S 2081 ISCommentsClose CommentsPermalink

To require manufacturers to demonstrate sufficient means to cover, for certain products distributed in commerce, costs of potential recalls, and for other purposes.CommentsClose CommentsPermalink

September 20, 2007

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

To require manufacturers to demonstrate sufficient means to cover, for certain products distributed in commerce, costs of potential recalls, 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 and Product Responsibility Act of 2007'.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





Sec. 2. Requirement that manufacturers demonstrate sufficient means to cover, for certain products, costs of potential recalls.CommentsClose CommentsPermalink





Sec. 3. Notification, nondistribution, and recall of adulterated or misbranded meat and meat food products.CommentsClose CommentsPermalink





Sec. 4. Notification, nondistribution, and recall of adulterated or misbranded poultry and poultry food products.CommentsClose CommentsPermalink





Sec. 5. Notification, nondistribution, and recall of adulterated or misbranded eggs and egg products.CommentsClose CommentsPermalink





Sec. 6. Notification, nondistribution, and recall of adulterated or misbranded foods.CommentsClose CommentsPermalink

SEC. 2. REQUIREMENT THAT MANUFACTURERS DEMONSTRATE SUFFICIENT MEANS TO COVER, FOR CERTAIN PRODUCTS, COSTS OF POTENTIAL RECALLS.

(a) Definitions- In this section:CommentsClose CommentsPermalink





(1) COMMERCE- The term `commerce' means trade, traffic, commerce, or transportation--CommentsClose CommentsPermalink





(A) between a place in a State and any place outside thereof, orCommentsClose CommentsPermalink





(B) which affects trade, traffic, commerce, or transportation described in subparagraph (A).CommentsClose CommentsPermalink





(2) COVERED PRODUCT- The term `covered product' means any of the following:CommentsClose CommentsPermalink





(A) Replacement equipment, as such term is used in section 30102 of title 49, United States Code.CommentsClose CommentsPermalink





(B) Food, drugs, devices, and cosmetics as such terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).CommentsClose CommentsPermalink





(C) A biological product as such term is defined in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i)).CommentsClose CommentsPermalink





(D) A consumer product, as such term is used in section 3(a) of the Consumer Product Safety Act (15 U.S.C. 2052).CommentsClose CommentsPermalink





(E)(i) Meat or meat food product (within the meaning of the Federal Meat Inspection Act (21 U.S.C. 601 et seq.)).CommentsClose CommentsPermalink





(ii) Poultry or poultry product (as defined in section 4 of the Poultry Products Inspection Act (21 U.S.C. 453)).CommentsClose CommentsPermalink





(iii) Egg or egg product (as defined in section 4 of the Egg Products Inspection Act (21 U.S.C. 1033)).CommentsClose CommentsPermalink





(3) DISTRIBUTE IN COMMERCE- The term `distribute in commerce' means to sell in commerce, to introduce or deliver for introduction into commerce, or to hold for sale or distribution after introduction into commerce.CommentsClose CommentsPermalink





(4) IMPORT- The term `import' includes reimporting a covered product manufactured or processed, in whole or in part, in the United States.CommentsClose CommentsPermalink





(5) MANUFACTURER- The term `manufacturer' means any person who manufactures or imports a covered product. A common carrier, contract carrier, or freight forwarder shall not, for purposes of this Act, be deemed to be a manufacturer of a covered product solely by reason of receiving or transporting a covered product in the ordinary course of its business as such a carrier or forwarder.CommentsClose CommentsPermalink





(6) RECALL- With respect to a covered product, the term `recall' means the following:CommentsClose CommentsPermalink





(A) In the case that the Secretary of Transportation makes a determination under section 30118(b)(1) of title 49, United States Code, that a covered product described in paragraph (2)(A) contains a defect related to motor vehicle safety or does not comply with an applicable motor vehicle safety standard prescribed under chapter 301 of such title, giving notification under section 30119 of such title and remedying such defect or noncompliance under section 30120 of such title.CommentsClose CommentsPermalink





(B) In the case of--CommentsClose CommentsPermalink





(i) a device, as defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321), an order under subsection (b)(1)(a) or (e) of section 518 of such Act (21 U.S.C. 360h (b), (e));CommentsClose CommentsPermalink





(ii) infant formula, as such term is defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321), a recall of infant formula begun by a manufacturer of infant formula that is carried out in accordance with section 412(f) of such Act (21 U.S.C. 350a(f)); andCommentsClose CommentsPermalink





