S 425 ISCommentsClose CommentsPermalink

To amend the Federal Food, Drug, and Cosmetic Act to provide for the establishment of a traceability system for food, to amend the Federal Meat Inspection Act, the Poultry Products Inspections Act, the Egg Products Inspection Act, and the Federal Food, Drug, and Cosmetic Act to provide for improved public health and food safety through enhanced enforcement, and for other purposes.CommentsClose CommentsPermalink

February 12, 2009CommentsClose CommentsPermalink

Mr. BROWN introduced the following bill; which was read twice and referred to the Committee on Agriculture, Nutrition, and ForestryCommentsClose CommentsPermalink

To amend the Federal Food, Drug, and Cosmetic Act to provide for the establishment of a traceability system for food, to amend the Federal Meat Inspection Act, the Poultry Products Inspections Act, the Egg Products Inspection Act, and the Federal Food, Drug, and Cosmetic Act to provide for improved public health and food safety through enhanced enforcement, and for other purposes.CommentsClose CommentsPermalink

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,CommentsClose CommentsPermalink

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) Short Title- This Act may be cited as the Food Safety and Tracking Improvement Act.CommentsClose CommentsPermalink





(b) Table of Contents- The table of contents for this Act is as follows:CommentsClose CommentsPermalink





Sec. 1. Short title; table of contents.CommentsClose CommentsPermalink

TITLE I--TRACEABILITY OF FOOD

Sec. 101. Traceability of food.CommentsClose CommentsPermalink

TITLE II--ENFORCEMENT AND RECALL FOR MEAT, POULTRY, AND FOOD

Sec. 201. Food safety enforcement for meat and meat food products.CommentsClose CommentsPermalink





Sec. 202. Food safety enforcement for poultry and poultry food products.CommentsClose CommentsPermalink





Sec. 203. Notification, nondistribution, and recall of adulterated or misbranded eggs and egg products.CommentsClose CommentsPermalink





Sec. 204. Notification, nondistribution, and recall of adulterated or misbranded articles of food.CommentsClose CommentsPermalink

TITLE I--TRACEABILITY OF FOODCommentsClose CommentsPermalink

SEC. 101. TRACEABILITY OF FOOD.

The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended--CommentsClose CommentsPermalink





(1) in section 301, by inserting at the end the following:CommentsClose CommentsPermalink





‘(oo) The failure to comply with any requirement of section 414A (relating to the traceability of food).’; andCommentsClose CommentsPermalink





(2) in chapter IV, by inserting after section 414 the following:CommentsClose CommentsPermalink

‘SEC. 414A. TRACEABILITY OF FOOD.

‘(a) Establishment of System- Not later than 3 years after the date of the enactment of this section, the Secretary shall establish a traceability system described in subsection (b) for all stages of manufacturing, processing, packaging, and distribution of food.CommentsClose CommentsPermalink





‘(b) Description of System- The traceability system required by subsection (a) shall require each article of food shipped in interstate commerce to be identified in a manner that enables the Secretary to retrieve the history, use, and location of the article through a recordkeeping and audit system, a secure, online database, or registered identification.CommentsClose CommentsPermalink





‘(c) Records-CommentsClose CommentsPermalink





‘(1) IN GENERAL- The Secretary may require that each person required to identify an article of food pursuant to subsection (b) maintain accurate records, as prescribed by the Secretary, regarding the purchase, sale, and identification of the article.CommentsClose CommentsPermalink





‘(2) ACCESS- Each person described in paragraph (1) shall, at all reasonable times, on notice by a duly authorized representative of the Secretary, allow the representative to access each place of business of the person to examine and copy the records described in paragraph (1).CommentsClose CommentsPermalink





‘(3) DURATION- Each person described in paragraph (1) shall maintain records as required under this subsection for such period of time as the Secretary prescribes.CommentsClose CommentsPermalink





‘(d) False Information- No person shall falsify or misrepresent to any other person or to the Secretary, any information as to any location at which any article of food was held.CommentsClose CommentsPermalink





‘(e) Alteration or Destruction of Records- No person shall, without authorization from the Secretary, alter, detach, or destroy any records or other means of identification prescribed by the Secretary for use in determining the location at which any article of food was held.CommentsClose CommentsPermalink





‘(f) Advisory Committee-CommentsClose CommentsPermalink





‘(1) IN GENERAL- In order to assist the Secretary in implementing the traceability system under subsection (a), the Secretary shall convene an advisory committee (referred to in this subsection as the ‘Committee’).CommentsClose CommentsPermalink





‘(2) MEMBERSHIP- The Committee shall consist of 13 members appointed by the Secretary which shall include--CommentsClose CommentsPermalink





‘(A) an equitable number of food safety and tracking technology experts, representatives of the food industry, and consumer advocates; andCommentsClose CommentsPermalink





‘(B) officials from the Center for Food Safety and Applied Nutrition and the Office of Regulatory Affairs of the Food and Drug Administration and the Agriculture Marketing Service of the Department of Agriculture.CommentsClose CommentsPermalink





‘(3) CHAIRPERSON- The Secretary shall appoint a Chairperson of the Committee.CommentsClose CommentsPermalink





‘(4) MEETING- The Committee shall convene not later than 180 days after the date of enactment of this section and periodically thereafter at the call of the Chairperson.CommentsClose CommentsPermalink





‘(5) REPORT OF COMMITTEE-CommentsClose CommentsPermalink





‘(A) IN GENERAL- Not later than 1 year after the date of enactment of this section, the Committee shall submit to the Secretary and the Office of the Commissioner a report that describes the recommendations regarding the most practicable approach to providing for the traceability of food, including the most efficient means of implementing the traceback of contaminated foods.CommentsClose CommentsPermalink





‘(B) CONSIDERATIONS- In developing the report under subparagraph (A), the Committee shall consider the following approaches to providing for the traceability of food:CommentsClose CommentsPermalink





‘(i) A national database or registry operated by the Food and Drug Administration.CommentsClose CommentsPermalink





‘(ii) Electronic records identifying each prior sale, purchase, or trade of the food and its ingredients, and establishing that the food and its ingredients were grown, prepared, handled, manufactured, processed, distributed, shipped, warehoused, imported, and conveyed under conditions that ensure the safety of the food. The records should include an electronic statement with the date of, and the names and addresses of all parties to, each prior sale, purchase, or trade, and any other information as appropriate.CommentsClose CommentsPermalink





‘(iii) Standardized tracking numbers on all shipments. These numbers would identify the country of origin, the unique facility registration number, date of production, and lot number (if applicable).CommentsClose CommentsPermalink





‘(iv) Recall performance standards for each food or commodity type.CommentsClose CommentsPermalink





‘(v) Safeguards for the combining, repacking, or otherwise mixing of items of food, particularly fresh produce.CommentsClose CommentsPermalink





‘(vi) Other approaches that enable the reliable tracking of food and food products.CommentsClose CommentsPermalink





‘(g) Authorization of Appropriations- For the purpose of carrying out this section, there is authorized to be appropriated $40,000,000 for the period of fiscal years 2010 through 2012.’.CommentsClose CommentsPermalink

TITLE II--ENFORCEMENT AND RECALL FOR MEAT, POULTRY, AND FOODCommentsClose CommentsPermalink

SEC. 201. FOOD SAFETY ENFORCEMENT FOR MEAT AND MEAT FOOD PRODUCTS.

