gineered plants or animals or add as condition to a loan 
the requirement that the producer use genetically engi-
neered plants or animals. 
SEC. 11. CIVIL PENALTIES FOR VIOLATION. 
(a) AUTHORITY TO ASSESS PENALTIES.—The Sec-
retary may assess, by written order, a civil penalty against 
a biotech company or other person that violates a provi-
sion of this Act, including a regulation promulgated or 
order issued under this Act. Each violation, and each day 
during which a violation continues, shall be a separate of-
fense. 
(b) AMOUNT
AND FACTORS
IN ASSESSING PEN-
ALTIES.—The maximum amount that may be assessed 
under this section for a violation may not exceed 
$100,000. In determining the amount of the civil penalty, 
the Secretary shall take into account— 
(1) the gravity of the violation; 
(2) the degree of culpability; 
(3) the size and type of the business; and 
(4) any history of prior offenses under this Act 
or other laws administered by the Secretary. 
(c) NOTICE AND OPPORTUNITY FOR HEARING.—The 
Secretary shall not assess a civil penalty under this section 
against a biotech company or other person unless the com-
pany is given notice and opportunity for a hearing on the 
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record before the Secretary in accordance with sections 
554 and 556 of title 5, United States Code. 
(d) JUDICIAL REVIEW.—(1) An order assessing a 
civil penalty against a person under subsection (a) may 
be reviewed only in accordance with this subsection. The 
order shall be final and conclusive unless the person— 
(A) not later than 30 days after the effective 
date of the order, files a petition for judicial review 
in the United States court of appeals for the circuit 
in which the person resides or has its principal place 
of business or in the United States Court of Appeals 
for the District of Columbia; and 
(B) simultaneously sends a copy of the petition 
by certified mail to the Secretary. 
(2) The Secretary shall promptly file in the court a 
certified copy of the record on which the violation was 
found and the civil penalty assessed. 
(e) COLLECTION ACTION FOR FAILURE TO PAY AS-
SESSMENT.—If a person fails to pay a civil penalty after 
the order assessing the civil penalty has become final and 
unappealable, the Secretary shall refer the matter to the 
Attorney General, who shall bring a civil action to recover 
the amount of the civil penalty in United States district 
court. In the collection action, the validity and appro-
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priateness of the order of the Secretary imposing the civil 
penalty shall not be subject to review. 
SEC. 12. CITIZEN SUITS. 
(a) IN GENERAL.—Except as provided in subsection 
(c), any person may commence a civil action in an appro-
priate district court of the United States against— 
(1) a person who has introduced a genetically 
engineered organism into the environment without 
approval under this Act; 
(2) the Secretary, where there is alleged a fail-
ure of the Secretary to perform any act or duty 
under this Act that is the responsibility of the Sec-
retary and is not discretionary; or 
(3) the head of another Federal agency, if there 
is alleged a failure of the agency head to perform 
any act or duty under this Act that is the responsi-
bility of the agency head and is not discretionary. 
(b) RELIEF.—In a civil action under this section, the 
district court involved may, as the case may be— 
(1) enforce the compliance of a person with the 
applicable provisions referred to in the complaint; or 
(2) order the Secretary or the agency head to 
perform the act or duty referred to in the complaint. 
(c) LIMITATIONS.— 
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