4 ,research4,title ,,iv--,enforcement,sec4 #dja4 ,prohibited acts4,sec4 #djb4 ,mandatory recall authority4,sec4 #djc4 ,injunction proceedings4,sec4 #djd4 ,civil and criminal penalties4,sec4 #dje4 ,presumption4,sec4 #djf4 ,whistleblower protection4,sec4 #djg4 ,administration and enforcement4,sec4 #djh4 ,citizen civil actions4,title ,v--,implementation,sec4 #eja4 ,definition4,sec4 #ejb4 ,reorganization plan4,sec4 #ejc4 ,transitional authorities4,sec4 #ejd4 ,savings provisions4,sec4 #eje4 ,conforming amendments4,sec4 #ejf4 ,additional technical and conforming amendments4,sec4 #ejg4 ,regulations4,sec4 #ejh4 ,authorization of appropriations4,sec4 #eji4 ,limitation on authorization of appropriations4 #b4 ,findings2 purposes 7a7 ,findings ,congress finds that-- 7#a7 the safety of the food supply of the ,united ,states is vital to the public health1 to public confidence in the food supply1 and to the success of the food sector of the ,nation's economy2 7#b7 lapses in the protection of the food supply and loss of public confidence in food safety are damaging to consumers and the food industry1 and place a burden on interstate commerce2 7#c7 the safety and security of the food supply requires an integrated1 systemwide approach to preventing foodborne illness1 a thorough and broad-based approach to basic and applied research1 and intensive1 effective1 and efficient management of the ,nation's food safety program2 7#d7 the task of preserving the safety of the food supply of the ,united ,states faces tremendous pressures with regard to-- 7,a7 emerging pathogens and other contaminants and the ability to detect all forms of contamination2 7,b7 an aging and immune-compromised population1 with a growing number of people at high risk for foodborne illnesses1 including infants and children2 7,c7 a concern regarding food fraud for economic gain1 especially with mislabeling and intentionally misleading claims2 7,d7 an increasing volume of imported food1 without adequate monitoring and inspection2 and 7,e7 maintenance of rigorous inspection of the domestic food processing and food service industries2 7#e7 ,federal food safety standard setting1 inspection1 enforcement1 and research efforts should be based on the best available science and public health considerations and food safety resources should be systematically deployed in ways that most effectively prevent foodborne illness2 7#f7 the ,federal food safety system is fragmented1 with at least #ae ,federal agencies sharing responsibility for food safety1 and operates under laws that do not reflect current conditions in the food system or current scientific knowledge about the cause and prevention of foodborne illness2 7#g7 the fragmented ,federal food safety system and outdated laws preclude an integrated1 systemwide approach to preventing foodborne illness1 to the effective and efficient operation of the ,nation's food safety program1 and to the most beneficial deployment of food safety resources2 7#h7 the ,national ,academy of ,sciences recommended in the report ,ensuring ,safe ,food from ,production to ,consumption that ,congress establish by statute a unified and central framework for managing ,federal food safety programs1 and recommended modifying ,federal statutes so that inspection1 enforcement1 and research efforts are based on scientifically supportable assessments of risks to public health2 and 7#i7 the lack of a single focal point for food safety leadership in the ,united ,states undercuts the ability of the ,united ,states to exert food safety leadership internationally1 which is detrimental to the public health and the international trade interests of the ,united ,states4 7b7 ,purposes ,the purposes of this ,act are-- 7#a7 to establish a single agency to be known as the ,food ,safety ,administration to-- 7,a7 regulate food safety and related labeling to strengthen the protection of the public health2 7,b7 ensure that food facilities fulfill their responsibility to produce food in a manner that protects the public health of all people in the ,united ,states2 7,c7 lead an integrated1 systemwide approach to food safety and to make more effective and efficient use of resources to prevent foodborne illness2 7,d7 provide a single focal point for food safety leadership1 both nationally and internationally2 and 7,e7 provide an integrated food safety research capability1 utilizing internally generated1 scientifically and statistically valid studies or other food safety initiatives1 in cooperation with academic institutions1 food safety nonprofit organizations1 and other scientific entities of the ,federal and ,state governments1 to achieve the continuous improvement of research on foodborne illness and contaminants2 7#b7 to transfer to the ,food ,safety ,administration the food safety1 labeling1 inspection1 and enforcement functions that1 as of the day before the date of enactment of this ,act1 are performed by other ,federal agencies2 and 7#c7 to modernize and strengthen the ,federal food safety laws to achieve more effective application and efficient management of the laws for the protection and improvement of public health4 #c4 ,definitions ,in this ,act3 7#a7 ,administration ,the term ,administration means the ,food ,safety ,administration established under section #aja7;a77#a74 7#b7 ,administrator ,the term ,administrator means the ,administrator of ,food ,safety appointed under section #aja7;a77#c74 7#c7 ,adulterated 7,a7 ,in general ,the term adulterated has the meaning given the term in-- 7i7 section #djb of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdb7 for food regulated under such ,act2 7ii7 section #a7m7 of the ,federal ,meat ,inspection ,act 7#ba ,u4,s4,c4 #fja7m77 for food regulated under such ,act2 7iii7 section #d7;g7 of the ,poultry ,products ,inspection ,act 7#ba ,u4,s4,c4 #dec7;g77 for food regulated under such ,act2 and 7iv7 section #d7;a7 of the ,egg ,products ,inspection ,act 7#ba ,u4,s4,c4 #ajcc7;a77 for food regulated under such ,act4 7,b7 ,inclusion ,in applying the definitions cited in subparagraph 7,a71 poisonous or deleterious substances in food shall be treated as an added substance if the poisonous or deleterious substances are known to cause serious illness or death in persons1 including in sensitive populations4 7#d7 ,agency ,the term agency has the meaning given the term in section #eea of title #e1 ,united ,states ,code4 7#e7 ,category #a food facility ,the term category #a food facility means a facility that slaughters animals for food4 7#f7 ,category #b food facility ,the term category #b food facility means a facility that processes-- 7,a7 raw meat1 poultry1 or seafood in a manner that may reduce but is not validated to destroy contaminants2 or 7,b7 other products that the ,administrator determines by regulation to be at high risk of contamination4 7#g7 ,category #c food facility ,the term category #c food facility means a facility-- 7,a7 that processes meat1 poultry1 or seafood1 or other products that the ,administrator determines by regulation to be at high risk of contamination2 and 7,b7 whose processes include one or more steps validated to destroy contaminants4 7#h7 ,category #d food facility ,the term category #d food facility means a facility that processes food but is not a category #a1 #b1 or #c food facility4 7#i7 ,category #e food facility ,the term category #e food facility means a facility that stores1 holds1 or transports food prior to delivery for retail sale4 7#aj7 ,contaminant ,the term contaminant includes biological1 chemical1 physical1 or radiological hazards1 natural toxins1 pesticides1 drug residues1 decomposition1 parasites1 allergens1 and unapproved food or color additives4 7#aa7 ,contamination ,the term contamination refers to a presence of a contaminant in food1 which may occur naturally or be introduced into a food4 7#ab7 ,feed facility ,the term feed facility means a domestic or foreign feed manufacturer1 processor1 packer1 warehouse1 or other facility that-- 7,a7 if operating in the ,united ,states1 manufactures1 slaughters1 processes1 or holds animal feed or feed ingredients2 or 7,b7 if operating elsewhere1 manufactures1 slaughters1 processes1 or holds animal feed or feed ingredients intended for consumption in the ,united ,states4 7#ac7 ,food 7,a7 ,in general ,the term food means a product intended to be used for food or drink for a human or an animal4 7,b7 ,inclusions ,the term food includes any product 7including a meat food product1 as defined in section #a7;j7 of the ,federal ,meat ,inspection ,act 7#ba ,u4,s4,c4 #fja7;j7771 capable for use as human and animal food that is made in whole or in part from any animal1 including cattle1 sheep1 swine1 goat1 or poultry 7as defined in section #d of the ,poultry ,products ,inspection ,act 7#ba ,u4,s4,c4 #dec771 and animal feed4 7#ad7 ,food facility 7,a7 ,in general ,the term food facility means a domestic or foreign food manufacturer1 slaughterhouse1 processor1 packer1 warehouse1 or other facility that-- 7i7 if operating in the ,united ,states1 manufactures1 slaughters1 processes1 or holds food or food ingredients2 or 7ii7 if operating outside the ,united ,states1 manufactures1 slaughters1 processes1 or holds food intended for consumption in the ,united ,states4 7,b7 ,exclusions ,for the purposes of registration1 the term food facility does not include-- 7i7 a farm1 restaurant1 other retail food establishment1 or nonprofit food establishment in which food is prepared for or served directly to the consumer2 or 7ii7 a fishing vessel 7other than a fishing vessel engaged in processing1 as that term is defined in section #abc4c7k7 of title #ba1 ,code of ,federal ,regulations74 7#ae7 ,food production establishment ,the term food production establishment means any farm1 ranch1 orchard1 vineyard1 aquaculture facility1 or confined animal-feeding operation4 7#af7 ,food safety law ,the term food safety law means-- 7,a7 the provisions of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 related to and requiring the safety1 labeling1 and inspection of food1 infant formulas1 food additives1 pesticide residues1 and other substances present in food under that ,act2 7,b7 the provisions of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 and of any other ,act that are administered by the ,center for ,veterinary ,medicine of the ,food and ,drug ,administration2 7,c7 the ,poultry ,products ,inspection ,act 7#ba ,u4,s4,c4 #dea et seq472 7,d7 the ,federal ,meat ,inspection ,act 7#ba ,u4,s4,c4 #fja et seq472 7,e7 the ,,fda ,food ,safety ,modernization ,act 7,public ,law #aaa-cec2 #abd ,stat4 #chhe72 7,f7 the ,egg ,products ,inspection ,act 7#ba ,u4,s4,c4 #ajca et seq472 7,g7 chapter #eg of title #di1 ,united ,states ,code 7formerly known as the ,sanitary ,food ,transportation ,act of #aiij72 7,h7 ,public ,law #he-gfe 7commonly known as the ,humane ,methods of ,slaughter ,act of #aieh7 7#g ,u4,s4,c4 #aija et seq472 7,i7 this ,act2 and 7,j7 such other provisions of law related to and requiring food safety1 labeling1 inspection1 and enforcement as the ,president designates by ,executive order as appropriate to include within the jurisdiction of the ,administration4 7#ag7 ,interstate commerce ,the term interstate commerce has the meaning given the term in section #bja7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;b774 7#ah7 ,misbranded ,the term misbranded has the meaning given the term in-- 7,a7 section #djc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc7 for food regulated under such ,act2 7,b7 section #a7n7 of the ,federal ,meat ,inspection ,act 7#ba ,u4,s4,c4 #fja7n77 for food regulated under such ,act2 7,c7 section #d7;h7 of the ,poultry ,products ,inspection ,act 7#ba ,u4,s4,c4 #dec7;h77 for food regulated under such ,act2 and 7,d7 section #d7l7 of the ,egg ,products ,inspection ,act 7#ba ,u4,s4,c4 #ajcc7l77 for food regulated under such ,act4 7#ai7 ,process ,the term process or processing means the commercial slaughter1 packing1 preparation1 or manufacture of food4 7#bj7 ,safe ,the term safe refers to human and animal health4 7#ba7 ,state ,the term ,state means-- 7,a7 a ,state2 7,b7 the ,district of ,columbia2 7,c7 the ,commonwealth of ,puerto ,rico2 and 7,d7 any other territory or possession of the ,united ,states4 7#bb7 ,validation ,the term validation means the act of obtaining evidence that the process control measure or measures selected to control a contaminant in food is capable of effectively and consistently controlling the contaminant4 7#bc7 ,statistically valid ,the term statistically valid means evaluated and conducted under standards set by the ,national ,institute of ,standards and ,technology4 ,i ,establishment of ,food ,safety ,administration #aja4 ,establishment of ,food ,safety ,administration 7a7 ,establishment 7#a7 ,in general ,there is established in the ,executive branch an agency to be known as the ,food ,safety ,administration4 7#b7 ,status ,the ,administration shall be an independent establishment 7as defined in section #ajd of title #e1 ,united ,states ,code74 7#c7 ,head of administration ,the ,administration shall be headed by the ,administrator of ,food ,safety1 who shall be appointed by the ,president1 by and with the advice and consent of the ,senate4 7b7 ,duties of ,administrator ,the ,administrator shall-- 7#a7 administer and enforce the food safety law2 7#b7 serve as a representative to international food safety bodies and discussions2 7#c7 promulgate regulations to ensure the security of the food supply from all forms of contamination1 including intentional contamination2 and 7#d7 oversee-- 7,a7 implementation of ,federal food safety inspection1 labeling1 enforcement1 and research efforts to protect the public health2 7,b7 development of consistent and science-based standards for safe food2 7,c7 coordination and prioritization of food safety research and education programs with other ,federal agencies2 7,d7 prioritization of ,federal food safety efforts and deployment of ,federal food safety resources to achieve the greatest benefit in reducing foodborne illness2 7,e7 coordination of the ,federal response to foodborne illness outbreaks with other ,federal and ,state agencies2 and 7,f7 integration of ,federal food safety activities with ,state and local agencies4 #ajb4 ,consolidation of separate food safety and inspection services and agencies 7a7 ,transfer of functions ,for each ,federal agency specified in subsection 7b71 there are transferred to the ,administration all functions that the head of the ,federal agency exercised on the day before the date of enactment of this ,act 7including all related functions of any officer or employee of the ,federal agency7 that relate to administration or enforcement of the food safety law1 as determined by the ,president4 7b7 ,transferred agencies ,the ,federal agencies referred to in subsection 7a7 are-- 7#a7 the ,food ,safety and ,inspection ,service of the ,department of ,agriculture2 7#b7 the ,center for ,food ,safety and ,applied ,nutrition of the ,food and ,drug ,administration2 7#c7 the part of the ,agriculture ,marketing ,service that administers shell egg surveillance services established under the ,egg ,products ,inspection ,act 7#ba ,u4,s4,c4 #ajca et seq472 7#d7 the resources and facilities of the ,office of ,regulatory ,affairs of the ,food and ,drug ,administration that administer and conduct inspections of food and feed facilities and imports2 7#e7 the ,center for ,veterinary ,medicine of the ,food and ,drug ,administration2 7#f7 the ,office of ,food ,policy and ,response of the ,food and ,drug ,administration2 7#g7 the part of the ,research1 ,education1 and ,economics mission area of the ,department of ,agriculture related to food and feed safety2 7#h7 the part of the ,national ,marine ,fisheries ,service of the ,national ,oceanic and ,atmospheric ,administration of the ,department of ,commerce that administers the seafood inspection program2 7#i7 the part of the ,animal and ,plant ,inspection ,health ,service of the ,department of ,agriculture related to the management of animals going into the food supply2 and 7#aj7 such other offices1 services1 or agencies as the ,president designates by ,executive order to carry out this ,act4 #ajc4 ,additional duties of the ,administration 7a7 ,officers and employees ,the ,administrator may-- 7#a7 appoint officers and employees for the ,administration in accordance with the provisions of title #e1 ,united ,states ,code1 relating to appointment in the competitive service2 and 7#b7 fix the compensation of those officers and employees in accordance with chapter #ea and with subchapter ,,iii of chapter #ec of that title1 relating to classification and ,general ,schedule pay rates4 7b7 ,experts and consultants ,the ,administrator may-- 7#a7 procure the services of temporary or intermittent experts and consultants as authorized by section #caji of title #e1 ,united ,states ,code2 and 7#b7 pay in connection with those services the travel expenses of the experts and consultants1 including transportation and per diem in lieu of subsistence while away from the homes or regular places of business of the individuals1 as authorized by section #egjc of that title4 7c7 ,bureaus1 offices1 and divisions ,the ,administrator may establish within the ,administration such bureaus1 offices1 and divisions as the ,administrator determines are necessary to perform the duties of the ,administrator4 7d7 ,advisory committees 7#a7 ,in general ,the ,administrator shall establish advisory committees that consist of representatives of scientific expert bodies1 academics1 industry specialists1 and consumers4 7#b7 ,duties ,the duties of an advisory committee established under paragraph 7#a7 may include developing recommendations with respect to the development of regulatory science and processes1 research1 communications1 performance standards1 and inspection4 ,,ii ,administration of food safety program #bja4 ,administration of national program 7a7 ,in general ,the ,administrator shall-- 7#a7 administer a national food safety program 7referred to in this section as the program7 to protect public health2 and 7#b7 ensure that persons who produce or process food meet their responsibility to prevent or minimize food safety hazards related to their products4 7b7 ,comprehensive analysis ,the program shall be based on a comprehensive analysis of the hazards associated with different food and with the processing of different food1 including the identification and evaluation of-- 7#a7 the severity of the health risks2 7#b7 the sources and specific points of potential contamination extending from the farm or ranch to the consumer that may render food unsafe2 7#c7 the potential for persistence1 multiplication1 or concentration of naturally occurring or added contaminants in food2 7#d7 opportunities across the food production1 processing1 distribution1 and retail system to manage and reduce potential health risks2 and 7#e7 opportunities for intentional contamination4 7c7 ,program elements ,in carrying out the program1 the ,administrator shall-- 7#a7 adopt and implement a national system for the registration of food facilities and regular unannounced inspection of food facilities2 7#b7 verify and enforce the adoption of preventive process controls in food facilities1 based on the best available scientific and public health considerations and best available technologies2 7#c7 establish and enforce science-based standards for-- 7,a7 substances that may contaminate food2 and 7,b7 safety and sanitation in the processing and handling of food2 7#d7 implement a statistically valid sampling program to ensure that industry programs and procedures that prevent food contamination are effective on an ongoing basis and that food meets the performance standards established under this ,act2 7#e7 implement procedures and requirements to ensure the safety and security of imported food2 7#f7 coordinate with other agencies and ,state or local governments in carrying out inspection1 enforcement1 research1 and monitoring2 7#g7 access the surveillance data of the ,centers for ,disease ,control and ,prevention1 and other ,federal ,government agencies1 in order to develop and implement a national surveillance system to assess the health risks associated with the human consumption of food or to create surveillance data and studies to mitigate food threats 7such as antibiotic resistance7 or to identify the ways that food contamination spreads through environments2 7#h7 partner with relevant agencies to identify and prevent terrorist threats to food2 7#i7 establish a process for providing a single point of contact to assist impacted consumers in navigating ,federal1 ,state1 and local agencies involved in responding to or monitoring a foodborne