(a) In General- The Federal Meat Inspection Act (21 U.S.C. 601 et seq.) is amended--CommentsClose CommentsPermalink





(1) by redesignating section 411 (21 U.S.C. 680) as section 414; andCommentsClose CommentsPermalink





(2) by inserting after section 410 (21 U.S.C. 679a) the following:CommentsClose CommentsPermalink

‘SEC. 411. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED ARTICLES.

‘(a) Notification to Secretary of Violation-CommentsClose CommentsPermalink





‘(1) IN GENERAL- A person (other than a household consumer) that has reason to believe that any carcass, part of a carcass, meat, or meat food product of an amenable species (referred to in this section as an ‘article’) transported, stored, distributed, or otherwise handled by the person is adulterated or misbranded shall, as soon as practicable, notify the Secretary of the identity and location of the article.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(b) Recall and Consumer Notification-CommentsClose CommentsPermalink





‘(1) VOLUNTARY ACTIONS- On receiving notification under subsection (a) or by other means, if the Secretary finds that an article is adulterated or misbranded and that there is a reasonable probability that human consumption of the article would present a threat to public health (as determined by the Secretary), the Secretary shall provide all appropriate persons (as determined by the Secretary), that transported, stored, distributed, or otherwise handled the article with an opportunity--CommentsClose CommentsPermalink





‘(A) to cease distribution of the article;CommentsClose CommentsPermalink





‘(B) to notify all persons that transport, store, distribute, or otherwise handle the article, or to which the article has been transported, sold, distributed, or otherwise handled, to cease immediately distribution of the article;CommentsClose CommentsPermalink





‘(C) to recall the article;CommentsClose CommentsPermalink





‘(D) in consultation with the Secretary, to provide notice of the finding of the Secretary to all consumers to which the article was, or may have been, distributed; orCommentsClose CommentsPermalink





‘(E) to notify State and local public health officials.CommentsClose CommentsPermalink





‘(2) MANDATORY ACTIONS- If the appropriate person referred to in paragraph (1) does not carry out the actions described in that paragraph with respect to an article within the time period and in the manner prescribed by the Secretary, the Secretary--CommentsClose CommentsPermalink





‘(A) shall require the person--CommentsClose CommentsPermalink





‘(i) to immediately cease distribution of the article; andCommentsClose CommentsPermalink





‘(ii) to immediately make the notification described in paragraph (1)(B); andCommentsClose CommentsPermalink





‘(B) may take control or possession of the article.CommentsClose CommentsPermalink





‘(3) NOTICE TO CONSUMERS AND HEALTH OFFICIALS- The Secretary shall, as the Secretary determines to be necessary, provide notice of the finding of the Secretary under paragraph (1) to consumers to which the article was, or may have been, distributed and to appropriate State and local public health officials.CommentsClose CommentsPermalink





‘(4) NONDISTRIBUTION BY NOTIFIED PERSONS- A person that transports, stores, distributes, or otherwise handles the article, or to which the article has been transported, sold, distributed, or otherwise handled, and that is notified under paragraph (1)(B) or (2)(B) shall cease immediately distribution of the article.CommentsClose CommentsPermalink





‘(5) AVAILABILITY OF RECORDS TO SECRETARY- Each appropriate person referred to in paragraph (1) that transported, stored, distributed, or otherwise handled an article shall make available to the Secretary information necessary to carry out this subsection, as determined by the Secretary, regarding--CommentsClose CommentsPermalink





‘(A) persons that transport, store, distribute, or otherwise handle the article; andCommentsClose CommentsPermalink





‘(B) persons to which the article has been transported, sold, distributed, or otherwise handled.CommentsClose CommentsPermalink





‘(c) Informal Hearings on Orders-CommentsClose CommentsPermalink





‘(1) IN GENERAL- The Secretary shall provide a person subject to an order under subsection (b) with an opportunity for an informal hearing (in accordance with such rules or regulations as the Secretary shall prescribe) on--CommentsClose CommentsPermalink





‘(A) the actions required by the order; andCommentsClose CommentsPermalink





‘(B) any reasons why the article that is the subject of the order should not be recalled.CommentsClose CommentsPermalink





‘(2) TIMING OF HEARINGS- The Secretary shall hold a hearing under paragraph (1) as soon as practicable, but not later than 2 business days, after the date of issuance of the order.CommentsClose CommentsPermalink





‘(d) Post-Hearing Recall Orders-CommentsClose CommentsPermalink





‘(1) AMENDMENT OF ORDERS- If, after providing an opportunity for an informal hearing under subsection (c), the Secretary determines that there is a reasonable probability that human consumption of the article that is the subject of an order under subsection (b) presents a threat to public health, the Secretary may, as the Secretary determines to be necessary--CommentsClose CommentsPermalink





‘(A) amend the order under subsection (b)--CommentsClose CommentsPermalink





‘(i) to require recall of the article or other appropriate action; andCommentsClose CommentsPermalink





‘(ii) to specify a timetable during which the recall shall occur;CommentsClose CommentsPermalink





‘(B) require periodic reports to the Secretary describing the progress of the recall;CommentsClose CommentsPermalink





‘(C) provide notice of the recall to consumers to which the article was, or may have been, distributed; orCommentsClose CommentsPermalink





‘(D) take any combination of actions described in subparagraphs (A) through (C).CommentsClose CommentsPermalink





‘(2) VACATION OF ORDERS- If, after providing an opportunity for an informal hearing under subsection (c), the Secretary determines that adequate grounds do not exist to continue the actions required by the order, the Secretary shall vacate the order.CommentsClose CommentsPermalink





‘(e) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.CommentsClose CommentsPermalink

‘SEC. 412. REFUSAL OR WITHDRAWAL OF INSPECTION OF ESTABLISHMENTS.

