[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3553 Introduced in House (IH)]
112th CONGRESS
1st Session
H. R. 3553
To amend the Federal Food, Drug, and Cosmetic Act, the Federal Meat
Inspection Act, and the Poultry Products Inspection Act to require that
food that contains a genetically engineered material, or that is
produced with a genetically engineered material, be labeled
accordingly.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
December 2, 2011
Mr. Kucinich (for himself, Mr. Grijalva, Ms. Lee of California, Mr.
Moran, Mr. Polis, Ms. Pingree of Maine, Ms. Slaughter, Ms. Speier, Mr.
Stark, Mr. Thompson of California, Ms. Waters, Ms. Woolsey, and Mr.
Young of Alaska) introduced the following bill; which was referred to
the Committee on Agriculture, and in addition to the Committee on
Energy and Commerce, for a period to be subsequently determined by the
Speaker, in each case for consideration of such provisions as fall
within the jurisdiction of the committee concerned
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act, the Federal Meat
Inspection Act, and the Poultry Products Inspection Act to require that
food that contains a genetically engineered material, or that is
produced with a genetically engineered material, 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; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Genetically
Engineered Food Right to Know Act''.
(b) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Labeling regarding genetically engineered material; amendments
to Federal Food, Drug, and Cosmetic Act.
Sec. 4. Labeling regarding genetically engineered material; amendments
to Federal Meat Inspection Act.
Sec. 5. Labeling regarding genetically engineered material; amendments
to Poultry Products Inspection Act.
Sec. 6. Effective date.
SEC. 2. FINDINGS.
Congress finds as follows:
(1) The process of genetically engineering foods results in
the material change of such foods.
(2) The Congress has previously required that all foods
bear labels that reveal material facts to consumers.
(3) Federal agencies have failed to uphold Congressional
intent by allowing genetically engineered foods to be marketed,
sold and otherwise used without labeling that reveals material
facts to the public.
(4) Consumers wish to know whether the food they purchase
and consume contains or is produced with a genetically
engineered material for a variety of reasons, including the
potential transfer of allergens into food and other health
risks, concerns about potential environmental risks associated
with the genetic engineering of crops, and religiously and
ethically based dietary restrictions.
(5) Consumers have a right to know whether the food they
purchase contains or was produced with genetically engineered
material.
(6) Labels voluntarily placed on foods are insufficient to
provide consumers with adequate information on whether or not
all the food they are purchasing contains or was produced with
genetically engineered material.
(7) Mandatory labeling provides a critical scientific
method necessary for the continual postmarket surveillance to
study long-term health impacts and enforcement of food safety
laws preventing adulterated foods from reaching consumers.
(8) Many of the United States key trading partners,
including countries in the European Union, Japan, and the
People's Republic of China, have established, or are in the
process of implementing, mandatory labeling requirements for
genetically engineered food.
(9) Adoption and implementation of mandatory labeling
requirements for genetically engineered food produced in the
United States would facilitate international trade by allowing
American farmers and companies to export and appropriately
market their products--both genetically engineered and non-
genetically engineered--to foreign customers.
SEC. 3. LABELING REGARDING GENETICALLY ENGINEERED MATERIAL; AMENDMENTS
TO 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 new subsection:
``(z)(1) If it contains a genetically engineered material, or was
produced with a genetically engineered material, unless it bears a
label (or labeling, in the case of a raw agricultural commodity, other
than the sale of such a commodity at retail) that provides notices in
accordance with the following:
``(A) A notice as follows: `GENETICALLY ENGINEERED'.
``(B) A notice as follows: `THIS PRODUCT CONTAINS A
GENETICALLY ENGINEERED MATERIAL, OR WAS PRODUCED WITH A
GENETICALLY ENGINEERED MATERIAL'.
``(C) The notice required in clause (A) immediately
precedes the notice required in clause (B) and is not less than
twice the size of the notice required in clause (B).
``(D) The notice required in clause (B) is of the same size
as would apply if the notice provided nutrition information
that is required in paragraph (q)(1).
``(E) The notices required in clauses (A) and (B) are
clearly legible and conspicuous.
``(2) For purposes of subparagraph (1):
``(A) The term `genetically engineered material' means
material derived from any part of a genetically engineered
organism, without regard to whether the altered molecular or
cellular characteristics of the organism are detectable in the
material.
