In the nature of a substitute.

SA 3450. Mr. McCONNELL (for Mr. Roberts) proposed an amendment to the
bill S. 764, to reauthorize and amend the National Sea Grant College
Program Act, and for other purposes; as follows:

Strike all after the enacting clause and insert the
following.
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,

SECTION 1. NATIONAL VOLUNTARY BIOENGINEERED FOOD LABELING
STANDARD.

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 Voluntary Bioengineered Food Labeling Standard

``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' has the meaning given the term
in section 201 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321).
``(3) Secretary.--The term `Secretary' means the Secretary
of Agriculture.

``SEC. 292. APPLICABILITY.

``This subtitle shall apply to any claim in the labeling of
food that indicates, directly or indirectly, that the food is
a bioengineered food or bioengineering was used in the
development or production of the food, including a claim that
a food is or contains an ingredient that was developed or
produced using bioengineering.

``SEC. 293. ESTABLISHMENT OF NATIONAL VOLUNTARY BIOENGINEERED
FOOD LABELING STANDARD.

``(a) Establishment of Standard.--Not later than 1 year
after the date of enactment of this subtitle, the Secretary
shall--
``(1) establish a national voluntary bioengineered food
labeling standard with respect to--
``(A) any bioengineered food; and
``(B) any food that may be bioengineered or may have been
produced or developed using bioengineering; and

[[Page S1468]]

``(2) establish such requirements and procedures as the
Secretary determines necessary to carry out the standard.
``(b) Regulations.--
``(1) In general.--A food may be labeled as 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 any express or implied claim that a food is
or is not safer or of higher quality solely based on whether
the food is or is not--
``(i) bioengineered; or
``(ii) produced or developed with the use of
bioengineering;
``(B) determine the amounts of a bioengineered substance
that may be present in food, as appropriate, in order for the
food to be labeled as 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 may be labeled as a
bioengineered food; and
``(D) require that, if a food is voluntarily labeled under
this section through means of scannable images or codes or
other similar technologies--
``(i) the label clearly indicates to consumers that more
information is available about the ingredients of the food;
and
``(ii) the scannable image, code, or similar technology
provides direct access to information regarding whether the
food is bioengineered or whether bioengineering was used in
the development or production of the food.
``(c) 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
bioengineered food labeling standard under this section that
is not identical to that voluntary standard.
``(d) Consistency With Certain Laws.--To the maximum extent
practicable, the Secretary shall establish consistency
between--
``(1) the national voluntary bioengineered food labeling
standard established under this section; and
``(2) the Organic Foods Production Act of 1990 (7 U.S.C.
6501 et seq.).

``SEC. 294. RULEMAKING ON SUBSTANTIAL PARTICIPATION.

``(a) Definition of Labeled Food.--In this section, the
term `labeled food' means food that bears, or to which is
attached, any written, printed, or graphic matter, including
on the immediate container or on the package of the food.
``(b) Rulemaking.--Not later than 1 year after the date of
enactment of this subtitle, the Secretary shall promulgate
regulations defining the circumstances that constitute
substantial participation by labeled foods with voluntary
disclosures of whether a food is, is not, or may be
bioengineered or whether bioengineering was, was not, or may
have been used in the development or production of the food.
``(c) Consideration.--In promulgating regulations under
subsection (b), the Secretary shall consider--
``(1) the percentage of the labeled foods consumed by
consumers that disclose whether the food is, is not, or may
be bioengineered or whether bioengineering was, was not, or
may have been used in the development or production of the
food; and
``(2) the extent to which there is clear indication in a
usual and customary form that information is available for
the most frequently consumed labeled foods or direct access
to disclosures for the most frequently consumed labeled
foods, including through means that are clear and direct
other than the label or labeling, such as responses to
consumer inquiries through call centers, the Internet,
websites, social media, scannable images or codes or other
similar technologies that would allow consumers to access the
information, or any other means the Secretary considers
appropriate for disclosing the bioengineered content of food.
``(d) Requirement.--In promulgating regulations under
subsection (b), the Secretary shall define the term `most
frequently consumed labeled foods'.

``SEC. 294A. NATIONAL MANDATORY BIOENGINEERED FOOD LABELING
STANDARD.

``(a) Requirement for Establishment of Mandatory
Standard.--
``(1) In general.--The mandatory standard under subsection
(b) shall be established only if the Secretary determines
there is not substantial participation as determined in
accordance with section 294(b).
``(2) Deadline.--The Secretary shall make the determination
as described in paragraph (1) not earlier than the date that
is 2 years after the date on which the Secretary has
promulgated regulations under each of sections 293 and
294(b).
``(3) Initiation.--If the Secretary determines that there
is not at least 70 percent substantial participation as
determined in accordance with section 294(b), the Secretary
shall promulgate regulations to establish a mandatory
standard in accordance with this section.
``(b) Establishment of Mandatory Standard.--If the
Secretary determines that there is not substantial
participation as described in subsection (a), the Secretary
shall--
``(1) establish a national mandatory bioengineered food
labeling standard with respect to--
``(A) bioengineered food; and
``(B) food that may be bioengineered or may have been
produced or developed using bioengineering; and
``(2) establish such requirements and procedures as the
Secretary determines necessary to carry out the standard.
``(c) Regulations.--
``(1) In general.--If the Secretary establishes a mandatory
standard under subsection (b), a food may be labeled as
bioengineered only in accordance with regulations promulgated
by the Secretary in accordance with this section.
``(2) Requirements.--A regulation promulgated by the
Secretary in carrying out this section shall--
``(A) prohibit any express or implied claim that a food is
or is not safer or of higher quality solely based on whether
the food is or is not--
``(i) bioengineered; or
``(ii) produced or developed with the use of
bioengineering;
``(B) determine the amounts of a bioengineered substance
that may be present in food, as appropriate, in order for the
food to be labeled as 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 may be labeled as a
bioengineered food;
``(D) exclude food served in a restaurant or similar
establishment; and
``(E) require an appropriate person (as determined by the
Secretary) to disclose food that is subject to the mandatory
standard either through--
``(i) a statement made on the food label or labeling; or
``(ii) means other than the label or labeling, including
responses to consumer inquiries through call centers, the
Internet, websites, social media, scannable images or codes
or other similar technologies that would allow consumers to
access the information, or any other means the Secretary
considers appropriate for disclosing the bioengineered
content of food.
``(3) Implementation.--The implementation date for
regulations promulgated in accordance with this section shall
be not earlier than 2 years after the later of--
``(A) the date on which the Secretary promulgates the final
regulations under this section; or
``(B) the date on which the Secretary makes a determination
under subsection (a)(1).
``(d) 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
bioengineered food labeling standard under this section that
is not identical to the mandatory labeling requirement under
this section.
``(e) 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
labeling 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
before an administrative law judge on the results of any
examination, audit, or similar activity.
``(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 is labeled as bioengineered or
developed or produced using bioengineering.

``SEC. 294B. SAVINGS PROVISIONS.

``(a) Trade.--This subtitle shall be applied in a manner
consistent with United States obligations under international
agreements.
``(b) Other.--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.).

``Subtitle F--Labeling of Certain Food

``SEC. 295. FEDERAL PREEMPTION.

``(a) Definition of Food.--In this subtitle, the term
`food' has the meaning given the

[[Page S1469]]

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.''.

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