‘‘(C) effective June 1, 2006, 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.’’. 
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(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: 
‘‘(g)(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. 
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‘‘(2) Paragraphs (3) through (5) of subsection (f) 
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 
(f).’’. 
(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 GENETIC FOOD AD-
DITIVES. 
‘‘(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) 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. 
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‘‘(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-
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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: 
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‘‘SEC. 409A. USER FEES REGARDING SAFETY OF GENETIC 
FOOD ADDITIVES. 
‘‘(a) IN GENERAL.—In the case of genetic food addi-
tives, 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 per-
son who submits the petition, is due upon submission of 
the petition, and shall be assessed in an amount deter-
mined under subsection (c). This section applies as of the 
first fiscal year that begins after the date of promulgation 
of the final rule required in section 6 of the Genetically 
Engineered Food Safety Act (referred to in this section 
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-
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missioner). The program shall address funda-
mental questions and problems that arise re-
peatedly during the process of reviewing peti-
tions under section 409(b)(1) with respect to 
genetic food additives, and shall not directly 
support the development of new genetically en-
gineered foods. 
‘‘(2) ALLOCATIONS
BY
SECRETARY.—Of the 
total fee revenues collected under subsection (a) for 
a fiscal year, the Secretary shall reserve and ex-
pend— 
‘‘(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 
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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. In assessing the 
individual fees, the Secretary shall by regulation provide 
for the assessment of reduced fee amounts for entities that 
are small businesses, or nonprofit private entities, as de-
fined by the Secretary for purposes of this section. 
‘‘(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 
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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.— 
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