I 

108TH CONGRESS 

1ST SESSION H. R. 3547

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 HOUSE OF REPRESENTATIVES 

NOVEMBER 20, 2003

Ms. DEGETTE (for herself, Ms. DELAURO, Mr. HINCHEY, Mr. STARK, and 

Mr. WAXMAN) introduced the following bill; which was referred to the 

Committee on Agriculture, and in addition to the Committee on Energy 

and Commerce, 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 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,
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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Safe And Fair En3 forcement and Recall for Meat, Poultry, and Food Act’’ 

4 or ‘‘SAFER Meat, Poultry, and Food Act’’. 

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

6 FOOD PRODUCTS. 

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

8 (21 U.S.C. 601 et seq.) is amended—

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

10 680) as section 414; and 

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

12 679a) the following: 

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

14 OF ADULTERATED OR MISBRANDED ARTI15 CLES. 

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

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

18 household consumer) that has reason to believe that 

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

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

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

22 ‘article’) transported, stored, distributed, or other23 wise handled by the person is adulterated or mis24 branded shall, as soon as practicable, notify the Sec25 retary of the identity and location of the article. 
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1 ‘‘(2) MANNER OF NOTIFICATION.—Notification 

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

3 and by such means as the Secretary may require by 

4 regulation. 

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

6 ‘‘(1) VOLUNTARY ACTIONS.—On receiving noti7 fication under subsection (a) or by other means, if 

8 the Secretary finds that an article is adulterated or 

9 misbranded and that there is a reasonable prob10 ability that human consumption of the article would 

11 present a threat to public health (as determined by 

12 the Secretary), the Secretary shall provide all appro13 priate persons (as determined by the Secretary), 

14 that transported, stored, distributed, or otherwise 

15 handled the article with an opportunity—

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

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

18 store, distribute, or otherwise handle the article, 

19 or to which the article has been transported, 

20 sold, distributed, or otherwise handled, to cease 

21 immediately distribution of the article; 

22 ‘‘(C) to recall the article; or 

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

24 provide notice of the finding of the Secretary to 
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1 all consumers to which the article was, or may 

2 have been, distributed. 

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

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

5 out the actions described in that paragraph with re6 spect to an article within the time period and in the 

7 manner prescribed by the Secretary, the Secretary 

8 shall, by order, require, as the Secretary determines 

9 to be necessary, the person—

10 ‘‘(A) to cease immediately distribution of 

11 the article; and 

12 ‘‘(B) to make immediately the notification 

13 described in paragraph (1)(B). 

14 ‘‘(3) NOTICE TO CONSUMERS.—The Secretary 

15 shall, as the Secretary determines to be necessary, 

16 provide notice of the finding of the Secretary under 

17 paragraph (1) to consumers to which the article was, 

18 or may have been, distributed. 

19 ‘‘(4) NONDISTRIBUTION BY NOTIFIED PER20 SONS.—A person that transports, stores, distributes, 

21 or otherwise handles the article, or to which the arti22 cle has been transported, sold, distributed, or other23 wise handled, and that is notified under paragraph 

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

25 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; or 

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

20 been, distributed. 

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

22 an opportunity for an informal hearing under sub23 section (c), the Secretary determines that adequate 

24 grounds do not exist to continue the actions required 

25 by the order, the Secretary shall vacate the order. 
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1 ‘‘(e) REMEDIES NOT EXCLUSIVE.—The remedies au2 thorized by this section shall be in addition to any other 

3 remedies that may be available. 

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

5 ESTABLISHMENTS. 

6 ‘‘(a) IN GENERAL.—The Secretary may, for such pe7 riod, or indefinitely, as the Secretary considers necessary 

8 to carry out this Act, refuse to provide or withdraw inspec9 tion under title I with respect to an establishment if the 

10 Secretary determines, after opportunity for a hearing on 

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

12 of, inspection, that the applicant or recipient, or any per13 son responsibly connected with the applicant or recipient 

14 (within the meaning of section 401), has committed a will15 ful violation or repeated violations of this Act (including 

16 a regulation promulgated under this Act). 

17 ‘‘(b) DENIAL OR SUSPENSION OF INSPECTION PEND18 ING HEARING.—The Secretary may deny or suspend in19 spection under title I, pending opportunity for an expe20 dited hearing, with respect to an action under subsection 

21 (a), if the Secretary determines that the denial or suspen22 sion is in the public interest to protect the health or wel23 fare of consumers or to ensure the effective performance 

24 of an official duty under this Act. 

25 ‘‘(c) JUDICIAL REVIEW.—
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1 ‘‘(1) IN GENERAL.—A determination and order 

2 of the Secretary with respect to the refusal or with3 drawal of inspection under this section shall be final 

4 unless, not later than 30 days after the effective 

5 date of the order, the affected applicant for, or re6 cipient of, inspection—

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

8 the order; and 

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

10 petition by certified mail to the Secretary. 

