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Organic Consumers Association

Safe and Accurate Food Labeling Act of 2014

  • By U.S. Congress
    Organic Consumers Association, April 10, 2014

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113TH CONGRESS
2D  SESSION

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

M.  introduced the following bill; which was referred to the Committee on

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.

1    Be it enacted by the Senate and House of Representa-
2    tives of the United States of America in Congress assembled,

3    SECTION 1. SHORT TITLE.
4    This Act may be cited as the ‘‘Safe and Accurate
5    Food Labeling Act of 2014’’.

6    SEC. 2. TABLE OF CONTENTS.
7    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.

1    SEC. 3. ENSURING SAFETY OF FOOD SUPPLY.

2    Nothing in this Act (or the amendments made by this
3    Act) is intended to alter or affect the authorities or regu-
4    latory programs, policies, and procedures otherwise avail-
5    able to the Food and Drug Administration to ensure the
6    safety of the food supply under the Federal Food, Drug,
7    and Cosmetic Act (21 U.S.C. 301 et seq.).

8    TITLE    I—FOOD    PRODUCED
9    FROM,  CONTAINING,  OR  CON-
10    SISTING    OF    A    BIOENGI-
11    NEERED ORGANISM

12    SEC. 101. DEFINITIONS.

13    Section 201 of the Federal Food, Drug, and Cosmetic
14    Act (21 U.S.C. 321) is amended by adding at the end the
15    following:
16    ‘‘(ss) The term ‘bioengineered organism’ refers to an
17    organism if—
 
1    ‘‘(1) the organism is a plant (or a seed, a fruit,
2    or any other part thereof);
3    ‘‘(2)  the  organism  contains  genetic  material
4    that has been modified through in vitro recombinant
5    deoxyribonucleic acid (DNA) techniques; and
6    ‘‘(3) the modification could not otherwise be ob-
7    tained using conventional breeding techniques.’’.

8    SEC. 102. MANDATORY PREMARKET BIOTECHNOLOGY NO-
9    TIFICATION PROGRAM.

10    (a)  PROHIBITED   ACT.—Section  301  of  the  Federal
11    Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend-
12    ed by adding at the end the following:
13    ‘‘(ddd) The initial introduction or delivery for intro-
14    duction in interstate commerce of a bioengineered orga-
15    nism intended for a food use or application, unless the
16    developer of the organism has complied with the notifica-
17    tion requirements, to the extent applicable, under section
18   424.’’.

19    (b)  NOTIFICATION   PROGRAM.—Chapter  IV  of  the
20    Federal  Food,  Drug,  and  Cosmetic  Act  (21  U.S.C.  341
21    et seq.) is amended by adding at the end the following:
 
1    ‘‘SEC. 424. NOTIFICATION RELATING TO CERTAIN BIOENGI-
2    NEERED ORGANISMS.

3    ‘‘(a) IN  GENERAL.—A bioengineered organism shall
4    not be introduced or delivered for introduction into inter-
5    state commerce for a food use or application unless—
6    ‘‘(1) the use or application of the bioengineered
7    organism in food has been addressed by the devel-
8    oper of the bioengineered organism in a premarket
9    biotechnology notification, to which the Secretary
10    has responded under subsection (d)(2)(A) by stating
11    no objections; or
12    ‘‘(2)(A) food produced from, containing, or con-
13    sisting of the bioengineered organism was evaluated
14    by the Secretary pursuant to the Food and Drug
15    Administration’s  voluntary  consultation  process  for
16    foods and food products from genetically engineered
17    plants in effect prior to the date of enactment of the
18    Safe and Accurate Food Labeling Act of 2014; and
19    ‘‘(B) the Secretary informed the developer of
20    the bioengineered organism that all questions about
21    safety have been resolved.

