‘‘(1) the organism is a plant (or a seed, a fruit, 
or any other part thereof); 
‘‘(2) the organism contains genetic material 
that has been modified through in vitro recombinant 
deoxyribonucleic acid (DNA) techniques; and 
‘‘(3) the modification could not otherwise be ob-
tained using conventional breeding techniques.’’. 
SEC. 102. MANDATORY PREMARKET BIOTECHNOLOGY NO-
TIFICATION PROGRAM. 
(a) PROHIBITED ACT.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend-
ed by adding at the end the following: 
‘‘(ddd) The initial introduction or delivery for intro-
duction in interstate commerce of a bioengineered orga-
nism intended for a food use or application, unless the 
developer of the organism has complied with the notifica-
tion requirements, to the extent applicable, under section 
424.’’. 
(b) NOTIFICATION PROGRAM.—Chapter IV of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341 
et seq.) is amended by adding at the end the following: 
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‘‘SEC. 424. NOTIFICATION RELATING TO CERTAIN BIOENGI-
NEERED ORGANISMS. 
‘‘(a) IN GENERAL.—A bioengineered organism shall 
not be introduced or delivered for introduction into inter-
state commerce for a food use or application unless— 
‘‘(1) the use or application of the bioengineered 
organism in food has been addressed by the devel-
oper of the bioengineered organism in a premarket 
biotechnology notification, to which the Secretary 
has responded under subsection (d)(2)(A) by stating 
no objections; or 
‘‘(2)(A) food produced from, containing, or con-
sisting 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 2014; and 
‘‘(B) the Secretary informed the developer of 
the bioengineered organism that all questions about 
safety have been resolved. 
‘‘(b) EXCEPTIONS.—This section does not apply with 
respect to the introduction or delivery for introduction into 
interstate commerce of a bioengineered organism— 
‘‘(1) for the purpose of development or testing 
conducted to generate data and information that 
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could be used in a premarket biotechnology notifica-
tion or other regulatory submission; or 
‘‘(2) solely because— 
‘‘(A) a processing aid or enzyme produced 
from the bioengineered organism is intended to 
be used to produce food; or 
‘‘(B) food produced from, containing, or 
consisting of the bioengineered organism is in-
tended to be fed to an animal from which food 
is intended to be produced or derived. 
‘‘(c) 
PREMARKET
BIOTECHNOLOGY
NOTIFICA-
TION.— 
‘‘(1) SUBMISSION.—At least 210 days before a 
bioengineered organism is first introduced or deliv-
ered for introduction into interstate commerce for a 
food use or application, a premarket biotechnology 
notification shall be submitted to the Secretary by 
the developer of the bioengineered organism. Such 
notification shall provide— 
‘‘(A) the basis for the notifier’s determina-
tion that food produced from, containing, or 
consisting of such bioengineered organism is as 
safe for use by humans or animals, as applica-
ble, as one or more comparable marketed foods 
that are not produced from, do not contain, or 
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do not consist of such bioengineered organism; 
and 
‘‘(B) whether any other Federal agency is 
conducting or has conducted any review of the 
bioengineered organism and the status or con-
clusions of any such review. 
‘‘(2) CONSULTATION PRIOR TO SUBMISSION.—A 
prospective notifier may consult informally with the 
Secretary concerning a bioengineered organism in-
tended for a food use or application before submit-
ting a premarket biotechnology notification. 
‘‘(d) RESPONSE TO A PREMARKET BIOTECHNOLOGY 
NOTIFICATION.— 
‘‘(1) PRELIMINARY
RESPONSE.—Within 30 
days of receipt of a premarket biotechnology notifi-
cation, the Secretary shall— 
‘‘(A) inform the notifier in writing that the 
notification is complete and has been filed; or 
‘‘(B) inform the notifier in writing of any 
missing elements that prevent the Secretary 
from filing and reviewing the notification. 
The Secretary shall limit any request under subpara-
graph (B) to data or information necessary to per-
form the evaluation specified in paragraph (2) and 
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shall not delay informing the notifier under para-
graph (1)(A) for any other purpose. 
‘‘(2) SUBSTANTIVE
RESPONSE.—Within 180 
days of the Secretary informing the notifier under 
paragraph (1)(A) that the premarket biotechnology 
notification is complete, the Secretary— 
‘‘(A) shall respond in writing to the noti-
fier that the Secretary has evaluated the notifi-
cation and has no objections to the notifier’s 
determination that food produced from, con-
taining, or consisting of the bioengineered orga-
nism that is the subject of the notification is as 
safe for use by humans or animals, as applica-
ble, as one or more comparable marketed foods 
that are not produced from, do not contain, or 
do not consist of such bioengineered organism; 
or 
‘‘(B) shall— 
‘‘(i) respond in writing to the notifier 
that the Secretary has evaluated the notifi-
cation and has determined the notification 
does not provide an adequate basis for the 
notifier’s determination; and 
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‘‘(ii) include in such response the Sec-
retary’s basis for the Secretary’s deter-
mination. 