‘(a) In General- The Secretary may, for such period, or indefinitely, as the Secretary considers necessary to carry out this Act, refuse to provide or withdraw inspection under title I with respect to an establishment if the Secretary determines, after opportunity for a hearing on the record is provided to the applicant for, or recipient of, inspection, that the applicant or recipient, or any person responsibly connected with the applicant or recipient (within the meaning of section 401), has committed a willful violation or repeated violations of this Act (including a regulation promulgated under this Act).CommentsClose CommentsPermalink





‘(b) Denial or Suspension of Inspection Pending Hearing- The Secretary may deny or suspend inspection under title I, pending opportunity for an expedited hearing, with respect to an action under subsection (a), if the Secretary determines that the denial or suspension is in the public interest to protect the health or welfare of consumers or to ensure the effective performance of an official duty under this Act.CommentsClose CommentsPermalink





‘(c) Judicial Review-CommentsClose CommentsPermalink





‘(1) IN GENERAL- A determination and order of the Secretary with respect to the refusal or withdrawal of inspection under this section shall be final unless, not later than 30 days after the effective date of the order, the affected applicant for, or recipient of, inspection--CommentsClose CommentsPermalink





‘(A) files a petition for judicial review of the order; andCommentsClose CommentsPermalink





‘(B) simultaneously sends a copy of the petition by certified mail to the Secretary.CommentsClose CommentsPermalink





‘(2) REFUSAL OR WITHDRAWAL OF INSPECTION PENDING REVIEW- Inspection shall be refused or withdrawn as of the effective date of the order pending any judicial review of the order unless the Secretary directs otherwise.CommentsClose CommentsPermalink





‘(3) VENUE; RECORD- Judicial review of the order shall be--CommentsClose CommentsPermalink





‘(A) in--CommentsClose CommentsPermalink





‘(i) the United States court of appeals for the circuit in which the applicant for, or recipient of, inspection resides or has its principal place of business; orCommentsClose CommentsPermalink





‘(ii) the United States Court of Appeals for the District of Columbia Circuit; andCommentsClose CommentsPermalink





‘(B) on the record on which the determination and order are based.CommentsClose CommentsPermalink





‘(d) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.CommentsClose CommentsPermalink

‘SEC. 413. CIVIL PENALTIES.

‘(a) In General-CommentsClose CommentsPermalink





‘(1) ASSESSMENT- The Secretary may assess against a person that violates section 411 (including a regulation promulgated or order issued under that section) a civil penalty for each violation of not more than $100,000.CommentsClose CommentsPermalink





‘(2) SEPARATE OFFENSES- Each violation and each day during which the violation continues shall be considered to be a separate offense.CommentsClose CommentsPermalink





‘(3) NOTICE AND OPPORTUNITY FOR HEARING- The Secretary shall not assess a civil penalty under this section against a person 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.CommentsClose CommentsPermalink





‘(4) DETERMINATION OF CIVIL PENALTY AMOUNT- The amount of a civil penalty under this section--CommentsClose CommentsPermalink





‘(A) shall be assessed by the Secretary by written order, taking into account--CommentsClose CommentsPermalink





‘(i) the gravity of the violation;CommentsClose CommentsPermalink





‘(ii) the degree of culpability of the person;CommentsClose CommentsPermalink





‘(iii) the size and type of the business of the person; andCommentsClose CommentsPermalink





‘(iv) any history of prior offenses by the person under this Act; andCommentsClose CommentsPermalink





‘(B) shall be reviewed only in accordance with subsection (b).CommentsClose CommentsPermalink





‘(b) Judicial Review-CommentsClose CommentsPermalink





‘(1) IN GENERAL- An order assessing a civil penalty against a person under subsection (a) shall be final unless the person--CommentsClose CommentsPermalink





‘(A) not later than 30 days after the effective date of the order, files a petition for judicial review of the order in--CommentsClose CommentsPermalink





‘(i) the United States court of appeals for the circuit in which the person resides or has its principal place of business; orCommentsClose CommentsPermalink





‘(ii) the United States Court of Appeals for the District of Columbia Circuit; andCommentsClose CommentsPermalink





‘(B) simultaneously sends a copy of the petition by certified mail to the Secretary.CommentsClose CommentsPermalink





‘(2) FILING OF COPY OF RECORD- The Secretary shall promptly file in the court a certified copy of the record on which the order was issued.CommentsClose CommentsPermalink





‘(c) Collection Actions for Failure To Pay Assessment-CommentsClose CommentsPermalink





‘(1) REFERRAL TO ATTORNEY GENERAL- If a person fails to pay a civil penalty assessed under subsection (a) after the order assessing the civil penalty has become a final order, or after the court of appeals has entered final judgment in favor of the Secretary, the Secretary shall refer the matter to the Attorney General.CommentsClose CommentsPermalink





‘(2) ACTION BY ATTORNEY GENERAL- The Attorney General shall bring a civil action to recover the amount of the civil penalty in United States district court.CommentsClose CommentsPermalink





‘(3) SCOPE OF REVIEW- In a civil action under paragraph (2), the validity and appropriateness of the order of the Secretary assessing the civil penalty shall not be subject to review.CommentsClose CommentsPermalink





‘(d) Refusal or Withdrawal of Inspection Pending Payment- If a person fails to pay the amount of a civil penalty after the order assessing the civil penalty has become a final order, the Secretary may refuse to provide or withdraw inspection under title I of the person until the civil penalty is paid or until the Secretary directs otherwise.CommentsClose CommentsPermalink





‘(e) Penalties in Lieu of Other Actions- Nothing in this Act requires the Secretary to report for prosecution, or for the commencement of an action, any violation of section 411 in any case in which the Secretary believes that the public interest will be adequately served by the assessment of a civil penalty under this section.CommentsClose CommentsPermalink





‘(f) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.’.CommentsClose CommentsPermalink





(b) Conforming Amendments-CommentsClose CommentsPermalink





(1) Section 1 of the Federal Meat Inspection Act (21 U.S.C. 601) is amended by adding at the end the following:CommentsClose CommentsPermalink





‘(x) Person- The term ‘person’ means any individual, partnership, corporation, association, or other business unit.’.CommentsClose CommentsPermalink





(2) The Federal Meat Inspection Act (21 U.S.C. 601 et seq.) is amended--CommentsClose CommentsPermalink





(A) by striking ‘person, firm, or corporation’ each place it appears and inserting ‘person’;CommentsClose CommentsPermalink





(B) by striking ‘persons, firms, and corporations’ each place it appears and inserting ‘persons’; andCommentsClose CommentsPermalink





(C) by striking ‘persons, firms, or corporations’ each place it appears and inserting ‘persons’.CommentsClose CommentsPermalink

SEC. 202. FOOD SAFETY ENFORCEMENT FOR POULTRY AND POULTRY FOOD PRODUCTS.

