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114th Congress } { Rept. 114-208
HOUSE OF REPRESENTATIVES
1st Session } { Part 1
======================================================================
SAFE AND ACCURATE FOOD LABELING ACT OF 2015
_______
July 16, 2015.--Ordered to be printed
_______
Mr. Conaway, from the Committee on Agriculture, submitted the following
R E P O R T
together with
DISSENTING VIEWS
[To accompany H.R. 1599]
The Committee on Agriculture, to whom was referred the bill
(H.R. 1599) to amend the Federal Food, Drug, and Cosmetic Act
with respect to food produced from, containing, or consisting
of a bioengineered organism, the labeling of natural foods, and
for other purposes, having considered the same, report
favorably thereon with an amendment and recommend that the bill
as amended do pass.
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
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
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 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 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 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 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 regulatory
submission; or
``(B) research involving 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 introduction or delivery for introduction
into 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 introduced or delivered for
introduction 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 introduced 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 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 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 genetically engineered plants
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 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 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.
``(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, 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 produced with 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.
``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 without the use of genetic
engineering or a genetically engineered plant or with 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) 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 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 subject to a civil penalty of not more than $10,000.
``(2) Misuse of label.--
``(A) In general.--Any person who knowingly sells or
labels any covered product as having been produced
without the use of genetic engineering or a genetically
engineered plant or with the use of genetic engineering
or a genetically 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 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
without the use of genetic engineering or a
genetically engineered plant or with 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,
requiring 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 without the use of genetic engineering or a
genetically engineered plant or as having been produced
with 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 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, without further
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.--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 unless the State (or a political
subdivision thereof) establishes either of the following programs for
the regulation of such claims:
(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 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.
Brief Explanation
The Safe and Accurate Food Labeling Act of 2015 would
ensure national uniformity regarding labeling of foods derived
from genetically engineered plants by preventing a patchwork of
conflicting State or local labeling laws which inherently
interfere with interstate and foreign commerce.
Purpose and Need
Agricultural biotechnology is one of the important tools
available to producers to cope with an increasing world
population and increasing production risks in the 21st century.
Despite the need for this technology, an ever more vocal
minority of citizens are creating doubt in the minds of many
consumers and policymakers through misinformation regarding the
safety and wise use of genetically engineered inputs.
In Washington and across the country, we are hearing about
``GMOs'' and the use of biotechnology in food and agricultural
production. There is a great deal of misinformation that can be
confusing to consumers and policymakers alike.
This misinformation is influencing policymakers at the
local, state, and federal levels and could threaten our
farmers' ability to feed an ever growing population and
increase the cost of food for consumers. Right now,
biotechnology is helping farmers grow more food with less--less
water, less land, and less energy.
Over the past several years, political activists in a
growing number of states have attempted to pass ballot
initiatives and legislative proposals that would require
labeling of certain foods that contain genetically engineered
(GE) ingredients. In November 2014, voters in Oregon and
Colorado defeated mandatory labeling initiatives. In previous
years, voters in California and Washington have defeated
similar proposals. To date, Vermont is the only state that has
passed a unilateral labeling law, which is scheduled to take
effect in 2016, although it is currently being challenged in
court. Maine and Connecticut each have a labeling law that can
be fully enacted if neighboring states pass similar
legislation. Anti-biotechnology activists continue to advocate
for these proposals despite the clear scientific consensus on
the issue.
State labeling initiatives would produce a state-by-state
patchwork of laws that lead to misinformation and confusion for
consumers as well as costly disruptions to the food supply
chain. The exemptions that have been included in every proposal
have raised questions about what, exactly, defines ``Right-to-
Know.'' Under Vermont's labeling law, for example, vegetable
soup would be labeled ``GE'' while vegetable beef soup would
not because it contains meat. A proposal pushed by anti-
biotechnology activists in California would have required
``GE'' labels on soymilk but not cow's milk. In Colorado,
chewing gum would have been exempt from ``GE'' labeling but
breath mints would not.
Food supply chain stakeholders are navigating the
consequences of mandatory labeling laws. Farmers have to
segregate non-GE crops from GE crops and use more water and
pesticides. Food manufacturers have to set up separate food
processing units and warehouse space--not to mention additional
transportation routes for products. All of these additional
steps would add up to higher costs for farmers, manufacturers,
and consumers. According to a recent study out of Cornell,
state labeling laws would lead to a $500 increase in grocery
prices for the average family of four.
In a June 17, 2015 letter to Vermont Governor Peter
Shumlin, one food industry trade association laid out the high
costs associated with compliance of the state's labeling law
which is set to go into effect next July. The letter states
that:
In addition to the large costs associated with changing
labels, companies will be subject to costly fines due to errors
in the supply chain that are no fault of the manufacturer.
Under the Vermont law, manufacturers are strictly liable for
violations under the law for all instances of a product
exhibiting the wrong label on store shelves--regardless of
whether the violation was inadvertent; the violation was fault
of some other participant in the supply chain; the
manufacturers have no legal custody or any control over the
product once it leaves their own distribution center; or the
violation was a deliberate act by someone who purchased product
out of state and placed it on shelves.
The letter continues:
Even with the best of intentions, excellent supply chain
logistics and herculean efforts, product will be in the wrong
place at any given time, resulting in millions upon millions of
dollars in potential fines. For example, assume a 90-95%
success rate that the properly labeled products are on shelves.
This means that 5% to 10% of products will be mislabeled, or
have ``slipped'' through the supply chain (i.e., slippage
rate). Vermont's law imposes a $1,000 daily fine for each item
that does not bear the legally designated label. For a company
that has 2,500 items that require the Vermont label, that
slippage rate of products would translate to a $125,000 to
$250,000 daily fine. We estimate that industry wide, there
could be over 100,000 items sold in Vermont that would require
Vermont-specific labels. That means our industry could be
facing fines as much as $10 million per day.
THE SOLUTION: THE SAFE AND ACCURATE FOOD LABELING ACT
The Safe and Accurate Food Labeling Act was introduced in
the U.S. House of Representatives in March 2015.
Participants in the market typically employ measures to
promote and distinguish their products utilizing a number of
marketing tools. Regarding the use or non-use of biotechnology,
a voluntary marketing claim is permitted so long as the label
is truthful and not misleading. There is, however, no standard
definition for the terminology proliferating in commerce
generating confusion and inconsistency which is inherently
misleading to consumers.
This legislation will create a consumer-friendly, science-
based, uniform food labeling framework for products produced
using genetically engineered ingredients. By ensuring that food
labeling is the sole purview of the federal government, the
bill guarantees that state labeling mandates do not mislead and
misinform consumers. Additionally, the bill will prevent the
costly price hikes associated with a patchwork of state
labeling laws.
By creating a national non-GE certification program that is
overseen by the U.S. Department of Agriculture (USDA), this
bill brings transparency and consistency to an area of food
labeling where it is urgently needed. This program mimics the
widely popular National Organic Program and will provide those
who prefer to buy non-GE foods a reliable means of doing so.
Similar to organics, non-GE foods also are a small percentage
of the U.S. food market. The USDA Certified Organic program is
a successful precedent for labeling the exception rather than
the rule.
With the passage of this bill, farmers will feel confident
an important technology they rely on is safe from unwarranted
stigmatization; food producers will have the assurance that
their interstate supply chains will remain intact and
unhindered; and grocery shoppers across the United States will
have the peace of mind that the costs associated with feeding
their families are not increased due to misguided labeling
laws.
Section-by-Section Summary of the Manager's Amendment to H.R. 1599
Section 1 is the short title of the bill and table of
contents.
The Committee intends that this legislation will provide
consumers with assurance that the American food supply remains
the safest in the world and that accurate, reliable information
is readily available concerning the extent to which food is
produced from, contains, or consists of genetically engineered
plants. The Committee further intends to recognize and
reinforce the valuable role that the Coordinated Framework for
Regulation of Biotechnology (Coordinated Framework) and its
nationally uniform, science-based regulatory review process
have played and should continue to play in our national
agricultural economy and in providing consumers with an
adequate, wholesome, and economical food supply.
Sec. 2. Savings clause
Section 2 preserves current jurisdiction and regulatory
authority, regulations, policies, definitions, and procedures
of the Food and Drug Administration (FDA) under the Federal
Food, Drug, and Cosmetic Act (FFDCA) and Animal and the Plant
Health Inspection Service (APHIS) under the Plant Protection
Act (PPA). In particular, the Committee intends for the
Secretary of Health and Human Services and the Secretary of
Agriculture to retain and use their respective authorities 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
Sec. 101 creates a new section 424 in the Federal Food,
Drug, and Cosmetic Act (FFDCA) recognizing the Food and Drug
Administration's (FDA's) current premarket consultation process
for food derived from new plant varieties, including
genetically engineered plants, and directing the Secretary of
Health and Human Services (HHS) to continue to administer that
process. The voluntary consultation process is derived from
FDA's 1992 Statement of Policy (Policy), which provides
guidance on how existing FDA authority related to food safety
and food labeling should be applied to foods derived from
genetically engineered plants. FDA states in that Policy that
it does not believe that the ``method of development'' of a
food is material information under the FFDCA ``and would not
usually be required to be disclosed in labeling for the food.''
Under the Policy, such labeling would be required under the
same circumstances as it would for any other food product. A
possible example of such material information would be the need
to disclose information about the potential allergenicity of a
food product that was not previously recognized by consumers as
being allergenic. Such material differences between food from a
genetically engineered plant and comparable (i.e., non-
genetically engineered) food might also include those that
alter the characteristics of a food product such that its
common or usual name no longer adequately describes the food,
or those that result in a significantly different nutritional
property in the food. This section of the bill clarifies that
the use of genetic engineering, by itself, is not information
that is material for determining whether there is a difference
between food from bioengineered plants and comparable food. FDA
has the discretion to 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 produced and
comparable food if the FDA determines 1) there is a material
difference in the functional, nutritional, or compositional
characteristics, allergenicity, or other attributes between the
food produced and comparable food; and 2) the disclosure of the
material difference is necessary to protect public health and
safety or to prevent the label or labeling of the food from
being false or misleading.
The Committee intends that this subtitle recognize the
FDA's 1992 Statement of Policy as to Foods Derived from New
Plant Varieties and reinforce its purpose to provide consumers,
the food industry, and trading partners with assurance that the
foods reviewed under that Policy are as safe to eat as non-
genetically engineered foods.
The Committee expects that, in continuing to administer the
voluntary consultation process established by the 1992 policy,
the FDA will continue to assess whether the use or application
of a genetically engineered plant in the production of food
raises any safety or regulatory issues under the FFDCA and, if
no such issues are identified, promptly notify the consulting
party that the FDA did not identify any such safety or
regulatory issues that would require further evaluation, and
considers the consultation to be complete, thereby providing
affirmation of the safety of the foods reviewed.
SUBTITLE B--DEPARTMENT OF AGRICULTURE
Sec. 111. Regulation
Subsection (a) amends the PPA by adding a new subtitle F,
Coordination of Food Safety and Agriculture Programs, to
further the objectives of the Coordinated Framework for
Regulation of Biotechnology established in 1986 and provide
consumers, the food industry, trading partners, and other
interested parties with a clear affirmation of safety for food
produced from, containing, or consisting of genetically
engineered plants.
