I 

111TH CONGRESS 

1ST SESSION H. R. 815 

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 

FEBRUARY 3, 2009 

Ms. DEGETTE (for herself, Mr. NADLER of New York, and Ms. DELAURO) 

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, 

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 


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1 2009’’ or ‘‘SAFER Meat, Poultry, and Food Act of 

2 2009’’. 

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

4 FOOD PRODUCTS. 

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

6 (21 U.S.C. 601 et seq.) is amended— 

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

8 680) as section 414; and 

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

10 679a) the following: 

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

12 OF ADULTERATED OR MISBRANDED ARTI13 CLES. 

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

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

16 household consumer) that has reason to believe that 

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

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

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

20 ‘article’) transported, stored, distributed, or other21 wise handled by the person is adulterated or mis22 branded shall, as soon as practicable, notify the Sec23 retary of the identity and location of the article. 

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

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


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1 and by such means as the Secretary may require by 

2 regulation. 

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

4 ‘‘(1) VOLUNTARY ACTIONS.—On receiving noti5 fication under subsection (a) or by other means, if 

6 the Secretary finds that an article is adulterated or 

7 misbranded and that there is a reasonable prob8 ability that human consumption of the article would 

9 present a threat to public health (as determined by 

10 the Secretary), the Secretary shall provide all appro11 priate persons (as determined by the Secretary), 

12 that transported, stored, distributed, or otherwise 

13 handled the article with an opportunity— 

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

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

16 store, distribute, or otherwise handle the article, 

17 or to which the article has been transported, 

18 sold, distributed, or otherwise handled, to cease 

19 immediately distribution of the article; 

20 ‘‘(C) to recall the article; 

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

22 provide notice of the finding of the Secretary to 

23 all consumers to which the article was, or may 

24 have been, distributed; or 


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

2 officials. 

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 ‘‘(A) shall require the person— 

9 ‘‘(i) to immediately cease distribution 

10 of the article; and 

11 ‘‘(ii) to immediately make the notifica12 tion described in paragraph (1)(B); and 

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

14 article. 

15 ‘‘(3) NOTICE TO CONSUMERS AND HEALTH OF16 FICIALS.—The Secretary shall, as the Secretary de17 termines to be necessary, provide notice of the find18 ing of the Secretary under paragraph (1) to con19 sumers to which the article was, or may have been, 

20 distributed and to appropriate State and local public 

21 health officials. 

22 ‘‘(4) NONDISTRIBUTION BY NOTIFIED PER23 SONS.—A person that transports, stores, distributes, 

24 or otherwise handles the article, or to which the arti25 cle has been transported, sold, distributed, or otherVerDate Nov 24 2008 00:16 Feb 05, 2009 Jkt 079200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H815.IH H815

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1 wise handled, and that is notified under paragraph 

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

3 of the article. 

4 ‘‘(5) AVAILABILITY OF RECORDS TO SEC5 RETARY.—Each appropriate person referred to in 

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

7 or otherwise handled an article shall make available 

8 to the Secretary information necessary to carry out 

9 this subsection, as determined by the Secretary, re10 garding— 

11 ‘‘(A) persons that transport, store, dis12 tribute, or otherwise handle the article; and 

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

14 transported, sold, distributed, or otherwise han15 dled. 

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

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

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

19 with an opportunity for an informal hearing (in ac20 cordance with such rules or regulations as the Sec21 retary shall prescribe) on— 

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

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

24 the subject of the order should not be recalled. 


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

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

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

4 the date of issuance of the order. 

5 ‘‘(d) POST-HEARING RECALL ORDERS.— 

6 ‘‘(1) AMENDMENT OF ORDERS.—If, after pro7 viding an opportunity for an informal hearing under 

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

9 a reasonable probability that human consumption of 

10 the article that is the subject of an order under sub11 section (b) presents a threat to public health, the 

12 Secretary may, as the Secretary determines to be 

13 necessary— 

14 ‘‘(A) amend the order under subsection 

15 (b)— 

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

17 other appropriate action; and 

18 ‘‘(ii) to specify a timetable during 

19 which the recall shall occur; 

20 ‘‘(B) require periodic reports to the Sec21 retary describing the progress of the recall; 

22 ‘‘(C) provide notice of the recall to con23 sumers to which the article was, or may have 

24 been, distributed; or 


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1 ‘‘(D) take any combination of actions de2 scribed in subparagraphs (A) through (C). 

