114TH CONGRESS 
1ST SESSION H. R. 1599 
AN ACT 
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,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Safe and Accurate Food Labeling Act of 2015’’. 
(b) TABLE OF CONTENTS.—The table of contents of 
this Act is as follows: 
Sec. 1. Short title; table of contents. 
Sec. 2. Savings clause. 
TITLE I—FOOD SAFETY AFFIRMATION FOR CERTAIN PLANT 
PRODUCTS 
Subtitle A—Food and Drug Administration 
Sec. 101. Consultation process. 
Subtitle B—Department of Agriculture 
Sec. 111. Regulation. 
Sec. 112. Regulations. 
Sec. 113. Preemption. 
Sec. 114. Rule of construction. 
Sec. 115. Implementation report. 
TITLE II—GENETIC ENGINEERING CERTIFICATION 
Sec. 201. Genetic engineering certification. 
Sec. 202. Regulations. 
Sec. 203. Preemption. 
Sec. 204. Applicability. 
TITLE III—NATURAL FOODS 
Sec. 301. Labeling of natural foods. 
Sec. 302. Regulations. 
Sec. 303. Preemption. 
Sec. 304. Effective date. 
SEC. 2. SAVINGS CLAUSE. 
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, or the definitions used by, the Food and Drug 
Administration under the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 301 et seq.) or the Animal and Plant
Health Inspection Service under the Plant Protection Act 
(7 U.S.C. 7701 et seq.), to ensure the safety of the food 
supply and the protection of plant health. 
TITLE I—FOOD SAFETY AFFIR-
MATION FOR CERTAIN PLANT 
PRODUCTS 
Subtitle A—Food and Drug 
Administration 
SEC. 101. CONSULTATION PROCESS. 
Chapter IV of the Federal Food, Drug, and Cosmetic 
Act is amended by inserting after section 423 of such Act 
(21 U.S.C. 350l) the following: 
‘‘SEC. 424. FOOD DERIVED FROM NEW PLANT VARIETIES. 
‘‘(a) IN GENERAL.—The Secretary shall continue to 
administer the consultation process established under the 
Food and Drug Administration’s policy statement entitled 
‘Statement of Policy: Food Derived from New Plant Vari-
eties’ published in the Federal Register on May 29, 1992 
(57 Fed. Reg. 22,984). 
‘‘(b) DETERMINATION OF MATERIAL DIFFERENCE 
BETWEEN
FOOD
FROM
GENETICALLY
ENGINEERED 
PLANTS AND COMPARABLE FOODS.— 
‘‘(1) IN GENERAL.—For purposes of subsection 
(a), the use of genetic engineering does not, by 
itself, constitute information that is material for
purposes of determining whether there is a dif-
ference between a food produced from, containing, 
or consisting of a genetically engineered plant and a 
comparable food. 
‘‘(2) LABELING
REQUIRED.—The Secretary 
may require that the labeling of a food produced 
from, containing, or consisting of a genetically engi-
neered plant contain a statement to adequately in-
form consumers of a difference between the food so 
produced and its comparable food if the Secretary 
determines that— 
‘‘(A) there is a material difference in the 
functional, nutritional, or compositional charac-
teristics, allergenicity, or other attributes be-
tween the food so produced and its comparable 
food; and 
‘‘(B) the disclosure of such material dif-
ference is necessary to protect public health and 
safety or to prevent the label or labeling of the 
food so produced from being false or misleading 
in any particular.’’.
Subtitle B—Department of 
Agriculture 
SEC. 111. REGULATION. 
The Plant Protection Act (7 U.S.C. 7701 et seq.) is 
amended by adding at the end the following new subtitle: 
‘‘Subtitle F—Coordination of Food 
Safety and Agriculture Programs 
‘‘SEC. 461. NOTIFICATION RELATING TO CERTAIN GENETI-
CALLY ENGINEERED PLANTS. 