A new section 461 is added to create a notification program
for genetically engineered plants prior to use or application
in food. Under this section, it is unlawful to introduce into
interstate commerce a nonregulated genetically engineered plant
for a use or application in food or a food produced from,
containing, or consisting of such a plant unless: (1) FDA has
notified the entity seeking evaluation of food from the
genetically engineered plant in writing under FDA's 1992 policy
statement that it has no objections to the entity's
determination that the food is as safe for use by humans or
animals as one or more comparable foods and the entity provides
the notification of FDA's finding to USDA; or (2) FDA had
previously evaluated the food pursuant to the voluntary
consultation process established in FDA's 1992 policy
statement, informed the entity in writing that all questions
with respect to the safety of food from the genetically
engineered plant have been resolved, and published the
notification on the public website of the FDA. The USDA
premarket notification program would not apply to genetically
engineered plants that are introduced into commerce for the
purpose of research testing, such as regulated field trials, or
development activities, such as multiplication of seed. The
notification program would also not apply solely because a
processing aid or enzyme produced from a genetically engineered
plant is intended to be used to produce food, or because the GE
plant is used as a nutrient source for microorganisms.
The Committee recognizes that the petition process
established by APHIS for genetically engineered plants under
the Coordinated Framework and the Plant Protection Act provides
developers with the national clearance they need to
commercialize their genetically engineered crops. It also
provides farmers with confirmation that genetically engineered
crops are as safe to grow as non-genetically engineered crops
and gives them clarity with respect to the crops they can
legally grow. The Committee further recognizes that the
consultation process administered by FDA is an important step
in obtaining national clearance to commercialize the crop from
which genetically engineered foods are derived in conjunction
with the petition process administered by the Secretary of
Agriculture. The Committee intends that the notification and
public disclosure process created by this Act will further the
objectives of the existing processes already in place at APHIS
and FDA.
Nothing in section 461(b)(1) may be construed as
authorizing the introduction or delivery into 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.
USDA is required to publish on its website a registry
listing of each nonregulated genetically engineered plant
intended for a use or application in food that may be
introduced into commerce in accordance with section 461(a), the
petitions to and determinations made by USDA related to the
plants, and the FDA notifications related to the plants.
Nothing in this section is intended to alter current
confidential commercial or trade secrets protections.
Congress intends that the provision of a public registry
listing each nonregulated genetically engineered plant that has
been cleared for introduction into commerce for use or
application in food will further the goal of increased
regulatory transparency set by this Congress and recently
identified by the Office of Science and Technology Policy in
its July 2, 2015 Memorandum for Heads of Food and Drug
Administration, Environmental Protection Agency, and Department
of Agriculture.
The provisions of this section apply to foods imported into
the United States that are produced from, contain, or consist
of a plant that is 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 Regulations, or any successor regulations, in the same
manner and to the same extent as the provisions apply to a food
that is not imported.
A new section 462 is added to the PPA to re-designate and
define terms and phrases within the PPA. The term ``food'' has
the same meaning given to it under the FFDCA. A ``nonregulated
genetically engineered plant'' is defined as a genetically
engineered plant for which the Secretary of Agriculture has
approved a petition under 7 C.F.R. 340.6 for a determination
that the plant should not be regulated under the PPA; or that
1) is not subject to regulation as a plant pest under the PPA,
2) contains genetic material from a different species, and 3)
has been modified through in vitro recombinant deoxyribonucleic
acid (rDNA) techniques.
Sec. 112. Regulations
Section 112 requires the Secretary of Agriculture to
promulgate interim final regulations to carry out the premarket
notification program within one year of enactment of the bill.
Sec. 113. Preemption
Under Section 113, 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 regarding the use or application in food of
genetically engineered plants that is not identical to the
requirements established under Section 111 of this Act. This is
true regardless of whether regulations have been promulgated
under section 112.
Sec. 114. Rule of construction
Section 114 clarifies that nothing in this Act is intended
to alter the ability of the Secretary of Health and Human
Services (HHS) to take enforcement actions with respect to a
violation of the FFDCA or the ability of the Secretary of
Agriculture to take enforcement actions with respect to a
violation of the PPA.
Sec. 115. Implementation report
Subsection (a) requires the Secretary of Agriculture and
the Secretary of HHS, to submit a report to Congress evaluating
the progress made in the implementation of subtitle F of the
PPA, as added by section 111. The report should include 1) an
analysis of plants requiring regulatory oversight under
subtitle F; 2) an analysis of the extent to which the
provisions of subtitle F establish an appropriate scope of
regulatory oversight for APHIS and FDA, including their
oversight of public research programs; and 3) any potential
changes to the relevant provisions of the PPA that would better
facilitate implementation of a coordinated, predictable, and
efficient science-based regulatory process.
The Committee recognizes that the development of valuable
new breeding techniques is ongoing in both the public and
private sectors and intends to exercise appropriate oversight
to ensure that the regulation, if any, of products developed
using these techniques is commensurate with any potential
risks.
Subsection (b) requires that the report should be prepared
to the greatest extent possible 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 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).
The Committee intends that implementation of Section 115
will ensure that the Secretary of Agriculture and the Secretary
of Health and Human Services are provided with an opportunity
to encourage and promote further innovation using new breeding
technologies. The Committee further recognizes that the smooth
movement of food and feed crops and other agricultural products
into, out of, or within the United States is vital to the
United States economy and should be facilitated to the greatest
extent possible.
Title II--Genetic Engineering Certification
Sec. 201. Genetic engineering certification
Section 201 establishes a voluntary genetically engineered
food certification program within USDA to govern label claims
with respect to the use or non-use of genetic engineering in
the production and processing of food in a nationally uniform
manner. Section 201 would amend the Agricultural Marketing Act
of 1946 (AMA) to add new sections 291, 291A, 291B, 291C, 291D,
291E, 291F, and 291G.
The Committee intends this legislation to address the
desires of some consumers to know, via food product labeling,
whether they are purchasing or consuming food produced with or
without genetic engineering. Some states and localities have
attempted to mandate such labeling, creating the potential for
a patchwork of regulatory approaches and increased costs of
food for consumers and a substantial adverse economic effect on
interstate commerce.
The Committee recognizes that the interests of consumers
are protected and advanced when consumers have access to
truthful and non-misleading food product information, and that
the FDA has consistently found no basis to require special
labeling for food produced using genetic engineering. The
Committee further recognizes that food should be labeled in a
way that is meaningful, accurate, and not deceptive or
confusing to consumers.
A covered product is defined under this section as
including a raw or processed agricultural product. The use of
``processed'' in the definition is intended to apply to any
food that contains an ingredient derived from an agricultural
product, regardless of the level of the ingredient in the
product. Highly processed foods that contain even small amounts
of ingredients derived from agricultural products would be
considered a ``processed'' agricultural product under this
definition. In addition, ``covered products'' are defined to
include any other foods as defined by Section 201 of the
Federal Food, Drug, and Cosmetic Act (FFDCA) that are not
derived from agricultural products, and seed or other
propagative material.
Section 201 requires the Secretary to implement the program
through the use of certifying agents, who would certify that a
covered product is or is not produced with the use of genetic
engineering in accordance with the standards established under
the certification program. The Committee supports the creation
of a single, unified food labeling standard for the presence or
absence of genetically engineered plants in food. The Committee
intends for the program created in Section 201 to provide the
sole standard by which all food producers, processors and
handlers may make claims regarding the use of genetic
engineering in the production and processing of food, including
claims for foods that fall within the definition of raw or
processed agricultural products and for those foods that do
not, as well as for seeds.
AMA Sec. 291. Definitions
Section 291 of the AMA is amended by adding several new
definitions to the Act. In this subtitle, the term ``certifying
agent'' means the chief executive officer of a State or, in the
case of an official to be responsible solely for the
administration of the agricultural operations of the State,
such official, or 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 whose
label may indicate whether the product is produced with or
without the use of genetic engineering.
In this subtitle, the term ``covered product'' means A) any
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 not derived from agricultural products; and C) seed or
other propagative material.
In this subtitle, the term ``genetically engineered plant''
means a plant or plant product (as defined in section 403 of
the PPA) if it contains genetic material that has been modified
through in vitro recombinant deoxyribonucleic acid (DNA)
techniques and the modification could not otherwise be obtained
using conventional breeding techniques.
In this subtitle, the term ``comparable food'' means, with
respect to a covered product produced from, containing, or
consisting of a genetically engineered plant 1) the parental
variety of the plant; 2) another commonly consumed variety of
the plant; or 3) a commonly consumed covered product with
properties comparable to the covered product produced from,
containing, or consisting of the plant that is genetically
engineered.
AMA Sec. 291A. National genetically engineered food
certification program
Subsection (a) of section 291A of the AMA directs the
Secretary of Agriculture to establish a voluntary genetically
engineered food certification program for covered products to
govern labeling with respect to the use of genetic engineering
in the production of food in a nationally uniform manner. The
Committee expects the Secretary to establish the requirements
and procedures that the Secretary deems necessary to carry out
the certification program such that entities seeking to make
claims under section 291B or 291C receive the requisite
certification.
Subsection (b) requires the Secretary to consult with such
other parties as are necessary to develop the certification
program.
Subsection (c) requires the Secretary to implement the
certification program through the use of certifying agents, who
would certify that a covered product is or is not produced with
the use of genetic engineering or a genetically engineered
plant, in accordance with the standards established under the
program.
Subsection (d) requires the Secretary to establish a seal
to identify covered products in interstate commerce using
terminology the Secretary considers appropriate, including
terminology commonly used in interstate commerce or established
by the Secretary in regulations.
AMA Sec. 291B. National standards for labeling non-
genetically engineered food
Subsection (a) establishes the standards for entities that
want to participate in the voluntary program for selling or
labeling of a covered product as produced without the use of
genetic engineering. To be sold or labeled without the use of
genetic engineering, covered products must be: 1) subjected to
supply chain process controls that address the producer
planting seed that is not genetically engineered, the producer
and other individuals keeping the crop separated during growth,
harvesting, storage, processing, and transportation, and
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 2) produced
and handled in compliance with a nongenetically engineered food
plan, described in subsection (c) below. In the case of covered
products derived from livestock that are marketed in the U.S.
for human consumption, the product, the livestock, the products
consumed by the livestock, and the products used in processing
the products consumed by such livestock must be produced
without the use of products derived from genetic engineering.
This section prohibits labeling or advertising material from
suggesting, either expressly or by implication, that covered
products developed without genetic engineering are safer or of
higher quality than those produced from, containing, or
consisting of a genetically engineered plant.
Subsection (b) precludes a covered product from being
considered as not meeting the criteria under subsection (a)
solely because the product is 1) produced with a genetically
engineered microorganism or a processing aid or enzyme; 2)
derived from microorganisms that consumed a nutrient source
produced from, containing, or consisting of a genetically
engineered plant; or 3) an approved substance on the National
List established under section 2118 of the Organic Foods
Production Act of 1990 (7 U.S.C. 6517).
Subsection (c) requires producers or handlers seeking
certification under the non-GE labeling program to submit for
review and approval by a certifying agent a non-GE food plan
addressing the handling and processing procedures to be used.
Producers and handlers are required to maintain the non-GE food
plan and related records, which are subjected to review by USDA
and certifying agents.
The legislation requires the Secretary to establish
national standards for labeling non-genetically engineered
food. In the case of covered products consumed by or derived
from livestock, the Committee intends that a covered product
will not be labeled as a covered product produced without the
use of genetic engineering unless livestock, feed, feed
ingredients, feed additives (including pharmaceuticals) and any
other products consumed by livestock are produced without the
use of products derived from genetic engineering. Additionally,
the Committee fully intends that products used in the
processing of covered agriculture products derived from
livestock are produced without the use of products derived from
genetic engineering. Exceptions to this provision include those
items found on the National List established under Section 2118
of the Organic Foods Production Act of 1990 (7 U.S.C. 6517).
