I
106TH CONGRESS
2D SESSION
H. R. 3883
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
safety of genetically engineered foods.
IN THE HOUSE OF REPRESENTATIVES
MARCH 9, 2000
Mr. KUCINICH (for himself, Mr. METCALF, Mr. HINCHEY, Mr. CONYERS, Mr.
SANDERS, Ms. WOOLSEY, and Ms. LEE) introduced the following bill;
which was referred to the Committee on Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with
respect to the safety of genetically engineered foods.
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:
(1) Genetic engineering is an artificial gene
transfer process wholly different from traditional
breeding.
(2) Genetic engineering can be used to produce
new versions of virtually all plant and animal foods.
Thus, within a short time, the food supply could
consist almost entirely of genetically engineered
products.
(3) This conversion from a food supply based
on traditionally bred organisms to one based on or-
ganisms produced through genetic engineering could
be one the most important changes in our food sup-
ply in this century.
(4) Genetically engineered foods present new
issues of safety that have not been adequately stud-
ied.
(5) The Congress has previously required that
food additives be analyzed for their safety prior to
their placement on the market.
(6) Adding new genes into a food should be
considered adding a food additive, thus requiring an
analysis of safety factors.
(7) Federal agencies have failed to uphold con-
gressional intent of the Food Additives Amendment
of 1958 by allowing genetically engineered foods to
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.
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, or tissue culture, 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, the Sec-
retary, promptly after providing the notice under subpara-
graph (A), shall make available 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 determination of the safety for use of the additive. Such
notice shall state whether any information in the petition
is not being made available to the public because the Sec-
retary has made a determination that the information does
not relate to the safety for use of the additive. Any person
may petition the Secretary for a reconsideration of such
a determination, and if the Secretary finds in favor of such
person, the period for public comment under subsection
(c)(2)(B) shall be extended accordingly.
‘‘(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) In the case of a genetic food additive, an order
under paragraph (1)(A) may not be issued before the expi-
ration of the 30-day period beginning on the date on which
the Secretary has under subsection (b)(5) made informa-
tion available to the public pursuant to a notification
under such subsection regarding the petition involved.
During such period (or such longer period as the Secretary
may designate), the Secretary shall provide interested per-
sons an opportunity to submit to the Secretary comments
on the petition. In publishing such notice, the Secretary
shall inform the public of such opportunity.’’.
(3) 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).
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.’’.
(5) PROHIBITED ADDITIVES.—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:
‘‘(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, 2004, 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.’’.
(6) ADDITIONAL PROVISIONS.—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:
‘‘(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) In the case of genetic food additives, petitions
under subsection (b)(1) may not be categorically excluded
for purposes of the National Environmental Policy Act.’’.
(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) 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
this section assess and collect a fee on each petition that
is filed under section 409(b)(1). The fee shall be collected
from the person who submits the petition, is due upon sub-
mission of the petition, and shall be assessed in an amount
determined under subsection (c). This section applies as
of the first fiscal year that begins after the date of promul-
gation of the final rule required in section 5 of the Geneti-
cally Engineered Food Safety Act (referred to in this sec-
tion as the ‘first applicable fiscal year’).
‘‘(b) PURPOSE OF FEES.—
‘‘(1) IN GENERAL.—The purposes of fees under
subsection (a) are as follows:
‘‘(A) To defray increases in the costs of
the resources allocated for carrying out section
409 for the first applicable fiscal year over the
costs of carrying out such section for the pre-
ceding fiscal year, other than increases that are
not attributable to the responsibilities of the
Secretary with respect to genetic food additives.
‘‘(B) To provide for a program of basic
and applied research on the safety of genetic
food additives (to be carried out by the Com-
missioner of Food and Drugs). The program
shall address fundamental questions and prob-
lems that arise repeatedly during the process of
reviewing petitions under section 409(b)(1) with
respect to genetic food additives, and shall not
directly support the development of new geneti-
cally engineered foods.
‘‘(2) ALLOCATIONS
BY
SECRETARY.—Of the
total fee revenues collected under subsection (a) for
a fiscal year, the Secretary shall reserve and
expend—
‘‘(A) 95 percent for the purpose described
in paragraph (1)(A) and
‘‘(B) 5 percent for the purpose described
in paragraph (1)(B).
‘‘(3) CERTAIN
PROVISIONS
REGARDING
IN-
CREASED ADMINISTRATIVE COSTS.—With respect to
fees under subsection (a):
‘‘(A) Increases referred to in paragraph
(1)(A) include the costs of the Secretary in pro-
viding 
for 
investigations 
under 
section
409(c)(9)(A).