outbreak2 7#aj7 develop public education risk communication and advisory programs2 7#aa7 implement a basic and applied research program to further the purposes of this ,act2 and 7#ab7 coordinate and prioritize food safety research and educational programs with other agencies1 including ,state or local agencies4 #bjb4 ,registration of food facilities 7a7 ,in general ,the ,administrator shall require that all food and feed facilities register before the facility can operate in the ,united ,states or import food1 feed1 or ingredients into the ,united ,states4 7b7 ,registration requirements 7#a7 ,in general ,to be registered under subsection 7a7-- 7,a7 all food facilities covered under this ,act shall comply with registration requirements in section #dae of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cej;d72 7,b7 for food facilities that have not registered under such section #dae prior to the date of enactment of this ,act1 the requirement in subparagraph 7,a7 applies beginning on the day that is #ahj days after the date of enactment of this ,act2 and 7,c7 for food facilities that have registered under such section #dae prior to the date of enactment of this ,act1 such facilities shall file an amended registration within #ahj days of such date of enactment to deliver the information required by paragraph 7#b74 7#b7 ,categories ,in addition to the information required under section #dae of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cej;d7 to be included in registration1 a food facility shall-- 7,a7 list the facility's primary purpose and business activity1 including the dates of operation if the food facility is operating seasonally2 and 7,b7 list the types of food handled at the facility and identify the activities conducted in the facility1 that are relevant to determining whether the facility is a category #a1 #b1 #c1 #d1 or #e facility4 7#c7 ,procedure ,upon receipt of a completed or amended registration described in paragraph 7#a71 the ,administrator shall notify the registrant of the receipt of the registration1 review the activities identified in the registration1 designate the facility as a category #a1 #b1 #c1 #d1 or #e food facility for the purposes of inspection1 and assign a registration number to each food facility4 7#d7 ,list ,the ,administrator-- 7,a7 shall compile and maintain an up-to-date list of food facilities that are registered under this section1 in accordance with section #dae7;a77#e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cej;d7a77#e772 and 7,b7 may establish regulations on how the list may be shared with other governmental authorities4 #bjc4 ,preventive process controls to reduce adulteration of food 7a7 ,in general ,the ,administrator shall review existing regulations on hazard analysis and process controls and amend existing regulations as appropriate1 upon the basis of best available public health1 scientific1 and technological information1 to ensure that those regulations are working effectively to-- 7#a7 ensure food facilities operate in a sanitary manner so that food is not adulterated2 7#b7 limit the presence of contaminants in food2 7#c7 meet the performance standards established under section #bjd2 7#d7 ensure fully processed or ready-to-eat foods are processed using reasonably available techniques and technologies to eliminate contaminants2 7#e7 label food intended for final processing outside commercial food facilities with instructions for handling and preparation for consumption that will destroy contaminants2 7#f7 require sampling and testing at a frequency and in a manner sufficient to ensure that process controls are effective on an ongoing basis and that performance standards are being met2 and 7#g7 provide for agency access to records kept by food facilities and submission of copies of the records to the ,administrator1 as the ,administrator determines appropriate4 7b7 ,processing controls ,the ,administrator may require any person with responsibility for or control over food or food ingredients to adopt process controls1 if the process controls are needed to ensure the protection of the public health4 #bjd4 ,performance standards for contaminants in food 7a7 ,performance standards ,whenever the ,administrator determines that a foodborne contaminant presents the risk of serious adverse health consequences or death to consumers1 causes food to be adulterated1 or could promote the spread of communicable disease described in section #cfa of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfd71 the ,administrator shall issue a performance standard 7in the form of guidance1 action levels1 or regulations7 to prevent or control the contaminant4 7b7 ,enforcement 7#a7 ,in general ,not later than #a year after the promulgation of a performance standard under this section1 the ,administrator shall implement a statistically significant sampling program to determine whether food facilities are complying with the standards promulgated under this section4 7#b7 ,actions ,if the ,administrator determines that a food facility fails to meet a standard promulgated under this section1 and such facility fails to take appropriate corrective action as determined by the ,administrator1 the ,administrator shall1 as appropriate-- 7,a7 detain1 seize1 or condemn food from the food facility under section #bji7;i72 7,b7 order a recall of food from the food facility under section #djb2 7,c7 increase the inspection frequency for the food facility2 7,d7 withdraw the mark of inspection from the food facility1 if in use2 or 7,e7 take other appropriate enforcement action concerning the food facility1 including suspension of registration4 7c7 ,newly identified contaminants ,notwithstanding any other provision of this section1 the ,administrator shall promulgate interim performance standards for newly identified contaminants as necessary to protect the public health4 7d7 ,revocation by ,administrator ,all performance standards1 tolerances1 action levels1 or other similar standards with respect to food in effect on the date of enactment of this ,act shall remain in effect until revised or revoked by the ,administrator4 #bje4 ,inspections of food facilities 7a7 ,in general ,the ,administrator shall establish an inspection program1 which shall include sampling and testing of food and food facilities1 to determine if each food facility-- 7#a7 is operating in a sanitary manner2 7#b7 has continuous systems1 interventions1 and processes in place to minimize or eliminate contaminants in food2 7#c7 uses validated process controls and ongoing verification2 7#d7 is in compliance with applicable performance standards established under section #bjd1 process control regulations1 and other requirements2 7#e7 is processing food that is safe and not adulterated or misbranded2 7#f7 maintains records of process control plans under section #bjc1 and other records related to the processing1 sampling1 and handling of food2 and 7#g7 is in compliance with the requirements of the applicable food safety law4 7b7 ,facility categories and inspection frequencies ,inspections of food facilities under this ,act shall be based on the following categories and inspection frequencies1 subject to subsections 7c71 7d71 and 7e73 7#a7 ,category #a food facilities ,a category #a food facility shall be subject to antemortem1 postmortem1 and continuous inspection of each slaughter line during all operating hours1 and other inspection on a daily basis1 sufficient to verify that-- 7,a7 diseased animals are not offered for slaughter2 7,b7 the food facility has successfully identified and removed from the slaughter line visibly defective or contaminated carcasses1 has avoided cross-contamination1 and has destroyed or reprocessed contaminated carcasses in a manner acceptable to the ,administrator2 and 7,c7 applicable performance standards and other provisions of the food safety law1 including those intended to eliminate or reduce pathogens1 have been satisfied4 7#b7 ,category #b food facilities ,a category #b food facility shall be randomly inspected at least daily4 7#c7 ,category #c food facilities ,a category #c food facility shall-- 7,a7 provide documentation to the ,administrator on request that ongoing verification shows that its processes are controlled2 and 7,b7 be randomly inspected at least monthly4 7#d7 ,category #d food facilities ,a category #d food facility shall be randomly inspected at least quarterly4 7#e7 ,category #e food facilities ,a category #e food facility shall be randomly inspected at least annually4 7c7 ,establishment of inspection procedures ,the ,administrator shall establish procedures under which inspectors or safety officers inspect food facilities1 which shall allow the taking of random samples1 photographs1 and copies of records in food facilities4 7d7 ,alternative inspection frequencies 7#a7 ,in general ,with respect to a category #b1 #c1 #d1 or #e food facility1 to foster a risk-based allocation of resources1 the ,administrator may establish1 in accordance with this subsection1 alternative increased or decreased inspection frequencies for-- 7,a7 #a or more subcategories of food facilities under paragraph 7#b72 and 7,b7 #a or more specific food facilities under paragraph 7#c74 7#b7 ,determination of subcategories and frequencies 7,a7 ,in general ,the ,administrator shall define1 by regulation1 each subcategory of food facilities established under paragraph 7#a77;,a7 and the alternative inspection frequency of that subcategory4 7,b7 ,considerations ,in defining a subcategory of food facilities and the alternative inspection frequency of that subcategory under subparagraph 7,a71 the ,administrator shall consider-- 7i7 the nature of the foods being processed1 stored1 or transported2 7ii7 the manner in which foods are processed1 stored1 or transported2 7iii7 the inherent likelihood that the foods will contribute to the risk of foodborne illness2 7iv7 the best available evidence concerning reported illnesses associated with the foods produced in the proposed subcategory of facilities2 and 7v7 the overall record of compliance with the food safety law among facilities in the proposed subcategory1 including compliance with applicable performance standards and the frequency of recalls4 7#c7 ,specific facilities 7,a7 ,in general ,the ,administrator-- 7i7 may establish an alternative inspection frequency for increased