AMA Sec. 291C. National standards for labeling genetically
engineered food
Subsection (a) establishes the standards for entities that
want to participate in the voluntary program for selling or
labeling of a covered product as having been produced using
genetic engineering. To be sold or labeled as produced with
genetic engineering, the covered product must be produced and
handled in compliance with a genetically engineered food plan,
and the labeling of or advertising material on, or in
conjunction with such products may not claim that covered
products produced with genetic engineering are safer or of
higher quality than those produced without genetic engineering.
Nor may the claims be false or misleading. The labeling of
covered products produced with the use of genetic engineering
also must contain any other information the Secretary considers
appropriate.
Subsection (b) requires producers or handlers of covered
products with the use of genetic engineering who want to
participate in the program to submit a genetically engineered
food plan, which would be subject to review by the USDA and
certifying agents. Producers must adhere to recordkeeping
requirements and make such records available for review and
copying by the Secretary or certifying agent.
Subsection (c) prohibits the Secretary of Agriculture from
preventing a person from: 1) disclosing voluntarily on the
labeling of a covered product produced 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 labeling, that a covered product was
developed with the use of genetic engineering. The Committee
intends for persons to be able to disclose voluntarily that the
products they develop or sell have been developed with the use
of genetic engineering and to do so without regard to whether
such persons elect to participate in the certification program
under section 291C. As an example, seed companies that
otherwise comply with the Federal Seed Act requirements that
set accurate labeling and purity standards for seed in commerce
would not be prohibited from disclosing the manner in which
those seeds were developed to growers who intend to plant those
seeds, as is standard practice today.
AMA Sec. 291D. Imported products
This section allows imported covered products to be sold or
labeled as produced with or without the use of genetic
engineering if the Secretary determines that they have been
produced and handled under a genetic engineering certification
program with safeguards and guidelines that are at least
equivalent to the USDA labeling standards.
AMA Sec. 291E. Accreditation program
Subsection (a) directs the Secretary of Agriculture to
establish and implement a program to accredit any State
official or private person that meets the requirements of a
certifying agent under the requirements set forth in this
section.
Subsection (b) sets forth requirements for a governing
State official or private person to be accredited as a
certifying agent under this section. In order to be accredited,
a government State official or private person must 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.
Subsection (c) states that the duration of an accreditation
made under this section can only be for five years or less. The
duration of accreditation is determined by the Secretary and
the accreditation may be renewed once the accreditation
expires.
Subsection (d) requires that 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, be
deemed to be accredited to certify covered products under this
Section.
AMA Sec. 291F. Recordkeeping, investigations, and
enforcement
Subsection (a) requires each person who sells, labels, or
represents any covered product as having been produced without
the use of genetic engineering or a genetically engineered
plant or with the use of genetic engineering or a genetically
engineered plant to 1) maintain records in a manner prescribed
by the Secretary; and 2) upon request by the Secretary, make
available to the Secretary all records associated with the
covered product. A certifying agent is required to 1) 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 2)
upon request by the Secretary, make available to the Secretary
all records associated with such activities. If a private
person who was a certifying agent is dissolved or loses
accreditation, all records or copies of records concerning the
activities of the person shall be transferred to the Secretary
as it relates to this subtitle. This subsection makes it
unlawful for any person covered by this subtitle to fail or
refuse to provide accurate information in a timely manner as
required by the Secretary under this subtitle.
Subsection (b) allows the Secretary to take investigative
actions as the Secretary considers to be necessary in order to
1) verify the accuracy of any information reported or made
available under this subtitle; and 2) determine whether a
person covered by this subtitle has committed a violation,
including an order or regulation promulgated by the Secretary
pursuant to this subtitle. In order to carry out this subtitle,
the Secretary can, but is not required to, 1) administer oaths
and affirmations; 2) subpoena witnesses; 3) compel attendance
of witnesses; 4) take evidence; and 5) require the production
of any records required to be maintained under this subtitle
that are relevant to an investigation.
Subsection (c) states that any person who, after notice and
opportunity to be heard, is found to have knowingly sold or
labeled any covered product as having been produced without or
with the use of genetic engineering or a genetically engineered
plant, except in accordance with this subtitle, would be
subject to a civil penalty of not more than $10,000. Each day
in which this violation occurs is considered to be a separate
violation.
If a person is found, after notice and an opportunity to be
heard, to have carried out any of the following activities, the
person, will 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: 1) makes a
false statement; 2) performs a violation described in paragraph
(1)(A) of this subtitle; 3) attempts 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 4) otherwise violates
the purposes of the genetically engineered food certification
program under section 291A, as determined by the Secretary. The
Secretary may modify or waive a period of ineligibility if the
Secretary determines that the modification or waiver is in the
best interests of the genetically engineered food certification
program.
A certifying agent must immediately report any violation of
this subtitle to the Secretary.
After providing notice and an opportunity to be heard, the
Secretary may issue an order, requiring 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 without the use of genetic engineering or a
genetically engineered plant or as having been produced with
the use of genetic engineering or a genetically engineered
plant. The order imposing a cease-and-desist order must be
final and conclusive unless the affected person files an appeal
from the Secretary's order with the appropriate district court
in the U.S. within 30 days after the date of the issuance of
the order.
If a certifying agent that is a private person violates
provisions of this subtitle or falsely or negatively 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,
after notice and an opportunity to be heard, the certifying
agent will lose accreditation as a certifying agent, and be
ineligible to be accredited as a certifying agent for at least
three years, beginning on the date of determination. The
Secretary may suspend the accreditation of the certifying agent
for a violation of this subtitle after providing notice and an
opportunity to be heard until the Secretary makes a final
determination with respect to the violation that is the subject
of the suspension.
The Attorney General may bring a civil action against a
person in a district court of the U.S. to enforce this subtitle
or a requirement under the subtitle, with the action being
brought in the judicial district where the person does business
or in which the violation occurred.
AMA Sec. 291G. Authorization of appropriations, fees
Subsection (a) authorizes $2 million to be appropriated to
establish the genetically engineered food program under section
291A.
Subsection (b) directs the Secretary of Agriculture to
notice, charge, and collect fees in order to cover the
estimated costs to the Secretary of carrying out this subtitle
after establishment of the genetically engineered food
certification program. Fees collected under this subsection
must be deposited into a fund in the Treasury of the United
States and must remain available until expended, without
further appropriations, to carry out this subtitle.
Sec. 202. Regulations
Subsection (a) requires USDA, in promulgating regulations
to carry out the amendments made in section 201, 1) to provide
a process to account for certified non-genetically engineered
covered products that contain genetically engineered plant
material due to the inadvertent presence of such material, 2)
to the greatest extent practicable, to establish consistency
between the certification program established under section 201
of this Act, the organic certification program, and other USDA
voluntary labeling programs, and 3) regarding covered products
intended for consumption by non-food animals, to 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) to
provide a process for requesting and granting exemptions under
conditions established by the Secretary.
The Committee recognizes that cats and dogs rely on pet
food as their primary source of nutrition, and that pet food
manufacturers are required by law to include certain vitamins,
minerals, amino acids, and fatty acids in their formulations to
provide pets with a complete and balanced diet. This
requirement exists without regard to the availability of these
essential ingredients from any one specific source. The
Committee expects that the Secretary, in promulgating
regulations to carry out the amendments made by section 201,
will ensure that such regulations strictly provide for animal
well-being. Such regulations should authorize the use of
alternative sources, as needed, for securing the essential
vitamins, minerals and micronutrients. In providing for
consistency between the NOP and the non-genetically engineered
labeling program, the Secretary is expected to provide a
process for requesting and granting exemptions from the
requirements of subtitle E of the Agricultural Marketing Act of
1946, without penalty to pet food manufacturers who choose to
sell or label covered products as produced without the use of
genetic engineering under the provisions of proposed Section
291B of the AMA. The Committee also expects that such
regulations promulgated by the Secretary will apply the same
principles to food for other non-food animals.
Sec. 203. Preemption
Subsection (a) requires that the amendments made by section
201 of the Act take effect beginning on the date of enactment
of this Act regardless of whether regulation have been
promulgated under section 202.
Subsection (b) prohibits States or political subdivisions
of a State from directly or indirectly establishing under any
authority, or continuing in effect, as to any covered products
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, except
that such State (or political subdivision thereof) may
establish either of the following voluntary programs for the
regulation of such claims: 1) A program that relates to a
voluntary claim to which paragraph (1) of section 204(a) of the
Act applies; or 2) a program that is A) voluntary, B)
accredited by the Secretary pursuant to Section 291E of the
Act, and C) identical to the standards established under
section 291B or 291C of the Agricultural Marketing Act, as
added by section 201 of the Act.
The Committee recognizes the hardship the food industry
would face if each state were to adopt a different standard or
separate requirements for labeling whether or not a covered
product contains a genetically engineered plant. Section 203 is
intended to give preemptive effect to the single national
standard for such labeling established by USDA. No state or
political subdivision could create a different standard for the
voluntary labeling of foods that have or have not been
developed through genetic engineering. In addition to creating
a single standard for voluntary claims regarding the use of
genetic engineering, Section 203 also is intended to preempt
any state laws, such as those in place in Vermont, Connecticut,
and Maine, that would mandate the labeling of foods that
contain genetically engineered plants. These state laws as
written today would be in conflict with the national standard
because they are creating state requirements for covered
products that are not identical to the federal standard. States
that want to establish their own programs for the labeling of
whether a food has or has not been produced with genetic
engineering would be allowed to do so provided the state
program (1) is voluntary, (2) is accredited by the Secretary,
and (3) is identical to the standards established by the
Secretary.
Sec. 204. Applicability
Subsection (a) states that a voluntary claim made with
respect to whether a covered product was produced with or
without the use of genetic engineering or a genetically
engineered plant before this Act is enacted 1) may be made for
such a product during the 36-month period beginning on the date
of enactment of the Safe and Accurate Food Labeling Act; and 2)
after the expiration of the 36-month period, may be made so
long as the labels associated with such claims meet the
standards specified in section 291B or 291C of the Agricultural
Marketing Act of 1946. The Committee intends that covered
products labeled with voluntary claims regarding genetic
engineering should have a reasonable opportunity to clear the
channels of trade prior to any changes made necessary in order
to meet the national labeling standards established under this
subtitle.
Subsection (b) states that if a covered product is produced
by a farm or handling operation certified 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.
Title III--Natural Foods
Sec. 301. Labeling of natural foods
Section 301 of the Act amends section 403 of the FFDCA, to
deem a food misbranded if its labeling contains an express or
implied claim that the food is `natural' unless the claim uses
terms that have been defined by, and the food meets the
requirements that have been established in, regulations
promulgated by FDA. Prior to finalization of regulations to
carry out this section, the use of any claim that the food is
`natural' is allowed if it is consistent with the Secretary's
existing policy for such claims. This section directs the
Secretary to differentiate between food for human consumption
and food intended for consumption by animals other than humans
when promulgating regulations to carry out this section. A
`natural claim' includes 1) the use of the terms `natural,'
`100% natural', `naturally grown', `all natural', `made with
natural ingredients', and any other terms specified by the
Secretary.