‘‘(3) WITHDRAWAL
BY
NOTIFIER.—At any 
point before receiving a written response from the 
Secretary under subparagraph (A) or (B) of para-
graph (2), the notifier may withdraw a premarket 
biotechnology notification without prejudice as to 
any future notifications. 
‘‘(4) EFFECTIVE
DATE.—A notification sub-
mitted under subsection (c) shall become effective on 
the date that is 180 days after the Secretary in-
forms the notifier under paragraph (1)(A) that the 
notification is complete, and as of such date the bio-
engineered organism that is the subject of the notifi-
cation may be introduced or delivered for introduc-
tion into interstate commerce, unless the Secretary 
provides a response under paragraph (2)(B). 
‘‘(e) LABELING.—If the Secretary determines that 
there is a material difference between a food produced 
from, containing, or consisting of a bioengineered orga-
nism and its comparable marketed food and that disclo-
sure of such difference is necessary to protect health and 
safety or to prevent the label or labeling of such food from 
being false or misleading, the Secretary may, in a response 
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under subsection (d)(2)(A), specify labeling that would 
adequately inform consumers of such material difference. 
The use of bioengineering does not, by itself, constitute 
a material difference. 
‘‘(f) PUBLIC DISCLOSURE.—The existence and con-
tents of a premarket biotechnology notification shall be 
made available to the public as of the date the Secretary 
issues a written response under subsection (d)(2)(A), sub-
ject to review by the Secretary pursuant to the provisions 
on exemptions from disclosure under chapter 5 of title 5, 
United States Code. 
‘‘(g) DEFINITIONS.—In this section: 
‘‘(1)(A) The term ‘comparable marketed food’ 
means, with respect to the food produced from, con-
taining, or consisting of a plant that is a bioengi-
neered organism— 
‘‘(i) the parental variety of the plant; 
‘‘(ii) another commonly consumed variety 
of the plant; or 
‘‘(iii) a plant variety from which is derived 
a commonly consumed food with properties 
comparable to the food produced from, con-
taining, or consisting of the plant that is a bio-
engineered organism. 
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‘‘(B) A food produced from, containing, or con-
sisting of a bioengineered organism may have more 
than one comparable marketed food. 
‘‘(2) The term ‘notifier’ means the person who 
submits a premarket biotechnology notification. 
‘‘(3) The term ‘premarket biotechnology notifi-
cation’— 
‘‘(A) means a submission to the Secretary 
under subsection (c); and 
‘‘(B) includes all scientific data and other 
information in the original submission and in 
any amendments to the original submission. 
‘‘(4) The term ‘material difference’ means a dif-
ference that— 
‘‘(A) significantly alters the characteristics, 
including the functional or compositional char-
acteristics, of a food, such that the common or 
usual name no longer adequately describes the 
food; 
‘‘(B) results in a significantly different nu-
tritional property in the food produced from, 
containing, or consisting of the bioengineered 
organism; or 
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‘‘(C) results in the food containing an al-
lergen that consumers would not expect to be 
present based upon the name of the food.’’. 
(c) APPLICABILITY.—The amendments made by this 
section apply beginning on the date that is 30 days after 
the date of enactment of this Act, irrespective of whether 
regulations or guidance have been finalized or issued by 
such date to carry out such amendments. 
(d) PENDING SUBMISSIONS.—The Secretary shall— 
(1) deem to be a premarket biotechnology noti-
fication under section 424 of the Federal Food, 
Drug, and Cosmetic Act, as added by this section, 
any submission that— 
(A) is pending as of the date of enactment 
of this Act; and 
(B) is for voluntary consultation with re-
spect to food produced from, containing, or con-
sisting of a bioengineered organism (as such 
term is used in section 301(ddd) of the Federal 
Food, Drug, and Cosmetic Act, as added by 
subsection (a)); and 
(2) evaluate such notifications expeditiously. 
(e) PREEMPTION.—Section 403A(a) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 343–2(a)) is 
amended— 
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(1) by striking ‘‘or’’ at the end of paragraph 
(4); 
(2) by striking the period at the end of para-
graph (5) and inserting a comma; and 
(3) by adding at the end the following: 
‘‘(6) any requirement respecting, prohibition 
against, or restriction on, the sale, distribution, or 
marketing of— 
‘‘(A) a bioengineered organism intended 
for a food use or application, or 
‘‘(B) food produced from, containing, or 
consisting of a bioengineered organism, as such 
term is used in section 301(ddd), or’’. 
