I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Food and Product Responsibility Act of 2008’’. 

6 (b) TABLE OF CONTENTS.—The table of contents for 

7 this Act is as follows: 


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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. 

1 SEC. 2. REQUIREMENT THAT MANUFACTURERS DEM2 ONSTRATE SUFFICIENT MEANS TO COVER, 

3 FOR CERTAIN PRODUCTS, COSTS OF POTEN4 TIAL RECALLS. 

5 (a) DEFINITIONS.—In this section: 

6 (1) COMMERCE.—The term ‘‘commerce’’ means 

7 trade, traffic, commerce, or transportation— 

8 (A) between a place in a State and any 

9 place outside thereof; or 

10 (B) which affects trade, traffic, commerce, 

11 or transportation described in subparagraph 

12 (A). 

13 (2) COVERED PRODUCT.—The term ‘‘covered 

14 product’’ means any of the following: 

15 (A) Replacement equipment, as such term 

16 is used in section 30102 of title 49, United 

17 States Code. 

18 (B) Food, drugs, devices, and cosmetics as 

19 such terms are defined in section 201 of the 


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1 Federal Food, Drug, and Cosmetic Act (21 

2 U.S.C. 321). 

3 (C) A biological product as such term is 

4 defined in section 351(i) of the Public Health 

5 Service Act (42 U.S.C. 262(i)). 

6 (D) A consumer product, as such term is 

7 used in section 3(a) of the Consumer Product 

8 Safety Act (15 U.S.C. 2052). 

9 (E)(i) Meat or meat food product (within 

10 the meaning of the Federal Meat Inspection Act 

11 (21 U.S.C. 601 et seq.)). 

12 (ii) Poultry or poultry product (as defined 

13 in section 4 of the Poultry Products Inspection 

14 Act (21 U.S.C. 453)). 

15 (iii) Egg or egg product (as defined in sec16 tion 4 of the Egg Products Inspection Act (21 

17 U.S.C. 1033)). 

18 (3) DISTRIBUTE IN COMMERCE.—The term 

19 ‘‘distribute in commerce’’ means to sell in commerce, 

20 to introduce or deliver for introduction into com21 merce, or to hold for sale or distribution after intro22 duction into commerce. 

23 (4) IMPORT.—The term ‘‘import’’ includes re24 importing a covered product manufactured or proc25 essed, in whole or in part, in the United States. 


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1 (5) MANUFACTURER.—The term ‘‘manufac2 turer’’ means any person who manufactures or im3 ports a covered product. A common carrier, contract 

4 carrier, or freight forwarder shall not, for purposes 

5 of this Act, be deemed to be a manufacturer of a 

6 covered product solely by reason of receiving or 

7 transporting a covered product in the ordinary 

8 course of its business as such a carrier or forwarder. 

9 (6) RECALL.—With respect to a covered prod10 uct, the term ‘‘recall’’ means the following: 

11 (A) In the case that the Secretary of 

12 Transportation makes a determination under 

13 section 30118(b)(1) of title 49, United States 

14 Code, that a covered product described in para15 graph (2)(A) contains a defect related to motor 

16 vehicle safety or does not comply with an appli17 cable motor vehicle safety standard prescribed 

18 under chapter 301 of such title, giving notifica19 tion under section 30119 of such title and rem20 edying such defect or noncompliance under sec21 tion 30120 of such title. 

22 (B) In the case of— 

23 (i) a device, as defined in section 201 

24 of the Federal Food, Drug, and Cosmetic 

25 Act (21 U.S.C. 321), an order under subVerDate Aug 31 2005 23:01 Jan 18, 2008 Jkt 069200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H5069.IH H5069

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1 section (b)(1)(A) or (e) of section 518 of 

2 such Act (21 U.S.C. 360h (b)(1)(A), (e)); 

3 (ii) infant formula, as such term is 

4 defined in section 201 of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 321), 

6 a recall of infant formula begun by a man7 ufacturer of infant formula that is carried 

8 out in accordance with section 412(f) of 

9 such Act (21 U.S.C. 350a(f)); and 

10 (iii) any other covered product de11 scribed in paragraph (2)(B), a recall of the 

12 covered product by the manufacturer or 

13 distributor in response to an advisory or 

14 other alert issued by the Commissioner of 

15 Food and Drugs that advises consumers to 

16 avoid the covered product. 