or decreased inspection for a specific food facility2 and 7ii7 shall annually publish a list of food facilities subject to alternative inspection frequencies under clause 7i74 7,b7 ,considerations ,in establishing an alternative inspection frequency for a specific food facility1 the ,administrator shall consider-- 7i7 the supporting evidence that the specific food facility shall submit to the ,administrator relating to whether an alternative inspection frequency should be established for that facility by the ,administrator2 7ii7 whether products from the specific food facility have been associated with a case or an outbreak of foodborne illness2 7iii7 the record of the facility of compliance with the food safety law1 including compliance with applicable performance standards and the frequency of recalls2 and 7iv7 the considerations described in clauses 7i7 through 7iii7 of paragraph 7#b77;,b74 7#d7 ,frequency requirements for categories #b1 #c1 and #d ,an alternative inspection frequency for a subcategory of food facilities or a specific food facility under this subsection shall be-- 7,a7 in the case of a category #b food facility1 not less frequently than monthly2 and 7,b7 in the case of a category #c or #d food facility1 not less frequently than annually4 7#e7 ,requirements for decreased frequencies ,before issuing a regulation or order establishing a decreased alternative inspection frequency for a subcategory of food facilities or an individual food facility under this subsection1 the ,administrator shall-- 7,a7 describe1 in general terms1 the alternative uses of resources of the ,administration that would have been required to carry out the inspection activity2 and 7,b7 determine1 based on the best available evidence1 that the alternative uses of the resources would make a greater contribution to protecting the public health and reducing the risk of foodborne illness4 7e7 ,inspection transition ,the ,administrator shall manage the transition to the inspection system described in this ,act as follows3 7#a7 ,regulations ,the ,administrator shall promulgate regulations to implement this section no later than #bd months after the date of enactment of this ,act4 7#b7 ,limit on reduction in inspection frequency ,for any food facility1 the ,administrator shall not reduce the inspection frequency from the frequency required pursuant to the ,federal ,meat ,inspection ,act 7#ba ,u4,s4,c4 #fja et seq471 the ,poultry ,products ,inspection ,act 7#ba ,u4,s4,c4 #dea et seq471 and the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 until the food facility has demonstrated that sufficient changes in facilities1 procedures1 personnel1 or other aspects of the process control system have been made such that the ,administrator determines that compliance with the food safety law is achieved4 7f7 ,official mark 7#a7 ,in general 7,a7 ,establishment ,before the completion of the transition process under subsection 7e71 the ,administrator shall by regulation establish an official mark that can be affixed to a food produced in a category #a1 #b1 or #c food facility if-- 7i7 the facility is in compliance with the food safety law2 and 7ii7 has been inspected in accordance with the inspection frequencies under this section4 7,b7 ,removal of official mark ,the ,administrator shall promulgate regulations that provide for the removal of the official mark under this subsection if-- 7i7 the ,administrator makes a finding that the facility is not in compliance with the food safety law2 or 7ii7 the ,administrator suspends the registration of the facility4 7#b7 ,category #a1 #b1 or #c food facilities ,in the case of products manufactured1 slaughtered1 processed1 or held in a category #a1 #b1 or #c food facility-- 7,a7 products subject to the ,federal ,meat ,inspection ,act 7#ba ,u4,s4,c4 #fja et seq471 the ,poultry ,products ,inspection ,act 7#ba ,u4,s4,c4 #dea et seq471 the ,egg ,products ,inspection ,act 7#ba ,u4,s4,c4 #ajca et seq471 and the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq47 as of the date of enactment of this ,act shall remain subject to the requirement under those ,acts that they bear the mark of inspection pending completion of the transition process under subsection 7e72 7,b7 the ,administrator shall publicly certify on a monthly basis that the inspection frequencies required under this section have been achieved2 and 7,c7 a product from a facility that has not been inspected in accordance with the required frequencies under this section shall not bear the official mark and shall not be shipped in interstate commerce4 7#c7 ,category #d and #e food facilities ,in the case of a product manufactured1 slaughtered1 processed1 or held in a category #d or #e food facility1 the ,administrator shall provide by regulation for the voluntary use of the official mark established under paragraph 7#a71 subject to-- 7,a7 such minimum inspection frequencies as determined appropriate by the ,administrator2 7,b7 compliance with applicable performance standards and other provisions of the food safety law2 and 7,c7 such other requirements as the ,administrator considers appropriate4 7g7 ,maintenance and inspection of records 7#a7 ,in general 7,a7 ,records ,a food facility shall-- 7i7 maintain such records as the ,administrator requires by regulation1 including all records relating to the processing1 distributing1 receipt1 or importation of any food2 and 7ii7 permit the ,administrator1 in addition to any authority of the food safety agencies in effect on the day before the date of enactment of this ,act1 upon presentation of appropriate credentials and at reasonable times and in a reasonable manner1 to have access to and copy all records maintained by or on behalf of such food facility representative in any format 7including paper or electronic7 and at any location1 that are necessary to assist the ,administrator to determine whether the food is contaminated or not in compliance with the food safety law4 7,b7 ,required disclosure ,a food facility shall have an affirmative obligation to disclose to the ,administrator the results of testing or sampling of food1 equipment1 or material in contact with food that is positive for any contaminant4 7#b7 ,maintenance of records ,the records required by paragraph 7#a7 shall be maintained for a reasonable period of time1 as determined by the ,administrator4 7#c7 ,requirements ,the records required by paragraph 7#a7 shall include records describing-- 7,a7 the origin1 receipt1 delivery1 sale1 movement1 holding1 and disposition of food or ingredients2 7,b7 the identity and quantity of ingredients used in the food2 7,c7 the processing of the food2 7,d7 the results of laboratory1 sanitation1 or other tests performed on the food or in the food facility2 7,e7 consumer complaints concerning the food or packaging of the food2 7,f7 the production codes1 open date codes1 and locations of food production2 and 7,g7 other matters reasonably related to whether food is unsafe1 is adulterated or misbranded1 or otherwise fails to meet the requirements of this ,act4 7h7 ,protection of sensitive information 7#a7 ,in general ,the ,administrator shall develop and maintain procedures to prevent the unauthorized disclosure of any trade secret or confidential information obtained by the ,administrator4 7#b7 ,limitation ,the requirement under this subsection does not-- 7,a7 limit the authority of the ,administrator to inspect or copy records or to require the facility or maintenance of records under this ,act2 7,b7 have any legal effect on section #aije of title #ah1 ,united ,states ,code2 7,c7 extend to any food recipe1 financial data1 pricing data1 personnel data1 or sales data 7other than shipment dates relating to sales72 7,d7 limit the public disclosure of distribution records or other records related to food subject to a voluntary or mandatory recall under section #djb2 or 7,e7 limit the authority of the ,administrator to promulgate regulations to permit the sharing of data with other governmental authorities4 7i7 ,bribery of or gifts to inspector or other officers and acceptance of gifts ,section #bb of the ,federal ,meat ,inspection ,act 7#ba ,u4,s4,c4 #fbb7 shall apply under this ,act4 #bjf4 ,food production establishments ,in carrying out the duties of the ,administrator and the purposes of this ,act1 the ,administrator shall have the authority1 with respect to food production establishments1 to-- 7#a7 visit and inspect food production establishments in the ,united ,states and in foreign countries for food safety purposes2 7#b7 review food safety records as needed to carry out traceback and for other food safety purposes2 7#c7 set good practice standards to protect the public and promote food safety2 7#d7 partner with appropriate agencies to monitor animals1 plants1 products1 or the environment1 as appropriate2 and 7#e7 collect and maintain information relevant to public health and farm practices4 #bjg4 ,federal and ,state cooperation 7a7 ,in general ,the ,administrator shall work with the ,states to carry out activities and programs that create a national food safety program so that ,federal and ,state programs function in a coordinated and cost-effective manner4 7b7 ,state action ,the ,administrator shall work with ,states to-- 7#a7 continue1 strengthen1 or establish ,state food safety programs1 especially with respect to the regulation of retail commercial food establishments1 transportation1 harvesting1 and fresh markets2 7#b7 continue1 strengthen1 or establish inspection programs and requirements to ensure that food under the jurisdiction of the ,state is safe2 and 7#c7 support recall authorities at the ,state and local levels4 7c7 ,assistance ,to assist in planning1 developing1 and implementing a food safety program1 the ,administrator may provide to a ,state-- 7#a7 advisory assistance2 7#b7 technical and laboratory assistance and training 7including necessary materials and equipment72 and 7#c7 financial assistance1 in kind assistance1 and other aid4 7d7 ,service agreements 7#a7 ,in general ,the ,administrator may1 under agreements entered into with ,federal1 ,state1 or local agencies1 use on a reimbursable basis or otherwise the personnel and services of those agencies in carrying out this ,act4 7#b7 ,training ,agreements with a ,state under this subsection may provide for training of ,state employees4 7#c7 ,maintenance