Safe and Accurate Food Labeling Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act to establish premarket notification requirements for a bioengineered organism intended for a food use or application. Defines “bioengineered organism” to mean a plant or any part of a plant which contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques when such modification could not otherwise be obtained using conventional breeding techniques.
Sets forth exceptions if: (1) the bioengineered organism is used for development or testing conducted to generate data and information that could be used in a premarket biotechnology notification or other regulatory submission; (2) a processing aid or enzyme produced from the bioengineered organism is intended to be used to produce food; or (3) food produced from, containing, or consisting of the bioengineered organism is intended to be fed to an animal from which food is intended to be produced or derived.
Directs the developer of a bioengineered organism to submit a premarket biotechnology notification to the Secretary of Health and Human Services (HHS) at least 210 days before the organism is first introduced into interstate commerce for a food use or application. Requires such notification to include: (1) the basis for the determination that food produced from, containing, or consisting of that bioengineered organism is as safe for use by humans or animals as comparable marketed foods without the bioengineered organism, and (2) whether any other federal agency is conducting or has conducted any review of the bioengineered organism and the status or conclusions of any such review. Requires the Secretary to determine whether such food is as safe as food made without the bioengineered organism. Requires public disclosure of the premarket notification.
Authorizes the Secretary to require the label of such food to disclose a material difference between food produced from, containing, or consisting of a bioengineered organism and its comparable marketed food, as necessary to protect health and safety or to prevent the label or labeling of such food from being false or misleading.
Makes these requirements applicable 30 days after enactment of this Act, regardless of whether relevant regulations or guidance have been finalized or issued.
Preempts any state or local requirement respecting a bioengineered organism intended for a food use or application, or food produced from, containing, or consisting of a bioengineered organism.
Sets forth standards for any food label that contains claims that bioengineering was or was not used in the production of the food. Preempts any state and local labeling requirements with respect to bioengineered food.
Requires the Secretary to issue regulations setting standards for a natural claim on food labels. Preempts any state or local regulations that are not identical to the requirements of this Act.
[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4432 Introduced in House (IH)]
113th CONGRESS
2d Session
H. R. 4432
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.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
April 9, 2014
Mr. Pompeo (for himself, Mr. Butterfield, Mr. Matheson, Mrs. Blackburn,
and Mr. Whitfield) introduced the following bill; which was referred to
the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
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.
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 ``Safe and Accurate Food Labeling Act
of 2014''.
SEC. 2. TABLE OF CONTENTS.
The table of contents of this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Ensuring safety of food supply.
TITLE I--FOOD PRODUCED FROM, CONTAINING, OR CONSISTING OF A
BIOENGINEERED ORGANISM
Sec. 101. Definitions.
Sec. 102. Mandatory premarket biotechnology notification program.
Sec. 103. Labeling of whether food is bioengineered.
Sec. 104. Preemption.
TITLE II--NATURAL FOODS
Sec. 201. Labeling of natural foods.
Sec. 202. Regulations.
Sec. 203. Preemption.
Sec. 204. Effective date.
SEC. 3. ENSURING SAFETY OF FOOD SUPPLY.
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 the Food and Drug
Administration to ensure the safety of the food supply under the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
TITLE I--FOOD PRODUCED FROM, CONTAINING, OR CONSISTING OF A
BIOENGINEERED ORGANISM
SEC. 101. DEFINITIONS.
Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321) is amended by adding at the end the following:
``(ss) The term `bioengineered organism' refers to an organism if--
``(1) the organism is a plant (or a seed, a fruit, or any
other part thereof);
``(2) the organism contains genetic material that has been
modified through in vitro recombinant deoxyribonucleic acid
(DNA) techniques; and
``(3) the modification could not otherwise be obtained
using conventional breeding techniques.''.
SEC. 102. MANDATORY PREMARKET BIOTECHNOLOGY NOTIFICATION PROGRAM.
(a) Prohibited Act.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the
following:
``(ddd) The initial introduction or delivery for introduction in
interstate commerce of a bioengineered organism intended for a food use
or application, unless the developer of the organism has complied with
the notification requirements, to the extent applicable, under section
424.''.
(b) Notification Program.--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. NOTIFICATION RELATING TO CERTAIN BIOENGINEERED ORGANISMS.
