II 

109TH CONGRESS 

2D SESSION S. 3615 

To amend the Federal Meat Inspection Act, the Poultry Products Inspection 

Act, and the Federal Food, Drug, and Cosmetic Act to provide for 

improved public health and food safety through enhanced enforcement, 

and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

JUNE 29, 2006 

Mr. HARKIN introduced the following bill; which was read twice and referred 

to the Committee on Agriculture, Nutrition, and Forestry 

A BILL 

To amend the Federal Meat Inspection Act, the Poultry 

Products Inspection Act, and the Federal Food, Drug, 

and Cosmetic Act to provide for improved public health 

and food safety through enhanced enforcement, and for 

other purposes. 

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. 

4 This Act may be cited as the ‘‘Safe And Fair En5 forcement and Recall for Meat, Poultry, and Food Act of 

6 2006’’ or ‘‘SAFER Meat, Poultry, and Food Act of 

7 2006’’. 


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1 SEC. 2. FOOD SAFETY ENFORCEMENT FOR MEAT AND MEAT 

2 FOOD PRODUCTS. 

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

4 (21 U.S.C. 601 et seq.) is amended— 

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

6 680) as section 414; and 

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

8 679a) the following: 

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

10 OF ADULTERATED OR MISBRANDED ARTI11 CLES. 

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

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

14 household consumer) that has reason to believe that 

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

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

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

18 ‘article’) transported, stored, distributed, or other19 wise handled by the person is adulterated or mis20 branded shall, as soon as practicable, notify the Sec21 retary of the identity and location of the article. 

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

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

24 and by such means as the Secretary may require by 

25 regulation. 

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


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1 ‘‘(1) VOLUNTARY ACTIONS.—On receiving noti2 fication under subsection (a) or by other means, if 

3 the Secretary finds that an article is adulterated or 

4 misbranded and that there is a reasonable prob5 ability that human consumption of the article would 

6 present a threat to public health (as determined by 

7 the Secretary), the Secretary shall provide all appro8 priate persons (as determined by the Secretary), 

9 that transported, stored, distributed, or otherwise 

10 handled the article with an opportunity— 

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

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

13 store, distribute, or otherwise handle the article, 

14 or to which the article has been transported, 

15 sold, distributed, or otherwise handled, to cease 

16 immediately distribution of the article; 

17 ‘‘(C) to recall the article; 

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

19 provide notice of the finding of the Secretary to 

20 all consumers to which the article was, or may 

21 have been, distributed; or 

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

23 officials. 

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

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


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1 out the actions described in that paragraph with re2 spect to an article within the time period and in the 

3 manner prescribed by the Secretary, the Secretary— 

4 ‘‘(A) shall require the person— 

5 ‘‘(i) to immediately cease distribution 

6 of the article; and 

7 ‘‘(ii) to immediately make the notifica8 tion described in paragraph (1)(B); and 

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

10 article. 

11 ‘‘(3) NOTICE TO CONSUMERS AND HEALTH OF12 FICIALS.—The Secretary shall, as the Secretary de13 termines to be necessary, provide notice of the find14 ing of the Secretary under paragraph (1) to con15 sumers to which the article was, or may have been, 

16 distributed and to appropriate State and local public 

17 health officials. 

18 ‘‘(4) NONDISTRIBUTION BY NOTIFIED PER19 SONS.—A person that transports, stores, distributes, 

20 or otherwise handles the article, or to which the arti21 cle has been transported, sold, distributed, or other22 wise handled, and that is notified under paragraph 

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

24 of the article. 


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1 ‘‘(5) AVAILABILITY OF RECORDS TO SEC2 RETARY.—Each appropriate person referred to in 

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

4 or otherwise handled an article shall make available 

5 to the Secretary information necessary to carry out 

6 this subsection, as determined by the Secretary, re7 garding— 

8 ‘‘(A) persons that transport, store, dis9 tribute, or otherwise handle the article; and 

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

11 transported, sold, distributed, or otherwise han12 dled. 