``(B) The term `genetically engineered organism' means--
``(i) an organism (including fish) that has been
altered at the molecular or cellular level by means
that are not possible under natural conditions or
processes (including but not limited to recombinant DNA
and RNA techniques, cell fusion, microencapsulation,
macroencapsulation, gene deletion and doubling,
introducing a foreign gene, and changing the positions
of genes), other than a means consisting exclusively of
breeding, conjugation, fermentation, hybridization, in
vitro fertilization, tissue culture, or mutagenesis,
and
``(ii) an organism made through sexual or asexual
reproduction (or both) involving an organism described
in subclause (i), if possessing any of the altered
molecular or cellular characteristics of the organism
so described.
``(3) For purposes of subparagraph (1), a food shall be considered
to have been produced with a genetically engineered material if--
``(A) the organism (including fish) from which the food is
derived has been injected or otherwise treated with a
genetically engineered material (except that the use of manure
as a fertilizer for raw agricultural commodities may not be
construed to mean that such commodities are produced with a
genetically engineered material),
``(B) the animal (including fish) from which the food is
derived has been fed genetically engineered material, or
``(C) the food contains an ingredient that is a food to
which clause (A) or (B) applies.
``(4) This paragraph does not apply to food that--
``(A) is served in restaurants or other establishments in
which food is served for immediate human consumption,
``(B) is processed and prepared primarily in a retail
establishment, is ready for human consumption, which is of the
type described in clause (A), and is offered for sale to
consumers but not for immediate human consumption in such
establishment and is not offered for sale outside such
establishment, or
``(C) is a medical food as defined in section 5(b) of the
Orphan Drug Act.
``(5) In the case of the transfer of food from manufacturers or
producers to distributors, and from distributors to other distributors
or to other persons in the chain of distribution, including persons who
hold food for sale to consumers, regulations under this paragraph and
paragraph (z) shall require periodic testing of foods by the Secretary
for purposes of determining the accuracy of labels under such
paragraphs. Such regulations shall require the use of the best
available technology for such testing, and shall identify tests that
meet such requirement. This subparagraph and subparagraph (6) do not
apply to (A) foods that are certified and comply with the Organic Foods
Production Act and its implementing regulations; or (B) foods produced
with genetically engineered material if the Secretary has not through
such regulations identified a validated method of testing for such
material in the food; or (C) genetically engineered material contained
in a food if the Secretary has not through such regulations identified
a validated method of testing for such material in the food.
``(6) For purposes of this paragraph and paragraph (z), a food with
respect to which a test has been identified under subparagraph (5)
shall not be considered to contain a genetically engineered material
if, as indicated by such a test--
``(A) the food does not contain any genetically engineered
material, or
``(B) the food contains an adventitious genetically
engineered material and the amount of the material in the food
is one percent or less, except that a lower percentage
designated by the Secretary shall apply for purposes of this
subparagraph if the Secretary determines that a test identified
under subparagraph (5) can detect a percentage lower than one
percent.
``(aa) If it bears a label indicating (within the meaning of
paragraph (z)) that it does not contain a genetically engineered
material, or that it was not produced with a genetically engineered
material, unless the label is in accordance with regulations
promulgated by the Secretary. With respect to such regulations:
``(1) The regulations may not require such a label to
include any statement indicating that the fact that a food does
not contain such material, or was not produced with such
material, has no bearing on the safety of the food for human
consumption.
``(2) The regulations may not prohibit such a label on the
basis that, in the case of the type of food involved, there is
no version of the food in commercial distribution that does
contain a genetically engineered material.''.
(b) Civil Penalties.--Section 303 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 333) is amended by adding at the end the
following subsection:
``(h)(1) With respect to a violation of section 301(a), 301(b), or
301(c) involving the misbranding of food within the meaning of section
403(z) or 403(aa), any person engaging in such a violation shall be
liable to the United States for a civil penalty in an amount not to
exceed $100,000 for each such violation.
``(2) Paragraphs (5) through (7) of subsection (f) apply with
respect to a civil penalty under paragraph (1) of this subsection to
the same extent and in the same manner as such paragraphs (5) through
(7) apply with respect to a civil penalty under paragraph (1), (2),
(3), (4), or (9) of subsection (f).''.
(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 new
paragraph:
``(2)(A) Subject to subparagraph (C) and section 403(z)(5), no
person shall be subject to the penalties of subsection (a)(1) or (h)
for a violation of section 301(a), 301(b), or 301(c) involving the
misbranding of food within the meaning of section 403(z) and 403(aa) if
such person (referred to in this paragraph as the `recipient')
establishes a guaranty or undertaking signed by, and containing the
name and address of, the 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), to the effect that (within
the meaning of section 403(z)) the food does not contain a genetically
engineered material or was not produced with a genetically engineered
material.
``(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 use of the
food by the recipient, including--
``(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.''.
(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 ``303(c)(2)''.
