IB 
114TH CONGRESS 
1ST SESSION H. R. 1599 
[Report No. 114–208, Part I] 
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 
JULY 16, 2015 
Additional sponsors: Mr. LONG, Mr. HUELSKAMP, Mr. LUETKEMEYER, Mr. 
DESJARLAIS, Mr. PERRY, Mr. SIMPSON, Mr. SMITH of Nebraska, Mr. 
YOUNG of Iowa, Mr. CHABOT, Mrs. LAWRENCE, Mr. LAMBORN, Mr. 
FLEISCHMANN, Mr. BYRNE, Mr. ZINKE, Mr. GRAVES of Missouri, Mr. 
SHIMKUS, Mr. AMODEI, Mr. THOMPSON of Mississippi, Mr. GROTHMAN, 
Mr. ROONEY of Florida, Mr. CLEAVER, Mr. MESSER, Mr. JONES, Mr. 
ROKITA, Mr. GUTHRIE, Mr. RIBBLE, Mr. FINCHER, Mr. COSTA, Mr. POE 
of Texas, Mr. ROSS, Mr. TIBERI, Mr. MACARTHUR, Mr. WENSTRUP, Mr. 
JOHNSON of Ohio, Mr. COLLINS of Georgia, Mr. YOUNG of Indiana, Mr. 
BARR, Mr. CARTER of Georgia, Mr. MARINO, Mr. HOLDING, Mr. HARRIS, 
Mr. KNIGHT, Mr. RENACCI, Mr. WESTERMAN, Mr. THOMPSON of Penn-
sylvania, Mr. DENT, Mr. BRIDENSTINE, Mr. MULVANEY, Mrs. 
HARTZLER, Ms. MICHELLE LUJAN GRISHAM of New Mexico, Mr. NOR-
CROSS, Mr. FRANKS of Arizona, Mr. WOODALL, Mr. PITTENGER, Mr. 
ABRAHAM, Mr. STIVERS, Mr. JORDAN, Mr. BUCK, Mr. BUCSHON, Mr. 
PETERSON, Mr. CONAWAY, Mr. CRAWFORD, Mr. RODNEY DAVIS of Illi-
nois, Mr. MOOLENAAR, Mr. ROUZER, Mr. BOST, Mr. ROGERS of Ala-
bama, Mr. GOODLATTE, Mr. NEUGEBAUER, Mr. GIBBS, Mr. EMMER of 
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Minnesota, Mr. LUCAS, Mr. KELLY of Mississippi, Mr. BENISHEK, Mr. 
AUSTIN SCOTT of Georgia, Mr. LAMALFA, Mr. YOHO, Mrs. WALORSKI, 
Mr. ALLEN, Mrs. NOEM, Mr. KINZINGER of Illinois, Mr. GOSAR, Mr. 
HURT of Virginia, Mr. BROOKS of Alabama, Mr. STUTZMAN, Mr. 
SCHWEIKERT, Mr. SHUSTER, Mr. DENHAM, and Mrs. MILLER of Michi-
gan 
JULY 16, 2015 
Reported from the Committee on Agriculture with an amendment and ordered 
to be printed 
[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced on March 25, 2015] 
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. 
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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 Ad-
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ministration under the Federal Food, Drug, and Cosmetic 
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 BE-
TWEEN FOOD FROM GENETICALLY ENGINEERED PLANTS 
AND COMPARABLE FOODS.— 
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‘‘(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 difference between a 
food produced from, containing, or consisting of a ge-
netically engineered plant and a comparable food. 
‘‘(2) LABELING REQUIRED.—The Secretary may 
require that the labeling of a food produced from, con-
taining, or consisting of a genetically engineered 
plant contain a statement to adequately inform con-
sumers 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 between 
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.’’. 