(a) In General- The Poultry Products Inspection Act (21 U.S.C. 451 et seq.) is amended by adding at the end the following:CommentsClose CommentsPermalink

‘SEC. 32. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED ARTICLES.

‘(a) Notification to Secretary of Violation-CommentsClose CommentsPermalink





‘(1) IN GENERAL- A person (other than a household consumer) that has reason to believe that any poultry or poultry product (referred to in this section as an ‘article’) transported, stored, distributed, or otherwise handled by the person is adulterated or misbranded shall, as soon as practicable, notify the Secretary of the identity and location of the article.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(b) Recall and Consumer Notification-CommentsClose CommentsPermalink





‘(1) VOLUNTARY ACTIONS- On receiving notification under subsection (a) or by other means, if the Secretary finds that an article is adulterated or misbranded and that there is a reasonable probability that human consumption of the article would present a threat to public health (as determined by the Secretary), the Secretary shall provide all appropriate persons (as determined by the Secretary), that transported, stored, distributed, or otherwise handled the article with an opportunity--CommentsClose CommentsPermalink





‘(A) to cease distribution of the article;CommentsClose CommentsPermalink





‘(B) to notify all persons that transport, store, distribute, or otherwise handle the article, or to which the article has been transported, sold, distributed, or otherwise handled, to cease immediately distribution of the article;CommentsClose CommentsPermalink





‘(C) to recall the article;CommentsClose CommentsPermalink





‘(D) in consultation with the Secretary, to provide notice of the finding of the Secretary to all consumers to which the article was, or may have been, distributed; orCommentsClose CommentsPermalink





‘(E) to notify State and local public health officials.CommentsClose CommentsPermalink





‘(2) MANDATORY ACTIONS- If the appropriate person referred to in paragraph (1) does not carry out the actions described in that paragraph with respect to an article within the time period and in the manner prescribed by the Secretary, the Secretary--CommentsClose CommentsPermalink





‘(A) shall require the person--CommentsClose CommentsPermalink





‘(i) to immediately cease distribution of the article; andCommentsClose CommentsPermalink





‘(ii) to immediately make the notification described in paragraph (1)(B); andCommentsClose CommentsPermalink





‘(B) may take control or possession of the article.CommentsClose CommentsPermalink





‘(3) NOTICE TO CONSUMERS AND HEALTH OFFICIALS- The Secretary shall, as the Secretary determines to be necessary, provide notice of the finding of the Secretary under paragraph (1) to consumers to which the article was, or may have been, distributed and to appropriate State and local health officials.CommentsClose CommentsPermalink





‘(4) NONDISTRIBUTION BY NOTIFIED PERSONS- A person that transports, stores, distributes, or otherwise handles the article, or to which the article has been transported, sold, distributed, or otherwise handled, and that is notified under paragraph (1)(B) or (2)(B) shall cease immediately distribution of the article.CommentsClose CommentsPermalink





‘(5) AVAILABILITY OF RECORDS TO SECRETARY- Each appropriate person referred to in paragraph (1) that transported, stored, distributed, or otherwise handled an article shall make available to the Secretary information necessary to carry out this subsection, as determined by the Secretary, regarding--CommentsClose CommentsPermalink





‘(A) persons that transport, store, distribute, or otherwise handle the article; andCommentsClose CommentsPermalink





‘(B) persons to which the article has been transported, sold, distributed, or otherwise handled.CommentsClose CommentsPermalink





‘(c) Informal Hearings on Orders-CommentsClose CommentsPermalink





‘(1) IN GENERAL- The Secretary shall provide a person subject to an order under subsection (b) with an opportunity for an informal hearing (in accordance with such rules or regulations as the Secretary shall prescribe) on--CommentsClose CommentsPermalink





‘(A) the actions required by the order; andCommentsClose CommentsPermalink





‘(B) any reasons why the article that is the subject of the order should not be recalled.CommentsClose CommentsPermalink





‘(2) TIMING OF HEARINGS- The Secretary shall hold a hearing under paragraph (1) as soon as practicable, but not later than 2 business days, after the date of issuance of the order.CommentsClose CommentsPermalink





‘(d) Post-Hearing Recall Orders-CommentsClose CommentsPermalink





‘(1) AMENDMENT OF ORDERS- If, after providing an opportunity for an informal hearing under subsection (c), the Secretary determines that there is a reasonable probability that human consumption of the article that is the subject of an order under subsection (b) presents a threat to public health, the Secretary may, as the Secretary determines to be necessary--CommentsClose CommentsPermalink





‘(A) amend the order under subsection (b)--CommentsClose CommentsPermalink





‘(i) to require recall of the article or other appropriate action; andCommentsClose CommentsPermalink





‘(ii) to specify a timetable during which the recall shall occur;CommentsClose CommentsPermalink





‘(B) require periodic reports to the Secretary describing the progress of the recall; orCommentsClose CommentsPermalink





‘(C) provide notice of the recall to consumers to which the article was, or may have been, distributed.CommentsClose CommentsPermalink





‘(2) VACATION OF ORDERS- If, after providing an opportunity for an informal hearing under subsection (c), the Secretary determines that adequate grounds do not exist to continue the actions required by the order, the Secretary shall vacate the order.CommentsClose CommentsPermalink





‘(e) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.CommentsClose CommentsPermalink

‘SEC. 33. REFUSAL OR WITHDRAWAL OF INSPECTION OF ESTABLISHMENTS.