Sec. 302. Regulations
Subsection (a) directs the Secretary of Health and Human
Services (HHS) to issue proposed regulations to implement
section 403(aa) of the FFDCA (as added by section 301 of this
Act) not later than 18 months after the date of enactment of
this Act.
Subsection (b) directs the Secretary of HHS to issue final
regulations to implement such Section 403(z) not later than 30
months after the date of enactment of this Act.
Sec. 303 Preemption
Section 303 of this Act amends Section 403(A) of the FFDCA,
as amended by section 103 of this Act, by requiring that no
State or political subdivision of a State may directly or
indirectly establish under any authority or continue in effect
as any food in interstate commerce any requirement for the
labeling of food of the type required by section 403(z) that is
not identical to the requirement by such section.
Sec. 304. Effective date
The labeling requirements of section 403(z) of the FFDCA,
as added by section 301 of this Act, will take effect on the
effective date of final regulations promulgated under section
302(b) of this Act. The provisions of section 403A(a)(7), as
added by section 303 of this Act, take effect upon the date of
enactment of this Act.
Committee Consideration
I. HEARINGS
On June 25, 2015, the Subcommittee on Biotechnology,
Horticulture, and Research held a public hearing to review USDA
marketing programs.
Members of the Subcommittee heard testimony and discussed
programs that allow the Agricultural Marketing Service to help
producers and processors address consumer demand through
development of voluntary and unique marketing claims. During
the hearing, the following witness testified on matters
included in H.R. 1599:
Mr. Craig Morris, Deputy Administrator,
Livestock Poultry and Seed Program, Agricultural
Marketing Service, USDA, Washington, D.C.
II. FULL COMMITTEE
The Committee on Agriculture met, pursuant to notice, with
a quorum present, on July 14, 2015, to consider H.R. 1599, the
Safe and Accurate Food Labeling Act of 2015.
H.R. 1599 was placed before the Committee for
consideration. Without objection, a first reading of the bill
was waived and it was open for amendment at any point. Mr.
Davis was recognized to offer an Amendment in the Nature of a
Substitute to H.R. 1599. Without objection, Davis's Amendment
in Nature of a Substitute was considered as original text for
purposes of amendment.
Chairman Conaway, Mr. Peterson, and Mr. Davis were
recognized for statements. There being no other amendments, Mr.
Peterson was recognized to offer a motion that the Amendment in
the Nature of a Substitute to H.R. 1599 be approved. The
Amendment in the Nature of a Substitute was adopted by a voice
vote. Mr. Peterson was then recognized to offer a motion that
the bill H.R. 1599 be reported, as amended, favorably to the
House with recommendation that it do pass. The motion was
subsequently approved by voice vote.
At the conclusion of the meeting, Chairman Conaway advised
Members that pursuant to the rules of the House of
Representatives Members had until July 16, 2015, to file any
supplemental, minority, additional, or dissenting views with
the Committee.
Without objection, staff was given permission to make any
necessary clerical, technical or conforming changes to reflect
the intent of the Committee. Chairman Conaway thanked all the
Members and adjourned the meeting.
Committee Votes
In compliance with clause 3(b) of rule XIII of the House of
Representatives, H.R. 1599 was reported by voice vote with a
majority quorum present. There was no request for a recorded
vote.
Committee Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the Committee on Agriculture's
oversight findings and recommendations are reflected in the
body of this report.
Budget Act Compliance (Sections 308, 402, and 423)
The provisions of clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives and section 308(a)(1) of the
Congressional Budget Act of 1974 (relating to estimates of new
budget authority, new spending authority, new credit authority,
or increased or decreased revenues or tax expenditures) are not
considered applicable. The estimate and comparison required to
be prepared by the Director of the Congressional Budget Office
under clause 3(c)(3) of rule XIII of the Rules of the House of
Representatives and sections 402 and 423 of the Congressional
Budget Act of 1974 were not received by the Committee prior to
the filing of this report.
Performance Goals and Objectives
With respect to the requirement of clause 3(c)(4) of rule
XIII of the Rules of the House of Representatives, the
performance goals and objectives of this legislation are to
provide for a consistent, uniform, national standard for
voluntary food marketing claims related to the use or non-use
of genetic engineering. This free market alternative to a 50-
State patchwork of labeling requirements will allow consumers
access to meaningful information, create market opportunities
for those on the agricultural production and food processing
side, and will facilitate future innovation.
Committee Cost Estimate
Pursuant to clause 3(d)(1) of rule XIII of the Rules of the
House of Representatives, the Committee estimates that this
bill would have no significant net effect on direct spending or
revenues in this fiscal year or in each of the five fiscal
years following this fiscal year. The Committee may revise this
statement when the requested Congressional Budget Office cost
estimate is received.
Advisory Committee Statement
No advisory committee within the meaning of section 5(b) of
the Federal Advisory Committee Act was created by this
legislation.
Applicability to the Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act (Public Law
104-1).
Federal Mandates Statement
The Committee adopted as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act (Public Law 104-4).
Earmark Statement Required by Clause 9 of Rule XXI of the Rules of
House of Representatives
H.R. 1599 does not contain any congressional earmarks,
limited tax benefits, or limited tariff benefits as defined in
clause 9(e), 9(f), or 9(g) of rule XXI of the Rules of the
House Representatives.
Duplication of Federal Programs
This bill does not establish or reauthorize a program of
the Federal Government known to be duplicative of another
Federal program, a program that was included in any report from
the Government Accountability Office to Congress pursuant to
section 21 of Public Law 111-139, or a program related to a
program identified in the most recent Catalog of Federal
Domestic Assistance.
Disclosure of Directed Rule Makings
The Committee estimates that H.R. 1599 specifically directs
USDA to conduct two rule making proceedings within the meaning
of 5 U.S.C. 551.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italic, and existing law in which no
change is proposed is shown in roman):
FEDERAL FOOD, DRUG, AND COSMETIC ACT
* * * * * * *
CHAPTER IV--FOOD
* * * * * * *
misbranded food
Sec. 403. A food shall be deemed to be misbranded--
(a) If (1) its labeling is false or misleading in any
particular, or (2) in the case of a food to which section 411
applies, its advertising is false or misleading in a material
respect or its labeling is in violation of section 411(b)(2).
(b) If it is offered for sale under the name of another food.
(c) If it is an imitation of another food, unless its label
bears, in type of uniform size and prominence, the word
``imitation'' and, immediately thereafter, the name of the food
imitated.
(d) If its container is so made, formed, or filled as to be
misleading.
(e) If in package form unless it bears a label containing (1)
the name and place of business of the manufacturer, packer, or
distributor; and (2) an accurate statement of the quantity of
the contents in terms of weight, measure, or numerical count,
except that under clause (2) of this paragraph reasonable
variations shall be permitted, and exemptions as to small
packages shall be established, by regulations prescribed by the
Secretary.
(f) If any word, statement, or other information required by
or under authority of this Act to appear on the label or
labeling is not prominently placed thereon with such
conspicuousness (as compared with other words, statements,
designs, or devices, in the labeling) and in such terms as to
render it likely to be read and understood by the ordinary
individual under customary conditions of purchase and use.
(g) If it purports to be or is represented as a food for
which a definition and standard of identity has been prescribed
by regulations as provided by section 401, unless (1) it
conforms to such definition and standard, and (2) its label
bears the name of the food specified in the definition and
standard, and, insofar as may be required by such regulations,
the common names of optional ingredients (other than spices,
flavoring, and coloring) present in such food.
(h) If it purports to be or is represented as--
(1) a food for which a standard of quality has been
prescribed by regulations as provided by section 401,
and its quality falls below such standard, unless its
label bears, in such manner and form as such
regulations specify, a statement that it falls below
such standard;
(2) a food for which a standard or standards of fill
of container have been prescribed by regulations as
provided by section 401, and it falls below the
standard of fill of container applicable thereto,
unless its label bears, in such manner and form as such
regulations specify, a statement that it falls below
such standard; or
(3) a food that is pasteurized unless--
(A) such food has been subjected to a safe
process or treatment that is prescribed as
pasteurization for such food in a regulation
promulgated under this Act; or
(B)(i) such food has been subjected to a safe
process or treatment that--
(I) is reasonably certain to achieve
destruction or elimination in the food
of the most resistant microorganisms of
public health significance that are
likely to occur in the food;
(II) is at least as protective of the
public health as a process or treatment
described in subparagraph (A);
(III) is effective for a period that
is at least as long as the shelf life
of the food when stored under normal
and moderate abuse conditions; and
(IV) is the subject of a notification
to the Secretary, including
effectiveness data regarding the
process or treatment; and
(ii) at least 120 days have passed after the
date of receipt of such notification by the
Secretary without the Secretary making a
determination that the process or treatment
involved has not been shown to meet the
requirements of subclauses (I) through (III) of
clause (i).
For purposes of paragraph (3), a determination by the Secretary
that a process or treatment has not been shown to meet the
requirements of subclauses (I) through (III) of subparagraph
(B)(i) shall constitute final agency action under such
subclauses.
(i) Unless its label bears (1) the common or usual name of
the food, if any there be, and (2) in case it is fabricated
from two or more ingredients, the common or usual name of each
such ingredient and if the food purports to be a beverage
containing vegetable or fruit juice, a statement with
appropriate prominence on the information panel of the total
percentage of such fruit or vegetable juice contained in the
food; except that spices, flavorings, and colors not required
to be certified under section 721(c) unless sold as spices,
flavorings, or such colors, may be designated as spices,
flavorings, and colorings without naming each. To the extent
that compliance with the requirements of clause (2) of this
paragraph is impracticable, or results in deception or unfair
competition, exemptions shall be established by regulations
promulgated by the Secretary.
(j) If it purports to be or is represented for special
dietary uses, unless its label bears such information
concerning its vitamin, mineral, and other dietary properties
as the Secretary determines to be, and by regulations
prescribes as, necessary in order fully to inform purchasers as
to its value for such uses.
(k) If it bears or contains any artificial flavoring,
artificial coloring, or chemical preservative, unless it bears
labeling stating that fact, except that to the extent that
compliance with the requirements of this paragraph is
impracticable, exemptions shall be established by regulations
promulgated by the Secretary. The provisions of this paragraph
and paragraphs (g) and (i) with respect to artificial coloring
shall not apply in the case of butter, cheese, or ice cream.
The provisions of this paragraph with respect to chemical
preservatives shall not apply to a pesticide chemical when used
in or on a raw agricultural commodity which is the produce of
the soil.
(l) If it is a raw agricultural commodity which is the
produce of the soil, bearing or containing a pesticide chemical
applied after harvest, unless the shipping container of such
commodity bears labeling which declares the presence of such
chemical in or on such commodity and the common or usual name
and the function of such chemical, except that no such
declaration shall be required while such commodity, having been
removed from the shipping container, is being held or displayed
for sale at retail out of such container in accordance with the
custom of the trade.
(m) If it is a color additive, unless its packaging and
labeling are in conformity with such packaging and labeling
requirements, applicable to such color additive, as may be
contained in regulations issued under section 721.
(n) If its packaging or labeling is in violation of an
applicable regulation issued pursuant to section 3 or 4 of the
Poison Prevention Packaging Act of 1970.