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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 introduce or deliver for introduction into 
interstate commerce a nonregulated genetically engineered 
plant for use or application in food or a food produced 
from, containing, or consisting of a nonregulated geneti-
cally 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 section 424(a) 
of the Federal Food, Drug, and Cosmetic Act, has no 
objections to the entity’s determination that food pro-
duced from, containing, or consisting of the geneti-
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cally engineered plant that is the subject of the notifi-
cation is as safe for use by humans or animals, as 
applicable, as one or more comparable foods; and 
‘‘(B) the entity seeking evaluation of a food pro-
duced from, containing, or consisting of the geneti-
cally engineered plant submits to the Secretary of Ag-
riculture the notification of the finding of the Sec-
retary of Health and Human Services under subpara-
graph (A); or 
‘‘(2) before the date of the enactment of the Safe 
and Accurate Food Labeling Act of 2015, the Sec-
retary of Health and Human Services— 
‘‘(A) considered the consultation process re-
ferred to in section 424(a) of the Federal Food, 
Drug, and Cosmetic Act with respect to such ge-
netically engineered plant to be complete; 
‘‘(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 pub-
lic Internet website of the Food and Drug Ad-
ministration. 
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‘‘(b) EXCEPTIONS.—Notwithstanding subsection (a), 
this section does not apply with respect to the introduction 
or delivery for introduction into interstate commerce of a 
genetically engineered 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 submission 
to the Secretary under this title or other regu-
latory submission; or 
‘‘(B) research involving multiplication of 
seed or hybrid and variety development con-
ducted before submitting 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 subsection 
(b)(1) may be construed as authorizing the introduction or 
delivery for introduction into interstate commerce of a non-
regulated genetically engineered plant for use or application 
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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 Agriculture, 
and update as necessary, a registry that includes— 
‘‘(A) a list of each nonregulated genetically 
engineered plant intended for a use or applica-
tion in food that may be introduced or delivered 
for introduction in interstate commerce, in ac-
cordance with subsection (a); 
‘‘(B) the petitions submitted to, and deter-
minations made by, the Secretary of Agriculture 
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 INFOR-
MATION.—Notwithstanding paragraph (1), nothing 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 
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disclosure pursuant to section 552(b) of title 5, 
United States Code, as such provisions would be ap-
plied 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 introduced 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 ENGINEERED 
PLANT.—The term ‘nonregulated genetically engi-
neered plant’ means a genetically engineered plant— 
‘‘(A) for which the Secretary of Agriculture 
has approved a petition under section 340.6 of 
title 7, Code of Federal Regulations (or any suc-
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cessor regulations), for a determination that the 
genetically engineered plant should not be regu-
lated 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 one 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 enact-
ment of this Act, 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 with respect to genetically engineered 
plants for use or application in food that is not identical 
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to the requirement of section 461 of the Plant Protection 
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 Services 
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 sec-
tion 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 report 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 
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of regulatory oversight for the Animal and Plant 
Health Inspection Service and the Food and Drug 
Administration, including their oversight of public re-
search programs; and 
(3) any potential changes to the Plant Protection 
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 ac-
cordance 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 Bio-
technology Products’’, including the directive specified in 
such memorandum to update the ‘‘Coordinated Framework 
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). 
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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 following 
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 administration of the 
agricultural operations of the State, such official, and 
any person (including a private entity) who is ac-
credited 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 prod-
uct is produced with or without the use of genetic en-
gineering. 
‘‘(2) The term ‘covered product’ means— 
‘‘(A) an agricultural product, whether raw 
or processed (including any product derived from 
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livestock that is marketed in the United States 
for consumption by humans or other animals); 
‘‘(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 techniques. 
‘‘(4) The term ‘comparable food’ means, with re-
spect to a covered product produced from, containing, 
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 product 
with properties comparable to the covered prod-
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uct produced from, containing, or consisting of 
the plant that is a 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 program 
for covered products with respect to the use of genetic engi-
neering in the production of such products, as provided for 
in this subtitle. The Secretary shall establish the require-
ments and procedures as the Secretary determines are nec-
essary 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. 
‘‘(c) CERTIFICATION.—The Secretary shall implement 
the program established under subsection (a) through certi-
fying agents. Such certifying agents may certify that cov-
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ered products were or were not produced with the use of 
genetic engineering or a genetically engineered plant, in ac-
cordance with this subtitle. 