of agreements ,the ,administrator shall maintain any agreement that is in effect on the day before the date of enactment of this ,act until the ,administrator evaluates such agreement and determines whether to maintain or substitute such agreement4 7e7 ,audits 7#a7 ,in general ,the ,administrator shall annually conduct a comprehensive review of each ,state program that provides services to the ,administrator in carrying out the responsibilities under this ,act1 including mandated inspections under section #bje4 7#b7 ,requirements ,the review shall-- 7,a7 include a determination of the effectiveness of the ,state program2 and 7,b7 identify any changes necessary to ensure enforcement of ,federal requirements under this ,act4 7f7 ,no ,federal preemption ,nothing in this ,act shall be construed to preempt the enforcement of ,state food safety laws and standards that are at least as stringent as those under this ,act4 #bjh4 ,foreign supplier verification program 7a7 ,in general ,the ,administrator shall require that each importer of products from a feed facility1 food facility1 or food producer establishment be in compliance with the foreign supplier verification program requirements under section #hje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chd;a74 7b7 ,rule of construction ,in applying subsection 7a7 with respect to products subject to the ,federal ,meat ,inspection ,act 7#ba ,u4,s4,c4 #fja et seq471 the ,poultry ,products ,inspection ,act 7#ba ,u4,s4,c4 #dea et seq471 or the ,egg ,products ,inspection ,act 7#ba ,u4,s4,c4 #ajca et seq471 references in section #hje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chd;a7 to sections #djb1 #djc7w71 #dah1 and #dai of such ,act 7#ba ,u4,s4,c4 #cdb1 #cdc7w71 #cej;g1 and #cej;h7 shall be construed to be references to the corresponding provisions of the food safety law1 if any1 that apply to such products1 as determined by the ,administrator4 7c7 ,repeal of exemptions ,section #hje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chd;a7 is amended-- 7#a7 in subsection 7a77#a71 by striking subsections 7e7 and 7f7 and inserting subsection 7e72 7#b7 by striking subsection 7e72 and 7#c7 by redesignating subsections 7f7 and 7g7 as subsections 7e7 and 7f71 respectively4 #bji4 ,imports 7a7 ,in general ,not later than #b years after the date of enactment of this ,act1 the ,administrator shall establish a system under which a foreign government seeking to certify food for importation into the ,united ,states shall submit a request for accreditation to the ,administrator4 7b7 ,accreditation standard ,a foreign government requesting to be accredited to certify food for importation into the ,united ,states shall demonstrate1 in a manner determined appropriate by the ,administrator1 that the foreign government 7or an agency thereof7 is capable of adequately ensuring that eligible entities or foods certified by such government 7or agency7 meet the requirements of the food safety law4 7c7 ,request by foreign government ,prior to granting accreditation to a foreign government under this section1 the ,administrator shall review and audit the food safety program of the requesting foreign government and certify that such program 7including all statutes1 regulations1 and inspection authority7 meets the standard specified in subsection 7b74 7d7 ,limitations ,any accreditation of a foreign government under this section shall-- 7#a7 specify the foods covered by the accreditation2 and 7#b7 be limited to a period not to exceed #e years4 7e7 ,withdrawal of accreditation ,the ,administrator may withdraw accreditation fully or partially from a foreign government if the ,administrator finds that-- 7#a7 food covered by the accreditation is linked to an outbreak of human illness2 7#b7 the programs or procedures of the foreign government no longer meet the standards of the food safety programs and procedures of the ,united ,states2 or 7#c7 the foreign government refuses to allow ,united ,states officials to conduct such audits and investigations as may be necessary to fulfill the requirements under this section4 7f7 ,renewal of accreditation ,the ,administrator shall audit foreign governments accredited under this section at least every #e years to ensure the continued compliance by such governments with the standard set forth in subsection 7b74 7g7 ,required routine inspection ,the ,administrator shall routinely inspect food or food animals by physical examination before the food or food animals enter the ,united ,states to ensure that the food or food animals-- 7#a7 are safe2 7#b7 are labeled as required for food produced in the ,united ,states2 and 7#c7 otherwise meet the requirements of the food safety law4 7h7 ,enforcement ,the ,administrator may-- 7#a7 deny importation of food from any country if the country's government does not permit ,united ,states officials to enter the country to conduct such audits and inspections as may be necessary to fulfill the requirements under this section2 7#b7 deny importation of food from any country or foreign facility that does not consent to an investigation by the ,administrator when food from that country or foreign facility is linked to a foodborne illness outbreak or is otherwise found to be adulterated or mislabeled2 and 7#c7 promulgate regulations to carry out the purposes of this section1 including setting terms and conditions for the destruction of products that fail to meet the standards of the food safety law4 7i7 ,detention and seizure ,any food imported for consumption in the ,united ,states that fails to meet the standards of the food safety law may be detained1 seized1 or condemned4 #baj4 ,traceback 7a7 ,in general ,the ,administrator1 in order to protect the public health1 shall establish requirements for a national system for tracing food1 animals1 or ingredients from point of origin to retail sale1 subject to subsection 7b74 7b7 ,applicability ,traceability requirements shall-- 7#a7 be established in accordance with regulations and guidelines issued by the ,administrator2 and 7#b7 apply to food production establishments and food facilities4 #baa4 ,food safety technology 7a7 ,in general ,the ,administrator shall establish and implement a program1 to be known as the ,food ,safety ,technology ,program1 to foster innovation in food technologies and foods that have the potential to improve food safety at the point of production1 processing1 transport1 storage1 or final preparation4 7b7 ,program described ,the program under this section shall consist of technical guidance to and consultation with technology developers to assist them in meeting requirements for approval of technologies and products described in subsection 7a74 ,,iii ,research and education #cja4 ,public health assessment system 7a7 ,in general ,the ,administrator1 acting in coordination with the ,director of the ,centers for ,disease ,control and ,prevention and the ,deputy ,under ,secretary of ,agriculture for ,research1 ,education1 and ,economics1 shall-- 7#a7 have access to the applicable data systems of the ,centers for ,disease ,control and ,prevention and to the databases made available by a ,state2 7#b7 partner with relevant agencies to maintain or access an active surveillance system of food and epidemiological evidence submitted by ,states to the ,centers for ,disease ,control and ,prevention based on a representative proportion of the population of the ,united ,states2 7#c7 assess the frequency and sources of human illness in the ,united ,states associated with the consumption of food2 7#d7 partner with relevant agencies to maintain or access a state-of-the-art partial or full genome sequencing system and epidemiological system dedicated to foodborne illness identification1 outbreaks1 and containment2 and 7#e7 have access to the surveillance data created via monitoring and statistical studies conducted as part of its own inspection4 7b7 ,public health sampling 7#a7 ,in general ,not later than #a year after the date of enactment of this ,act1 the ,administrator shall establish guidelines for a sampling system under which the ,administrator shall take and analyze samples of food-- 7,a7 to assist the ,administrator in carrying out this ,act2 and 7,b7 to assess the nature1 frequency of occurrence1 and quantities of contaminants in food4 7#b7 ,requirements ,the sampling system described in paragraph 7#a7 shall provide-- 7,a7 statistically valid monitoring1 including market-based studies1 on the nature1 frequency of occurrence1 and quantities of contaminants in food available to consumers2 and 7,b7 at the request of the ,administrator1 such other information1 including analysis of monitoring and verification samples1 as the ,administrator determines may be useful in assessing the occurrence of contaminants in food4 7c7 ,assessment of health hazards ,through the surveillance system referred to in subsection 7a71 the sampling system described in subsection 7b71 and other available data1 the ,administrator shall-- 7#a7 rank food categories based on the hazard to human health presented by the food category2 7#b7 identify appropriate industry and regulatory approaches to minimize hazards in the food supply2 and 7#c7 assess the public health environment for emerging diseases1 including zoonosis1 for their risk of appearance in the ,united ,states food supply4 #cjb4 ,public education and advisory system 7a7 ,public education ,the ,administrator shall-- 7#a7 in cooperation with private and public organizations1 including the cooperative extension services and building on the efforts of appropriate ,state and local entities1 establish a national public education program on food safety2 and 7#b7 coordinate with other ,federal departments and agencies to integrate food safety messaging into all food-related agricultural1 nutrition1 and health promotion programs4 7b7 ,health advisories ,the ,administrator1 in consultation with such other ,federal departments and agencies as the ,administrator determines necessary1 shall work with the ,states and other appropriate entities-- 7#a7 to develop and distribute regional and national advisories concerning food safety2 7#b7 to develop standardized formats for written and broadcast advisories2 7#c7 to incorporate ,state and local advisories into the national public education program established under subsection 7a72 and 7#d7 to present prompt1 specific