ceutical crop or industrial crop in an open air environ-
ment. 
(c) PROHIBITION
ON USE
OF COMMON HUMAN 
FOODS OR ANIMAL FEEDS.—No person may grow, raise, 
or otherwise cultivate a pharmaceutical crop or industrial 
crop in a food commonly used for human food or domestic 
animal feed. 
(d) BIOTECH
TRACKING
SYSTEM.—The United 
States Department of Agriculture shall establish a track-
ing system to regulate the growing, handling, transpor-
tation, and disposal of all pharmaceutical and industrial 
crops and their byproducts to prevent contamination. 
(e) REGULATIONS.—The Secretary of Agriculture 
shall issue regulations— 
(1) to enforce the prohibitions imposed by sub-
sections (b) and (c); 
(2) to designate the foods commonly used for 
human food or domestic animal feed, the use of 
which as a source of a pharmaceutical crop or indus-
trial crop is prohibited by subsection (c); and 
(3) to establish the tracking system required by 
subsection (d). 
SEC. 105. CIVIL PENALTIES FOR VIOLATION. 
(a) AUTHORITY TO ACCESS PENALTIES.—The Sec-
retary of Agriculture may assess, by written order, a civil 
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penalty against a person that violates a provision of sec-
tion 105, including a regulation promulgated or order 
issued under such section. Each violation, and each day 
during which a violation continues, shall be a separate of-
fense. 
(b) AMOUNT
AND FACTORS
IN ACCESSING PEN-
ALTIES.—The maximum amount that may be accessed 
under this section for a violation may not exceed 
$1,000,000. In determining the amount of the civil pen-
alty, 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 such sec-
tion 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 person unless the company is given notice and 
opportunity for a hearing on the record before the Sec-
retary 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— 
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(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-
priateness of the order of the Secretary imposing the civil 
penalty shall not be subject to review. 
SEC. 106. REPORT TO CONGRESS ON ALTERNATIVE METH-
ODS TO PRODUCE PHARMACEUTICAL AND IN-
DUSTRIAL CROPS. 
The National Academy of Sciences shall submit to 
Congress a report that explores alternative methods to 
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