‘‘(a) IN GENERAL.—Subject to subsection (b), it shall 
be unlawful to sell or offer for sale in interstate commerce 
a nonregulated genetically engineered plant for use or ap-
plication in food or a food produced from, containing, or 
consisting of a nonregulated genetically engineered plant 
unless— 
‘‘(1)(A) the Secretary of Health and Human 
Services notified the entity seeking evaluation of a 
food produced from, containing, or consisting of the 
genetically engineered plant in writing that the Sec-
retary of Health and Human Services, in evaluating 
the food from the genetically engineered plant 
through the consultation process referred to in sec-
tion 424(a) of the Federal Food, Drug, and Cos-
metic Act, has no objections to the entity’s deter-
mination that food produced from, containing, or
consisting of the genetically engineered plant that is 
the subject of the notification is safe for use by hu-
mans or animals, as applicable, and lawful under the 
Federal Food, Drug, and Cosmetic Act; and 
‘‘(B) the entity seeking evaluation of a food 
produced from, containing, or consisting of the ge-
netically engineered plant submits to the Secretary 
of Agriculture the notification of the finding of the 
Secretary of Health and Human Services under sub-
paragraph (A); or 
‘‘(2) before the date of the enactment of the 
Safe and Accurate Food Labeling Act of 2015, the 
Secretary of Health and Human Services— 
‘‘(A) considered the consultation process 
referred to in section 424(a) of the Federal 
Food, Drug, and Cosmetic Act with respect to 
such genetically engineered plant to be com-
plete; 
‘‘(B) notified the consulting party in writ-
ing that all questions with respect to the safety 
of food produced from, containing, or consisting 
of the genetically engineered plant have been re-
solved; and
‘‘(C) published such notification on the 
public Internet website of the Food and Drug 
Administration. 
‘‘(b) EXCEPTIONS.—Notwithstanding subsection (a), 
this section does not apply with respect to the sale or of-
fering for sale in interstate commerce of a genetically engi-
neered plant— 
‘‘(1) for the purpose of research or development 
testing, including— 
‘‘(A) testing conducted to generate data 
and information that could be used in a submis-
sion to the Secretary under this title or other 
regulatory submission; or 
‘‘(B) multiplication of seed or hybrid and 
variety development conducted before submit-
ting a notification under subsection (a)(1)(B); 
‘‘(2) solely because a processing aid or enzyme 
produced from the genetically engineered plant is in-
tended to be used to produce food; or 
‘‘(3) solely because the genetically engineered 
plant is used as a nutrient source for microorga-
nisms. 
‘‘(c) RULE
OF CONSTRUCTION.—Nothing in sub-
section (b)(1) may be construed as authorizing the sale 
or offering for sale in interstate commerce of a nonregu-
lated genetically engineered plant for use or application 
in food or a food produced from, containing, or consisting 
of a nonregulated genetically engineered plant. 
‘‘(d) PUBLIC DISCLOSURE.— 
‘‘(1) IN GENERAL.—Subject to paragraph (2), 
the Secretary of Agriculture shall publish on the 
public Internet website of the Department of Agri-
culture, and update as necessary, a registry that in-
cludes— 
‘‘(A) a list of each nonregulated genetically 
engineered plant intended for a use or applica-
tion in food that may be sold or offered for sale 
in interstate commerce, in accordance with sub-
section (a); 
‘‘(B) the petitions submitted to, and deter-
minations made by, the Secretary of Agri-
culture with respect to such a plant; and 
‘‘(C) the notifications of findings issued by 
the Secretary of Health and Human Services 
with respect to such a plant or the use or appli-
cation of such a plant in food. 
‘‘(2) TRADE SECRETS AND CONFIDENTIAL IN-
FORMATION.—Notwithstanding paragraph (1), noth-
ing in this section shall be construed to alter the 
protections offered by laws, regulations, and policies
governing disclosure of confidential commercial or 
trade secret information, and any other information 
exempt from disclosure pursuant to section 552(b) 
of title 5, United States Code, as such provisions 
would be applied to the documents and information 
referred to in subparagraphs (A) through (C) of 
paragraph (1). 
‘‘(e) IMPORTED FOOD.—In the case of food imported 
into the United States that is food produced from, con-
taining, or consisting of a plant that meets the definition 
of a nonregulated genetically engineered plant or a plant 
that, if sold in interstate commerce, would be subject to 
regulation under part 340 of title 7, Code of Federal Reg-
ulations (or any successor regulations), the provisions of 
this section shall apply to such food in the same manner 
and to the same extent as such provisions apply to a food 
that is not so imported. 
‘‘SEC. 462. DEFINITIONS. 
‘‘In this subtitle: 
‘‘(1) FOOD.—The term ‘food’ has the meaning 
given such term in section 201(f) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321(f)). 
‘‘(2) 
NONREGULATED
GENETICALLY
ENGI-
NEERED
PLANT.—The term ‘nonregulated geneti-
cally engineered plant’ means a genetically engi-
neered plant— 
‘‘(A) for which the Secretary of Agri-
culture has approved a petition under section 
340.6 of title 7, Code of Federal Regulations 
(or any successor regulations), for a determina-
tion that the genetically engineered plant should 
not be regulated under this Act; or 
‘‘(B) that— 
‘‘(i) is not subject to regulation as a 
plant pest under this Act; 
‘‘(ii) contains genetic material from a 
different species; and 
‘‘(iii) has been modified through in 
vitro recombinant deoxyribonucleic acid 
(DNA) techniques.’’. 
