P.L. 114-216 Bioengineered Food Disclosure Standard

PUBLIC LAW 114–216—JULY 29, 2016

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NATIONAL BIOENGINEERED FOOD
DISCLOSURE STANDARD

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130 STAT. 834

PUBLIC LAW 114–216—JULY 29, 2016

Public Law 114–216
114th Congress
An Act
July 29, 2016
[S. 764]

To reauthorize and amend the National Sea Grant College Program Act, and for
other purposes.

Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION

1.

NATIONAL
STANDARD.

BIOENGINEERED

FOOD

DISCLOSURE

The Agricultural Marketing Act of 1946 (7 U.S.C. 1621 et
seq.) is amended by adding at the end the following:

‘‘Subtitle E—National Bioengineered Food
Disclosure Standard
7 USC 1639.

‘‘SEC. 291. DEFINITIONS.

‘‘In this subtitle:
‘‘(1) BIOENGINEERING.—The term ‘bioengineering’, and any
similar term, as determined by the Secretary, with respect
to a food, refers to a food—
‘‘(A) that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid
(DNA) techniques; and
‘‘(B) for which the modification could not otherwise
be obtained through conventional breeding or found in
nature.
‘‘(2) FOOD.—The term ‘food’ means a food (as defined in
section 201 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321)) that is intended for human consumption.
‘‘(3) SECRETARY.—The term ‘Secretary’ means the Secretary
of Agriculture.

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7 USC 1639a.

‘‘SEC. 292. APPLICABILITY.

‘‘(a) IN GENERAL.—This subtitle shall apply to any claim in
a disclosure that a food bears that indicates that the food is a
bioengineered food.
‘‘(b) APPLICATION OF DEFINITION.—The definition of the term
‘bioengineering’ under section 291 shall not affect any other definition, program, rule, or regulation of the Federal Government.
‘‘(c) APPLICATION TO FOODS.—This subtitle shall apply only
to a food subject to—
‘‘(1) the labeling requirements under the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); or
‘‘(2) the labeling requirements under the Federal Meat
Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products

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130 STAT. 835

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Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products
Inspection Act (21 U.S.C. 1031 et seq.) only if—
‘‘(A) the most predominant ingredient of the food would
independently be subject to the labeling requirements
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.); or
‘‘(B)(i) the most predominant ingredient of the food
is broth, stock, water, or a similar solution; and
‘‘(ii) the second-most predominant ingredient of the
food would independently be subject to the labeling requirements under the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301 et seq.).

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‘‘SEC. 293. ESTABLISHMENT OF NATIONAL BIOENGINEERED FOOD
DISCLOSURE STANDARD.

7 USC 1639b.

‘‘(a) ESTABLISHMENT OF MANDATORY STANDARD.—Not later than
2 years after the date of enactment of this subtitle, the Secretary
shall—
‘‘(1) establish a national mandatory bioengineered food
disclosure standard with respect to any bioengineered food and
any food that may be bioengineered; and
‘‘(2) establish such requirements and procedures as the
Secretary determines necessary to carry out the standard.
‘‘(b) REGULATIONS.—
‘‘(1) IN GENERAL.—A food may bear a disclosure that the
food is bioengineered only in accordance with regulations
promulgated by the Secretary in accordance with this subtitle.
‘‘(2) REQUIREMENTS.—A regulation promulgated by the Secretary in carrying out this subtitle shall—
‘‘(A) prohibit a food derived from an animal to be
considered a bioengineered food solely because the animal
consumed feed produced from, containing, or consisting
of a bioengineered substance;
‘‘(B) determine the amounts of a bioengineered substance that may be present in food, as appropriate, in
order for the food to be a bioengineered food;
‘‘(C) establish a process for requesting and granting
a determination by the Secretary regarding other factors
and conditions under which a food is considered a bioengineered food;
‘‘(D) in accordance with subsection (d), require that
the form of a food disclosure under this section be a text,
symbol, or electronic or digital link, but excluding Internet
website Uniform Resource Locators not embedded in the
link, with the disclosure option to be selected by the food
manufacturer;
‘‘(E) provide alternative reasonable disclosure options
for food contained in small or very small packages;
‘‘(F) in the case of small food manufacturers, provide—
‘‘(i) an implementation date that is not earlier
than 1 year after the implementation date for regulations promulgated in accordance with this section; and
‘‘(ii) on-package disclosure options, in addition to
those available under subparagraph (D), to be selected
by the small food manufacturer, that consist of—
‘‘(I) a telephone number accompanied by
appropriate language to indicate that the phone

Deadline.

