II 

109TH CONGRESS 

1ST SESSION S. 1534 

To reduce the risk to the food supply from intentional contamination, and 

for other purposes. 

IN THE SENATE OF THE UNITED STATES 

JULY 28, 2005 

Mr. DURBIN (for himself and Mr. AKAKA) introduced the following bill; which 

was read twice and referred to the Committee on Agriculture, Nutrition, 

and Forestry 

A BILL 

To reduce the risk to the food supply from intentional 

contamination, and for other purposes. 

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

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

5 ‘‘Safe and Secure Food Act of 2005’’. 

6 (b) TABLE OF CONTENTS.— 

Sec. 1. Short title; table of contents. 

TITLE I—FOOD SECURITY 

Subtitle A—Department of Agriculture 

Sec. 101. Food security for meat and meat food products. 

Sec. 102. Food security for poultry and poultry food products. 

Sec. 103. Food security for eggs and egg products. 
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Sec. 104. Confidentiality of information. 

Subtitle B—Food and Drug Administration 

Sec. 111. Food security for food products. 

Subtitle C—Inspector Training 

Sec. 121. Inspector training for food security. 

TITLE II—RECALL AUTHORITY 

Subtitle A—Department of Agriculture 

Sec. 201. Food safety enforcement for meat and meat food products. 

Sec. 202. Food safety enforcement for poultry and poultry food products. 

Sec. 203. Food safety enforcement for eggs and egg products. 

Sec. 204. Liability. 

Subtitle B—Food and Drug Administration 

Sec. 211. Food safety enforcement for food. 

Sec. 212. Liability. 

TITLE III—IMPORTED FOOD 

Sec. 301. Imported food. 

TITLE IV—RISK ASSESSMENT INFORMATION SHARING 

Sec. 401. Risk assessment information sharing. 

1 TITLE I—FOOD SECURITY 

2 Subtitle A—Department of 

3 Agriculture 

4 SEC. 101. FOOD SECURITY FOR MEAT AND MEAT FOOD 

5 PRODUCTS. 

6 The Federal Meat Inspection Act (21 U.S.C. 601 et 

7 seq.) is amended— 

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

9 680) as section 415; and 

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

11 679a) the following: 
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1 ‘‘SEC. 411. FOOD SECURITY. 

2 ‘‘(a) IN GENERAL.—The Secretary, in consultation 

3 with the Secretary of Health and Human Services, shall 

4 promulgate regulations that require persons to implement 

5 procedures to prevent both unintentional and intentional 

6 contamination of meat and meat food products at estab7 lishments covered by this Act. 

8 ‘‘(b) SCOPE OF REGULATIONS.—The regulations 

9 shall require a person responsible for an establishment 

10 covered by this Act to implement security procedures for 

11 the entire establishment, as determined by the Secretary, 

12 including— 

13 ‘‘(1) developing a security plan that addresses 

14 the specific vulnerabilities of the establishment; 

15 ‘‘(2) developing an emergency response plan for 

16 the establishment; 

17 ‘‘(3) securing establishment boundaries; 

18 ‘‘(4) providing guards, alarms, and outside 

19 lighting, as necessary; 

20 ‘‘(5) performing background checks before hir21 ing new personnel; 

22 ‘‘(6) limiting access to the establishment; 

23 ‘‘(7) accounting for missing stock; 

24 ‘‘(8) implementing mail-handling procedures; 

25 and 
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1 ‘‘(9) such other security procedures as the Sec2 retary determines to be necessary to prevent unin3 tentional or intentional contamination of meat and 

4 meat food products. 

5 ‘‘(c) TRAINING OF FIELD INSPECTORS.—The Sec6 retary shall provide training for field inspectors of the 

7 Food Safety and Inspection Service to monitor the imple8 mentation of the regulations described in subsection (a).’’. 

9 SEC. 102. FOOD SECURITY FOR POULTRY AND POULTRY 

10 FOOD PRODUCTS. 

11 (a) IN GENERAL.—The Poultry Products Inspection 

12 Act (21 U.S.C. 451 et seq.) is amended— 

13 (1) by redesignating sections 26 through 29 as 

14 sections 31 through 34 and moving those sections to 

15 the end of that Act; 

16 (2) by redesignating section 30 as section 26; 

17 and 

18 (3) by inserting after section 26 (as redesig19 nated by paragraph (2)) the following: 

20 ‘‘SEC. 27. FOOD SECURITY. 

21 ‘‘(a) IN GENERAL.—The Secretary, in consultation 

22 with the Secretary of Health and Human Services, shall 

23 promulgate regulations that require persons to implement 

24 procedures to prevent both unintentional and intentional 
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1 contamination of poultry and poultry food products at es2 tablishments covered by this Act. 

3 ‘‘(b) SCOPE OF REGULATIONS.—The regulations 

4 shall require a person that is responsible for an establish5 ment covered by this Act to implement security procedures 

6 for the entire establishment, as determined by the Sec7 retary, including— 

8 ‘‘(1) developing a security plan that addresses 

9 the specific vulnerabilities of the establishment; 

10 ‘‘(2) developing an emergency response plan for 

11 the establishment; 

12 ‘‘(3) securing establishment boundaries; 

13 ‘‘(4) providing guards, alarms, and outside 

14 lighting, as necessary; 

15 ‘‘(5) performing background checks before hir16 ing new personnel; 

17 ‘‘(6) limiting access to the establishment; 

18 ‘‘(7) accounting for missing stock; 

19 ‘‘(8) implementing mail-handling procedures; 

20 and 

21 ‘‘(9) such other security procedures as the Sec22 retary determines to be necessary to prevent unin23 tentional or intentional contamination of poultry and 

24 poultry food products. 
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1 ‘‘(c) TRAINING OF FIELD INSPECTORS.—The Sec2 retary shall provide training for field inspectors of the 

3 Food Safety and Inspection Service to monitor the imple4 mentation of the regulations described in subsection (a).’’. 

5 (b) CONFORMING AMENDMENTS.—Section 5(c)(1) of 

6 the Poultry Products Inspection Act (21 U.S.C. 

7 454(c)(1)) is amended in the first sentence— 

8 (1) by striking ‘‘, by thirty days prior to the ex9 piration of two years after enactment of the Whole10 some Poultry Products Act,’’; and 

11 (2) by striking ‘‘sections 1–4, 6–10, and 12–22 

12 of this Act’’ and inserting ‘‘sections 1 through 4, 6 

13 through 10, 12 through 22, and 27 through 30’’. 

14 SEC. 103. FOOD SECURITY FOR EGGS AND EGG PRODUCTS. 

15 The Egg Products Inspection Act (21 U.S.C. 1031 

16 et seq.) is amended— 

17 (1) by redesignating sections 27 through 29 as 

18 sections 31 through 33, respectively; 

19 (2) by inserting after section 26 (21 U.S.C. 

20 1054) the following: 

21 ‘‘SEC. 27. FOOD SECURITY. 

