105 STAT. 1900 PUBLIC LAW 102-237—DEC. 13, 1991 (2) by designating the last sentence of subsection (a) as subsection (d) and transferring such subsection to the end of the section; (3) by redesignating subsection (b) as subsection (e) and transferring such subsection to the end of the section; (4) by redesignating subsection (c) as subsection (b); and (5) by inserting after subsection (b) the following new subsection: "(c)(l)(A) Except as otherwise provided in this subsection, any person who violates any provision of this Act or any regulation issued under this Act, other than a violation for which a criminal penalty has been imposed under this Act, may be assessed a civil penalty by the Secretary of not more than $5,000 for each such violation. Each violation to which this subparagraph applies shall be considered a separate offense. "(B) No penalty shall be assessed against any person under this subsection unless the person is given notice and opportunity for a hearing on the record before the Secretary in accordance with sections 554 and 556 of title 5, United States Code. "(C) The amount of the civil penalty imposed under this subsection— "(i) shall be assessed by the Secretary, by written order, taking into account the gravity of the violation, degree of culpability, and history of prior offenses; and (ii) may be reviewed only as provided in paragraph (2). "(2)(A) The determination and order of the Secretary under this subsection shall be final and conclusive unless the person against whom such a violation is found under paragraph (1) files an application for judicial review within 30 days after service of the order in the United States court of appeals for the circuit in which the person has its principal place of business or in the United States Court of Appeals for the District of Columbia Circuit. "(B) Judicial review of any such order shall be based on the record on which the determination and order are based. "(C) If the court determines that additional evidence needs to be taken, the court shall order the hearing to be reopened for this purpose in such manner and on such terms and conditions as the court considers proper. The Secretary may modify the findings of the Secretary as to the facts, or make new findings, on the basis of the additional evidence so taken. "(3) If any person fails to pay an assessment of a civil penalty after the penalty has become a final and unappealable order, or after the appropriate court of appeals has entered a final judgment in favor of the Secretary, the Secretary shall refer the matter to the Attorney General. The Attorney General shall institute a civil action to recover the amount assessed in an appropriate district court of the United States. In the collection action, the validity and appropriateness of the Secretary's order imposing the civil penalty shall not be subject to review. "(4) AH penalties collected under this subsection shall be paid into the Treasury of the United States. "(5) The Secretary may compromise, modify, or remit, with or without conditions, any civil penalty assessed under this subsection. "(6) Paragraph (1) shall not apply to an officisd plant.". (e) REPORTING OF VIOLATION TO UNITED STATES ATTORNEY FOR INSTITUTION OF CRIMINAL PROCEEDINGS. —The last sentence of section 13 of such Act (21 U.S.C. 1042) is amended by inserting before
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