‘‘(d) SEAL.—The Secretary shall establish a seal to 
identify covered products in interstate commerce using ter-
minology the Secretary considers appropriate, including 
terminology commonly used in interstate commerce or es-
tablished 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 covered 
product produced without the use of genetic engineering— 
‘‘(1) the covered product shall— 
‘‘(A) be subject to supply chain process con-
trols that address— 
‘‘(i) the producer planting seed that is 
not genetically engineered; 
‘‘(ii) the producer keeping the crop sep-
arated during growth, harvesting, storage, 
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 
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from other products that are or are derived 
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 sug-
gest either expressly or by implication that covered 
products developed without the use of genetic engi-
neering are safer or of higher quality than covered 
products produced from, containing, or consisting 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 produced with a genetically engineered 
microorganism or a processing aid or enzyme; 
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‘‘(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 seek-
ing certification under this section shall submit a 
nongenetically 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 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 
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the plan shall be available for review and copying by 
the Secretary or a certifying agent. 
‘‘SEC. 291C. NATIONAL STANDARDS FOR LABELING GENETI-
CALLY ENGINEERED FOOD. 
‘‘(a) IN GENERAL.—To be sold or labeled as a covered 
product produced with the use of genetic engineering— 
‘‘(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 seek-
ing certification under this section shall submit a ge-
netically engineered food plan to the certifying agent 
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and such plan shall be reviewed by the certifying 
agent who shall determine if such plan meets the re-
quirements 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 engineered 
food plan and the records maintained under the plan 
shall be available for review and copying by the Sec-
retary or a certifying agent. 
‘‘(c) PROHIBITION AGAINST RESTRICTING CERTAIN 
DISCLOSURES.—With respect to a covered product that oth-
erwise meets the criteria specified in subsection (a), the Sec-
retary may not prevent a person— 
‘‘(1) from disclosing voluntarily on the labeling 
of such a covered product developed with the use of ge-
netic engineering the manner in which the product 
has been modified to express traits or characteristics 
that differ from its comparable food; or 
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‘‘(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 ge-
netic 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 pro-
duced and handled under a genetic engineering certification 
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 requirements 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 genetically 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— 
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‘‘(1) prepare and submit to the Secretary an ap-
plication for such accreditation; 
‘‘(2) have sufficient expertise in agricultural pro-
duction 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 covered 
products under this subtitle. 
‘‘SEC. 291F. RECORDKEEPING, INVESTIGATIONS, AND EN-
FORCEMENT. 
‘‘(a) RECORDKEEPING.— 
‘‘(1) IN GENERAL.—Except as otherwise provided 
in this title, each person who sells, labels, or rep-
resents any covered product as having been produced 
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without the use of genetic engineering or a genetically 
engineered plant or with the use of genetic engineer-
ing 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 re-
quest 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 re-
spect to the certification of covered products 
under this subtitle in a manner prescribed 
by the Secretary; and 
‘‘(ii) make available to the Secretary, 
on request by the Secretary, all records asso-
ciated 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. 
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‘‘(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 covered 
by this subtitle has committed a violation of any 
provision of this subtitle, including an order or 
regulation promulgated by the Secretary pursu-
ant to this subtitle. 
‘‘(2) SPECIFIC INVESTIGATIVE POWERS.—In car-
rying 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) UNLAWFUL ACT.—Any person covered by 
this subtitle who, after notice and an opportunity to 
be heard, has been found by the Secretary to have 
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failed or refused to provide accurate information (in-
cluding a delay in the timely delivery of such infor-
mation) required by the Secretary under this subtitle, 
shall be subject to a civil penalty of not more than 
$10,000. 
‘‘(2) MISUSE OF LABEL.— 
‘‘(A) IN GENERAL.—Any person who know-
ingly sells or labels any covered product as hav-
ing been produced without the use of genetic en-
gineering or a genetically engineered plant or 
with the use of genetic engineering or a geneti-
cally engineered plant, except in accordance with 
this subtitle, shall be subject to 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 sepa-
rate 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 certification 
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under this subtitle with respect to any covered 
product. 
‘‘(B) DESCRIPTION OF ACTIVITIES.—An ac-
tivity 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 pro-
duced without the use of genetic engineering 
or a genetically engineered plant or with 
the use of genetic engineering or a geneti-
cally 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 
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waiver is in the best interests of the genetically 
engineered food certification program established 
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, requiring any person who 
the Secretary reasonably believes is selling or la-
beling a covered product in violation of this sub-
title to cease and desist from selling or labeling 
such covered product as having been produced 
without the use of genetic engineering or a ge-
netically engineered plant or as having been pro-
duced with the use of genetic engineering or a ge-
netically engineered plant. 