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

4 an opportunity for an informal hearing under sub5 section (c), the Secretary determines that adequate 

6 grounds do not exist to continue the actions required 

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

8 ‘‘(e) REMEDIES NOT EXCLUSIVE.—The remedies au9 thorized by this section shall be in addition to any other 

10 remedies that may be available. 

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

12 ESTABLISHMENTS. 

13 ‘‘(a) IN GENERAL.—The Secretary may, for such pe14 riod, or indefinitely, as the Secretary considers necessary 

15 to carry out this Act, refuse to provide or withdraw inspec16 tion under title I with respect to an establishment if the 

17 Secretary determines, after opportunity for a hearing on 

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

19 of, inspection, that the applicant or recipient, or any per20 son responsibly connected with the applicant or recipient 

21 (within the meaning of section 401), has committed a will22 ful violation or repeated violations of this Act (including 

23 a regulation promulgated under this Act). 

24 ‘‘(b) DENIAL OR SUSPENSION OF INSPECTION PEND25 ING HEARING.—The Secretary may deny or suspend inVerDate Nov 24 2008 00:16 Feb 05, 2009 Jkt 079200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H815.IH H815

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1 spection under title I, pending opportunity for an expe2 dited hearing, with respect to an action under subsection 

3 (a), if the Secretary determines that the denial or suspen4 sion is in the public interest to protect the health or wel5 fare of consumers or to ensure the effective performance 

6 of an official duty under this Act. 

7 ‘‘(c) JUDICIAL REVIEW.— 

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

9 of the Secretary with respect to the refusal or with10 drawal of inspection under this section shall be final 

11 unless, not later than 30 days after the effective 

12 date of the order, the affected applicant for, or re13 cipient of, inspection— 

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

15 the order; and 

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

17 petition by certified mail to the Secretary. 

18 ‘‘(2) REFUSAL OR WITHDRAWAL OF INSPEC19 TION PENDING REVIEW.—Inspection shall be refused 

20 or withdrawn as of the effective date of the order 

21 pending any judicial review of the order unless the 

22 Secretary directs otherwise. 

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

24 order shall be— 

25 ‘‘(A) in— 


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1 ‘‘(i) the United States court of ap2 peals for the circuit in which the applicant 

3 for, or recipient of, inspection resides or 

4 has its principal place of business; or 

5 ‘‘(ii) the United States Court of Ap6 peals for the District of Columbia Circuit; 

7 and 

8 ‘‘(B) on the record on which the deter9 mination and order are based. 

10 ‘‘(d) REMEDIES NOT EXCLUSIVE.—The remedies au11 thorized by this section shall be in addition to any other 

12 remedies that may be available. 

13 ‘‘SEC. 413. CIVIL PENALTIES. 

14 ‘‘(a) IN GENERAL.— 

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

16 against a person that violates this Act (including a 

17 regulation promulgated or order issued under this 

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

19 than $100,000. 

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

21 and each day during which the violation continues 

22 shall be considered to be a separate offense. 

23 ‘‘(3) NOTICE AND OPPORTUNITY FOR HEAR24 ING.—The Secretary shall not assess a civil penalty 

25 under this section against a person unless the person 


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1 is given notice and opportunity for a hearing on the 

2 record before the Secretary in accordance with sec3 tions 554 and 556 of title 5, United States Code. 

4 ‘‘(4) DETERMINATION OF CIVIL PENALTY

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

6 section— 

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

8 written order, taking into account— 

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

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

11 person; 

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

13 of the person; and 

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

15 the person under this Act; and 

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

17 with subsection (b). 

18 ‘‘(b) JUDICIAL REVIEW.— 

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

20 penalty against a person under subsection (a) shall 

21 be final unless the person— 

22 ‘‘(A) not later than 30 days after the effec23 tive date of the order, files a petition for judi24 cial review of the order in— 


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1 ‘‘(i) the United States court of ap2 peals for the circuit in which the person re3 sides or has its principal place of business; 

4 or 

5 ‘‘(ii) the United States Court of Ap6 peals for the District of Columbia Circuit; 

7 and 

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

9 petition by certified mail to the Secretary. 

