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 (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 man-
ner as such paragraphs (5) through (7) apply with respect 
to a civil penalty under paragraph (1), (2), (3), (4), or 
(9) 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: 
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‘‘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. 
‘‘(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 
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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 
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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. 204. USER FEES REGARDING DETERMINATION OF 
SAFETY 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: 
‘‘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 206 of the Genetically 
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