I
107TH CONGRESS
2D SESSION
H. R. 4813
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
safety of genetically engineered foods, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
MAY 22, 2002
Mr. KUCINICH (for himself, Mr. SANDERS, Ms. MCKINNEY, Ms. RIVERS, Mr.
PALLONE, Mrs. MINK of Hawaii, Ms. CARSON of Indiana, Mr. DEFAZIO,
Mr. GUTIERREZ, Mr. NADLER, Mr. OLVER, Mr. UDALL of New Mexico,
Ms. VELA´ZQUEZ, Ms. WATERS, Ms. WOOLSEY, Mr. JACKSON of Illinois,
Ms. WATSON of California, Mr. RODRIGUEZ, Ms. BERKLEY, Mr. OWENS,
Ms. SOLIS, Mr. GEORGE MILLER of California, Mr. HINCHEY, and Ms.
LEE) 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 the safety of genetically engineered foods, and
for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Genetically Engineered
Food Safety Act’’.
SEC. 2. FINDINGS.
The Congress finds as follows:
be marketed, sold and otherwise used without re-
quiring pre-market safety testing addressing their
unique characteristics.
(8) The food additive process gives the Food
and Drug Administration discretion in applying the
safety factors that are generally recognized as ap-
propriate to evaluate the safety of food and food in-
gredients.
(9) Given the consensus among the scientific
community that genetic engineering can potentially
introduce hazards, such as allergens or toxins, ge-
netically engineered foods need to be evaluated on a
case-by-case basis and cannot be presumed to be
generally recognized as safe.
SEC. 3. FEDERAL DETERMINATION OF SAFETY OF GENETI-
CALLY ENGINEERED FOOD; REGULATION AS
FOOD ADDITIVE.
(a) INCLUSION
IN DEFINITION
OF FOOD ADDI-
TIVE.—Section 201 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 321) is amended—
(1) in paragraph (s), by adding after and below
subparagraph (6) the following sentence:
‘‘Such term includes the different genetic constructs, pro-
teins of such constructs, vectors, promoters, marker sys-
tems, and other appropriate terms that are used or cre-
ated as a result of the creation of a genetically engineered
food (as defined in paragraph (kk)), other than a genetic
construct, protein, vector, promoter, or marker system or
other appropriate term for which an application under sec-
tion 505 or 512 has been filed. For purposes of this Act,
the term ‘genetic food additive’ means a genetic construct,
protein, vector, promoter, or marker system or other ap-
propriate term that is so included.’’; and
(2) by adding at the end the following:
‘‘(kk)(1) The term ‘genetically engineered food’
means food that contains or was produced with a geneti-
cally engineered material.
‘‘(2) The term ‘genetically engineered material’
means material derived from any part of a genetically en-
gineered organism, without regard to whether the altered
molecular or cellular characteristics of the organism are
detectable in the material.
‘‘(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 (in-
cluding but not limited to recombinant DNA and
RNA techniques, cell fusion, microencapsulation,
macroencapsulation, gene deletion and doubling, in-
troducing a foreign gene, and changing the positions
of genes), other than a means consisting exclusively
of breeding, conjugation, fermentation, hybridiza-
tion, in vitro fertilization, tissue culture, or
mutagenesis; and
‘‘(B) an organism made through sexual or asex-
ual reproduction (or both) involving an organism de-
scribed in clause (A), if possessing any of the altered
molecular or cellular characteristics of the organism
so described.
‘‘(4) For purposes of subparagraph (1), a food shall
be considered to have been produced with a genetically en-
gineered material if the organism from which the food is
derived has been injected or otherwise treated with a ge-
netically engineered material (except that the use of ma-
nure as a fertilizer for raw agricultural commodities may
not be construed to mean that such commodities are pro-
duced with a genetically engineered material).’’.
(b) PETITION TO ESTABLISH SAFETY.—
(1) DATA IN PETITION.—Section 409(b)(2)(E)
of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 348(b)(2)(E)) is amended by adding at the
end the following sentence: ‘‘In the case of a genetic
food additive, such reports shall include all data that
was collected or developed pursuant to the investiga-
tions, including data that does not support the claim
of safety for use.’’.
(2) NOTICES; PUBLIC AVAILABILITY OF INFOR-
MATION.—Section 409(b)(5) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 348(b)(5)) is
amended—
(A) by striking ‘‘(5)’’ and inserting
‘‘(5)(A)’’; and
(B) by adding at the end the following sub-
paragraphs:
‘‘(B) In the case of a genetic food additive:
‘‘(i) Promptly after providing the notice under
subparagraph (A), the Secretary shall make avail-
able to the public all reports and data described in
paragraph (2)(E) that are contained in the petition
involved, and all other information in the petition to
the extent that the information is relevant to a de-
termination of the safety for use of the additive.