17 (C) In the case of a biological product, as 

18 defined in section 351(i) of the Public Health 

19 Service Act (42 U.S.C. 262(i)), an order under 

20 section 351(d) of such Act (42 U.S.C. 262(d)). 

21 (D) In the case of a covered product de22 scribed in paragraph (2)(D), an action under 

23 subsection (c) and (d) of section 15 of the Con24 sumer Product Safety Act (15 U.S.C. 2064). 


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1 (E) In the case of a covered product de2 scribed in paragraph (2)(E), a recall of the cov3 ered product under— 

4 (i) the Federal Meat Inspection Act 

5 (21 U.S.C. 601 et seq.); 

6 (ii) the Poultry Products Inspection 

7 Act (21 U.S.C. 451 et seq.); or 

8 (iii) the Egg Products Inspection Act 

9 (21 U.S.C. 1031 et seq.). 

10 (b) FINANCIAL RESPONSIBILITY REQUIRED.— 

11 (1) IN GENERAL.—Beginning on the date that 

12 is 2 years after the date of the enactment of this 

13 Act, a manufacturer may not distribute in commerce 

14 a covered product unless the manufacturer holds a 

15 recall responsibility certificate described in para16 graph (2) for such covered product. 

17 (2) RECALL RESPONSIBILITY CERTIFICATE.—A 

18 recall responsibility certificate described in this para19 graph is a certification from the U.S. Customs and 

20 Border Protection that a manufacturer possess suffi21 cient means (through insurance or otherwise), for 

22 the 5-year period beginning on the date the manu23 facturer begins to distribute in commerce a covered 

24 product, to cover— 


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1 (A) the entire cost of a recall of that prod2 uct, including any administrative costs associ3 ated with such recall; and 

4 (B) compensatory damages and costs (in5 cluding reasonable attorneys fees) of any prod6 uct liability or other lawsuit filed for claims 

7 arising out of, relating to, or resulting from any 

8 defect in that product. 

9 (c) ANNUAL REPORT.— 

10 (1) IN GENERAL.—Not later than 2 years after 

11 the date of the enactment of this Act and each year 

12 thereafter, the Secretary of Homeland Security shall 

13 submit to Congress a report on the implementation 

14 of this Act, including an assessment of the com15 ments received from the public in accordance with 

16 paragraph (3). 

17 (2) CONSULTATION.—In preparing the annual 

18 report required by paragraph (1), the Secretary of 

19 Homeland Security shall consult with the following: 

20 (A) The Secretary of State. 

21 (B) The Consumer Product Safety Com22 mission. 

23 (C) Secretary of Health and Human Serv24 ices. 

25 (D) The Secretary of Agriculture. 


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1 (E) The Secretary of Commerce. 

2 (3) PUBLIC COMMENTS.—In preparing the an3 nual report required by paragraph (1), the Secretary 

4 of Homeland Security shall solicit comments from 

5 the public on the implementation of this Act. 

6 SEC. 3. NOTIFICATION, NONDISTRIBUTION, AND RECALL 

7 OF ADULTERATED OR MISBRANDED MEAT 

8 AND MEAT FOOD PRODUCTS. 

9 (a) IN GENERAL.—The Federal Meat Inspection Act 

10 (21 U.S.C. 601 et seq.) is amended— 

11 (1) by redesignating section 411 (21 U.S.C. 

12 680) as section 412; and 

13 (2) by inserting after section 410 (21 U.S.C. 

14 679a) the following: 

15 ‘‘SEC. 411. NOTIFICATION, NONDISTRIBUTION, AND RECALL 

16 OF ADULTERATED OR MISBRANDED MEAT 

17 AND MEAT FOOD PRODUCTS. 

18 ‘‘(a) NOTIFICATION TO SECRETARY OF VIOLATION.— 

19 ‘‘(1) IN GENERAL.—A person (other than a 

20 household consumer) that has reason to believe that 

21 any carcass, part of a carcass, meat, or meat food 

22 product of cattle, sheep, swine, goats, horses, mules, 

23 or other equines (referred to in this section as an 

24 ‘article’) transported, stored, distributed, or other25 wise handled by the person is adulterated or misVerDate Aug 31 2005 23:01 Jan 18, 2008 Jkt 069200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H5069.IH H5069

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1 branded shall, as soon as practicable, notify the Sec2 retary of the identity and location of the article. 