SEC. 112. REGULATIONS. 
Not later than 1 year after the date of the enactment 
of this Act, the Secretary of Agriculture shall promulgate 
interim final regulations to carry out the amendments 
made by section 111. 
SEC. 113. PREEMPTION. 
Regardless of whether regulations have been promul-
gated under section 112, beginning on the date of the en-
actment of this Act, no State or political subdivision of
a State may directly or indirectly establish under any au-
thority or continue in effect as to any food in interstate 
commerce any requirement with respect to the sale or of-
fering for sale in interstate commerce of a genetically engi-
neered plant for use or application in food that is not iden-
tical to the requirement of section 461 of the Plant Protec-
tion Act (as added by section 111 of this Act). 
SEC. 114. RULE OF CONSTRUCTION. 
Nothing in the amendments made by this subtitle is 
intended to alter or affect the ability of— 
(1) the Secretary of Health and Human Serv-
ices to take enforcement actions with respect to a 
violation of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 301 et seq.), including section 301 
of such Act (21 U.S.C. 331); or 
(2) the Secretary of Agriculture to take enforce-
ment actions with respect to a violation of the Plant 
Protection Act (7 U.S.C. 7701 et seq.), including 
section 411 of such Act (7 U.S.C. 7711). 
SEC. 115. IMPLEMENTATION REPORT. 
(a) STUDY.—Not later than 1 year after the date of 
the enactment of this Act, the Secretary of Agriculture 
and the Secretary of Health and Human Services shall 
jointly submit to Congress a report evaluating the 
progress made in the implementation of subtitle F of the
Plant Protection Act, as added by section 111. Such re-
port shall include— 
(1) an analysis of plants over which regulatory 
oversight under such subtitle is required; 
(2) an analysis of the extent to which the provi-
sions of such subtitle establish an appropriate scope 
of regulatory oversight for the Animal and Plant 
Health Inspection Service and the Food and Drug 
Administration, including their oversight of public 
research programs; and 
(3) any potential changes to the Plant Protec-
tion Act that would better facilitate implementation 
of a coordinated, predictable, and efficient science- 
based regulatory process. 
(b) COORDINATION WITH OTHER EFFORTS TO MOD-
ERNIZE REGULATION.—The report under subsection (a) 
shall be prepared, to the greatest extent practicable, in 
accordance with the process described in the memorandum 
issued by the Executive Office of the President on July 
2, 2015, entitled ‘‘Modernizing the Regulatory System for 
Biotechnology Products’’, including the directive specified 
in such memorandum to update the ‘‘Coordinated Frame-
work for Regulation of Biotechnology’’ published by the 
Executive Office of the President, Office of Science and
Technology Policy, in the Federal Register on June 26, 
1986 (51 Fed. Reg. 23302). 
TITLE II—GENETIC 
ENGINEERING CERTIFICATION 
SEC. 201. GENETIC ENGINEERING CERTIFICATION. 
The Agricultural Marketing Act of 1946 (7 U.S.C. 
1621 et seq.) is amended by adding at the end the fol-
lowing new subtitle: 
‘‘Subtitle E—Genetic Engineering 
Certification 
‘‘SEC. 291. DEFINITIONS. 
‘‘In this subtitle: 
‘‘(1) The term ‘certifying agent’ means the 
chief executive officer of a State or, in the case of 
a State that provides for the statewide election of an 
official to be responsible solely for the administra-
tion of the agricultural operations of the State, such 
official, and any person (including a private entity) 
who is accredited by the Secretary as a certifying 
agent for the purpose of certifying a covered product 
as a product, the labeling of which may indicate 
whether the product is produced with or without the 
use of genetic engineering. 
‘‘(2) The term ‘covered product’ means—
‘‘(A) an agricultural product, whether raw 
or processed (including any product derived 
from livestock that is marketed in the United 
States for consumption by humans or other ani-
mals); 
‘‘(B) any other food (as defined in section 
201 of the Federal Food, Drug, and Cosmetic 
Act) not derived from an agricultural product; 
and 
‘‘(C) seed or other propagative material. 
‘‘(3) The term ‘genetically engineered plant’ re-
fers to a plant or plant product (as those terms are 
defined in section 403 of the Plant Protection Act 
(7 U.S.C. 7702)), if— 
‘‘(A) it contains genetic material that has 
been modified through in vitro recombinant 
deoxyribonucleic acid (DNA) techniques; and 
‘‘(B) the modification could not otherwise 
be obtained using conventional breeding tech-
niques. 