22 ‘‘(a) IN GENERAL.—The Secretary, in consultation 

23 with the Secretary of Health and Human Services, shall 

24 promulgate regulations that require persons to implement 

25 procedures to prevent both unintentional and intentional 
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1 contamination of eggs and egg products at establishments 

2 covered by this Act. 

3 ‘‘(b) SCOPE OF REGULATIONS.—The regulations 

4 shall require a person that is responsible for an establish5 ment covered by this Act to implement security procedures 

6 for the entire establishment, as determined by the Sec7 retary, including— 

8 ‘‘(1) developing a security plan that addresses 

9 the specific vulnerabilities of the establishment; 

10 ‘‘(2) developing an emergency response plan for 

11 the establishment; 

12 ‘‘(3) securing establishment boundaries; 

13 ‘‘(4) providing guards, alarms, and outside 

14 lighting, as necessary; 

15 ‘‘(5) performing background checks before hir16 ing new personnel; 

17 ‘‘(6) limiting access to the establishment; 

18 ‘‘(7) accounting for missing stock; 

19 ‘‘(8) implementing mail-handling procedures; 

20 and 

21 ‘‘(9) such other security procedures as the Sec22 retary determines to be necessary to prevent unin23 tentional or intentional contamination of eggs and 

24 egg products. 
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1 ‘‘(c) TRAINING OF FIELD INSPECTORS.—The Sec2 retary shall provide training for field inspectors of the 

3 Food Safety and Inspection Service to monitor the imple4 mentation of the regulations described in subsection (a).’’. 

5 SEC. 104. CONFIDENTIALITY OF INFORMATION. 

6 Section 1770(d) of the Food Security Act of 1985 

7 (7 U.S.C. 2276(d)) is amended— 

8 (1) in paragraph (11), by striking ‘‘or’’; and 

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

10 ‘‘(13) section 411 of the Federal Meat Inspec11 tion Act; 

12 ‘‘(14) section 31 of the Poultry Products In13 spection Act; or 

14 ‘‘(15) section 27 of the Egg Products Inspec15 tion Act.’’. 

16 Subtitle B—Food and Drug 

17 Administration 

18 SEC. 111. FOOD SECURITY FOR FOOD PRODUCTS. 

19 (a) IN GENERAL.—Chapter IV of the Federal Food, 

20 Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is amend21 ed by adding at the end the following: 

22 ‘‘SEC. 416. FOOD SECURITY. 

23 ‘‘(a) IN GENERAL.—The Secretary, in consultation 

24 with the Secretary of Agriculture, shall promulgate regula25 tions that require persons to implement procedures to pre-
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1 vent both unintentional and intentional contamination of 

2 food at domestic facilities covered by this Act. 

3 ‘‘(b) SCOPE OF REGULATIONS.—The regulations 

4 shall— 

5 ‘‘(1) direct food inspectors to check for the 

6 safety and security of food during an inspection of 

7 a domestic facility; and 

8 ‘‘(2) require a person that is responsible for a 

9 domestic facility to implement security procedures 

10 for the entire domestic facility, as determined by the 

11 Secretary, including— 

12 ‘‘(A) developing a security plan that ad13 dresses the specific vulnerabilities of the facil14 ity; 

15 ‘‘(B) developing an emergency response 

16 plan for the facility; 

17 ‘‘(C) securing establishment boundaries; 

18 ‘‘(D) providing guards, alarms, and outside 

19 lighting, as necessary; 

20 ‘‘(E) performing background checks before 

21 hiring new personnel; 

22 ‘‘(F) limiting access to the facility; 

23 ‘‘(G) accounting for missing stock; 

24 ‘‘(H) implementing mail-handling proce25 dures; and 
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1 ‘‘(I) such other security procedures as the 

2 Secretary determines to be necessary to prevent 

3 unintentional or intentional contamination of 

4 food. 

5 ‘‘(c) TRAINING OF FIELD INSPECTORS.—The Sec6 retary shall provide training for field inspectors of the 

7 Food and Drug Administration to monitor the implemen8 tation of the regulations described in subsection (a). 

9 ‘‘(d) PROTECTION OF INFORMATION.—Information 

10 furnished under the regulations described in subsection (a) 

11 shall not be disclosed under section 552 of title 5, United 

12 States Code (commonly known as the Freedom of Infor13 mation Act). 

14 ‘‘(e) DEFINITION.—In this section, the term ‘domes15 tic facility’ has the meaning given that term under section 

16 415(b)(2).’’. 

17 Subtitle C—Inspector Training 

18 SEC. 121. INSPECTOR TRAINING FOR FOOD SECURITY. 

19 (a) IN GENERAL.—Not later than 180 days after the 

20 date of enactment of this Act, the Secretary of Agri21 culture, in consultation with the Secretary of Health and 

22 Human Services, shall develop, publish, and initiate imple23 mentation of a joint training program for individuals who 

24 perform inspections with respect to the food security regu-
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1 lations promulgated pursuant to the amendments made by 

2 this title. 

3 (b) CONTINUING TRAINING.—As part of the training 

4 program implemented under subsection (a), the Secretary 

5 of Agriculture and the Secretary of Health and Human 

6 Services shall require individuals described in subsection 

7 (a) to meet training and retraining requirements, as deter8 mined by the Secretaries, at least once every 2 years. 

9 TITLE II—RECALL AUTHORITY 

10 Subtitle A—Department of 

11 Agriculture 

12 SEC. 201. FOOD SAFETY ENFORCEMENT FOR MEAT AND 

13 MEAT FOOD PRODUCTS. 

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

15 (21 U.S.C. 601 et seq.) is amended by adding after section 

16 411 (as added by section 101) the following: 

17 ‘‘SEC. 412. NOTIFICATION, NONDISTRIBUTION, AND RECALL 

18 OF ADULTERATED OR MISBRANDED ARTI19 CLES. 

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

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

22 household consumer) that has reason to believe that 

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

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

25 or other equines (referred to in this section as an 
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1 ‘article’) transported, stored, distributed, or other2 wise handled by the person is adulterated or mis3 branded shall, as soon as practicable, notify the Sec4 retary of the identity and location of the article. 

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

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

7 and by such means as the Secretary may require by 

8 regulation. 

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

10 ‘‘(1) VOLUNTARY ACTIONS.—On receiving noti11 fication under subsection (a) or by other means, if 

12 the Secretary finds that an article is adulterated or 

13 misbranded and that there is a reasonable prob14 ability that human consumption of the article would 

15 present a threat to public health (as determined by 

16 the Secretary), the Secretary shall provide all appro17 priate persons (as determined by the Secretary), 

18 that transported, stored, distributed, or otherwise 

19 handled the article with an opportunity— 

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

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

22 store, distribute, or otherwise handle the article, 

23 or to which the article has been transported, 

24 sold, distributed, or otherwise handled, to cease 

25 immediately distribution of the article; 
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1 ‘‘(C) to recall the article; or 

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

3 provide notice of the finding of the Secretary to 

4 all consumers to which the article was, or may 

5 have been, distributed. 

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 shall, by order, require, as the Secretary determines 

12 to be necessary, the person— 

13 ‘‘(A) to cease immediately distribution of 

14 the article; and 

15 ‘‘(B) to make immediately the notification 

16 described in paragraph (1)(B). 

