,i #aacth ,,congress #b;d ,session ,h4 ,r4 #ddcb ,,in ,,the ,,house ,,of ,,representatives ,april #i1 #bjad ,mr4 ,pompeo 7for himself1 ,mr4 ,butterfield1 ,mr4 ,matheson1 ,mrs4 ,blackburn1 and ,mr4 ,whitfield7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act with respect to food produced from1 containing1 or consisting of a bioengineered organism1 the labeling of natural foods1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,safe and ,accurate ,food ,labeling ,act of #bjad4 #b4 ,table of contents ,the table of contents of this ,act is as follows3 ,sec4 #a4 ,short title4 ,sec4 #b4 ,table of contents4 ,sec4 #c4 ,ensuring safety of food supply4 ,title ,i--,food produced from1 containing1 or consisting of a bioengineered organism ,sec4 #aja4 ,definitions4 ,sec4 #ajb4 ,mandatory premarket biotechnology notification program4 ,sec4 #ajc4 ,labeling of whether food is bioengineered4 ,sec4 #ajd4 ,preemption4 ,title ,,ii--,natural foods ,sec4 #bja4 ,labeling of natural foods4 ,sec4 #bjb4 ,regulations4 ,sec4 #bjc4 ,preemption4 ,sec4 #bjd4 ,effective date4 #c4 ,ensuring safety of food supply ,nothing in this ,act 7or the amendments made by this ,act7 is intended to alter or affect the authorities or regulatory programs1 policies1 and procedures otherwise available to the ,food and ,drug ,administration to ensure the safety of the food supply under the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq474 ,i ,food produced from1 containing1 or consisting of a bioengineered organism #aja4 ,definitions ,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 7ss7 ,the term bioengineered organism refers to an organism if-- 7#a7 the organism is a plant 7or a seed1 a fruit1 or any other part thereof72 7#b7 the organism contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid 7,,dna7 techniques2 and 7#c7 the modification could not otherwise be obtained using conventional breeding techniques4 4 #ajb4 ,mandatory premarket biotechnology notification program 7a7 ,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 7ddd7 ,the initial introduction or delivery for introduction in interstate commerce of a bioengineered organism intended for a food use or application1 unless the developer of the organism has complied with the notification requirements1 to the extent applicable1 under section #dbd4 4 7b7 ,notification program ,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 #dbd4 ,notification relating to certain bioengineered organisms 7a7 ,in general ,a bioengineered organism shall not be introduced or delivered for introduction into interstate commerce for a food use or application unless-- 7#a7 the use or application of the bioengineered organism in food has been addressed by the developer of the bioengineered organism in a premarket biotechnology notification1 to which the ,secretary has responded under subsection 7d77#b77;,a7 by stating no objections2 or 7#b7 7,a7 food produced from1 containing1 or consisting of the bioengineered organism was evaluated by the ,secretary pursuant to the ,food and ,drug ,administration's voluntary consultation process for foods and food products from genetically engineered plants in effect prior to the date of enactment of the ,safe and ,accurate ,food ,labeling ,act of #bjad2 and 7,b7 the ,secretary informed the developer of the bioengineered organism that all questions about safety have been resolved4 7b7 ,exceptions ,this section does not apply with respect to the introduction or delivery for introduction into interstate commerce of a bioengineered organism-- 7#a7 for the purpose of development or testing conducted to generate data and information that could be used in a premarket biotechnology notification or other regulatory submission2 or 7#b7 solely because-- 7,a7 a processing aid or enzyme produced from the bioengineered organism is intended to be used to produce food2 or 7,b7 food produced from1 containing1 or consisting of the bioengineered organism is intended to be fed to an animal from which food is intended to be produced or derived4 7c7 ,premarket ,biotechnology ,notification 7#a7 ,submission ,at least #baj days before a bioengineered organism is first introduced or delivered for introduction into interstate commerce for a food use or application1 a premarket biotechnology notification shall be submitted to the ,secretary by the developer of the bioengineered organism4 ,such notification shall provide-- 7,a7 the basis for the notifier's determination that food produced from1 containing1 or consisting of such bioengineered organism is as safe for use by humans or animals1 as applicable1 as one or more comparable marketed foods that are not produced from1 do not contain1 or do not consist of such bioengineered organism2 and 7,b7 whether any other ,federal agency is conducting or has conducted any review of the bioengineered organism and the status or conclusions of any such review4 7#b7 ,consultation prior to submission ,a prospective notifier may consult informally with the ,secretary concerning a bioengineered organism intended for a food