[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 511 Introduced in Senate (IS)]
114th CONGRESS
1st Session
S. 511
To amend the Federal Food, Drug, and Cosmetic Act to require that
genetically engineered food and foods that contain genetically
engineered ingredients be labeled accordingly.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
February 12, 2015
Mrs. Boxer (for herself, Mr. Leahy, Mr. Sanders, Mr. Blumenthal, Mrs.
Feinstein, Mr. Murphy, Mr. Merkley, Ms. Mikulski, Mr. Reed, Mrs.
Shaheen, Mr. Heinrich, Ms. Warren, Mr. Tester, and Mr. Booker)
introduced the following bill; which was read twice and referred to the
Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to require that
genetically engineered food and foods that contain genetically
engineered ingredients be labeled accordingly.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Genetically Engineered Food Right-
to-Know Act''.
SEC. 2. PURPOSE AND FINDINGS.
(a) Purpose.--The purposes of this Act are to--
(1) establish a consistent and enforceable standard for
labeling of foods produced using genetic engineering, thereby
providing consumers with knowledge of how their food is
produced; and
(2) 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.
(b) Findings.--Congress finds that--
(1) the process of genetically engineering food organisms
results in material changes and the fact that foods are
genetically engineered is of material importance to consumers;
(2) the Food and Drug Administration requires the labeling
of more than 3,000 ingredients, additives, and processes;
(3) individuals in the United States have a right to know
if their food was produced with genetic engineering for a
variety of reasons, including health, economic, environmental,
religious, and ethical;
(4) more than 60 countries, including the United Kingdom
and all other countries of the European Union, South Korea,
Japan, Brazil, Australia, India, China, and other key United
States trading partners have laws or regulations mandating
disclosure of genetically engineered food on food labels;
(5) in 2011, Codex Alimentarius, the food standards
organization of the United Nations, adopted a text that
indicates that governments can decide on whether and how to
label foods produced with genetic engineering;
(6) mandatory identification of food produced with genetic
engineering can be a critical method of preserving the economic
value of exports or domestically sensitive markets with
labeling requirements for genetically engineered foods; and
(7) the cultivation of genetically engineered crops can
have adverse effects on the environment in the form of cross-
pollination of native plants, increased herbicide usage, and
impacts on non-target and beneficial organisms, including the
Monarch butterfly.
SEC. 3. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.
(a) In General.--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 it is a food that has been genetically engineered or
contains 1 or more genetically engineered ingredients, unless the
ingredients label clearly states that the food has been genetically
engineered or identifies any genetically engineered ingredients, as
applicable.
``(2) This paragraph does not apply to food that--
``(A) is served in restaurants or other similar eating
establishments, such as cafeterias and carryouts;
``(B) is a medical food (as defined in section 5(b) of the
Orphan Drug Act);
``(C) would be subject to this paragraph solely because it
was produced using a genetically engineered vaccine or drug;
``(D) is a food or processed food that would be subject to
this paragraph solely because it includes the use of a
genetically engineered processing aid (including yeast) or
enzyme; or
``(E) is a packaged food consisting of materials produced
through genetic engineering that do not account for more than
nine-tenths of 1 percent of the total weight of the packaged
food.
``(3) In this paragraph and in paragraph (aa):
``(A) The term `genetic engineering' means a process--
``(i) involving the application of in vitro nucleic
acid techniques, including recombinant deoxyribonucleic
acid (DNA) and direct injection of nucleic acid into
cells or organelles;
``(ii) involving the application of fusion of cells
beyond the taxonomic family; or
``(iii) that overcomes natural physiological,
reproductive, or recombinant barriers and that is not a
process used in traditional breeding and selection.
``(B) The term `genetically engineered', used with respect
to a food, means a material intended for human consumption that
is--
``(i) an organism that is produced through the
intentional use of genetic engineering; or
``(ii) the progeny of intended sexual or asexual
reproduction (or both) of 1 or more organisms that is
the product of genetic engineering.
``(C) The term `genetically engineered ingredient' means a
material that is an ingredient in a food that is derived from
any part of an organism that has been genetically engineered,
without regard to whether--
``(i) the altered molecular or cellular
characteristics of the organism are detectable in the
material; and
``(ii) the organism is capable for use as human
food.''.
