,,ii #aafth ,,congress #ast ,session ,s4 #cjec ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,december #af1 #bjai,mr4 ,enzi 7for himself and ,mr4 ,tester7 introduced the following bill2 which was read twice and referred to the ,committee on ,agriculture1 ,nutrition1 and ,forestry ,a ,,bill ,to provide for the regulation1 inspection1 and labeling of food produced using animal cell culture technology1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,food ,safety ,modernization for ,innovative ,technologies ,act4 #b4 ,regulation of food produced using animal cell culture technology ,chapter ,,iv of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cda et seq47 is amended by adding at the end the following3 #dbd4 ,food produced using animal cell culture technology 7a7 ,in general ,the ,secretary shall regulate food intended for humans that is produced using animal cell culture technology derived from cell lines of animals other than livestock or poultry and1 in coordination with the ,secretary of ,agriculture1 food intended for humans that is produced using animal cell culture technology derived from cell lines of livestock or poultry4 7b7 ,duties ,pursuant to subsection 7a71 the ,secretary shall-- 7#a7 conduct premarket consultation processes to evaluate production materials1 processes1 and manufacturing controls with respect to food intended for humans that is produced using animal cell culture technology1 derived from cell lines of livestock or poultry and food intended for humans that is produced using animal cell culture technology1 derived from cell lines of animals other than livestock or poultry1 including oversight of tissue collection1 cell lines1 cell banks1 and all components and inputs2 7#b7 oversee initial cell collection and the development and maintenance of qualified cell banks1 including by issuing regulations or guidance and conducting inspections1 as appropriate2 7#c7 oversee proliferation and differentiation of cells through the time of cell harvest1 including by issuing regulations or guidance and conducting inspections1 as appropriate2 7#d7 ensure that cell bank and cell culturing facilities comply with facility registration1 applicable good manufacturing practices and preventive controls1 and requirements applicable to substances that become a component of food or otherwise affect the characteristics of food2 7#e7 develop pursuant to notice and comment rulemaking additional requirements for cell bank and cell culturing facility conditions and processes to ensure that biological material exiting the culture process is safe and not adulterated within the meaning of this chapter2 7#f7 conduct appropriate inspections and follow-up activities1 including taking enforcement action if necessary1 to ensure that cell bank and cell-culturing facilities are in compliance with applicable laws and regulations2 7#g7 coordinate the transfer of regulatory oversight of harvested cells derived from livestock or poultry to the ,secretary of the ,department of ,agriculture during cell harvest1 including providing such ,secretary with any information necessary to determine whether harvested cells are eligible to be processed into food intended for humans that is produced using animal cell culture technology1 derived from cell lines of livestock or poultry2 7#h7 inspect establishments that process1 package1 and label food intended for humans that is produced using animal cell culture technology1 derived from cell lines other than livestock or poultry2 7#i7 promulgate regulations regarding the safety and accurate labeling of food intended for humans that is produced using animal cell culture technology1 derived from cell lines other than livestock or poultry2 and 7#aj7 establish appropriate nomenclature for food intended for humans that is produced using animal cell culture technology1 derived from cell lines other than livestock or poultry4 7c7 ,collaboration with ,,usda ,in carrying out this section1 the ,secretary shall share information1 as appropriate1 with the ,department of ,agriculture1 including notifying the ,department of ,agriculture if objectionable conditions are identified at a facility carrying out any of the activities described in subsection 7b71 including conditions which may result in production of adulterated or misbranded food1 collaborating with such department to address such conditions with respect to the harvesting of cell cultures1 and rely on the ,department of ,agriculture to address such conditions with respect to processing1 packaging1 and labeling4 7d7 ,limitation ,the ,secretary shall not inspect activities of an establishment that are solely regulated by the ,secretary of ,agriculture4 7e7 ,definitions ,in this section-- 7#a7 the term livestock means cattle1 sheep1 swine1 goats1 and fish of the order ,siluriformes2 and 7#b7 the term poultry means any domesticated bird1 whether live or dead4 7f7 ,authorities related to livestock and poultry ,notwithstanding any other provision of law1 the provisions of this section shall not derogate from any authority under the ,federal ,meat ,inspection ,act or ,poultry ,product ,inspection ,act1 as in effect on the date of enactment of the ,food ,safety ,modernization for ,innovative ,technologies ,act1 