,,ii #aaith ,,congress #ast ,session ,s4 #cabb ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,november #f1 #bjbe ,mr4 ,marshall 7for himself1 ,mrs4 ,britt1 and ,mr4 ,scott of ,florida7 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 require notifications to the ,food and ,drug ,administration regarding food substances generally recognized as safe1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,better ,food ,disclosure ,act of #bjbe or the ,better ,,fda ,act of #bjbe4 #b4 ,mandatory reporting of substances generally recognized as safe 7a7 ,in general ,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 the following3 #dji;,a4 ,food substances generally recognized as safe 7a7 ,in general ,beginning on the date that is #b years after the date of enactment of the ,better ,food ,disclosure ,act of #bjbe1 a food substance generally recognized as safe 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 the ,secretary includes the food substance on the list described in subsection 7c72 or 7#b7 the food substance is under review under subsection 7e77#a77;,a7 and the ,secretary has not yet made a final determination under subsection 7e77#b74 7b7 ,notice to ,,fda 7#a7 ,in general ,any person may1 with respect to any intended use of a food substance generally recognized as safe1 file with the ,secretary a notice proposing inclusion of such food substance on the list described in subsection 7c74 7#b7 ,timeframes ,the timeframes for filing of a notice under paragraph 7#a7 are as follows3 7,a7 ,with respect to a food substance used in food offered in interstate commerce as of the date of enactment of the ,better ,food ,disclosure ,act of #bjbe1 and1 as of such date of enactment1 considered to be a food substance generally recognized as safe1 not later than #b years after such date of enactment4 7,b7 ,with respect to a food substance first used in food offered in interstate commerce after the date of enactment of the ,better ,food ,disclosure ,act of #bjbe1 not later than #abj days before the first use of the food substance in such food4 7c7 ,regulations ,not later than #b years after the date of enactment of the ,better ,food ,disclosure ,act of #bjbe1 the ,secretary shall promulgate regulations to establish the procedures to establish and maintain a publicly accessible list of food substances generally recognized as safe4 7d7 ,,fda listing 7#a7 ,in general ,not later than #ahj days after receiving a notice under subsection 7b77#a71 the ,secretary shall accept such notice and-- 7,a7 add the food substance to the list described in subsection 7c72 or 7,b7 subject to subsection 7e71 make a preliminary determination to exclude the food substance from such list4 7#b7 ,effectiveness of notice ,if the ,secretary does not make a preliminary determination to exclude a food substance under subparagraph 7,b7 of paragraph 7#a7 by the deadline described in such paragraph1 such food substance shall be deemed to be added to the list described in subsection 7c74 7e7 ,excluded or delisted substances 7#a7 ,in general ,if the ,secretary makes a preliminary determination under subsection 7d77#a77;,b7 to exclude a food substance for which a notice was submitted under subsection 7b77#a7 from the list described in subsection 7c71 or removes a food substance from such list after reevaluation in accordance with section #dji;,b1 the ,secretary shall require any person using such food substance in food to submit to the ,secretary1 not later than #ahj days after issuance of an preliminary or removal determination1 at the option of such person-- 7,a7 a request for the ,secretary to reconsider such preliminary determination or removal determination1 including any additional information the ,secretary may request in order to make a final determination of whether the food substance is a food substance generally recognized as safe2 7,b7 a food additive petition under section #dji2 or 7,c7 a plan for phasing out use of the food substance4 7#b7 ,final determinations ,if a person requests under paragraph 7#a77;,a7 that the ,secretary reconsider a preliminary determination under subsection 7d77#a77;,b7 to exclude a food substance for which a notice was submitted under subsection 7b77#a7 from the list described in subsection 7c7 or the removal of a food substance from such list after reevaluation in accordance with section #dji;,b1 not later than #ahj days after receiving sufficient information paragraph 7#a77;,a71 the ,secretary shall make a final determination of whether the food substance is a food substance generally recognized as safe4 4 7b7 ,definitions ,section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7 is amended-- 7#a7 in paragraph 7s7-- 7,a7 by striking 1 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 use2 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 food substance generally recognized as safe1 as defined in paragraph 7tt74 2 and 7#b7 by adding at the end the following3 7tt7 ,the term food substance generally recognized as safe means 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 if 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 use1 except