22    ‘‘(b) EXCEPTIONS.—This section does not apply with
23    respect to the introduction or delivery for introduction into
24    interstate commerce of a bioengineered organism—
25    ‘‘(1) for the purpose of development or testing
26    conducted to generate data and information that

1    could be used in a premarket biotechnology notifica-
2    tion or other regulatory submission; or
3    ‘‘(2) solely because—
4    ‘‘(A) a processing aid or enzyme produced
5    from the bioengineered organism is intended to
6    be used to produce food; or
7    ‘‘(B) food produced from, containing, or
8    consisting of the bioengineered organism is in-
9    tended to be fed to an animal from which food
10    is intended to be produced or derived.

11    ‘‘(c)    PREMARKET    BIOTECHNOLOGY    NOTIFICA-
12    TION.—

13    ‘‘(1)  SUBMISSION.—At  least  210  days  before  a
14    bioengineered organism is first introduced or deliv-
15    ered for introduction into interstate commerce for a
16    food use or application, a premarket biotechnology
17    notification shall be submitted to the Secretary by
18    the developer of the bioengineered organism. Such
19    notification shall provide—
20    ‘‘(A) the basis for the notifier’s determina-
21    tion that food produced from, containing, or
22    consisting of such bioengineered organism is as
23    safe for use by humans or animals, as applica-
24    ble, as one or more comparable marketed foods
25    that are not produced from, do not contain, or
 
1    do not consist of such bioengineered organism;
2    and
3    ‘‘(B) whether any other Federal agency is
4    conducting or has conducted any review of the
5    bioengineered organism and the status or con-
6    clusions of any such review.

7    ‘‘(2) CONSULTATION PRIOR TO SUBMISSION.—A
8    prospective notifier may consult informally with the
9    Secretary concerning a bioengineered organism in-
10    tended for a food use or application before submit-
11    ting a premarket biotechnology notification.

12    ‘‘(d) RESPONSE TO A PREMARKET BIOTECHNOLOGY
13    NOTIFICATION.—

14    ‘‘(1)    PRELIMINARY    RESPONSE.—Within    30
15    days of receipt of a premarket biotechnology notifi-
16    cation, the Secretary shall—
17    ‘‘(A) inform the notifier in writing that the
18    notification is complete and has been filed; or
19    ‘‘(B) inform the notifier in writing of any
20    missing  elements  that  prevent  the  Secretary
21    from filing and reviewing the notification.
22    The Secretary shall limit any request under subpara-
23    graph (B) to data or information necessary to per-
24    form the evaluation specified in paragraph (2) and
 
1    shall not delay informing the notifier under para-
2    graph (1)(A) for any other purpose.

3    ‘‘(2)    SUBSTANTIVE    RESPONSE.—Within    180
4    days of the Secretary informing the notifier under
5    paragraph (1)(A) that the premarket biotechnology
6    notification is complete, the Secretary—
7    ‘‘(A) shall respond in writing to the noti-
8    fier that the Secretary has evaluated the notifi-
9    cation and has no objections to the notifier’s
10    determination that food produced from, con-
11    taining, or consisting of the bioengineered orga-
12    nism that is the subject of the notification is as
13    safe for use by humans or animals, as applica-
14    ble, as one or more comparable marketed foods
15    that are not produced from, do not contain, or
16    do not consist of such bioengineered organism;
17    or
18    ‘‘(B) shall—
19    ‘‘(i) respond in writing to the notifier
20    that the Secretary has evaluated the notifi-
21    cation and has determined the notification
22    does not provide an adequate basis for the
23    notifier’s determination; and
 
1    ‘‘(ii) include in such response the Sec-
2    retary’s  basis  for  the  Secretary’s  deter-
3    mination.

4    ‘‘(3)    WITHDRAWAL    BY    NOTIFIER.—At    any
5    point before receiving a written response from the
6    Secretary under subparagraph (A) or (B) of para-
7    graph (2), the notifier may withdraw a premarket
8    biotechnology notification without prejudice as to
9    any future notifications.