3 ‘‘(2) MANNER OF NOTIFICATION.—Notification 

4 under paragraph (1) shall be made in such manner 

5 and by such means as the Secretary may require by 

6 regulation. 

7 ‘‘(b) RECALL AND CONSUMER NOTIFICATION.— 

8 ‘‘(1) VOLUNTARY ACTIONS.—On receiving noti9 fication under subsection (a) or by other means, if 

10 the Secretary finds that an article is adulterated or 

11 misbranded and that there is a reasonable prob12 ability that human consumption of the article would 

13 present a threat to public health (as determined by 

14 the Secretary), the Secretary shall provide all appro15 priate persons (as determined by the Secretary), 

16 that transported, stored, distributed, or otherwise 

17 handled the article with an opportunity— 

18 ‘‘(A) to cease distribution of the article; 

19 ‘‘(B) to notify all persons that transport, 

20 store, distribute, or otherwise handle the article, 

21 or to which the article has been transported, 

22 sold, distributed, or otherwise handled, to cease 

23 immediately distribution of the article; 

24 ‘‘(C) to recall the article; 


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1 ‘‘(D) in consultation with the Secretary, to 

2 provide notice of the finding of the Secretary to 

3 all consumers to which the article was, or may 

4 have been, distributed; or 

5 ‘‘(E) to notify State and local public health 

6 officials. 

7 ‘‘(2) MANDATORY ACTIONS.—If the appropriate 

8 person referred to in paragraph (1) does not carry 

9 out the actions described in that paragraph with re10 spect to an article within the time period and in the 

11 manner prescribed by the Secretary, the Secretary— 

12 ‘‘(A) shall require the person— 

13 ‘‘(i) to immediately cease distribution 

14 of the article; and 

15 ‘‘(ii) to immediately make the notifica16 tion described in paragraph (1)(B); and 

17 ‘‘(B) may take control or possession of the 

18 article. 

19 ‘‘(3) NOTICE TO CONSUMERS AND HEALTH OF20 FICIALS.—The Secretary shall, as the Secretary de21 termines to be necessary, provide notice of the find22 ing of the Secretary under paragraph (1) to con23 sumers to which the article was, or may have been, 

24 distributed and to appropriate State and local public 

25 health officials. 


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1 ‘‘(4) NONDISTRIBUTION BY NOTIFIED PER2 SONS.—A person that transports, stores, distributes, 

3 or otherwise handles the article, or to which the arti4 cle has been transported, sold, distributed, or other5 wise handled, and that is notified under paragraph 

6 (1)(B) or (2)(B) shall cease immediately distribution 

7 of the article. 

8 ‘‘(5) AVAILABILITY OF RECORDS TO SEC9 RETARY.—Each appropriate person referred to in 

10 paragraph (1) that transported, stored, distributed, 

11 or otherwise handled an article shall make available 

12 to the Secretary information necessary to carry out 

13 this subsection, as determined by the Secretary, re14 garding— 

15 ‘‘(A) persons that transport, store, dis16 tribute, or otherwise handle the article; and 

17 ‘‘(B) persons to which the article has been 

18 transported, sold, distributed, or otherwise han19 dled. 

20 ‘‘(c) INFORMAL HEARINGS ON ORDERS.— 

21 ‘‘(1) IN GENERAL.—The Secretary shall provide 

22 a person subject to an order under subsection (b) 

23 with an opportunity for an informal hearing (in ac24 cordance with such rules or regulations as the Sec25 retary shall prescribe) on— 


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1 ‘‘(A) the actions required by the order; and 

2 ‘‘(B) any reasons why the article that is 

3 the subject of the order should not be recalled. 

4 ‘‘(2) TIMING OF HEARINGS.—The Secretary 

5 shall hold a hearing under paragraph (1) as soon as 

6 practicable, but not later than 2 business days, after 

7 the date of issuance of the order. 

