S.Amdt. 4948

SA 4948. Mr. SANDERS submitted an amendment intended to be proposed
to amendment SA 4935 proposed by Mr. McConnell (for Mr. Roberts) to the
bill S. 764, to reauthorize and amend the National Sea Grant College
Program Act, and for other purposes; which was ordered to lie on the
table; as follows:

In lieu of the matter proposed to be inserted, insert the
following:

SECTION 1. SHORT TITLE.

This Act may be cited as the ``GMO Labeling Act of 2016''.

SEC. 2. PURPOSES.

The purposes of this Act are to--
(1) establish a system by which people may make informed
decisions about the food they purchase and consume and by
which, if they choose, people may avoid food produced from
genetic engineering;
(2) inform the purchasing decisions of consumers who are
concerned about the potential environmental effects of the
production of food from genetic engineering;
(3) reduce and prevent consumer confusion and deception by
prohibiting the labeling of products produced from genetic
engineering as ``natural'' and by promoting the disclosure of
factual information on food labels to allow consumers to make
informed decisions; and
(4) provide consumers with data from which they may make
informed decisions for religious reasons.

SEC. 3. LABELING REQUIREMENTS.

(a) In General.--Chapter IV of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 341 et seq.) is amended by adding at
the end the following:

``SEC. 424. LABELING OF FOOD PRODUCED WITH GENETIC
ENGINEERING.

``(a) In General.--Except as provided in subsection (d),
any food that is entirely or partially produced with genetic
engineering and offered for retail sale after January 1,
2017, shall be labeled or shall be displayed, as applicable,
in accordance with subsection (b).
``(b) Labeling Requirements.--In the case of a food
described in subsection (a), the manufacturer or retailer
shall ensure that such food is labeled or displayed in
accordance with the following:
``(1) Manufacturers.--
``(A) Raw agricultural commodities.--In the case of a
packaged raw agricultural commodity, the manufacturer shall
label the package offered for retail sale, in a clear and
conspicuous manner, with the words `produced with genetic
engineering'.
``(B) Processed food.--In the case of any processed food
that contains a product or products of genetic engineering,
the manufacturer shall label the package in which the
processed food is offered for sale, in a clear and
conspicuous manner, with the words: `Partially produced with
genetic engineering', `May be produced with genetic
engineering', or `Produced with genetic engineering', as
applicable.
``(2) Retailers.--In the case of any raw agricultural
commodity that is not separately packaged, the retailer shall
post a label appearing on the retail store shelf or bin in
which the commodity is displayed for sale, in a clear and
conspicuous manner, with the words `produced with genetic
engineering'.
``(c) Prohibited Labeling.--Except as provided in
subsection (d), a manufacturer or retailer of a food produced
entirely or in part from genetic engineering shall not label
the product on the package, in signage, or in advertising as
`natural', `naturally made', `naturally grown', `all
natural', or using any words of similar import that would
have a tendency to mislead a consumer.
``(d) Exemptions.--The labeling requirements of subsection
(b) shall not apply with respect to the following:
``(1) Food consisting entirely of, or derived entirely
from, an animal that has not itself been produced with
genetic engineering, regardless of whether the animal has
been fed or injected with any food, drug, or other substance
produced with genetic engineering.
``(2) A raw agricultural commodity or processed food
derived from a raw agricultural commodity that has been
grown, raised, or produced without the knowing or intentional
use of food or seed produced with genetic engineering, except
that the exception described in this paragraph shall apply
only if the person otherwise responsible for complying with
the requirements of subsection (b) with respect to a raw
agricultural commodity or processed food obtains, from
whomever sold the raw agricultural commodity or processed
food to that person, a sworn statement that the raw
agricultural commodity or processed food has not been
knowingly or intentionally produced with genetic engineering
and has been segregated from and has not been knowingly or
intentionally commingled with food that may have been
produced with genetic engineering at any time. In providing
such a sworn statement, any person may rely on a sworn
statement from a direct supplier that contains such an
affirmation.
``(3) Animal feed.
``(4) A processed food that would be subject to such
requirements solely because such food includes one or more
processing aids or enzymes produced with genetic engineering.
``(5) Alcoholic beverages.
``(6) A processed food that would be subject to such
requirements solely because such food includes one or more
materials that have been produced with genetic engineering,
provided that the genetically engineered materials in the
aggregate do not account for more than 0.9 percent of the
total weight of the processed food.
``(7) Food that an independent organization has verified
has not been knowingly or intentionally produced from or
commingled with food or seed produced with genetic
engineering. The Secretary, shall approve, by regulation, any
independent organizations from which verification shall be
acceptable under this paragraph.
``(8) Food that is not packaged for retail sale and that
is--
``(A) a processed food prepared and intended for immediate
human consumption; or
``(B) served, sold, or otherwise provided in a restaurant
or other establishment in which food is served for immediate
human consumption.
``(9) Medical food, as that term is defined in section 5(b)
of the Orphan Drug Act.
``(e) Disclaimer.--The Secretary may, through regulation,
require that labeling required under this section include a
disclaimer that the Food and Drug Administration does not
consider foods produced from genetic engineering to be
materially different from other foods.
``(f) Definitions.--In this section--
``(1) the term `enzyme' means a protein that catalyzes
chemical reactions of other substances without itself being
destroyed or altered upon completion of the reactions;
``(2) the term `genetic engineering' is a process by which
a food is produced from an organism or organisms in which the
genetic material has been changed through the application
of--
``(A) in vitro nucleic acid techniques, including
recombinant deoxyribonucleic acid (DNA) techniques and the
direct injection of nucleic acid into cells or organelles; or
``(B) fusion of cells (including protoplast fusion) or
hybridization techniques that overcome natural physiological,
reproductive, or recombination barriers, where the