(d) Unintended Contamination.--Section 303(d) of the Federal Food,
Drug, and Cosmetic Act, as amended by subsection (c)(1) of this
section, is amended by adding at the end the following paragraph:
``(3)(A) No person shall be subject to the penalties of subsection
(a)(1) or (h) for a violation of section 301(a), 301(b), or 301(c)
involving the misbranding of food within the meaning of section 403(z)
or 403(aa) 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 (including
contamination by mingling the two), 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) Citizen Suits.--Chapter III of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331 et seq.) is amended by adding at the end
the following section:
``SEC. 311. CITIZEN SUITS REGARDING MISBRANDING OF FOOD WITH RESPECT TO
GENETICALLY ENGINEERED MATERIAL.
``(a) In General.--Except as provided in subsection (c), any person
may on his or her behalf commence a civil action in an appropriate
district court of the United States against--
``(1) a person who is alleged to have engaged in a
violation of section 301(a), 301(b), or 301(c) involving the
misbranding of food within the meaning of section 403(z) or
403(aa); or
``(2) the Secretary where there is alleged a failure of the
Secretary to perform any act or duty under section 403(z) or
403(aa) that is not discretionary.
``(b) Relief.--In a civil action under subsection (a), the district
court involved may, as the case may be--
``(1) enforce the compliance of a person with the
applicable provisions referred to paragraph (1) of such
subsection; or
``(2) order the Secretary to perform an act or duty
referred to in paragraph (2) of such subsection.
``(c) Limitations.--
``(1) Notice to secretary.--A civil action may not be
commenced under subsection (a)(1) prior to 60 days after the
plaintiff has provided to the Secretary notice of the violation
involved.
``(2) Relation to actions of secretary.--A civil action may
not be commenced under subsection (a)(2) if the Secretary has
commenced and is diligently prosecuting a civil or criminal
action in a district court of the United States to enforce
compliance with the applicable provisions referred to in
subsection (a)(1).
``(d) Right of Secretary To Intervene.--In any civil action under
subsection (a), the Secretary, if not a party, may intervene as a
matter of right.
``(e) Award of Costs; Filing of Bond.--In a civil action under
subsection (a), the district court involved may award costs of
litigation (including reasonable attorney and expert witness fees) to
any party whenever the court determines such an award is appropriate.
The court may, if a temporary restraining order or preliminary
injunction is sought, require the filing of a bond or equivalent
security in accordance with the Federal Rules of Civil Procedure.
``(f) Savings Provision.--This section does not restrict any right
that a person (or class of persons) may have under any statute or
common law to seek enforcement of the provisions referred to subsection
(a)(1), or to seek any other relief (including relief against the
Secretary).''.
SEC. 4. LABELING REGARDING GENETICALLY ENGINEERED MATERIAL; AMENDMENTS
TO FEDERAL MEAT INSPECTION ACT.
(a) Requirements.--The Federal Meat Inspection Act is amended by
inserting after section 7 (21 U.S.C. 607) the following section:
``SEC. 7A. REQUIREMENTS FOR LABELING REGARDING GENETICALLY ENGINEERED
MATERIAL.
``(a) Definitions.--In this section:
``(1) The term `meat food' means a carcass, part of a
carcass, meat, or meat food product that is derived from
cattle, sheep, swine, goats, horses, mules, or other equines
and is capable of use as human food.
``(2) The term `genetically engineered material' means
material derived from any part of a genetically engineered
organism, without regard to whether the altered molecular or
cellular characteristics of the organism are detectable in the
material (and without regard to whether the organism is capable
of use as human food).
``(3) The term `genetically engineered organism' means--
``(A) an organism that has been altered at the
molecular or cellular level by means that are not
possible under natural conditions or processes
(including but not limited to recombinant DNA and RNA
techniques, cell fusion, microencapsulation,
macroencapsulation, gene deletion and doubling,
introducing a foreign gene, and changing the positions
of genes), other than a means consisting exclusively of
breeding, conjugation, fermentation, hybridization, in
vitro fertilization, tissue culture, or mutagenesis;
and
``(B) an organism made through sexual or asexual
reproduction (or both) involving an organism described
in subparagraph (A), if possessing any of the altered
molecular or cellular characteristics of the organism
so described.
``(b) Labeling Requirement.--
``(1) Required labeling to avoid misbranding.--
``(A) Involvement of genetically engineered
material.--For purposes of sections 1(n) and 10, a meat
food is misbranded if it--
``(i) contains a genetically engineered
material or was produced with a genetically
engineered material; and
``(ii) does not bear a label (or include
labeling, in the case of a meat food that is
not packaged in a container) that provides, in
a clearly legible and conspicuous manner, the
notices described in subsection (c).