8 ‘‘(d) POST-HEARING RECALL ORDERS.— 

9 ‘‘(1) AMENDMENT OF ORDERS.—If, after pro10 viding an opportunity for an informal hearing under 

11 subsection (c), the Secretary determines that there is 

12 a reasonable probability that human consumption of 

13 the article that is the subject of an order under sub14 section (b) presents a threat to public health, the 

15 Secretary may, as the Secretary determines to be 

16 necessary— 

17 ‘‘(A) amend the order under subsection 

18 (b)— 

19 ‘‘(i) to require recall of the article or 

20 other appropriate action; and 

21 ‘‘(ii) to specify a timetable during 

22 which the recall shall occur; 

23 ‘‘(B) require periodic reports to the Sec24 retary describing the progress of the recall; 


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1 ‘‘(C) provide notice of the recall to con2 sumers to which the article was, or may have 

3 been, distributed; or 

4 ‘‘(D) take any combination of actions de5 scribed in subparagraphs (A) through (C). 

6 ‘‘(2) VACATION OF ORDERS.—If, after providing 

7 an opportunity for an informal hearing under sub8 section (c), the Secretary determines that adequate 

9 grounds do not exist to continue the actions required 

10 by the order, the Secretary shall vacate the order. 

11 ‘‘(e) REMEDIES NOT EXCLUSIVE.—The remedies au12 thorized by this section shall be in addition to any other 

13 remedies that may be available.’’. 

14 (b) CONFORMING AMENDMENTS.— 

15 (1) Section 1 of the Federal Meat Inspection 

16 Act (21 U.S.C. 601) is amended by adding at the 

17 end the following: 

18 ‘‘(x) PERSON.—The term ‘person’ means any indi19 vidual, partnership, corporation, association, or other busi20 ness unit.’’. 

21 (2) The Federal Meat Inspection Act (21 

22 U.S.C. 601 et seq.) is amended— 

23 (A) by striking ‘‘person, firm, or corpora24 tion’’ each place it appears and inserting ‘‘per25 son’’; 


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1 (B) by striking ‘‘persons, firms, and cor2 porations’’ each place it appears and inserting 

3 ‘‘persons’’; and 

4 (C) by striking ‘‘persons, firms, or corpora5 tions’’ each place it appears and inserting ‘‘per6 sons’’. 

7 SEC. 4. NOTIFICATION, NONDISTRIBUTION, AND RECALL 

8 OF ADULTERATED OR MISBRANDED POUL9 TRY AND POULTRY FOOD PRODUCTS. 

10 The Poultry Products Inspection Act (21 U.S.C. 451 

11 et seq.) is amended— 

12 (1) in the first sentence of section 5(c)(1) (21 

13 U.S.C. 454(c)(1))— 

14 (A) by striking ‘‘, by thirty days prior to 

15 the expiration of two years after enactment of 

16 the Wholesome Poultry Products Act,’’; and 

17 (B) by striking ‘‘sections 1-4, 6-10, and 

18 12-22 of this Act’’ and inserting ‘‘sections 1 

19 through 4, 6 through 10, 12 through 22, and 

20 31’’; and 

21 (2) by adding at the end the following: 

22 ‘‘SEC. 31. NOTIFICATION, NONDISTRIBUTION, AND RECALL 

23 OF ADULTERATED OR MISBRANDED POUL24 TRY AND POULTRY FOOD PRODUCTS. 

25 ‘‘(a) NOTIFICATION TO SECRETARY OF VIOLATION.— 


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1 ‘‘(1) IN GENERAL.—A person (other than a 

2 household consumer) that has reason to believe that 

3 any poultry or poultry product (referred to in this 

4 section as an ‘article’) transported, stored, distrib5 uted, or otherwise handled by the person is adulter6 ated or misbranded shall, as soon as practicable, no7 tify the Secretary of the identity and location of the 

8 article. 

9 ‘‘(2) MANNER OF NOTIFICATION.—Notification 

10 under paragraph (1) shall be made in such manner 

11 and by such means as the Secretary may require by 

12 regulation. 

