,,ii #aahth ,,congress #b;d ,session ,s4 #dcjc ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,may #i1 #bjbd,ms4 ,klobuchar 7for herself and ,ms4 ,duckworth7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to ensure the safety of food and limit the presence of contaminants in infant and toddler food1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,baby ,food ,safety ,act of #bjbd4 #b4 ,definition of infant and toddler food ,section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7 is amended by adding at the end the following3 7tt7 ,the term infant and toddler food means food that purports to be1 or is represented as being1 specifically for infants or children up to the age of #bd months4 4 #c4 ,contaminants in food1 including infant and toddler food 7a7 ,in general ,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 #dbe4 ,contaminants in food1 including infant and toddler food 7a7 ,administrative orders for contaminants in food 7#a7 ,in general ,within the applicable timeframe specified in paragraph 7#d71 the ,secretary1 by administrative order-- 7,a7 shall establish limits on-- 7i7 lead1 cadmium1 mercury1 and total arsenic in infant and toddler food2 7ii7 lead1 cadmium1 mercury1 and total arsenic in food pouches made with fruit or vegetable puree or juice2 and 7iii7 lead and arsenic in juice2 and 7,b7 if the ,secretary determines appropriate upon review of relevant health data and other relevant available information1 may-- 7i7 establish limits for additional contaminants in infant and toddler food2 7ii7 establish limits for additional contaminants in juice2 7iii7 establish limits for additional contaminants in food pouches made with fruit or vegetable puree or juice2 and 7iv7 revise limits established pursuant to subparagraph 7,a74 7#b7 ,procedure ,in establishing or revising any limit under paragraph 7#a71 the ,secretary shall-- 7,a7 evaluate relevant health data and other information the ,secretary considers relevant2 7,b7 take into account relevant differences among food types1 groups1 and categories1 as appropriate1 including the extent to which the presence of a contaminant cannot be avoided2 and 7,c7 notwithstanding the requirements of subchapter ,,ii of chapter #e of title #e1 ,united ,states ,code1 and chapter #f of title #e1 ,united ,states ,code-- 7i7 publish any administrative order under paragraph 7#a7 in the ,federal ,register following-- 7,i7 publication of a proposed order in the ,federal ,register2 and 7,,ii7 consideration of comments to a public docket open for not fewer than #de calendar days2 and 7ii7 set forth in any proposed or final administrative order under paragraph 7#a7 a substantive summary of the valid scientific evidence concerning the proposed or final limit4 7#c7 ,additional contaminants2 changes to limits ,if the ,secretary determines appropriate after review of relevant data and available health information1 the ,secretary may revise any limit established under this subsection by administrative order published in the ,federal ,register in accordance with paragraph 7#b77;,c74 7#d7 ,timeframe for initial limits 7,a7 ,proposed orders ,subject to the requirements of paragraph 7#b77;,c71 the ,secretary shall issue proposed orders for limits under paragraph 7#a77;,a7 as follows3 7i7 ,for lead1 not later than ,december #ca1 #bjbe4 7ii7 ,for total arsenic1 not later than ,december #ca1 #bjbe4 7iii7 ,for cadmium1 not later than ,april #cj1 #bjbf4 7iv7 ,for mercury1 not later than ,april #cj1 #bjbh4 7,b7 ,final orders ,the ,secretary shall issue each final administrative order for a limit established pursuant to paragraph 7#a77;,a7 not later than the earlier of-- 7i7 the applicable deadline for a final order specified in paragraph 7#a72 or 7ii7 #ah months after issuance of the respective proposed order4 7#e7 ,criteria ,the limits established under this section shall represent the level at which the ,secretary finds necessary for the protection of public health4 ,in determining such limits the ,secretary shall take into account the extent to which the use of such substance is required or cannot be avoided in the production of each such article1 and the other ways in which a consumer may be affected by the same or other contaminants1 taking into consideration relevant information and data that has been made available4 7#f7 ,adulterated food ,a food may be determined adulterated1 at the final product stage1 under section #djb7;j71 if such food bears or contains any contaminant in excess of a limit established under this subsection when considering variability of the validated method of analysis4 7#g7 ,periodic review ,the ,secretary shall periodically review the limits established under this subsection1 taking into consideration relevant information and available data to consider whether such limits should be revised1 following the procedure described in paragraph 7#b71 in accordance with the criteria specified in paragraph 7#e74 7b7 ,sampling and testing for contaminants in food1 including infant and toddler food 7#a7 ,in general ,beginning not later than #ahj days after the date of enactment of the ,baby ,food ,safety ,act of #bjbd1 the owner1 operator1 or agent in charge of a facility engaged in manufacturing