use or application before submitting a premarket biotechnology notification4 7d7 ,response to a ,premarket ,biotechnology ,notification 7#a7 ,preliminary response ,within #cj days of receipt of a premarket biotechnology notification1 the ,secretary shall-- 7,a7 inform the notifier in writing that the notification is complete and has been filed2 or 7,b7 inform the notifier in writing of any missing elements that prevent the ,secretary from filing and reviewing the notification4 ,the ,secretary shall limit any request under subparagraph 7,b7 to data or information necessary to perform the evaluation specified in paragraph 7#b7 and shall not delay informing the notifier under paragraph 7#a77;,a7 for any other purpose4 7#b7 ,substantive response ,within #ahj days of the ,secretary informing the notifier under paragraph 7#a77;,a7 that the premarket biotechnology notification is complete1 the ,secretary-- 7,a7 shall respond in writing to the notifier that the ,secretary has evaluated the notification and has no objections to the notifier's determination that food produced from1 containing1 or consisting of the bioengineered organism that is the subject of the notification is as safe for use by humans or animals1 as applicable1 as one or more comparable marketed foods that are not produced from1 do not contain1 or do not consist of such bioengineered organism2 or 7,b7 shall-- 7i7 respond in writing to the notifier that the ,secretary has evaluated the notification and has determined the notification does not provide an adequate basis for the notifier's determination2 and 7ii7 include in such response the ,secretary's basis for the ,secretary's determination4 7#c7 ,withdrawal by notifier ,at any point before receiving a written response from the ,secretary under subparagraph 7,a7 or 7,b7 of paragraph 7#b71 the notifier may withdraw a premarket biotechnology notification without prejudice as to any future notifications4 7#d7 ,effective date ,a notification submitted under subsection 7c7 shall become effective on the date that is #ahj days after the ,secretary informs the notifier under paragraph 7#a77;,a7 that the notification is complete1 and as of such date the bioengineered organism that is the subject of the notification may be introduced or delivered for introduction into interstate commerce1 unless the ,secretary provides a response under paragraph 7#b77;,b74 7e7 ,labeling ,if the ,secretary determines that there is a material difference between a food produced from1 containing1 or consisting of a bioengineered organism and its comparable marketed food and that disclosure of such difference is necessary to protect health and safety or to prevent the label or labeling of such food from being false or misleading1 the ,secretary may1 in a response under subsection 7d77#b77;,a71 specify labeling that would adequately inform consumers of such material difference4 ,the use of bioengineering does not1 by itself1 constitute a material difference4 7f7 ,public ,disclosure ,the existence and contents of a premarket biotechnology notification shall be made available to the public as of the date the ,secretary issues a written response under subsection 7d77#b77;,a71 subject to review by the ,secretary pursuant to the provisions on exemptions from disclosure under chapter #e of title #e1 ,united ,states ,code4 7g7 ,definitions ,in this section3 7#a7 7,a7 ,the term comparable marketed food means1 with respect to the food produced from1 containing1 or consisting of a plant that is a bioengineered organism-- 7i7 the parental variety of the plant2 7ii7 another commonly consumed variety of the plant2 or 7iii7 a plant variety from which is derived a commonly consumed food with properties comparable to the food produced from1 containing1 or consisting of the plant that is a bioengineered organism4 7,b7 ,a food produced from1 containing1 or consisting of a bioengineered organism may have more than one comparable marketed food4 7#b7 ,the term notifier means the person who submits a premarket biotechnology notification4 7#c7 ,the term premarket biotechnology notification-- 7,a7 means a submission to the ,secretary under subsection 7c72 and 7,b7 includes all scientific data and other information in the original submission and in any amendments to the original submission4 7#d7 ,the term material difference means a difference that-- 7,a7 significantly alters the characteristics1 including the functional or compositional characteristics1 of a food1 such that the common or usual name no longer adequately describes the food2 7,b7 results in a significantly different nutritional property in the food produced from1 containing1 or consisting of the bioengineered organism2 or 7,c7 results in the food containing an allergen that consumers would not expect to be present based upon the name of the food4 4 7c7 ,applicability ,the amendments made by this section apply beginning on the date that is #cj days after the date of enactment of this ,act1 irrespective of whether regulations or guidance have been finalized or issued