``(B) No involvement of genetically engineered
material.--For purposes of sections 1(n) and 10, a meat
food is misbranded if it bears a label indicating that
it does not contain a genetically engineered material,
or that it was not produced with a genetically
engineered material, unless the label is in accordance
with regulations promulgated by the Secretary. With
respect to such regulations:
``(i) The regulations may not require such
a label to include any statement indicating
that the fact that a meat food does not contain
such material, or was not produced with such
material, has no bearing on the safety of the
food for human consumption.
``(ii) The regulations may not prohibit
such a label on the basis that, in the case of
the type of meat food involved, there is no
version of the food in commercial distribution
that does contain a genetically engineered
material.
``(2) Rule of construction.--For purposes of subparagraphs
(A)(i) and (B) of paragraph (1), a meat food shall be
considered to have been produced with a genetically engineered
material if--
``(A) the organism from which the food is derived
has been injected or otherwise treated with a
genetically engineered material;
``(B) the animal from which the food is derived has
been fed genetically engineered material; or
``(C) the food contains an ingredient that is a
food to which subparagraph (A) or (B) of this paragraph
applies.
``(3) Testing.--For purposes of sections 1(n) and 10:
``(A) In the case of the transfer of meat foods
from manufacturers or producers to distributors, and
from distributors to other distributors or to other
persons in the chain of distribution, including persons
who hold meat food for sale to consumers, regulations
under subparagraphs (A)(i) and (B) of paragraph (1)
shall require periodic testing of meat foods by the
Secretary for purposes of determining the accuracy of
labels under such subparagraphs. Such regulations shall
require the use of the best available technology for
such testing, and shall identify tests that meet such
requirement. This subparagraph and subparagraph (B) of
this paragraph do not apply to (i) meat foods that are
certified and comply with the Organic Foods Production
Act and its implementing regulations; or (ii) meat
foods produced with genetically engineered material if
the Secretary has not through such regulations
identified a validated method of testing for such
material in the food; or (iii) genetically engineered
material contained in a meat food if the Secretary has
not through such regulations identified a validated
method of testing for such material in the food.
``(B) A meat food with respect to which a test has
been identified under subparagraph (A) shall not be
considered to contain a genetically engineered material
for purposes of subparagraphs (A)(i) and (B) of
paragraph (1) if, as indicated by such a test--
``(i) the food does not contain any
genetically engineered material; or
``(ii) the food contains an adventitious
genetically engineered material and the amount
of the material in the food is one percent or
less, except that a lower percentage designated
by the Secretary shall apply for purposes of
this subparagraph if the Secretary determines
that a test identified under subparagraph (A)
can detect a percentage lower than one percent.
``(c) Specifics of Label Notices.--
``(1) Required notices.--The notices referred to in
subsection (b)(1)(B) are the following:
``(A) A notice as follows: `GENETICALLY
ENGINEERED'.
``(B) A notice as follows: `THIS PRODUCT CONTAINS A
GENETICALLY ENGINEERED MATERIAL, OR WAS PRODUCED WITH A
GENETICALLY ENGINEERED MATERIAL'.
``(2) Location and size.--(A) The notice required in
paragraph (1)(A) shall immediately precede the notice required
in paragraph (1)(B) and shall be not less than twice the size
of the notice required in paragraph (1)(B).
``(B) The notice required in paragraph (1)(B) shall be of
the same size as would apply if the notice provided nutrition
information that is required in section 403(q)(1) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343).
``(d) Exceptions to Requirements.--Subsection (a) does not apply to
any meat food that--
``(1) is served in restaurants or other establishments in
which food is served for immediate human consumption; or
``(2) is processed and prepared primarily in a retail
establishment, is ready for human consumption, is offered for
sale to consumers but not for immediate human consumption in
such establishment, and is not offered for sale outside such
establishment.
``(e) Guaranty.--
``(1) In general.--Subject to subsection (b)(3)(A) and
paragraph (3), a packer, processor, or other person shall not
be considered to have violated the requirements of this section
with respect to the labeling of meat food if the packer,
processor, or other person (referred to in this subsection as
the `recipient') establishes a guaranty or undertaking signed
by, and containing the name and address of, the person residing
in the United States from whom the recipient received in good
faith the meat food or the animal from which the meat food was
derived, or received in good faith food intended to be fed to
such animal, to the effect that the meat food, or such animal,
or such food, respectively, does not contain genetically
engineered material or was not produced with a genetically
engineered material.