‘‘(ii) Such notice shall state whether any infor-
mation in the petition is not being made available to
the public because the Secretary has made a deter-
mination that the information does not relate to the
safety for use of the additive. Any person may peti-
tion the Secretary for a reconsideration of such a de-
termination.
‘‘(C) In the case of genetic food additives:
‘‘(i) The Secretary shall maintain and make
available to the public through telecommunications a
list of petitions that are pending under this sub-
section and a list of petitions for which regulations
under subsection (c)(1)(A) have been established.
Such list shall include information on the additives
involved, including the source of the additives, and
including any information received by the Secretary
pursuant to clause (ii).
‘‘(ii) If a regulation is in effect under sub-
section (c)(1)(A) for a genetic food additive, any
person who manufactures such additive for commer-
cial use shall submit to the Secretary a notification
of any knowledge of data that relate to the adverse
health effects of the additive, when knowledge is ac-
quired by the person after the date on which the
regulation took effect. If the manufacturer is in pos-
session of the data, the notification shall include the
data. The Secretary shall by regulation establish the
scope of the responsibilities of manufacturers under
this clause, including such limits on the responsibil-
ities as the Secretary determines to be appropriate.’’.
(3) EFFECTIVE DATE OF REGULATION REGARD-
ING
SAFE
USE; OPPORTUNITY
FOR
PUBLIC
COM-
MENT.—Section 409(c)(2) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 348(c)(2)) is
amended—
(A) by striking ‘‘(2)’’ and inserting
‘‘(2)(A)’’; and
(B) by adding at the end the following sub-
paragraph:
‘‘(B)(i) In the case of a genetic food additive, an
order under paragraph (1)(A) may not be issued regarding
the petition involved before the expiration of the applicable
period under clause (ii). During such period, and con-
tinuing until an order under paragraph (1) is issued, the
Secretary shall provide interested persons an opportunity
to submit to the Secretary comments on the petition. In
publishing such notice, the Secretary shall inform the pub-
lic of such opportunity.
‘‘(ii) For purposes of clause (i), the applicable period
under this clause regarding a petition is the 30-day period
beginning on the date on which the Secretary has under
subparagraph (B)(i) of subsection (b)(5) made informa-
tion available to the public regarding the petition, except
that, if under subparagraph (B)(ii) of such subsection the
Secretary finds in favor of a person who files for reconsid-
eration (relating to a determination by the Secretary that
information does not relate to safety), such 30-day period
is extended by an additional period of 30-days. For pur-
poses of the preceding sentence, a discrete 30-day exten-
sion applies to each such reconsideration for which the
Secretary finds in favor of the person filing for reconsider-
ation.’’.
(4) CONSIDERATION OF CERTAIN FACTORS.—
Section 409(c) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 348(c)) is amended by adding
at the end the following paragraph:
‘‘(6) In the case of a genetic food additive, the factors
considered by the Secretary regarding safety for use shall
include (but not be limited to) the results of the following
analyses:
‘‘(A) Allergenicity effects resulting from the
added proteins, including proteins not found in the
food supply.
‘‘(B) Pleiotropic effects. The Secretary shall re-
quire tests to determine the potential for such ef-
fects (using molecular characterization, biochemical
characterization, mRNA profiling, or other tech-
niques, or as appropriate, combinations of such tech-
niques).
‘‘(C) Appearance of new toxins or increased lev-
els of existing toxins.
‘‘(D) Changes in the functional characteristics
of food.
‘‘(E) Changes in the levels of important nutri-
ents.
‘‘(F) Changes in the levels of anti-nutrients.’’.
(5) CERTAIN
TESTS.—Section 409(c) of the
Federal Food, Drug, and Cosmetic Act, as amended
by paragraph (4), is amended by adding at the end
the following paragraph:
‘‘(7) In the case of genetic food additives:
‘‘(A) If a genetic food additive is a protein from
a commonly or severely allergenic food, the Sec-
retary may not establish a regulation under para-
graph (1)(A) if the petition under subsection (b)(1)
fails to include full reports of investigations that
used serum or skin tests (or other advanced tech-
niques) on a sensitive population to determine
whether such additive is commonly or severely aller-
genic.
‘‘(B)(i) If a genetic food additive is a protein
that has not undergone the investigations described
in subparagraph (A), the Secretary may not estab-
lish a regulation under paragraph (1)(A) if the peti-
tion under subsection (b)(1) fails to include full re-
ports of investigations that used the best available
biochemical and physiological protocols to evaluate
whether it is likely that the protein involved is an al-
lergen.