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

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

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

16 with an opportunity for an informal hearing (in ac17 cordance with such rules or regulations as the Sec18 retary shall prescribe) on— 

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

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

21 the subject of the order should not be recalled. 

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

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

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

25 the date of issuance of the order. 


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1 ‘‘(d) POST-HEARING RECALL ORDERS.— 

2 ‘‘(1) AMENDMENT OF ORDERS.—If, after pro3 viding an opportunity for an informal hearing under 

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

5 a reasonable probability that human consumption of 

6 the article that is the subject of an order under sub7 section (b) presents a threat to public health, the 

8 Secretary may, as the Secretary determines to be 

9 necessary— 

10 ‘‘(A) amend the order under subsection 

11 (b)— 

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

13 other appropriate action; and 

14 ‘‘(ii) to specify a timetable during 

15 which the recall shall occur; 

16 ‘‘(B) require periodic reports to the Sec17 retary describing the progress of the recall; 

18 ‘‘(C) provide notice of the recall to con19 sumers to which the article was, or may have 

20 been, distributed; or 

21 ‘‘(D) take any combination of actions de22 scribed in subparagraphs (A) through (C). 

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

24 an opportunity for an informal hearing under sub25 section (c), the Secretary determines that adequate 


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1 grounds do not exist to continue the actions required 

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

3 ‘‘(e) REMEDIES NOT EXCLUSIVE.—The remedies au4 thorized by this section shall be in addition to any other 

5 remedies that may be available. 

6 ‘‘SEC. 412. REFUSAL OR WITHDRAWAL OF INSPECTION OF 

7 ESTABLISHMENTS. 

8 ‘‘(a) IN GENERAL.—The Secretary may, for such pe9 riod, or indefinitely, as the Secretary considers necessary 

10 to carry out this Act, refuse to provide or withdraw inspec11 tion under title I with respect to an establishment if the 

12 Secretary determines, after opportunity for a hearing on 

13 the record is provided to the applicant for, or recipient 

14 of, inspection, that the applicant or recipient, or any per15 son responsibly connected with the applicant or recipient 

16 (within the meaning of section 401), has committed a will17 ful violation or repeated violations of this Act (including 

18 a regulation promulgated under this Act). 

19 ‘‘(b) DENIAL OR SUSPENSION OF INSPECTION PEND20 ING HEARING.—The Secretary may deny or suspend in21 spection under title I, pending opportunity for an expe22 dited hearing, with respect to an action under subsection 

23 (a), if the Secretary determines that the denial or suspen24 sion is in the public interest to protect the health or welVerDate Aug 31 2005 02:51 Jul 04, 2006 Jkt 049200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S3615.IS S3615

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1 fare of consumers or to ensure the effective performance 

2 of an official duty under this Act. 

3 ‘‘(c) JUDICIAL REVIEW.— 

4 ‘‘(1) IN GENERAL.—A determination and order 

5 of the Secretary with respect to the refusal or with6 drawal of inspection under this section shall be final 

7 unless, not later than 30 days after the effective 

8 date of the order, the affected applicant for, or re9 cipient of, inspection— 

10 ‘‘(A) files a petition for judicial review of 

11 the order; and 

12 ‘‘(B) simultaneously sends a copy of the 

13 petition by certified mail to the Secretary. 

14 ‘‘(2) REFUSAL OR WITHDRAWAL OF INSPEC15 TION PENDING REVIEW.—Inspection shall be refused 

16 or withdrawn as of the effective date of the order 

17 pending any judicial review of the order unless the 

18 Secretary directs otherwise. 

19 ‘‘(3) VENUE; RECORD.—Judicial review of the 

20 order shall be— 

21 ‘‘(A) in— 

22 ‘‘(i) the United States court of ap23 peals for the circuit in which the applicant 

24 for, or recipient of, inspection resides or 

25 has its principal place of business; or 


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1 ‘‘(ii) the United States Court of Ap2 peals for the District of Columbia Circuit; 

3 and 

4 ‘‘(B) on the record on which the deter5 mination and order are based. 