‘‘(B) Increases referred to in paragraph
(1)(A) include increases in costs for an addi-
tional number of full-time equivalent positions
in the Department of Health and Human Serv-
ices to be engaged in carrying out section 409
with respect to genetic food additives.
‘‘(c) TOTAL
FEE
REVENUES; INDIVIDUAL
FEE
AMOUNTS.—The total fee revenues collected under sub-
section (a) for a fiscal year shall be the amounts appro-
priated under subsection (f)(2) for such fiscal year. Indi-
vidual fees shall be assessed by the Secretary on the basis
of an estimate by the Secretary of the amount necessary
to ensure that the sum of the fees collected for such fiscal
year equals the amount so appropriated.
‘‘(d) FEE WAIVER OR REDUCTION.—The Secretary
shall grant a waiver from or a reduction of a fee assessed
under subsection (a) if the Secretary finds that the fee
to be paid will exceed the anticipated present and future
costs incurred by the Secretary in carrying out the pur-
poses described in subsection (b) (which finding may be
made by the Secretary using standard costs).
‘‘(e) ASSESSMENT OF FEES.—
‘‘(1) LIMITATION.—Fees may not be assessed
under subsection (a) for a fiscal year beginning after
the first applicable fiscal year unless the amount ap-
propriated for salaries and expenses of the Food and
Drug Administration for such fiscal year is equal to
or greater than the amount appropriated for salaries
and expenses of the Food and Drug Administration
for the first applicable fiscal year multiplied by the
adjustment factor applicable to the fiscal year in-
volved, except that in making determinations under
this paragraph for the fiscal years involved there
shall be excluded—
‘‘(A) the amounts appropriated under sub-
section (f)(2) for the fiscal years involved; and
‘‘(B) the amounts appropriated under sec-
tion 736(g) for such fiscal years.
‘‘(2) AUTHORITY.—If under paragraph (1) the
Secretary does not have authority to assess fees
under subsection (a) during a portion of a fiscal
year, but does at a later date in such fiscal year
have such authority, the Secretary, notwithstanding
the due date under such subsection for fees, may as-
sess and collect such fees at any time in such fiscal
year, without any modification in the rate of the
fees.
‘‘(f) CREDITING AND AVAILABILITY OF FEES.—
‘‘(1) IN GENERAL.—Fees collected for a fiscal
year pursuant to subsection (a) shall be credited to
the appropriation account for salaries and expenses
of the Food and Drug Administration and shall be
available in accordance with appropriation Acts until
expended without fiscal year limitation. Such sums
as may be necessary may be transferred from the
Food and Drug Administration salaries and ex-
penses appropriation account without fiscal year lim-
itation to such appropriation account for salaries
and expenses with such fiscal year limitation. The
sums transferred shall be available solely for the
purposes described in paragraph (1) of subsection
(b), and the sums are subject to allocations under
paragraph (2) of such subsection.
‘‘(2) AUTHORIZATION OF APPROPRIATIONS.—
‘‘(A) FIRST FISCAL YEAR.—For the first
applicable fiscal year—
‘‘(i) there is authorized to be appro-
priated for fees under subsection (a) an
amount equal to the amount of increase
determined under subsection (b)(1) by the
Secretary (which amount shall be pub-
lished in the Federal Register); and
‘‘(ii) in addition, there is authorized to
be appropriated for fees under subsection
(a) an amount determined by the Secretary
to be necessary to carry out the purpose
described in subsection (b)(2) (which
amount shall be so published).
‘‘(B) SUBSEQUENT
FISCAL
YEARS.—For
each of the four fiscal years following the first
applicable fiscal year—
‘‘(i) there is authorized to be appro-
priated for fees under subsection (a) an
amount equal to the amount that applied
under subparagraph (A)(i) for the first ap-
plicable fiscal year, except that such
amount shall be adjusted under paragraph
(3)(A) for the fiscal year involved; and
‘‘(ii) in addition, there is authorized to
be appropriated for fees under subsection
(a) an amount equal to the amount that
applied under subparagraph (A)(ii) for the
first applicable fiscal year, except that such
amount shall be adjusted under paragraph
(3)(B) for the fiscal year involved.