(q)(1) Except as provided in subparagraphs (3), (4), and (5),
if it is a food intended for human consumption and is offered
for sale, unless its label or labeling bears nutrition
information that provides--
(A)(i) the serving size which is an amount
customarily consumed and which is expressed in a common
household measure that is appropriate to the food, or
(ii) if the use of the food is not typically
expressed in a serving size, the common household unit
of measure that expresses the serving size of the food,
(B) the number of servings or other units of measure
per container,
(C) the total number of calories--
(i) derived from any source, and
(ii) derived from the total fat,
in each serving size or other unit of measure of the
food,
(D) the amount of the following nutrients: Total fat,
saturated fat, cholesterol, sodium, total
carbohydrates, complex carbohydrates, sugars, dietary
fiber, and total protein contained in each serving size
or other unit of measure,
(E) any vitamin, mineral, or other nutrient required
to be placed on the label and labeling of food under
this Act before October 1, 1990, if the Secretary
determines that such information will assist consumers
in maintaining healthy dietary practices.
The Secretary may by regulation require any information
required to be placed on the label or labeling by this
subparagraph or subparagraph (2)(A) to be highlighted on the
label or labeling by larger type, bold type, or contrasting
color if the Secretary determines that such highlighting will
assist consumers in maintaining healthy dietary practices.
(2)(A) If the Secretary determines that a nutrient other than
a nutrient required by subparagraph (1)(C), (1)(D), or (1)(E)
should be included in the label or labeling of food subject to
subparagraph (1) for purposes of providing information
regarding the nutritional value of such food that will assist
consumers in maintaining healthy dietary practices, the
Secretary may by regulation require that information relating
to such additional nutrient be included in the label or
labeling of such food.
(B) If the Secretary determines that the information relating
to a nutrient required by subparagraph (1)(C), (1)(D), or
(1)(E) or clause (A) of this subparagraph to be included in the
label or labeling of food is not necessary to assist consumers
in maintaining healthy dietary practices, the Secretary may by
regulation remove information relating to such nutrient from
such requirement.
(3) For food that is received in bulk containers at a retail
establishment, the Secretary may, by regulation, provide that
the nutrition information required by subparagraphs (1) and (2)
be displayed at the location in the retail establishment at
which the food is offered for sale.
(4)(A) The Secretary shall provide for furnishing the
nutrition information required by subparagraphs (1) and (2)
with respect to raw agricultural commodities and raw fish by
issuing voluntary nutrition guidelines, as provided by clause
(B) or by issuing regulations that are mandatory as provided by
clause (D).
(B)(i) Upon the expiration of 12 months after the date of the
enactment of the Nutrition Labeling and Education Act of 1990,
the Secretary, after providing an opportunity for comment,
shall issue guidelines for food retailers offering raw
agricultural commodities or raw fish to provide nutrition
information specified in subparagraphs (1) and (2). Such
guidelines shall take into account the actions taken by food
retailers during such 12-month period to provide to consumers
nutrition information on raw agricultural commodities and raw
fish. Such guidelines shall only apply--
(I) in the case of raw agricultural commodities, to
the 20 varieties of vegetables most frequently consumed
during a year and the 20 varieties of fruit most
frequently consumed during a year, and
(II) to the 20 varieties of raw fish most frequently
consumed during a year.
The vegetables, fruits, and raw fish to which such guidelines
apply shall be determined by the Secretary by regulation and
the Secretary may apply such guidelines regionally.
(ii) Upon the expiration of 12 months after the date of the
enactment of the Nutrition Labeling and Education Act of 1990,
the Secretary shall issue a final regulation defining the
circumstances that constitute substantial compliance by food
retailers with the guidelines issued under subclause (i). The
regulation shall provide that there is not substantial
compliance if a significant number of retailers have failed to
comply with the guidelines. The size of the retailers and the
portion of the market served by retailers in compliance with
the guidelines shall be considered in determining whether the
substantial-compliance standard has been met.
(C)(i) Upon the expiration of 30 months after the date of the
enactment of the Nutrition Labeling and Education Act of 1990,
the Secretary shall issue a report on actions taken by food
retailers to provide consumers with nutrition information for
raw agricultural commodities and raw fish under the guidelines
issued under clause (A). Such report shall include a
determination of whether there is substantial compliance with
the guidelines.
(ii) If the Secretary finds that there is substantial
compliance with the guidelines, the Secretary shall issue a
report and make a determination of the type required in
subclause (i) every two years.
(D)(i) If the Secretary determines that there is not
substantial compliance with the guidelines issued under clause
(A), the Secretary shall at the time such determination is made
issue proposed regulations requiring that any person who offers
raw agricultural commodities or raw fish to consumers provide,
in a manner prescribed by regulations, the nutrition
information required by subparagraphs (1) and (2). The
Secretary shall issue final regulations imposing such
requirements 6 months after issuing the proposed regulations.
The final regulations shall become effective 6 months after the
date of their promulgation.
(ii) Regulations issued under subclause (i) may require that
the nutrition information required by subparagraphs (1) and (2)
be provided for more than 20 varieties of vegetables, 20
varieties of fruit, and 20 varieties of fish most frequently
consumed during a year if the Secretary finds that a larger
number of such products are frequently consumed. Such
regulations shall permit such information to be provided in a
single location in each area in which raw agricultural
commodities and raw fish are offered for sale. Such regulations
may provide that information shall be expressed as an average
or range per serving of the same type of raw agricultural
commodity or raw fish. The Secretary shall develop and make
available to the persons who offer such food to consumers the
information required by subparagraphs (1) and (2).
(iii) Regulations issued under subclause (i) shall permit the
required information to be provided in each area of an
establishment in which raw agricultural commodities and raw
fish are offered for sale. The regulations shall permit food
retailers to display the required information by supplying
copies of the information provided by the Secretary, by making
the information available in brochure, notebook or leaflet
form, or by posting a sign disclosing the information. Such
regulations shall also permit presentation of the required
information to be supplemented by a video, live demonstration,
or other media which the Secretary approves.
(E) For purposes of this subparagraph, the term ``fish''
includes freshwater or marine fin fish, crustaceans, and
mollusks, including shellfish, amphibians, and other forms of
aquatic animal life.
(F) No person who offers raw agricultural commodities or raw
fish to consumers may be prosecuted for minor violations of
this subparagraph if there has been substantial compliance with
the requirements of this paragraph.
(5)(A) Subparagraphs (1), (2), (3), and (4) shall not apply
to food--
(i) except as provided in clause (H)(ii)(III), which
is served in restaurants or other establishments in
which food is served for immediate human consumption or
which is sold for sale or use in such establishments,
(ii) except as provided in clause (H)(ii)(III), which
is processed and prepared primarily in a retail
establishment, which is ready for human consumption,
which is of the type described in subclause (i), and
which is offered for sale to consumers but not for
immediate human consumption in such establishment and
which is not offered for sale outside such
establishment,
(iii) which is an infant formula subject to section
412,
(iv) which is a medical food as defined in section
5(b) of the Orphan Drug Act (21 U.S.C. 360ee(b)), or
(v) which is described in section 405(2).
(B) Subparagraphs (1) and (2) shall not apply to the label of
a food if the Secretary determines by regulations that
compliance with such subparagraphs is impracticable because the
package of such food is too small to comply with the
requirements of such subparagraphs and if the label of such
food does not contain any nutrition information.
(C) If a food contains insignificant amounts, as determined
by the Secretary, of all the nutrients required by
subparagraphs (1) and (2) to be listed in the label or labeling
of food, the requirements of such subparagraphs shall not apply
to such food if the label, labeling, or advertising of such
food does not make any claim with respect to the nutritional
value of such food. If a food contains insignificant amounts,
as determined by the Secretary, of more than one-half the
nutrients required by subparagraphs (1) and (2) to be in the
label or labeling of the food, the Secretary shall require the
amounts of such nutrients to be stated in a simplified form
prescribed by the Secretary.
(D) If a person offers food for sale and has annual gross
sales made or business done in sales to consumers which is not
more than $500,000 or has annual gross sales made or business
done in sales of food to consumers which is not more than
$50,000, the requirements of subparagraphs (1), (2), (3), and
(4) shall not apply with respect to food sold by such person to
consumers unless the label or labeling of food offered by such
person provides nutrition information or makes a nutrition
claim.
(E)(i) During the 12-month period for which an exemption from
subparagraphs (1) and (2) is claimed pursuant to this
subclause, the requirements of such subparagraphs shall not
apply to any food product if--
(I) the labeling for such product does not provide
nutrition information or make a claim subject to
paragraph (r),
(II) the person who claims for such product an
exemption from such subparagraphs employed fewer than
an average of 100 full-time equivalent employees,
(III) such person provided the notice described in
subclause (iii), and
(IV) in the case of a food product which was sold in
the 12-month period preceding the period for which an
exemption was claimed, fewer than 100,000 units of such
product were sold in the United States during such
preceding period, or in the case of a food product
which was not sold in the 12-month period preceding the
period for which such exemption is claimed, fewer than
100,000 units of such product are reasonably
anticipated to be sold in the United States during the
period for which such exemption is claimed.
(ii) During the 12-month period after the applicable date
referred to in this sentence, the requirements of subparagraphs
(1) and (2) shall not apply to any food product which was first
introduced into interstate commerce before May 8, 1994, if the
labeling for such product does not provide nutrition
information or make a claim subject to paragraph (r), if such
person provided the notice described in subclause (iii), and
if--
(I) during the 12-month period preceding May 8, 1994,
the person who claims for such product an exemption
from such subparagraphs employed fewer than an average
of 300 full-time equivalent employees and fewer than
600,000 units of such product were sold in the United
States,
(II) during the 12-month period preceding May 8,
1995, the person who claims for such product an
exemption from such subparagraphs employed fewer than
an average of 300 full-time equivalent employees and
fewer than 400,000 units of such product were sold in
the United States, or
(III) during the 12-month period preceding May 8,
1996, the person who claims for such product an
exemption from such subparagraphs employed fewer than
an average of 200 full-time equivalent employees and
fewer than 200,000 units of such product were sold in
the United States.
(iii) The notice referred to in subclauses (i) and (ii) shall
be given to the Secretary prior to the beginning of the period
during which the exemption under subclause (i) or (ii) is to be
in effect, shall state that the person claiming such exemption
for a food product has complied with the applicable
requirements of subclause (i) or (ii), and shall--
(I) state the average number of full-time equivalent
employees such person employed during the 12 months
preceding the date such person claims such exemption,
(II) state the approximate number of units the person
claiming the exemption sold in the United States,
(III) if the exemption is claimed for a food product
which was sold in the 12-month period preceding the
period for which the exemption was claimed, state the
approximate number of units of such product which were
sold in the United States during such preceding period,
and, if the exemption is claimed for a food product
which was not sold in such preceding period, state the
number of units of such product which such person
reasonably anticipates will be sold in the United
States during the period for which the exemption was
claimed, and
(IV) contain such information as the Secretary may
require to verify the information required by the
preceding provisions of this subclause if the Secretary
has questioned the validity of such information.
If a person is not an importer, has fewer than 10 full-time
equivalent employees, and sells fewer than 10,000 units of any
food product in any year, such person is not required to file a
notice for such product under this subclause for such year.
(iv) In the case of a person who claimed an exemption under
subclause (i) or (ii), if, during the period of such exemption,
the number of full-time equivalent employees of such person
exceeds the number in such subclause or if the number of food
products sold in the United States exceeds the number in such
subclause, such exemption shall extend to the expiration of 18
months after the date the number of full-time equivalent
employees or food products sold exceeded the applicable number.
(v) For any food product first introduced into interstate
commerce after May 8, 2002, the Secretary may by regulation
lower the employee or units of food products requirement of
subclause (i) if the Secretary determines that the cost of
compliance with such lower requirement will not place an undue
burden on persons subject to such lower requirement.
