,,ii #aaith ,,congress #ast ,session ,s4 #bcda ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,july #ag1 #bjbe,mr4 ,markey 7for himself1 ,mr4 ,booker1 ,ms4 ,warren1 and ,mr4 ,blumenthal7 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 impose requirements for substances generally recognized as safe1 to require the ,commissioner of ,food and ,drugs to reassess the safety of chemicals added to food1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,ensuring ,safe and ,toxic-,free ,foods ,act of #bjbe4 #b4 ,substances generally recognized as safe 7a7 ,in general ,chapter ,,iv of the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #dji 7#ba ,u4,s4,c4 #cdh7 the following3 #dji;,a4 ,substances generally recognized as safe 7a7 ,in general ,any substance the intended use of which results or may reasonably be expected to result1 directly or indirectly1 in its becoming a component or otherwise affecting the characteristics of any food 7including any substance intended for use in producing1 manufacturing1 packing1 processing1 preparing1 treating1 packaging1 transporting1 or holding food2 and including any source of radiation intended for any such use71 shall1 with respect to any particular use or intended use1 be deemed to be unsafe for the purposes of the application of clause 7#b77;,c7 of section #djb7;a71 unless-- 7#a7 such substance is a food additive in compliance with section #dji2 7#b7 subject to subsection 7e77#b71 the manufacturer has submitted1 prior to the date of enactment of the ,ensuring ,safe and ,toxic-,free ,foods ,act of #bjbe1 a notice to the ,secretary that the manufacturer has concluded that such substance is generally recognized as safe under the conditions of its intended use1 and the ,secretary has not issued a response or has issued a response stating that the ,secretary does not question the basis for such conclusion2 or 7#c7 7,a7 the manufacturer has submitted1 during the period beginning on the date of enactment of the ,ensuring ,safe and ,toxic-,free ,foods ,act of #bjbe and ending on the day before the effective date described in section #b7;d7 of such ,act1 a notice to the ,secretary that the manufacturer has determined such substance to be generally recognized as safe under the conditions of its intended use2 7,b7 such notice includes supporting information sufficient to justify the basis of such determination1 including full reports of investigations made with respect to the safety for use of such substance1 including-- 7i7 full information as to the methods and controls used in conducting such investigations2 7ii7 information on the cumulative effects of such substance2 7iii7 information on hazard1 dose response1 and exposure2 7iv7 application of adequately protective safety factors to ensure an appropriate margin of safety to take into account uncertainties in hazard identification1 dose response1 exposure1 and sensitivities2 7v7 information demonstrating that the weight of the evidence analysis shows that such substance has not been found to be carcinogenic2 and 7vi7 information demonstrating that the weight of the evidence analysis shows that such substance has not been found to induce reproductive toxicity or developmental toxicity in humans or animals1 including through an endocrine mode of action2 and 7,c7 the ,secretary has not objected to such determination under subsection 7c74 7b7 ,public availability and comment ,on receipt of a notice of a determination described in subsection 7a77#c77;,a71 the ,secretary shall-- 7#a7 make such notice and the supporting information included with such notice publicly available on the website of the ,food and ,drug ,administration2 and 7#b7 provide an opportunity for public comment for a period of not less than #fj days4 7c7 ,determination of ,secretary 7#a7 ,in general ,the ,secretary shall issue a written statement objecting to a determination described in subsection 7a77#c77;,a7 if #a or more of the criteria described in paragraph 7#b7 are not met4 7#b7 ,criteria ,the criteria described in this paragraph are the following3 7,a7 ,the manufacturer has submitted complete documentation justifying the basis for its determination as described in subsection 7a77#c77;,b74 7,b7 ,with respect to data used for such justification that was provided by an expert1 such expert does not have a conflict of interest4 7,c7 ,the available evidence adequately supports a determination that the substance is generally recognized as safe under the conditions of its intended use4 7#c7 ,determination not to object ,with respect to a determination described in subsection 7a77#c77;,a71 if the ,secretary determines that all of the criteria described in paragraph 7#b7 are met1 the ,secretary shall issue a written statement that the ,secretary is not objecting to such determination described in subsection 7a77#c77;,a74 7#d7 ,additional information ,before objecting to a determination