with respect to the regulation of meat and poultry produced in the traditional manner4 7g7 ,no inspection of farms ,nothing in this section shall be construed to authorize the ,secretary to conduct an inspection of a farm4 4 #c4 ,inspection and labeling of food produced using animal cell culture technology from livestock and poultry cell lines 7a7 ,definitions ,in this section3 7#a7 ,adulterated ,the term adulterated1 with respect to food intended for humans that is produced using animal cell culture technology1 derived from cell lines of livestock or poultry1 means food-- 7,a7 that bears or contains any poisonous or deleterious substance which may render it injurious to health1 except that the food shall not be considered adulterated if the substance is not an added substance and the quantity of the substance in the food does not ordinarily render the food injurious to health2 7,b7 7i7 that bears or contains any added poisonous or added deleterious substance 7other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity or processed food1 a food additive1 or a color additive7 that is unsafe within the meaning of section #djf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdf72 7ii7 that bears or contains a pesticide chemical residue that is unsafe within the meaning of section #djh7;a7 of that ,act 7#ba ,u4,s4,c4 #cdf;a7a772 or 7iii7 that bears or contains-- 7,i7 any food additive that is unsafe within the meaning of section #dji of that ,act 7#ba ,u4,s4,c4 #cdh72 or 7,,ii7 a new animal drug 7or conversion product thereof7 that is unsafe within the meaning of section #eab of that ,act 7#ba ,u4,s4,c4 #cfj;b72 7,c7 that consists in whole or in part of any filthy1 putrid1 or decomposed substance1 or if the food is otherwise unfit for food2 7,d7 that has been prepared1 packed1 or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health2 7,e7 that1 in whole or in part1 is the product of a diseased animal or of an animal which has died otherwise than by slaughter2 7,f7 the container of which is composed1 in whole or in part1 of any poisonous or deleterious substance which may render the contents injurious to health2 7,g7 that has been intentionally subjected to radiation1 unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section #dji of that ,act 7#ba ,u4,s4,c4 #cdh72 7,h7 7i7 of which any valuable constituent has been in whole or in part omitted or abstracted therefrom2 7ii7 for which any substance has been substituted in whole or in part2 7iii7 for which damage or inferiority has been concealed in any manner2 or 7iv7 to which any substance has been added or mixed or packed so as to increase the bulk or weight of the food1 reduce the quality or strength of the food1 or make the food appear better or of greater value than the food is2 7,i7 that bears or contains a color additive which is unsafe within the meaning of section #gba7;a7 of that ,act 7#ba ,u4,s4,c4 #cgi;e7a772 or 7,j7 that is transported or offered for transport by a shipper1 carrier by motor vehicle or rail vehicle1 receiver1 or any other person engaged in the transportation of food under conditions that are not in compliance with regulations promulgated under section #daf of that ,act 7#ba ,u4,s4,c4 #cej;e74 7#b7 ,livestock ,the term livestock has the meaning given the term in section #dbd7;e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 7#c7 ,misbranded ,the term misbranded1 with respect to food intended for humans that is produced using animal cell culture technology1 derived from cell lines of livestock or poultry1 means food-- 7,a7 the label of which-- 7i7 does not bear-- 7,i7 the name of the food1 in accordance with subsection 7c72 7,,ii7 in the case of the food being fabricated from #b or more ingredients1 the common or usual name of each ingredient1 except that spices1 flavorings1 and colorings may1 when authorized by the appropriate agency head1 be designated as spices1 flavorings1 and colorings without naming each1 provided that to the extent that compliance is impracticable1 or results in deception or unfair competition1 exemptions shall be established by regulations promulgated by the ,secretary2 or 7,,iii7 an official inspection legend directly on the food or on the container of the food and such other information as the ,secretary requires to assure that the food will not have false or misleading labeling and that the public will be informed of the manner of handling required to maintain the food in a wholesome condition2 7,b7 the label of which is false or misleading2 7,c7 that is in a package or other container the label of which does not bear-- 7i7 the name and place of business of the manufacturer1 packer1 or distributor2 or 7ii7 an accurate statement of the quantity of the contents in terms of weight1 measure1 or numerical count1 subject to-- 7,i7 reasonable variations permitted by the ,secretary2 and 7,,ii7 in the case of a small package or container1 exemptions established by the ,secretary by regulation2 7,d7 for which any word1 statement1 or other information required by the ,secretary to appear on the label is not prominently placed on the label with such conspicuousness 7compared to any other words1 statements1 designs1 or devices on the label7 and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use2 