‘(a) In General- The Secretary may, for such period, or indefinitely, as the Secretary considers necessary to carry out this Act, refuse to provide or withdraw inspection under this Act with respect to an establishment if the Secretary determines, after opportunity for a hearing on the record is provided to the applicant for, or recipient of, inspection, that the applicant or recipient, or any person responsibly connected with the applicant or recipient (within the meaning of section 18(a)), has committed a willful violation or repeated violations of this Act (including a regulation promulgated under this Act).CommentsClose CommentsPermalink





‘(b) Denial or Suspension of Inspection Pending Hearing- The Secretary may deny or suspend inspection under this Act, pending opportunity for an expedited hearing, with respect to an action under subsection (a), if the Secretary determines that the denial or suspension is in the public interest to protect the health or welfare of consumers or to ensure the effective performance of an official duty under this Act.CommentsClose CommentsPermalink





‘(c) Judicial Review-CommentsClose CommentsPermalink





‘(1) IN GENERAL- A determination and order of the Secretary with respect to the refusal or withdrawal of inspection under this section shall be final unless, not later than 30 days after the effective date of the order, the affected applicant for, or recipient of, inspection--CommentsClose CommentsPermalink





‘(A) files a petition for judicial review of the order; andCommentsClose CommentsPermalink





‘(B) simultaneously sends a copy of the petition by certified mail to the Secretary.CommentsClose CommentsPermalink





‘(2) REFUSAL OR WITHDRAWAL OF INSPECTION PENDING REVIEW- Inspection shall be refused or withdrawn as of the effective date of the order pending any judicial review of the order unless the Secretary directs otherwise.CommentsClose CommentsPermalink





‘(3) VENUE; RECORD- Judicial review of the order shall be--CommentsClose CommentsPermalink





‘(A) in--CommentsClose CommentsPermalink





‘(i) the United States court of appeals for the circuit in which the applicant for, or recipient of, inspection resides or has its principal place of business; orCommentsClose CommentsPermalink





‘(ii) the United States Court of Appeals for the District of Columbia Circuit; andCommentsClose CommentsPermalink





‘(B) on the record on which the determination and order are based.CommentsClose CommentsPermalink





‘(d) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.CommentsClose CommentsPermalink

‘SEC. 34. CIVIL PENALTIES.

‘(a) In General-CommentsClose CommentsPermalink





‘(1) ASSESSMENT- The Secretary may assess against a person that violates section 32 (including a regulation promulgated or order issued under that section) a civil penalty for each violation of not more than $100,000.CommentsClose CommentsPermalink





‘(2) SEPARATE OFFENSES- Each violation and each day during which the violation continues shall be considered to be a separate offense.CommentsClose CommentsPermalink





‘(3) NOTICE AND OPPORTUNITY FOR HEARING- The Secretary shall not assess a civil penalty under this section against a person 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.CommentsClose CommentsPermalink





‘(4) DETERMINATION OF CIVIL PENALTY AMOUNT- The amount of a civil penalty under this section--CommentsClose CommentsPermalink





‘(A) shall be assessed by the Secretary by written order, taking into account--CommentsClose CommentsPermalink





‘(i) the gravity of the violation;CommentsClose CommentsPermalink





‘(ii) the degree of culpability of the person;CommentsClose CommentsPermalink





‘(iii) the size and type of the business of the person; andCommentsClose CommentsPermalink





‘(iv) any history of prior offenses by the person under this Act; andCommentsClose CommentsPermalink





‘(B) shall be reviewed only in accordance with subsection (b).CommentsClose CommentsPermalink





‘(b) Judicial Review-CommentsClose CommentsPermalink





‘(1) IN GENERAL- An order assessing a civil penalty against a person under subsection (a) shall be final unless the person--CommentsClose CommentsPermalink





‘(A) not later than 30 days after the effective date of the order, files a petition for judicial review of the order in--CommentsClose CommentsPermalink





‘(i) the United States court of appeals for the circuit in which the person resides or has its principal place of business; orCommentsClose CommentsPermalink





‘(ii) the United States Court of Appeals for the District of Columbia Circuit; andCommentsClose CommentsPermalink





‘(B) simultaneously sends a copy of the petition by certified mail to the Secretary.CommentsClose CommentsPermalink





‘(2) FILING OF COPY OF RECORD- The Secretary shall promptly file in the court a certified copy of the record on which the order was issued.CommentsClose CommentsPermalink





‘(c) Collection Actions for Failure To Pay Assessment-CommentsClose CommentsPermalink





‘(1) REFERRAL TO ATTORNEY GENERAL- If a person fails to pay a civil penalty assessed under subsection (a) after the order assessing the civil penalty has become a final order, or after the court of appeals has entered final judgment in favor of the Secretary, the Secretary shall refer the matter to the Attorney General.CommentsClose CommentsPermalink





‘(2) ACTION BY ATTORNEY GENERAL- The Attorney General shall bring a civil action to recover the amount of the civil penalty in United States district court.CommentsClose CommentsPermalink





‘(3) SCOPE OF REVIEW- In a civil action under paragraph (2), the validity and appropriateness of the order of the Secretary assessing the civil penalty shall not be subject to review.CommentsClose CommentsPermalink





‘(d) Refusal or Withdrawal of Inspection Pending Payment- If a person fails to pay the amount of a civil penalty after the order assessing the civil penalty has become a final order, the Secretary may refuse to provide or withdraw inspection under this Act of the person until the civil penalty is paid or until the Secretary directs otherwise.CommentsClose CommentsPermalink





‘(e) Penalties in Lieu of Other Actions- Nothing in this Act requires the Secretary to report for prosecution, or for the commencement of an action, any violation of section 32 in any case in which the Secretary believes that the public interest will be adequately served by the assessment of a civil penalty under this section.CommentsClose CommentsPermalink





‘(f) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.’.CommentsClose CommentsPermalink





(b) Conforming Amendments- Section 5(c)(1) of the Poultry Products Inspection Act (21 U.S.C. 454(c)(1)) is amended in the first sentence--CommentsClose CommentsPermalink





(1) by striking ‘, by thirty days prior to the expiration of two years after enactment of the Wholesome Poultry Products Act,’; andCommentsClose CommentsPermalink





(2) by striking ‘sections 1-4, 6-10, and 12-22 of this Act’ and inserting ‘sections 1 through 4, 6 through 10, 12 through 22, and 32 through 34’; andCommentsClose CommentsPermalink

SEC. 203. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED EGGS AND EGG PRODUCTS.

The Egg Products Inspection Act is amended by inserting after section 20 (21 U.S.C. 1049) the following:CommentsClose CommentsPermalink

‘SEC. 20A. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED EGGS AND EGG PRODUCTS.