described in subsection 7a77#c77;,a71 the ,secretary may request additional information from the manufacturer if the ,secretary determines the manufacturer has failed to submit complete documentation justifying the basis for its determination as described in subsection 7a77#c77;,b74 7#e7 ,final agency action ,the determination of the ,secretary to object or not to object under this subsection to a determination described in subsection 7a77#c77;,a7 shall be considered to be a final agency action4 7#f7 ,publication ,the ,secretary shall publish the basis of a determination to object or to not object under this subsection to a determination described in subsection 7a77#c77;,a7 on the website of the ,food and ,drug ,administration1 including any chemistry and toxicology memoranda produced or relied on by the ,secretary in making such determination4 ,failure to publish such a determination shall not be construed as an affirmative finding by the ,secretary that the substance is generally recognized as safe4 7#g7 ,definition of conflict of interest ,in this subsection1 the term conflict of interest means a financial interest that could potentially compromise the professional judgment or objectivity of an individual in designing1 conducting1 reporting1 or reviewing research or the applicability of research1 potentially undermining the integrity of such research4 7d7 ,standards for experts evaluating whether a substance is ,,gras ,not later than #ahj days after the date of enactment of the ,ensuring ,safe and ,toxic-,free ,foods ,act of #bjbe1 the ,secretary shall issue guidance to strengthen the recommendations contained in the ,december #bjbb guidance of the ,food and ,drug ,administration entitled ,best ,practices for ,convening a ,,gras ,panel4 7e7 ,reassessment 7#a7 ,in general ,with respect to a substance for which the ,secretary has determined under subsection 7c77#c7 not to object to the manufacturer's determination under subsection 7a77#c77;,a7 that such substance is generally recognized as safe under the conditions of its intended use1 the ,secretary may1 at any time-- 7,a7 reassess in accordance with subsection 7c7 whether such substance is generally recognized as safe under the conditions of its intended use2 and 7,b7 pursuant to such reassessment1 withdraw the determination of the ,secretary not to object under subsection 7c77#c74 7#b7 ,prior submissions to ,,gras notification program ,the ,secretary may require the manufacturer of a substance described in subsection 7a77#b7 to submit a notice for such substance that includes the information described in subsection 7a77#c74 ,the ,secretary shall review such notice in accordance with subsections 7b7 and 7c74 7f7 ,timeline for review of ,,gras submissions 7#a7 ,in general ,the ,secretary shall review not fewer than #ej notices described in paragraphs 7#b7 and 7#c7 of subsection 7a7 each year until all such notices have been reviewed4 7#b7 ,requirements ,in conducting a review described in paragraph 7#a71 the ,secretary shall-- 7,a7 with respect to a noticed described in subsection 7a77#b71 issue a response to such notice stating that1 as applicable-- 7i7 the ,secretary does not question the basis for such conclusion2 or 7ii7 the ,secretary has concluded that such notice does not provide a sufficient basis for such conclusion2 and 7,b7 with respect to a notice described in subsection 7a77#c71 issue a response in accordance with1 as applicable1 paragraph 7#a7 or 7#c7 of subsection 7c74 7g7 ,definitions ,in this section3 7#a7 ,carcinogenic 7,a7 ,in general ,the term carcinogenic1 with respect to a substance1 means such substance is found to induce cancer when ingested by humans or animals1 or is found1 after tests that are appropriate for the evaluation of the safety of substances1 to induce cancer in humans or animals4 7,b7 ,requirement ,in determining whether a substance is carcinogenic for purposes of subparagraph 7,a71 the ,secretary shall consider assessments conducted by authoritative bodies1 including the ,national ,toxicology ,program1 the ,international ,agency for ,research on ,cancer1 and the ,environmental ,protection ,agency4 7#b7 ,cumulative effects ,the term cumulative effects1 with respect to a substance1 means the combined health effects of all chemically or pharmacologically related substances4 7#c7 ,developmental toxicity ,the term developmental toxicity1 with respect to the effect of exposure to a substance on a human or animal1 means an adverse effect on the development of such human or animal that results from such exposure-- 7,a7 to the mother prior to conception of1 or during the prenatal period for1 such human or animal2 or 7,b7 to such human or animal before the time of sexual maturity4 7#d7 ,generally recognized as safe 7,a7 ,in general ,the term generally recognized as safe1 with respect to a substance1 means such substance is generally recognized1 among