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Requirements.
Procedures.

Determination.

Implementation
date.
Time period.

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130 STAT. 836

Web site.

Deadline.

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Determination.
Consultation.

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PUBLIC LAW 114–216—JULY 29, 2016

number provides access to additional information;
and
‘‘(II) an Internet website maintained by the
small food manufacturer in a manner consistent
with subsection (d), as appropriate; and
‘‘(G) exclude—
‘‘(i) food served in a restaurant or similar retail
food establishment; and
‘‘(ii) very small food manufacturers.
‘‘(3) SAFETY.—For the purpose of regulations promulgated
and food disclosures made pursuant to paragraph (2), a bioengineered food that has successfully completed the pre-market
Federal regulatory review process shall not be treated as safer
than, or not as safe as, a non-bioengineered counterpart of
the food solely because the food is bioengineered or produced
or developed with the use of bioengineering.
‘‘(c) STUDY OF ELECTRONIC OR DIGITAL LINK DISCLOSURE.—
‘‘(1) IN GENERAL.—Not later than 1 year after the date
of enactment of this subtitle, the Secretary shall conduct a
study to identify potential technological challenges that may
impact whether consumers would have access to the bioengineering disclosure through electronic or digital disclosure
methods.
‘‘(2) PUBLIC COMMENTS.—In conducting the study under
paragraph (1), the Secretary shall solicit and consider comments
from the public.
‘‘(3) FACTORS.—The study conducted under paragraph (1)
shall consider whether consumer access to the bioengineering
disclosure through electronic or digital disclosure methods
under this subtitle would be affected by the following factors:
‘‘(A) The availability of wireless Internet or cellular
networks.
‘‘(B) The availability of landline telephones in stores.
‘‘(C) Challenges facing small retailers and rural
retailers.
‘‘(D) The efforts that retailers and other entities have
taken to address potential technology and infrastructure
challenges.
‘‘(E) The costs and benefits of installing in retail stores
electronic or digital link scanners or other evolving technology that provide bioengineering disclosure information.
‘‘(4) ADDITIONAL DISCLOSURE OPTIONS.—If the Secretary
determines in the study conducted under paragraph (1) that
consumers, while shopping, would not have sufficient access
to the bioengineering disclosure through electronic or digital
disclosure methods, the Secretary, after consultation with food
retailers and manufacturers, shall provide additional and comparable options to access the bioengineering disclosure.
‘‘(d) DISCLOSURE.—In promulgating regulations under this section, the Secretary shall ensure that—
‘‘(1) on-package language accompanies—
‘‘(A) the electronic or digital link disclosure, indicating
that the electronic or digital link will provide access to
an Internet website or other landing page by stating only
‘Scan here for more food information’, or equivalent language that only reflects technological changes; or

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130 STAT. 837

‘‘(B) any telephone number disclosure, indicating that
the telephone number will provide access to additional
information by stating only ‘Call for more food information.’;
‘‘(2) the electronic or digital link will provide access to
the bioengineering disclosure located, in a consistent and conspicuous manner, on the first product information page that
appears for the product on a mobile device, Internet website,
or other landing page, which shall exclude marketing and promotional information;
‘‘(3)(A) the electronic or digital link disclosure may not
collect, analyze, or sell any personally identifiable information
about consumers or the devices of consumers; but
‘‘(B) if information described in subparagraph (A) must
be collected to carry out the purposes of this subtitle, that
information shall be deleted immediately and not used for
any other purpose;
‘‘(4) the electronic or digital link disclosure also includes
a telephone number that provides access to the bioengineering
disclosure; and
‘‘(5) the electronic or digital link disclosure is of sufficient
size to be easily and effectively scanned or read by a digital
device.
‘‘(e) STATE FOOD LABELING STANDARDS.—Notwithstanding section 295, 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 relating
to the labeling or disclosure of whether a food is bioengineered
or was developed or produced using bioengineering for a food that
is the subject of the national bioengineered food disclosure standard
under this section that is not identical to the mandatory disclosure
requirement under that standard.
‘‘(f) CONSISTENCY WITH CERTAIN LAWS.—The Secretary shall
consider establishing consistency between—
‘‘(1) the national bioengineered food disclosure standard
established under this section; and
‘‘(2) the Organic Foods Production Act of 1990 (7 U.S.C.
6501 et seq.) and any rules or regulations implementing that
Act.
‘‘(g) ENFORCEMENT.—
‘‘(1) PROHIBITED ACT.—It shall be a prohibited act for a
person to knowingly fail to make a disclosure as required
under this section.
‘‘(2) RECORDKEEPING.—Each person subject to the mandatory disclosure requirement under this section shall maintain,
and make available to the Secretary, on request, such records
as the Secretary determines to be customary or reasonable
in the food industry, by regulation, to establish compliance
with this section.
‘‘(3) EXAMINATION AND AUDIT.—
‘‘(A) IN GENERAL.—The Secretary may conduct an
examination, audit, or similar activity with respect to any
records required under paragraph (2).
‘‘(B) NOTICE AND HEARING.—A person subject to an
examination, audit, or similar activity under subparagraph
(A) shall be provided notice and opportunity for a hearing
on the results of any examination, audit, or similar activity.