6 ‘‘(d) REMEDIES NOT EXCLUSIVE.—The remedies au7 thorized by this section shall be in addition to any other 

8 remedies that may be available. 

9 ‘‘SEC. 413. CIVIL PENALTIES. 

10 ‘‘(a) IN GENERAL.— 

11 ‘‘(1) ASSESSMENT.—The Secretary may assess 

12 against a person that violates this Act (including a 

13 regulation promulgated or order issued under this 

14 Act) a civil penalty for each violation of not more 

15 than $100,000. 

16 ‘‘(2) SEPARATE OFFENSES.—Each violation 

17 and each day during which the violation continues 

18 shall be considered to be a separate offense. 

19 ‘‘(3) NOTICE AND OPPORTUNITY FOR HEAR20 ING.—The Secretary shall not assess a civil penalty 

21 under this section against a person unless the person 

22 is given notice and opportunity for a hearing on the 

23 record before the Secretary in accordance with sec24 tions 554 and 556 of title 5, United States Code. 


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1 ‘‘(4) DETERMINATION OF CIVIL PENALTY

2 AMOUNT.—The amount of a civil penalty under this 

3 section— 

4 ‘‘(A) shall be assessed by the Secretary by 

5 written order, taking into account— 

6 ‘‘(i) the gravity of the violation; 

7 ‘‘(ii) the degree of culpability of the 

8 person; 

9 ‘‘(iii) the size and type of the business 

10 of the person; and 

11 ‘‘(iv) any history of prior offenses by 

12 the person under this Act; and 

13 ‘‘(B) shall be reviewed only in accordance 

14 with subsection (b). 

15 ‘‘(b) JUDICIAL REVIEW.— 

16 ‘‘(1) IN GENERAL.—An order assessing a civil 

17 penalty against a person under subsection (a) shall 

18 be final unless the person— 

19 ‘‘(A) not later than 30 days after the effec20 tive date of the order, files a petition for judi21 cial review of the order in— 

22 ‘‘(i) the United States court of ap23 peals for the circuit in which the person re24 sides or has its principal place of business; 

25 or 


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1 ‘‘(ii) the United States Court of Ap2 peals for the District of Columbia Circuit; 

3 and 

4 ‘‘(B) simultaneously sends a copy of the 

5 petition by certified mail to the Secretary. 

6 ‘‘(2) FILING OF COPY OF RECORD.—The Sec7 retary shall promptly file in the court a certified 

8 copy of the record on which the order was issued. 

9 ‘‘(c) COLLECTION ACTIONS FOR FAILURE TO PAY

10 ASSESSMENT.— 

11 ‘‘(1) REFERRAL TO ATTORNEY GENERAL.—If a 

12 person fails to pay a civil penalty assessed under 

13 subsection (a) after the order assessing the civil pen14 alty has become a final order, or after the court of 

15 appeals has entered final judgment in favor of the 

16 Secretary, the Secretary shall refer the matter to the 

17 Attorney General. 

18 ‘‘(2) ACTION BY ATTORNEY GENERAL.—The 

19 Attorney General shall bring a civil action to recover 

20 the amount of the civil penalty in United States dis21 trict court. 

22 ‘‘(3) SCOPE OF REVIEW.—In a civil action 

23 under paragraph (2), the validity and appropriate24 ness of the order of the Secretary assessing the civil 

25 penalty shall not be subject to review. 


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1 ‘‘(d) REFUSAL OR WITHDRAWAL OF INSPECTION

2 PENDING PAYMENT.—If a person fails to pay the amount 

3 of a civil penalty after the order assessing the civil penalty 

4 has become a final order, the Secretary may refuse to pro5 vide or withdraw inspection under title I of the person 

6 until the civil penalty is paid or until the Secretary directs 

7 otherwise. 

8 ‘‘(e) PENALTIES IN LIEU OF OTHER ACTIONS.— 

9 Nothing in this Act requires the Secretary to report for 

10 prosecution, or for the commencement of an action, any 

11 violation of this Act in any case in which the Secretary 

12 believes that the public interest will be adequately served 

13 by the assessment of a civil penalty under this section. 