13 ‘‘(b) RECALL AND CONSUMER NOTIFICATION.— 

14 ‘‘(1) VOLUNTARY ACTIONS.—On receiving noti15 fication under subsection (a) or by other means, if 

16 the Secretary finds that an article is adulterated or 

17 misbranded and that there is a reasonable prob18 ability that human consumption of the article would 

19 present a threat to public health (as determined by 

20 the Secretary), the Secretary shall provide all appro21 priate persons (as determined by the Secretary), 

22 that transported, stored, distributed, or otherwise 

23 handled the article with an opportunity— 

24 ‘‘(A) to cease distribution of the article; 


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1 ‘‘(B) to notify all persons that transport, 

2 store, distribute, or otherwise handle the article, 

3 or to which the article has been transported, 

4 sold, distributed, or otherwise handled, to cease 

5 immediately distribution of the article; 

6 ‘‘(C) to recall the article; 

7 ‘‘(D) in consultation with the Secretary, to 

8 provide notice of the finding of the Secretary to 

9 all consumers to which the article was, or may 

10 have been, distributed; or 

11 ‘‘(E) to notify State and local public health 

12 officials. 

13 ‘‘(2) MANDATORY ACTIONS.—If the appropriate 

14 person referred to in paragraph (1) does not carry 

15 out the actions described in that paragraph with re16 spect to an article within the time period and in the 

17 manner prescribed by the Secretary, the Secretary— 

18 ‘‘(A) shall require the person— 

19 ‘‘(i) to immediately cease distribution 

20 of the article; and 

21 ‘‘(ii) to immediately make the notifica22 tion described in paragraph (1)(B); and 

23 ‘‘(B) may take control or possession of the 

24 article. 


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1 ‘‘(3) NOTICE TO CONSUMERS AND HEALTH OF2 FICIALS.—The Secretary shall, as the Secretary de3 termines to be necessary, provide notice of the find4 ing of the Secretary under paragraph (1) to con5 sumers to which the article was, or may have been, 

6 distributed and to appropriate State and local health 

7 officials. 

8 ‘‘(4) NONDISTRIBUTION BY NOTIFIED PER9 SONS.—A person that transports, stores, distributes, 

10 or otherwise handles the article, or to which the arti11 cle has been transported, sold, distributed, or other12 wise handled, and that is notified under paragraph 

13 (1)(B) or (2)(B) shall cease immediately distribution 

14 of the article. 

15 ‘‘(5) AVAILABILITY OF RECORDS TO SEC16 RETARY.—Each appropriate person referred to in 

17 paragraph (1) that transported, stored, distributed, 

18 or otherwise handled an article shall make available 

19 to the Secretary information necessary to carry out 

20 this subsection, as determined by the Secretary, re21 garding— 

22 ‘‘(A) persons that transport, store, dis23 tribute, or otherwise handle the article; and 


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1 ‘‘(B) persons to which the article has been 

2 transported, sold, distributed, or otherwise han3 dled. 

4 ‘‘(c) INFORMAL HEARINGS ON ORDERS.— 

5 ‘‘(1) IN GENERAL.—The Secretary shall provide 

6 a person subject to an order under subsection (b) 

7 with an opportunity for an informal hearing (in ac8 cordance with such rules or regulations as the Sec9 retary shall prescribe) on— 

10 ‘‘(A) the actions required by the order; and 

11 ‘‘(B) any reasons why the article that is 

12 the subject of the order should not be recalled. 

13 ‘‘(2) TIMING OF HEARINGS.—The Secretary 

14 shall hold a hearing under paragraph (1) as soon as 

15 practicable, but not later than 2 business days, after 

16 the date of issuance of the order. 

17 ‘‘(d) POST-HEARING RECALL ORDERS.— 

18 ‘‘(1) AMENDMENT OF ORDERS.—If, after pro19 viding an opportunity for an informal hearing under 

20 subsection (c), the Secretary determines that there is 

21 a reasonable probability that human consumption of 

22 the article that is the subject of an order under sub23 section (b) presents a threat to public health, the 

24 Secretary may, as the Secretary determines to be 

25 necessary— 


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1 ‘‘(A) amend the order under subsection 

2 (b)— 

3 ‘‘(i) to require recall of the article or 

4 other appropriate action; and 

5 ‘‘(ii) to specify a timetable during 

6 which the recall shall occur; 

7 ‘‘(B) require periodic reports to the Sec8 retary describing the progress of the recall; or 

9 ‘‘(C) provide notice of the recall to con10 sumers to which the article was, or may have 

11 been, distributed. 