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

18 shall, as the Secretary determines to be necessary, 

19 provide notice of the finding of the Secretary under 

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

21 or may have been, distributed. 

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 other-
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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; or 

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

24 been, distributed. 
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1 ‘‘(2) VACATION OF ORDERS.—If, after providing 

2 an opportunity for an informal hearing under sub3 section (c), the Secretary determines that adequate 

4 grounds do not exist to continue the actions required 

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

6 ‘‘(e) 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. REFUSAL OR WITHDRAWAL OF INSPECTION OF 

10 ESTABLISHMENTS. 

11 ‘‘(a) IN GENERAL.—The Secretary may, for such pe12 riod, or indefinitely, as the Secretary considers necessary 

13 to carry out this Act, refuse to provide or withdraw inspec14 tion under title I with respect to an establishment if the 

15 Secretary determines, after opportunity for a hearing on 

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

17 of, inspection, that the applicant or recipient, or any per18 son responsibly connected with the applicant or recipient 

19 (within the meaning of section 401), has committed a will20 ful violation or repeated violations of this Act (including 

21 a regulation promulgated under this Act). 

22 ‘‘(b) DENIAL OR SUSPENSION OF INSPECTION PEND23 ING HEARING.—The Secretary may deny or suspend in24 spection under title I, pending opportunity for an expe25 dited hearing, with respect to an action under subsection 
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1 (a), if the Secretary determines that the denial or suspen2 sion is in the public interest to protect the health or wel3 fare of consumers or to ensure the effective performance 

4 of an official duty under this Act. 

5 ‘‘(c) JUDICIAL REVIEW.— 

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

7 of the Secretary with respect to the refusal or with8 drawal of inspection under this section shall be final 

9 unless, not later than 30 days after the effective 

10 date of the order, the affected applicant for, or re11 cipient of, inspection— 

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

13 the order; and 

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

15 petition by certified mail to the Secretary. 

16 ‘‘(2) REFUSAL OR WITHDRAWAL OF INSPEC17 TION PENDING REVIEW.—Inspection shall be refused 

18 or withdrawn as of the effective date of the order 

19 pending any judicial review of the order unless the 

20 Secretary directs otherwise. 

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

22 order shall be— 

23 ‘‘(A) in— 

24 ‘‘(i) the United States court of ap25 peals for the circuit in which the applicant 
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1 for, or recipient of, inspection resides or 

2 has its principal place of business; or 

3 ‘‘(ii) the United States Court of Ap4 peals for the District of Columbia Circuit; 

5 and 

6 ‘‘(B) on the record on which the deter7 mination and order are based. 

8 ‘‘(d) 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. 414. CIVIL PENALTIES. 

12 ‘‘(a) IN GENERAL.— 

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

14 against a person that commits a serious violation (as 

15 defined by the Secretary by regulation) of this Act 

16 (including a regulation promulgated or order issued 

17 under this Act) a civil penalty for each violation of 

18 not more than $100,000. 

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

20 and each day during which the violation continues 

21 shall be considered to be a separate offense. 

22 ‘‘(3) NOTICE AND OPPORTUNITY FOR HEAR23 ING.—The Secretary shall not assess a civil penalty 

24 under this section against a person unless the person 

25 is given notice and opportunity for a hearing on the 
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1 record before the Secretary in accordance with sec2 tions 554 and 556 of title 5, United States Code. 

3 ‘‘(4) DETERMINATION OF CIVIL PENALTY

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

5 section— 

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

7 written order, taking into account— 

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

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

10 person; 

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

12 of the person; and 

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

14 the person under this Act; and 

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

16 with subsection (b). 

17 ‘‘(b) JUDICIAL REVIEW.— 

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

19 penalty against a person under subsection (a) shall 

20 be final unless the person— 

21 ‘‘(A) not later than 30 days after the effec22 tive date of the order, files a petition for judi23 cial review of the order in— 

24 ‘‘(i) the United States court of ap25 peals for the circuit in which the person re-
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1 sides or has its principal place of business; 

2 or 

3 ‘‘(ii) the United States Court of Ap4 peals for the District of Columbia Circuit; 

5 and 

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

7 petition by certified mail to the Secretary. 

8 ‘‘(2) FILING OF COPY OF RECORD.—The Sec9 retary shall promptly file in the court a certified 

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

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

12 ASSESSMENT.— 

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

14 person fails to pay a civil penalty assessed under 

15 subsection (a) after the order assessing the civil pen16 alty has become a final order, or after the court of 

17 appeals has entered final judgment in favor of the 

18 Secretary, the Secretary shall refer the matter to the 

19 Attorney General. 

20 ‘‘(2) ACTION BY ATTORNEY GENERAL.—Upon 

21 referral of a matter under paragraph (1), the Attor22 ney General shall bring a civil action to recover the 

23 amount of the civil penalty in United States district 

24 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) CRIMINAL PENALTIES.— 

22 (1) ASSAULTING, RESISTING, OR IMPEDING

23 CERTAIN PERSONS.—Section 405 of the Federal 

24 Meat Inspection Act (21 U.S.C. 675) is amended— 
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1 (A) in the first sentence, by striking ‘‘not 

2 more than $5,000’’ and inserting ‘‘under title 

3 18, United States Code,’’; and 

4 (B) in the second sentence, by striking 

5 ‘‘not more than $10,000’’ and inserting ‘‘under 

6 title 18, United States Code,’’. 

7 (2) VIOLATIONS.—Section 406 of the Federal 

8 Meat Inspection Act (21 U.S.C. 676) is amended— 

9 (A) by striking ‘‘of not more than $1,000,’’ 

10 and inserting ‘‘under title 18, United States 

11 Code,’’; and 

12 (B) by striking ‘‘of not more than 

13 $10,000,’’ and inserting ‘‘under title 18, United 

14 States Code,’’. 

15 (c) CONFORMING AMENDMENTS.— 

16 (1) Section 1 of the Federal Meat Inspection 

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

18 end the following: 

19 ‘‘(w) PERSON.—The term ‘person’ means any indi20 vidual, partnership, corporation, association, or other busi21 ness unit.’’. 

22 (2) The Federal Meat Inspection Act (21 

23 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. 202. FOOD SAFETY ENFORCEMENT FOR POULTRY AND 

11 POULTRY FOOD PRODUCTS. 

12 (a) IN GENERAL.—The Poultry Products Inspection 

13 Act (21 U.S.C. 451 et seq.) (as amended by section 102) 

14 is amended by inserting after section 27 (as added by sec15 tion 102(a)(3)) the following: 

16 ‘‘SEC. 28. NOTIFICATION, NONDISTRIBUTION, AND RECALL 

17 OF ADULTERATED OR MISBRANDED ARTI18 CLES. 

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

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

21 household consumer) that has reason to believe that 

22 any poultry or poultry product (referred to in this 

23 section as an ‘article’) transported, stored, distrib24 uted, or otherwise handled by the person is adulter25 ated or misbranded shall, as soon as practicable, no-
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1 tify the Secretary of the identity and location of the 

2 article. 