``(a) In General.--A bioengineered organism shall not be introduced
or delivered for introduction into interstate commerce for a food use
or application unless--
``(1) the use or application of the bioengineered organism
in food has been addressed by the developer of the
bioengineered organism in a premarket biotechnology
notification, to which the Secretary has responded under
subsection (d)(2)(A) by stating no objections; or
``(2)(A) food produced from, containing, or consisting of
the bioengineered organism was evaluated by the Secretary
pursuant to the Food and Drug Administration's voluntary
consultation process for foods and food products from
genetically engineered plants in effect prior to the date of
enactment of the Safe and Accurate Food Labeling Act of 2014;
and
``(B) the Secretary informed the developer of the
bioengineered organism that all questions about safety have
been resolved.
``(b) Exceptions.--This section does not apply with respect to the
introduction or delivery for introduction into interstate commerce of a
bioengineered organism--
``(1) for the purpose of development or testing conducted
to generate data and information that could be used in a
premarket biotechnology notification or other regulatory
submission; or
``(2) solely because--
``(A) a processing aid or enzyme produced from the
bioengineered organism is intended to be used to
produce food; or
``(B) food produced from, containing, or consisting
of the bioengineered organism is intended to be fed to
an animal from which food is intended to be produced or
derived.
``(c) Premarket Biotechnology Notification.--
``(1) Submission.--At least 210 days before a bioengineered
organism is first introduced or delivered for introduction into
interstate commerce for a food use or application, a premarket
biotechnology notification shall be submitted to the Secretary
by the developer of the bioengineered organism. Such
notification shall provide--
``(A) the basis for the notifier's determination
that food produced from, containing, or consisting of
such bioengineered organism is as safe for use by
humans or animals, as applicable, as one or more
comparable marketed foods that are not produced from,
do not contain, or do not consist of such bioengineered
organism; and
``(B) whether any other Federal agency is
conducting or has conducted any review of the
bioengineered organism and the status or conclusions of
any such review.
``(2) Consultation prior to submission.--A prospective
notifier may consult informally with the Secretary concerning a
bioengineered organism intended for a food use or application
before submitting a premarket biotechnology notification.
``(d) Response to a Premarket Biotechnology Notification.--
``(1) Preliminary response.--Within 30 days of receipt of a
premarket biotechnology notification, the Secretary shall--
``(A) inform the notifier in writing that the
notification is complete and has been filed; or
``(B) inform the notifier in writing of any missing
elements that prevent the Secretary from filing and
reviewing the notification.
The Secretary shall limit any request under subparagraph (B) to
data or information necessary to perform the evaluation
specified in paragraph (2) and shall not delay informing the
notifier under paragraph (1)(A) for any other purpose.
``(2) Substantive response.--Within 180 days of the
Secretary informing the notifier under paragraph (1)(A) that
the premarket biotechnology notification is complete, the
Secretary--
``(A) shall respond in writing to the notifier that
the Secretary has evaluated the notification and has no
objections to the notifier's determination that food
produced from, containing, or consisting of the
bioengineered organism that is the subject of the
notification is as safe for use by humans or animals,
as applicable, as one or more comparable marketed foods
that are not produced from, do not contain, or do not
consist of such bioengineered organism; or
``(B) shall--
``(i) respond in writing to the notifier
that the Secretary has evaluated the
notification and has determined the
notification does not provide an adequate basis
for the notifier's determination; and
``(ii) include in such response the
Secretary's basis for the Secretary's
determination.
``(3) Withdrawal by notifier.--At any point before
receiving a written response from the Secretary under
subparagraph (A) or (B) of paragraph (2), the notifier may
withdraw a premarket biotechnology notification without
prejudice as to any future notifications.
``(4) Effective date.--A notification submitted under
subsection (c) shall become effective on the date that is 180
days after the Secretary informs the notifier under paragraph
(1)(A) that the notification is complete, and as of such date
the bioengineered organism that is the subject of the
notification may be introduced or delivered for introduction
into interstate commerce, unless the Secretary provides a
response under paragraph (2)(B).
``(e) Labeling.--If the Secretary determines that there is a
material difference between a food produced from, containing, or
consisting of a bioengineered organism and its comparable marketed food
and that disclosure of such difference is necessary to protect health
and safety or to prevent the label or labeling of such food from being
false or misleading, the Secretary may, in a response under subsection
(d)(2)(A), specify labeling that would adequately inform consumers of
such material difference. The use of bioengineering does not, by
itself, constitute a material difference.
``(f) Public Disclosure.--The existence and contents of a premarket
biotechnology notification shall be made available to the public as of
the date the Secretary issues a written response under subsection
(d)(2)(A), subject to review by the Secretary pursuant to the
provisions on exemptions from disclosure under chapter 5 of title 5,
United States Code.