10 ‘‘(2) FILING OF COPY OF RECORD.—The Sec11 retary shall promptly file in the court a certified 

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

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 shall 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) REFUSAL OR WITHDRAWAL OF INSPECTION

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

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

8 has become a final order, the Secretary may refuse to pro9 vide or withdraw inspection under title I of the person 

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

11 otherwise. 

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

13 Nothing in this Act requires the Secretary to report for 

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

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

16 believes that the public interest will be adequately served 

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

18 ‘‘(f) REMEDIES NOT EXCLUSIVE.—The remedies au19 thorized by this section shall be in addition to any other 

20 remedies that may be available.’’. 

21 (b) CONFORMING AMENDMENTS.— 

22 (1) Section 1 of the Federal Meat Inspection 

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

24 end the following: 


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1 ‘‘(x) PERSON.—The term ‘person’ means any indi2 vidual, partnership, corporation, association, or other busi3 ness unit.’’. 

4 (2) The Federal Meat Inspection Act (21 

5 U.S.C. 601 et seq.) is amended— 

6 (A) by striking ‘‘person, firm, or corpora7 tion’’ each place it appears and inserting ‘‘per8 son’’; 

9 (B) by striking ‘‘persons, firms, and cor10 porations’’ each place it appears and inserting 

11 ‘‘persons’’; and 

12 (C) by striking ‘‘persons, firms, or corpora13 tions’’ each place it appears and inserting ‘‘per14 sons’’. 

15 SEC. 3. FOOD SAFETY ENFORCEMENT FOR POULTRY AND 

16 POULTRY FOOD PRODUCTS. 

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

18 et seq.) is amended— 

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

20 U.S.C. 454(c)(1))— 

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

22 the expiration of two years after enactment of 

23 the Wholesome Poultry Products Act,’’; and 

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

25 12–22 of this Act’’ and inserting ‘‘sections 1 


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

2 31 through 33’’; and 

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

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

5 OF ADULTERATED OR MISBRANDED ARTI6 CLES. 

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

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

9 household consumer) that has reason to believe that 

10 any poultry or poultry product (referred to in this 

11 section as an ‘article’) transported, stored, distrib12 uted, or otherwise handled by the person is adulter13 ated or misbranded shall, as soon as practicable, no14 tify the Secretary of the identity and location of the 

15 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 is adulterated or 

24 misbranded and that there is a reasonable prob25 ability that human consumption of the article would 


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1 present a threat to public health (as determined by 

2 the Secretary), the Secretary shall provide all appro3 priate persons (as determined by the Secretary), 

4 that transported, stored, distributed, or otherwise 

5 handled the article with an opportunity— 

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

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

8 store, distribute, or otherwise handle the article, 

9 or to which the article has been transported, 

10 sold, distributed, or otherwise handled, to cease 

11 immediately distribution of the article; 

12 ‘‘(C) to recall the article; 

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

14 provide notice of the finding of the Secretary to 

15 all consumers to which the article was, or may 

16 have been, distributed; or 

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

18 officials. 

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

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

21 out the actions described in that paragraph with re22 spect to an article within the time period and in the 

23 manner prescribed by the Secretary, the Secretary— 

24 ‘‘(A) shall require the person— 


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1 ‘‘(i) to immediately cease distribution 

2 of the article; and 

3 ‘‘(ii) to immediately make the notifica4 tion described in paragraph (1)(B); and 

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

6 article. 

7 ‘‘(3) NOTICE TO CONSUMERS AND HEALTH OF8 FICIALS.—The Secretary shall, as the Secretary de9 termines to be necessary, provide notice of the find10 ing of the Secretary under paragraph (1) to con11 sumers to which the article was, or may have been, 

12 distributed and to appropriate State and local health 

13 officials. 

14 ‘‘(4) NONDISTRIBUTION BY NOTIFIED PER15 SONS.—A person that transports, stores, distributes, 

16 or otherwise handles the article, or to which the arti17 cle has been transported, sold, distributed, or other18 wise handled, and that is notified under paragraph 

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

20 of the article. 