information regarding foods found to pose a threat to the public health4 #cjc4 ,research 7a7 ,in general ,the ,administrator shall conduct research to carry out this ,act1 including studies to-- 7#a7 improve sanitation and food safety practices in the processing of food2 7#b7 develop improved techniques to monitor and inspect food2 7#c7 develop efficient1 rapid1 and sensitive methods to detect contaminants in food2 7#d7 determine the sources of contamination of contaminated food2 7#e7 develop food consumption data2 7#f7 identify ways that animal production techniques could improve the safety of the food supply2 7#g7 draw upon research and educational programs that exist at the ,state and local level2 7#h7 determine the food safety education needs of vulnerable populations1 including children less than #aj years of age1 pregnant women1 adults #fe years of age and older1 and individuals with compromised immune systems2 7#i7 utilize the partial or full genome sequencing system and other processes to identify and control pathogens2 7#aj7 address common and emerging zoonotic diseases2 7#aa7 develop methods to reduce or destroy harmful pathogens before1 during1 and after processing2 7#ab7 analyze the incidence of antibiotic resistance as it pertains to the food supply and develop new methods to reduce infection by antibiotic resistant bacteria in humans and animals2 and 7#ac7 conduct other research that supports the purposes of this ,act4 7b7 ,contract authority ,the ,administrator may enter into contracts and agreements with any ,state1 institution of higher education1 ,federal ,government agency1 or person to carry out this section4 ,,iv ,enforcement #dja4 ,prohibited acts ,it shall be unlawful-- 7#a7 for a person-- 7,a7 to manufacture1 introduce1 deliver for introduction1 or receive into interstate commerce any food that is adulterated1 misbranded1 or otherwise unsafe2 7,b7 to adulterate or misbrand any food in interstate commerce2 7,c7 to refuse to permit access to a food facility for the inspection and copying of a record as required under section #bje7;g72 7,d7 to fail to establish or maintain any record or to make any report as required under section #bje7;g72 7,e7 to refuse to permit entry to or inspection of a food facility as required under section #bje2 7,f7 to fail to provide to the ,administrator the results of a testing or sampling of a food1 equipment1 or material in contact with contaminated food under section #bje7;g77#a77;,b72 7,g7 to fail to comply with an applicable provision of1 or a regulation or order of the ,administrator under1 section #bjb1 #bjd1 or #bjh2 7,h7 to slaughter an animal that is capable for use in whole or in part as human food at a food facility processing any such food for commerce1 except in compliance with the food safety law2 7,i7 to fail to comply with a recall or other order under section #djb2 or 7,j7 to otherwise violate the food safety law2 and 7#b7 for a food facility or foreign food facility to fail to register under section #bjb1 or to operate without a valid registration4 #djb4 ,mandatory recall authority 7a7 ,voluntary procedures ,if the ,administrator determines that there is a reasonable probability that an article of food 7other than infant formula7 is adulterated or misbranded and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals1 the ,administrator shall provide to the owner1 operator1 or agent in charge of the facility that created1 caused1 or was otherwise responsible for that article of food an opportunity to cease distribution and recall that article of food in a manner and within a time period determined by the ,administrator4 7b7 ,prehearing ,order ,to ,cease ,distribution and ,give ,notice 7#a7 ,in general ,if the owner1 operator1 or agent in charge of a facility refuses to1 or does not voluntarily1 cease distribution or recall an article of food in the manner and within the time period determined by the ,administrator under subsection 7a71 the ,administrator may by order require1 as the ,administrator determines to be necessary-- 7,a7 that owner1 operator1 or agent-- 7i7 to immediately cease distribution of that article of food2 and 7ii7 as applicable1 to immediately notify all persons manufacturing1 processing1 packing1 transporting1 distributing1 receiving1 holding1 or importing and selling that article of food2 and 7,b7 any person to which that article of food has been distributed1 transported1 or sold1 to immediately cease distribution of that article of food4 7#b7 ,required additional information 7,a7 ,in general ,if an article of food covered by a recall order issued under paragraph 7#a7 has been distributed to a warehouse-based1 third-party logistics provider without providing such provider sufficient information to know or reasonably determine the precise identity of the article of food covered by a recall order that is in its possession1 the notice provided by the owner1 operator1 or agent of a facility under paragraph 7#a77;,a77ii7 shall include such information as is necessary for the warehouse-based1 third-party logistics provider to identify the article of food4 7,b7 ,rules of construction ,nothing in this paragraph shall be construed-- 7i7 to exempt a warehouse-based1 third-party logistics provider from the requirements of food safety law2 or 7ii7 to exempt a warehouse-based1 third-party logistics provider from being the subject of a mandatory recall order4 7#c7 ,determination to limit areas affected ,if the ,administrator requires an owner1 operator1 or agent in charge of the facility to cease distribution under paragraph 7#a77;,a77i7 of an article of food identified under subsection 7a71 the ,administrator may limit the size of the geographic area and the markets affected by such cessation if such limitation would not compromise the public health4 7c7 ,hearing on order ,the ,administrator shall provide the owner1 operator1 or agent in charge of the facility subject to an order under subsection 7b7 with an opportunity for an informal hearing1 to be held as soon as possible1 but not later than #b days after the issuance of the order1 on the actions required by the order and on why the article that is the subject of the order should not be recalled4 7d7 ,post-,hearing ,recall ,order and ,modification of ,order 7#a7 ,amendment of order ,if1 after providing opportunity for an informal hearing under subsection 7c71 the ,administrator determines that removal of the applicable article of food from commerce is necessary1 the ,administrator shall1 as appropriate-- 7,a7 amend the order to require recall of such article or other appropriate action2 7,b7 specify a timetable in which the recall shall occur2 7,c7 require periodic reports to the ,administrator describing the progress of the recall2 and 7,d7 provide notice to consumers to whom such article was1 or may have been1 distributed4 7#b7 ,vacating of order ,if1 after an informal hearing under subsection 7c71 the ,administrator determines that adequate grounds do not exist to continue the actions required by the applicable order1 or that such actions should be modified1 the ,administrator shall vacate the order or modify the order1 as appropriate4 7e7 ,rule regarding alcoholic beverages ,the ,administrator shall not initiate a mandatory recall or take any other action under this section with respect to any alcohol beverage until the ,administrator has provided the ,administrator of the ,alcohol and ,tobacco ,tax and ,trade ,bureau with a reasonable opportunity to cease distribution and recall the alcohol beverage under the authority of the ,administrator of the ,alcohol and ,tobacco ,tax and ,trade ,bureau4 7f7 ,cooperation and consultation ,the ,administrator shall work with ,state and local public health officials in carrying out this section1 as appropriate4 7g7 ,public notification ,in conducting a recall under this section1 the ,administrator shall-- 7#a7 ensure that a press release is published regarding the recall1 as well as alerts and public notices1 as appropriate1 in order to provide notification-- 7,a7 of the recall to consumers and retailers to whom the applicable article of food was1 or may have been1 distributed2 and 7,b7 that includes1 at a minimum-- 7i7 the name of the article of food subject to the recall2 7ii7 a description of the risk associated with such article2 and 7iii7 to the extent practicable1 information for consumers about similar articles of food that are not affected by the recall2 7#b7 provide to the public a list of retail consignees receiving products for which there is determined to be a reasonable probability that eating the food will cause serious adverse health consequences or death to humans or animals2 and 7#c7 if available1 publish on the internet website of the ,administration an image of the article that is the subject of the press release described in paragraph 7#a74 7h7 ,no delegation ,the authority conferred by this section to order a recall or vacate a recall order shall not be delegated to any officer or employee other than the ,administrator4 7i7 ,effect ,nothing in this section shall affect the authority of the ,administrator to request or participate in a voluntary recall1 or to issue an order to cease distribution or to recall under any other provision of the food safety law or under the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bja et seq474 7j7 ,coordinated communication 7#a7 ,in general ,to assist in carrying out the requirements of this subsection1 the ,administrator shall establish an incident command operation or a similar operation that will operate not later than #bd hours after the initiation of a mandatory recall or the recall of an article of food for which the use of1 or exposure to1 such article will cause serious adverse health consequences or death to humans or animals4 7#b7 ,requirements ,to reduce the potential for miscommunication during recalls or regarding investigations of a foodborne illness outbreak associated with a food that is subject to a recall1 each incident command operation or similar operation under paragraph 7#a7 shall use regular staff and resources of the ,administration to-- 7,a7 ensure timely and coordinated communication within the ,administration1 including enhanced communication and coordination between different agencies and organizations within the ,administration2 7,b7 ensure timely and coordinated