12 ‘‘(2) VACATION OF ORDERS.—If, after providing 

13 an opportunity for an informal hearing under sub14 section (c), the Secretary determines that adequate 

15 grounds do not exist to continue the actions required 

16 by the order, the Secretary shall vacate the order. 

17 ‘‘(e) REMEDIES NOT EXCLUSIVE.—The remedies au18 thorized by this section shall be in addition to any other 

19 remedies that may be available.’’. 

20 SEC. 5. NOTIFICATION, NONDISTRIBUTION, AND RECALL 

21 OF ADULTERATED OR MISBRANDED EGGS 

22 AND EGG PRODUCTS. 

23 The Egg Products Inspection Act is amended by in24 serting after section 20 (21 U.S.C. 1049) the following: 


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1 ‘‘SEC. 20A. NOTIFICATION, NONDISTRIBUTION, AND RECALL 

2 OF ADULTERATED OR MISBRANDED EGGS 

3 AND EGG PRODUCTS. 

4 ‘‘(a) NOTIFICATION TO SECRETARY OF VIOLATION.— 

5 ‘‘(1) IN GENERAL.—A person (other than a 

6 household consumer) that has reason to believe that 

7 any egg or egg product (referred to in this section 

8 as an ‘article’) transported, stored, distributed, or 

9 otherwise handled by the person is adulterated or 

10 misbranded shall, as soon as practicable, notify the 

11 Secretary of the identity and location of the article. 

12 ‘‘(2) MANNER OF NOTIFICATION.—Notification 

13 under paragraph (1) shall be made in such manner 

14 and by such means as the Secretary may require by 

15 regulation. 

16 ‘‘(b) RECALL AND CONSUMER NOTIFICATION.— 

17 ‘‘(1) VOLUNTARY ACTIONS.—On receiving noti18 fication under subsection (a) or by other means, if 

19 the Secretary finds that an article is adulterated or 

20 misbranded and that there is a reasonable prob21 ability that human consumption of the article would 

22 present a threat to public health (as determined by 

23 the Secretary), the Secretary shall provide all appro24 priate persons (as determined by the Secretary), 

25 that transported, stored, distributed, or otherwise 

26 handled the article with an opportunity— 


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1 ‘‘(A) to cease distribution of the article; 

2 ‘‘(B) to notify all persons that transport, 

3 store, distribute, or otherwise handle the article, 

4 or to which the article has been transported, 

5 sold, distributed, or otherwise handled, to cease 

6 immediately distribution of the article; 

7 ‘‘(C) to recall the article; 

8 ‘‘(D) in consultation with the Secretary, to 

9 provide notice of the finding of the Secretary to 

10 all consumers to which the article was, or may 

11 have been, distributed; or 

12 ‘‘(E) to notify State and local public health 

13 officials. 

14 ‘‘(2) MANDATORY ACTIONS.—If the appropriate 

15 person referred to in paragraph (1) does not carry 

16 out the actions described in that paragraph with re17 spect to an article within the time period and in the 

18 manner prescribed by the Secretary, the Secretary— 

19 ‘‘(A) shall require the person— 

20 ‘‘(i) to immediately cease distribution 

21 of the article; and 

22 ‘‘(ii) to immediately make the notifica23 tion described in paragraph (1)(B); and 

24 ‘‘(B) may take control or possession of the 

25 article. 


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1 ‘‘(3) NOTICE TO CONSUMERS AND HEALTH OF2 FICIALS.—The Secretary shall, as the Secretary de3 termines to be necessary, provide notice of the find4 ing of the Secretary under paragraph (1) to con5 sumers to which the article was, or may have been, 

6 distributed and to appropriate State and local health 

7 officials. 

8 ‘‘(4) NONDISTRIBUTION BY NOTIFIED PER9 SONS.—A person that transports, stores, distributes, 

10 or otherwise handles the article, or to which the arti11 cle has been transported, sold, distributed, or other12 wise handled, and that is notified under paragraph 

13 (1)(B) or (2)(B) shall cease immediately distribution 

14 of the article. 

15 ‘‘(5) AVAILABILITY OF RECORDS TO SEC16 RETARY.—Each appropriate person referred to in 

17 paragraph (1) that transported, stored, distributed, 

18 or otherwise handled an article shall make available 

19 to the Secretary information necessary to carry out 

20 this subsection, as determined by the Secretary, re21 garding— 

22 ‘‘(A) persons that transport, store, dis23 tribute, or otherwise handle the article; and 


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1 ‘‘(B) persons to which the article has been 

2 transported, sold, distributed, or otherwise han3 dled. 