14 ‘‘(f) REMEDIES NOT EXCLUSIVE.—The remedies au15 thorized by this section shall be in addition to any other 

16 remedies that may be available.’’. 

17 (b) CONFORMING AMENDMENTS.— 

18 (1) Section 1 of the Federal Meat Inspection 

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

20 end the following: 

21 ‘‘(x) PERSON.—The term ‘person’ means any indi22 vidual, partnership, corporation, association, or other busi23 ness unit.’’. 

24 (2) The Federal Meat Inspection Act (21 

25 U.S.C. 601 et seq.) is amended— 


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1 (A) by striking ‘‘person, firm, or corpora2 tion’’ each place it appears and inserting ‘‘per3 son’’; 

4 (B) by striking ‘‘persons, firms, and cor5 porations’’ each place it appears and inserting 

6 ‘‘persons’’; and 

7 (C) by striking ‘‘persons, firms, or corpora8 tions’’ each place it appears and inserting ‘‘per9 sons’’. 

10 SEC. 3. FOOD SAFETY ENFORCEMENT FOR POULTRY AND 

11 POULTRY FOOD PRODUCTS. 

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

13 et seq.) is amended— 

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

15 U.S.C. 454(c)(1))— 

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

17 the expiration of two years after enactment of 

18 the Wholesome Poultry Products Act,’’; and 

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

20 12-22 of this Act’’ and inserting ‘‘sections 1 

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

22 31 through 33’’; and 

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


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

2 OF ADULTERATED OR MISBRANDED ARTI3 CLES. 

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 poultry or poultry product (referred to in this 

8 section as an ‘article’) transported, stored, distrib9 uted, or otherwise handled by the person is adulter10 ated or misbranded shall, as soon as practicable, no11 tify the Secretary of the identity and location of the 

12 article. 

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

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

15 and by such means as the Secretary may require by 

16 regulation. 

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

18 ‘‘(1) VOLUNTARY ACTIONS.—On receiving noti19 fication under subsection (a) or by other means, if 

20 the Secretary finds that an article is adulterated or 

21 misbranded and that there is a reasonable prob22 ability that human consumption of the article would 

23 present a threat to public health (as determined by 

24 the Secretary), the Secretary shall provide all appro25 priate persons (as determined by the Secretary), 


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1 that transported, stored, distributed, or otherwise 

2 handled the article with an opportunity— 

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

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

5 store, distribute, or otherwise handle the article, 

6 or to which the article has been transported, 

7 sold, distributed, or otherwise handled, to cease 

8 immediately distribution of the article; 

9 ‘‘(C) to recall the article; 

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

11 provide notice of the finding of the Secretary to 

12 all consumers to which the article was, or may 

13 have been, distributed; or 

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

15 officials. 

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

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

18 out the actions described in that paragraph with re19 spect to an article within the time period and in the 

20 manner prescribed by the Secretary, the Secretary— 

21 ‘‘(A) shall require the person— 

22 ‘‘(i) to immediately cease distribution 

23 of the article; and 

24 ‘‘(ii) to immediately make the notifica25 tion described in paragraph (1)(B); and 


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

2 article. 

3 ‘‘(3) NOTICE TO CONSUMERS AND HEALTH OF4 FICIALS.—The Secretary shall, as the Secretary de5 termines to be necessary, provide notice of the find6 ing of the Secretary under paragraph (1) to con7 sumers to which the article was, or may have been, 

8 distributed and to appropriate State and local health 

9 officials. 

10 ‘‘(4) NONDISTRIBUTION BY NOTIFIED PER11 SONS.—A person that transports, stores, distributes, 

12 or otherwise handles the article, or to which the arti13 cle has been transported, sold, distributed, or other14 wise handled, and that is notified under paragraph 

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

16 of the article. 