communication from the ,administration1 including public statements1 throughout the duration of the investigation and related foodborne illness outbreak2 7,c7 identify a single point of contact within the ,administration for public inquiries regarding any actions by the ,administrator related to a recall2 7,d7 coordinate with ,federal1 ,state1 local1 and ,tribal authorities1 as appropriate1 that have responsibilities related to the recall of a food or a foodborne illness outbreak associated with a food that is subject to the recall1 including notification of the ,secretary of ,agriculture and the ,secretary of ,education in the event such recalled food is a commodity intended for use in a child nutrition program 7as defined in section #be7;b7 of the ,richard ,b4 ,russell ,national ,school ,lunch ,act 7#db ,u4,s4,c4 #agfi;f7b7772 and 7,e7 conclude operations at such time as the ,administrator determines appropriate4 7#c7 ,multiple recalls ,the ,administrator may establish multiple or concurrent incident command operations or similar operations in the event of multiple recalls or foodborne illness outbreaks4 7#d7 ,fees applicable to all facilities ,fees described in section #gdc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ca7 for not complying with a recall order are applicable to all food facilities under this ,act as if-- 7,a7 the term responsible party means owner1 operator1 or agent in charge of the facility2 and 7,b7 references to section #dbc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4#cejl7 are references to section #djb of this ,act4 #djc4 ,injunction proceedings 7a7 ,jurisdiction ,the district courts of the ,united ,states1 and the ,united ,states courts of the territories and possessions of the ,united ,states1 shall have jurisdiction1 for cause shown1 to restrain a violation of section #bjb1 #bjc1 #bjd1 #bjg1 or #dja 7or a regulation promulgated under that section74 7b7 ,trial ,in a case in which violation of an injunction or restraining order issued under this section also constitutes a violation of the food safety law1 trial shall be by the court or1 upon demand of the accused1 by a jury4 #djd4 ,civil and criminal penalties 7a7 ,civil sanctions 7#a7 ,civil penalty 7,a7 ,in general ,any person that violates section #dja may be assessed a civil penalty by the ,administrator of not more than #bej1jjj for each violation4 7,b7 ,separate offense ,each violation described in subparagraph 7,a7 and each day during which that violation continues shall be considered a separate offense4 7#b7 ,other requirements 7,a7 ,written order ,the civil penalty described in paragraph 7#a7 shall be assessed by the ,administrator by a written order1 which shall specify the amount of the penalty and the basis for the penalty under subparagraph 7,b7 considered by the ,administrator4 7,b7 ,amount of penalty ,subject to paragraph 7#a77;,a71 the amount of the civil penalty shall be determined by the ,administrator1 after considering-- 7i7 the gravity of the violation2 7ii7 the degree of culpability of the person2 7iii7 the size and type of the business of the person2 and 7iv7 any history of prior offenses by the person under the food safety law4 7,c7 ,review of order ,a written order under subparagraph 7,a7 may be reviewed only in accordance with subsection 7c74 7b7 ,criminal sanctions 7#a7 ,in general ,except as provided in paragraphs 7#b7 and 7#c71 a person that violates subparagraph 7,a7 or 7,b7 of section #dja7a7 shall be imprisoned for not more than #a year1 fined not more than #aj1jjj1 or both4 7#b7 ,severe violations ,a person that commits a violation described in paragraph 7#a7 after a conviction of that person under this section has become final1 or commits such a violation with the intent to defraud or mislead1 shall be imprisoned for not more than #c years1 fined not more than #ajj1jjj1 or both4 7#c7 ,exception ,no person shall be subject to the penalties of this subsection-- 7,a7 for having received1 proffered1 or delivered in interstate commerce any food1 if the receipt1 proffer1 or delivery was made in good faith1 unless that person refuses to furnish 7on request of an officer or employee designated by the ,administrator7-- 7i7 the name1 address1 and contact information of the person from whom that person purchased or received the food2 7ii7 copies of all documents relating to the person from whom that person purchased or received the food2 and 7iii7 copies of all documents pertaining to the delivery of the food to that person2 or 7,b7 if that person establishes a guaranty signed by1 and containing the name and address of1 the person from whom that person received in good faith the food1 stating that the food is not adulterated or misbranded within the meaning of this ,act4 7c7 ,judicial review 7#a7 ,in general ,an order assessing a civil penalty under subsection 7a7 shall be a final order unless the person-- 7,a7 not later than #cj days after the effective date of the order1 files a petition for judicial review of the order in-- 7i7 the court of appeals of the ,united ,states for the judicial circuit in which that person resides or has its principal place of business2 or 7ii7 the ,united ,states ,court of ,appeals for the ,district of ,columbia ,circuit2 and 7,b7 simultaneously serves a copy of the petition by certified mail to the ,administrator4 7#b7 ,filing of record ,not later than #de days after the service of a copy of the petition under paragraph 7#a77;,b71 the ,administrator shall file in the court a certified copy of the administrative record upon which the order was issued4 7#c7 ,standard of review ,the findings of the ,administrator relating to the order shall be set aside only if found to be unsupported by substantial evidence on the record as a whole4 7d7 ,collection ,actions for ,failure ,to ,pay 7#a7 ,in general ,if any person fails to pay a civil penalty assessed under subsection 7a7 after the order assessing the penalty has become a final order1 or after the court of appeals described in subsection 7c7 has entered final judgment in favor of the ,administrator1 the ,administrator shall refer the matter to the ,attorney ,general1 who shall institute in a district court of the ,united ,states of competent jurisdiction a civil action to recover the amount assessed4 7#b7 ,limitation on review ,in a civil action under paragraph 7#a71 the validity and appropriateness of the order of the ,administrator assessing the civil penalty shall not be subject to judicial review4 7e7 ,penalties paid into account ,the ,administrator-- 7#a7 shall deposit penalties collected under this section in an account in the ,treasury2 and 7#b7 may use the funds in the account1 without further appropriation or fiscal year limitation-- 7,a7 to carry out enforcement activities under food safety law2 or 7,b7 to provide assistance to ,states to inspect retail commercial food establishments or other food or firms under the jurisdiction of ,state food safety programs4 7f7 ,discretion of the ,administrator ,to ,prosecute ,nothing in this ,act requires the ,administrator to report for prosecution1 or for the commencement of an action1 the violation of the food safety law in a case in which the ,administrator finds that the public interest will be adequately served by the assessment of a civil penalty under this section4 7g7 ,remedies not exclusive ,the remedies provided in this section may be in addition to1 and not exclusive of1 other remedies that may be available4 #dje4 ,presumption ,in any action to enforce the requirements of the food safety law1 the connection with interstate commerce required for jurisdiction shall be presumed to exist4 #djf4 ,whistleblower protection ,section #ajac of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cii;d7 shall apply with respect to any violation of1 or any act or omission an employee reasonably believes to be a violation of1 any provision of this ,act to the same extent and in the same manner as that section applies with respect to a violation of1 or any act or omission an employee reasonably believes to be a violation of1 any provision of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq474 #djg4 ,administration and enforcement 7a7 ,in general ,for the efficient administration and enforcement of the food safety law1 the provisions 7including provisions relating to penalties7 of sections #f1 #h1 #i1 and #aj of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #df1 #dh1 #di1 and #ej7 7except subsections 7c7 through 7h7 of section #f of that ,act 7#ae ,u4,s4,c4 #df771 relating to the jurisdiction1 powers1 and duties of the ,federal ,trade ,commission and the ,attorney ,general to administer and enforce that ,act1 and to the rights and duties of persons with respect to whom the powers are exercised1 shall apply to the jurisdiction1 powers1 and duties of the ,administrator and the ,attorney ,general in administering and enforcing the provisions of the food safety law and to the rights and duties of persons with respect to whom the powers are exercised1 respectively4 7b7 ,inquiries and actions 7#a7 ,in general ,the ,administrator1 in person or by such agents as the ,administrator may designate1 may prosecute any inquiry necessary to carry out the duties of the ,administrator under the food safety law in any part of the ,united ,states4 7#b7 ,powers ,the powers conferred by sections #i and #aj of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #di1 #ej7 on the ,united ,states district courts may be exercised for the purposes of this chapter by any district court of the ,united ,states of competent jurisdiction4 #djh4 ,citizen civil actions 7a7 ,civil actions ,a person may commence a civil action against-- 7#a7 a person that violates a regulation 7including a regulation establishing a performance standard71 order1 or other action of the ,administrator to ensure the safety of food2 or 7#b7 the ,administrator 7in his or her capacity as the ,administrator71 if the ,administrator fails to perform an act or duty to ensure the safety of food that is not discretionary under the food safety law4 7b7 ,court 7#a7 ,in general ,the action shall be commenced in the district court of the ,united ,states for the judicial district in which the defendant resides1 is found1 or has an agent4 7#b7 ,jurisdiction ,the court described in paragraph 7#a7 shall have jurisdiction1 without regard to the amount in controversy