,,ii #aahth ,,congress #b;d ,session ,s4 #dgbh ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,july #aa 7legislative day1 ,july #aj71 #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 or 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 or toddler food means food that purports to be1 or is represented as being1 for infants or children up to the age of #bd months4 ,such term does not include infant formula4 4 #c4 ,contaminants in food1 including infant or 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 or toddler food 7a7 ,administrative orders for contaminants1 including toxic elements1 in food 7#a7 ,in general 7,a7 ,required limits ,the ,secretary1 by administrative order1 shall establish limits on the toxic elements of lead1 cadmium1 mercury1 and arsenic 7or a species of any such toxic element7 in-- 7i7 any infant or toddler food2 and 7ii7 food predominantly composed of a fruit or vegetable puree or juice2 7,b7 ,additional limits ,if the ,secretary determines appropriate upon review of relevant health data and other relevant available information1 the ,secretary1 by administrative order1 may-- 7i7 establish limits for contaminants1 including toxic elements1 in infant or toddler food1 in addition to the limits for toxic elements described in subparagraph 7,a72 and 7ii7 establish limits for contaminants1 including toxic elements1 in food predominantly composed of a fruit or vegetable puree or juice1 in addition to the limits for toxic elements described in subparagraph 7,a72 and 7#b7 ,procedure ,in establishing or revising any limit under paragraph 7#a71 the ,secretary shall-- 7,a7 evaluate relevant health data and assessments1 data from ,state and local health departments1 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 use of such substances cannot be avoided in the production of the applicable food and its ingredients1 based on an evaluation of alternative ingredients1 use of best manufacturing and agricultural practices1 and full compliance with section #dah2 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 ,changes to limits ,if the ,secretary determines appropriate after review of relevant data and assessments and other available and relevant 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#b74 7#d7 ,timeframe for initial limits 7,a7 ,proposed orders ,subject to the requirements of paragraph 7#b71 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 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 subparagraph 7,a7 or 7,b7 of paragraph 7#a7 not later than #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 contaminant may render the infant or toddler food injurious to health4 ,in determining such limits the ,secretary shall take into account the extent to which the use of such substance cannot be avoided in the production of each such food and its ingredients1 based on an evaluation of alternative ingredients1 use of best manufacturing and agricultural practices1 and compliance with section #dah4 7#f7 ,adulterated food ,a food may be determined adulterated1 at the final product form1 under section #djb7;j71 if such food bears or contains any contaminant 7including any toxic element7 in excess of a limit established under this subsection4 7#g7 ,periodic review ,the ,secretary shall review1 not less frequently than every #d years1 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 toxic elements and 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 or toddler food2 food predominantly composed of a fruit or vegetable puree or juice2 or such other food as the ,secretary may specify by regulation1 for consumption in the ,united ,states1 shall-- 7,a7 have a control program in place for toxic elements and contaminants subject to limits under subsection 7a77#a72 7,b7 collect representative samples of each such food in final product form in accordance with a sampling plan described in paragraph 7#b72 and 7,c7 conduct testing of the samples collected from the final food product for toxic elements and contaminants1 in accordance with a sampling plan described in paragraph 7#b74 7#b7 ,requirements for sampling and testing 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 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 plan described in clause 7i74 7,b7 ,sampling plan ,a sampling and testing 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 toxic elements and contaminants in each food2 7ii7 one or more appropriate test methods and procedures to be used to analyze the samples2 and 7iii7 appropriate testing frequencies not less frequently than every quarter and whenever a significant change in the product or process necessitates such testing4 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 and testing plans4 ,such guidance shall address the standards for adequate and appropriate sampling and testing of each toxic element and contaminant as required by the ,secretary1 the minimum frequency at which samples should be tested for toxic elements and contaminants or specific species of toxic elements or contaminants1 and standards for compliance4 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 arsenic2 and 7,b7 any other contaminant that the ,secretary may specify1 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 foods predominantly composed of a fruit or vegetable puree or juice2 and 7,c7 such other foods in final product form as the ,secretary has specified1 as appropriate for the protection of 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 and copying 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 7vii7 identification of the analytical methods used to perform the sampling and testing2 7viii7 analytical findings of the sampling and testing2 and 7ix7 such other data and information as the ,secretary may require4 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-- 7,a7 is in compliance with the requirements regarding laboratory accreditation described in section #dbb2 or 7,b7 if the requirements described in subparagraph 7,a7 do not apply to the laboratory1 is accredited by an accreditation body that conforms to international accreditation standards4 7#g7 ,sampling and testing program ,the ,secretary shall develop and implement a sampling and testing program for infant and toddler food that is sufficient to-- 7,a7 support the periodic review under subsection 7a77#g7 of limits on toxic elements in infant and toddler food2 and 7,b7 independently verify that products are compliant with the limits proscribed pursuant to 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 ,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 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 monitoring and verifying the accuracy of records described in section #dbe7;b7 after for shipments14 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 predominantly composed of a fruit or vegetable puree or juice1 or such other food as the ,secretary may specify and-- 7#a7 such food bears or contains any toxic element or contaminant in excess of a limit 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 #bjbb77 7or any successor rule74 ,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 remotely inspect or copy 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 of1 at the time of1 or in the case in which an in-person inspection would be unsafe1 in lieu of1 an in-person1 on-site 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 or other information requested4 7ii7 ,the activities described in this clause are records relating to-- 7,i7 the manufacturing1 processing1 sampling1 testing1 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 obtained or copied1 or other information obtained or copied 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 that an article of food is adulterated under paragraph 7a77#a7 or 7j7 of section #djb14 #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 7other than infant formula7 shall establish and implement an environmental monitoring program to verify the effectiveness of sanitation and hygiene controls during the manufacturing and packaging process where the food has the potential to be exposed to pathogens4 ,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 pathogens 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 effective1 and shall occur not less frequently than every #c years4 7e7 ,records 7#a7 ,availability to the secretary ,a manufacturer of infant and toddler food shall make all the records required under this section available promptly to the ,secretary1 upon request by the ,secretary1 for inspection and copying4 7#b7 ,maintenance of records pertaining to environmental monitoring ,records of environmental sampling1 testing1 and 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 or other information 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 of1 at the time of1 or in the case in which an in-person inspection would be unsafe1 in lieu of1 an in-person1 on-site 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