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BILL ALERT: Legislation S. 425: 111th Congress
May 20, 2009
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Congress > Legislation S. 425: 111th Congress
This is a bill in the U.S. Congress originating in the Senate ("S."). A bill must be passed by both the Senate and House and then be signed by the President before it becomes law.
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2009-2010 Food Safety and Tracking Improvement Act
A bill 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.
Overview
Sponsor: Sen. Sherrod Brown [D-OH](no cosponsors)
Cosponsors [as of 2009-04-18]
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Text: Summary | Full Text
Summaries
Congressional Research Service Summary
The following summary was written by the Congressional Research Service, a well-respected nonpartisan arm of the Library of Congress. GovTrack did not write and has no control over these summaries.
2/12/2009--Introduced.
Food Safety and Tracking Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require the Secretary of Health and Human Services to establish a traceability system for all stages of manufacturing, processing, packaging, and distribution of food through which the Secretary can retrieve the history, use, and location of each article of food shipped in interstate commerce.
Amends the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act to require a person (other than a household consumer) who has reason to believe that any meat, poultry, egg, or egg product handled by such person is adulterated or misbranded to notify the Secretary of Agriculture of the identity and location of the article.
Directs the Secretary, upon finding that the article is adulterated or misbranded and there is a reasonable probability that human consumption would present a threat to public health, to:
(1) provide all appropriate persons an opportunity to cease distribution of the article, make appropriate notifications, and recall the article; and
(2) require an immediate cessation of distribution if voluntary action is not taken.
Authorizes the Secretary to:
(1) refuse to provide, or to withdraw, inspections of an establishment for willful or repeated violations of the respective Act;
(2) deny or suspend inspection in the public interest to protect the health or welfare of consumers or to ensure the effective performance of an official duty under the respective Act; and (3) assess civil penalties for violations.
Amends the FFDCA to require a person (other than a household consumer or other individual who is an intended consumer) who has reason to believe that an article of food introduced into interstate commerce is adulterated or misbranded in a manner that, if consumed, may result in illness or injury to notify the Secretary of Health and Human Services. Directs the Secretary, upon finding that to be the case, to:
(1) provide all appropriate persons an opportunity to cease distribution of such article, make appropriate notifications, and recall the article; and
(2) require an immediate cessation of distribution if voluntary action is not taken.
Allows the Secretary to assess penalties for prohibited acts.
This version: Introduced in Senate. This is the original text of the bill as it was written by its sponsor and submitted to the Senate for consideration. This is the latest version of the bill available on this website.
S 425 IS
111th CONGRESS
1st Session
S. 425
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.
IN THE SENATE OF THE UNITED STATES
February 12, 2009
Mr. BROWN introduced the following bill; which was read twice and referred to the Committee on Agriculture, Nutrition, and Forestry
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A BILL
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.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title- This Act may be cited as the Food Safety and Tracking Improvement Act.
(b) Table of Contents- The table of contents for this Act is as follows:
Sec. 1. Short title; table of contents.
TITLE I--TRACEABILITY OF FOOD
Sec. 101. Traceability of food.
TITLE II--ENFORCEMENT AND RECALL FOR MEAT, POULTRY, AND FOOD
Sec. 201. Food safety enforcement for meat and meat food products.
Sec. 202. Food safety enforcement for poultry and poultry food products.
Sec. 203. Notification, nondistribution, and recall of adulterated or misbranded eggs and egg products.
Sec. 204. Notification, nondistribution, and recall of adulterated or misbranded articles of food.
TITLE I--TRACEABILITY OF FOOD
SEC. 101. TRACEABILITY OF FOOD.
The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended--
(1) in section 301, by inserting at the end the following:
?‘(oo) The failure to comply with any requirement of section 414A (relating to the traceability of food).?’; and
(2) in chapter IV, by inserting after section 414 the following:
?‘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.
?‘(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.
?‘(c) Records-
?‘(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.
?‘(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).
?‘(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.
?‘(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.
?‘(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.
?‘(f) Advisory Committee-
?‘(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?’).
?‘(2) MEMBERSHIP- The Committee shall consist of 13 members appointed by the Secretary which shall include--
?‘(A) an equitable number of food safety and tracking technology experts, representatives of the food industry, and consumer advocates; and
?‘(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.
?‘(3) CHAIRPERSON- The Secretary shall appoint a Chairperson of the Committee.