‘‘(3) ADJUSTMENTS.—
‘‘(A) AGENCY COST OF RESOURCES.—For
each fiscal year other than the first applicable
fiscal year, the amount that applied under para-
graph (2)(A)(i) for the first applicable fiscal
year shall be multiplied by the adjustment fac-
tor (as defined in subsection (i)).
‘‘(B) RESEARCH PROGRAM.—For each fis-
cal year other than the first applicable fiscal
year, the amount that applied under paragraph
(2)(A)(ii) for the first applicable fiscal year
shall be adjusted by the Secretary (and as ad-
justed shall be published in the Federal Reg-
ister) to reflect the greater of—
‘‘(i) the total percentage change that
occurred during the preceding fiscal year
in the Consumer Price Index for all urban
consumers (all items; U.S. city average); or
‘‘(ii) the total percentage change for
such fiscal year in basic pay under the
General Schedule in accordance with sec-
tion 5332 of title 5, United States Code,
as adjusted by any locality-based com-
parability payment pursuant to section
5304 of such title for Federal employees
stationed in the District of Columbia.
‘‘(4) OFFSET.—Any amount of fees collected
for a fiscal year under subsection (a) that exceeds
the amount of fees specified in appropriation Acts
for such fiscal year shall be credited to the appro-
priation account of the Food and Drug Administra-
tion as provided in paragraph (1), and shall be sub-
tracted from the amount of fees that would other-
wise be authorized to be collected under this section
pursuant to appropriation Acts for a subsequent fis-
cal year.
‘‘(g) COLLECTION OF UNPAID FEES.—In any case
where the Secretary does not receive payment of a fee as-
sessed under subsection (a) within 30 days after it is due,
such fee shall be treated as a claim of the United States
Government subject to subchapter II of chapter 37 of title
31, United States Code.
‘‘(h) CONSTRUCTION.—This section may not be con-
strued as requiring that the number of full-time equivalent
positions in the Department of Health and Human Serv-
ices, for officers, employers, and advisory committees not
engaged in carrying out section 409 with respect to ge-
netic food additives be reduced to offset the number of
officers, employees, and advisory committees so engaged.
‘‘(i) DEFINITION
OF ADJUSTMENT FACTOR.—For
purposes of this section, the term ‘adjustment factor’ ap-
plicable to a fiscal year is the lower of—
‘‘(1) the Consumer Price Index for all urban
consumers (all items; United States city average) for
April of the preceding fiscal year divided by such
Index for April of the first applicable fiscal year; or
‘‘(2) the total of discretionary budget authority
provided for programs in categories other than the
defense category for the immediately preceding fiscal
year (as reported in the Office of Management and
Budget sequestration preview report, if available, re-
quired under section 254(c) of the Balanced Budget
and Emergency Deficit Control Act of 1985) divided
by such budget authority for the first applicable fis-
cal year (as reported in the Office of Management
and Budget final sequestration report submitted for
such year).
For purposes of this subsection, the terms ‘budget author-
ity’ and ‘category’ have the meaning given such terms in
the Balanced Budget and Emergency Deficit Control Act
of 1985.’’.
SEC. 5. RULEMAKING; EFFECTIVE DATE; PREVIOUSLY UN-
REGULATED MARKETED ADDITIVES.
(a) RULEMAKING; EFFECTIVE DATE.—Not later
than one year after the date of the enactment of this Act,
the Secretary of Health and Human Services shall by reg-
ulation establish criteria for carrying out section 409 of
the Federal Food, Drug, and Cosmetic Act in accordance
with the amendments made by section 3, and criteria for
carrying out section 409A of such Act (as added by section
4). Such amendments take effect upon the expiration of
the 30-day period beginning on the date on which the Sec-
retary promulgates the final rule under the preceding sen-
tence, subject to subsection (b).
(b) PREVIOUSLY UNREGULATED MARKETED ADDI-
TIVES.—
(1) IN GENERAL.—In the case of a genetic food
additive (as defined pursuant to the amendments
made by section (3)) that in the United States was
in commercial use in food as of the day before the
date on which the final rule under subsection (a) is
promulgated, the amendments made by this Act
apply to the additive upon the expiration of the two-
year period beginning on the date on which the final
rule is promulgated, subject to paragraph (2).
(2) USER
FEES.—With respect to a genetic
food additive described in paragraph (1), such para-
graph does not waive the applicability of section
409A of the Federal Food, Drug, and Cosmetic Act
to a petition under section 409(b)(1) of such Act
that is filed before the expiration of the two-year pe-
riod described in such paragraph.
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