11 ‘‘(2) REFUSAL OR WITHDRAWAL OF INSPEC12 TION PENDING REVIEW.—Inspection shall be refused 

13 or withdrawn as of the effective date of the order 

14 pending any judicial review of the order unless the 

15 Secretary directs otherwise. 

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

17 order shall be—

18 ‘‘(A) in—

19 ‘‘(i) the United States court of ap20 peals for the circuit in which the applicant 

21 for, or recipient of, inspection resides or 

22 has its principal place of business; or 

23 ‘‘(ii) the United States Court of Ap24 peals for the District of Columbia Circuit; 

25 and 
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1 ‘‘(B) on the record on which the deter2 mination and order are based. 

3 ‘‘(d) 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. 413. CIVIL PENALTIES. 

7 ‘‘(a) IN GENERAL.—

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

9 against a person that violates this Act (including a 

10 regulation promulgated or order issued under this 

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

12 than $100,000. 

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

14 and each day during which the violation continues 

15 shall be considered to be a separate offense. 

16 ‘‘(3) NOTICE AND OPPORTUNITY FOR HEAR17 ING.—The Secretary shall not assess a civil penalty 

18 under this section against a person unless the person 

19 is given notice and opportunity for a hearing on the 

20 record before the Secretary in accordance with sec21 tions 554 and 556 of title 5, United States Code. 

22 ‘‘(4) DETERMINATION OF CIVIL PENALTY

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

24 section—
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1 ‘‘(A) shall be assessed by the Secretary by 

2 written order, taking into account—

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

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

5 person; 

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

7 of the person; and 

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

9 the person under this Act; and 

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

11 with subsection (b). 

12 ‘‘(b) JUDICIAL REVIEW.—

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

14 penalty against a person under subsection (a) shall 

15 be final unless the person—

16 ‘‘(A) not later than 30 days after the effec17 tive date of the order, files a petition for judi18 cial review of the order in—

19 ‘‘(i) the United States court of ap20 peals for the circuit in which the person re21 sides or has its principal place of business; 

22 or 

23 ‘‘(ii) the United States Court of Ap24 peals for the District of Columbia Circuit; 

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

2 petition by certified mail to the Secretary. 

3 ‘‘(2) FILING OF COPY OF RECORD.—The Sec4 retary shall promptly file in the court a certified 

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

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

7 ASSESSMENT.—

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

9 person fails to pay a civil penalty assessed under 

10 subsection (a) after the order assessing the civil pen11 alty has become a final order, or after the court of 

12 appeals has entered final judgment in favor of the 

13 Secretary, the Secretary shall refer the matter to the 

14 Attorney General. 

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

16 Attorney General shall bring a civil action to recover 

17 the amount of the civil penalty in United States dis18 trict court. 

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

20 under paragraph (2), the validity and appropriate21 ness of the order of the Secretary assessing the civil 

22 penalty shall not be subject to review. 

23 ‘‘(d) REFUSAL OR WITHDRAWAL OF INSPECTION

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

25 of a civil penalty after the order assessing the civil penalty 
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1 has become a final order, the Secretary may refuse to pro2 vide or withdraw inspection under title I of the person 

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

4 otherwise. 

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

6 Nothing in this Act requires the Secretary to report for 

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

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

9 believes that the public interest will be adequately served 

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

11 ‘‘(f) 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 ‘‘(w) 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. 3. FOOD SAFETY ENFORCEMENT FOR POULTRY AND 

8 POULTRY FOOD PRODUCTS. 

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

10 et seq.) is amended—

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

12 U.S.C. 454(c)(1))—

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

14 the expiration of two years after enactment of 

15 the Wholesome Poultry Products Act,’’; and 

16 (B) by striking ‘‘sections 1–4, 6–10, and 

17 12–22 of this Act’’ and inserting ‘‘sections 1 

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

19 31 through 33’’; and 

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

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

22 OF ADULTERATED OR MISBRANDED ARTI23 CLES. 

24 ‘‘(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; or 

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. 

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

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

13 out the actions described in that paragraph with re14 spect to an article within the time period and in the 

15 manner prescribed by the Secretary, the Secretary 

16 shall, by order, require, as the Secretary determines 

17 to be necessary, the person—

18 ‘‘(A) to cease immediately distribution of 

19 the article; and 

20 ‘‘(B) to make immediately the notification 

21 described in paragraph (1)(B). 

22 ‘‘(3) NOTICE TO CONSUMERS.—The Secretary 

23 shall, as the Secretary determines to be necessary, 

24 provide notice of the finding of the Secretary under 
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1 paragraph (1) to consumers to which the article was, 

2 or may have been, distributed. 