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

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

5 and by such means as the Secretary may require by 

6 regulation. 

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

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

10 the Secretary finds that an article is adulterated or 

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

13 present a threat to public health (as determined by 

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

16 that transported, stored, distributed, or otherwise 

17 handled the article with an opportunity— 

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

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

20 store, distribute, or otherwise handle the article, 

21 or to which the article has been transported, 

22 sold, distributed, or otherwise handled, to cease 

23 immediately distribution of the article; 

24 ‘‘(C) to recall the article; or 
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1 ‘‘(D) in consultation with the Secretary, to 

2 provide notice of the finding of the Secretary to 

3 all consumers to which the article was, or may 

4 have been, distributed. 

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

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

7 out the actions described in that paragraph with re8 spect to an article within the time period and in the 

9 manner prescribed by the Secretary, the Secretary 

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

11 to be necessary, the person— 

12 ‘‘(A) to cease immediately distribution of 

13 the article; and 

14 ‘‘(B) to make immediately the notification 

15 described in paragraph (1)(B). 

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

17 shall, as the Secretary determines to be necessary, 

18 provide notice of the finding of the Secretary under 

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

20 or may have been, distributed. 

21 ‘‘(4) NONDISTRIBUTION BY NOTIFIED PER22 SONS.—A person that transports, stores, distributes, 

23 or otherwise handles the article, or to which the arti24 cle has been transported, sold, distributed, or other25 wise handled, and that is notified under paragraph 
26 

•S 1534 IS

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

2 of the article. 

3 ‘‘(5) AVAILABILITY OF RECORDS TO SEC4 RETARY.—Each appropriate person referred to in 

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

6 or otherwise handled an article shall make available 

7 to the Secretary information necessary to carry out 

8 this subsection, as determined by the Secretary, re9 garding— 

10 ‘‘(A) persons that transport, store, dis11 tribute, or otherwise handle the article; and 

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

13 transported, sold, distributed, or otherwise han14 dled. 

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

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

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

18 with an opportunity for an informal hearing (in ac19 cordance with such rules or regulations as the Sec20 retary shall prescribe) on— 

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

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

23 the subject of the order should not be recalled. 

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

25 shall hold a hearing under paragraph (1) as soon as 
27 

•S 1534 IS

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

2 the date of issuance of the order. 

3 ‘‘(d) POST-HEARING RECALL ORDERS.— 

4 ‘‘(1) AMENDMENT OF ORDERS.—If, after pro5 viding an opportunity for an informal hearing under 

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

7 a reasonable probability that human consumption of 

8 the article that is the subject of an order under sub9 section (b) presents a threat to public health, the 

10 Secretary may, as the Secretary determines to be 

11 necessary— 

12 ‘‘(A) amend the order under subsection 

13 (b)— 

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

15 other appropriate action; and 

16 ‘‘(ii) to specify a timetable during 

17 which the recall shall occur; 

18 ‘‘(B) require periodic reports to the Sec19 retary describing the progress of the recall; or 

20 ‘‘(C) provide notice of the recall to con21 sumers to which the article was, or may have 

22 been, distributed. 

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

24 an opportunity for an informal hearing under sub25 section (c), the Secretary determines that adequate 
28 

•S 1534 IS

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. 29. 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 this Act 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 18(a)), has committed a 

17 willful violation or repeated violations of this Act (includ18 ing 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 this Act, 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 wel-
29 

•S 1534 IS

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 
30 

•S 1534 IS

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. 30. CIVIL PENALTIES. 

10 ‘‘(a) IN GENERAL.— 

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

12 against a person that commits a serious violation (as 

13 defined by the Secretary by regulation) of this Act 

14 (including a regulation promulgated or order issued 

15 under this Act) a civil penalty for each violation of 

16 not more than $100,000. 

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

18 and each day during which the violation continues 

19 shall be considered to be a separate offense. 

20 ‘‘(3) NOTICE AND OPPORTUNITY FOR HEAR21 ING.—The Secretary shall not assess a civil penalty 

22 under this section against a person unless the person 

23 is given notice and opportunity for a hearing on the 

24 record before the Secretary in accordance with sec25 tions 554 and 556 of title 5, United States Code. 
31 

•S 1534 IS

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 
32 

•S 1534 IS

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.—Upon 

19 referral of a matter under paragraph (1), the Attor20 ney General shall bring a civil action to recover the 

21 amount of the civil penalty in United States district 

22 court. 

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

24 under paragraph (2), the validity and appropriate-
33 

•S 1534 IS

1 ness of the order of the Secretary assessing the civil 

2 penalty shall not be subject to review. 

3 ‘‘(d) REFUSAL OR WITHDRAWAL OF INSPECTION

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

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

6 has become a final order, the Secretary may refuse to pro7 vide or withdraw inspection under this Act of the person 

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

9 otherwise. 

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

11 Nothing in this Act requires the Secretary to report for 

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

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

14 believes that the public interest will be adequately served 

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

16 ‘‘(f) REMEDIES NOT EXCLUSIVE.—The remedies au17 thorized by this section shall be in addition to any other 

18 remedies that may be available.’’. 

19 (b) CRIMINAL PENALTIES.—Section 12 of the Poul20 try Products Inspection Act (21 U.S.C. 461) is amend21 ed— 

22 (1) in the first sentence of subsection (a)— 

23 (A) by striking ‘‘not more than $1,000’’ 

24 and inserting ‘‘under title 18, United States 

25 Code,’’; and 
34 

•S 1534 IS

1 (B) by striking ‘‘not more than $10,000’’ 

2 and inserting ‘‘under title 18, United States 

3 Code,’’; and 

4 (2) in subsection (c)— 

5 (A) in the first sentence, by striking ‘‘not 

6 more than $5,000’’ and inserting ‘‘under title 

7 18, United States Code,’’; and 

8 (B) in the second sentence, by striking 

9 ‘‘not more than $10,000’’ and inserting ‘‘under 

10 title 18, United States Code,’’. 

11 SEC. 203. FOOD SAFETY ENFORCEMENT FOR EGGS AND 

12 EGG PRODUCTS. 

13 (a) IN GENERAL.—The Egg Products Inspection Act 

14 (21 U.S.C. 1031 et seq.) is amended by inserting after 

15 section 27 (as added by section 103) the following: 

16 ‘‘SEC. 28. NOTIFICATION, NONDISTRIBUTION, AND RECALL 

17 OF ADULTERATED OR MISBRANDED ARTI18 CLES. 

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

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

21 household consumer) that has reason to believe that 

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

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

24 otherwise handled by the person is adulterated or 
35 

•S 1534 IS

1 misbranded shall, as soon as practicable, notify the 

2 Secretary of the identity and location of the article. 

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

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

5 and by such means as the Secretary may require by 

6 regulation. 