?‘(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.
?‘(5) REPORT OF COMMITTEE-
?‘(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.
?‘(B) CONSIDERATIONS- In developing the report under subparagraph (A), the Committee shall consider the following approaches to providing for the traceability of food:
?‘(i) A national database or registry operated by the Food and Drug Administration.
?‘(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.
?‘(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).
?‘(iv) Recall performance standards for each food or commodity type.
?‘(v) Safeguards for the combining, repacking, or otherwise mixing of items of food, particularly fresh produce.
?‘(vi) Other approaches that enable the reliable tracking of food and food products.
?‘(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.?’.
TITLE II--ENFORCEMENT AND RECALL FOR MEAT, POULTRY, AND FOOD
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--
(1) by redesignating section 411 (21 U.S.C. 680) as section 414; and
(2) by inserting after section 410 (21 U.S.C. 679a) the following:
?‘SEC. 411. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED ARTICLES.
?‘(a) Notification to Secretary of Violation-
?‘(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.
?‘(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-
?‘(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--
?‘(A) to cease distribution of the article;
?‘(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;
?‘(C) to recall the article;
?‘(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; or
?‘(E) to notify State and local public health officials.
?‘(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--
?‘(A) shall require the person--
?‘(i) to immediately cease distribution of the article; and
?‘(ii) to immediately make the notification described in paragraph (1)(B); and
?‘(B) may take control or possession of the article.
?‘(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.
?‘(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.
?‘(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--
?‘(A) persons that transport, store, distribute, or otherwise handle the article; and
?‘(B) persons to which the article has been transported, sold, distributed, or otherwise handled.
?‘(c) Informal Hearings on Orders-
?‘(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--
?‘(A) the actions required by the order; and
?‘(B) any reasons why the article that is the subject of the order should not be recalled.
?‘(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.
?‘(d) Post-Hearing Recall Orders-
?‘(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--
?‘(A) amend the order under subsection (b)--
?‘(i) to require recall of the article or other appropriate action; and
?‘(ii) to specify a timetable during which the recall shall occur;
?‘(B) require periodic reports to the Secretary describing the progress of the recall;
?‘(C) provide notice of the recall to consumers to which the article was, or may have been, distributed; or
?‘(D) take any combination of actions described in subparagraphs (A) through (C).
?‘(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.
?‘(e) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.
?‘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).
?‘(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.
?‘(c) Judicial Review-
?‘(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--
?‘(A) files a petition for judicial review of the order; and
?‘(B) simultaneously sends a copy of the petition by certified mail to the Secretary.
?‘(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.
?‘(3) VENUE; RECORD- Judicial review of the order shall be--
?‘(A) in--
?‘(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; or
?‘(ii) the United States Court of Appeals for the District of Columbia Circuit; and
?‘(B) on the record on which the determination and order are based.
?‘(d) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.
?‘SEC. 413. CIVIL PENALTIES.
?‘(a) In General-
?‘(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.
?‘(2) SEPARATE OFFENSES- Each violation and each day during which the violation continues shall be considered to be a separate offense.
?‘(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.
?‘(4) DETERMINATION OF CIVIL PENALTY AMOUNT- The amount of a civil penalty under this section--
?‘(A) shall be assessed by the Secretary by written order, taking into account--
?‘(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; and
?‘(B) shall be reviewed only in accordance with subsection (b).
?‘(b) Judicial Review-
?‘(1) IN GENERAL- An order assessing a civil penalty against a person under subsection (a) shall be final 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--
?‘(i) the United States court of appeals for the circuit in which the person resides or has its principal place of business; or
?‘(ii) the United States Court of Appeals for the District of Columbia Circuit; and
?‘(B) simultaneously sends a copy of the petition by certified mail to the Secretary.
?‘(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.
?‘(c) Collection Actions for Failure To Pay Assessment-
?‘(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.
?‘(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.
?‘(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.
?‘(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.
?‘(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.
?‘(f) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.?’.
(b) Conforming Amendments-
(1) Section 1 of the Federal Meat Inspection Act (21 U.S.C. 601) is amended by adding at the end the following:
?‘(x) Person- The term ?‘person?’ means any individual, partnership, corporation, association, or other business unit.?’.