``(2) Scope of guaranty.--In the case of a recipient who
establishes a guaranty or undertaking in accordance with
paragraph (1), the exclusion under such paragraph from being
subject to penalties applies to the recipient without regard to
the use of the meat food by the recipient (or the use by the
recipient of the animal from which the meat food was derived,
or of food intended to be fed to such animal), including--
``(A) processing the meat food;
``(B) using the meat food as an ingredient in
another food product;
``(C) packing or repacking the meat food; or
``(D) raising the animal from which the meat food
was derived.
``(3) Testing.--In the case of recipients who establish
guaranties or undertakings in accordance with paragraph (1),
regulations under subsection (b)(3)(A) may exempt the
recipients from the requirement under such subsection regarding
testing of the meat food involved (relating to the accuracy of
labels regarding genetically engineered material). In
determining whether to establish such exemptions, the Secretary
shall, with respect to the meat food involved, take into
account the number of times the food has been transferred from
one recipient to another, the number of recipients who took any
of the actions described in paragraph (2), and such other
factors as the Secretary determines to be appropriate.
``(4) False guaranty.--It is a violation of this Act for a
person to give a guaranty or undertaking in accordance with
paragraph (1) that the person knows or has reason to know is
false.
``(f) Civil Penalties.--
``(1) In general.--The Secretary may assess a civil penalty
against a person that violates subsection (b) or (c)(2) in an
amount not to exceed $100,000 for each such violation.
``(2) Notice and opportunity for hearing.--A civil penalty
under paragraph (1) shall be assessed by the Secretary by an
order made on the record after opportunity for a hearing
provided in accordance with this subparagraph and section 554
of title 5, United States Code. Before issuing such an order,
the Secretary shall give written notice to the person to be
assessed a civil penalty under such order of the Secretary's
proposal to issue such order and provide such person an
opportunity for a hearing on the order. In the course of any
investigation, the Secretary may issue subpoenas requiring the
attendance and testimony of witnesses and the production of
evidence that relates to the matter under investigation.
``(3) Considerations regarding amount of penalty.--In
determining the amount of a civil penalty under paragraph (1),
the Secretary shall take into account the nature,
circumstances, extent, and gravity of the violation or
violations and, with respect to the violator, ability to pay,
effect on ability to continue to do business, any history of
prior such violations, the degree of culpability, and such
other matters as justice may require.
``(4) Certain authorities.--The Secretary may compromise,
modify, or remit, with or without conditions, any civil penalty
under paragraph (1). The amount of such penalty, when finally
determined, or the amount agreed upon in compromise, may be
deducted from any sums owing by the United States to the person
charged.
``(5) Judicial review.--Any person who requested, in
accordance with paragraph (2), a hearing respecting the
assessment of a civil penalty under paragraph (1) and who is
aggrieved by an order assessing a civil penalty may file a
petition for judicial review of such order with the United
States Court of Appeals for the District of Columbia Circuit or
for any other circuit in which such person resides or transacts
business. Such a petition may only be filed within the 60-day
period beginning on the date the order making such assessment
was issued.
``(6) Failure to pay.--If a person fails to pay an
assessment of a civil penalty--
``(A) after the order making the assessment becomes
final, and if such person does not file a petition for
judicial review of the order in accordance with
paragraph (5); or
``(B) after a court in an action brought under
paragraph (4) has entered a final judgment in favor of
the Secretary;
the Attorney General shall recover the amount assessed (plus
interest at currently prevailing rates from the date of the
expiration of the 60-day period referred to in paragraph (5) or
the date of such final judgment, as the case may be) in an
action brought in any appropriate district court of the United
States. In such an action, the validity, amount, and
appropriateness of such penalty shall not be subject to review.
``(g) Citizen Suits.--
``(1) In general.--Except as provided in paragraph (3), any
person may on his or her behalf commence a civil action in an
appropriate district court of the United States against--
``(A) a person who is alleged to have engaged in a
violation of subsection (b) or (c)(2); or
``(B) the Secretary where there is alleged a
failure of the Secretary to perform any act or duty
under subsection (b) or (c)(2) that is not
discretionary.
``(2) Relief.--In a civil action under paragraph (1), the
district court involved may, as the case may be--
``(A) enforce the compliance of a person with the
applicable provisions referred to subparagraph (A) of
such paragraph; or
``(B) order the Secretary to perform an act or duty
referred to in subparagraph (B) of such paragraph.
``(3) Limitations.--
``(A) Notice to secretary.--A civil action may not
be commenced under paragraph (1)(A) prior to 60 days
after the plaintiff has provided to the Secretary
notice of the violation involved.
``(B) Relation to actions of secretary.--A civil
action may not be commenced under paragraph (1)(B) if
the Secretary has commenced and is diligently
prosecuting a civil or criminal action in a district
court of the United States to enforce compliance with
the applicable provisions referred to in paragraph
(1)(A).