or processing infant and toddler food1 food pouches made with fruit or vegetable puree or juice1 or juice for consumption in the ,united ,states shall-- 7,a7 have a control program pursuant to section #dah in place for contaminants subject to ordered limits under subsection 7a71 or be in compliance with the ,juice ,hazard ,analysis ,critical ,control ,points ,program of the ,food and ,drug ,administration1 as applicable2 7,b7 be in compliance with regulations promulgated under section #dbj7;b72 7,c7 collect representative samples of each such food in final product form in accordance with a sampling plan described in paragraph 7#b72 and 7,d7 conduct testing of the samples collected from the final food product for contaminants1 in accordance with such sampling plan4 7#b7 ,requirements for sampling plan 7,a7 ,in general ,the owner1 operator1 or agent in charge of a facility described in paragraph 7#a7 shall-- 7i7 prepare a written sampling plan for all sampling and testing required under this subsection2 and 7ii7 ensure that all sampling and testing conducted under this subsection is conducted in accordance with the sampling plan4 7,b7 ,sampling plan ,a sampling plan required by subparagraph 7,a7 shall identify-- 7i7 the number of sampling units and sample unit size based upon appropriate criteria for identifying1 in a representative fashion1 the levels of contaminants in each food2 and 7ii7 one or more appropriate test methods and procedures to be used to analyze the samples4 7,c7 ,guidance ,not later than #ah months after the date of enactment of the ,baby ,food ,safety ,act of #bjbd1 the ,secretary shall issue guidance to assist facilities described under paragraph 7#a7 with developing sampling plans4 ,such guidance may1 as the ,secretary determines appropriate1 address when samples should be tested for specific species of contaminants4 7#c7 ,contaminants to be tested ,in carrying out the sampling and testing under this subsection1 the owner1 operator1 or agent in charge of a facility described in paragraph 7#a7 shall ensure that each sample is tested for levels of-- 7,a7 lead1 cadmium1 mercury1 and total arsenic2 7,b7 any other contaminant that the ,secretary may specify by regulation1 and in accordance with the sampling plan under paragraph 7#b74 7#d7 ,foods to be tested ,the sampling and testing conducted under this subsection shall be conducted for-- 7,a7 infant and toddler foods1 in final product form2 7,b7 pouches made with fruit and vegetable puree or juice2 7,c7 juice2 and 7,d7 such other foods in final product form as the ,secretary may specify1 by regulation1 as appropriate to protect the public health4 7#e7 ,recordkeeping 7,a7 ,in general ,the owner1 operator1 or agent in charge of a facility described in paragraph 7#a7 shall maintain1 for not less than #b years or the shelf-life of each food product manufactured or processed by the facility1 whichever is longer1 records documenting the sampling plan and results of testing conducted under this subsection with respect to the food4 ,the owner1 operator1 or agent in charge of such a facility shall make such records available for inspection by the ,secretary upon request by the ,secretary4 7,b7 ,requirements ,the records maintained as required under subparagraph 7,a7 shall include-- 7i7 a detailed description of the foods sampled and tested2 7ii7 the number of samples and tests performed2 7iii7 the size and number of items in each sample unit2 7iv7 a copy of the sampling plan required under paragraph 7#b72 7v7 identification of the entity conducting the sampling2 7vi7 identification of the entity conducting the testing2 and 7vii7 identification of the analytical methods used to perform the sampling and testing4 7,c7 ,applicability ,the requirements of this paragraph shall apply to all records of sampling and testing conducted pursuant to this subsection1 regardless of the findings4 7#f7 ,laboratory accreditation ,the owner1 operator1 or agent in charge of a facility described in paragraph 7#a7 shall ensure that testing required pursuant to this subsection is performed in accordance with international standards by a laboratory that is accredited by an accreditation body that conforms to international accreditation standards4 ,testing conducted under this subsection is not subject to the requirements regarding laboratory accreditation described in section #dbb4 7#g7 ,sampling and testing program ,the ,secretary shall develop and implement a sampling and testing program for infant and toddler food for sale to consumers that is sufficient to-- 7,a7 support the periodic review under subsection 7a77#g7 of limits on lead1 cadmium1 mercury1 and arsenic in infant and toddler food2 and 7,b7 independently verify the effectiveness of the sampling and testing conducted pursuant to this subsection by the owner1 operator1 or agent in charge of a food facility4 7#h7 ,guidance ,the ,secretary shall issue guidance to assist food facilities in complying with this subsection4 7c7 ,record availability 7#a7 ,in general ,upon request by the ,secretary1 the owner1 operator1 or agent in charge of a facility described in subsection 7b77#a7 shall-- 7,a7 make all records required under this section available promptly to the ,secretary