3 ‘‘(4) NONDISTRIBUTION BY NOTIFIED PER4 SONS.—A person that transports, stores, distributes, 

5 or otherwise handles the article, or to which the arti6 cle has been transported, sold, distributed, or other7 wise handled, and that is notified under paragraph 

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

9 of the article. 

10 ‘‘(5) AVAILABILITY OF RECORDS TO SEC11 RETARY.—Each appropriate person referred to in 

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

13 or otherwise handled an article shall make available 

14 to the Secretary information necessary to carry out 

15 this subsection, as determined by the Secretary, re16 garding—

17 ‘‘(A) persons that transport, store, dis18 tribute, or otherwise handle the article; and 

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

20 transported, sold, distributed, or otherwise han21 dled. 

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

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

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

25 with an opportunity for an informal hearing (in ac-
17

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1 cordance with such rules or regulations as the Sec2 retary shall prescribe) on—

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

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

5 the subject of the order should not be recalled. 

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

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

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

9 the date of issuance of the order. 

10 ‘‘(d) POST-HEARING RECALL ORDERS.—

11 ‘‘(1) AMENDMENT OF ORDERS.—If, after pro12 viding an opportunity for an informal hearing under 

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

14 a reasonable probability that human consumption of 

15 the article that is the subject of an order under sub16 section (b) presents a threat to public health, the 

17 Secretary may, as the Secretary determines to be 

18 necessary—

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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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 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 ‘‘SEC. 32. REFUSAL OR WITHDRAWAL OF INSPECTION OF 

15 ESTABLISHMENTS. 

16 ‘‘(a) IN GENERAL.—The Secretary may, for such pe17 riod, or indefinitely, as the Secretary considers necessary 

18 to carry out this Act, refuse to provide or withdraw inspec19 tion under this Act with respect to an establishment if the 

20 Secretary determines, after opportunity for a hearing on 

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

22 of, inspection, that the applicant or recipient, or any per23 son responsibly connected with the applicant or recipient 

24 (within the meaning of section 18(a)), has committed a 
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1 willful violation or repeated violations of this Act (includ2 ing a regulation promulgated under this Act). 

3 ‘‘(b) DENIAL OR SUSPENSION OF INSPECTION PEND4 ING HEARING.—The Secretary may deny or suspend in5 spection under this Act, pending opportunity for an expe6 dited hearing, with respect to an action under subsection 

7 (a), if the Secretary determines that the denial or suspen8 sion is in the public interest to protect the health or wel9 fare of consumers or to ensure the effective performance 

10 of an official duty under this Act. 

11 ‘‘(c) JUDICIAL REVIEW.—

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

13 of the Secretary with respect to the refusal or with14 drawal of inspection under this section shall be final 

15 unless, not later than 30 days after the effective 

16 date of the order, the affected applicant for, or re17 cipient of, inspection—

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

19 the order; and 

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

21 petition by certified mail to the Secretary. 

22 ‘‘(2) REFUSAL OR WITHDRAWAL OF INSPEC23 TION PENDING REVIEW.—Inspection shall be refused 

24 or withdrawn as of the effective date of the order 
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1 pending any judicial review of the order unless the 

2 Secretary directs otherwise. 

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

4 order shall be—

5 ‘‘(A) in—

6 ‘‘(i) the United States court of ap7 peals for the circuit in which the applicant 

8 for, or recipient of, inspection resides or 

9 has its principal place of business; or 

10 ‘‘(ii) the United States Court of Ap11 peals for the District of Columbia Circuit; 

12 and 

13 ‘‘(B) on the record on which the deter14 mination and order are based. 

15 ‘‘(d) REMEDIES NOT EXCLUSIVE.—The remedies au16 thorized by this section shall be in addition to any other 

17 remedies that may be available. 

18 ‘‘SEC. 33. CIVIL PENALTIES. 

19 ‘‘(a) IN GENERAL.—

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

21 against a person that violates this Act (including a 

22 regulation promulgated or order issued under this 

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

24 than $100,000. 
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1 ‘‘(2) SEPARATE OFFENSES.—Each violation 

2 and each day during which the violation 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 under this Act; 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 ‘‘(c) COLLECTION ACTIONS FOR FAILURE TO PAY

20 ASSESSMENT.—

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

22 person fails to pay a civil penalty assessed under 

23 subsection (a) after the order assessing the civil pen24 alty has become a final order, or after the court of 

25 appeals has entered final judgment in favor of the 
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1 Secretary, the Secretary shall refer the matter to the 

2 Attorney General. 

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

4 Attorney General shall bring a civil action to recover 

5 the amount of the civil penalty in United States dis6 trict court. 

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

8 under paragraph (2), the validity and appropriate9 ness of the order of the Secretary assessing the civil 

10 penalty shall not be subject to review. 

