[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5069 Introduced in House (IH)]







110th CONGRESS
  2d Session
                                H. R. 5069

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            January 17, 2008

    Mr. Visclosky (for himself, Mr. Wilson of Ohio, Mr. Cohen, Mr. 
  Mollohan, Ms. DeLauro, Mr. Pastor, Ms. Kaptur, Mr. Murtha, and Mr. 
    Allen) introduced the following bill; which was referred to the 
 Committee on Energy and Commerce, and in addition to the Committee on 
Agriculture, for a period to be subsequently determined by the Speaker, 
 in each case for consideration of such provisions as fall within the 
                jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
To require manufacturers to demonstrate sufficient means to cover, for 
 certain products distributed in commerce, costs of potential recalls, 
                        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 and Product 
Responsibility Act of 2008''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Requirement that manufacturers demonstrate sufficient means to 
                            cover, for certain products, costs of 
                            potential recalls.
Sec. 3. Notification, nondistribution, and recall of adulterated or 
                            misbranded meat and meat food products.
Sec. 4. Notification, nondistribution, and recall of adulterated or 
                            misbranded poultry and poultry food 
                            products.
Sec. 5. Notification, nondistribution, and recall of adulterated or 
                            misbranded eggs and egg products.
Sec. 6. Notification, nondistribution, and recall of adulterated or 
                            misbranded foods.

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

    (a) Definitions.--In this section:
            (1) Commerce.--The term ``commerce'' means trade, traffic, 
        commerce, or transportation--
                    (A) between a place in a State and any place 
                outside thereof; or
                    (B) which affects trade, traffic, commerce, or 
                transportation described in subparagraph (A).
            (2) Covered product.--The term ``covered product'' means 
        any of the following:
                    (A) Replacement equipment, as such term is used in 
                section 30102 of title 49, United States Code.
                    (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).
                    (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)).
                    (D) A consumer product, as such term is used in 
                section 3(a) of the Consumer Product Safety Act (15 
                U.S.C. 2052).
                    (E)(i) Meat or meat food product (within the 
                meaning of the Federal Meat Inspection Act (21 U.S.C. 
                601 et seq.)).
                    (ii) Poultry or poultry product (as defined in 
                section 4 of the Poultry Products Inspection Act (21 
                U.S.C. 453)).
                    (iii) Egg or egg product (as defined in section 4 
                of the Egg Products Inspection Act (21 U.S.C. 1033)).
            (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.
            (4) Import.--The term ``import'' includes reimporting a 
        covered product manufactured or processed, in whole or in part, 
        in the United States.
            (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.
            (6) Recall.--With respect to a covered product, the term 
        ``recall'' means the following:
                    (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.
                    (B) In the case of--
                            (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)(1)(A), (e));
                            (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)); and
                            (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.
                    (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)).
                    (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).
                    (E) In the case of a covered product described in 
                paragraph (2)(E), a recall of the covered product 
                under--
                            (i) the Federal Meat Inspection Act (21 
                        U.S.C. 601 et seq.);
                            (ii) the Poultry Products Inspection Act 
                        (21 U.S.C. 451 et seq.); or
                            (iii) the Egg Products Inspection Act (21 
                        U.S.C. 1031 et seq.).
    (b) Financial Responsibility Required.--
            (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.
            (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--
                    (A) the entire cost of a recall of that product, 
                including any administrative costs associated with such 
                recall; and
                    (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.
    (c) Annual Report.--
            (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).
            (2) Consultation.--In preparing the annual report required 
        by paragraph (1), the Secretary of Homeland Security shall 
        consult with the following:
                    (A) The Secretary of State.
                    (B) The Consumer Product Safety Commission.
                    (C) Secretary of Health and Human Services.
                    (D) The Secretary of Agriculture.
                    (E) The Secretary of Commerce.
            (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.

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--
            (1) by redesignating section 411 (21 U.S.C. 680) as section 
        412; and
            (2) by inserting after section 410 (21 U.S.C. 679a) the 
        following:

``SEC. 411. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR 
              MISBRANDED MEAT AND MEAT FOOD PRODUCTS.

    ``(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 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.
            ``(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.''.
    (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. 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--
            (1) in the first sentence of section 5(c)(1) (21 U.S.C. 
        454(c)(1))--
                    (A) by striking ``, by thirty days prior to the 
                expiration of two years after enactment of the 
                Wholesome Poultry Products Act,''; and
                    (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''; and
            (2) by adding at the end the following:

``SEC. 31. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR 
              MISBRANDED POULTRY AND POULTRY FOOD PRODUCTS.

    ``(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. 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:

``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. 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:

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

    ``(a) Notification to Secretary of Violation.--
            ``(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.
            ``(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)(A)(ii) 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.''.
                                 <all>