``(4) Right of secretary to intervene.--In any civil action
under paragraph (1), the Secretary, if not a party, may
intervene as a matter of right.
``(5) Award of costs; filing of bond.--In a civil action
under paragraph (1), the district court involved may award
costs of litigation (including reasonable attorney and expert
witness fees) to any party whenever the court determines such
an award is appropriate. The court may, if a temporary
restraining order or preliminary injunction is sought, require
the filing of a bond or equivalent security in accordance with
the Federal Rules of Civil Procedure.
``(6) Savings provision.--This subsection does not restrict
any right that a person (or class of persons) may have under
any statute or common law to seek enforcement of the provisions
referred to in paragraph (1)(A), or to seek any other relief
(including relief against the Secretary).''.
(b) Inclusion of Labeling Requirements in Definition of
Misbranded.--Section 1(n) of the Federal Meat Inspection Act (21 U.S.C.
601(n)) is amended--
(1) by striking ``or'' at the end of paragraph (11);
(2) by striking the period at the end of paragraph (12) and
inserting ``; or''; and
(3) by adding at the end the following paragraph:
``(13) if it fails to bear a label or labeling as required
by section 7A.''.
SEC. 5. LABELING REGARDING GENETICALLY ENGINEERED MATERIAL; AMENDMENTS
TO POULTRY PRODUCTS INSPECTION ACT.
(a) Requirements.--The Poultry Products Inspection Act is amended
by inserting after section 8 (21 U.S.C. 457) the following section:
``SEC. 8A. REQUIREMENTS FOR LABELING REGARDING GENETICALLY ENGINEERED
MATERIAL.
``(a) Definitions.--In this section:
``(1) The term `genetically engineered material' means
material derived from any part of a genetically engineered
organism, without regard to whether the altered molecular or
cellular characteristics of the organism are detectable in the
material (and without regard to whether the organism is capable
of use as human food).
``(2) The term `genetically engineered organism' means--
``(A) an organism that has been altered at the
molecular or cellular level by means that are not
possible under natural conditions or processes
(including but not limited to recombinant DNA and RNA
techniques, cell fusion, microencapsulation,
macroencapsulation, gene deletion and doubling,
introducing a foreign gene, and changing the positions
of genes), other than a means consisting exclusively of
breeding, conjugation, fermentation, hybridization, in
vitro fertilization, tissue culture, or mutagenesis;
and
``(B) an organism made through sexual or asexual
reproduction (or both) involving an organism described
in subparagraph (A), if possessing any of the altered
molecular or cellular characteristics of the organism
so described.
``(b) Labeling Requirement.--
``(1) Required labeling to avoid misbranding.--
``(A) Involvement of genetically engineered
material.--For purposes of sections 4(h) and 9(a), a
poultry product is misbranded if it--
``(i) contains a genetically engineered
material or was produced with a genetically
engineered material; and
``(ii) does not bear a label (or include
labeling, in the case of a poultry product that
is not packaged in a container) that provides,
in a clearly legible and conspicuous manner,
the notices described in subsection (c).
``(B) No involvement of genetically engineered
material.--For purposes of sections 4(h) and 9(a), a
poultry product is misbranded if it bears a label
indicating that it does not contain a genetically
engineered material, or that it was not produced with a
genetically engineered material, unless the label is in
accordance with regulations promulgated by the
Secretary. With respect to such regulations:
``(i) The regulations may not require such
a label to include any statement indicating
that the fact that a poultry product does not
contain such material, or was not produced with
such material, has no bearing on the safety of
the product for human consumption.
``(ii) The regulations may not prohibit
such a label on the basis that, in the case of
the type of poultry product involved, there is
no version of the product in commercial
distribution that does contain a genetically
engineered material.
``(2) Rule of construction.--For purposes of subparagraphs
(A)(i) and (B) of paragraph (1), a poultry product shall be
considered to have been produced with a genetically engineered
material if--
``(A) the poultry from which the food is derived
has been injected or otherwise treated with a
genetically engineered material;
``(B) the poultry from which the food is derived
has been fed genetically engineered material; or
``(C) the food contains an ingredient that is a
food to which subparagraph (A) or (B) of this paragraph
applies.