(vi) For purposes of subclauses (i), (ii), (iii), (iv), and
(v)--
(I) the term ``unit'' means the packaging or, if
there is no packaging, the form in which a food product
is offered for sale to consumers,
(II) the term ``food product'' means food in any
sized package which is manufactured by a single
manufacturer or which bears the same brand name, which
bears the same statement of identity, and which has
similar preparation methods, and
(III) the term ``person'' in the case of a
corporation includes all domestic and foreign
affiliates of the corporation.
(F) A dietary supplement product (including a food to which
section 411 applies) shall comply with the requirements of
subparagraphs (1) and (2) in a manner which is appropriate for
the product and which is specified in regulations of the
Secretary which shall provide that--
(i) nutrition information shall first list those
dietary ingredients that are present in the product in
a significant amount and for which a recommendation for
daily consumption has been established by the
Secretary, except that a dietary ingredient shall not
be required to be listed if it is not present in a
significant amount, and shall list any other dietary
ingredient present and identified as having no such
recommendation;
(ii) the listing of dietary ingredients shall include
the quantity of each such ingredient (or of a
proprietary blend of such ingredients) per serving;
(iii) the listing of dietary ingredients may include
the source of a dietary ingredient; and
(iv) the nutrition information shall immediately
precede the ingredient information required under
subclause (i), except that no ingredient identified
pursuant to subclause (i) shall be required to be
identified a second time.
(G) Subparagraphs (1), (2), (3), and (4) shall not apply to
food which is sold by a food distributor if the food
distributor principally sells food to restaurants or other
establishments in which food is served for immediate human
consumption and does not manufacture, process, or repackage the
food it sells.
(H) Restaurants, Retail Food Establishments, and Vending
Machines.--
(i) General requirements for restaurants and similar
retail food establishments.--Except for food described
in subclause (vii), in the case of food that is a
standard menu item that is offered for sale in a
restaurant or similar retail food establishment that is
part of a chain with 20 or more locations doing
business under the same name (regardless of the type of
ownership of the locations) and offering for sale
substantially the same menu items, the restaurant or
similar retail food establishment shall disclose the
information described in subclauses (ii) and (iii).
(ii) Information required to be disclosed by
restaurants and retail food establishments.--Except as
provided in subclause (vii), the restaurant or similar
retail food establishment shall disclose in a clear and
conspicuous manner--
(I)(aa) in a nutrient content disclosure
statement adjacent to the name of the standard
menu item, so as to be clearly associated with
the standard menu item, on the menu listing the
item for sale, the number of calories contained
in the standard menu item, as usually prepared
and offered for sale; and
(bb) a succinct statement concerning
suggested daily caloric intake, as specified by
the Secretary by regulation and posted
prominently on the menu and designed to enable
the public to understand, in the context of a
total daily diet, the significance of the
caloric information that is provided on the
menu;
(II)(aa) in a nutrient content disclosure
statement adjacent to the name of the standard
menu item, so as to be clearly associated with
the standard menu item, on the menu board,
including a drive-through menu board, the
number of calories contained in the standard
menu item, as usually prepared and offered for
sale; and
(bb) a succinct statement concerning
suggested daily caloric intake, as specified by
the Secretary by regulation and posted
prominently on the menu board, designed to
enable the public to understand, in the context
of a total daily diet, the significance of the
nutrition information that is provided on the
menu board;
(III) in a written form, available on the premises of
the restaurant or similar retail establishment and to
the consumer upon request, the nutrition information
required under clauses (C) and (D) of subparagraph (1);
and
(IV) on the menu or menu board, a prominent, clear,
and conspicuous statement regarding the availability of
the information described in item (III).
(iii) Self-service food and food on display.--Except
as provided in subclause (vii), in the case of food
sold at a salad bar, buffet line, cafeteria line, or
similar self-service facility, and for self-service
beverages or food that is on display and that is
visible to customers, a restaurant or similar retail
food establishment shall place adjacent to each food
offered a sign that lists calories per displayed food
item or per serving.
(iv) Reasonable basis.--For the purposes of this
clause, a restaurant or similar retail food
establishment shall have a reasonable basis for its
nutrient content disclosures, including nutrient
databases, cookbooks, laboratory analyses, and other
reasonable means, as described in section 101.10 of
title 21, Code of Federal Regulations (or any successor
regulation) or in a related guidance of the Food and
Drug Administration.
(v) Menu variability and combination meals.--The
Secretary shall establish by regulation standards for
determining and disclosing the nutrient content for
standard menu items that come in different flavors,
varieties, or combinations, but which are listed as a
single menu item, such as soft drinks, ice cream,
pizza, doughnuts, or children's combination meals,
through means determined by the Secretary, including
ranges, averages, or other methods.
(vi) Additional information.--If the Secretary
determines that a nutrient, other than a nutrient
required under subclause (ii)(III), should be disclosed
for the purpose of providing information to assist
consumers in maintaining healthy dietary practices, the
Secretary may require, by regulation, disclosure of
such nutrient in the written form required under
subclause (ii)(III).
(vii) Nonapplicability to certain food.--
(I) In general.--Subclauses (i) through (vi)
do not apply to--
(aa) items that are not listed on a
menu or menu board (such as condiments
and other items placed on the table or
counter for general use);
(bb) daily specials, temporary menu
items appearing on the menu for less
than 60 days per calendar year, or
custom orders; or
(cc) such other food that is part of
a customary market test appearing on
the menu for less than 90 days, under
terms and conditions established by the
Secretary.
(II) Written forms.--Subparagraph (5)(C)
shall apply to any regulations promulgated
under subclauses (ii)(III) and (vi).
(viii) Vending machines.--
(I) In general.--In the case of an article of food
sold from a vending machine that--
(aa) does not permit a prospective
purchaser to examine the Nutrition
Facts Panel before purchasing the
article or does not otherwise provide
visible nutrition information at the
point of purchase; and
(bb) is operated by a person who is
engaged in the business of owning or
operating 20 or more vending machines,
the vending machine operator shall provide a
sign in close proximity to each article of food
or the selection button that includes a clear
and conspicuous statement disclosing the number
of calories contained in the article.
(ix) Voluntary provision of nutrition information.--
(I) In general.--An authorized official of
any restaurant or similar retail food
establishment or vending machine operator not
subject to the requirements of this clause may
elect to be subject to the requirements of such
clause, by registering biannually the name and
address of such restaurant or similar retail
food establishment or vending machine operator
with the Secretary, as specified by the
Secretary by regulation.
(II) Registration.--Within 120 days of
enactment of this clause, the Secretary shall
publish a notice in the Federal Register
specifying the terms and conditions for
implementation of item (I), pending
promulgation of regulations.
(III) Rule of construction.--Nothing in this
subclause shall be construed to authorize the
Secretary to require an application, review, or
licensing process for any entity to register
with the Secretary, as described in such item.
(x) Regulations.--
(I) Proposed regulation.--Not later than 1
year after the date of enactment of this
clause, the Secretary shall promulgate proposed
regulations to carry out this clause.
(II) Contents.--In promulgating regulations,
the Secretary shall--
(aa) consider standardization of
recipes and methods of preparation,
reasonable variation in serving size
and formulation of menu items, space on
menus and menu boards, inadvertent
human error, training of food service
workers, variations in ingredients, and
other factors, as the Secretary
determines; and
(bb) specify the format and manner of
the nutrient content disclosure
requirements under this subclause.
(III) Reporting.--The Secretary shall submit
to the Committee on Health, Education, Labor,
and Pensions of the Senate and the Committee on
Energy and Commerce of the House of
Representatives a quarterly report that
describes the Secretary's progress toward
promulgating final regulations under this
subparagraph.
(xi) Definition.--In this clause, the term ``menu''
or ``menu board'' means the primary writing of the
restaurant or other similar retail food establishment
from which a consumer makes an order selection.
(r)(1) Except as provided in clauses (A) through (C) of
subparagraph (5), if it is a food intended for human
consumption which is offered for sale and for which a claim is
made in the label or labeling of the food which expressly or by
implication--
(A) characterizes the level of any nutrient which is
of the type required by paragraph (q)(1) or (q)(2) to
be in the label or labeling of the food unless the
claim is made in accordance with subparagraph (2), or
(B) characterizes the relationship of any nutrient
which is of the type required by paragraph (q)(1) or
(q)(2) to be in the label or labeling of the food to a
disease or a health-related condition unless the claim
is made in accordance with subparagraph (3) or (5)(D).
A statement of the type required by paragraph (q) that appears
as part of the nutrition information required or permitted by
such paragraph is not a claim which is subject to this
paragraph and a claim subject to clause (A) is not subject to
clause (B).
(2)(A) Except as provided in subparagraphs (4)(A)(ii) and
(4)(A)(iii) and clauses (A) through (C) of subparagraph (5), a
claim described in subparagraph (1)(A)--
(i) may be made only if the characterization of the
level made in the claim uses terms which are defined in
regulations of the Secretary,
(ii) may not state the absence of a nutrient unless--
(I) the nutrient is usually present in the
food or in a food which substitutes for the
food as defined by the Secretary by regulation,
or
(II) the Secretary by regulation permits such
a statement on the basis of a finding that such
a statement would assist consumers in
maintaining healthy dietary practices and the
statement discloses that the nutrient is not
usually present in the food,
(iii) may not be made with respect to the level of
cholesterol in the food if the food contains, as
determined by the Secretary by regulation, fat or
saturated fat in an amount which increases to persons
in the general population the risk of disease or a
health related condition which is diet related unless--
(I) the Secretary finds by regulation that
the level of cholesterol is substantially less
than the level usually present in the food or
in a food which substitutes for the food and
which has a significant market share, or the
Secretary by regulation permits a statement
regarding the absence of cholesterol on the
basis of a finding that cholesterol is not
usually present in the food and that such a
statement would assist consumers in maintaining
healthy dietary practices and a requirement
that the statement disclose that cholesterol is
not usually present in the food, and
(II) the label or labeling of the food
discloses the level of such fat or saturated
fat in immediate proximity to such claim and
with appropriate prominence which shall be no
less than one-half the size of the claim with
respect to the level of cholesterol,
(iv) may not be made with respect to the level of
saturated fat in the food if the food contains
cholesterol unless the label or labeling of the food
discloses the level of cholesterol in the food in
immediate proximity to such claim and with appropriate
prominence which shall be no less than one-half the
size of the claim with respect to the level of
saturated fat,
(v) may not state that a food is high in dietary
fiber unless the food is low in total fat as defined by
the Secretary or the label or labeling discloses the
level of total fat in the food in immediate proximity
to such statement and with appropriate prominence which
shall be no less than one-half the size of the claim
with respect to the level of dietary fiber, and
(vi) may not be made if the Secretary by regulation
prohibits the claim because the claim is misleading in
light of the level of another nutrient in the food.
(B) If a claim described in subparagraph (1)(A) is made with
respect to a nutrient in a food and the Secretary makes a
determination that the food contains a nutrient at a level that
increases to persons in the general population the risk of a
disease or health-related condition that is diet related, the
label or labeling of such food shall contain, prominently and
in immediate proximity to such claim, the following statement:
``See nutrition information for __ content.'' The blank shall
identify the nutrient associated with the increased disease or
health-related condition risk. In making the determination
described in this clause, the Secretary shall take into account
the significance of the food in the total daily diet.