17 ‘‘(5) AVAILABILITY OF RECORDS TO SEC18 RETARY.—Each appropriate person referred to in 

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

20 or otherwise handled an article shall make available 

21 to the Secretary information necessary to carry out 

22 this subsection, as determined by the Secretary, re23 garding— 

24 ‘‘(A) persons that transport, store, dis25 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. 32. REFUSAL OR WITHDRAWAL OF INSPECTION OF 

21 ESTABLISHMENTS. 

22 ‘‘(a) IN GENERAL.—The Secretary may, for such pe23 riod, or indefinitely, as the Secretary considers necessary 

24 to carry out this Act, refuse to provide or withdraw inspec25 tion under this Act with respect to an establishment if the 


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1 Secretary determines, after opportunity for a hearing on 

2 the record is provided to the applicant for, or recipient 

3 of, inspection, that the applicant or recipient, or any per4 son responsibly connected with the applicant or recipient 

5 (within the meaning of section 18(a)), has committed a 

6 willful violation or repeated violations of this Act (includ7 ing a regulation promulgated under this Act). 

8 ‘‘(b) DENIAL OR SUSPENSION OF INSPECTION PEND9 ING HEARING.—The Secretary may deny or suspend in10 spection under this Act, pending opportunity for an expe11 dited hearing, with respect to an action under subsection 

12 (a), if the Secretary determines that the denial or suspen13 sion is in the public interest to protect the health or wel14 fare of consumers or to ensure the effective performance 

15 of an official duty under this Act. 

16 ‘‘(c) JUDICIAL REVIEW.— 

17 ‘‘(1) IN GENERAL.—A determination and order 

18 of the Secretary with respect to the refusal or with19 drawal of inspection under this section shall be final 

20 unless, not later than 30 days after the effective 

21 date of the order, the affected applicant for, or re22 cipient of, inspection— 

23 ‘‘(A) files a petition for judicial review of 

24 the order; and 


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1 ‘‘(B) simultaneously sends a copy of the 

2 petition by certified mail to the Secretary. 

3 ‘‘(2) REFUSAL OR WITHDRAWAL OF INSPEC4 TION PENDING REVIEW.—Inspection shall be refused 

5 or withdrawn as of the effective date of the order 

6 pending any judicial review of the order unless the 

7 Secretary directs otherwise. 

8 ‘‘(3) VENUE; RECORD.—Judicial review of the 

9 order shall be— 

10 ‘‘(A) in— 

11 ‘‘(i) the United States court of ap12 peals for the circuit in which the applicant 

13 for, or recipient of, inspection resides or 

14 has its principal place of business; or 

15 ‘‘(ii) the United States Court of Ap16 peals for the District of Columbia Circuit; 

17 and 

18 ‘‘(B) on the record on which the deter19 mination and order are based. 

20 ‘‘(d) REMEDIES NOT EXCLUSIVE.—The remedies au21 thorized by this section shall be in addition to any other 

22 remedies that may be available. 

23 ‘‘SEC. 33. CIVIL PENALTIES. 

24 ‘‘(a) IN GENERAL.— 


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1 ‘‘(1) ASSESSMENT.—The Secretary may assess 

2 against a person that violates this Act (including a 

3 regulation promulgated or order issued under this 

4 Act) a civil penalty for each violation of not more 

5 than $100,000. 

6 ‘‘(2) SEPARATE OFFENSES.—Each violation 

7 and each day during which the violation continues 

8 shall be considered to be a separate offense. 

9 ‘‘(3) NOTICE AND OPPORTUNITY FOR HEAR10 ING.—The Secretary shall not assess a civil penalty 

11 under this section against a person unless the person 

12 is given notice and opportunity for a hearing on the 

13 record before the Secretary in accordance with sec14 tions 554 and 556 of title 5, United States Code. 

15 ‘‘(4) DETERMINATION OF CIVIL PENALTY

16 AMOUNT.—The amount of a civil penalty under this 

17 section— 

18 ‘‘(A) shall be assessed by the Secretary by 

19 written order, taking into account— 

20 ‘‘(i) the gravity of the violation; 

21 ‘‘(ii) the degree of culpability of the 

22 person; 

23 ‘‘(iii) the size and type of the business 

24 of the person; and 


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1 ‘‘(iv) any history of prior offenses by 

2 the person under this Act; and 

3 ‘‘(B) shall be reviewed only in accordance 

4 with subsection (b). 