by such date to carry out such amendments4 7d7 ,pending submissions ,the ,secretary shall-- 7#a7 deem to be a premarket biotechnology notification under section #dbd of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by this section1 any submission that-- 7,a7 is pending as of the date of enactment of this ,act2 and 7,b7 is for voluntary consultation with respect to food produced from1 containing1 or consisting of a bioengineered organism 7as such term is used in section #cja7;ddd7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a772 and 7#b7 evaluate such notifications expeditiously4 7e7 ,preemption ,section #djc;,a7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc-b7;a77 is amended-- 7#a7 by striking or at the end of paragraph 7#d72 7#b7 by striking the period at the end of paragraph 7#e7 and inserting a comma2 and 7#c7 by adding at the end the following3 7#f7 any requirement respecting1 prohibition against1 or restriction on1 the sale1 distribution1 or marketing of-- 7,a7 a bioengineered organism intended for a food use or application1 or 7,b7 food produced from1 containing1 or consisting of a bioengineered organism1 as such term is used in section #cja7;ddd71 or 4 7f7 ,technical corrections ,section #djc;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc-a7 is amended-- 7#a7 by striking the section designation and enumerator and all that follows through 7a7 ,except and inserting the following3 #djc;,a4 ,state requirements 7a7 ,in general ,except 2 and 7#b7 in subsection 7b71 by striking 7b7 ,upon petition and inserting the following3 7b7 ,petitions for exemptions ,upon petition 4 #ajc4 ,labeling of whether food is bioengineered 7a7 ,misbranding ,section #djc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc7 is amended by adding at the end the following3 7z7 ,if it bears labeling 7indicating that bioengineering was or was not used in the production of the food7 in violation of section #dbe4 4 7b7 ,labeling requirements ,chapter ,,iv of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cda et seq471 as amended by section #ajb of this ,act1 is further amended by adding at the end the following3 #dbe4 ,labeling of whether food is bioengineered 7a7 ,claims that bioengineering was not used 7#a7 ,in general ,if a claim in the labeling of food indicates1 directly or indirectly1 that bioengineering was not used in the production of the food1 such claim shall be subject to this subsection4 7#b7 ,requirements ,a claim described in paragraph 7#a7-- 7,a7 may be made only if the food bearing the claim is comprised of ingredients subject to supply chain process controls that address-- 7i7 the producer planting a seed developed by means other than through the use of bioengineering2 7ii7 the producer keeping the crop separated during growth1 harvesting1 storage1 and transportation2 and 7iii7 persons in direct contact with such crop or foods derived from such crop during transportation1 storage1 or processing keeping the product separated from foods or food ingredients derived through bioengineering2 7,b7 may be made for a food produced in accordance with subparagraph 7,a7 in which food produced from1 containing1 or consisting of a bioengineered organism is inadvertently present2 7,c7 may not suggest either expressly or by implication that foods developed without the use of bioengineering are safer than foods produced from1 containing1 or consisting of a bioengineered organism2 7,d7 may be made on dairy products derived from cows or other milk-producing animals1 on shell eggs derived from chickens and other birds1 and on products consisting of or derived from fish or animals 7that are under the jurisdiction of the ,food and ,drug ,administration7 that consumed feed or a feed ingredient1 or received a drug or biological product1 that-- 7i7 was developed with the use of bioengineering2 and 7ii7 has been authorized for such use by the ,secretary2 7,e7 may be made on a food produced with a bioengineered processing aid or enzyme2 and 7,f7 shall comply with any other requirements established by the ,secretary by regulation to ensure that the food's labeling is not false or misleading4 7#c7 ,regulations 7,a7 ,in general ,the ,secretary shall promulgate regulations to carry out this section4 ,such regulations shall specify a maximum permissible level of food produced from1 containing1 or consisting of a bioengineered organism that may be inadvertently present in food bearing claims under paragraph 7#a74 7,b7 ,separate categories ,such regulations may specify different permissible levels for separate categories of food4 7,c7 ,claims prior to finalization of regulations ,this section does not limit the ability of persons to make claims described in paragraph 7#a7 before the finalization of regulations under this paragraph4 7,d7 ,initial regulations ,the ,secretary shall promulgate final regulations under this paragraph not later than #bd months after the date of enactment of the ,safe and ,accurate ,food ,labeling ,act of #bjad4 7b7 ,claims that bioengineering was used 7#a7 ,in