(f) TECHNICAL CORRECTIONS.—Section 403A of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343– 
1) is amended— 
(1) by striking the section designation and enu-
merator and all that follows through ‘‘(a) Except’’ 
and inserting the following: 
‘‘SEC. 403A. STATE REQUIREMENTS. 
‘‘(a) IN GENERAL.—Except’’; and 
(2) in subsection (b), by striking ‘‘(b) Upon pe-
tition’’ and inserting the following: 
‘‘(b) PETITIONS FOR EXEMPTIONS.—Upon petition’’. 
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SEC. 103. LABELING OF WHETHER FOOD IS BIOENGI-
NEERED. 
(a) MISBRANDING.—Section 403 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amend-
ed by adding at the end the following: 
‘‘(z) If it bears labeling (indicating that bio-
engineering was or was not used in the production of the 
food) in violation of section 425.’’. 
(b) LABELING REQUIREMENTS.—Chapter IV of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341 
et seq.), as amended by section 102 of this Act, is further 
amended by adding at the end the following: 
‘‘SEC. 425. LABELING OF WHETHER FOOD IS BIOENGI-
NEERED. 
‘‘(a) CLAIMS THAT BIOENGINEERING WAS NOT 
USED.— 
‘‘(1) IN GENERAL.—If a claim in the labeling of 
food indicates, directly or indirectly, that bio-
engineering was not used in the production of the 
food, such claim shall be subject to this subsection. 
‘‘(2) REQUIREMENTS.—A claim described in 
paragraph (1)— 
‘‘(A) may be made only if the food bearing 
the claim is comprised of ingredients subject to 
supply chain process controls that address— 
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‘‘(i) the producer planting a seed de-
veloped by means other than through the 
use of bioengineering; 
‘‘(ii) the producer keeping the crop 
separated during growth, harvesting, stor-
age, and transportation; and 
‘‘(iii) persons in direct contact with 
such crop or foods derived from such crop 
during transportation, storage, or proc-
essing keeping the product separated from 
foods or food ingredients derived through 
bioengineering; 
‘‘(B) may be made for a food produced in 
accordance with subparagraph (A) in which 
food produced from, containing, or consisting of 
a bioengineered organism is inadvertently 
present; 
‘‘(C) may not suggest either expressly or 
by implication that foods developed without the 
use of bioengineering are safer than foods pro-
duced from, containing, or consisting of a bio-
engineered organism; 
‘‘(D) may be made on dairy products de-
rived from cows or other milk-producing ani-
mals, on shell eggs derived from chickens and 
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other birds, and on products consisting of or 
derived from fish or animals (that are under 
the jurisdiction of the Food and Drug Adminis-
tration) that consumed feed or a feed ingre-
dient, or received a drug or biological product, 
that— 
‘‘(i) was developed with the use of bio-
engineering; and 
‘‘(ii) has been authorized for such use 
by the Secretary; 
‘‘(E) may be made on a food produced 
with a bioengineered processing aid or enzyme; 
and 
‘‘(F) shall comply with any other require-
ments established by the Secretary by regula-
tion to ensure that the food’s labeling is not 
false or misleading. 
‘‘(3) REGULATIONS.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
promulgate regulations to carry out this sec-
tion. Such regulations shall specify a maximum 
permissible level of food produced from, con-
taining, or consisting of a bioengineered orga-
nism that may be inadvertently present in food 
bearing claims under paragraph (1). 
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‘‘(B) SEPARATE CATEGORIES.—Such regu-
lations may specify different permissible levels 
for separate categories of food. 
‘‘(C) CLAIMS PRIOR TO FINALIZATION OF 
REGULATIONS.—This section does not limit the 
ability of persons to make claims described in 
paragraph (1) before the finalization of regula-
tions under this paragraph. 
‘‘(D) INITIAL
REGULATIONS.—The Sec-
retary shall promulgate final regulations under 
this paragraph not later than 24 months after 
the date of enactment of the Safe and Accurate 
Food Labeling Act of 2014. 
‘‘(b) CLAIMS THAT BIOENGINEERING WAS USED.— 
‘‘(1) IN GENERAL.—If a claim in the labeling of 
food indicates, directly or indirectly, that bio-
engineering was used in the production of the food, 
such claim shall be subject to this subsection. 