10    ‘‘(4)    EFFECTIVE    DATE.—A    notification    sub-
11    mitted under subsection (c) shall become effective on
12    the date  that  is  180  days  after  the  Secretary  in-
13    forms the notifier under paragraph (1)(A) that the
14    notification is complete, and as of such date the bio-
15    engineered organism that is the subject of the notifi-
16    cation may be introduced or delivered for introduc-
17    tion into interstate commerce, unless the Secretary
18    provides a response under paragraph (2)(B).

19    ‘‘(e)  LABELING.—If  the  Secretary  determines  that
20    there is a material difference between a food produced
21    from, containing, or consisting of a bioengineered orga-
22    nism and its comparable marketed food and that disclo-
23    sure of such difference is necessary to protect health and
24    safety or to prevent the label or labeling of such food from
25    being false or misleading, the Secretary may, in a response
 
1    under subsection (d)(2)(A), specify labeling that would
2    adequately inform consumers of such material difference.
3    The use of bioengineering does not, by itself, constitute
4    a material difference.

5    ‘‘(f) PUBLIC  DISCLOSURE.—The existence and con-
6    tents of a premarket biotechnology notification shall be
7    made available to the public as of the date the Secretary
8    issues a written response under subsection (d)(2)(A), sub-
9    ject to review by the Secretary pursuant to the provisions
10    on exemptions from disclosure under chapter 5 of title 5,
11    United States Code.

12    ‘‘(g) DEFINITIONS.—In this section:
13    ‘‘(1)(A) The term ‘comparable marketed food’
14    means, with respect to the food produced from, con-
15    taining, or consisting of a plant that is a bioengi-
16    neered  organism—
17    ‘‘(i) the parental variety of the plant;
18    ‘‘(ii) another commonly consumed variety
19    of the plant; or
20    ‘‘(iii) a plant variety from which is derived
21    a    commonly    consumed    food    with    properties
22    comparable to the food produced from, con-
23    taining, or consisting of the plant that is a bio-
24    engineered organism.
 
1    ‘‘(B) A food produced from, containing, or con-
2    sisting of a bioengineered organism may have more
3    than one comparable marketed food.
4    ‘‘(2) The term ‘notifier’ means the person who
5    submits a premarket biotechnology notification.
6    ‘‘(3) The term ‘premarket biotechnology notifi-
7    cation’—
8    ‘‘(A) means a submission to the Secretary
9    under subsection (c); and
10    ‘‘(B) includes all scientific data and other
11    information in the original submission and in
12    any amendments to the original submission.
13    ‘‘(4) The term ‘material difference’ means a dif-
14    ference that—
15    ‘‘(A) significantly alters the characteristics,
16    including the functional or compositional char-
17    acteristics, of a food, such that the common or
18    usual name no longer adequately describes the
19    food;
20    ‘‘(B) results in a significantly different nu-
21    tritional property in the food produced from,
22    containing, or consisting of the bioengineered
23    organism; or
 
1    ‘‘(C) results in the food containing an al-
2    lergen that consumers would not expect to be
3    present based upon the name of the food.’’.

4    (c) APPLICABILITY.—The amendments made by this
5    section apply beginning on the date that is 30 days after
6    the date of enactment of this Act, irrespective of whether
7    regulations or guidance have been finalized or issued by
8    such date to carry out such amendments.

9    (d) PENDING  SUBMISSIONS.—The Secretary shall—
10    (1) deem to be a premarket biotechnology noti-
11    fication  under  section  424  of  the  Federal  Food,
12    Drug, and Cosmetic Act, as added by this section,
13    any submission that—
14    (A) is pending as of the date of enactment
15    of this Act; and
16    (B) is for voluntary consultation with re-
17    spect to food produced from, containing, or con-
18    sisting of a bioengineered organism (as such
19    term is used in section 301(ddd) of the Federal
20    Food,  Drug,  and  Cosmetic  Act,  as  added  by
21    subsection (a)); and
22    (2) evaluate such notifications expeditiously.