‘(a) Notification to Secretary of Violation-CommentsClose CommentsPermalink





‘(1) IN GENERAL- A person (other than a household consumer) that has reason to believe that any egg or egg product (referred to in this section as an ‘article’) transported, stored, distributed, or otherwise handled by the person is adulterated or misbranded shall, as soon as practicable, notify the Secretary of the identity and location of the article.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(b) Recall and Consumer Notification-CommentsClose CommentsPermalink





‘(1) VOLUNTARY ACTIONS- On receiving notification under subsection (a) or by other means, if the Secretary finds that an article is adulterated or misbranded and that there is a reasonable probability that human consumption of the article would present a threat to public health (as determined by the Secretary), the Secretary shall provide all appropriate persons (as determined by the Secretary), that transported, stored, distributed, or otherwise handled the article with an opportunity--CommentsClose CommentsPermalink





‘(A) to cease distribution of the article;CommentsClose CommentsPermalink





‘(B) to notify all persons that transport, store, distribute, or otherwise handle the article, or to which the article has been transported, sold, distributed, or otherwise handled, to cease immediately distribution of the article;CommentsClose CommentsPermalink





‘(C) to recall the article;CommentsClose CommentsPermalink





‘(D) in consultation with the Secretary, to provide notice of the finding of the Secretary to all consumers to which the article was, or may have been, distributed; orCommentsClose CommentsPermalink





‘(E) to notify State and local public health officials.CommentsClose CommentsPermalink





‘(2) MANDATORY ACTIONS- If the appropriate person referred to in paragraph (1) does not carry out the actions described in that paragraph with respect to an article within the time period and in the manner prescribed by the Secretary, the Secretary--CommentsClose CommentsPermalink





‘(A) shall require the person--CommentsClose CommentsPermalink





‘(i) to immediately cease distribution of the article; andCommentsClose CommentsPermalink





‘(ii) to immediately make the notification described in paragraph (1)(B); andCommentsClose CommentsPermalink





‘(B) may take control or possession of the article.CommentsClose CommentsPermalink





‘(3) NOTICE TO CONSUMERS AND HEALTH OFFICIALS- The Secretary shall, as the Secretary determines to be necessary, provide notice of the finding of the Secretary under paragraph (1) to consumers to which the article was, or may have been, distributed and to appropriate State and local health officials.CommentsClose CommentsPermalink





‘(4) NONDISTRIBUTION BY NOTIFIED PERSONS- A person that transports, stores, distributes, or otherwise handles the article, or to which the article has been transported, sold, distributed, or otherwise handled, and that is notified under paragraph (1)(B) or (2)(B) shall cease immediately distribution of the article.CommentsClose CommentsPermalink





‘(5) AVAILABILITY OF RECORDS TO SECRETARY- Each appropriate person referred to in paragraph (1) that transported, stored, distributed, or otherwise handled an article shall make available to the Secretary information necessary to carry out this subsection, as determined by the Secretary, regarding--CommentsClose CommentsPermalink





‘(A) persons that transport, store, distribute, or otherwise handle the article; andCommentsClose CommentsPermalink





‘(B) persons to which the article has been transported, sold, distributed, or otherwise handled.CommentsClose CommentsPermalink





‘(c) Informal Hearings on Orders-CommentsClose CommentsPermalink





‘(1) IN GENERAL- The Secretary shall provide a person subject to an order under subsection (b) with an opportunity for an informal hearing (in accordance with such rules or regulations as the Secretary shall prescribe) on--CommentsClose CommentsPermalink





‘(A) the actions required by the order; andCommentsClose CommentsPermalink





‘(B) any reasons why the article that is the subject of the order should not be recalled.CommentsClose CommentsPermalink





‘(2) TIMING OF HEARINGS- The Secretary shall hold a hearing under paragraph (1) as soon as practicable, but not later than 2 business days, after the date of issuance of the order.CommentsClose CommentsPermalink





‘(d) Post-Hearing Recall Orders-CommentsClose CommentsPermalink





‘(1) AMENDMENT OF ORDERS- If, after providing an opportunity for an informal hearing under subsection (c), the Secretary determines that there is a reasonable probability that human consumption of the article that is the subject of an order under subsection (b) presents a threat to public health, the Secretary may, as the Secretary determines to be necessary--CommentsClose CommentsPermalink





‘(A) amend the order under subsection (b)--CommentsClose CommentsPermalink





‘(i) to require recall of the article or other appropriate action; andCommentsClose CommentsPermalink





‘(ii) to specify a timetable during which the recall shall occur;CommentsClose CommentsPermalink





‘(B) require periodic reports to the Secretary describing the progress of the recall; orCommentsClose CommentsPermalink





‘(C) provide notice of the recall to consumers to which the article was, or may have been, distributed.CommentsClose CommentsPermalink





‘(2) VACATION OF ORDERS- If, after providing an opportunity for an informal hearing under subsection (c), the Secretary determines that adequate grounds do not exist to continue the actions required by the order, the Secretary shall vacate the order.CommentsClose CommentsPermalink





‘(e) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.CommentsClose CommentsPermalink

‘SEC. 20B. REFUSAL OR WITHDRAWAL OF INSPECTION OF ESTABLISHMENTS.

‘(a) In General- The Secretary may, for such period, or indefinitely, as the Secretary considers necessary to carry out this Act, refuse to provide or withdraw inspection under this Act with respect to an establishment if the Secretary determines, after opportunity for a hearing on the record is provided to the applicant for, or recipient of, inspection, that the applicant or recipient, or any person responsibly connected with the applicant or recipient (within the meaning of section 18), has committed a willful violation or repeated violations of this Act (including a regulation promulgated under this Act).CommentsClose CommentsPermalink





‘(b) Denial or Suspension of Inspection Pending Hearing- The Secretary may deny or suspend inspection under this Act, pending opportunity for an expedited hearing, with respect to an action under subsection (a), if the Secretary determines that the denial or suspension is in the public interest to protect the health or welfare of consumers or to ensure the effective performance of an official duty under this Act.CommentsClose CommentsPermalink





‘(c) Judicial Review-CommentsClose CommentsPermalink





‘(1) IN GENERAL- A determination and order of the Secretary with respect to the refusal or withdrawal of inspection under this section shall be final unless, not later than 30 days after the effective date of the order, the affected applicant for, or recipient of, inspection--CommentsClose CommentsPermalink





‘(A) files a petition for judicial review of the order; andCommentsClose CommentsPermalink





‘(B) simultaneously sends a copy of the petition by certified mail to the Secretary.CommentsClose CommentsPermalink





‘(2) REFUSAL OR WITHDRAWAL OF INSPECTION PENDING REVIEW- Inspection shall be refused or withdrawn as of the effective date of the order pending any judicial review of the order unless the Secretary directs otherwise.CommentsClose CommentsPermalink





‘(3) VENUE; RECORD- Judicial review of the order shall be--CommentsClose CommentsPermalink





‘(A) in--CommentsClose CommentsPermalink





‘(i) the United States court of appeals for the circuit in which the applicant for, or recipient of, inspection resides or has its principal place of business; orCommentsClose CommentsPermalink





‘(ii) the United States Court of Appeals for the District of Columbia Circuit; andCommentsClose CommentsPermalink





‘(B) on the record on which the determination and order are based.CommentsClose CommentsPermalink





‘(d) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.CommentsClose CommentsPermalink

‘SEC. 20C. CIVIL PENALTIES.