4 ‘‘(c) INFORMAL HEARINGS ON ORDERS.— 

5 ‘‘(1) IN GENERAL.—The Secretary shall provide 

6 a person subject to an order under subsection (b) 

7 with an opportunity for an informal hearing (in ac8 cordance with such rules or regulations as the Sec9 retary shall prescribe) on— 

10 ‘‘(A) the actions required by the order; and 

11 ‘‘(B) any reasons why the article that is 

12 the subject of the order should not be recalled. 

13 ‘‘(2) TIMING OF HEARINGS.—The Secretary 

14 shall hold a hearing under paragraph (1) as soon as 

15 practicable, but not later than 2 business days, after 

16 the date of issuance of the order. 

17 ‘‘(d) POST-HEARING RECALL ORDERS.— 

18 ‘‘(1) AMENDMENT OF ORDERS.—If, after pro19 viding an opportunity for an informal hearing under 

20 subsection (c), the Secretary determines that there is 

21 a reasonable probability that human consumption of 

22 the article that is the subject of an order under sub23 section (b) presents a threat to public health, the 

24 Secretary may, as the Secretary determines to be 

25 necessary— 


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1 ‘‘(A) amend the order under subsection 

2 (b)— 

3 ‘‘(i) to require recall of the article or 

4 other appropriate action; and 

5 ‘‘(ii) to specify a timetable during 

6 which the recall shall occur; 

7 ‘‘(B) require periodic reports to the Sec8 retary describing the progress of the recall; or 

9 ‘‘(C) provide notice of the recall to con10 sumers to which the article was, or may have 

11 been, distributed. 

12 ‘‘(2) VACATION OF ORDERS.—If, after providing 

13 an opportunity for an informal hearing under sub14 section (c), the Secretary determines that adequate 

15 grounds do not exist to continue the actions required 

16 by the order, the Secretary shall vacate the order. 

17 ‘‘(e) REMEDIES NOT EXCLUSIVE.—The remedies au18 thorized by this section shall be in addition to any other 

19 remedies that may be available.’’. 

20 SEC. 6. NOTIFICATION, NONDISTRIBUTION, AND RECALL 

21 OF ADULTERATED OR MISBRANDED FOODS. 

22 Chapter III of the Federal, Food, Drug, and Cos23 metic Act (21 U.S.C. 331 et seq.) is amended by inserting 

24 after section 304 the following: 


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1 ‘‘SEC. 304A. NOTIFICATION, NONDISTRIBUTION, AND RE2 CALL OF ADULTERATED OR MISBRANDED 

3 FOODS. 

4 ‘‘(a) NOTIFICATION TO SECRETARY OF VIOLATION.— 

5 ‘‘(1) IN GENERAL.—A person (other than a 

6 household consumer) that has reason to believe that 

7 any food (referred to in this section as an ‘article’) 

8 transported, stored, distributed, or otherwise han9 dled by the person is adulterated or misbranded 

10 shall, as soon as practicable, notify the Secretary of 

11 the identity and location of the article. 

12 ‘‘(2) MANNER OF NOTIFICATION.—Notification 

13 under paragraph (1) shall be made in such manner 

14 and by such means as the Secretary may require by 

15 regulation. 

16 ‘‘(b) RECALL AND CONSUMER NOTIFICATION.— 

17 ‘‘(1) VOLUNTARY ACTIONS.—On receiving noti18 fication under subsection (a) or by other means, if 

19 the Secretary finds that an article is adulterated or 

20 misbranded and that there is a reasonable prob21 ability that human consumption of the article would 

22 present a threat to public health (as determined by 

23 the Secretary), the Secretary shall provide all appro24 priate persons (as determined by the Secretary), 

25 that transported, stored, distributed, or otherwise 

26 handled the article with an opportunity— 


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•HR 5069 IH

1 ‘‘(A) to cease distribution of the article; 

2 ‘‘(B) to notify all persons that transport, 

3 store, distribute, or otherwise handle the article, 

4 or to which the article has been transported, 

5 sold, distributed, or otherwise handled, to cease 

6 immediately distribution of the article; 

7 ‘‘(C) to recall the article; 

8 ‘‘(D) in consultation with the Secretary, to 

9 provide notice of the finding of the Secretary to 

10 all consumers to which the article was, or may 

11 have been, distributed; or 

12 ‘‘(E) to notify State and local public health 

13 officials. 