‘‘(B) FINAL AND CONCLUSIVE.—The order of 
the Secretary imposing a cease-and-desist order 
under this paragraph shall be final and conclu-
sive unless the affected person files an appeal 
from the Secretary’s order with the appropriate 
district court of the United States not later than 
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30 days after the date of the issuance of the 
order. 
‘‘(6) VIOLATIONS BY CERTIFYING AGENT.—A cer-
tifying agent that is a private person that violates the 
provisions of this subtitle or falsely or negligently cer-
tifies any covered product that does not meet the 
terms and conditions of the genetically engineered 
food certification program established under section 
291A, as determined by the Secretary, shall, after no-
tice 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 certi-
fying 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 period 
of a suspension under subparagraph (A) shall 
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terminate on the date the Secretary makes a 
final determination with respect to the violation 
that is the subject of the suspension. 
‘‘(8) ENFORCEMENT BY ATTORNEY GENERAL.— 
On request of the Secretary, the Attorney General 
may bring a civil action against a person in a dis-
trict 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 person does busi-
ness 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 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 estimated 
costs to the Secretary of carrying out this subtitle. 
‘‘(2) AVAILABILITY.—Fees collected under para-
graph (1) shall be deposited into a fund in the Treas-
ury of the United States and shall remain available 
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until expended, without further 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 containing 
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 estab-
lished under subtitle E of the Agricultural Marketing 
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 ad-
ministered 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, includ-
ing the essential vitamins, minerals, and micronutri-
ents required to be added to animal food to formulate 
a complete and balanced diet; and 
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(4) provide a process for requesting and granting 
exemptions from the requirements of subtitle E of the 
Agricultural Marketing Act of 1946 (as added by sec-
tion 201 of this Act) under conditions established by 
the Secretary. 
SEC. 203. EFFECTIVE DATE; PREEMPTION. 
(a) EFFECTIVE DATE.—Regardless of whether regula-
tions have been promulgated under section 202 of this Act, 
the amendments made by section 201 shall take effect begin-
ning on the date of the enactment of this Act. 
(b) PROHIBITIONS AGAINST MANDATORY LABELING OF 
FOOD DEVELOPED USING GENETIC ENGINEERING.—No 
State or political subdivision of a State may directly or 
indirectly establish under any authority or continue in ef-
fect as to any covered product (as defined in section 291 
of the Agricultural Marketing Act of 1946, as added by sec-
tion 201 of this Act) in interstate commerce, any require-
ment for the labeling of a covered product indicating the 
product as having been produced from, containing, or con-
sisting of a genetically engineered plant, including any re-
quirements for claims that a covered product is or contains 
an ingredient that was produced from, contains, or consists 
of a genetically engineered plant unless the State (or a po-
litical subdivision thereof) establishes either of the following 
programs for the regulation of such claims: 
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(1) A program that relates to voluntary claims 
to which paragraph (1) of section 204(a) of this Act 
applies. 
(2) A program that— 
(A) is voluntary; 
(B) is accredited by the Secretary pursuant 
to section 291E of the Agricultural Marketing 
Act of 1946 (as added by section 201 of this Act); 
and 
(C) establishes standards that are identical 
to the standards established under section 291B 
or 291C of the Agricultural Marketing Act of 
1946, as applicable (as added by section 201 of 
this Act). 
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 enact-
ment of this Act; and 
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(2) after the expiration of such 36-month period, 
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 covered 
product (as defined in section 291 of the Agricultural Mar-
keting Act of 1946, as added by section 201 of this Act) 
produced by a farm or handling operation that is certified 
as an organic farm or handling operation under the Or-
ganic Foods Production Act of 1990 (7 U.S.C. 6501 et seq.), 
such product is deemed to be certified as a product produced 
without the use of genetic engineering under the genetically 
engineered food certification program established under sec-
tion 291A of the Agricultural Marketing 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). 
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‘‘(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 es-
tablished 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 consumption 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 Secretary 
of Health and Human Services shall issue proposed regula-
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tions 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 Fed-
eral Food, Drug, and Cosmetic Act, as added by section 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 Federal Food, 
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