(b) Restrictions on the Term ``Natural''.--Section 403 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343), as amended by
subsection (a), is further amended by adding at the end the following:
``(aa) If it is a food intended for human consumption that has been
produced using genetic engineering or that contains one or more
genetically engineered ingredients and it bears a label, or for which
there is signage or advertising, containing a claim that the food is
`natural', `naturally made', `naturally grown', `all natural', or using
any similar words that would be misleading to a consumer.''.
(c) Guaranty.--
(1) In general.--Section 303(d) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 333(d)) is amended--
(A) by striking ``(d)'' and inserting ``(d)(1)'';
and
(B) by adding at the end the following:
``(2)(A) No person shall be subject to the penalties of
subsection (a)(1) for a violation of subsection (a), (b), or
(c) of section 301 involving food that is misbranded within the
meaning of paragraph (z) or (aa) of section 403 if such person
(referred to in this paragraph as the `recipient') establishes
a guaranty or undertaking that--
``(i) is signed by, and contains the name and
address of, a person residing in the United States from
whom the recipient received in good faith the food
(including the receipt of seeds to grow raw
agricultural commodities); and
``(ii) contains a statement to the effect that the
food is not genetically engineered or does not contain
a genetically engineered ingredient.
``(B) In the case of a recipient who, with respect to a
food, establishes a guaranty or undertaking in accordance with
subparagraph (A), the exclusion under such subparagraph from
being subject to penalties applies to the recipient without
regard to the manner in which the recipient uses the food,
including whether the recipient is--
``(i) processing the food;
``(ii) using the food as an ingredient in a food
product;
``(iii) repacking the food; or
``(iv) growing, raising, or otherwise producing the
food.
``(C) No person may avoid responsibility or liability for a
violation of subsection (a), (b), or (c) of section 301
involving food that is misbranded within the meaning of
paragraph (z) or (aa) of section 403 by entering into a
contract or other agreement that specifies that another person
shall bear such responsibility or liability, except that a
recipient may require a guaranty or undertaking as described in
this subsection.
``(D) For purposes of this Act, food will be considered not
to have been produced with the knowing or intentional use of
genetic engineering if--
``(i) such food is lawfully certified to be
labeled, marketed, and offered for sale as `organic'
pursuant to the Organic Foods Production Act of 1990;
or
``(ii) an independent organization has determined
that the food has not been knowingly or intentionally
genetically engineered and has been segregated from,
and not knowingly or intentionally commingled with,
foods that may have been genetically engineered at any
time, if such a determination has been made pursuant to
a sampling and testing procedure that--
``(I) is consistent with sampling and
testing principles recommended by
internationally recognized standards
organizations; and
``(II) does not rely on testing processed
foods in which no DNA is detectable.
``(E) In this subsection, the terms `genetically
engineered' and `genetically engineered ingredient' have the
meanings given the terms in section 403(z).''.
(2) False guaranty.--Section 301(h) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331(h)) is amended by
inserting ``or 303(d)(2)'' after ``section 303(c)(2)''.
(d) Unintended Contamination.--Section 303(d) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 333(d)), as amended by subsection
(b), is further amended by adding at the end the following:
``(3)(A) No person shall be subject to the penalties of
subsection (a)(1) for a violation of subsection (a), (b), or
(c) of section 301 involving food that is misbranded within the
meaning of section 403(z) if--
``(i) such person is an agricultural producer and
the violation occurs because food that is grown,
raised, or otherwise produced by such producer, which
food does not contain a genetically engineered material
and was not produced with a genetically engineered
material, is contaminated with a food that contains a
genetically engineered material or was produced with a
genetically engineered material; and
``(ii) such contamination is not intended by the
agricultural producer.
``(B) Subparagraph (A) does not apply to an agricultural
producer to the extent that the contamination occurs as a
result of the negligence of the producer.''.
(e) Promulgation of Regulations.--Not later than 1 year after the
date of enactment of this Act, the Secretary shall promulgate proposed
regulations establishing labeling requirements for compliance in
accordance with section 403(z) of the Federal Food, Drug, and Cosmetic
Act, as added by subsection (a).
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