110 HR 5069 IH: Food and Product Responsibility U.S. House of Representatives 2008-01-17 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
I 110th CONGRESS 2d Session H. R. 5069 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.
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.
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.
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:
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.
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:
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.
.
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:
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.
.
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:
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.
.