(2) The Federal Meat Inspection Act (21 U.S.C. 601 et seq.) is amended--
(A) by striking ?‘person, firm, or corporation?’ each place it appears and inserting ?‘person?’;
(B) by striking ?‘persons, firms, and corporations?’ each place it appears and inserting ?‘persons?’; and
(C) by striking ?‘persons, firms, or corporations?’ each place it appears and inserting ?‘persons?’.
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:
?‘SEC. 32. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED ARTICLES.
?‘(a) Notification to Secretary of Violation-
?‘(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.
?‘(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-
?‘(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--
?‘(A) to cease distribution of the article;
?‘(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;
?‘(C) to recall the article;
?‘(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; or
?‘(E) to notify State and local public health officials.
?‘(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--
?‘(A) shall require the person--
?‘(i) to immediately cease distribution of the article; and
?‘(ii) to immediately make the notification described in paragraph (1)(B); and
?‘(B) may take control or possession of the article.
?‘(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.
?‘(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.
?‘(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--
?‘(A) persons that transport, store, distribute, or otherwise handle the article; and
?‘(B) persons to which the article has been transported, sold, distributed, or otherwise handled.
?‘(c) Informal Hearings on Orders-
?‘(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--
?‘(A) the actions required by the order; and
?‘(B) any reasons why the article that is the subject of the order should not be recalled.
?‘(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.
?‘(d) Post-Hearing Recall Orders-
?‘(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--
?‘(A) amend the order under subsection (b)--
?‘(i) to require recall of the article or other appropriate action; and
?‘(ii) to specify a timetable during which the recall shall occur;
?‘(B) require periodic reports to the Secretary describing the progress of the recall; or
?‘(C) provide notice of the recall to consumers to which the article was, or may have been, distributed.
?‘(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.
?‘(e) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.
?‘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).
?‘(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.
?‘(c) Judicial Review-
?‘(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--
?‘(A) files a petition for judicial review of the order; and
?‘(B) simultaneously sends a copy of the petition by certified mail to the Secretary.
?‘(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.
?‘(3) VENUE; RECORD- Judicial review of the order shall be--
?‘(A) in--
?‘(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; or
?‘(ii) the United States Court of Appeals for the District of Columbia Circuit; and
?‘(B) on the record on which the determination and order are based.
?‘(d) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.
?‘SEC. 34. CIVIL PENALTIES.
?‘(a) In General-
?‘(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.
?‘(2) SEPARATE OFFENSES- Each violation and each day during which the violation continues shall be considered to be a separate offense.
?‘(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.
?‘(4) DETERMINATION OF CIVIL PENALTY AMOUNT- The amount of a civil penalty under this section--
?‘(A) shall be assessed by the Secretary by written order, taking into account--
?‘(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; and
?‘(B) shall be reviewed only in accordance with subsection (b).
?‘(b) Judicial Review-
?‘(1) IN GENERAL- An order assessing a civil penalty against a person under subsection (a) shall be final 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--
?‘(i) the United States court of appeals for the circuit in which the person resides or has its principal place of business; or
?‘(ii) the United States Court of Appeals for the District of Columbia Circuit; and
?‘(B) simultaneously sends a copy of the petition by certified mail to the Secretary.
?‘(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.
?‘(c) Collection Actions for Failure To Pay Assessment-
?‘(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.
?‘(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.
?‘(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.
?‘(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.
?‘(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.
?‘(f) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.?’.
(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--
(1) by striking ?‘, by thirty days prior to the expiration of two years after enactment of the Wholesome Poultry Products Act,?’; and
(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?’; and
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:
?‘SEC. 20A. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED EGGS AND EGG PRODUCTS.
?‘(a) Notification to Secretary of Violation-
?‘(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.
?‘(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-
?‘(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--
?‘(A) to cease distribution of the article;
?‘(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;
?‘(C) to recall the article;
?‘(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; or
?‘(E) to notify State and local public health officials.
?‘(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--
?‘(A) shall require the person--
?‘(i) to immediately cease distribution of the article; and
?‘(ii) to immediately make the notification described in paragraph (1)(B); and
?‘(B) may take control or possession of the article.
?‘(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.
?‘(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.
?‘(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--
?‘(A) persons that transport, store, distribute, or otherwise handle the article; and
?‘(B) persons to which the article has been transported, sold, distributed, or otherwise handled.