21 ‘‘(5) AVAILABILITY OF RECORDS TO SEC22 RETARY.—Each appropriate person referred to in 

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

24 or otherwise handled an article shall make available 

25 to the Secretary information necessary to carry out 


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1 this subsection, as determined by the Secretary, re2 garding— 

3 ‘‘(A) persons that transport, store, dis4 tribute, or otherwise handle the article; and 

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

6 transported, sold, distributed, or otherwise han7 dled. 

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

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

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

11 with an opportunity for an informal hearing (in ac12 cordance with such rules or regulations as the Sec13 retary shall prescribe) on— 

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

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

16 the subject of the order should not be recalled. 

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

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

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

20 the date of issuance of the order. 

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

22 ‘‘(1) AMENDMENT OF ORDERS.—If, after pro23 viding an opportunity for an informal hearing under 

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

25 a reasonable probability that human consumption of 


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1 the article that is the subject of an order under sub2 section (b) presents a threat to public health, the 

3 Secretary may, as the Secretary determines to be 

4 necessary— 

5 ‘‘(A) amend the order under subsection 

6 (b)— 

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

8 other appropriate action; and 

9 ‘‘(ii) to specify a timetable during 

10 which the recall shall occur; 

11 ‘‘(B) require periodic reports to the Sec12 retary describing the progress of the recall; or 

13 ‘‘(C) provide notice of the recall to con14 sumers to which the article was, or may have 

15 been, distributed. 

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

17 an opportunity for an informal hearing under sub18 section (c), the Secretary determines that adequate 

19 grounds do not exist to continue the actions required 

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

21 ‘‘(e) REMEDIES NOT EXCLUSIVE.—The remedies au22 thorized by this section shall be in addition to any other 

23 remedies that may be available. 


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

2 ESTABLISHMENTS. 

3 ‘‘(a) IN GENERAL.—The Secretary may, for such pe4 riod, or indefinitely, as the Secretary considers necessary 

5 to carry out this Act, refuse to provide or withdraw inspec6 tion under this Act with respect to an establishment if the 

7 Secretary determines, after opportunity for a hearing on 

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

9 of, inspection, that the applicant or recipient, or any per10 son responsibly connected with the applicant or recipient 

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

12 willful violation or repeated violations of this Act (includ13 ing a regulation promulgated under this Act). 

14 ‘‘(b) DENIAL OR SUSPENSION OF INSPECTION PEND15 ING HEARING.—The Secretary may deny or suspend in16 spection under this Act, pending opportunity for an expe17 dited hearing, with respect to an action under subsection 

18 (a), if the Secretary determines that the denial or suspen19 sion is in the public interest to protect the health or wel20 fare of consumers or to ensure the effective performance 

21 of an official duty under this Act. 

22 ‘‘(c) JUDICIAL REVIEW.— 

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

24 of the Secretary with respect to the refusal or with25 drawal of inspection under this section shall be final 

26 unless, not later than 30 days after the effective 


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1 date of the order, the affected applicant for, or re2 cipient of, inspection— 

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

4 the order; and 

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

6 petition by certified mail to the Secretary. 

7 ‘‘(2) REFUSAL OR WITHDRAWAL OF INSPEC8 TION PENDING REVIEW.—Inspection shall be refused 

9 or withdrawn as of the effective date of the order 

10 pending any judicial review of the order unless the 

11 Secretary directs otherwise. 

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

13 order shall be— 

14 ‘‘(A) in— 

15 ‘‘(i) the United States court of ap16 peals for the circuit in which the applicant 

17 for, or recipient of, inspection resides or 

18 has its principal place of business; or 

19 ‘‘(ii) the United States Court of Ap20 peals for the District of Columbia Circuit; 

21 and 

22 ‘‘(B) on the record on which the deter23 mination and order are based. 


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1 ‘‘(d) 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. 33. CIVIL PENALTIES. 

5 ‘‘(a) IN GENERAL.— 

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

7 against a person that violates this Act (including a 

8 regulation promulgated or order issued under this 

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

10 than $100,000. 

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

12 and each day during which the violation continues 

13 shall be considered to be a separate offense. 

