,,ii #aahth ,,congress #ast ,session ,s4 #cchg ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,december #d1 #bjbc,mr4 ,markey 7for himself1 ,mr4 ,booker1 ,mr4 ,blumenthal1 and ,ms4 ,warren7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to direct the ,secretary of ,health and ,human ,services to update and clarify its rule on substances generally recognized as safe and to establish within the ,food and ,drug ,administration the ,office of ,food ,chemical ,safety1 ,dietary ,supplements1 and ,innovation1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,ensuring ,safe and ,toxic-,free ,foods ,act of #bjbc4 #b4 ,directed rulemaking regarding substances generally recognized as safe 7a7 ,definitions ,in this section3 7#a7 ,,gras ,the term ,,gras1 with respect to the use of a substance in food1 has the meaning given the term generally recognized as safe for use in food in section #dji;,a7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #c4 7#b7 ,reproductive or developmental toxicity ,the term reproductive or developmental toxicity has the meaning given such term in such section #dji;,a7a74 7#c7 ,secretary ,the term ,secretary means the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs4 7#d7 ,vulnerable human populations ,the term vulnerable human population has the meaning given such term in such section #dji;,a7a74 7b7 ,directed rulemaking 7#a7 ,in general ,the ,secretary shall-- 7,a7 not later than #a year after the date of enactment of this ,act1 publish a proposed revision to the final rule titled ,substances ,generally ,recognized as ,safe1 published by the ,food and ,drug ,administration on ,august #ag1 #bjaf 7#ha ,fed4 ,reg4 #edifj72 7,b7 not later than #ahj days after the close of the period for public comment on the revision proposed under subparagraph 7,a71 publish a final revision to such final rule2 and 7,c7 not later than #ahj days after the date of enactment of this ,act1 publish a plan for monitoring industry compliance with the rules1 regulations1 and guidance of the ,food and ,drug ,administration relating to ,,gras1 including the ,december #bjbb guidance titled ,best ,practices for ,convening a ,,gras ,panel4 7#b7 ,contents ,the revision required by subparagraphs 7,a7 and 7,b7 of paragraph 7#a7 shall include each of the following3 7,a7 ,the revision shall prohibit a manufacturer from marketing a substance as ,,gras1 or manufacturing or selling food that contains a substance the manufacturer has determined to be ,,gras1 unless-- 7i7 the ,secretary has made a final determination1 which is conveyed to the manufacturer in writing1 that the ,secretary has received sufficient notice from the manufacturer that the manufacturer has determined such substance to be ,,gras under the conditions of its intended use2 and 7ii7 the manufacturer has provided the ,secretary with supporting information sufficient to understand the basis of the determination1 including-- 7,i7 the cumulative effects of the substance1 as required under section #dji of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdh72 7,,ii7 an adequately protective use of safety factors1 as described under such section #dji1 including safety factors to account for the particular sensitivities of vulnerable human populations1 to the extent that data are available to derive safety factors for each vulnerable human population2 7,,iii7 information demonstrating that the weight of evidence analysis shows the substance has not been found to induce cancer when ingested by humans or animals2 and 7,,iv7 information demonstrating that the weight of evidence analysis shows the substance has not been found to induce reproductive or developmental toxicity when ingested by humans or animals1 including through an endocrine mode of action4 7,b7 ,the revision shall require-- 7i7 the ,secretary to make each determination that is submitted pursuant to subparagraph 7,a77i71 and the supporting information submitted pursuant to subparagraph 7,a77ii71 publicly available on the website of the ,food and ,drug ,administration2 7ii7 a period of at least #ij days for the ,secretary and the public to review each such determination and object1 if appropriate1 in order to ensure that the substance involved is safe taking into account the factors listed in subparagraph 7,a7 and in paragraphs 7#c7 through 7#e7 of section #dji7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdh7;c772 and 7iii7 the ,secretary's objection1 or decision not to object1 to be considered final agency action4 7,c7 ,the revision shall clarify that substances that are known 7or reasonably anticipated7 to cause cancer in humans or animals identified by the ,national ,toxicology ,program cannot be ,,gras4 7,d7 ,the revision shall clarify that substances that show clear evidence 7or some evidence7 of human reproductive or developmental toxicity identified by the ,national ,toxicology ,program cannot be ,,gras4 7,e7 ,the revision shall clarify that any substance that was not marketed for use in foods in the ,united ,states before issuance of the revised rule cannot be ,,gras and shall be approved by the ,secretary through a food additive petition as required by section #dji7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdh7;c77 prior to being marketed in food4 7,f7 ,the revision shall-- 7i7 incorporate standards prohibiting conflict of interests among experts providing data for substances submitted for ,,gras review2 and 7ii7 incorporate measures to strengthen the recommendations in the ,december #bjbb guidance of the ,food and ,drug ,administration titled ,best ,practices for ,convening a ,,gras ,panel4 7,g7 ,the revision shall create a process that requires the ,secretary to systematically reassess any substance that was determined to be ,,gras if the initial determination did not meet the revised standards for such a determination1 in