23    (e)  PREEMPTION.—Section  403A(a)  of  the  Federal
24    Food, Drug, and Cosmetic Act (21 U.S.C. 343–2(a)) is
25    amended—

1
2    (4);
3
(1)    by striking ‘‘or’’ at the end of paragraph
(2)    by striking the period at the end of para-
 
4    graph (5) and inserting a comma; and
5    (3) by adding at the end the following:
6    ‘‘(6)    any    requirement    respecting,    prohibition
7    against, or restriction on, the sale, distribution, or
8    marketing of—
9    ‘‘(A) a bioengineered organism intended
10    for a food use or application, or
11    ‘‘(B) food produced from, containing, or
12    consisting of a bioengineered organism, as such
13    term is used in section 301(ddd), or’’.

14    (f) TECHNICAL  CORRECTIONS.—Section 403A of the
15    Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343–
16    1) is amended—
17    (1) by striking the section designation and enu-
18    merator and all that follows through ‘‘(a) Except’’
19    and inserting the following:

20    ‘‘SEC. 403A. STATE REQUIREMENTS.

21    ‘‘(a) IN GENERAL.—Except’’; and
22    (2) in subsection (b), by striking ‘‘(b) Upon pe-
23    tition’’ and inserting the following:

24    ‘‘(b) PETITIONS FOR EXEMPTIONS.—Upon petition’’.
 
1    SEC.   103.   LABELING   OF   WHETHER   FOOD   IS   BIOENGI-
2    NEERED.

3    (a)    MISBRANDING.—Section    403    of    the    Federal
4    Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amend-
5    ed by adding at the end the following:
6    ‘‘(z)    If    it    bears    labeling    (indicating    that    bio-
7    engineering was or was not used in the production of the
8    food) in violation of section 425.’’.

9    (b)  LABELING   REQUIREMENTS.—Chapter  IV  of  the
10    Federal  Food,  Drug,  and  Cosmetic  Act  (21  U.S.C.  341
11    et seq.), as amended by section 102 of this Act, is further
12    amended by adding at the end the following:

13    ‘‘SEC.   425.   LABELING   OF   WHETHER   FOOD   IS   BIOENGI-
14    NEERED.

15    ‘‘(a)    CLAIMS    THAT    BIOENGINEERING    WAS    NOT
16    USED.—

17    ‘‘(1) IN  GENERAL.—If a claim in the labeling of
18    food    indicates,    directly    or    indirectly,    that    bio-
19    engineering was not used in the production of the
20    food, such claim shall be subject to this subsection.

21    ‘‘(2)    REQUIREMENTS.—A    claim    described    in
22    paragraph (1)—
23    ‘‘(A) may be made only if the food bearing
24    the claim is comprised of ingredients subject to
25    supply chain process controls that address—
 
1    ‘‘(i) the producer planting a seed de-
2    veloped by means other than through the
3    use of bioengineering;
4    ‘‘(ii) the producer keeping the crop
5    separated during growth, harvesting, stor-
6    age, and transportation; and
7    ‘‘(iii) persons in direct contact with
8    such crop or foods derived from such crop
9    during    transportation,    storage,    or    proc-
10    essing keeping the product separated from
11    foods or food ingredients derived through
12    bioengineering;
13    ‘‘(B) may be made for a food produced in
14    accordance    with    subparagraph    (A)    in    which
15    food produced from, containing, or consisting of
16    a    bioengineered    organism    is    inadvertently
17    present;
18    ‘‘(C) may not suggest either expressly or
19    by implication that foods developed without the
20    use of bioengineering are safer than foods pro-
21    duced from, containing, or consisting of a bio-
22    engineered  organism;
23    ‘‘(D) may be made on dairy products de-
24    rived from cows or other milk-producing ani-
25    mals, on shell eggs derived from chickens and
 
1    other birds, and on products consisting of or
2    derived from fish or animals (that are under
3    the jurisdiction of the Food and Drug Adminis-
4    tration) that consumed feed or a feed ingre-
5    dient, or received a drug or biological product,
6    that—
7    ‘‘(i) was developed with the use of bio-
8    engineering; and
9    ‘‘(ii) has been authorized for such use
10    by the Secretary;
11    ‘‘(E)  may  be  made  on  a  food  produced
12    with a bioengineered processing aid or enzyme;
13    and
14    ‘‘(F) shall comply with any other require-
15    ments established by the Secretary by regula-
16    tion to ensure that the food’s labeling is not
17    false or misleading.