‘‘(4) The term ‘comparable food’ means, with 
respect to a covered product produced from, con-
taining, or consisting of a genetically engineered 
plant— 
‘‘(A) the parental variety of the plant;
‘‘(B) another commonly consumed variety 
of the plant; or 
‘‘(C) a commonly consumed covered prod-
uct with properties comparable to the covered 
product produced from, containing, or con-
sisting of the genetically engineered plant. 
‘‘(5) The term ‘handle’ means to sell, process, 
or package covered products. 
‘‘(6) The term ‘producer’ means a person who 
engages in the business of growing or producing cov-
ered products. 
‘‘(7) The term ‘Secretary’ means the Secretary 
of Agriculture, acting through the Agricultural Mar-
keting Service. 
‘‘SEC. 291A. NATIONAL GENETICALLY ENGINEERED FOOD 
CERTIFICATION PROGRAM. 
‘‘(a) IN GENERAL.—The Secretary shall establish a 
voluntary genetically engineered food certification pro-
gram for covered products with respect to the use of ge-
netic engineering in the production of such products, as 
provided for in this subtitle. The Secretary shall establish 
the requirements and procedures as the Secretary deter-
mines are necessary to carry out such program. 
‘‘(b) CONSULTATION.—In developing the program 
under subsection (a), the Secretary shall consult with such
other parties as are necessary to develop such program 
to ensure that producers or handlers seeking to make 
claims under section 291B or 291C are certified to make 
such claims. 
‘‘(c) CERTIFICATION.—The Secretary shall imple-
ment the program established under subsection (a) 
through certifying agents. Such certifying agents may cer-
tify that covered products were or were not produced with 
the use of genetic engineering or a genetically engineered 
plant, in accordance with this subtitle. 
‘‘(d) SEAL.—The Secretary shall establish a seal to 
identify covered products in interstate commerce using 
terminology the Secretary considers appropriate for cov-
ered products certified under this title, including termi-
nology commonly used in interstate commerce or estab-
lished by the Secretary in regulations. 
‘‘SEC. 291B. NATIONAL STANDARDS FOR LABELING NON-
GENETICALLY ENGINEERED FOOD. 
‘‘(a) IN GENERAL.—To be sold or labeled as a cov-
ered product produced without the use of genetic engineer-
ing— 
‘‘(1) the covered product shall— 
‘‘(A) be subject to supply chain process 
controls that address—
‘‘(i) the producer planting seed that is 
not genetically engineered; 
‘‘(ii) the producer keeping the crop 
separated during growth, harvesting, stor-
age, and transportation; and 
‘‘(iii) persons in direct contact with 
such crop or products derived from such 
crop during transportation, storage, or 
processing keeping the product separated 
from other products that are, or are de-
rived from, genetically engineered plants; 
and 
‘‘(B) be produced and handled in compli-
ance with a nongenetically engineered food plan 
developed and approved in accordance with sub-
section (c); 
‘‘(2) in the case of a covered product derived 
from livestock that is marketed in the United States 
for human consumption, the covered product and the 
livestock, products consumed by such livestock, and 
products used in processing the products consumed 
by such livestock shall be produced without the use 
of products derived from genetic engineering; and 
‘‘(3) labeling or advertising material on, or in 
conjunction with, such covered product shall not
suggest either expressly or by implication that cov-
ered products developed without the use of genetic 
engineering are safer or of higher quality than cov-
ered products produced from, containing, or con-
sisting of a genetically engineered plant. 
‘‘(b) EXCEPTIONS.—A covered product shall not be 
considered as not meeting the criteria specified in sub-
section (a) solely because the covered product— 
‘‘(1) is manufactured or processed using a ge-
netically engineered microorganism or a processing 
aid or enzyme; 
‘‘(2) is derived from microorganisms that con-
sumed a nutrient source produced from, containing, 
or consisting of a genetically engineered plant; or 
‘‘(3) is an approved substance on the National 
List established under section 2118 of the Organic 
Foods Production Act of 1990 (7 U.S.C. 6517). 
‘‘(c) NONGENETICALLY ENGINEERED FOOD PLAN.— 
‘‘(1) IN
GENERAL.—A producer or handler 
seeking certification under this section shall submit 
a nongenetically engineered food plan to the certi-
fying agent and such plan shall be reviewed by the 
certifying agent who shall determine if such plan 
meets the requirements of this section.
‘‘(2) CONTENTS.—A nongenetically engineered 
food plan shall contain a description of— 
‘‘(A) the procedures that will be followed 
to assure compliance with this section; 
‘‘(B) a description of the monitoring 
records that will be maintained; and 
‘‘(C) any corrective actions that will be im-
plemented in the event there is a deviation from 
the plan. 