``(g) Definitions.--In this section:
``(1)(A) The term `comparable marketed food' means, with
respect to the food produced from, containing, or consisting of
a plant that is a bioengineered organism--
``(i) the parental variety of the plant;
``(ii) another commonly consumed variety of the
plant; or
``(iii) a plant variety from which is derived a
commonly consumed food with properties comparable to
the food produced from, containing, or consisting of
the plant that is a bioengineered organism.
``(B) A food produced from, containing, or consisting of a
bioengineered organism may have more than one comparable
marketed food.
``(2) The term `notifier' means the person who submits a
premarket biotechnology notification.
``(3) The term `premarket biotechnology notification'--
``(A) means a submission to the Secretary under
subsection (c); and
``(B) includes all scientific data and other
information in the original submission and in any
amendments to the original submission.
``(4) The term `material difference' means a difference
that--
``(A) significantly alters the characteristics,
including the functional or compositional
characteristics, of a food, such that the common or
usual name no longer adequately describes the food;
``(B) results in a significantly different
nutritional property in the food produced from,
containing, or consisting of the bioengineered
organism; or
``(C) results in the food containing an allergen
that consumers would not expect to be present based
upon the name of the food.''.
(c) Applicability.--The amendments made by this section apply
beginning on the date that is 30 days after the date of enactment of
this Act, irrespective of whether regulations or guidance have been
finalized or issued by such date to carry out such amendments.
(d) Pending Submissions.--The Secretary shall--
(1) deem to be a premarket biotechnology notification under
section 424 of the Federal Food, Drug, and Cosmetic Act, as
added by this section, any submission that--
(A) is pending as of the date of enactment of this
Act; and
(B) is for voluntary consultation with respect to
food produced from, containing, or consisting of a
bioengineered organism (as such term is used in section
301(ddd) of the Federal Food, Drug, and Cosmetic Act,
as added by subsection (a)); and
(2) evaluate such notifications expeditiously.
(e) Preemption.--Section 403A(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 343-2(a)) is amended--
(1) by striking ``or'' at the end of paragraph (4);
(2) by striking the period at the end of paragraph (5) and
inserting a comma; and
(3) by adding at the end the following:
``(6) any requirement respecting, prohibition against, or
restriction on, the sale, distribution, or marketing of--
``(A) a bioengineered organism intended for a food
use or application, or
``(B) food produced from, containing, or consisting
of a bioengineered organism, as such term is used in
section 301(ddd), or''.
(f) Technical Corrections.--Section 403A of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 343-1) is amended--
(1) by striking the section designation and enumerator and
all that follows through ``(a) Except'' and inserting the
following:
``SEC. 403A. STATE REQUIREMENTS.
``(a) In General.--Except''; and
(2) in subsection (b), by striking ``(b) Upon petition''
and inserting the following:
``(b) Petitions for Exemptions.--Upon petition''.
SEC. 103. LABELING OF WHETHER FOOD IS BIOENGINEERED.
(a) Misbranding.--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) If it bears labeling (indicating that bioengineering was or
was not used in the production of the food) in violation of section
425.''.
(b) Labeling Requirements.--Chapter IV of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 341 et seq.), as amended by section 102 of
this Act, is further amended by adding at the end the following:
``SEC. 425. LABELING OF WHETHER FOOD IS BIOENGINEERED.
``(a) Claims That Bioengineering Was Not Used.--
``(1) In general.--If a claim in the labeling of food
indicates, directly or indirectly, that bioengineering was not
used in the production of the food, such claim shall be subject
to this subsection.
``(2) Requirements.--A claim described in paragraph (1)--
``(A) may be made only if the food bearing the
claim is comprised of ingredients subject to supply
chain process controls that address--
``(i) the producer planting a seed
developed by means other than through the use
of bioengineering;
``(ii) the producer keeping the crop
separated during growth, harvesting, storage,
and transportation; and
``(iii) persons in direct contact with such
crop or foods derived from such crop during
transportation, storage, or processing keeping
the product separated from foods or food
ingredients derived through bioengineering;
``(B) may be made for a food produced in accordance
with subparagraph (A) in which food produced from,
containing, or consisting of a bioengineered organism
is inadvertently present;
``(C) may not suggest either expressly or by
implication that foods developed without the use of
bioengineering are safer than foods produced from,
containing, or consisting of a bioengineered organism;
``(D) may be made on dairy products derived from
cows or other milk-producing animals, on shell eggs
derived from chickens and other birds, and on products
consisting of or derived from fish or animals (that are
under the jurisdiction of the Food and Drug
Administration) that consumed feed or a feed
ingredient, or received a drug or biological product,
that--
``(i) was developed with the use of
bioengineering; and
``(ii) has been authorized for such use by
the Secretary;
``(E) may be made on a food produced with a
bioengineered processing aid or enzyme; and
``(F) shall comply with any other requirements
established by the Secretary by regulation to ensure
that the food's labeling is not false or misleading.