18    ‘‘(3)  REGULATIONS.—

19    ‘‘(A)  IN   GENERAL.—The  Secretary  shall
20    promulgate regulations to carry out this sec-
21    tion. Such regulations shall specify a maximum
22    permissible level of food produced from, con-
23    taining, or consisting of a bioengineered orga-
24    nism that may be inadvertently present in food
25    bearing claims under paragraph (1).
 
1    ‘‘(B) SEPARATE  CATEGORIES.—Such regu-
2    lations may specify different permissible levels
3    for separate categories of food.

4    ‘‘(C) CLAIMS  PRIOR  TO  FINALIZATION  OF
5    REGULATIONS.—This section does not limit the
6    ability of persons to make claims described in
7    paragraph (1) before the finalization of regula-
8    tions under this paragraph.

9    ‘‘(D)    INITIAL    REGULATIONS.—The    Sec-
10    retary shall promulgate final regulations under
11    this paragraph not later than 24 months after
12    the date of enactment of the Safe and Accurate
13    Food Labeling Act of 2014.

14    ‘‘(b) CLAIMS  THAT BIOENGINEERING WAS  USED.—

15    ‘‘(1) IN  GENERAL.—If a claim in the labeling of
16    food    indicates,    directly    or    indirectly,    that    bio-
17    engineering was used in the production of the food,
18    such claim shall be subject to this subsection.

19    ‘‘(2)    REGULATIONS.—A    claim    described    in
20    paragraph (1) may be made only in accordance with
21    regulations promulgated by the Secretary. Such reg-
22    ulations—
23    ‘‘(A) shall not require the labeling to de-
24    clare the use of bioengineering solely because
 
1    the food was developed with the use of bio-
2    engineering;
3    ‘‘(B)  shall  not  allow  the  labeling  to  ex-
4    pressly or impliedly claim that food developed
5    with the use of bioengineering is safer solely be-
6    cause the food is a food developed with the use
7    of bioengineering;
8    ‘‘(C) shall allow any claims which the Sec-
9    retary deems necessary under section 424(e);
10    and
11    ‘‘(D) may contain other requirements es-
12    tablished by the Secretary to ensure that the
13    food’s labeling is not false or misleading.

14    ‘‘(3)  PROHIBITION  AGAINST  RESTRICTING  CER-
15    TAIN    DISCLOSURES.—The    regulations    under    this
16    subsection shall not prevent a person—
17    ‘‘(A) from disclosing voluntarily on the la-
18    beling of food developed with the use of bio-
19    engineering the manner in which the food has
20    been modified to express traits or characteris-
21    tics that differ from its comparable marketed
22    food (as defined in section 424); or
23    ‘‘(B) from disclosing in advertisements, on
24    the Internet, in response to consumer inquiries,
25    or on other communications, other than in the
 
1    labeling, that a food was developed with the use
2    of bioengineering.

3    ‘‘(c)  DEFINITION.—The  term  ‘bioengineered  orga-
4    nism’ means a bioengineered organism, as such term is
5    used in section 301(ddd).’’.

6    SEC.  104.  PREEMPTION.

7    (a) IN  GENERAL.—Section 403A(a) of the Federal
8    Food, Drug, and Cosmetic Act (21 U.S.C. 343–2(a)) is
9    amended by adding at the end the following:
10    ‘‘(7) any requirement for the labeling of food of
11    the type described in subsection (a)(1) or (b)(1) of
12    section 425 that is not identical to the requirement
13    of such section, or’’.