?‘(c) Informal Hearings on Orders-
?‘(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--
?‘(A) the actions required by the order; and
?‘(B) any reasons why the article that is the subject of the order should not be recalled.
?‘(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.
?‘(d) Post-Hearing Recall Orders-
?‘(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--
?‘(A) amend the order under subsection (b)--
?‘(i) to require recall of the article or other appropriate action; and
?‘(ii) to specify a timetable during which the recall shall occur;
?‘(B) require periodic reports to the Secretary describing the progress of the recall; or
?‘(C) provide notice of the recall to consumers to which the article was, or may have been, distributed.
?‘(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.
?‘(e) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.
?‘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).
?‘(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.
?‘(c) Judicial Review-
?‘(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--
?‘(A) files a petition for judicial review of the order; and
?‘(B) simultaneously sends a copy of the petition by certified mail to the Secretary.
?‘(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.
?‘(3) VENUE; RECORD- Judicial review of the order shall be--
?‘(A) in--
?‘(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; or
?‘(ii) the United States Court of Appeals for the District of Columbia Circuit; and
?‘(B) on the record on which the determination and order are based.
?‘(d) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.
?‘SEC. 20C. CIVIL PENALTIES.
?‘(a) In General-
?‘(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.
?‘(2) SEPARATE OFFENSES- Each violation and each day during which the violation continues shall be considered to be a separate offense.
?‘(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.
?‘(4) DETERMINATION OF CIVIL PENALTY AMOUNT- The amount of a civil penalty under this section--
?‘(A) shall be assessed by the Secretary by written order, taking into account--
?‘(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; and
?‘(B) shall be reviewed only in accordance with subsection (b).
?‘(b) Judicial Review-
?‘(1) IN GENERAL- An order assessing a civil penalty against a person under subsection (a) shall be final 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--
?‘(i) the United States court of appeals for the circuit in which the person resides or has its principal place of business; or
?‘(ii) the United States Court of Appeals for the District of Columbia Circuit; and
?‘(B) simultaneously sends a copy of the petition by certified mail to the Secretary.
?‘(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.
?‘(c) Collection Actions for Failure To Pay Assessment-
?‘(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.
?‘(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.
?‘(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.
?‘(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.
?‘(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.
?‘(f) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.?’.
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:
?‘(pp)(1) The failure to notify the Secretary in violation of section 311(a).
?‘(2) The failure to comply with--
?‘(A) an order issued under section 311(b) following any hearing requested under section 311(c); or
?‘(B) an amended order issued under section 311(d)(1).?’.
(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:
?‘SEC. 311. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED ARTICLES OF FOOD.
?‘(a) Notification to Secretary of Violation-
?‘(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.
?‘(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-
?‘(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)--
?‘(A) to cease distribution of the article;
?‘(B) to notify all persons--
?‘(i) that produce, manufacture, pack, process, prepare, treat, package, distribute, or hold the article, to cease immediately those activities with respect to the article; or
?‘(ii) to which the article has been distributed, transported, or sold, to cease immediately distribution of the article;
?‘(C) to recall the article;
?‘(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; or
?‘(E) to notify State and local public health officials.
?‘(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--
?‘(A) shall require the person--
?‘(i) to immediately cease distribution of the article; and
?‘(ii) to immediately make the notification described in paragraph (1)(B); and
?‘(B) may take control or possession of the article.
?‘(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.
?‘(c) Hearings on Orders-
?‘(1) IN GENERAL- The Secretary shall provide a person subject to an order under subsection (b) with an opportunity for a hearing on--
?‘(A) the actions required by the order; and
?‘(B) any reasons why the article of food that is the subject of the order should not be recalled.
?‘(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.
?‘(d) Post-Hearing Recall Orders-
?‘(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--
?‘(A) amend the order under subsection (b)--
?‘(i) to require recall of the article or other appropriate action; and
?‘(ii) to specify a timetable during which the recall shall occur;
?‘(B) require periodic reports to the Secretary describing the progress of the recall; or
?‘(C) provide notice of the recall to consumers to which the article was, or may have been, distributed.
?‘(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.
?‘(e) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.
?‘SEC. 312. CIVIL PENALTIES RELATING TO FOODS.
?‘(a) In General-
?‘(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--
?‘(A) $100,000, in the case of an individual; and
?‘(B) $500,000, in the case of any other person.