‘(a) In General-CommentsClose CommentsPermalink





‘(1) ASSESSMENT- The Secretary may assess against a person that violates section 20A (including a regulation promulgated or order issued under that section) a civil penalty for each violation of not more than $100,000.CommentsClose CommentsPermalink





‘(2) SEPARATE OFFENSES- Each violation and each day during which the violation continues shall be considered to be a separate offense.CommentsClose CommentsPermalink





‘(3) NOTICE AND OPPORTUNITY FOR HEARING- The Secretary shall not assess a civil penalty under this section against a person 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.CommentsClose CommentsPermalink





‘(4) DETERMINATION OF CIVIL PENALTY AMOUNT- The amount of a civil penalty under this section--CommentsClose CommentsPermalink





‘(A) shall be assessed by the Secretary by written order, taking into account--CommentsClose CommentsPermalink





‘(i) the gravity of the violation;CommentsClose CommentsPermalink





‘(ii) the degree of culpability of the person;CommentsClose CommentsPermalink





‘(iii) the size and type of the business of the person; andCommentsClose CommentsPermalink





‘(iv) any history of prior offenses by the person under this Act; andCommentsClose CommentsPermalink





‘(B) shall be reviewed only in accordance with subsection (b).CommentsClose CommentsPermalink





‘(b) Judicial Review-CommentsClose CommentsPermalink





‘(1) IN GENERAL- An order assessing a civil penalty against a person under subsection (a) shall be final unless the person--CommentsClose CommentsPermalink





‘(A) not later than 30 days after the effective date of the order, files a petition for judicial review of the order in--CommentsClose CommentsPermalink





‘(i) the United States court of appeals for the circuit in which the person resides or has its principal place of business; orCommentsClose CommentsPermalink





‘(ii) the United States Court of Appeals for the District of Columbia Circuit; andCommentsClose CommentsPermalink





‘(B) simultaneously sends a copy of the petition by certified mail to the Secretary.CommentsClose CommentsPermalink





‘(2) FILING OF COPY OF RECORD- The Secretary shall promptly file in the court a certified copy of the record on which the order was issued.CommentsClose CommentsPermalink





‘(c) Collection Actions for Failure To Pay Assessment-CommentsClose CommentsPermalink





‘(1) REFERRAL TO ATTORNEY GENERAL- If a person fails to pay a civil penalty assessed under subsection (a) after the order assessing the civil penalty has become a final order, or after the court of appeals has entered final judgment in favor of the Secretary, the Secretary shall refer the matter to the Attorney General.CommentsClose CommentsPermalink





‘(2) ACTION BY ATTORNEY GENERAL- The Attorney General shall bring a civil action to recover the amount of the civil penalty in United States district court.CommentsClose CommentsPermalink





‘(3) SCOPE OF REVIEW- In a civil action under paragraph (2), the validity and appropriateness of the order of the Secretary assessing the civil penalty shall not be subject to review.CommentsClose CommentsPermalink





‘(d) Refusal or Withdrawal of Inspection Pending Payment- If a person fails to pay the amount of a civil penalty after the order assessing the civil penalty has become a final order, the Secretary may refuse to provide or withdraw inspection under this Act of the person until the civil penalty is paid or until the Secretary directs otherwise.CommentsClose CommentsPermalink





‘(e) Penalties in Lieu of Other Actions- Nothing in this Act requires the Secretary to report for prosecution, or for the commencement of an action, any violation of section 20A in any case in which the Secretary believes that the public interest will be adequately served by the assessment of a civil penalty under this section.CommentsClose CommentsPermalink





‘(f) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.’.CommentsClose CommentsPermalink

SEC. 204. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED ARTICLES OF FOOD.

(a) Prohibited Acts- Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following:CommentsClose CommentsPermalink





‘(pp)(1) The failure to notify the Secretary in violation of section 311(a).CommentsClose CommentsPermalink





‘(2) The failure to comply with--CommentsClose CommentsPermalink





‘(A) an order issued under section 311(b) following any hearing requested under section 311(c); orCommentsClose CommentsPermalink





‘(B) an amended order issued under section 311(d)(1).’.CommentsClose CommentsPermalink





(b) Notification, Nondistribution, and Recall of Adulterated or Misbranded Articles of Food; Civil Penalties Relating to Foods- 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:CommentsClose CommentsPermalink

‘SEC. 311. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED ARTICLES OF FOOD.

‘(a) Notification to Secretary of Violation-CommentsClose CommentsPermalink





‘(1) IN GENERAL- A person (other than a household consumer or other individual who is the intended consumer of an article of food) that has reason to believe that an article of food when introduced into or while in interstate commerce, or while held for sale (regardless of whether the first sale) after shipment in interstate commerce, is adulterated or misbranded in a manner that, if consumed, may result in illness or injury shall, as soon as practicable, notify the Secretary of the identity and location of the article.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(b) Recall and Consumer Notification-CommentsClose CommentsPermalink





‘(1) VOLUNTARY ACTIONS- On receiving notification under subsection (a) or by other means, if the Secretary finds that an article of food when introduced into or while in interstate commerce, or while held for sale (regardless of whether the first sale) after shipment in interstate commerce, is adulterated or misbranded in a manner that, if consumed, may result in illness or injury (as determined by the Secretary), the Secretary shall provide all appropriate persons (including the manufacturer, importer, distributor, or retailer of the article) with an opportunity (as determined by the Secretary)--CommentsClose CommentsPermalink





‘(A) to cease distribution of the article;CommentsClose CommentsPermalink





‘(B) to notify all persons--CommentsClose CommentsPermalink





‘(i) that produce, manufacture, pack, process, prepare, treat, package, distribute, or hold the article, to cease immediately those activities with respect to the article; orCommentsClose CommentsPermalink





‘(ii) to which the article has been distributed, transported, or sold, to cease immediately distribution of the article;CommentsClose CommentsPermalink





‘(C) to recall the article;CommentsClose CommentsPermalink





‘(D) in consultation with the Secretary, to provide notice of the finding of the Secretary to all consumers to which the article was, or may have been, distributed and to appropriate State and local health officials; orCommentsClose CommentsPermalink





‘(E) to notify State and local public health officials.CommentsClose CommentsPermalink





