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Full Text of this Amendment

SA 1027. Mr. DURBIN submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:

At the appropriate place, insert the following:
TITLE __--FOOD SAFETY


SEC. __. FOOD SAFETY FOR HUMANS AND PETS.
Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is amended by adding at the end the following:
``SEC. 417. NOTIFICATION AND RECALL.
``(a) Notice to Secretary of Violation.--
``(1) IN GENERAL.--A person that has reason to believe that any food introduced into or in interstate commerce, or held for sale (whether or not the first sale) after shipment in interstate commerce, may be in violation of this Act shall immediately notify the Secretary of the identity and location of the food.
``(2) MANNER OF NOTIFICATION.--Notification under paragraph (1) shall be made in such manner and by such means as the Secretary may require by regulation.
``(b) Recall and Consumer Notification; Voluntary Actions.--If the Secretary determines that food is in violation of this Act when introduced into or while in interstate commerce or while held for sale (whether or not the first sale) after shipment in interstate commerce and that there is a reasonable probability that the food, if consumed, would present a threat to public health, as determined by the Secretary, the Secretary shall give the appropriate persons (including the manufacturers,
importers, distributors, or retailers of the food) an opportunity to--
``(1) cease distribution of the food;
``(2) notify all persons--
``(A) processing, distributing, or otherwise handling the food to immediately cease such activities with respect to the food; or
``(B) to which the food has been distributed, transported, or sold, to immediately cease distribution of the food;
``(3) recall the food;
``(4) in conjunction with the Secretary, provide notice of the finding of the Secretary--
``(A) to consumers to whom the food was, or may have been, distributed; and
``(B) to State and local public health officials; or
``(5) take any combination of the measures described in this paragraph, as determined by the Secretary to be appropriate in the circumstances.
``(c) Civil and Criminal Penalties.--
``(1) CIVIL SANCTIONS.--
``(A) CIVIL PENALTY.--Any person that commits an act that violates the notification and recall standards under subsection (b) (including a regulation promulgated or order issued under this Act) may be assessed a civil penalty by the Secretary of not more than $10,000 for each such act.
``(B) SEPARATE OFFENSE.--Each act described in subparagraph (A) and each day during which that act continues shall be considered a separate offense.
``(2) OTHER REQUIREMENTS.--
``(A) WRITTEN ORDER.--The civil penalty described in paragraph (1) shall be assessed by the Secretary by a written order, which shall specify the amount of the penalty and the basis for the penalty under subparagraph (B) considered by the Secretary.
``(B) AMOUNT OF PENALTY.--Subject to paragraph (1)(A), the amount of the civil penalty shall be determined by the Secretary, after considering--
``(i) the gravity of the violation;
``(ii) the degree of culpability of the person;
``(iii) the size and type of the business of the person; and
``(iv) any history of prior offenses by the person under this Act.
``(C) REVIEW OF ORDER.--The order may be reviewed only in accordance with subsection (d).
``(3) EXCEPTION.--No person shall be subject to the penalties of this subsection--
``(A) for having received, proffered, or delivered in interstate commerce any food, if the receipt, proffer, or delivery was made in good faith, unless that person refuses to furnish (on request of an officer or employee designated by the Secretary)--
``(i) the name, address and contact information of the person from whom that person purchased or received the food;
``(ii) copies of all documents relating to the person from whom that person purchased or received the food; and
``(iii) copies of all documents pertaining to the delivery of the food to that person; or
``(B) if that person establishes a guaranty signed by, and containing the name and address of, the person from whom that person received in good faith the food, stating that the food is not adulterated or misbranded within the meaning of this Act.
``(d) Judicial Review.--
``(1) IN GENERAL.--An order assessing a civil penalty under subsection (c) shall be a final order unless the person--
``(A) not later than 30 days after the effective date of the order, files a petition for judicial review of the order in the United States court of appeals for the circuit in which that person resides or has its principal place of business or the United States Court of Appeals for the District of Columbia; and
``(B) simultaneously serves a copy of the petition by certified mail to the Secretary.
``(2) FILING OF RECORD.--Not later than 45 days after the service of a copy of the petition under paragraph (1)(B), the Secretary shall file in the court a certified copy of the administrative record upon which the order was issued.
``(3) STANDARD OF REVIEW.--The findings of the Secretary relating to the order shall be set aside only if found to be unsupported by substantial evidence on the record as a whole.
``(e) Collection Actions for Failure to Pay.--