or the citizenship of the parties1 to enforce a regulation 7including a regulation establishing a performance standard71 order1 or other action of the ,administrator1 or to order the ,administrator to perform the act or duty4 7#c7 ,damages ,the court described in paragraph 7#a7 may-- 7,a7 award damages1 in the amount of damages actually sustained2 and 7,b7 if the court determines it to be in the interest of justice1 award the plaintiff the costs of suit1 including reasonable attorney's fees1 reasonable expert witness fees1 and penalties4 7c7 ,remedies not exclusive ,the remedies provided for in this section shall be in addition to1 and not exclusive of1 other remedies that may be available4 ,v ,implementation #eja4 ,definition ,in this title1 the term transition period means the #ab-month period beginning on the date of enactment of this ,act4 #ejb4 ,reorganization plan 7a7 ,submission of plan ,not later than #ahj days after the date of enactment of this ,act1 the ,president shall transmit to the appropriate congressional committees a reorganization plan regarding the following3 7#a7 ,the transfer of agencies1 personnel1 assets1 and obligations to the ,administration pursuant to this ,act4 7#b7 ,any consolidation1 reorganization1 or streamlining of agencies transferred to the ,administration pursuant to this ,act4 7b7 ,plan elements ,the plan transmitted under subsection 7a7 shall contain1 consistent with this ,act1 such elements as the ,president determines appropriate1 including the following3 7#a7 ,identification of any functions of agencies designated to be transferred to the ,administration pursuant to this ,act that will not be transferred to the ,administration under the plan4 7#b7 ,specification of the steps to be taken by the ,administrator to organize the ,administration1 including the delegation or assignment of functions transferred to the ,administration among the officers of the ,administration in order to permit the ,administration to carry out the functions transferred under the plan4 7#c7 ,specification of the funds available to each agency that will be transferred to the ,administration as a result of transfers under the plan4 7#d7 ,specification of the proposed allocations within the ,administration of unexpended funds transferred in connection with transfers under the plan4 7#e7 ,specification of any proposed disposition of property1 facilities1 contracts1 records1 and other assets and obligations of agencies transferred under the plan4 7#f7 ,specification of the proposed allocations within the ,administration of the functions of the agencies and subdivisions that are not related directly to ensuring the safety of food4 7c7 ,modification of plan ,the ,president may1 on the basis of consultations with the appropriate congressional committees1 modify or revise any part of the plan until that part of the plan becomes effective in accordance with subsection 7d74 7d7 ,effective date 7#a7 ,in general ,the reorganization plan described in this section1 including any modifications or revisions of the plan under subsection 7c71 shall become effective for an agency on the earlier of-- 7,a7 the date specified in the plan 7or the plan as modified pursuant to subsection 7c771 except that such date may not be earlier than #ij days after the date the ,president has transmitted the reorganization plan to the appropriate congressional committees pursuant to subsection 7a72 or 7,b7 the end of the transition period4 7#b7 ,statutory construction ,nothing in this subsection may be construed to require the transfer of functions1 personnel1 records1 balances of appropriations1 or other assets of an agency on a single date4 7#c7 ,supercedes existing law ,paragraph 7#a7 shall apply notwithstanding section #ije7;b7 of title #e1 ,united ,states ,code4 #ejc4 ,transitional authorities 7a7 ,provision of assistance by officials ,until the transfer of an agency to the ,administration1 any official having authority over or function relating to the agency on the day before the date of enactment of this ,act shall provide the ,administrator such assistance1 including the use of personnel and assets1 as the ,administrator may request in preparing for the transfer and integration of the agency to the ,administration4 7b7 ,services and personnel ,during the transition period1 upon the request of the ,administrator1 the head of any ,executive agency may1 on a reimbursable basis1 provide services or detail personnel to assist with the transition4 7c7 ,acting officials 7#a7 ,in general ,during the transition period1 pending the advice and consent of the ,senate to the appointment of an officer required by this ,act to be appointed by and with such advice and consent1 the ,president may designate any officer whose appointment was required to be made by and with such advice and consent and who was such an officer on the day before the date of enactment of this ,act 7and who continues to be in office7 or immediately before such designation1 to act in such office until the same is filled as provided in this ,act4 7#b7 ,compensation ,while acting pursuant to paragraph 7#a71 such officers shall receive compensation at the higher of-- 7,a7 the rates provided by this ,act for the respective offices in which they act2 or 7,b7 the rates provided for the offices held at the time of designation4 7#c7 ,limitation ,nothing in this ,act shall be construed to require the advice and consent of the ,senate to the appointment by the ,president to a position in the ,administration of any officer whose agency is transferred to the ,administration pursuant to this ,act and whose duties following such transfer are germane to those performed before such transfer4 7d7 ,transfer of personnel1 assets1 obligations1 and function 7#a7 ,in general ,consistent with section #aeca of title #ca1 ,united ,states ,code1 the personnel1 assets1 liabilities1 contracts1 property1 records1 and unexpended balances of appropriations1 authorizations1 allocations1 and other funds that relate to the functions transferred under subsection 7a7 from a ,federal agency shall be transferred to the ,administration4 7#b7 ,unexpended funds ,unexpended funds transferred under this subsection shall be used by the ,administration only for the purposes for which the funds were originally authorized and appropriated4 #ejd4 ,savings provisions 7a7 ,completed administrative actions ,the enactment of this ,act or the transfer of functions under this ,act shall not affect any order1 determination1 rule1 regulation1 permit1 personnel action1 agreement1 grant1 contract1 certificate1 license1 registration1 privilege1 or other administrative action issued1 made1 granted1 or otherwise in effect or final with respect to that agency on the day before the transfer date with respect to the transferred functions4 7b7 ,pending proceedings ,subject to the authority of the ,administrator under this ,act-- 7#a7 pending proceedings in an agency1 including notices of proposed rulemaking1 and applications for licenses1 permits1 certificates1 grants1 and financial assistance1 shall continue notwithstanding the enactment of this ,act or the transfer of the agency to the ,administration1 unless discontinued or modified under the same terms and conditions and to the same extent that such discontinuance could have occurred if such enactment or transfer had not occurred2 and 7#b7 orders issued in such proceedings1 and appeals from those orders1 and payments made pursuant to such orders1 shall be issued in the same manner on the same terms as if this ,act had not been enacted or the agency had not been transferred1 and any such order shall continue in effect until amended1 modified1 superceded1 terminated1 set aside1 or revoked by an officer of the ,united ,states or a court of competent jurisdiction1 or by operation of law4 7c7 ,pending civil actions ,subject to the authority of the ,administrator under this ,act1 any civil action commenced with regard to that agency pending before that agency on the day before the transfer date with respect to the transferred functions shall continue notwithstanding the enactment of this ,act or the transfer of an agency to the ,administration4 7d7 ,references 7#a7 ,in general ,after the transfer of functions from a ,federal agency under this ,act1 any reference in any other ,federal law1 ,executive order1 rule1 regulation1 directive1 document1 or other material to that ,federal agency or the head of that agency in connection with the administration or enforcement of the food safety laws shall be deemed to be a reference to the ,administration or the ,administrator1 respectively4 7#b7 ,statutory reporting requirements ,statutory reporting requirements that applied in relation to such an agency on the day before the date of enactment of this ,act shall continue to apply following such transfer if the reporting requirements refer to the agency by name4 #eje4 ,conforming amendments ,section #ecac of title #e1 ,united ,states ,code1 is amended by adding at the end the following new item3 ,administrator of ,food ,safety4 4 #ejf4 ,additional technical and conforming amendments ,not later than #fj days after the submission of the reorganization plan under section #ejb1 the ,president shall prepare and submit proposed legislation to ,congress containing necessary and appropriate technical and conforming amendments to any food safety law to reflect the changes made by this ,act4 #ejg4 ,regulations ,the ,administrator may promulgate such regulations as the ,administrator determines are necessary or appropriate to perform the duties of the ,administrator4 #ejh4 ,authorization of appropriations ,there are authorized to be appropriated such sums as are necessary to carry out this ,act4 #eji4 ,limitation on authorization of appropriations ,for the fiscal year that includes the date of enactment of this ,act1 the amount authorized to be appropriated to carry out this ,act shall not exceed-- 7#a7 the amount appropriated for that fiscal year for the ,federal agencies identified in section #ajb7;b7 for the purpose of administering or enforcing the food safety law2 or 7#b7 the amount appropriated for those agencies for that purpose for the preceding fiscal year1 if1 as of the date of enactment of this ,act1 appropriations for those agencies for the fiscal year that includes that date of enactment have not yet been made4