experts qualified by scientific training and experience to evaluate its safety1 as having been adequately shown through scientific procedures 7or1 in the case of a substance used in food prior to ,january #a1 #aieh1 through either scientific procedures or experience based on common use in food7 to be safe under the conditions of its intended use4 7,b7 ,exclusions ,the term generally recognized as safe1 with respect to a substance1 does not include a substance that-- 7i7 is carcinogenic2 7ii7 shows evidence of reproductive toxicity or developmental toxicity2 7iii7 is otherwise identified as toxic by the ,national ,toxicology ,program1 the ,environmental ,protection ,agency1 the ,agency for ,toxic ,substances and ,disease ,registry1 or the ,california ,office of ,environmental ,health ,hazard ,assessment2 7iv7 was not marketed for use in foods in the ,united ,states prior to the date of enactment of the ,ensuring ,safe and ,toxic-,free ,foods ,act of #bjbe2 or 7v7 was not synthesized1 characterized1 or isolated prior to the date of enactment of the ,ensuring ,safe and ,toxic-,free ,foods ,act of #bjbe4 7#e7 ,reproductive toxicity ,the term reproductive toxicity1 with respect to the effect of exposure to a substance on a human or animal1 means an adverse effect on the reproductive system of such human or animal1 which may include alterations to reproductive system development1 the endocrine system1 fertility1 pregnancy1 pregnancy outcomes1 or modifications in other functions that are dependent on the integrity of the reproductive system4 7h7 ,authorization of appropriations ,there are authorized to be appropriated to carry out this section such sums as are necessary4 4 7b7 ,adulteration ,section #djb7;a77#b77;,c77i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdb7;a77#b77;,c77i77 is amended by inserting or any other substance that is not generally recognized as safe in compliance with section #dji;,a after section #dji4 7c7 ,definitions ,section #bja7s7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7s77 is amended-- 7#a7 by striking if such substance is not generally recognized1 among experts qualified by scientific training and experience to evaluate its safety1 as having been adequately shown through scientific procedures 7or1 in the case of a substance used in food prior to ,january #a1 #aieh1 through either scientific procedures or experience based on common use in food7 to be safe under the conditions of its intended use22 7#b7 in paragraph 7#e71 by striking or at the end2 7#c7 in paragraph 7#f71 by striking the period and inserting 2 or2 and 7#d7 by adding at the end the following3 7#g7 a substance generally recognized as safe in compliance with section #dji;,a4 4 7d7 ,effective date ,the amendments made by this section shall take effect on the date that is #b years after the date of enactment of this ,act4 #c4 ,food chemical reassessment ,chapter ,,iv of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cda et seq47 is amended by inserting after section #dji;,a 7as added by section #b7;a77 the following3 #dji;,b4 ,food chemical reassessment 7a7 ,safety reassessments 7#a7 ,in general ,not later than #c years after the date of enactment of this section1 and not less frequently than once every #c years thereafter1 the ,secretary shall reassess the safety1 within the meaning of section #dji or section #dji;,a1 of not less than #aj substances or classes of substances-- 7,a7 to determine if such substance or class of substances is safe within the meaning of section #dji or section #dji;,a2 and 7,b7 to establish the conditions of use1 if any1 under which any such substance or class of substances may be used safely within the meaning of such section #dji or #dji;,a4 7#b7 ,requirements for manufacturers ,the ,secretary may require any manufacturer of a substance or class of substances that is being reassessed under paragraph 7#a7 to provide data or to conduct evaluations of such substance or class of substances for purposes of the reassessment under paragraph 7#a74 7#c7 ,priority ,the ,secretary may give priority to the reassessment of a substance or class of substances that is the subject of-- 7,a7 a food additive petition under section #dji7;b72 7,b7 a color additive petition under section #gba7;d72 or 7,c7 a citizen petition to request the reassessment1 restriction1 or revocation of an existing authorization of such substance or class of substances4 7b7 ,considerations ,in determining1 for the purposes of this section1 whether a substance or class of substances is unsafe within the meaning of section #dji or section #dji;,a1 the ,secretary shall consider the information described in clauses 7i7 through 7vi7 of section #dji;,a7a77#c77;,b74 7c7 ,rule of construction ,nothing in this section alters the authority or duties of the ,secretary with respect to the administration and enforcement of section #dji or section #dji;,a4 4