11 ‘‘(d) REFUSAL OR WITHDRAWAL OF INSPECTION

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

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

14 has become a final order, the Secretary may refuse to pro15 vide or withdraw inspection under this Act of the person 

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

17 otherwise. 

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

19 Nothing in this Act requires the Secretary to report for 

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

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

22 believes that the public interest will be adequately served 

23 by the assessment of a civil penalty 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.’’. 

4 SEC. 4. NOTIFICATION, NONDISTRIBUTION, AND RECALL 

5 OF ADULTERATED OR MISBRANDED ARTI6 CLES OF FOOD. 

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

8 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend9 ed by adding at the end the following: 

10 ‘‘(hh)(1) The failure to notify the Secretary in viola11 tion of section 311(a). 

12 ‘‘(2) The failure to comply with—

13 ‘‘(A) an order issued under section 311(b) fol14 lowing any hearing requested under section 311(c); 

15 or 

16 ‘‘(B) an amended order issued under section 

17 311(d)(1).’’. 

18 (b) NOTIFICATION, NONDISTRIBUTION, AND RECALL

19 OF ADULTERATED OR MISBRANDED ARTICLES OF FOOD; 

20 CIVIL PENALTIES RELATING TO FOODS.—Chapter III of 

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

22 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 adul-
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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; or 

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. 

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

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

24 out the actions described in that paragraph with re25 spect to an article within the time period and in the 
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•HR 3547 IH 

1 manner prescribed by the Secretary, the Secretary 

2 shall, by order, require, as the Secretary determines 

3 to be necessary, the person—

4 ‘‘(A) to cease immediately distribution of 

5 the article; and 

6 ‘‘(B) to make immediately the notification 

7 described in paragraph (1)(B). 

8 ‘‘(3) NOTICE TO CONSUMERS.—The Secretary 

9 shall, as the Secretary determines to be necessary, 

10 provide notice of the finding of the Secretary under 

11 paragraph (1) to consumers to which the article was, 

12 or may have been, distributed. 

13 ‘‘(c) 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 a hearing on—

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

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

19 that is the subject of the order should not be 

20 recalled. 

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

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

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

24 the date of issuance of the order. 

25 ‘‘(d) POST-HEARING RECALL ORDERS.—
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1 ‘‘(1) AMENDMENT OF ORDERS.—If, after pro2 viding an opportunity for a hearing under subsection 

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

4 when introduced into or while in interstate com5 merce, or while held for sale (regardless of whether 

6 the first sale) after shipment in interstate commerce, 

7 is adulterated or misbranded in a manner that, if 

8 consumed, may result in illness or injury, the Sec9 retary may, as the Secretary determines to be nec10 essary—

11 ‘‘(A) amend the order under subsection 

12 (b)—

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

14 other appropriate action; and 

15 ‘‘(ii) to specify a timetable during 

16 which the recall shall occur; 

17 ‘‘(B) require periodic reports to the Sec18 retary describing the progress of the recall; or 

19 ‘‘(C) provide notice of the recall to con20 sumers to which the article was, or may have 

21 been, distributed. 

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

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

24 the Secretary determines that adequate grounds do 
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•HR 3547 IH 

1 not exist to continue the actions required by the 

2 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. 312. CIVIL PENALTIES RELATING TO FOODS. 

7 ‘‘(a) IN GENERAL.—

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

9 against a person that commits an act prohibited by 

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

11 penalty for each such act of not more than—

12 ‘‘(A) $100,000, in the case of an indi13 vidual; and 

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

15 person. 

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

17 act and each day during which the act 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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•HR 3547 IH 

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; 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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•HR 3547 IH 

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

10 the Secretary relating to the order shall be set aside 

11 only if the findings are found to be unsupported by 

12 substantial evidence on the record as a whole. 

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

14 ASSESSMENT.—

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

16 person fails to pay a civil penalty assessed under 

17 subsection (a) after the order assessing the civil pen18 alty has become a final order, or after the court of 

19 appeals has entered final judgment in favor of the 

20 Secretary, the Secretary may refer the matter to the 

21 Attorney General. 

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

23 Attorney General shall bring a civil action to recover 

24 the amount of the civil penalty in United States dis25 trict court. 
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1 ‘‘(3) SCOPE OF REVIEW.—In a civil action 

2 under paragraph (2), the validity and appropriate3 ness of the order of the Secretary assessing the civil 

4 penalty shall not be subject to review. 

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

6 amounts collected as civil penalties under this section shall 

7 be deposited in the Treasury of the United States. 

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 any libel or in11 junction proceeding, any violation of this Act in any case 

12 in which the Secretary believes that the public interest will 

13 be adequately served by the assessment of a civil penalty 

14 under this section. 

15 ‘‘(f) REMEDIES NOT EXCLUSIVE.—The remedies au16 thorized by this section shall be in addition to any other 

17 remedies that may be available.’’.

Æ