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130 STAT. 838

PUBLIC LAW 114–216—JULY 29, 2016
‘‘(C) AUDIT RESULTS.—After the notice and opportunity
for a hearing under subparagraph (B), the Secretary shall
make public the summary of any examination, audit, or
similar activity under subparagraph (A).
‘‘(4) RECALL AUTHORITY.—The Secretary shall have no
authority to recall any food subject to this subtitle on the
basis of whether the food bears a disclosure that the food
is bioengineered.

7 USC 1639c.

‘‘SEC. 294. SAVINGS PROVISIONS.

Applicability.

‘‘(a) TRADE.—This subtitle shall be applied in a manner consistent with United States obligations under international agreements.
‘‘(b) OTHER AUTHORITIES.—Nothing in this subtitle—
‘‘(1) affects the authority of the Secretary of Health and
Human Services or creates any rights or obligations for any
person under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.); or
‘‘(2) affects the authority of the Secretary of the Treasury
or creates any rights or obligations for any person under the
Federal Alcohol Administration Act (27 U.S.C. 201 et seq.).
‘‘(c) OTHER.—A food may not be considered to be ‘not bioengineered’, ‘non-GMO’, or any other similar claim describing the
absence of bioengineering in the food solely because the food is
not required to bear a disclosure that the food is bioengineered
under this subtitle.

‘‘Subtitle F—Labeling of Certain Food
7 USC 1639i.

‘‘SEC. 295. FEDERAL PREEMPTION.

‘‘(a) DEFINITION OF FOOD.—In this subtitle, the term ‘food’
has the meaning given the term in section 201 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321).
‘‘(b) FEDERAL PREEMPTION.—No State or a political subdivision
of a State may directly or indirectly establish under any authority
or continue in effect as to any food or seed in interstate commerce
any requirement relating to the labeling of whether a food (including
food served in a restaurant or similar establishment) or seed is
genetically engineered (which shall include such other similar terms
as determined by the Secretary of Agriculture) or was developed
or produced using genetic engineering, including any requirement
for claims that a food or seed is or contains an ingredient that
was developed or produced using genetic engineering.
7 USC 1639j.

‘‘SEC. 296. EXCLUSION FROM FEDERAL PREEMPTION.

‘‘Nothing in this subtitle, subtitle E, or any regulation, rule,
or requirement promulgated in accordance with this subtitle or
subtitle E shall be construed to preempt any remedy created by
a State or Federal statutory or common law right.’’.

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Claims.
7 USC 6524.

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SEC. 2. ORGANICALLY PRODUCED FOOD.

In the case of a food certified under the national organic program established under the Organic Foods Production Act of 1990
(7 U.S.C. 6501 et seq.), the certification shall be considered sufficient
to make a claim regarding the absence of bioengineering in the

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food, such as ‘‘not bioengineered’’, ‘‘non-GMO’’, or another similar
claim.

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Approved July 29, 2016.

LEGISLATIVE HISTORY—S. 764:
SENATE REPORTS: No. 114–90 (Comm. on Commerce, Science, and Transportation).
CONGRESSIONAL RECORD:
Vol. 161 (2015): July 28, considered and passed Senate.
Sept. 18, considered and passed House, amended, pursuant to
H. Res. 421.
Vol. 162 (2016): Mar. 14–16, June 29, July 6, 7, Senate considered and
concurred in House amendment with an amendment.
July 14, House concurred in Senate amendment.

Æ

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