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

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

10 the Secretary finds that an article is adulterated or 

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

13 present a threat to public health (as determined by 

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

16 that transported, stored, distributed, or otherwise 

17 handled the article with an opportunity— 

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

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

20 store, distribute, or otherwise handle the article, 

21 or to which the article has been transported, 

22 sold, distributed, or otherwise handled, to cease 

23 immediately distribution of the article; 

24 ‘‘(C) to recall the article; or 
36 

•S 1534 IS

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

2 provide notice of the finding of the Secretary to 

3 all consumers to which the article was, or may 

4 have been, distributed. 

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

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

7 out the actions described in that paragraph with re8 spect to an article within the time period and in the 

9 manner prescribed by the Secretary, the Secretary 

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

11 to be necessary, the person— 

12 ‘‘(A) to cease immediately distribution of 

13 the article; and 

14 ‘‘(B) to make immediately the notification 

15 described in paragraph (1)(B). 

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

17 shall, as the Secretary determines to be necessary, 

18 provide notice of the finding of the Secretary under 

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

20 or may have been, distributed. 

21 ‘‘(4) NONDISTRIBUTION BY NOTIFIED PER22 SONS.—A person that transports, stores, distributes, 

23 or otherwise handles the article, or to which the arti24 cle has been transported, sold, distributed, or other25 wise handled, and that is notified under paragraph 
37 

•S 1534 IS

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

2 of the article. 

3 ‘‘(5) AVAILABILITY OF RECORDS TO SEC4 RETARY.—Each appropriate person referred to in 

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

6 or otherwise handled an article shall make available 

7 to the Secretary information necessary to carry out 

8 this subsection, as determined by the Secretary, re9 garding— 

10 ‘‘(A) persons that transport, store, dis11 tribute, or otherwise handle the article; and 

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

13 transported, sold, distributed, or otherwise han14 dled. 

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

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

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

18 with an opportunity for an informal hearing (in ac19 cordance with such rules or regulations as the Sec20 retary shall prescribe) on— 

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

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

23 the subject of the order should not be recalled. 

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

25 shall hold a hearing under paragraph (1) as soon as 
38 

•S 1534 IS

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

2 the date of issuance of the order. 

3 ‘‘(d) POST-HEARING RECALL ORDERS.— 

4 ‘‘(1) AMENDMENT OF ORDERS.—If, after pro5 viding an opportunity for an informal hearing under 

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

7 a reasonable probability that human consumption of 

8 the article that is the subject of an order under sub9 section (b) presents a threat to public health, the 

10 Secretary may, as the Secretary determines to be 

11 necessary— 

12 ‘‘(A) amend the order under subsection 

13 (b)— 

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

15 other appropriate action; and 

16 ‘‘(ii) to specify a timetable during 

17 which the recall shall occur; 

18 ‘‘(B) require periodic reports to the Sec19 retary describing the progress of the recall; or 

20 ‘‘(C) provide notice of the recall to con21 sumers to which the article was, or may have 

22 been, distributed. 

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

24 an opportunity for an informal hearing under sub25 section (c), the Secretary determines that adequate 
39 

•S 1534 IS

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. 29. 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 this Act 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 18), 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 this Act, 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 wel-
40 

•S 1534 IS

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 
41 

•S 1534 IS

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. 30. CIVIL PENALTIES. 

10 ‘‘(a) IN GENERAL.— 

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

12 against a person that commits a serious violation (as 

13 defined by the Secretary by regulation) of this Act 

14 (including a regulation promulgated or order issued 

15 under this Act) a civil penalty for each violation of 

16 not more than $100,000. 

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

18 and each day during which the violation continues 

19 shall be considered to be a separate offense. 

20 ‘‘(3) NOTICE AND OPPORTUNITY FOR HEAR21 ING.—The Secretary shall not assess a civil penalty 

22 under this section against a person unless the person 

23 is given notice and opportunity for a hearing on the 

24 record before the Secretary in accordance with sec25 tions 554 and 556 of title 5, United States Code. 
42 

•S 1534 IS

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 
43 

•S 1534 IS

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.—Upon 

19 referral of a matter under paragraph (1), the Attor20 ney General shall bring a civil action to recover the 

21 amount of the civil penalty in United States district 

22 court. 

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

24 under paragraph (2), the validity and appropriate-
44 

•S 1534 IS

1 ness of the order of the Secretary assessing the civil 

2 penalty shall not be subject to review. 

3 ‘‘(d) REFUSAL OR WITHDRAWAL OF INSPECTION

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

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

6 has become a final order, the Secretary may refuse to pro7 vide or withdraw inspection under this Act of the person 

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

9 otherwise. 

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

11 Nothing in this Act requires the Secretary to report for 

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

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

14 believes that the public interest will be adequately served 

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

16 ‘‘(f) REMEDIES NOT EXCLUSIVE.—The remedies au17 thorized by this section shall be in addition to any other 

18 remedies that may be available.’’. 

19 (b) CRIMINAL PENALTIES.—Section 12 of the Egg 

20 Products Inspection Act (21 U.S.C. 1041) is amended— 

21 (1) in subsection (a)— 

22 (A) by striking ‘‘of not more than $5,000’’ 

23 and inserting ‘‘under title 18, United States 

24 Code’’; and 
45 

•S 1534 IS

1 (B) by striking ‘‘of not more than 

2 $10,000’’ and inserting ‘‘under title 18, United 

3 States Code’’; 

4 (2) in subsection (b)— 

5 (A) by striking ‘‘not more than $5,000’’ 

6 and inserting ‘‘under title 18, United States 

7 Code’’; and 

8 (B) by striking ‘‘not more than $10,000’’ 

9 and inserting ‘‘under title 18, United States 

10 Code’’; 

11 (3) by striking subsection (c); 

12 (4) in subsection (e), by striking ‘‘paragraph (c) 

13 of this section 12’’ and inserting ‘‘section 30’’; and 

14 (5) by redesignating subsections (d) and (e) as 

15 subsections (c) and (d), respectively. 

16 SEC. 204. LIABILITY. 

17 This subtitle and the amendments made by this sub18 title shall not affect the liability of any person under any 

19 provision of law as in effect before the application of this 

20 subtitle and the amendments made by this subtitle. 

21 Subtitle B—Food and Drug 

22 Administration 

23 SEC. 211. FOOD SAFETY ENFORCEMENT FOR FOOD. 

24 (a) IN GENERAL.—Chapter IV of the Federal Food, 

25 Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) (as 
46 

•S 1534 IS

1 amended by section 111) is amended by adding at the end 

2 the following: 

3 ‘‘SEC. 417. NOTIFICATION, NONDISTRIBUTION, AND RECALL 

4 OF ADULTERATED OR MISBRANDED FOOD. 

5 ‘‘(a) NOTICE TO SECRETARY OF VIOLATION.— 

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

7 household consumer or other individual who is the 

8 intended consumer of a food) that has reason to be9 lieve that any food introduced into or in interstate 

10 commerce, or held for sale (whether or not the first 

11 sale) after shipment in interstate commerce, may be 

12 in violation of this Act shall immediately notify the 

13 Secretary of the identity and location of the food. 

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

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

16 and by such means as the Secretary may require by 

17 regulation. 