‘‘(3) AVAILABILITY.—The nongenetically engi-
neered food plan and the records maintained under 
the plan shall be available for review and copying by 
the Secretary or a certifying agent. 
‘‘(d) TREATMENT OF LIVESTOCK.—In the case of a 
covered product derived from livestock that is marketed 
in the United States for human consumption, the covered 
product shall not be considered to be genetically engi-
neered solely because the livestock consumed feed pro-
duced from containing, or consisting of a genetically engi-
neered plant. 
‘‘SEC. 291C. NATIONAL STANDARDS FOR LABELING GENETI-
CALLY ENGINEERED FOOD. 
‘‘(a) IN GENERAL.—To be sold or labeled as a cov-
ered product produced with the use of genetic engineer-
ing—
‘‘(1) the covered product shall be produced and 
handled in compliance with a genetically engineered 
food plan developed and approved in accordance with 
subsection (b); and 
‘‘(2) the labeling of, or advertising material on, 
or in conjunction with, such covered product shall— 
‘‘(A) not expressly or impliedly claim that 
a covered product developed with the use of ge-
netic engineering is safer or of higher quality 
solely because the covered product is a product 
developed with the use of genetic engineering; 
‘‘(B) not make any claims that are false or 
misleading; and 
‘‘(C) contain such information as the Sec-
retary considers appropriate. 
‘‘(b) GENETICALLY ENGINEERED FOOD PLAN.— 
‘‘(1) IN
GENERAL.—A producer or handler 
seeking certification under this section shall submit 
a genetically engineered food plan to the certifying 
agent and such plan shall be reviewed by the certi-
fying agent who shall determine if such plan meets 
the requirements of this section. 
‘‘(2) CONTENTS.—A genetically engineered food 
plan shall contain a description of—
‘‘(A) the procedures that will be followed 
to assure compliance with this section; 
‘‘(B) a description of the monitoring 
records that will be maintained; and 
‘‘(C) any corrective actions that will be im-
plemented in the event there is a deviation from 
the plan. 
‘‘(3) 
AVAILABILITY.—The 
genetically 
engi-
neered food plan and the records maintained under 
the plan shall be available for review and copying by 
the Secretary or a certifying agent. 
‘‘(c) PROHIBITION AGAINST RESTRICTING CERTAIN 
DISCLOSURES.—With respect to a covered product that 
otherwise meets the criteria specified in subsection (a), the 
Secretary may not prevent a person— 
‘‘(1) from disclosing voluntarily on the labeling 
of such a covered product developed with the use of 
genetic engineering the manner in which the product 
has been modified to express traits or characteristics 
that differ from its comparable food; or 
‘‘(2) from disclosing in advertisements, on the 
Internet, in response to consumer inquiries, or on 
other communications, other than in the labeling, 
that a covered product was developed with the use 
of genetic engineering.
‘‘SEC. 291D. IMPORTED PRODUCTS. 
‘‘Imported covered products may be sold or labeled 
as produced with or without the use of genetic engineering 
if the Secretary determines that such products have been 
produced and handled under a genetic engineering certifi-
cation program that provides safeguards and guidelines 
governing the production and handling of such products 
that are at least equivalent to the requirements of this 
subtitle. 
‘‘SEC. 291E. ACCREDITATION PROGRAM. 
‘‘(a) IN GENERAL.—The Secretary shall establish 
and implement a program to accredit a governing State 
official, and any private person, that meets the require-
ments of this section as a certifying agent for the purpose 
of certifying a covered product as having been produced 
with or without the use of genetic engineering or a geneti-
cally engineered plant, in accordance with this subtitle. 
‘‘(b) REQUIREMENTS.—To be accredited as a certi-
fying agent under this section, a governing State official 
or private person shall— 
‘‘(1) prepare and submit to the Secretary an 
application for such accreditation; 
‘‘(2) have sufficient expertise in agricultural 
production and handling techniques as determined 
by the Secretary; and
‘‘(3) comply with the requirements of this sec-
tion. 
‘‘(c) DURATION OF ACCREDITATION.—An accredita-
tion made under this section shall be for a period of not 
to exceed 5 years, as determined appropriate by the Sec-
retary, and may be renewed. 
‘‘(d) COORDINATION WITH EXISTING ORGANIC PRO-
GRAM ACCREDITATION.—A governing State official or pri-
vate person who is accredited to certify a farm or handling 
operation as a certified organic farm or handling operation 
pursuant to section 2115 of the Organic Foods Production 
Act of 1990 (7 U.S.C. 6415) (and such accreditation is 
in effect) shall be deemed to be accredited to certify cov-
ered products under this subtitle. 