14    (b)    PROHIBITION    AGAINST    MANDATORY    LABEL-
15    ING.—Section 403A of the Federal Food, Drug, and Cos-
16    metic Act (21 U.S.C. 343–1) is amended by adding at the
17    end the following:

18    ‘‘(c) PROHIBITIONS AGAINST MANDATORY LABELING
19    OF FOOD DEVELOPED USING BIOENGINEERING.—Except
20    for claims under subsection (a)(1) or (b)(1) of section 425,
21    no State or political subdivision of a State may directly
22    or indirectly establish under any authority or continue in
23    effect as to any food in interstate commerce any require-
24    ment for the labeling of a food by virtue of its having been
25    developed using bioengineering, including any require-
 
1    ments for claims that a food is or contains an ingredient
2    that was developed using bioengineering.’’.

3    TITLE II—NATURAL FOODS

4    SEC. 201. LABELING OF NATURAL FOODS.
5    Section 403 of the Federal Food, Drug, and Cosmetic
6    Act (21 U.S.C. 343), as amended by section 103 of this
7    Act, is further amended by adding at the end the fol-
8    lowing:
9    ‘‘(aa)(1) If its labeling contains an express or implied
10    claim that the food is ‘natural’ unless the claim is made
11    in accordance with subparagraph (2).
12    ‘‘(2) A claim described in subparagraph (1) may be
13    made only if the claim uses terms that have been defined
14    by, and the food meets the requirements that have been
15    established in, regulations promulgated to carry out this
16    paragraph.
17    ‘‘(3) Notwithstanding subparagraph (2), prior to the
18    finalization of regulations to carry out this paragraph, the
19    use of any claim that a food is ‘natural’ shall be allowed
20    if consistent with the Secretary’s existing policy for such
21    claims.
22    ‘‘(4) In promulgating regulations to carry out this
23    paragraph, the Secretary shall differentiate between food
24    for human consumption and food intended for consump-
25    tion by animals other than humans.
 
1    ‘‘(5) For purposes of subparagraph (1), a natural
2    claim includes the use of—
3    ‘‘(A) the terms ‘natural’, ‘100% natural’, ‘natu-
4    rally grown’, ‘all natural’, and ‘made with natural
5    ingredients’; and
6    ‘‘(B)  any  other  terms  specified  by  the  Sec-
7    retary.’’.

8    SEC. 202. REGULATIONS.

9    (a)  PROPOSED   REGULATIONS.—Not  later  than  12
10    months after the date of enactment of this Act, the Sec-
11    retary of Health and Human Services shall issue proposed
12    regulations to implement section 403(aa) of the Federal
13    Food, Drug, and Cosmetic Act, as added by section 201
14    of this Act.

15    (b) FINAL REGULATIONS.—Not later than 24 months
16    after the date of enactment of this Act, the Secretary of
17    Health and Human Services shall issue final regulations
18    to implement such section 403(aa).

19    SEC.  203.  PREEMPTION.

20    Section 403A(a) of the Federal Food, Drug, and Cos-
21    metic Act (21 U.S.C. 343–1(a)), as amended by section
22    104 of this Act, is further amended by adding at the end
23    the following:
 
1    ‘‘(8) any requirement for the labeling of food of
2    the  type  required  by  section  403(aa)  that  is  not
3    identical to the requirement of such section.’’.

4    SEC. 204. EFFECTIVE DATE.

5    The labeling requirements of section 403(aa) of the
6    Federal Food, Drug, and Cosmetic Act, as added by sec-
7    tion 201 of this Act, shall take effect on the effective date
8    of final regulations promulgated under section 202(b) of
9    this Act. The provisions of section 403A(a)(8) of the Fed-
10    eral Food, Drug, and Cosmetic Act, as added by section
11    203 of this Act, take effect on the date of enactment of
12    this Act.

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