‘(2) MANDATORY ACTIONS- If the appropriate person referred to in paragraph (1) does not carry out the actions described in that paragraph with respect to an article within the time period and in the manner prescribed by the Secretary, the Secretary--CommentsClose CommentsPermalink





‘(A) shall require the person--CommentsClose CommentsPermalink





‘(i) to immediately cease distribution of the article; andCommentsClose CommentsPermalink





‘(ii) to immediately make the notification described in paragraph (1)(B); andCommentsClose CommentsPermalink





‘(B) may take control or possession of the article.CommentsClose CommentsPermalink





‘(3) NOTICE TO CONSUMERS AND HEALTH OFFICIALS- The Secretary shall, as the Secretary determines to be necessary, provide notice of the finding of the Secretary under paragraph (1) to consumers to which the article was, or may have been, distributed and to appropriate State and local health officials.CommentsClose CommentsPermalink





‘(c) Hearings on Orders-CommentsClose CommentsPermalink





‘(1) IN GENERAL- The Secretary shall provide a person subject to an order under subsection (b) with an opportunity for a hearing on--CommentsClose CommentsPermalink





‘(A) the actions required by the order; andCommentsClose CommentsPermalink





‘(B) any reasons why the article of food that is the subject of the order should not be recalled.CommentsClose CommentsPermalink





‘(2) TIMING OF HEARINGS- The Secretary shall hold a hearing under paragraph (1) as soon as practicable, but not later than 2 business days, after the date of issuance of the order.CommentsClose CommentsPermalink





‘(d) Post-Hearing Recall Orders-CommentsClose CommentsPermalink





‘(1) AMENDMENT OF ORDERS- If, after providing an opportunity for a hearing under subsection (c), the Secretary determines that an article of food when introduced into or while in interstate commerce, or while held for sale (regardless of whether the first sale) after shipment in interstate commerce, is adulterated or misbranded in a manner that, if consumed, may result in illness or injury, the Secretary may, as the Secretary determines to be necessary--CommentsClose CommentsPermalink





‘(A) amend the order under subsection (b)--CommentsClose CommentsPermalink





‘(i) to require recall of the article or other appropriate action; andCommentsClose CommentsPermalink





‘(ii) to specify a timetable during which the recall shall occur;CommentsClose CommentsPermalink





‘(B) require periodic reports to the Secretary describing the progress of the recall; orCommentsClose CommentsPermalink





‘(C) provide notice of the recall to consumers to which the article was, or may have been, distributed.CommentsClose CommentsPermalink





‘(2) VACATION OF ORDERS- If, after providing an opportunity for a hearing under subsection (c), the Secretary determines that adequate grounds do not exist to continue the actions required by the order, the Secretary shall vacate the order.CommentsClose CommentsPermalink





‘(e) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.CommentsClose CommentsPermalink

‘SEC. 312. CIVIL PENALTIES RELATING TO FOODS.

‘(a) In General-CommentsClose CommentsPermalink





‘(1) ASSESSMENT- The Secretary may assess against a person that commits an act prohibited by section 301(pp) a civil penalty for each such act of not more than--CommentsClose CommentsPermalink





‘(A) $100,000, in the case of an individual; andCommentsClose CommentsPermalink





‘(B) $500,000, in the case of any other person.CommentsClose CommentsPermalink





‘(2) SEPARATE OFFENSES- Each prohibited act and each day during which the act continues shall be considered to be a separate offense.CommentsClose CommentsPermalink





‘(3) NOTICE AND OPPORTUNITY FOR HEARING- The Secretary shall not assess a civil penalty under this section against a person 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.CommentsClose CommentsPermalink





‘(4) DETERMINATION OF CIVIL PENALTY AMOUNT- The amount of a civil penalty under this section--CommentsClose CommentsPermalink





‘(A) shall be assessed by the Secretary by written order, taking into account--CommentsClose CommentsPermalink





‘(i) the gravity of the violation;CommentsClose CommentsPermalink





‘(ii) the degree of culpability of the person;CommentsClose CommentsPermalink





‘(iii) the size and type of the business of the person; andCommentsClose CommentsPermalink





‘(iv) any history of prior offenses by the person; andCommentsClose CommentsPermalink





‘(B) shall be reviewed only in accordance with subsection (b).CommentsClose CommentsPermalink





‘(b) Judicial Review-CommentsClose CommentsPermalink





‘(1) IN GENERAL- An order assessing a civil penalty against a person under subsection (a) shall be final unless the person--CommentsClose CommentsPermalink





‘(A) not later than 30 days after the effective date of the order, files a petition for judicial review of the order in--CommentsClose CommentsPermalink





‘(i) the United States court of appeals for the circuit in which the person resides or has its principal place of business; orCommentsClose CommentsPermalink





‘(ii) the United States Court of Appeals for the District of Columbia Circuit; andCommentsClose CommentsPermalink





‘(B) simultaneously sends a copy of the petition by certified mail to the Secretary.CommentsClose CommentsPermalink





‘(2) FILING OF COPY OF RECORD- The Secretary shall promptly file in the court a certified copy of the record on which the order was issued.CommentsClose CommentsPermalink





‘(3) STANDARD OF REVIEW- The findings of the Secretary relating to the order shall be set aside only if the findings are found to be unsupported by substantial evidence on the record as a whole.CommentsClose CommentsPermalink





‘(c) Collection Actions for Failure To Pay Assessment-CommentsClose CommentsPermalink





‘(1) REFERRAL TO ATTORNEY GENERAL- If a person fails to pay a civil penalty assessed under subsection (a) after the order assessing the civil penalty has become a final order, or after the court of appeals has entered final judgment in favor of the Secretary, the Secretary may refer the matter to the Attorney General.CommentsClose CommentsPermalink





‘(2) ACTION BY ATTORNEY GENERAL- The Attorney General shall bring a civil action to recover the amount of the civil penalty in United States district court.CommentsClose CommentsPermalink





‘(3) SCOPE OF REVIEW- In a civil action under paragraph (2), the validity and appropriateness of the order of the Secretary assessing the civil penalty shall not be subject to review.CommentsClose CommentsPermalink





‘(d) Penalties Deposited in Treasury- All amounts collected as civil penalties under this section shall be deposited in the Treasury of the United States.CommentsClose CommentsPermalink





‘(e) Penalties in Lieu of Other Actions- Nothing in this Act requires the Secretary to report for prosecution, or for the commencement of any libel or injunction proceeding, any violation of section 301(pp) in any case in which the Secretary believes that the public interest will be adequately served by the assessment of a civil penalty under this section.CommentsClose CommentsPermalink





‘(f) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.’.CommentsClose CommentsPermalink