accordance with the procedures and resources in section #dji;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #c4 #c4 ,office of ,food ,chemical ,safety1 ,dietary ,supplements1 and ,innovation ,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 7#ba ,u4,s4,c4 #cdh7 the following3 #dji;,a4 ,office of ,food ,chemical ,safety1 ,dietary ,supplements1 and ,innovation 7a7 ,definitions ,in this section3 7#a7 ,food contact substance ,the term food contact substance has the meaning given such term in section #dji7;h77#f74 7#b7 ,generally recognized as safe for use in food ,the term generally recognized as safe for use in food means1 with respect to the use of a substance in food1 that the 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 use1 as described in section #bja7s74 7#c7 ,prior-sanctioned substance ,the term prior-sanctioned substance means a substance described in paragraph 7#d7 of section #bja7s74 7#d7 ,reproductive or developmental toxicity ,the term reproductive or developmental toxicity means-- 7,a7 adverse effects on the reproductive systems of female or male humans or animals1 that may include alterations to the female or male reproductive system development1 the endocrine system1 fertility1 pregnancy1 pregnancy outcomes1 or modifications in other functions that are dependent on the integrity of the reproductive system2 or 7,b7 adverse effects on developing organisms that result from exposure prior to conception1 during the prenatal period1 or until the time of sexual maturity4 7#e7 ,vulnerable human population ,the term vulnerable human population means a human population that is subject to the potential for disproportionate exposure to1 or the potential for disproportionate adverse effects from exposure to1 a chemical substance or mixture1 including-- 7,a7 infants1 children1 and adolescents2 7,b7 pregnant1 postpartum1 or breastfeeding women2 7,c7 older adults2 7,d7 individuals with preexisting medical conditions2 7,e7 workers who may be exposed to chemical substances and mixtures2 7,f7 residents in communities subject to disproportionate exposures or adverse effects2 and 7,g7 members of any other appropriate population identified by the ,secretary4 7b7 ,establishment ,not later than #a year after the date of enactment of this section1 the ,secretary shall establish within the ,food and ,drug ,administration an office1 to be known as the ,office of ,food ,chemical ,safety1 ,dietary ,supplements1 and ,innovation 7referred to in this section as the ,office71 to evaluate and reassess the safety1 within the meaning of section #dji1 of substances and classes of substances1 including food additives1 food contact substances1 substances generally recognized as safe for use in food1 color additives1 and prior-sanctioned substances4 7c7 ,safety reassessments ,not later than #c years after the date on which the ,office is established1 and not less frequently than once every #c years thereafter1 the ,office shall-- 7#a7 reassess the safety of not less than #aj of the substances or classes of substances described in subsection 7b72 and 7#b7 issue final regulations-- 7,a7 determining that any such substance or class of substance is safe within the meaning of section #dji and establishing the conditions of use1 if any1 under which any such substance or class of substances can be used safely within the meaning of such section2 or 7,b7 determining that any such substance or class of substances is unsafe within the meaning of such section4 7d7 ,considerations ,in determining1 for the purposes of this section1 whether a substance or class of substances is unsafe within the meaning of section #dji1 the ,secretary shall consider among other relevant factors-- 7#a7 the cumulative effects of the substance1 as described under such section #dji2 and 7#b7 an adequately protective use of safety factors1 as described under such section #dji1 including safety factors to account for the particular sensitivities of vulnerable human populations4 7e7 ,notice prior to selecting substances for reassessment ,prior to selecting substances or classes of substances to reassess under subsection 7c71 the ,secretary shall post a notice in the ,federal ,register requesting information and recommendations on which substances and classes should be reassessed4 ,the information shall include substance or class name1 uses1 and data relating to the actual and potential hazards and impact on public health4 7f7 ,notice prior to commencement ,prior to commencing a reassessment of a substance or class of substances under subsection 7c71 the ,secretary shall post a notice in the ,federal ,register requesting information on any uses of such substance or class in food1 including as a prior-sanctioned substance1 food contact substance1 or substance that is generally recognized as safe for use in food4 ,the information requested shall include when the uses commenced1 the specific conditions of use1 how they were determined to be safe1 scientific evidence relevant to the safety of the substance that has become available since its use in food commenced1 and the anticipated amounts that may be found in food4 7g7 ,food ,chemical ,committee of the ,science ,board ,not later than #ahj days after the date of enactment of this section1 the ,secretary shall establish a standing ,food ,chemical ,committee 7referred to in this subsection as the ,committee7 within the ,science ,board to the ,food and ,drug ,administration and provide resources and staffing as are necessary for the ,committee to meet regularly and complete their work4 ,the ,committee shall advise the ,secretary with respect to the process and methods necessary to complete the work of the ,office4 7h7 ,rule of construction ,nothing in this section alters the authority or duties of the ,secretary with respect to the administration and enforcement of section #dji4 4