(C) Subparagraph (2)(A) does not apply to a claim described
in subparagraph (1)(A) and contained in the label or labeling
of a food if such claim is contained in the brand name of such
food and such brand name was in use on such food before October
25, 1989, unless the brand name contains a term defined by the
Secretary under subparagraph (2)(A)(i). Such a claim is subject
to paragraph (a).
(D) Subparagraph (2) does not apply to a claim described in
subparagraph (1)(A) which uses the term ``diet'' and is
contained in the label or labeling of a soft drink if (i) such
claim is contained in the brand name of such soft drink, (ii)
such brand name was in use on such soft drink before October
25, 1989, and (iii) the use of the term ``diet'' was in
conformity with section 105.66 of title 21 of the Code of
Federal Regulations. Such a claim is subject to paragraph (a).
(E) Subclauses (i) through (v) of subparagraph (2)(A) do not
apply to a statement in the label or labeling of food which
describes the percentage of vitamins and minerals in the food
in relation to the amount of such vitamins and minerals
recommended for daily consumption by the Secretary.
(F) Subclause (i) clause (A) does not apply to a statement in
the labeling of a dietary supplement that characterizes the
percentage level of a dietary ingredient for which the
Secretary has not established a reference daily intake, daily
recommended value, or other recommendation for daily
consumption.
(G) A claim of the type described in subparagraph (1)(A) for
a nutrient, for which the Secretary has not promulgated a
regulation under clause (A)(i), shall be authorized and may be
made with respect to a food if--
(i) a scientific body of the United States Government
with official responsibility for public health
protection or research directly relating to human
nutrition (such as the National Institutes of Health or
the Centers for Disease Control and Prevention) or the
National Academy of Sciences or any of its subdivisions
has published an authoritative statement, which is
currently in effect, which identifies the nutrient
level to which the claim refers;
(ii) a person has submitted to the Secretary, at
least 120 days (during which the Secretary may notify
any person who is making a claim as authorized by
clause (C) that such person has not submitted all the
information required by such clause) before the first
introduction into interstate commerce of the food with
a label containing the claim, (I) a notice of the
claim, which shall include the exact words used in the
claim and shall include a concise description of the
basis upon which such person relied for determining
that the requirements of subclause (i) have been
satisfied, (II) a copy of the statement referred to in
subclause (i) upon which such person relied in making
the claim, and (III) a balanced representation of the
scientific literature relating to the nutrient level to
which the claim refers;
(iii) the claim and the food for which the claim is
made are in compliance with clauses (A) and (B), and
are otherwise in compliance with paragraph (a) and
section 201(n); and
(iv) the claim is stated in a manner so that the
claim is an accurate representation of the
authoritative statement referred to in subclause (i)
and so that the claim enables the public to comprehend
the information provided in the claim and to understand
the relative significance of such information in the
context of a total daily diet.
For purposes of this clause, a statement shall be regarded as
an authoritative statement of a scientific body described in
subclause (i) only if the statement is published by the
scientific body and shall not include a statement of an
employee of the scientific body made in the individual capacity
of the employee.
(H) A claim submitted under the requirements of clause (G)
may be made until--
(i) such time as the Secretary issues a regulation--
(I) prohibiting or modifying the claim and
the regulation has become effective, or
(II) finding that the requirements of clause
(G) have not been met, including finding that
the petitioner had not submitted all the
information required by such clause; or
(ii) a district court of the United States in an
enforcement proceeding under chapter III has determined
that the requirements of clause (G) have not been met.
(3)(A) Except as provided in subparagraph (5), a claim
described in subparagraph (1)(B) may only be made--
(i) if the claim meets the requirements of the
regulations of the Secretary promulgated under clause
(B), and
(ii) if the food for which the claim is made does not
contain, as determined by the Secretary by regulation,
any nutrient in an amount which increases to persons in
the general population the risk of a disease or health-
related condition which is diet related, taking into
account the significance of the food in the total daily
diet, except that the Secretary may by regulation
permit such a claim based on a finding that such a
claim would assist consumers in maintaining healthy
dietary practices and based on a requirement that the
label contain a disclosure of the type required by
subparagraph (2)(B).
(B)(i) The Secretary shall promulgate regulations authorizing
claims of the type described in subparagraph (1)(B) only if the
Secretary determines, based on the totality of publicly
available scientific evidence (including evidence from well-
designed studies conducted in a manner which is consistent with
generally recognized scientific procedures and principles),
that there is significant scientific agreement, among experts
qualified by scientific training and experience to evaluate
such claims, that the claim is supported by such evidence.
(ii) A regulation described in subclause (i) shall describe--
(I) the relationship between a nutrient of the type
required in the label or labeling of food by paragraph
(q)(1) or (q)(2) and a disease or health-related
condition, and
(II) the significance of each such nutrient in
affecting such disease or health-related condition.
(iii) A regulation described in subclause (i) shall require
such claim to be stated in a manner so that the claim is an
accurate representation of the matters set out in subclause
(ii) and so that the claim enables the public to comprehend the
information provided in the claim and to understand the
relative significance of such information in the context of a
total daily diet.
(C) Notwithstanding the provisions of clauses (A)(i) and (B),
a claim of the type described in subparagraph (1)(B) which is
not authorized by the Secretary in a regulation promulgated in
accordance with clause (B) shall be authorized and may be made
with respect to a food if--
(i) a scientific body of the United States Government
with official responsibility for public health
protection or research directly relating to human
nutrition (such as the National Institutes of Health or
the Centers for Disease Control and Prevention) or the
National Academy of Sciences or any of its subdivisions
has published an authoritative statement, which is
currently in effect, about the relationship between a
nutrient and a disease or health-related condition to
which the claim refers;
(ii) a person has submitted to the Secretary, at
least 120 days (during which the Secretary may notify
any person who is making a claim as authorized by
clause (C) that such person has not submitted all the
information required by such clause) before the first
introduction into interstate commerce of the food with
a label containing the claim, (I) a notice of the
claim, which shall include the exact words used in the
claim and shall include a concise description of the
basis upon which such person relied for determining
that the requirements of subclause (i) have been
satisfied, (II) a copy of the statement referred to in
subclause (i) upon which such person relied in making
the claim, and (III) a balanced representation of the
scientific literature relating to the relationship
between a nutrient and a disease or health-related
condition to which the claim refers;
(iii) the claim and the food for which the claim is
made are in compliance with clause (A)(ii) and are
otherwise in compliance with paragraph (a) and section
201(n); and
(iv) the claim is stated in a manner so that the
claim is an accurate representation of the
authoritative statement referred to in subclause (i)
and so that the claim enables the public to comprehend
the information provided in the claim and to understand
the relative significance of such information in the
context of a total daily diet.
For purposes of this clause, a statement shall be regarded as
an authoritative statement of a scientific body described in
subclause (i) only if the statement is published by the
scientific body and shall not include a statement of an
employee of the scientific body made in the individual capacity
of the employee.
(D) A claim submitted under the requirements of clause (C)
may be made until--
(i) such time as the Secretary issues a regulation
under the standard in clause (B)(i)--
(I) prohibiting or modifying the claim and
the regulation has become effective, or
(II) finding that the requirements of clause
(C) have not been met, including finding that
the petitioner has not submitted all the
information required by such clause; or
(ii) a district court of the United States in an
enforcement proceeding under chapter III has determined
that the requirements of clause (C) have not been met.
(4)(A)(i) Any person may petition the Secretary to issue a
regulation under subparagraph (2)(A)(i) or (3)(B) relating to a
claim described in subparagraph (1)(A) or (1)(B). Not later
than 100 days after the petition is received by the Secretary,
the Secretary shall issue a final decision denying the petition
or file the petition for further action by the Secretary. If
the Secretary does not act within such 100 days, the petition
shall be deemed to be denied unless an extension is mutually
agreed upon by the Secretary and the petitioner. If the
Secretary denies the petition or the petition is deemed to be
denied, the petition shall not be made available to the public.
If the Secretary files the petition, the Secretary shall deny
the petition or issue a proposed regulation to take the action
requested in the petition not later than 90 days after the date
of such decision. If the Secretary does not act within such 90
days, the petition shall be deemed to be denied unless an
extension is mutually agreed upon by the Secretary and the
petitioner. If the Secretary issues a proposed regulation, the
rulemaking shall be completed within 540 days of the date the
petition is received by the Secretary. If the Secretary does
not issue a regulation within such 540 days, the Secretary
shall provide the Committee on Commerce of the House of
Representatives and the Committee on Labor and Human Resources
of the Senate the reasons action on the regulation did not
occur within such 540 days.
(ii) Any person may petition the Secretary for permission to
use in a claim described in subparagraph (1)(A) terms that are
consistent with the terms defined by the Secretary under
subparagraph (2)(A)(i). Within 90 days of the submission of
such a petition, the Secretary shall issue a final decision
denying the petition or granting such permission.
(iii) Any person may petition the Secretary for permission to
use an implied claim described in subparagraph (1)(A) in a
brand name. After publishing notice of an opportunity to
comment on the petition in the Federal Register and making the
petition available to the public, the Secretary shall grant the
petition if the Secretary finds that such claim is not
misleading and is consistent with terms defined by the
Secretary under subparagraph (2)(A)(i). The Secretary shall
grant or deny the petition within 100 days of the date it is
submitted to the Secretary and the petition shall be considered
granted if the Secretary does not act on it within such 100
days.
(B) A petition under clause (A)(i) respecting a claim
described in subparagraph (1)(A) or (1)(B) shall include an
explanation of the reasons why the claim meets the requirements
of this paragraph and a summary of the scientific data which
supports such reasons.
(C) If a petition for a regulation under subparagraph (3)(B)
relies on a report from an authoritative scientific body of the
United States, the Secretary shall consider such report and
shall justify any decision rejecting the conclusions of such
report.
(5)(A) This paragraph does not apply to infant formulas
subject to section 412(h) and medical foods as defined in
section 5(b) of the Orphan Drug Act.
(B) Subclauses (iii) through (v) of subparagraph (2)(A) and
subparagraph (2)(B) do not apply to food which is served in
restaurants or other establishments in which food is served for
immediate human consumption or which is sold for sale or use in
such establishments.
(C) A subparagraph (1)(A) claim made with respect to a food
which claim is required by a standard of identity issued under
section 401 shall not be subject to subparagraph (2)(A)(i) or
(2)(B).
(D) A subparagraph (1)(B) claim made with respect to a
dietary supplement of vitamins, minerals, herbs, or other
similar nutritional substances shall not be subject to
subparagraph (3) but shall be subject to a procedure and
standard, respecting the validity of such claim, established by
regulation of the Secretary.
(6) For purposes of paragraph (r)(1)(B), a statement for a
dietary supplement may be made if--
(A) the statement claims a benefit related to a
classical nutrient deficiency disease and discloses the
prevalence of such disease in the United States,
describes the role of a nutrient or dietary ingredient
intended to affect the structure or function in humans,
characterizes the documented mechanism by which a
nutrient or dietary ingredient acts to maintain such
structure or function, or describes general well-being
from consumption of a nutrient or dietary ingredient,
(B) the manufacturer of the dietary supplement has
substantiation that such statement is truthful and not
misleading, and
(C) the statement contains, prominently displayed and
in boldface type, the following: ``This statement has
not been evaluated by the Food and Drug Administration.
This product is not intended to diagnose, treat, cure,
or prevent any disease.''.