5 ‘‘(b) JUDICIAL REVIEW.— 

6 ‘‘(1) IN GENERAL.—An order assessing a civil 

7 penalty against a person under subsection (a) shall 

8 be final unless the person— 

9 ‘‘(A) not later than 30 days after the effec10 tive date of the order, files a petition for judi11 cial review of the order in— 

12 ‘‘(i) the United States court of ap13 peals for the circuit in which the person re14 sides or has its principal place of business; 

15 or 

16 ‘‘(ii) the United States Court of Ap17 peals for the District of Columbia Circuit; 

18 and 

19 ‘‘(B) simultaneously sends a copy of the 

20 petition by certified mail to the Secretary. 

21 ‘‘(2) FILING OF COPY OF RECORD.—The Sec22 retary shall promptly file in the court a certified 

23 copy of the record on which the order was issued. 

24 ‘‘(c) COLLECTION ACTIONS FOR FAILURE TO PAY

25 ASSESSMENT.— 


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1 ‘‘(1) REFERRAL TO ATTORNEY GENERAL.—If a 

2 person fails to pay a civil penalty assessed under 

3 subsection (a) after the order assessing the civil pen4 alty has become a final order, or after the court of 

5 appeals has entered final judgment in favor of the 

6 Secretary, the Secretary shall refer the matter to the 

7 Attorney General. 

8 ‘‘(2) ACTION BY ATTORNEY GENERAL.—The 

9 Attorney General shall bring a civil action to recover 

10 the amount of the civil penalty in United States dis11 trict court. 

12 ‘‘(3) SCOPE OF REVIEW.—In a civil action 

13 under paragraph (2), the validity and appropriate14 ness of the order of the Secretary assessing the civil 

15 penalty shall not be subject to review. 

16 ‘‘(d) REFUSAL OR WITHDRAWAL OF INSPECTION

17 PENDING PAYMENT.—If a person fails to pay the amount 

18 of a civil penalty after the order assessing the civil penalty 

19 has become a final order, the Secretary may refuse to pro20 vide or withdraw inspection under this Act of the person 

21 until the civil penalty is paid or until the Secretary directs 

22 otherwise. 

23 ‘‘(e) PENALTIES IN LIEU OF OTHER ACTIONS.— 

24 Nothing in this Act requires the Secretary to report for 

25 prosecution, or for the commencement of an action, any 


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1 violation of this Act in any case in which the Secretary 

2 believes that the public interest will be adequately served 

3 by the assessment of a civil penalty under this section. 

4 ‘‘(f) REMEDIES NOT EXCLUSIVE.—The remedies au5 thorized by this section shall be in addition to any other 

6 remedies that may be available.’’. 

7 SEC. 4. NOTIFICATION, NONDISTRIBUTION, AND RECALL 

8 OF ADULTERATED OR MISBRANDED ARTI9 CLES OF FOOD. 

10 (a) PROHIBITED ACTS.—Section 301 of the Federal 

11 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend12 ed by adding at the end the following: 

13 ‘‘(ii)(1) The failure to notify the Secretary in viola14 tion of section 311(a). 

15 ‘‘(2) The failure to comply with— 

16 ‘‘(A) an order issued under section 311(b) 

17 following any hearing requested under section 

18 311(c); or 

19 ‘‘(B) an amended order issued under sec20 tion 311(d)(1).’’. 

21 (b) NOTIFICATION, NONDISTRIBUTION, AND RECALL

22 OF ADULTERATED OR MISBRANDED ARTICLES OF FOOD; 

23 CIVIL PENALTIES RELATING TO FOODS.—Chapter III of 

24 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331 

25 et seq.) is amended by adding at the end the following: 


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1 ‘‘SEC. 311. NOTIFICATION, NONDISTRIBUTION, AND RECALL 

2 OF ADULTERATED OR MISBRANDED ARTI3 CLES OF FOOD. 

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

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

6 household consumer or other individual who is the 

7 intended consumer of an article of food) that has 

8 reason to believe that an article of food when intro9 duced into or while in interstate commerce, or while 

10 held for sale (regardless of whether the first sale) 

11 after shipment in interstate commerce, is adulter12 ated or misbranded in a manner that, if consumed, 

13 may result in illness or injury shall, as soon as prac14 ticable, notify the Secretary of the identity and loca15 tion of the article. 