``(3) Regulations.--
``(A) In general.--The Secretary shall promulgate
regulations to carry out this section. Such regulations
shall specify a maximum permissible level of food
produced from, containing, or consisting of a
bioengineered organism that may be inadvertently
present in food bearing claims under paragraph (1).
``(B) Separate categories.--Such regulations may
specify different permissible levels for separate
categories of food.
``(C) Claims prior to finalization of
regulations.--This section does not limit the ability
of persons to make claims described in paragraph (1)
before the finalization of regulations under this
paragraph.
``(D) Initial regulations.--The Secretary shall
promulgate final regulations under this paragraph not
later than 24 months after the date of enactment of the
Safe and Accurate Food Labeling Act of 2014.
``(b) Claims That Bioengineering Was Used.--
``(1) In general.--If a claim in the labeling of food
indicates, directly or indirectly, that bioengineering was used
in the production of the food, such claim shall be subject to
this subsection.
``(2) Regulations.--A claim described in paragraph (1) may
be made only in accordance with regulations promulgated by the
Secretary. Such regulations--
``(A) shall not require the labeling to declare the
use of bioengineering solely because the food was
developed with the use of bioengineering;
``(B) shall not allow the labeling to expressly or
impliedly claim that food developed with the use of
bioengineering is safer solely because the food is a
food developed with the use of bioengineering;
``(C) shall allow any claims which the Secretary
deems necessary under section 424(e); and
``(D) may contain other requirements established by
the Secretary to ensure that the food's labeling is not
false or misleading.
``(3) Prohibition against restricting certain
disclosures.--The regulations under this subsection shall not
prevent a person--
``(A) from disclosing voluntarily on the labeling
of food developed with the use of bioengineering the
manner in which the food has been modified to express
traits or characteristics that differ from its
comparable marketed food (as defined in section 424);
or
``(B) from disclosing in advertisements, on the
Internet, in response to consumer inquiries, or on
other communications, other than in the labeling, that
a food was developed with the use of bioengineering.
``(c) Definition.--The term `bioengineered organism' means a
bioengineered organism, as such term is used in section 301(ddd).''.
SEC. 104. PREEMPTION.
(a) In General.--Section 403A(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 343-2(a)) is amended by adding at the end the
following:
``(7) any requirement for the labeling of food of the type
described in subsection (a)(1) or (b)(1) of section 425 that is
not identical to the requirement of such section, or''.
(b) Prohibition Against Mandatory Labeling.--Section 403A of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343-1) is amended by
adding at the end the following:
``(c) Prohibitions Against Mandatory Labeling of Food Developed
Using Bioengineering.--Except for claims under subsection (a)(1) or
(b)(1) of section 425, 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 for the
labeling of a food by virtue of its having been developed using
bioengineering, including any requirements for claims that a food is or
contains an ingredient that was developed using bioengineering.''.
TITLE II--NATURAL FOODS
SEC. 201. LABELING OF NATURAL FOODS.
Section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
343), as amended by section 103 of this Act, is further amended by
adding at the end the following:
``(aa)(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. 202. REGULATIONS.
(a) Proposed Regulations.--Not later than 12 months after the date
of enactment of this Act, the Secretary of Health and Human Services
shall issue proposed regulations to implement section 403(aa) of the
Federal Food, Drug, and Cosmetic Act, as added by section 201 of this
Act.
(b) Final Regulations.--Not later than 24 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(aa).
SEC. 203. PREEMPTION.
Section 403A(a) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 343-1(a)), as amended by section 104 of this Act, is further
amended by adding at the end the following:
``(8) any requirement for the labeling of food of the type
required by section 403(aa) that is not identical to the
requirement of such section.''.
SEC. 204. EFFECTIVE DATE.
The labeling requirements of section 403(aa) of the Federal Food,
Drug, and Cosmetic Act, as added by section 201 of this Act, shall take
effect on the effective date of final regulations promulgated under
section 202(b) of this Act. The provisions of section 403A(a)(8) of the
Federal Food, Drug, and Cosmetic Act, as added by section 203 of this
Act, take effect on the date of enactment of this Act.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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