[[Page S4832]]

donor cells or protoplasts do not fall within the same
taxonomic group, in a way that does not occur by natural
multiplication or natural recombination;
``(3) the term `in vitro nucleic acid techniques' means
techniques, including recombinant DNA or ribonucleic acid
techniques, that use vector systems and techniques involving
the direct introduction into the organisms of hereditary
materials prepared outside the organisms such as micro-
injection, chemoporation, electroporation, micro-
encapsulation, and liposome fusion;
``(4) the term `organism' means any biological entity
capable of replication, reproduction, or transferring of
genetic material;
``(5) the term `processing aid' means--
``(A) a substance that is added to a food during the
processing of the food but that is removed in some manner
from the food before the food is packaged in its finished
form;
``(B) a substance that is added to a food during
processing, is converted into constituents normally present
in the food, and does not significantly increase the amount
of the constituents naturally found in the food; or
``(C) a substance that is added to a food for its technical
or functional effect in the processing but is present in the
finished food at levels that do not have any technical or
functional effect in that finished food.
``(g) Rules of Construction.--This section shall not be
construed to require--
``(1) the listing or identification of any ingredient or
ingredients that were genetically engineered; or
``(2) the placement of the term `genetically engineered'
immediately preceding any common name or primary product
descriptor of a food.''.
(b) Penalties.--Section 303 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 333) is amended by adding at the end
the following:
``(h)(1) A manufacturer who introduces or delivers for
introduction into interstate commerce any food, the labeling
of which is not in compliance with the applicable
requirements of section 424, or a retailer who sells or
offers for retail sale a food, the display for which is not
in compliance with the applicable requirements of section
424, shall be liable for a civil penalty of not more than
$1,000 per day, for each uniquely named, designated, or
marketed food with respect to which such manufacturer or
retailer is not in compliance. Calculation of the civil
penalty shall not be made or multiplied by the number of
individual packages of the same product introduced or
delivered for introduction into interstate commerce, or
displayed or offered for retail sale.
``(2) A person who knowingly provides a false statement
under section 424(d)(4) that a raw agricultural commodity or
processed food has not been knowingly or intentionally
produced with genetic engineering and has been segregated
from and has not been knowingly or intentionally commingled
with food that may have been produced with genetic
engineering at any time shall be liable for a civil penalty
of not more than $100,000.''.
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