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

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

18 and by such means as the Secretary may require by 

19 regulation. 

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

21 ‘‘(1) VOLUNTARY ACTIONS.—On receiving noti22 fication under subsection (a) or by other means, if 

23 the Secretary finds that an article of food when in24 troduced into or while in interstate commerce, or 

25 while held for sale (regardless of whether the first 

26 sale) after shipment in interstate commerce, is adulVerDate Aug 31 2005 02:51 Jul 04, 2006 Jkt 049200 PO 00000 Frm 00025 Fmt 6652 Sfmt 6201 E:\BILLS\S3615.IS S3615

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1 terated or misbranded in a manner that, if con2 sumed, may result in illness or injury (as determined 

3 by the Secretary), the Secretary shall provide all ap4 propriate persons (including the manufacturer, im5 porter, distributor, or retailer of the article) with an 

6 opportunity (as determined by the Secretary)— 

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

8 ‘‘(B) to notify all persons— 

9 ‘‘(i) that produce, manufacture, pack, 

10 process, prepare, treat, package, distribute, 

11 or hold the article, to cease immediately 

12 those activities with respect to the article; 

13 or 

14 ‘‘(ii) to which the article has been dis15 tributed, transported, or sold, to cease im16 mediately distribution of the article; 

17 ‘‘(C) to recall the article; 

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

19 provide notice of the finding of the Secretary to 

20 all consumers to which the article was, or may 

21 have been, distributed and to appropriate State 

22 and local health officials; or 

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

24 officials. 


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

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

3 out the actions described in that paragraph with re4 spect to an article within the time period and in the 

5 manner prescribed by the Secretary, the Secretary— 

6 ‘‘(A) shall require the person— 

7 ‘‘(i) to immediately cease distribution 

8 of the article; and 

9 ‘‘(ii) to immediately make the notifica10 tion described in paragraph (1)(B); and 

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

12 article. 

13 ‘‘(3) NOTICE TO CONSUMERS AND HEALTH OF14 FICIALS.—The Secretary shall, as the Secretary de15 termines to be necessary, provide notice of the find16 ing of the Secretary under paragraph (1) to con17 sumers to which the article was, or may have been, 

18 distributed and to appropriate State and local health 

19 officials. 

20 ‘‘(c) 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 a hearing on— 

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


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•S 3615 IS

1 ‘‘(B) any reasons why the article of food 

2 that is the subject of the order should not be 

3 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 a hearing under subsection 

11 (c), the Secretary determines that an article of food 

12 when introduced into or while in interstate com13 merce, or while held for sale (regardless of whether 

14 the first sale) after shipment in interstate commerce, 

15 is adulterated or misbranded in a manner that, if 

16 consumed, may result in illness or injury, the Sec17 retary may, as the Secretary determines to be nec18 essary— 

19 ‘‘(A) amend the order under subsection 

20 (b)— 

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

22 other appropriate action; and 

23 ‘‘(ii) to specify a timetable during 

24 which the recall shall occur; 


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•S 3615 IS

1 ‘‘(B) require periodic reports to the Sec2 retary describing the progress of the recall; or 

3 ‘‘(C) provide notice of the recall to con4 sumers to which the article was, or may have 

5 been, distributed. 

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

7 an opportunity for a hearing under subsection (c), 

8 the Secretary determines that adequate grounds do 

9 not exist to continue the actions required by the 

10 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 ‘‘SEC. 312. CIVIL PENALTIES RELATING TO FOODS. 