that such term does not include-- 7#a7 food additives1 as defined in paragraph 7s71 that are subject to section #dji2 or 7#b7 any article described in subparagraphs 7#a7 through 7#f7 of paragraph 7s74 4 7c7 ,adulterated food ,section #djb7;a77#b77;,c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdb7;a77#b77;,c77 is amended-- 7#a7 by striking or 7ii7 a new and inserting 7ii7 a new2 and 7#b7 by inserting or 7iii7 a food substance generally recognized as safe that is not included on the list maintained by the ,secretary pursuant to section #dji;,a7c7 or is under review pursuant to section #dji;,a7e72 after section #eab24 7d7 ,conforming amendments 7#a7 ,section #cja7ll77#c77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7ll77#c77;,a77 is amended by inserting 1 or the requirements of section #dji;,a1 as applicable before the semicolon4 7#b7 ,section #djh7l77#e77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdf;a7l77#e77;,b77 is amended by inserting listing of a food substance generally recognized as safe under section #dji;,a7c71 after food additive regulation4 7#c7 ,section #gba7;b77#d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;e7b77#d77 is amended by striking while there is in effect a published finding of the ,secretary declaring such substance exempt from the term food additive because of its being generally recognized by qualified experts as safe for its intended use1 as provided in section #bja7s7 and inserting if it is included on the list maintained by the ,secretary pursuant to section #dji;,a7c74 7#d7 ,section #hja7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;d77 is amended by inserting food substance generally recognized as safe1 after color additive1 each place such term appears4 7#e7 ,section #hjc7;c77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chc7;c77#b77 is amended by striking and color additives and inserting color additives1 and food substances generally recognized as safe4 #c4 ,postmarket assessment of food additives1 color additives1 and food substances generally recognized as safe ,chapter ,,iv of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cda et seq47 is amended by adding after section #dji;,a 7as added by section #b7 the following3 #dji;,b4 ,postmarket assessment of food additives1 color additives1 and food substances generally recognized as safe 7a7 ,in general ,if the ,secretary receives a citizen petition or a notice from a ,state governmental official regarding concerns about the safety of a food additive for which #a or more regulations prescribing conditions of safe use have been issued under section #dji1 a color additive used in accordance with the requirements of section #gba1 or a food substance generally recognized as safe included on the list described in section #dji;,a7c71 or if the ,secretary determines through the ,secretary's initiative that such a concern exists1 the ,secretary may reevaluate the additive or substance in accordance with section #dji1 #gba1 or #dji;,a1 as applicable1 and1 as appropriate-- 7#a7 with respect to a food additive1 amend or revoke the #a or more regulations issued under section #dji with respect to the food additive2 7#b7 with respect to a color additive1 amend or revoke the #a or more regulations issued under section #dji with respect to the food additive2 and 7#c7 with respect to a food substance generally recognized as safe-- 7,a7 determine the food substance to be a food additive subject to the requirements of section #dji2 and 7,b7 by rulemaking under section #eec of title #e1 ,united ,states ,code1 remove the food substance from the list described in subsection #dji;,a7c74 7b7 ,priority considerations ,in considering citizen petitions and notices from ,state governmental officials received under subsection 7a71 the ,secretary shall give priority to petitions and notices regarding food additives1 color additives1 and food substances generally recognized as safe for which clear and convincing scientific evidence supports the concerns raised in the petition or notice4 7c7 ,safety information ,the ,secretary shall publish in the ,federal ,register a request for safety information for any food substance subject to reevaluation under subsection 7a74 7d7 ,review requirements 7#a7 ,in general ,any determination1 reevaluation1 or final action taken by the ,secretary under this section regarding the safety1 exclusion1 delisting1 or reclassification of a food additive1 color additive1 or food substance generally recognized as safe shall be subject to-- 7,a7 review and recommendation by individuals serving in positions in the ,food and ,drug ,administration under career appointments and who have relevant scientific and regulatory expertise2 and 7,b7 the notice and comment rulemaking procedures under section #eec of title #e1 ,united ,states ,code4 7#b7 ,limitation ,the ,secretary may not delegate the review under paragraph 7#a77;,a7 to-- 7,a7 an individual occupying a position for which appointment is made by the ,president2 or 7,b7 an individual who is not serving in a position in the ,food and ,drug ,administration under a career appointment4 4