14 ‘‘(2) MANDATORY ACTIONS.—If the appropriate 

15 person referred to in paragraph (1) does not carry 

16 out the actions described in that paragraph with re17 spect to an article within the time period and in the 

18 manner prescribed by the Secretary, the Secretary— 

19 ‘‘(A) shall require the person— 

20 ‘‘(i) to immediately cease distribution 

21 of the article; and 

22 ‘‘(ii) to immediately make the notifica23 tion described in paragraph (1)(B); and 

24 ‘‘(B) may take control or possession of the 

25 article. 


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1 ‘‘(3) NOTICE TO CONSUMERS AND HEALTH OF2 FICIALS.—The Secretary shall, as the Secretary de3 termines to be necessary, provide notice of the find4 ing of the Secretary under paragraph (1) to con5 sumers to which the article was, or may have been, 

6 distributed and to appropriate State and local health 

7 officials. 

8 ‘‘(4) NONDISTRIBUTION BY NOTIFIED PER9 SONS.—A person that transports, stores, distributes, 

10 or otherwise handles the article, or to which the arti11 cle has been transported, sold, distributed, or other12 wise handled, and that is notified under paragraph 

13 (1)(B) or (2)(A)(ii) shall cease immediately distribu14 tion of the article. 

15 ‘‘(5) AVAILABILITY OF RECORDS TO SEC16 RETARY.—Each appropriate person referred to in 

17 paragraph (1) that transported, stored, distributed, 

18 or otherwise handled an article shall make available 

19 to the Secretary information necessary to carry out 

20 this subsection, as determined by the Secretary, re21 garding— 

22 ‘‘(A) persons that transport, store, dis23 tribute, or otherwise handle the article; and 


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1 ‘‘(B) persons to which the article has been 

2 transported, sold, distributed, or otherwise han3 dled. 

4 ‘‘(c) INFORMAL HEARINGS ON ORDERS.— 

5 ‘‘(1) IN GENERAL.—The Secretary shall provide 

6 a person subject to an order under subsection (b) 

7 with an opportunity for an informal hearing (in ac8 cordance with such rules or regulations as the Sec9 retary shall prescribe) on— 

10 ‘‘(A) the actions required by the order; and 

11 ‘‘(B) any reasons why the article that is 

12 the subject of the order should not be recalled. 

13 ‘‘(2) TIMING OF HEARINGS.—The Secretary 

14 shall hold a hearing under paragraph (1) as soon as 

15 practicable, but not later than 2 business days, after 

16 the date of issuance of the order. 

17 ‘‘(d) POST-HEARING RECALL ORDERS.— 

18 ‘‘(1) AMENDMENT OF ORDERS.—If, after pro19 viding an opportunity for an informal hearing under 

20 subsection (c), the Secretary determines that there is 

21 a reasonable probability that human consumption of 

22 the article that is the subject of an order under sub23 section (b) presents a threat to public health, the 

24 Secretary may, as the Secretary determines to be 

25 necessary— 


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•HR 5069 IH

1 ‘‘(A) amend the order under subsection 

2 (b)— 

3 ‘‘(i) to require recall of the article or 

4 other appropriate action; and 

5 ‘‘(ii) to specify a timetable during 

6 which the recall shall occur; 

7 ‘‘(B) require periodic reports to the Sec8 retary describing the progress of the recall; or 

9 ‘‘(C) provide notice of the recall to con10 sumers to which the article was, or may have 

11 been, distributed. 

12 ‘‘(2) VACATION OF ORDERS.—If, after providing 

13 an opportunity for an informal hearing under sub14 section (c), the Secretary determines that adequate 

15 grounds do not exist to continue the actions required 

16 by the order, the Secretary shall vacate the order. 

17 ‘‘(e) REMEDIES NOT EXCLUSIVE.—The remedies au18 thorized by this section shall be in addition to any other 

19 remedies that may be available.’’. 

Æ 


rwilkins on PROD1PC63 with BILLS