15 ‘‘(a) IN GENERAL.— 

16 ‘‘(1) ASSESSMENT.—The Secretary may assess 

17 against a person that commits an act prohibited by 

18 section 301 with respect to an article of food a civil 

19 penalty for each such act of not more than— 

20 ‘‘(A) $100,000, in the case of an indi21 vidual; and 

22 ‘‘(B) $500,000, in the case of any other 

23 person. 


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1 ‘‘(2) SEPARATE OFFENSES.—Each prohibited 

2 act and each day during which the act continues 

3 shall be considered to be a separate offense. 

4 ‘‘(3) NOTICE AND OPPORTUNITY FOR HEAR5 ING.—The Secretary shall not assess a civil penalty 

6 under this section against a person unless the person 

7 is given notice and opportunity for a hearing on the 

8 record before the Secretary in accordance with sec9 tions 554 and 556 of title 5, United States Code. 

10 ‘‘(4) DETERMINATION OF CIVIL PENALTY

11 AMOUNT.—The amount of a civil penalty under this 

12 section— 

13 ‘‘(A) shall be assessed by the Secretary by 

14 written order, taking into account— 

15 ‘‘(i) the gravity of the violation; 

16 ‘‘(ii) the degree of culpability of the 

17 person; 

18 ‘‘(iii) the size and type of the business 

19 of the person; and 

20 ‘‘(iv) any history of prior offenses by 

21 the person; and 

22 ‘‘(B) shall be reviewed only in accordance 

23 with subsection (b). 

24 ‘‘(b) JUDICIAL REVIEW.— 


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1 ‘‘(1) IN GENERAL.—An order assessing a civil 

2 penalty against a person under subsection (a) shall 

3 be final unless the person— 

4 ‘‘(A) not later than 30 days after the effec5 tive date of the order, files a petition for judi6 cial review of the order in— 

7 ‘‘(i) the United States court of ap8 peals for the circuit in which the person re9 sides or has its principal place of business; 

10 or 

11 ‘‘(ii) the United States Court of Ap12 peals for the District of Columbia Circuit; 

13 and 

14 ‘‘(B) simultaneously sends a copy of the 

15 petition by certified mail to the Secretary. 

16 ‘‘(2) FILING OF COPY OF RECORD.—The Sec17 retary shall promptly file in the court a certified 

18 copy of the record on which the order was issued. 

19 ‘‘(3) STANDARD OF REVIEW.—The findings of 

20 the Secretary relating to the order shall be set aside 

21 only if the findings are found to be unsupported by 

22 substantial evidence on the record as a whole. 

23 ‘‘(c) COLLECTION ACTIONS FOR FAILURE TO PAY

24 ASSESSMENT.— 


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1 ‘‘(1) REFERRAL TO ATTORNEY GENERAL.—If a 

2 person fails to pay a civil penalty assessed under 

3 subsection (a) after the order assessing the civil pen4 alty has become a final order, or after the court of 

5 appeals has entered final judgment in favor of the 

6 Secretary, the Secretary may refer the matter to the 

7 Attorney General. 

8 ‘‘(2) ACTION BY ATTORNEY GENERAL.—The 

9 Attorney General shall bring a civil action to recover 

10 the amount of the civil penalty in United States dis11 trict court. 

12 ‘‘(3) SCOPE OF REVIEW.—In a civil action 

13 under paragraph (2), the validity and appropriate14 ness of the order of the Secretary assessing the civil 

15 penalty shall not be subject to review. 

16 ‘‘(d) PENALTIES DEPOSITED IN TREASURY.—All 

17 amounts collected as civil penalties under this section shall 

18 be deposited in the Treasury of the United States. 

19 ‘‘(e) PENALTIES IN LIEU OF OTHER ACTIONS.— 

20 Nothing in this Act requires the Secretary to report for 

21 prosecution, or for the commencement of any libel or in22 junction proceeding, any violation of this Act in any case 

23 in which the Secretary believes that the public interest will 

24 be adequately served by the assessment of a civil penalty 

25 under this section. 


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1 ‘‘(f) REMEDIES NOT EXCLUSIVE.—The remedies au2 thorized by this section shall be in addition to any other 

3 remedies that may be available.’’. 

Æ 


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