‘‘SEC. 291F. RECORDKEEPING, INVESTIGATIONS, AND EN-
FORCEMENT. 
‘‘(a) RECORDKEEPING.— 
‘‘(1) IN GENERAL.—Except as otherwise pro-
vided in this title, each person who sells, labels, or 
represents any covered product as having been pro-
duced with or without the use of genetic engineering 
or a genetically engineered plant shall— 
‘‘(A) maintain records in a manner pre-
scribed by the Secretary; and
‘‘(B) make available to the Secretary, on 
request by the Secretary, all records associated 
with the covered product. 
‘‘(2) CERTIFYING AGENTS.— 
‘‘(A) IN
GENERAL.—A certifying agent 
shall— 
‘‘(i) maintain all records concerning 
the activities of the certifying agent with 
respect to the certification of covered prod-
ucts under this subtitle in a manner pre-
scribed by the Secretary; and 
‘‘(ii) make available to the Secretary, 
on request by the Secretary, all records as-
sociated with such activities. 
‘‘(B) TRANSFERENCE OF RECORDS.—If a 
private person that was certified under this sub-
title is dissolved or loses accreditation, all 
records and copies of records concerning the ac-
tivities of the person under this subtitle shall be 
transferred to the Secretary. 
‘‘(b) INVESTIGATIONS.— 
‘‘(1) IN
GENERAL.—The Secretary may take 
such investigative actions as the Secretary considers 
to be necessary—
‘‘(A) to verify the accuracy of any informa-
tion reported or made available under this sub-
title; and 
‘‘(B) to determine whether a person cov-
ered by this subtitle has committed a violation 
of any provision of this subtitle, including an 
order or regulation promulgated by the Sec-
retary pursuant to this subtitle. 
‘‘(2) SPECIFIC
INVESTIGATIVE
POWERS.—In 
carrying out this subtitle, the Secretary may— 
‘‘(A) administer oaths and affirmations; 
‘‘(B) subpoena witnesses; 
‘‘(C) compel attendance of witnesses; 
‘‘(D) take evidence; and 
‘‘(E) require the production of any records 
required to be maintained under this subtitle 
that are relevant to an investigation. 
‘‘(c) VIOLATIONS OF SUBTITLE.— 
‘‘(1) FAILURE
TO
PROVIDE
INFORMATION.— 
Any person covered by this subtitle who, after notice 
and an opportunity to be heard, has been found by 
the Secretary to have failed or refused to provide ac-
curate information (including a delay in the timely 
delivery of such information) required by the Sec-
retary under this subtitle, shall be assessed a civil 
penalty of not more than $10,000. 
‘‘(2) MISUSE OF LABEL.— 
‘‘(A) IN GENERAL.—Any person who, after 
notice and an opportunity to be heard, is found 
by the Secretary to have knowingly sold or la-
beled any covered product as having been pro-
duced with or without the use of genetic engi-
neering or a genetically engineered plant, except 
in accordance with this subtitle, shall be as-
sessed a civil penalty of not more than $10,000. 
‘‘(B) CONTINUING VIOLATION.—Each day 
during which a violation described in subpara-
graph (A) occurs shall be considered to be a 
separate violation. 
‘‘(3) INELIGIBILITY.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (C), any person that carries out 
an activity described in subparagraph (B), after 
notice and an opportunity to be heard, shall not 
be eligible, for the 5-year period beginning on 
the date of the occurrence, to receive a certifi-
cation under this subtitle with respect to any 
covered product.
‘‘(B) DESCRIPTION
OF
ACTIVITIES.—An 
activity referred to in subparagraph (A) is— 
‘‘(i) making a false statement; 
‘‘(ii) a violation described in para-
graph (2)(A); 
‘‘(iii) attempting to have a label indi-
cating that a covered product has been 
produced with or without the use of genetic 
engineering or a genetically engineered 
plant affixed to a covered product that a 
person knows, or should have reason to 
know, to have been produced in a manner 
that is not in accordance with this subtitle; 
or 
‘‘(iv) otherwise violating the purposes 
of the genetically engineered food certifi-
cation program established under section 
291A, as determined by the Secretary. 
‘‘(C) WAIVER.—Notwithstanding subpara-
graph (A), the Secretary may modify or waive 
a period of ineligibility under this paragraph if 
the Secretary determines that the modification 
or waiver is in the best interests of the geneti-
cally engineered food certification program es-
tablished under section 291A.
‘‘(4) REPORTING OF VIOLATIONS.—A certifying 
agent shall immediately report any violation of this 
subtitle to the Secretary. 