‘‘(2) REGULATIONS.—A claim described in 
paragraph (1) may be made only in accordance with 
regulations promulgated by the Secretary. Such reg-
ulations— 
‘‘(A) shall not require the labeling to de-
clare the use of bioengineering solely because 
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the food was developed with the use of bio-
engineering; 
‘‘(B) shall not allow the labeling to ex-
pressly or impliedly claim that food developed 
with the use of bioengineering is safer solely be-
cause the food is a food developed with the use 
of bioengineering; 
‘‘(C) shall allow any claims which the Sec-
retary deems necessary under section 424(e); 
and 
‘‘(D) may contain other requirements es-
tablished by the Secretary to ensure that the 
food’s labeling is not false or misleading. 
‘‘(3) PROHIBITION AGAINST RESTRICTING CER-
TAIN
DISCLOSURES.—The regulations under this 
subsection shall not prevent a person— 
‘‘(A) from disclosing voluntarily on the la-
beling of food developed with the use of bio-
engineering the manner in which the food has 
been modified to express traits or characteris-
tics that differ from its comparable marketed 
food (as defined in section 424); or 
‘‘(B) from disclosing in advertisements, on 
the Internet, in response to consumer inquiries, 
or on other communications, other than in the 
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labeling, that a food was developed with the use 
of bioengineering. 
‘‘(c) DEFINITION.—The term ‘bioengineered orga-
nism’ means a bioengineered organism, as such term is 
used in section 301(ddd).’’. 
SEC. 104. PREEMPTION. 
(a) IN GENERAL.—Section 403A(a) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 343–2(a)) is 
amended by adding at the end the following: 
‘‘(7) any requirement for the labeling of food of 
the type described in subsection (a)(1) or (b)(1) of 
section 425 that is not identical to the requirement 
of such section, or’’. 
(b) PROHIBITION
AGAINST
MANDATORY
LABEL-
ING.—Section 403A of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 343–1) is amended by adding at the 
end the following: 
‘‘(c) PROHIBITIONS AGAINST MANDATORY LABELING 
OF FOOD DEVELOPED USING BIOENGINEERING.—Except 
for claims under subsection (a)(1) or (b)(1) of section 425, 
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 require-
ment for the labeling of a food by virtue of its having been 
developed using bioengineering, including any require-
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ments for claims that a food is or contains an ingredient 
that was developed using bioengineering.’’. 
TITLE II—NATURAL FOODS 
SEC. 201. LABELING OF NATURAL FOODS. 
Section 403 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 343), as amended by section 103 of this 
Act, is further amended by adding at the end the fol-
lowing: 
‘‘(aa)(1) If its labeling contains an express or implied 
claim that the food is ‘natural’ unless the claim is made 
in accordance with subparagraph (2). 
‘‘(2) A claim described in subparagraph (1) may be 
made only if the claim uses terms that have been defined 
by, and the food meets the requirements that have been 
established in, regulations promulgated to carry out this 
paragraph. 
‘‘(3) Notwithstanding subparagraph (2), prior to the 
finalization of regulations to carry out this paragraph, the 
use of any claim that a food is ‘natural’ shall be allowed 
if consistent with the Secretary’s existing policy for such 
claims. 
‘‘(4) In promulgating regulations to carry out this 
paragraph, the Secretary shall differentiate between food 
for human consumption and food intended for consump-
tion by animals other than humans. 
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‘‘(5) For purposes of subparagraph (1), a natural 
claim includes the use of— 
‘‘(A) the terms ‘natural’, ‘100% natural’, ‘natu-
rally grown’, ‘all natural’, and ‘made with natural 
ingredients’; and 
‘‘(B) any other terms specified by the Sec-
retary.’’. 
SEC. 202. REGULATIONS. 
(a) PROPOSED REGULATIONS.—Not later than 12 
months after the date of enactment of this Act, the Sec-
retary of Health and Human Services shall issue proposed 
regulations to implement section 403(aa) of the Federal 
Food, Drug, and Cosmetic Act, as added by section 201 
of this Act. 
(b) FINAL REGULATIONS.—Not later than 24 months 
after the date of enactment of this Act, the Secretary of 
Health and Human Services shall issue final regulations 
to implement such section 403(aa). 
SEC. 203. PREEMPTION. 
Section 403A(a) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 343–1(a)), as amended by section 
104 of this Act, is further amended by adding at the end 
the following: 
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‘‘(8) any requirement for the labeling of food of 
the type required by section 403(aa) that is not 
identical to the requirement of such section.’’. 
SEC. 204. EFFECTIVE DATE. 
The labeling requirements of section 403(aa) of the 
Federal Food, Drug, and Cosmetic Act, as added by sec-
tion 201 of this Act, shall take effect on the effective date 
of final regulations promulgated under section 202(b) of 
this Act. The provisions of section 403A(a)(8) of the Fed-
eral Food, Drug, and Cosmetic Act, as added by section 
203 of this Act, take effect on the date of enactment of 
this Act. 
Æ 
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