for inspection and copying2 and 7,b7 provide within a reasonable time an ,english translation of such records maintained in a language other than ,english4 7#b7 ,record availability in lieu of an inspection ,any records that the ,secretary may inspect under this section shall1 upon the request of the ,secretary1 be provided to the ,secretary by the owner1 operator1 or agent in charge of a facility described in subsection 7b77#a71 in advance of or in lieu of an inspection1 within a reasonable timeframe1 within reasonable limits1 and in a reasonable manner1 and in either electronic or physical form1 at the expense of such owner1 operator1 or agent4 ,the ,secretary's request shall include a sufficient description of the records requested4 7#c7 ,confirmation ,upon receipt of records requested under paragraph 7#a7 or 7#b71 the ,secretary shall provide to the owner1 operator1 or agent described in paragraph 7#b7 confirmation of the receipt4 7#d7 ,authority of the ,secretary ,nothing in this subsection supplants the authority of the ,secretary to conduct sampling1 testing1 or inspections otherwise permitted under this ,act in order to ensure compliance with this ,act4 7d7 ,delayed applicability ,the requirements for sampling and testing under this section shall apply beginning on the date that is #b years after the date of enactment of this subsection4 7e7 ,preemption of ,state and local requirements regarding food ingredients and contaminants in food1 including infant and toddler food ,no ,state or political subdivision of a ,state may establish or continue in effect with respect to contaminants in food1 including infant and toddler food1 food pouches made with fruit or vegetable puree or juice1 and juice1 any requirement that is different from1 or in addition to1 or not identical with any requirement under this section1 and relates to contaminant sampling and testing1 contaminant limits1 disclosure of contaminant test results1 contaminant labeling1 contaminant warnings1 or any other matter related to contaminants in food4 4 7b7 ,importer requirements ,section #hje7;c77#d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chd;a7c77#d77 is amended1 by inserting 1 including as described in section #dbe7;b7 before the period at the end4 7c7 ,enforcement 7#a7 ,adulteration ,section #djb of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdb7 is amended by adding at the end the following3 7j7 ,if it is an article of food in final product form that is an infant and toddler food1 a food pouch made with fruit or vegetable puree or juice1 or juice and-- 7#a7 such food bears or contains any contaminant in excess of limits established under section #dbe7;a72 or 7#b7 the owner1 operator1 or agent in charge of a facility that manufactures or processes the food is not in compliance with subsection 7b7 or 7c7 of section #dbe4 4 7#b7 ,prohibited act ,section #cja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is amended by adding at the end the following3 7jjj7 ,the failure of an owner1 operator1 or agent in charge of a facility that manufactures or processes food to comply with applicable requirements under subsection 7b7 or 7c7 of section #dbe4 4 #d4 ,implementation of food traceability plan2 study on inspections2 reporting on inspections 7a7 ,implementation plan ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary71 acting through the ,commissioner of ,food and ,drugs1 in coordination with the ,,fda ,human ,foods ,program and the ,center for ,food ,safety and ,applied ,nutrition1 shall finalize an implementation plan for the ,food and ,drug ,administration to achieve its goal of compliance1 not later than ,january #bj1 #bjbf1 with the rule issued by the ,food and ,drug ,administration titled1 ,requirements for ,additional ,traceability ,records for ,certain ,foods 7#hg ,fed4 ,reg4 #gjiaj 7,november #ba1 #bjbb774 ,such plan shall include a description of-- 7#a7 any resource needs of the ,food and ,drug ,administration2 7#b7 strategies for facilitating compliance with the rule2 and 7#c7 detailed plans for communicating with and educating regulated entities1 non-,federal regulatory partners1 and regulatory staff of the ,food and ,drug ,administration about the requirements under the rule4 7b7 ,study on inspections ,the ,secretary shall-- 7#a7 conduct a study to-- 7,a7 determine the annual number of facility inspections that is sufficient to determine that imported foods are held to the same safety standards as domestic food2 and 7,b7 identify whether such inspection targets are consistent with the targets in the most recent annual report regarding food conducted under section #ajjc7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cic7;h772 and 7#b7 not later than #a year after the date of enactment of this ,act1 submit a report to ,congress on the findings of such study1 and1 if applicable1 any factors preventing the ,secretary from meeting its goal for the number of inspections and a plan to ensure that such goal is met in the next #b years4 7c7 ,annual report regarding food ,section #ajjc7;h77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cic7;h77#a77 is amended-- 7#a7 in subparagraph 7,e71 by striking and at the end2 7#b7 in subparagraph 7,f71 by