‘‘(ii) For purposes of clause (i), the Secretary
shall by regulation determine the best available bio-
chemical and physiological protocols. In carrying out
rulemaking under the preceding sentence, the Sec-
retary shall consult with the Director of the Na-
tional Institutes of Health.’’.
(6) PROHIBITED ADDITIVES.—Section 409(c) of
the Federal Food, Drug, and Cosmetic Act, as
amended by paragraph (5), is amended by adding at
the end the following paragraph:
‘‘(8) In the case of a genetic food additive, the Sec-
retary may not establish a regulation under paragraph
(1)(A) if—
‘‘(A) the additive is a protein and a report of
an investigation finds that the additive is likely to be
commonly or severely allergenic;
‘‘(B) the additive is a protein and a report of
an investigation that uses a protocol described in
paragraph (7)(B) fails to find with reasonable cer-
tainty that the additive is unlikely to be an allergen;
or
‘‘(C) effective June 1, 2005, a selective marker
is used with respect to the additive, the selective
marker will remain in the food involved when the
food is marketed, and the selective marker inhibits
the function of one or more antibiotics.’’.
(7) ADDITIONAL PROVISIONS.—Section 409(c)
of the Federal Food, Drug, and Cosmetic Act, as
amended by paragraph (6), is amended by adding at
the end the following paragraph:
‘‘(9)(A) In determining the safety for use of genetic
food additives, the Secretary may (directly or through con-
tract) conduct investigations of such additives for pur-
poses of supplementing the information provided to the
Secretary pursuant to petitions under subsection (b)(1).
‘‘(B) To provide the Congress with a periodic inde-
pendent, external review of the Secretary’s formulation of
the approval process under paragraph (1)(A) that relates
to genetic food additives, the Secretary shall enter into
an agreement with the Institute of Medicine. Such agree-
ment shall provide that, if the Institute of Medicine has
any concerns regarding the approval process, the Institute
of Medicine will submit to the Congress a report describ-
ing such concerns.’’.
(c) REGULATION ISSUED ON SECRETARY’S INITIA-
TIVE.—Section 409(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 348(d)) is amended—
(1) by striking ‘‘(d) The Secretary’’ and insert-
ing ‘‘(d)(1) Subject to paragraph (2), the Sec-
retary’’; and
(2) by adding at the end the following para-
graph:
‘‘(2) The provisions of subsections (b) and (c) that
expressly reference genetic food additives apply with re-
spect to a regulation proposed by the Secretary under
paragraph (1) to the same extent and in the same manner
as such provisions apply with respect to a petition filed
under subsection (b)(1).’’.
(d) CIVIL PENALTIES.—Section 303 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amend-
ed 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 adulteration of food by rea-
son of failure to comply with the provisions of section 409
that relate to genetic food additives, 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 (3) through (5) of subsection (g)
apply with respect to a civil penalty under paragraph (1)
of this subsection to the same extent and in the same man-
ner as such paragraphs (3) through (5) apply with respect
to a civil penalty under paragraph (1) or (2) of subsection
(g).’’.
(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:
‘‘CITIZEN SUITS REGARDING GENETIC FOOD ADDITIVES
‘‘SEC. 311. (a) IN GENERAL.—Except as provided in
subsection (c), any person may on his or her behalf com-
mence 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) in-
volving the adulteration of food by reason of failing
to comply with the provisions of section 409 that re-
late to genetic food additives; or
‘‘(2) the Secretary where there is alleged a fail-
ure of the Secretary to perform any act or duty
under section 409 that relates to such additives and
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 sub-
section (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 com-
pliance 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 attor-
ney 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 in-
junction is sought, require the filing of a bond or equiva-
lent security in accordance with the Federal Rules of Civil
Procedure.
‘‘(f) SAVINGS PROVISION.—This section does not re-
strict any right that a person (or class of persons) may
have under any statute or common law to seek enforce-
ment of the provisions referred to subsection (a)(1), or to
seek any other relief (including relief against the Sec-
retary).’’.
(f) RULE OF CONSTRUCTION.—With respect to sec-
tion 409 of the Federal Food, Drug, and Cosmetic Act
as amended by this section, compliance with the provisions
of such section 409 that relate to genetic food additives
does not constitute an affirmative defense in any cause
of action under Federal or State law for personal injury
resulting in whole or in part from a genetic food additive.
SEC. 4. USER FEES REGARDING DETERMINATION OF SAFE-
TY OF GENETIC FOOD ADDITIVES.
Chapter IV of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 341 et seq.) is amended by inserting after
section 409 the following section:
‘‘USER FEES REGARDING SAFETY OF GENETIC FOOD
ADDITIVES
‘‘SEC. 409A. (a) IN GENERAL.—In the case of ge-
netic food additives, the Secretary shall in accordance with