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

19 ‘‘(1) VOLUNTARY ACTIONS.—If the Secretary 

20 determines that food is in violation of the food safe21 ty law when introduced into or while in interstate 

22 commerce or while held for sale (whether or not the 

23 first sale) after shipment in interstate commerce and 

24 that there is a reasonable probability that the food, 

25 if consumed, would present a threat to public health, 
47 

•S 1534 IS

1 as determined by the Secretary, the Secretary shall 

2 give the appropriate persons (including the manufac3 turers, importers, distributors, or retailers of the 

4 food) an opportunity to— 

5 ‘‘(A) cease distribution of the food; 

6 ‘‘(B) notify all persons— 

7 ‘‘(i) processing, distributing, or other8 wise handling the food to immediately 

9 cease such activities with respect to the 

10 food; or 

11 ‘‘(ii) to which the food has been dis12 tributed, transported, or sold, to imme13 diately cease distribution of the food; 

14 ‘‘(C) recall the food; 

15 ‘‘(D) in conjunction with the Secretary, 

16 provide notice of the finding of the Secretary— 

17 ‘‘(i) to consumers to whom the food 

18 was, or may have been, distributed; and 

19 ‘‘(ii) to State and local public health 

20 officials; or 

21 ‘‘(E) carry out any combination of the 

22 measures described in this paragraph, as deter23 mined by the Secretary to be appropriate in the 

24 circumstances. 
48 

•S 1534 IS

1 ‘‘(2) MANDATORY ACTIONS.—If a person re2 ferred to in paragraph (1) refuses to or does not 

3 adequately carry out the actions described in that 

4 paragraph within the time period and in the manner 

5 prescribed by the Secretary, the Secretary shall— 

6 ‘‘(A) have authority to control and possess 

7 the food, including ordering the shipment of the 

8 food from the food establishment to the Sec9 retary— 

10 ‘‘(i) at the expense of the food estab11 lishment; or 

12 ‘‘(ii) in an emergency (as determined 

13 by the Secretary), at the expense of the 

14 Administration; and 

15 ‘‘(B) by order, require, as the Secretary 

16 determines to be necessary, the person to imme17 diately— 

18 ‘‘(i) cease distribution of the food; and 

19 ‘‘(ii) notify all persons— 

20 ‘‘(I) processing, distributing, or 

21 otherwise handling the food to imme22 diately cease such activities with re23 spect to the food; or 
49 

•S 1534 IS

1 ‘‘(II) if the food has been distrib2 uted, transported, or sold, to imme3 diately cease distribution of the food. 

4 ‘‘(3) NOTIFICATION TO CONSUMERS BY SEC5 RETARY.—The Secretary shall, as the Secretary de6 termines to be necessary, provide notice of the find7 ing of the Secretary under paragraph (1)— 

8 ‘‘(A) to consumers to whom the food was, 

9 or may have been, distributed; and 

10 ‘‘(B) to State and local public health offi11 cials. 

12 ‘‘(4) NONDISTRIBUTION BY NOTIFIED PER13 SONS.—A person that processes, distributes, or oth14 erwise handles the food, or to which the food has 

15 been distributed, transported, or sold, and that is 

16 notified under paragraph (1)(B) or (2)(B) shall im17 mediately cease distribution of the food. 

18 ‘‘(5) AVAILABILITY OF RECORDS TO SEC19 RETARY.—Each person referred to in paragraph (1) 

20 that processed, distributed, or otherwise handled 

21 food shall make available to the Secretary informa22 tion necessary to carry out this subsection, as deter23 mined by the Secretary, regarding— 

24 ‘‘(A) persons that processed, distributed, 

25 or otherwise handled the food; and 
50 

•S 1534 IS

1 ‘‘(B) persons to which the food 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 any person subject to an order under subsection (b) 

7 with an opportunity for an informal hearing, to be 

8 held as soon as practicable but not later than 2 busi9 ness days after the issuance of the order. 

10 ‘‘(2) SCOPE OF THE HEARING.—In a hearing 

11 under paragraph (1), the Secretary shall consider 

12 the actions required by the order and any reasons 

13 why the food that is the subject of the order should 

14 not be recalled. 

15 ‘‘(d) POST HEARING RECALL ORDERS.— 

16 ‘‘(1) AMENDMENT OF ORDER.—If, after pro17 viding an opportunity for an informal hearing under 

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

19 a reasonable probability that the food that is the 

20 subject of an order under subsection (b), if con21 sumed, would present a threat to the public health, 

22 the Secretary, as the Secretary determines to be nec23 essary, may— 

24 ‘‘(A) amend the order to require recall of 

25 the food or other appropriate action; 
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1 ‘‘(B) specify a timetable in which the recall 

2 shall occur; 

3 ‘‘(C) require periodic reports to the Sec4 retary describing the progress of the recall; and 

5 ‘‘(D) provide notice of the recall to con6 sumers to whom the food was, or may have 

7 been, distributed. 

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

9 an opportunity for an informal hearing under sub10 section (c), the Secretary determines that adequate 

11 grounds do not exist to continue the actions required 

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

13 ‘‘(e) REMEDIES NOT EXCLUSIVE.—The remedies 

14 provided for in this section shall be in addition to, and 

15 not exclusive of, other remedies that may be available. 

16 ‘‘SEC. 418. REFUSAL OR WITHDRAWAL OF INSPECTION OF 

17 ESTABLISHMENTS. 

18 ‘‘(a) IN GENERAL.—The Secretary may, for such pe19 riod, or indefinitely, as the Secretary considers necessary 

20 to carry out this chapter, refuse to provide or withdraw 

21 inspection under this chapter with respect to an establish22 ment if the Secretary determines, after opportunity for a 

23 hearing on the record is provided to the applicant for, or 

24 recipient of, inspection, that the applicant or recipient, or 

25 any person responsibly connected (within the meaning 
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1 under section 18 of the Egg Products Inspection Act (21 

2 U.S.C. 1047)) with the applicant or recipient, has com3 mitted a willful violation or repeated violations of this 

4 chapter (including a regulation promulgated under this 

5 chapter). 

6 ‘‘(b) DENIAL OR SUSPENSION OF INSPECTION PEND7 ING HEARING.—The Secretary may deny or suspend in8 spection under this chapter, pending the opportunity for 

9 an expedited hearing, with respect to an action under sub10 section (a), if the Secretary determines that the denial or 

11 suspension is in the public interest to protect the health 

12 or welfare of consumers or to ensure the effective perform13 ance of an official duty under this Act. 

14 ‘‘(c) JUDICIAL REVIEW.— 

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

16 of the Secretary with respect to the refusal or with17 drawal of inspection under this section shall be final 

18 unless, not later than 30 days after the effective 

19 date of the order, the affected applicant for, or re20 cipient of, inspection— 

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

22 the order; and 

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

24 petition by certified mail to the Secretary. 
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1 ‘‘(2) REFUSAL OR WITHDRAWAL OF INSPEC2 TION PENDING REVIEW.—Inspection shall be refused 

3 or withdrawn as of the effective date of the order 

4 pending any judicial review of the order unless the 

5 Secretary directs otherwise. 

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

7 order shall be— 

8 ‘‘(A) in— 

9 ‘‘(i) the United States court of ap10 peals for the circuit in which the applicant 

11 for, or recipient of, inspection resides or 

12 has its principal place of business; or 

13 ‘‘(ii) the United States Court of Ap14 peals for the District of Columbia Circuit; 

15 and 

16 ‘‘(B) on the record on which the deter17 mination and order are based. 

