I 
114TH CONGRESS 
1ST SESSION H. R. 1599 
To amend the Federal Food, Drug, and Cosmetic Act with respect to food 
produced from, containing, or consisting of a bioengineered organism, 
the labeling of natural foods, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 25, 2015 
Mr. POMPEO (for himself, Mr. BUTTERFIELD, Mr. DAVID SCOTT of Georgia, 
Mr. ASHFORD, Mrs. KIRKPATRICK, Ms. ADAMS, Ms. PLASKETT, Mr. 
HASTINGS, Mr. SCHRADER, Mr. WHITFIELD, Mrs. ELLMERS of North 
Carolina, Mr. COLLINS of New York, Mrs. WAGNER, Mr. CRAMER, Mr. 
VALADAO, Mr. NEWHOUSE, Mr. NUNES, and Mr. BLUM) introduced the 
following bill; which was referred to the Committee on Energy and Com-
merce, and in addition to the Committee on Agriculture, for a period to 
be subsequently determined by the Speaker, in each case for consider-
ation of such provisions as fall within the jurisdiction of the committee 
concerned 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act with 
respect to food produced from, containing, or consisting 
of a bioengineered organism, the labeling of natural 
foods, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Safe and Accurate 
Food Labeling Act of 2015’’. 
SEC. 2. TABLE OF CONTENTS. 
The table of contents of this Act is as follows: 
Sec. 1. Short title. 
Sec. 2. Table of contents. 
Sec. 3. Ensuring safety of food supply. 
TITLE I—FOOD PRODUCED FROM, CONTAINING, OR CONSISTING 
OF A BIOENGINEERED ORGANISM 
Sec. 101. Definitions. 
Sec. 102. Mandatory premarket biotechnology notification program. 
Sec. 103. Labeling of whether food is bioengineered. 
Sec. 104. Preemption. 
TITLE II—NATURAL FOODS 
Sec. 201. Labeling of natural foods. 
Sec. 202. Regulations. 
Sec. 203. Preemption. 
Sec. 204. Effective date. 
TITLE III—NON-BIOENGINEERED FOOD CERTIFICATION 
Sec. 301. Non-bioengineered food certification. 
Sec. 302. Regulations. 
Sec. 303. Preemption. 
SEC. 3. ENSURING SAFETY OF FOOD SUPPLY. 
Nothing in this Act (or the amendments made by this 
Act) is intended to alter or affect the authorities or regu-
latory programs, policies, and procedures otherwise avail-
able to the Food and Drug Administration to ensure the 
safety of the food supply under the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.). 
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TITLE 
I—FOOD 
PRODUCED 
FROM, CONTAINING, OR CON-
SISTING 
OF 
A 
BIOENGI-
NEERED ORGANISM 
SEC. 101. DEFINITIONS. 
Section 201 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321) is amended by adding at the end the 
following: 
‘‘(ss) The term ‘bioengineered organism’ refers to an 
organism if— 
‘‘(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 
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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: 
‘‘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 2015; and 
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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; 
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. 
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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 
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 
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does not provide an adequate basis for the 
notifier’s determination; and 
‘‘(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 
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safety or to prevent the label or labeling of such food from 
being false or misleading, the Secretary may, in a response 
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-
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taining, or consisting of the plant that is a bio-
engineered organism. 
‘‘(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 defined 
in section 201(ss) 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. 343–1(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, 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; 
‘‘(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; and 
‘‘(G) may be made if— 
‘‘(i) the food is an agricultural prod-
uct, as such term is defined in section 207 
of the Agricultural Marketing Act of 1946; 
and 
‘‘(ii) such agricultural product has 
been certified as an agricultural product 
produced without the use of bioengineering 
under subtitle E of such Act. 
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‘‘(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). 
‘‘(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 2015. 
‘‘(b) CLAIMS THAT BIOENGINEERING WAS USED.— 
‘‘(1) IN GENERAL.—If a claim in the labeling of 
food indicates, directly or indirectly, that bio-
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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 
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— 
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