A statement under this subparagraph may not claim to diagnose,
mitigate, treat, cure, or prevent a specific disease or class
of diseases. If the manufacturer of a dietary supplement
proposes to make a statement described in the first sentence of
this subparagraph in the labeling of the dietary supplement,
the manufacturer shall notify the Secretary no later than 30
days after the first marketing of the dietary supplement with
such statement that such a statement is being made.
(7) The Secretary may make proposed regulations issued under
this paragraph effective upon publication pending consideration
of public comment and publication of a final regulation if the
Secretary determines that such action is necessary--
(A) to enable the Secretary to review and act
promptly on petitions the Secretary determines provide
for information necessary to--
(i) enable consumers to develop and maintain
healthy dietary practices;
(ii) enable consumers to be informed promptly
and effectively of important new knowledge
regarding nutritional and health benefits of
food; or
(iii) ensure that scientifically sound
nutritional and health information is provided
to consumers as soon as possible; or
(B) to enable the Secretary to act promptly to ban or
modify a claim under this paragraph.
Such proposed regulations shall be deemed final agency action
for purposes of judicial review.
(s) If--
(1) it is a dietary supplement; and
(2)(A) the label or labeling of the supplement fails
to list--
(i) the name of each ingredient of the
supplement that is described in section
201(ff); and
(ii)(I) the quantity of each such ingredient;
or
(II) with respect to a proprietary blend of
such ingredients, the total quantity of all
ingredients in the blend;
(B) the label or labeling of the dietary supplement
fails to identify the product by using the term
``dietary supplement'', which term may be modified with
the name of such an ingredient;
(C) the supplement contains an ingredient described
in section 201(ff)(1)(C), and the label or labeling of
the supplement fails to identify any part of the plant
from which the ingredient is derived;
(D) the supplement--
(i) is covered by the specifications of an
official compendium;
(ii) is represented as conforming to the
specifications of an official compendium; and
(iii) fails to so conform; or
(E) the supplement--
(i) is not covered by the specifications of
an official compendium; and
(ii)(I) fails to have the identity and
strength that the supplement is represented to
have; or
(II) fails to meet the quality (including
tablet or capsule disintegration), purity, or
compositional specifications, based on
validated assay or other appropriate methods,
that the supplement is represented to meet.
A dietary supplement shall not be deemed misbranded solely
because its label or labeling contains directions or conditions
of use or warnings.
(t) If it purports to be or is represented as catfish, unless
it is fish classified within the family Ictaluridae.
(u) If it purports to be or is represented as ginseng, unless
it is an herb or herbal ingredient derived from a plant
classified within the genus Panax.
(v) If--
(1) it fails to bear a label required by the
Secretary under section 801(n)(1) (relating to food
refused admission into the United States);
(2) the Secretary finds that the food presents a
threat of serious adverse health consequences or death
to humans or animals; and
(3) upon or after notifying the owner or consignee
involved that the label is required under section 801,
the Secretary informs the owner or consignee that the
food presents such a threat.
(w)(1) If it is not a raw agricultural commodity and it is,
or it contains an ingredient that bears or contains, a major
food allergen, unless either--
(A) the word ``Contains'', followed by the name of
the food source from which the major food allergen is
derived, is printed immediately after or is adjacent to
the list of ingredients (in a type size no smaller than
the type size used in the list of ingredients) required
under subsections (g) and (i); or
(B) the common or usual name of the major food
allergen in the list of ingredients required under
subsections (g) and (i) is followed in parentheses by
the name of the food source from which the major food
allergen is derived, except that the name of the food
source is not required when--
(i) the common or usual name of the
ingredient uses the name of the food source
from which the major food allergen is derived;
or
(ii) the name of the food source from which
the major food allergen is derived appears
elsewhere in the ingredient list, unless the
name of the food source that appears elsewhere
in the ingredient list appears as part of the
name of a food ingredient that is not a major
food allergen under section 201(qq)(2)(A) or
(B).
(2) As used in this subsection, the term ``name of the food
source from which the major food allergen is derived'' means
the name described in section 201(qq)(1); provided that in the
case of a tree nut, fish, or Crustacean shellfish, the term
``name of the food source from which the major food allergen is
derived'' means the name of the specific type of nut or species
of fish or Crustacean shellfish.
(3) The information required under this subsection may appear
in labeling in lieu of appearing on the label only if the
Secretary finds that such other labeling is sufficient to
protect the public health. A finding by the Secretary under
this paragraph (including any change in an earlier finding
under this paragraph) is effective upon publication in the
Federal Register as a notice.
(4) Notwithstanding subsection (g), (i), or (k), or any other
law, a flavoring, coloring, or incidental additive that is, or
that bears or contains, a major food allergen shall be subject
to the labeling requirements of this subsection.
(5) The Secretary may by regulation modify the requirements
of subparagraph (A) or (B) of paragraph (1), or eliminate
either the requirement of subparagraph (A) or the requirements
of subparagraph (B) of paragraph (1), if the Secretary
determines that the modification or elimination of the
requirement of subparagraph (A) or the requirements of
subparagraph (B) is necessary to protect the public health.
(6)(A) Any person may petition the Secretary to exempt a food
ingredient described in section 201(qq)(2) from the allergen
labeling requirements of this subsection.
(B) The Secretary shall approve or deny such petition within
180 days of receipt of the petition or the petition shall be
deemed denied, unless an extension of time is mutually agreed
upon by the Secretary and the petitioner.
(C) The burden shall be on the petitioner to provide
scientific evidence (including the analytical method used to
produce the evidence) that demonstrates that such food
ingredient, as derived by the method specified in the petition,
does not cause an allergic response that poses a risk to human
health.
(D) A determination regarding a petition under this paragraph
shall constitute final agency action.
(E) The Secretary shall promptly post to a public site all
petitions received under this paragraph within 14 days of
receipt and the Secretary shall promptly post the Secretary's
response to each.
(7)(A) A person need not file a petition under paragraph (6)
to exempt a food ingredient described in section 201(qq)(2)
from the allergen labeling requirements of this subsection, if
the person files with the Secretary a notification containing--
(i) scientific evidence (including the analytical
method used) that demonstrates that the food ingredient
(as derived by the method specified in the
notification, where applicable) does not contain
allergenic protein; or
(ii) a determination by the Secretary that the
ingredient does not cause an allergic response that
poses a risk to human health under a premarket approval
or notification program under section 409.
(B) The food ingredient may be introduced or delivered for
introduction into interstate commerce as a food ingredient that
is not a major food allergen 90 days after the date of receipt
of the notification by the Secretary, unless the Secretary
determines within the 90-day period that the notification does
not meet the requirements of this paragraph, or there is
insufficient scientific evidence to determine that the food
ingredient does not contain allergenic protein or does not
cause an allergenic response that poses a risk to human health.
(C) The Secretary shall promptly post to a public site all
notifications received under this subparagraph within 14 days
of receipt and promptly post any objections thereto by the
Secretary.
(x) Notwithstanding subsection (g), (i), or (k), or any other
law, a spice, flavoring, coloring, or incidental additive that
is, or that bears or contains, a food allergen (other than a
major food allergen), as determined by the Secretary by
regulation, shall be disclosed in a manner specified by the
Secretary by regulation.
(y) If it is a dietary supplement that is marketed in the
United States, unless the label of such dietary supplement
includes a domestic address or domestic phone number through
which the responsible person (as described in section 761) may
receive a report of a serious adverse event with such dietary
supplement.
(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. 403A. (a) Except as provided in subsection (b), 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--
(1) any requirement for a food which is the subject
of a standard of identity established under section 401
that is not identical to such standard of identity or
that is not identical to the requirement of section
403(g), except that this paragraph does not apply to a
standard of identity of a State or political
subdivision of a State for maple syrup that is of the
type required by sections 401 and 403(g),
(2) any requirement for the labeling of food of the
type required by section 403(c), 403(e), 403(i)(2),
403(w), or 403(x) that is not identical to the
requirement of such section, except that this paragraph
does not apply to a requirement of a State or political
subdivision of a State that is of the type required by
section 403(c) and that is applicable to maple syrup,
(3) any requirement for the labeling of food of the
type required by section 403(b), 403(d), 403(f),
403(h), 403(i)(1), or 403(k) that is not identical to
the requirement of such section, except that this
paragraph does not apply to a requirement of a State or
political subdivision of a State that is of the type
required by section 403(h)(1) and that is applicable to
maple syrup,
(4) any requirement for nutrition labeling of food
that is not identical to the requirement of section
403(q), except that this paragraph does not apply to
food that is offered for sale in a restaurant or
similar retail food establishment that is not part of a
chain with 20 or more locations doing business under
the same name (regardless of the type of ownership of
the locations) and offering for sale substantially the
same menu items unless such restaurant or similar
retail food establishment complies with the voluntary
provision of nutrition information requirements under
section 403(q)(5)(H)(ix), [or]
(5) any requirement respecting any claim of the type
described in section 403(r)(1) made in the label or
labeling of food that is not identical to the
requirement of section 403(r), except a requirement
respecting a claim made in the label or labeling of
food which is exempt under section 403(r)(5)(B)[.],
(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.
Paragraph (3) shall take effect in accordance with section 6(b)
of the Nutrition Labeling and Education Act of 1990.
(b) Upon petition of a State or a political subdivision of a
State, the Secretary may exempt from subsection (a), under such
conditions as may be prescribed by regulation, any State or
local requirement that--
(1) would not cause any food to be in violation of
any applicable requirement under Federal law,
(2) would not unduly burden interstate commerce, and
(3) is designed to address a particular need for
information which need is not met by the requirements
of the sections referred to in subsection (a).
* * * * * * *
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.
* * * * * * *
----------
PLANT PROTECTION ACT
TITLE II--AGRICULTURAL ASSISTANCE
* * * * * * *
Subtitle E--Nutrition Programs
* * * * * * *
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 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 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 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 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 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
regulatory submission; or
(B) research involving 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 introduction or delivery for
introduction into 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 introduced or
delivered for introduction 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
introduced 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.
* * * * * * *
----------
AGRICULTURAL MARKETING ACT OF 1946
TITLE II
* * * * * * *
Subtitle D--Country of Origin Labeling
* * * * * * *
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
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 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.
(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, 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 produced with 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.
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 without the use
of genetic engineering or a genetically engineered
plant or with 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) 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 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
subject to a civil penalty of not more than $10,000.
(2) Misuse of label.--
(A) In general.--Any person who knowingly
sells or labels any covered product as having
been produced without the use of genetic
engineering or a genetically engineered plant
or with the use of genetic engineering or a
genetically 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 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 without the use of
genetic engineering or a genetically
engineered plant or with 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, requiring 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 without the use of genetic engineering
or a genetically engineered plant or as having
been produced with 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
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, without further appropriation, to carry out
this subtitle.
* * * * * * *
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
DISSENTING VIEWS
Recent polling shows that nine out of ten Americans want
the right to know whether their food has been produced with
genetically modified food ingredients. Vermont, Connecticut and
Maine have acted to give consumers the right to know what is in
their food and how it is grown.
H.R. 1599 would preempt states from labeling GMO foods and
would invalidate existing state laws.
H.R. 1599 would make it virtually impossible for the Food
and Drug Administration to craft a national mandatory GMO
labeling system. It would codify the existing voluntary non-GMO
labeling policy that causes confusion among consumers.
H.R. 1599 also would allow ``natural'' claims on foods with
GMOs, which adds to consumer confusion.
Consumers have the right to know what is in their food and
how it is grown. H.R. 1599 makes it more difficult for
consumers to know that information.
James P. McGovern.
Ann McLane Kuster.
[all]