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

20 remedies that may be available. 

21 ‘‘SEC. 419. CIVIL PENALTIES. 

22 ‘‘(a) IN GENERAL.— 

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

24 against a person that commits a serious violation (as 

25 defined by the Secretary by regulation) of section 
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1 417 (including a regulation promulgated or order 

2 issued under such section) a civil penalty for each 

3 violation of not more than $100,000. 

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

5 and each day during which the violation continues 

6 shall be considered to be a separate offense. 

7 ‘‘(3) NOTICE AND OPPORTUNITY FOR HEAR8 ING.—The Secretary shall not assess a civil penalty 

9 under this section against a person unless the person 

10 is given notice and opportunity for a hearing on the 

11 record before the Secretary in accordance with sec12 tions 554 and 556 of title 5, United States Code. 

13 ‘‘(4) DETERMINATION OF CIVIL PENALTY

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

15 section— 

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

17 written order, taking into account— 

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

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

20 person; 

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

22 of the person; and 

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

24 the person under this Act; and 
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1 ‘‘(B) shall be reviewed only in accordance 

2 with subsection (b). 

3 ‘‘(b) JUDICIAL REVIEW.— 

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

5 penalty against a person under subsection (a) shall 

6 be final unless the person— 

7 ‘‘(A) not later than 30 days after the effec8 tive date of the order, files a petition for judi9 cial review of the order in— 

10 ‘‘(i) the United States court of ap11 peals for the circuit in which the person re12 sides or has its principal place of business; 

13 or 

14 ‘‘(ii) the United States Court of Ap15 peals for the District of Columbia Circuit; 

16 and 

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

18 petition by certified mail to the Secretary. 

19 ‘‘(2) FILING OF COPY OF RECORD.—The Sec20 retary shall promptly file in the court a certified 

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

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

23 ASSESSMENT.— 

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

25 person fails to pay a civil penalty assessed under 
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1 subsection (a) after the order assessing the civil pen2 alty has become a final order, or after the court of 

3 appeals has entered final judgment in favor of the 

4 Secretary, the Secretary shall refer the matter to the 

5 Attorney General. 

6 ‘‘(2) ACTION BY ATTORNEY GENERAL.—Upon 

7 referral of a matter under paragraph (1), the Attor8 ney General shall bring a civil action to recover the 

9 amount of the civil penalty in United States district 

10 court. 

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

12 under paragraph (2), the validity and appropriate13 ness of the order of the Secretary assessing the civil 

14 penalty shall not be subject to review. 

15 ‘‘(d) REFUSAL OR WITHDRAWAL OF INSPECTION

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

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

18 has become a final order, the Secretary may refuse to pro19 vide or withdraw inspection under this chapter of the per20 son until the civil penalty is paid or until the Secretary 

21 directs otherwise. 

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

23 Nothing in this Act requires the Secretary to report for 

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

25 violation of this chapter in any case in which the Secretary 
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1 believes that the public interest will be adequately served 

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

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

5 remedies that may be available.’’. 

6 (b) PROHIBITED ACTS.—Section 301 of the Federal 

7 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend8 ed by adding at the end the following: 

9 ‘‘(hh)(1) The failure to notify the Secretary in viola10 tion of section 417(a). 

11 ‘‘(2) The failure to comply with— 

12 ‘‘(A) an order under section 417(b); or 

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

14 417(d)(1).’’. 

15 SEC. 212. LIABILITY. 

16 This subtitle and the amendments made by this sub17 title shall not affect the liability of any person under any 

18 provision of law as in effect before the application of this 

19 subtitle and the amendments made by this subtitle. 

20 TITLE III—IMPORTED FOOD 

21 SEC. 301. IMPORTED FOOD. 

22 (a) CERTIFICATION OF FOREIGN FOOD FACILI23 TIES.—Section 415 of the Federal Food, Drug, and Cos24 metic Act (21 U.S.C. 350d) is amended by— 
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1 (1) striking paragraphs (3) and (4) of sub2 section (a); 

3 (2) redesignating subsections (b) as subsection 

4 (d); 

5 (3) striking subsection (c); 

6 (4) inserting after subsection (a) the following: 

7 ‘‘(b) CERTIFICATION OF FOREIGN FACILITIES AND

8 GOVERNMENTS.— 

9 ‘‘(1) IN GENERAL.—Not later than 1 year after 

10 the date of enactment of the Safe and Secure Food 

11 Act of 2005, a foreign facility or foreign government 

12 that submits a registration to import food to the 

13 United States under this section shall request certifi14 cation from the Secretary by demonstrating, in a 

15 manner determined appropriate by the Secretary, 

16 that food produced under the supervision of the for17 eign facility or foreign government has met stand18 ards for food safety, inspection, labeling, and con19 sumer protection that are at least equivalent to the 

20 standards applicable to food produced in the United 

21 States. 

22 ‘‘(2) CERTIFICATION APPROVAL.— 

23 ‘‘(A) REQUEST BY FOREIGN GOVERN24 MENT.—Prior to granting the certification re25 quest of a foreign government, the Secretary 
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1 shall review, audit, and certify the food safety 

2 program of a requesting foreign government 

3 (including all statutes, regulations, and inspec4 tion authority) as at least equivalent to the food 

5 safety program in the United States, as dem6 onstrated by the foreign government. 

7 ‘‘(B) REQUEST BY FOREIGN FACILITY.— 

8 Prior to granting the certification request of a 

9 foreign facility, the Secretary shall certify, 

10 based on an onsite inspection, the food safety 

11 programs and procedures of a requesting for12 eign facility as at least equivalent to the food 

13 safety programs and procedures of the United 

14 States. 

15 ‘‘(3) LIMITATION.—A foreign government or 

16 foreign facility approved by the Secretary to import 

17 food to the United States under this section shall be 

18 certified to export only the approved food products 

19 to the United States for a period not to exceed 5 

20 years. 

21 ‘‘(4) WITHDRAWAL OF CERTIFICATION.—The 

22 Secretary may withdraw certification of any food 

23 from a foreign government or foreign facility— 

24 ‘‘(A) if such food is linked to an outbreak 

25 of human illness; 
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1 ‘‘(B) following an investigation by the Sec2 retary that finds that the foreign government 

3 programs and procedures or foreign facility is 

4 no longer equivalent to the food safety pro5 grams and procedures in the United States; or 

6 ‘‘(C) following a refusal to allow United 

7 States officials to conduct such audits and in8 vestigations as may be necessary to fulfill the 

9 requirements under this section. 

10 ‘‘(5) RENEWAL OF CERTIFICATION.—The Sec11 retary shall audit a foreign government or a foreign 

12 facility that imports food to the United States every 

13 5 years to ensure the continued compliance with the 

14 standards set forth in this section. 