7,e7 that is offered for sale under the name of another food2 7,f7 that is an imitation of another food1 unless the label bears the word imitation1 in type of uniform size and prominence1 and the name of the food imitated immediately after the word imitation2 7,g7 the container of which is made1 formed1 or filled as to be misleading2 7,h7 that purports to be or is represented for special dietary uses but the label of which does not bear such information concerning the vitamin1 mineral1 and other dietary properties of the food as the ,secretary1 after consultation with the ,secretary of ,health and ,human ,services1 determines to be1 and by regulations prescribes as1 necessary in order to inform purchasers fully of the value of the food for those uses2 or 7,i7 that bears or contains any artificial flavoring1 artificial coloring1 or chemical preservative but the label of which does not state that fact1 subject to exemptions established by the ,secretary by regulation in cases of compliance being impracticable4 7#d7 ,official inspection legend ,the term official inspection legend means the symbol described in subsection 7b77#b74 7#e7 ,poultry ,the term poultry has the meaning given the term in section #dbd7;e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 7#f7 ,secretary ,the term ,secretary means the ,secretary of ,agriculture4 7b7 ,inspections 7#a7 ,in general ,the ,secretary shall inspect establishments that process1 package1 and label food intended for humans that is produced using animal cell culture technology1 derived from cell lines of livestock or poultry-- 7,a7 to ensure that-- 7i7 the food is-- 7,i7 not adulterated2 and 7,,ii7 not misbranded2 and 7ii7 the establishment is operating in accordance with the regulations promulgated under paragraph 7#c74 7#b7 ,official inspection legend ,the ,secretary shall establish an official inspection legend for the food described in paragraph 7#a71 which shall be a symbol that shows that a product made from that food was inspected and passed in accordance with the regulations described in paragraph 7#c74 7#c7 ,regulations ,the ,secretary shall promulgate regulations regarding-- 7,a7 the manner and frequency of inspections required for-- 7i7 the food described in paragraph 7#a72 and 7ii7 establishments that process1 package1 and label that food2 and 7,b7 the requirements for a product of the food described in paragraph 7#a7 to satisfactorily pass an inspection and receive an official inspection legend1 including-- 7i7 sanitation and physical product inspection requirements2 7ii7 food product testing and recordkeeping requirements2 and 7iii7 the requirement for ,hazard ,analysis and ,critical ,control ,points verification4 7#d7 ,limitation ,the ,secretary shall not inspect activities of an establishment under section #dbd of the ,federal ,food1 ,drug1 and ,cosmetic ,act that are solely regulated by the ,secretary of ,health and ,human ,services4 7c7 ,labeling 7#a7 ,in general ,the ,secretary shall-- 7,a7 approve1 before introduction into commerce1 the labeling of food intended for humans that is produced using animal cell culture technology1 derived from cell lines of livestock or poultry2 and 7,b7 verify the accuracy of that labeling through inspection4 7#b7 ,requirements ,the ,secretary shall establish1 after providing notice and an opportunity for comment1 any appropriate requirements in addition to the requirements under paragraph 7#a7 to ensure the safety and accurate labeling of the food described in paragraph 7#a77;,a74 7#c7 ,regulations ,the ,secretary shall promulgate regulations-- 7,a7 to establish appropriate nomenclature for the labeling approved under paragraph 7#a77;,a72 and 7,b7 to carry out paragraph 7#a77;,b74 7d7 ,enforcement ,the ,secretary shall1 pursuant to relevant enforcement authorities governing the regulation of amenable species 7as defined in section #a of the ,federal ,meat ,inspection ,act 7#ba ,u4,s4,c4 #fja771 conduct such enforcement action as is necessary to ensure that food intended for humans that is produced using animal cell culture technology1 derived from cell lines of livestock or poultry1 that is adulterated or misbranded does not enter or is removed from commerce4 7e7 ,collaboration with ,,hhs ,in carrying out this section1 the ,secretary shall-- 7#a7 review information shared by the ,secretary of ,health and ,human ,services under section #dbd7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 7#b7 share appropriate information relating to food intended for humans that is produced using animal cell culture technology1 derived from cell lines of livestock or poultry1 with the ,secretary of ,health and ,human ,services1 as appropriate2 and 7#c7 7,a7 notify the ,secretary of ,health and ,human ,services if objectionable conditions at an establishment are identified under an inspection under subsection 7b77#a72 7,b7 collaborate with the ,secretary of ,health and ,human ,services to address those conditions with respect to cell harvesting2 and 7,c7 rely on the ,secretary of ,health and ,human ,services to address those conditions with respect to initial cell collection1 development and maintenance of qualified cell banks1 and proliferation and differentiation of cells4