(iii) any other covered product described in paragraph (2)(B), a recall of the covered product by the manufacturer or distributor in response to an advisory or other alert issued by the Commissioner of Food and Drugs that advises consumers to avoid the covered product.CommentsClose CommentsPermalink





(C) In the case of a biological product, as defined in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i)), an order under section 351(d) of such Act (42 U.S.C. 262(d).CommentsClose CommentsPermalink





(D) In the case of a covered product described in paragraph (2)(D), an action under subsection (c) and (d) of section 15 of the Consumer Product Safety Act (15 U.S.C. 2064).CommentsClose CommentsPermalink





(E) In the case of a covered product described in paragraph (1)(E), a recall of the covered product under--CommentsClose CommentsPermalink





(i) the Federal Meat Inspection Act (21 U.S.C. 601 et seq.);CommentsClose CommentsPermalink





(ii) the Poultry Products Inspection Act (21 U.S.C. 451 et seq.); orCommentsClose CommentsPermalink





(iii) the Egg Products Inspection Act (21 U.S.C. 1031 et seq.).CommentsClose CommentsPermalink





(b) Financial Responsibility Required-CommentsClose CommentsPermalink





(1) IN GENERAL- Beginning on the date that is 2 years after the date of the enactment of this Act, a manufacturer may not distribute in commerce a covered product unless the manufacturer holds a recall responsibility certificate described in paragraph (2) for such covered product.CommentsClose CommentsPermalink





(2) RECALL RESPONSIBILITY CERTIFICATE- A recall responsibility certificate described in this paragraph is a certification from the U.S. Customs and Border Protection that a manufacturer possess sufficient means (through insurance or otherwise), for the 5-year period beginning on the date the manufacturer begins to distribute in commerce a covered product, to cover--CommentsClose CommentsPermalink





(A) the entire cost of a recall of that product, including any administrative costs associated with such recall; andCommentsClose CommentsPermalink





(B) compensatory damages and costs (including reasonable attorneys fees) of any product liability or other lawsuit filed for claims arising out of, relating to, or resulting from any defect in that product.CommentsClose CommentsPermalink





(c) Annual Report-CommentsClose CommentsPermalink





(1) IN GENERAL- Not later than 2 years after the date of the enactment of this Act and each year thereafter, the Secretary of Homeland Security shall submit to Congress a report on the implementation of this Act, including an assessment of the comments received from the public in accordance with paragraph (3).CommentsClose CommentsPermalink





(2) CONSULTATION- In preparing the annual report required by paragraph (1), the Secretary of Homeland Security shall consult with the following:CommentsClose CommentsPermalink





(A) The Secretary of State.CommentsClose CommentsPermalink





(B) The Consumer Product Safety Commission.CommentsClose CommentsPermalink





(C) Secretary of Health and Human Services.CommentsClose CommentsPermalink





(D) The Secretary of Agriculture.CommentsClose CommentsPermalink





(E) The Secretary of Commerce.CommentsClose CommentsPermalink





(3) PUBLIC COMMENTS- In preparing the annual report required by paragraph (1), the Secretary of Homeland Security shall solicit comments from the public on the implementation of this Act.CommentsClose CommentsPermalink

SEC. 3. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED 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 412; 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 MEAT AND MEAT FOOD 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 carcass, part of a carcass, meat, or meat food product of cattle, sheep, swine, goats, horses, mules, or other equines (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





(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. 4. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED POULTRY AND POULTRY FOOD PRODUCTS.

The Poultry Products Inspection Act (21 U.S.C. 451 et seq.) is amended--CommentsClose CommentsPermalink





(1) in the first sentence of section 5(c)(1) (21 U.S.C. 454(c)(1))--CommentsClose CommentsPermalink





(A) by striking `, by thirty days prior to the expiration of two years after enactment of the Wholesome Poultry Products Act,'; andCommentsClose CommentsPermalink





(B) 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 31'; andCommentsClose CommentsPermalink





(2) by adding at the end the following:CommentsClose CommentsPermalink

`SEC. 31. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED POULTRY AND POULTRY FOOD 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 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. 5. 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. 6. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED FOODS.

Chapter III of the Federal, Food, Drug, and Cosmetic Act (21 U.S.C. 331 et seq.) is amended by inserting after section 304 the following:CommentsClose CommentsPermalink

`SEC. 304A. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED FOODS.

`(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 food (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