``(3) Testing.--For purposes of sections 4(h) and 9(a):
``(A) In the case of the transfer of poultry
products from manufacturers or producers to
distributors, and from distributors to other
distributors or to other persons in the chain of
distribution, including persons who hold poultry
products for sale to consumers, regulations under
subparagraphs (A)(i) and (B) of paragraph (1) shall
require periodic testing of poultry products by the
Secretary for purposes of determining the accuracy of
labels under such subparagraphs. Such regulations shall
require the use of the best available technology for
such testing, and shall identify tests that meet such
requirement. This subparagraph and subparagraph (B) of
this paragraph do not apply to (i) poultry products
that are certified and comply with the Organic Foods
Production Act and its implementing regulations; or
(ii) poultry products produced with genetically
engineered material if the Secretary has not through
such regulations identified a validated method of
testing for such material in the food; or (iii)
genetically engineered material contained in a poultry
products if the Secretary has not through such
regulations identified a validated method of testing
for such material in the product.
``(B) A poultry product with respect to which a
test has been identified under subparagraph (A) shall
not be considered to contain a genetically engineered
material for purposes of subparagraphs (A)(i) and (B)
of paragraph (1) if, as indicated by such a test--
``(i) the product does not contain any
genetically engineered material; or
``(ii) the product contains an adventitious
genetically engineered material and the amount
of the material in the product is one percent
or less, except that a lower percentage
designated by the Secretary shall apply for
purposes of this subparagraph if the Secretary
determines that a test identified under
subparagraph (A) can detect a percentage lower
than one percent.
``(c) Specifics of Label Notices.--
``(1) Required notices.--The notices referred to in
subsection (b)(1)(B) are the following:
``(A) A notice as follows: `GENETICALLY
ENGINEERED'.
``(B) A notice as follows: `THIS PRODUCT CONTAINS A
GENETICALLY ENGINEERED MATERIAL, OR WAS PRODUCED WITH A
GENETICALLY ENGINEERED MATERIAL'.
``(2) Location and size.--(A) The notice required in
paragraph (1)(A) shall immediately precede the notice required
in paragraph (1)(B) and shall be not less than twice the size
of the notice required in paragraph (1)(B).
``(B) The notice required in paragraph (1)(B) shall be of
the same size as would apply if the notice provided nutrition
information that is required in section 403(q)(1) of the
Federal Food, Drug, and Cosmetic Act.
``(d) Exceptions to Requirements.--Subsection (a) does not apply to
any poultry product that--
``(1) is served in restaurants or other establishments in
which food is served for immediate human consumption; or
``(2) is processed and prepared primarily in a retail
establishment, is ready for human consumption, is offered for
sale to consumers but not for immediate human consumption in
such establishment, and is not offered for sale outside such
establishment.
``(e) Guaranty.--
``(1) In general.--Subject to subsection (b)(3)(A) and
paragraph (3), an official establishment or other person shall
not be considered to have violated the requirements of this
section with respect to the labeling of a poultry product if
the official establishment or other person (referred to in this
subsection as the `recipient') establishes a guaranty or
undertaking signed by, and containing the name and address of,
the person residing in the United States from whom the
recipient received in good faith the poultry product or the
poultry from which the poultry product was derived, or received
in good faith food intended to be fed to poultry, to the effect
that the poultry product, poultry, or such food, respectively,
does not contain genetically engineered material or was not
produced with a genetically engineered material.
``(2) Scope of guaranty.--In the case of a recipient who
establishes a guaranty or undertaking in accordance with
paragraph (1), the exclusion under such paragraph from being
subject to penalties applies to the recipient without regard to
the use of the poultry product by the recipient (or the use by
the recipient of the poultry from which the poultry product was
derived, or of food intended to be fed to such poultry),
including--
``(A) processing the poultry;
``(B) using the poultry product as an ingredient in
another food product;
``(C) packing or repacking the poultry product; or
``(D) raising the poultry from which the poultry
product was derived.
``(3) Testing.--In the case of recipients who establish
guaranties or undertakings in accordance with paragraph (1),
regulations under subsection (b)(3)(A) may exempt the
recipients from the requirement under such subsection regarding
testing of the poultry product involved (relating to the
accuracy of labels regarding genetically engineered material).
In determining whether to establish such exemptions, the
Secretary shall, with respect to the poultry product involved,
take into account the number of times the product has been
transferred from one recipient to another, the number of
recipients who took any of the actions described in paragraph
(2), and such other factors as the Secretary determines to be
appropriate.
``(4) False guaranty.--It is a violation of this Act for a
person to give a guaranty or undertaking in accordance with
paragraph (1) that the person knows or has reason to know is
false.
``(f) Civil Penalties.--
``(1) In general.--The Secretary may assess a civil penalty
against a person that violates subsection (b) or (c)(2) in an
amount not to exceed $100,000 for each such violation.