14 ‘‘(3) NOTICE AND OPPORTUNITY FOR HEAR15 ING.—The Secretary shall not assess a civil penalty 

16 under this section against a person unless the person 

17 is given notice and opportunity for a hearing on the 

18 record before the Secretary in accordance with sec19 tions 554 and 556 of title 5, United States Code. 

20 ‘‘(4) DETERMINATION OF CIVIL PENALTY

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

22 section— 

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

24 written order, taking into account— 

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


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

2 person; 

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

4 of the person; and 

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

6 the person under this Act; and 

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

8 with subsection (b). 

9 ‘‘(b) JUDICIAL REVIEW.— 

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

11 penalty against a person under subsection (a) shall 

12 be final unless the person— 

13 ‘‘(A) not later than 30 days after the effec14 tive date of the order, files a petition for judi15 cial review of the order in— 

16 ‘‘(i) the United States court of ap17 peals for the circuit in which the person re18 sides or has its principal place of business; 

19 or 

20 ‘‘(ii) the United States Court of Ap21 peals for the District of Columbia Circuit; 

22 and 

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

24 petition by certified mail to the Secretary. 


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1 ‘‘(2) FILING OF COPY OF RECORD.—The Sec2 retary shall promptly file in the court a certified 

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

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

5 ASSESSMENT.— 

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

7 person fails to pay a civil penalty assessed under 

8 subsection (a) after the order assessing the civil pen9 alty has become a final order, or after the court of 

10 appeals has entered final judgment in favor of the 

11 Secretary, the Secretary shall refer the matter to the 

12 Attorney General. 

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

14 Attorney General shall bring a civil action to recover 

15 the amount of the civil penalty in United States dis16 trict court. 

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

18 under paragraph (2), the validity and appropriate19 ness of the order of the Secretary assessing the civil 

20 penalty shall not be subject to review. 

21 ‘‘(d) REFUSAL OR WITHDRAWAL OF INSPECTION

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

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

24 has become a final order, the Secretary may refuse to pro25 vide or withdraw inspection under this Act of the person 


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

2 otherwise. 

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

4 Nothing in this Act requires the Secretary to report for 

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

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

7 believes that the public interest will be adequately served 

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

9 ‘‘(f) REMEDIES NOT EXCLUSIVE.—The remedies au10 thorized by this section shall be in addition to any other 

11 remedies that may be available.’’. 

12 SEC. 4. NOTIFICATION, NONDISTRIBUTION, AND RECALL 

13 OF ADULTERATED OR MISBRANDED ARTI14 CLES OF FOOD. 

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

16 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend17 ed by adding at the end the following: 

18 ‘‘(oo)(1) The failure to notify the Secretary in viola19 tion of section 311(a). 

20 ‘‘(2) The failure to comply with— 

21 ‘‘(A) an order issued under section 311(b) fol22 lowing any hearing requested under section 311(c); 

23 or 

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

25 311(d)(1).’’. 


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1 (b) NOTIFICATION, NONDISTRIBUTION, AND RECALL

2 OF ADULTERATED OR MISBRANDED ARTICLES OF FOOD; 

3 CIVIL PENALTIES RELATING TO FOODS.—Chapter III of 

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

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

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

7 OF ADULTERATED OR MISBRANDED ARTI8 CLES OF FOOD. 

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

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

11 household consumer or other individual who is the 

12 intended consumer of an article of food) that has 

13 reason to believe that an article of food when intro14 duced into or while in interstate commerce, or while 

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

16 after shipment in interstate commerce, is adulter17 ated or misbranded in a manner that, if consumed, 

18 may result in illness or injury shall, as soon as prac19 ticable, notify the Secretary of the identity and loca20 tion of the article. 

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

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

23 and by such means as the Secretary may require by 

24 regulation. 

25 ‘‘(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 of food when in4 troduced into or while in interstate commerce, or 

5 while held for sale (regardless of whether the first 

6 sale) after shipment in interstate commerce, is adul7 terated or misbranded in a manner that, if con8 sumed, may result in illness or injury (as determined 

9 by the Secretary), the Secretary shall provide all ap10 propriate persons (including the manufacturer, im11 porter, distributor, or retailer of the article) with an 

12 opportunity (as determined by the Secretary)— 

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

14 ‘‘(B) to notify all persons— 

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

16 process, prepare, treat, package, distribute, 

17 or hold the article, to cease immediately 

18 those activities with respect to the article; 

19 or 

20 ‘‘(ii) to which the article has been dis21 tributed, transported, or sold, to cease im22 mediately distribution of the article; 

23 ‘‘(C) to recall the article; 

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

25 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 and to appropriate State 

3 and local health officials; or 

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

5 officials. 