?‘(2) SEPARATE OFFENSES- Each prohibited act and each day during which the act continues shall be considered to be a separate offense.
?‘(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.
?‘(4) DETERMINATION OF CIVIL PENALTY AMOUNT- The amount of a civil penalty under this section--
?‘(A) shall be assessed by the Secretary by written order, taking into account--
?‘(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; and
?‘(B) shall be reviewed only in accordance with subsection (b).
?‘(b) Judicial Review-
?‘(1) IN GENERAL- An order assessing a civil penalty against a person under subsection (a) shall be final 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--
?‘(i) the United States court of appeals for the circuit in which the person resides or has its principal place of business; or
?‘(ii) the United States Court of Appeals for the District of Columbia Circuit; and
?‘(B) simultaneously sends a copy of the petition by certified mail to the Secretary.
?‘(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.
?‘(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.
?‘(c) Collection Actions for Failure To Pay Assessment-
?‘(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.
?‘(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.
?‘(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.
?‘(d) Penalties Deposited in Treasury- All amounts collected as civil penalties under this section shall be deposited in the Treasury of the United States.
?‘(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.
?‘(f) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.?’.
Status: Introduced Feb 12, 2009
Referred to Committee View Committee Assignments
Reported by Committee ...
Voted on in Senate ...
Voted on in House ...
Signed by President ...
This bill is in the first step in the legislative process. Introduced bills and resolutions first go to committees that deliberate, investigate, and revise them before they go to general debate. The majority of bills and resolutions never make it out of committee.
[Last Updated: Apr 18, 2009 9:08PM]
Last Action: Feb 12, 2009: Read twice and referred to the Committee on Agriculture, Nutrition, and Forestry.
Related:
See the Related Legislation page for other bills related to this one and a list of subject terms that have been applied to this bill. Sometimes the text of one bill or resolution is incorporated into another, and in those cases the original bill or resolution, as it would appear here, would seem to be abandoned.
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Apr 2, 2009 8:02 PM - There was mention of having to comply with using the pesticides etc even in a back yard garden... is this really true? - Read Answers
Answered by a visitor on Apr 8, 2009 6:06 PM - I too did not read anything about pesticide use in this bill.
Answered by a visitor on May 9, 2009 7:44 PM - If it isnt in this bill S425, try HR 875 being pushed by Monsanto and other "Big Agro businesses! They are the leading chemical and seed producing company for GMO seeds! They would basically force any and all growers to use their GMO seeds or it would be illegal to grow anything, even on your porch for your own consumption! If this bill passes, they would very generically gain control over everything grown and "how" to grow it! They are some of the largest producers of the chemicals used in fertilizers and pesticides. Think about it. What a way to "corner the market"!
Another note...have you heard of them suing farmers for using "heirloom" seeds the farmers have grown for decades and for some reason, wind blowing, birds, cross pollenation, the GMO seeds are being found in that farmers fields??? He didnt plant them, but a lot of farmers are losing thier farms or getting paid "settlements" to give up. Check it out!
Remember this...there are several ways to control a poplulation...Who controls the gold, makes the rules, who owns the seeds control the farmers and the food market, now there is legislature trying to "Nationalize" the water supplies!
Fear is the 4th and most used tactic to control the masses. Sorry for the long answer, but these things are "happening now" and people need to open their eyes to stop it (if we can...)!!!
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Apr 8, 2009 6:50 PM - I have a small plot of tomatoes,I give them to family members, does this mean I will soon have to stop,sounds like that is next, is it? -
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Answered by a visitor on May 5, 2009 2:43 PM -
Reading the Summary indicates this Senate bill refers to products intended for sale to strangers--for public consumption, at a farmers' market for instance. It also refers to "interstate commerce" meaning products shipped to stores.
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and 10 more questions.
GovTrack.us. S. 425--111th Congress (2009): Food Safety and Tracking Improvement Act, GovTrack.us (database of federal legislation)
{{cite web
|url=http://www.govtrack.us/congress/bill.xpd?bill=s111-425&page-command=print
|title=S. 425
|accessdate=May 20, 2009
|author=111th Congress (2009)
|date=Feb 12, 2009
|work=Legislation
|publisher=GovTrack.us
|quote=Food Safety and Tracking Improvement Act
Because the U.S. Congress posts most legislative information online one legislative day after events occur, GovTrack is usually one legislative day behind.
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