general ,if a claim in the labeling of food indicates1 directly or indirectly1 that bioengineering was used in the production of the food1 such claim shall be subject to this subsection4 7#b7 ,regulations ,a claim described in paragraph 7#a7 may be made only in accordance with regulations promulgated by the ,secretary4 ,such regulations-- 7,a7 shall not require the labeling to declare the use of bioengineering solely because the food was developed with the use of bioengineering2 7,b7 shall not allow the labeling to expressly or impliedly claim that food developed with the use of bioengineering is safer solely because the food is a food developed with the use of bioengineering2 7,c7 shall allow any claims which the ,secretary deems necessary under section #dbd7;e72 and 7,d7 may contain other requirements established by the ,secretary to ensure that the food's labeling is not false or misleading4 7#c7 ,prohibition against restricting certain disclosures ,the regulations under this subsection shall not prevent a person-- 7,a7 from disclosing voluntarily on the labeling of food developed with the use of bioengineering the manner in which the food has been modified to express traits or characteristics that differ from its comparable marketed food 7as defined in section #dbd72 or 7,b7 from disclosing in advertisements1 on the ,internet1 in response to consumer inquiries1 or on other communications1 other than in the labeling1 that a food was developed with the use of bioengineering4 7c7 ,definition ,the term bioengineered organism means a bioengineered organism1 as such term is used in section #cja7;ddd74 4 #ajd4 ,preemption 7a7 ,in general ,section #djc;,a7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc-b7;a77 is amended by adding at the end the following3 7#g7 any requirement for the labeling of food of the type described in subsection 7a77#a7 or 7b77#a7 of section #dbe that is not identical to the requirement of such section1 or 4 7b7 ,prohibition against mandatory labeling ,section #djc;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc-a7 is amended by adding at the end the following3 7c7 ,prohibitions against mandatory labeling of food developed using bioengineering ,except for claims under subsection 7a77#a7 or 7b77#a7 of section #dbe1 no ,state or political subdivision of a ,state may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce any requirement for the labeling of a food by virtue of its having been developed using bioengineering1 including any requirements for claims that a food is or contains an ingredient that was developed using bioengineering4 4 ,,ii ,natural foods #bja4 ,labeling of natural foods ,section #djc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc71 as amended by section #ajc of this ,act1 is further amended by adding at the end the following3 7aa7 7#a7 ,if its labeling contains an express or implied claim that the food is natural unless the claim is made in accordance with subparagraph 7#b74 7#b7 ,a claim described in subparagraph 7#a7 may be made only if the claim uses terms that have been defined by1 and the food meets the requirements that have been established in1 regulations promulgated to carry out this paragraph4 7#c7 ,notwithstanding subparagraph 7#b71 prior to the finalization of regulations to carry out this paragraph1 the use of any claim that a food is natural shall be allowed if consistent with the ,secretary's existing policy for such claims4 7#d7 ,in promulgating regulations to carry out this paragraph1 the ,secretary shall differentiate between food for human consumption and food intended for consumption by animals other than humans4 7#e7 ,for purposes of subparagraph 7#a71 a natural claim includes the use of-- 7,a7 the terms natural1 #ajj natural1 naturally grown1 all natural1 and made with natural ingredients2 and 7,b7 any other terms specified by the ,secretary4 4 #bjb4 ,regulations 7a7 ,proposed regulations ,not later than #ab months after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue proposed regulations to implement section #djc7;aa7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #bja of this ,act4 7b7 ,final regulations ,not later than #bd months after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue final regulations to implement such section #djc7;aa74 #bjc4 ,preemption ,section #djc;,a7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cdc-a7;a771 as amended by section #ajd of this ,act1 is further amended by adding at the end the following3 7#h7 any requirement for the labeling of food of the type required by section #djc7;aa7 that is not identical to the requirement of such section4 4 #bjd4 ,effective date ,the labeling requirements of section #djc7;aa7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #bja of this ,act1 shall take effect on the effective date of final regulations promulgated under section #bjb7;b7 of this ,act4 ,the provisions of section #djc;,a7a77#h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #bjc of this ,act1 take effect on the date of enactment of this ,act4