``(2) Notice and opportunity for hearing.--A civil penalty
under paragraph (1) shall be assessed by the Secretary by an
order made on the record after opportunity for a hearing
provided in accordance with this subparagraph and section 554
of title 5, United States Code. Before issuing such an order,
the Secretary shall give written notice to the person to be
assessed a civil penalty under such order of the Secretary's
proposal to issue such order and provide such person an
opportunity for a hearing on the order. In the course of any
investigation, the Secretary may issue subpoenas requiring the
attendance and testimony of witnesses and the production of
evidence that relates to the matter under investigation.
``(3) Considerations regarding amount of penalty.--In
determining the amount of a civil penalty under paragraph (1),
the Secretary shall take into account the nature,
circumstances, extent, and gravity of the violation or
violations and, with respect to the violator, ability to pay,
effect on ability to continue to do business, any history of
prior such violations, the degree of culpability, and such
other matters as justice may require.
``(4) Certain authorities.--The Secretary may compromise,
modify, or remit, with or without conditions, any civil penalty
under paragraph (1). The amount of such penalty, when finally
determined, or the amount agreed upon in compromise, may be
deducted from any sums owing by the United States to the person
charged.
``(5) Judicial review.--Any person who requested, in
accordance with paragraph (2), a hearing respecting the
assessment of a civil penalty under paragraph (1) and who is
aggrieved by an order assessing a civil penalty may file a
petition for judicial review of such order with the United
States Court of Appeals for the District of Columbia Circuit or
for any other circuit in which such person resides or transacts
business. Such a petition may only be filed within the 60-day
period beginning on the date the order making such assessment
was issued.
``(6) Failure to pay.--If a person fails to pay an
assessment of a civil penalty--
``(A) after the order making the assessment becomes
final, and if such person does not file a petition for
judicial review of the order in accordance with
paragraph (5); or
``(B) after a court in an action brought under
paragraph (4) has entered a final judgment in favor of
the Secretary;
the Attorney General shall recover the amount assessed (plus
interest at currently prevailing rates from the date of the
expiration of the 60-day period referred to in paragraph (5) or
the date of such final judgment, as the case may be) in an
action brought in any appropriate district court of the United
States. In such an action, the validity, amount, and
appropriateness of such penalty shall not be subject to review.
``(g) Citizen Suits.--
``(1) In general.--Except as provided in paragraph (3), any
person may on his or her behalf commence a civil action in an
appropriate district court of the United States against--
``(A) a person who is alleged to have engaged in a
violation of subsection (b) or (c)(2); or
``(B) the Secretary where there is alleged a
failure of the Secretary to perform any act or duty
under subsection (b) or (c)(2) that is not
discretionary.
``(2) Relief.--In a civil action under paragraph (1), the
district court involved may, as the case may be--
``(A) enforce the compliance of a person with the
applicable provisions referred to subparagraph (A) of
such paragraph; or
``(B) order the Secretary to perform an act or duty
referred to in subparagraph (B) of such paragraph.
``(3) Limitations.--
``(A) Notice to secretary.--A civil action may not
be commenced under paragraph (1)(A) prior to 60 days
after the plaintiff has provided to the Secretary
notice of the violation involved.
``(B) Relation to actions of secretary.--A civil
action may not be commenced under paragraph (1)(B) if
the Secretary has commenced and is diligently
prosecuting a civil or criminal action in a district
court of the United States to enforce compliance with
the applicable provisions referred to in paragraph
(1)(A).
``(4) Right of secretary to intervene.--In any civil action
under paragraph (1), the Secretary, if not a party, may
intervene as a matter of right.
``(5) Award of costs; filing of bond.--In a civil action
under paragraph (1), the district court involved may award
costs of litigation (including reasonable attorney and expert
witness fees) to any party whenever the court determines such
an award is appropriate. The court may, if a temporary
restraining order or preliminary injunction is sought, require
the filing of a bond or equivalent security in accordance with
the Federal Rules of Civil Procedure.
``(6) Savings provision.--This subsection does not restrict
any right that a person (or class of persons) may have under
any statute or common law to seek enforcement of the provisions
referred to in paragraph (1)(A), or to seek any other relief
(including relief against the Secretary).''.
(b) Inclusion of Labeling Requirements in Definition of
Misbranded.--Section 4(h) of the Poultry Products Inspection Act (21
U.S.C. 453(h)) is amended--
(1) by striking ``or'' at the end of paragraph (11);
(2) by striking the period at the end of paragraph (12) and
inserting ``; or''; and
(3) by adding at the end the following paragraph:
``(13) if it fails to bear a label or labeling as required
by section 8A.''.
SEC. 6. EFFECTIVE DATE.
This Act and the amendments made by this Act take effect upon the
expiration of the 180-day period beginning on the date of the enactment
of this Act.
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