striking the period and inserting 2 and2 and 7#c7 by adding at the end the following3 7,g7 the nature of domestic facility and foreign facility inspections described in subparagraph 7,c71 the aggregate inspection findings of such inspections1 and the compliance rate of foreign food importers with certification standards2 4 #e4 ,records for or in lieu of certain inspections ,section #gjd7;a77#d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;a77#d77 is amended-- 7#a7 by redesignating subparagraphs 7,b7 through 7,d7 as subparagraphs 7,c7 through 7,e71 respectively2 7#b7 by inserting after subparagraph 7,a7 the following new subparagraph3 7,b7 7i7 ,any records or other information that the ,secretary may inspect under authority of this ,act from a person that owns or operates1 or is an agent in charge of1 an establishment that is engaged in any of the activities described in clause 7ii7 shall1 upon the request of the ,secretary1 be provided to the ,secretary by such person1 in advance of or in lieu of an inspection1 within a reasonable timeframe1 within reasonable limits1 and in a reasonable manner1 and in either electronic or physical form1 at the expense of such person4 ,the ,secretary's request shall include a sufficient description of the records requested4 7ii7 ,the activities described in this clause are records relating to-- 7,i7 the manufacturing1 processing1 packing1 transporting1 distributing1 receiving1 holding1 or importing of an article of food2 or 7,,ii7 the distribution or use of animal feed bearing or containing a veterinary feed directive drug1 or the issuance of a veterinary feed directive4 2 and 7#c7 by adding at the end the following3 7,f7 ,section #gjc does not apply to records or other information obtained pursuant to a request made under this section4 4 #f4 ,mandatory recall authority ,section #dbc7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cejl7a77 is amended by inserting after animals1 the following3 or if the ,secretary determines through any means that an article of infant and toddler food 7other than infant formula7 bears or contains a contaminant that renders the product adulterated under section #djb7;a77#a714 #g4 ,environmental monitoring ,chapter ,,iv of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cda et seq471 as amended by section #c1 is further amended by adding the following3 #dbf4 ,environmental monitoring of infant and toddler food 7a7 ,in general ,a manufacturer of infant and toddler food shall establish and implement an environmental monitoring program to verify the effectiveness of sanitation and hygiene controls where the food has the potential to be exposed to environment pathogens during the manufacturing and packing process4 ,the environmental monitoring program shall be written and include procedures for determining sample location1 number of samples to be taken1 and timing and frequency of sample collection and testing4 7b7 ,organisms sampled ,the environmental monitoring program under subsection 7a7 shall include testing for environmental pathogens1 lead1 arsenic1 mercury1 or a reliable indicator organism4 7c7 ,sampling location and number of samples ,a manufacturer of infant and toddler food shall ensure that the sampling locations from which samples will be taken1 and the number of sites to be tested during routine environmental monitoring are adequate to determine whether sanitation and hygiene controls are effective4 7d7 ,timing and frequency ,the timing and frequency for collecting and testing samples shall be adequate to determine whether sanitation and hygiene controls are effective4 7e7 ,records 7#a7 ,availability to the secretary ,a manufacturer shall make all the records required under this section available promptly to the ,secretary1 upon request1 for inspection and copying4 7#b7 ,maintenance ,records of environmental monitoring conducted pursuant to this section shall be established and maintained by the manufacturer for not less than #b years or the shelf-life of the food1 whichever is longer4 7#c7 ,conditions of inspection ,any records that the ,secretary may inspect under this section shall1 upon the request of the ,secretary1 be provided to the ,secretary by the manufacturer1 in advance of or in lieu of an inspection1 within a reasonable timeframe1 within reasonable limits1 and in a reasonable manner1 and in either electronic or physical form1 at the expense of such manufacturer4 ,the ,secretary's request shall include a sufficient description of the records requested4 7#d7 ,confirmation of receipt ,upon receipt of the records requested under paragraph 7#c71 the ,secretary shall provide to the manufacturer confirmation of receipt4 7f7 ,authority of the secretary ,nothing in this section supplants the authority of the ,secretary to conduct inspections otherwise permitted under this ,act in order to ensure compliance with this ,act4 7g7 ,effective date ,the requirements of this section shall apply beginning on the date that is #b years after the date of enactment of the ,baby ,food ,safety ,act of #bjbd4 7h7 ,rule of construction ,nothing in this section shall be construed to exempt any manufacturer from the requirements of this ,act1 including the requirements under section #dah4 4