‘‘(5) CEASE-AND-DESIST ORDERS.— 
‘‘(A) IN
GENERAL.—The Secretary may, 
after providing notice and an opportunity to be 
heard, issue an order, require any person who 
the Secretary reasonably believes is selling or 
labeling a covered product in violation of this 
subtitle to cease and desist from selling or la-
beling such covered product as having been pro-
duced with or without the use of genetic engi-
neering or a genetically engineered plant. 
‘‘(B) FINAL AND CONCLUSIVE.—The order 
of the Secretary imposing a cease-and-desist 
order under this paragraph shall be final and 
conclusive unless the affected person files an 
appeal from the Secretary’s order with the ap-
propriate district court of the United States not 
later than 30 days after the date of the 
issuance of the order. 
‘‘(6) VIOLATIONS BY CERTIFYING AGENT.—A 
certifying agent that is a private person that violates 
the provisions of this subtitle or falsely or neg-
ligently certifies any covered product that does not
meet the terms and conditions of the genetically en-
gineered food certification program established 
under section 291A, as determined by the Secretary, 
shall, after notice and an opportunity to be heard— 
‘‘(A) lose accreditation as a certifying 
agent under this subtitle; and 
‘‘(B) be ineligible to be accredited as a cer-
tifying agent under this subtitle for a period of 
not less than 3 years, beginning on the date of 
the determination. 
‘‘(7) SUSPENSION.— 
‘‘(A) IN
GENERAL.—The Secretary may, 
after first providing the certifying agent notice 
and an opportunity to be heard, suspend the ac-
creditation of the certifying agent for a period 
specified in subparagraph (B) for a violation of 
this subtitle. 
‘‘(B) PERIOD
OF
SUSPENSION.—The pe-
riod of a suspension under subparagraph (A) 
shall terminate on the date the Secretary makes 
a final determination with respect to the viola-
tion that is the subject of the suspension. 
‘‘(8) 
ENFORCEMENT
BY
ATTORNEY
GEN-
ERAL.—On request of the Secretary, the Attorney 
General may bring a civil action against a person in
a district court of the United States to enforce this 
subtitle or a requirement or regulation prescribed, or 
an order issued, under this subtitle. The action may 
be brought in the judicial district in which the per-
son does business or in which the violation occurred. 
‘‘SEC. 291G. AUTHORIZATION OF APPROPRIATIONS; FEES. 
‘‘(a) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated to establish the geneti-
cally engineered food certification program under section 
291A, $2,000,000, to remain available until expended. 
‘‘(b) FEES.— 
‘‘(1) IN GENERAL.—Upon establishment of the 
genetically engineered food certification program 
under section 291A, the Secretary shall establish by 
notice, charge, and collect fees to cover the esti-
mated costs to the Secretary of carrying out this 
subtitle. 
‘‘(2) 
AVAILABILITY.—Fees 
collected 
under 
paragraph (1) shall be deposited into a fund in the 
Treasury of the United States and shall remain 
available until expended, subject to appropriation, to 
carry out this subtitle.’’.
SEC. 202. REGULATIONS. 
In promulgating regulations to carry out the amend-
ments made by section 201, the Secretary of Agriculture 
shall— 
(1) provide a process to account for certified 
nongenetically engineered covered products con-
taining material from genetically engineered plants 
due to the inadvertent presence of such material; 
(2) to the greatest extent practicable, establish 
consistency between the certification programs es-
tablished under subtitle E of the Agricultural Mar-
keting Act of 1946 (as added by section 201 of this 
Act), the organic certification program established 
under the Organic Foods Production Act of 1990 (7 
U.S.C. 6501 et seq.), and other voluntary labeling 
programs administered by the Secretary; 
(3) with respect to regulations for covered prod-
ucts intended for consumption by non-food animals, 
take into account the inherent differences between 
food intended for animal and human consumption, 
including the essential vitamins, minerals, and 
micronutrients required to be added to animal food 
to formulate a complete and balanced diet; and 
(4) provide a process for requesting and grant-
ing exemptions from the requirements of subtitle E 
of the Agricultural Marketing Act of 1946 (as added
by section 201 of this Act) under conditions estab-
lished by the Secretary. 
SEC. 203. EFFECTIVE DATE; PREEMPTION. 
(a) EFFECTIVE DATE.—Regardless of whether regu-
lations have been promulgated under section 202 of this 
Act, the amendments made by section 201 shall take effect 
beginning on the date of the enactment of this Act. 