``(1) IN GENERAL.--If any person fails to pay a civil penalty assessed under subsection (c) after the order assessing the penalty has become a final order, or after the court of appeals described in subsection (d) has entered final judgment in favor of the Secretary, the Secretary shall refer the matter to the Attorney General, who shall institute in a United States district court of competent jurisdiction a civil action to recover the amount assessed.
``(2) LIMITATION ON REVIEW.--In a civil action under paragraph (1), the validity and appropriateness of the order of the Secretary assessing the civil penalty shall not be subject to judicial review.
``(f) Penalties Paid Into Account.--The Secretary--
``(1) shall deposit penalties collected under this section in an account in the Treasury; and
``(2) may use the funds in the account, without further appropriation or fiscal year limitation--
``(A) to carry out enforcement activities under food safety law; or
``(B) to provide assistance to States to inspect retail commercial food establishments, such as an establishment that holds, stores, or transports food or food ingredients, or other food or firms under the jurisdiction of State food safety programs.
``(g) Discretion of the Secretary to Prosecute.--Nothing in this section or section 418 requires the Secretary to report for prosecution, or for the commencement of an action, the violation of this Act in a case in which the Secretary finds that the public interest will be adequately served by the assessment of a civil penalty under this section.
``(h) Remedies Not Exclusive.--The remedies provided in this section may be in addition to, and not exclusive of, other remedies that may be available.
``SEC. 418. MANDATORY RECALL ACTION.
``(a) Mandatory Actions.--If a person referred to in section 417(b) refuses to or does not adequately carry out the actions described in that section within the time period and in the manner prescribed by the Secretary, the Secretary shall--
``(1) have authority to control and possess the food, including ordering the shipment of the food from a food establishment, such as an establishment that holds, stores, or transports food or food ingredients, to the Secretary--
``(A) at the expense of such food establishment; or
``(B) in an emergency (as determined by the Secretary), at the expense of the Secretary; and
``(2) by order, require, as the Secretary determines to be necessary, the person to immediately--
``(A) cease distribution of the food; and
``(B) notify all persons--
``(i) processing, distributing, or otherwise handling the food to immediately cease such activities with respect to the food; or
``(ii) if the food has been distributed, transported, or sold, to immediately cease distribution of the food.
``(b) Notification to Consumers by Secretary.--The Secretary shall, as the Secretary determines to be necessary, provide notice of the finding of the Secretary under paragraph (1)--
``(1) to consumers to whom the food was, or may have been, distributed; and
``(2) to State and local public health officials.
``(c) Nondistribution by Notified Persons.--A person that processes, distributes, or otherwise handles the food, or to which the food has been distributed, transported, or sold, and that is notified under section 417(b)(2) or subsection (a)(2)(B) of this section shall immediately cease distribution of the food.
``(d) Availability of Records to Secretary.--Each person referred to in section 417 that processed, distributed, or otherwise handled food shall make available to the Secretary information necessary to carry out this subsection, as determined by the Secretary, regarding--
``(1) persons that processed, distributed, or otherwise handled the food; and
``(2) persons to which the food has been transported, sold, distributed, or otherwise handled.
``(e) Informal Hearings on Orders.--
``(1) IN GENERAL.--The Secretary shall provide any person subject to an order under subsection (a) with an opportunity for an informal hearing, to be held as soon as practicable but not later than 2 business days after the issuance of the order.
``(2) SCOPE OF THE HEARING.--In a hearing under paragraph (1), the Secretary shall consider the actions required by the order and any reasons why the food that is the subject of the order should not be recalled.
``(f) Post-Hearing Recall Orders.--
``(1) AMENDMENT OF ORDER.--If, after providing an opportunity for an informal hearing under subsection (e), the Secretary determines that there is a reasonable probability that the food that is the subject of an order under subsection (a), if consumed, would present a threat to the public health, the Secretary, as the Secretary determines to be necessary, may--
``(A) amend the order to require recall of the food or other appropriate action;
``(B) specify a timetable in which the recall shall occur;
``(C) require periodic reports to the Secretary describing the progress of the recall; and
``(D) provide notice of the recall to consumers to whom the food was, or may have been, distributed.
``(2) VACATION OF ORDERS.--If, after providing an opportunity for an informal hearing under subsection (e), the Secretary determines that adequate grounds do not exist to continue the actions required by the order, the Secretary shall vacate the order.
``(g) Remedies Not Exclusive.--The remedies provided in this section shall be in addition to, and not exclusive of, other remedies that may be available.''.


(As printed in the Congressional Record for the Senate on May 2, 2007.)