[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1599 Referred in Senate (RFS)]
114th CONGRESS
1st Session
H. R. 1599
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 24, 2015
Received; read twice and referred to the Committee on Agriculture,
Nutrition, and Forestry
_______________________________________________________________________
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 Representatives 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 regulatory programs,
policies, and procedures otherwise available to, or the definitions
used by, the Food and Drug Administration 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 AFFIRMATION 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 Varieties' 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 difference 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 engineered plant contain a statement to
adequately inform 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
characteristics, allergenicity, or other attributes
between the food so produced and its comparable food;
and
``(B) the disclosure of such material difference 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 GENETICALLY 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 application 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 Secretary 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 produced from,
containing, or consisting of the genetically engineered plant
that is the subject of the notification is safe for use by
humans 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 genetically engineered
plant submits to the Secretary of Agriculture the notification
of the finding of the Secretary of Health and Human Services
under subparagraph (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 complete;
``(B) notified the consulting party in writing that
all questions with respect to the safety of food
produced from, containing, or consisting of the
genetically engineered plant have been resolved; 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 offering for sale in
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 regulatory
submission; or
``(B) multiplication of seed or hybrid and variety
development conducted before submitting a notification
under subsection (a)(1)(B);
``(2) solely because a processing aid or enzyme produced
from the genetically engineered plant is intended to be used to
produce food; or
``(3) solely because the genetically engineered plant is
used as a nutrient source for microorganisms.
``(c) Rule of Construction.--Nothing in subsection (b)(1) may be
construed as authorizing the sale or offering for sale in interstate
commerce of a nonregulated 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 Agriculture, and update as necessary, a
registry that includes--
``(A) a list of each nonregulated genetically
engineered plant intended for a use or application in
food that may be sold or offered for sale in interstate
commerce, in accordance with subsection (a);
``(B) the petitions submitted to, and
determinations 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 application of such a plant
in food.
``(2) Trade secrets and confidential information.--
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 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, containing, 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 Regulations
(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 engineered 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 successor
regulations), for a determination 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 promulgated under
section 112, beginning on the date of the enactment 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 the sale or
offering for sale in interstate commerce of a genetically engineered
plant for use or application in food that is not identical 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 enforcement
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 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 provisions 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 Protection Act that
would better facilitate implementation of a coordinated,
predictable, and efficient science-based regulatory process.
(b) Coordination With Other Efforts To Modernize 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 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).
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 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 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' refers 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 respect 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 product produced
from, containing, or consisting 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 covered products.
``(7) The term `Secretary' means the Secretary of
Agriculture, acting through the Agricultural Marketing 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 engineering in the production of
such products, as provided for in this subtitle. The Secretary shall
establish the requirements and procedures as the Secretary determines
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 implement the program
established under subsection (a) through certifying agents. Such
certifying agents may certify 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 covered products certified under this title,
including terminology commonly used in interstate commerce or
established by the Secretary in regulations.
``SEC. 291B. NATIONAL STANDARDS FOR LABELING NONGENETICALLY 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 controls
that address--
``(i) the producer planting seed that is
not genetically engineered;
``(ii) the producer keeping the crop
separated 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 from other products that
are, or are derived from, genetically
engineered plants; and
``(B) be produced and handled in compliance with a
nongenetically engineered food plan developed and
approved in accordance with subsection (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 covered products developed
without the use of genetic engineering 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 subsection (a) solely because the
covered product--
``(1) is manufactured or processed using a genetically
engineered microorganism or a processing aid or enzyme;
``(2) is derived from microorganisms that consumed 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 certifying 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
implemented in the event there is a deviation from the
plan.
``(3) Availability.--The nongenetically engineered 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 engineered solely because the livestock consumed feed
produced from containing, or consisting of a genetically engineered
plant.
``SEC. 291C. NATIONAL STANDARDS FOR LABELING GENETICALLY 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 genetic
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 Secretary
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 certifying 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
implemented 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 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 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 certifying 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 section.
``(c) Duration of Accreditation.--An accreditation made under this
section shall be for a period of not to exceed 5 years, as determined
appropriate by the Secretary, and may be renewed.
``(d) Coordination With Existing Organic Program Accreditation.--A
governing State official or private 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 ENFORCEMENT.
``(a) Recordkeeping.--
``(1) In general.--Except as otherwise provided in this
title, each person who sells, labels, or represents any covered
product as having been produced with or without the use of
genetic engineering or a genetically engineered plant shall--
``(A) maintain records in a manner prescribed 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 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
associated with such activities.
``(B) Transference of records.--If a private person
that was certified under this subtitle is dissolved or
loses accreditation, all records and copies of records
concerning the activities 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 information
reported or made available under this subtitle; 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 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 accurate information (including a delay in
the timely delivery of such information) required by the
Secretary 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 labeled any covered product
as having been produced with or without the use of
genetic engineering or a genetically engineered plant,
except in accordance with this subtitle, shall be
assessed a civil penalty of not more than $10,000.
``(B) Continuing violation.--Each day during which
a violation described in subparagraph (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 certification 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 paragraph
(2)(A);
``(iii) attempting to have a label
indicating 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 certification
program established under section 291A, as
determined by the Secretary.
``(C) Waiver.--Notwithstanding subparagraph (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 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, 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 labeling such covered product as
having been produced with or without the use of genetic
engineering 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 appropriate 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 negligently certifies 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 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
certifying 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 accreditation 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 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 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 person
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 genetically 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 estimated 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 amendments 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 established
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 administered by the Secretary;
(3) with respect to regulations for covered products
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 granting
exemptions from the requirements of subtitle E of the
Agricultural Marketing Act of 1946 (as added by section 201 of
this Act) under conditions established by the Secretary.
SEC. 203. EFFECTIVE DATE; PREEMPTION.
(a) Effective Date.--Regardless of whether regulations 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 continue 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
interstate 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 requirements for claims that a covered
product is or contains an ingredient that was produced from,
contains, 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 paragraph:
(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
pursuant to section 291E of the Agricultural
Marketing Act of 1946 (as added by section 201
of this Act); and
(iii) 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).
(c) Rule of Construction.--For the sole purpose of subsection
(b)(1), a covered product derived from livestock that consumed
genetically engineered plants shall be deemed as having been produced
from, containing, or consisting 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 enactment of this Act;
and
(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 Marketing 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 Organic 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 section 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).
``(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 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', `naturally
grown', `all natural', and `made with natural ingredients'; and
``(B) any other terms specified by the Secretary.''.
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 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 Cosmetic 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 following:
``(6) any requirement for the labeling of food of the type
required by section 403(z) that is not identical 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 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, 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:
KAREN L. HAAS,
Clerk.