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

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

8 out the actions described in that paragraph with re9 spect to an article within the time period and in the 

10 manner prescribed by the Secretary, the Secretary— 

11 ‘‘(A) shall require the person— 

12 ‘‘(i) to immediately cease distribution 

13 of the article; and 

14 ‘‘(ii) to immediately make the notifica15 tion described in paragraph (1)(B); and 

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

17 article. 

18 ‘‘(3) NOTICE TO CONSUMERS AND HEALTH OF19 FICIALS.—The Secretary shall, as the Secretary de20 termines to be necessary, provide notice of the find21 ing of the Secretary under paragraph (1) to con22 sumers to which the article was, or may have been, 

23 distributed and to appropriate State and local health 

24 officials. 

25 ‘‘(c) HEARINGS ON ORDERS.— 


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

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

3 with an opportunity for a hearing on— 

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

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

6 that is the subject of the order should not be 

7 recalled. 

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

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

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

11 the date of issuance of the order. 

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

13 ‘‘(1) AMENDMENT OF ORDERS.—If, after pro14 viding an opportunity for a hearing under subsection 

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

16 when introduced into or while in interstate com17 merce, or while held for sale (regardless of whether 

18 the first sale) after shipment in interstate commerce, 

19 is adulterated or misbranded in a manner that, if 

20 consumed, may result in illness or injury, the Sec21 retary may, as the Secretary determines to be nec22 essary— 

23 ‘‘(A) amend the order under subsection 

24 (b)— 


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

2 other appropriate action; and 

3 ‘‘(ii) to specify a timetable during 

4 which the recall shall occur; 

5 ‘‘(B) require periodic reports to the Sec6 retary describing the progress of the recall; or 

7 ‘‘(C) provide notice of the recall to con8 sumers to which the article was, or may have 

9 been, distributed. 

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

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

12 the Secretary determines that adequate grounds do 

13 not exist to continue the actions required by the 

14 order, the Secretary shall vacate the order. 

15 ‘‘(e) 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. 312. CIVIL PENALTIES RELATING TO FOODS. 

19 ‘‘(a) IN GENERAL.— 

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

21 against a person that commits an act prohibited by 

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

23 penalty for each such act of not more than— 

24 ‘‘(A) $100,000, in the case of an indi25 vidual; and 


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

2 person. 

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

4 act and each day during which the act continues 

5 shall be considered to be a separate offense. 

6 ‘‘(3) NOTICE AND OPPORTUNITY FOR HEAR7 ING.—The Secretary shall not assess a civil penalty 

8 under this section against a person unless the person 

9 is given notice and opportunity for a hearing on the 

10 record before the Secretary in accordance with sec11 tions 554 and 556 of title 5, United States Code. 

12 ‘‘(4) DETERMINATION OF CIVIL PENALTY

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

14 section— 

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

16 written order, taking into account— 

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

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

19 person; 

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

21 of the person; and 

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

23 the person; and 

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

25 with subsection (b). 


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1 ‘‘(b) JUDICIAL REVIEW.— 

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

3 penalty against a person under subsection (a) shall 

4 be final unless the person— 

5 ‘‘(A) not later than 30 days after the effec6 tive date of the order, files a petition for judi7 cial review of the order in— 

8 ‘‘(i) the United States court of ap9 peals for the circuit in which the person re10 sides or has its principal place of business; 

11 or 

12 ‘‘(ii) the United States Court of Ap13 peals for the District of Columbia Circuit; 

14 and 

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

16 petition by certified mail to the Secretary. 

17 ‘‘(2) FILING OF COPY OF RECORD.—The Sec18 retary shall promptly file in the court a certified 

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

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

21 the Secretary relating to the order shall be set aside 

22 only if the findings are found to be unsupported by 

23 substantial evidence on the record as a whole. 

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 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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