15 ‘‘(6) REQUIRED ROUTINE INSPECTION.—The 

16 Secretary shall routinely inspect food before it enters 

17 the United States to ensure that it is— 

18 ‘‘(A) safe for human consumption; 

19 ‘‘(B) labeled as required for food produced 

20 in the United States; and 

21 ‘‘(C) otherwise meets requirements under 

22 the food safety law. 

23 ‘‘(7) ENFORCEMENT.—The Secretary— 

24 ‘‘(A) may deny importation of food from 

25 any foreign government that does not permit 
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1 United States officials to enter the foreign 

2 country to conduct such audits and inspections 

3 as may be necessary to fulfill the requirements 

4 under this section; 

5 ‘‘(B) may deny importation of food from 

6 any foreign government or foreign firm that 

7 does not consent to an investigation by the Ad8 ministration when food from that foreign coun9 try or foreign firm is linked to a food-borne ill10 ness outbreak or is otherwise found to be adul11 terated or mislabeled; and 

12 ‘‘(C) is authorized to promulgate rules and 

13 regulations to carry out the purposes of this 

14 section, including setting terms and conditions 

15 for the destruction of products that fail to meet 

16 the standards of this Act. 

17 ‘‘(c) ADMINISTRATIVE REQUIREMENTS.— 

18 ‘‘(1) PROCEDURE.— 

19 ‘‘(A) DOMESTIC FACILITIES.—Upon the 

20 receipt of a completed registration described in 

21 subsection (a)(1), the Secretary shall notify the 

22 domestic facility of the receipt of such registra23 tion and assign a registration number to each 

24 registered domestic facility. 
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1 ‘‘(B) FOREIGN FACILITIES.—Upon the re2 ceipt of a completed registration described in 

3 subsection (a)(1) and a certification under sub4 section (b), the Secretary shall notify the for5 eign facility of the receipt of such registration 

6 and certification and assign a registration num7 ber to each registered and certified foreign fa8 cility. 

9 ‘‘(2) LIST.—The Secretary shall maintain an 

10 up-to-date list of domestic facilities that are reg11 istered and of foreign facilities that are registered 

12 and certified under this section. Such list and any 

13 registration or certification documents submitted 

14 pursuant to this subsection shall not be subject to 

15 disclosure under section 552 of title 5, United States 

16 Code. Information derived from such list or registra17 tion or certification documents shall not be subject 

18 to disclosure under section 552 of title 5, United 

19 States Code, to the extent that it discloses the iden20 tity or location of a specific registered or certified 

21 person.’’; and 

22 (5) by adding at the end the following: 

23 ‘‘(e) EFFECT ON CERTAIN FOREIGN FACILITIES.— 

24 Foreign facilities maintaining a registration under this 

25 section on the day before the date of enactment of the 
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1 Safe and Secure Food Act of 2005 shall submit a request 

2 for certification under subsection (b)(1) not later than 3 

3 years after the date of enactment of such Act.’’. 

4 (b) IN GENERAL.—Section 801 of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 381) is amended by 

6 adding at the end the following: 

7 ‘‘(p)(1) The Secretary shall— 

8 ‘‘(A) conduct an evaluation comparing the laws 

9 of the United States with other countries with re10 spect to the inspection and security of food; and 

11 ‘‘(B) promulgate regulations to— 

12 ‘‘(i) develop new methods of detecting con13 taminated imported food; 

14 ‘‘(ii) increase coordination between Fed15 eral, State, and local food safety officials with 

16 regard to food safety and security; 

17 ‘‘(iii) direct food inspectors to check for 

18 the safety and security of food during an in19 spection of a foreign facility; and 

20 ‘‘(iv) require persons to implement proce21 dures to prevent the unintentional and inten22 tional contamination of food at foreign facilities 

23 covered by this Act. 

24 ‘‘(2) The regulations promulgated under paragraph 

25 (1) shall require a person to implement security proce-
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1 dures for the entire foreign facility, as determined by the 

2 Secretary, including— 

3 ‘‘(A) developing a security plan that addresses 

4 the specific vulnerabilities of the facility; 

5 ‘‘(B) developing an emergency response plan for 

6 the facility; 

7 ‘‘(C) securing establishment boundaries; 

8 ‘‘(D) providing guards, alarms, and outside 

9 lighting, as necessary; 

10 ‘‘(E) performing background checks before hir11 ing new personnel; 

12 ‘‘(F) limiting access to the facility; 

13 ‘‘(G) accounting for missing stock; 

14 ‘‘(H) implementing mail-handling procedures; 

15 and 

16 ‘‘(I) such other security procedures as the Sec17 retary determines to be necessary to prevent unin18 tentional or intentional contamination of food. 

19 ‘‘(3) In this subsection, the term ‘foreign facility’ has 

20 the meaning given that term in section 415(b)(3).’’. 

21 (c) ADULTERATION.—Section 402 of the Federal 

22 Food, Drug, and Cosmetic Act (21 U.S.C. 342) is amend23 ed by adding at the end the following: 

24 ‘‘(i) If it is food from a domestic or foreign facility 

25 (as those terms are defined in section 415(b)) that fails 
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1 to comply with the regulations promulgated under section 

2 416 or 801(p).’’. 

3 (d) CONFORMING AMENDMENT.—Section 801(l)(1) 

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

5 381(l)(1)) is amended by inserting ‘‘or that has not re6 ceived a certification from the Secretary’’ after ‘‘for which 

7 a registration has not been submitted to the Secretary’’. 

8 TITLE IV—RISK ASSESSMENT 

9 INFORMATION SHARING 

10 SEC. 401. RISK ASSESSMENT INFORMATION SHARING. 

11 (a) COORDINATION OF AGENCIES.—The Secretary of 

12 Health and Human Services shall coordinate with the Sec13 retary of Agriculture, the Secretary of Homeland Security, 

14 and the Director of the Centers for Disease Control and 

15 Prevention to— 

16 (1) assess the security risks to the food supply 

17 of the United States; and 

18 (2) not later than 1 year after the date of en19 actment of this Act, submit to Congress a report 

20 that— 

21 (A) describes the assessment under para22 graph (1); 

23 (B) outlines measures to address any secu24 rity risks described in such assessment; and 
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1 (C) describes the costs of addressing such 

2 security risks. 

3 (b) COORDINATION WITH UNDERSECRETARY FOR

4 SCIENCE AND TECHNOLOGY.— 

5 (1) IN GENERAL.—The Secretary of Health and 

6 Human Services shall coordinate with the Undersec7 retary of Science and Technology of the Department 

8 of Homeland Security with respect to entities award9 ed grants relating to food safety under section 

10 307(b) of the Homeland Security Act of 2002 (6 

11 U.S.C. 187(b)). 

12 (2) INFORMATION SHARING.—The Undersecre13 tary of Science and Technology shall grant access to 

14 the Secretary of Health and Human Services with 

15 respect to information and data gathered at entities 

16 awarded grants relating to food safety under section 

17 307(b) of the Homeland Security Act of 2002 (6 

18 U.S.C. 187(b)). 

Æ