(b) PROHIBITIONS AGAINST MANDATORY LABELING 
OF FOOD DEVELOPED USING GENETIC ENGINEERING.— 
(1) IN GENERAL.—Subject to paragraph (2), no 
State or political subdivision of a State may directly 
or indirectly establish under any authority or con-
tinue in effect as to any covered product (as defined 
in section 291 of the Agricultural Marketing Act of 
1946, as added by section 201 of this Act) in inter-
state commerce, any requirement for the labeling of 
a covered product indicating the product as having 
been produced from, containing, or consisting of a 
genetically engineered plant, including any require-
ments for claims that a covered product is or con-
tains an ingredient that was produced from, con-
tains, or consists of a genetically engineered plant. 
(2) EXCEPTION.—Notwithstanding paragraph 
(1), a State (or a political subdivision thereof) may 
establish either of the following voluntary programs
for the regulation of claims described in such para-
graph: 
(A) A program that relates to voluntary 
claims to which paragraph (1) of section 204(a) 
of this Act applies. 
(B) A program that— 
(i) is voluntary; 
(ii) is accredited by the Secretary pur-
suant to section 291E of the Agricultural 
Marketing Act of 1946 (as added by sec-
tion 201 of this Act); and 
(iii) establishes standards that are 
identical to the standards established 
under section 291B or 291C of the Agri-
cultural Marketing Act of 1946, as appli-
cable (as added by section 201 of this Act). 
(c) RULE OF CONSTRUCTION.—For the sole purpose 
of subsection (b)(1), a covered product derived from live-
stock that consumed genetically engineered plants shall be 
deemed as having been produced from, containing, or con-
sisting of a genetically engineered plant. 
SEC. 204. APPLICABILITY. 
(a) EXISTING CLAIMS.—A voluntary claim made with 
respect to whether a covered product (as defined in section 
291 of the Agricultural Marketing Act of 1946, as added
by section 201 of this Act) was produced with or without 
the use of genetic engineering or genetically engineered 
plants before the date of the enactment of this Act— 
(1) may be made for such a product during the 
36-month period that begins on the date of the en-
actment of this Act; and 
(2) after the expiration of such 36-month pe-
riod, may be made so long as the labels associated 
with such a claim meet the standards specified in 
section 291B or 291C of the Agricultural Marketing 
Act of 1946, as applicable (as added by section 201 
of this Act). 
(b) ORGANIC CERTIFICATION.—In the case of a cov-
ered product (as defined in section 291 of the Agricultural 
Marketing Act of 1946, as added by section 201 of this 
Act) produced by a farm or handling operation that is cer-
tified as an organic farm or handling operation under the 
Organic Foods Production Act of 1990 (7 U.S.C. 6501 
et seq.), such product is deemed to be certified as a prod-
uct produced without the use of genetic engineering under 
the genetically engineered food certification program es-
tablished under section 291A of the Agricultural Mar-
keting Act of 1946 (as added by section 201 of this Act).
TITLE III—NATURAL FOODS 
SEC. 301. LABELING OF NATURAL FOODS. 
Section 403 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 343) is amended by adding at the end the 
following: 
‘‘(z)(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. 
‘‘(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. 302. REGULATIONS. 
(a) PROPOSED REGULATIONS.—Not later than 18 
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(z) of the Federal 
Food, Drug, and Cosmetic Act, as added by section 301 
of this Act. 
(b) FINAL REGULATIONS.—Not later than 30 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(z). 
SEC. 303. PREEMPTION. 
Section 403A(a) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 343–1(a)) is amended— 
(1) in paragraph (4), by striking ‘‘or’’ at the 
end; 
(2) in paragraph (5), by striking the period and 
inserting a comma; and 
(3) by inserting after paragraph (5) the fol-
lowing:
‘‘(6) any requirement for the labeling of food of 
the type required by section 403(z) that is not iden-
tical to the requirement of such section.’’. 
SEC. 304. EFFECTIVE DATE. 
The labeling requirements of section 403(z) of the 
Federal Food, Drug, and Cosmetic Act, as added by sec-
tion 301 of this Act, shall take effect on the effective date 
of final regulations promulgated under section 302(b) of 
this Act. The provisions of section 403A(a)(6) of the Fed-
eral Food, Drug, and Cosmetic Act, as added by section 
303 of this Act, take effect on the date of enactment of 
this Act. 
Passed the House of Representatives July 23, 2015. 
Attest: 
Clerk.
114TH CONGRESS 
1ST SESSION 
H. R. 1599 
AN ACT 
To amend the Federal Food, Drug, and Cosmetic 
Act with respect to food produced from, con-
taining, or consisting of a bioengineered orga-
nism, the labeling of natural foods, and for other 
purposes.