II 

110TH CONGRESS 

1ST SESSION S. 1274 

To amend the Federal Food, Drug, and Cosmetic Act with respect to the 

safety of food for humans and pets. 

IN THE SENATE OF THE UNITED STATES 

MAY 2, 2007 

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

to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act with 

respect to the safety of food for humans and pets. 

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 ‘‘Human and Pet Food 

5 Safety Act of 2007’’. 

6 SEC. 2. FOOD SAFETY FOR HUMANS AND PETS. 

7 (a) ADVERSE EVENTS; INSPECTIONS; RECALL.— 

8 Chapter IV of the Federal Food, Drug, and Cosmetic Act 

9 (21 U.S.C. 341 et seq.) is amended by adding at the end 

10 the following: 

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1 ‘‘SEC. 417. NOTIFICATION AND RECALL. 

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

3 ‘‘(1) IN GENERAL.—A person that has reason 

4 to believe that any food introduced into or in inter5 state commerce, or held for sale (whether or not the 

6 first sale) after shipment in interstate commerce, 

7 may be in violation of this Act shall immediately no8 tify the Secretary of the identity and location of the 

9 food. 

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

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

12 and by such means as the Secretary may require by 

13 regulation. 

14 ‘‘(b) RECALL AND CONSUMER NOTIFICATION; VOL15 UNTARY ACTIONS.—If the Secretary determines that food 

16 is in violation of this Act when introduced into or while 

17 in interstate commerce or while held for sale (whether or 

18 not the first sale) after shipment in interstate commerce 

19 and that there is a reasonable probability that the food, 

20 if consumed, would present a threat to public health, as 

21 determined by the Secretary, the Secretary shall give the 

22 appropriate persons (including the manufacturers, import23 ers, distributors, or retailers of the food) an opportunity 

24 to— 

25 ‘‘(1) cease distribution of the food; 

26 ‘‘(2) notify all persons— 

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1 ‘‘(A) processing, distributing, or otherwise 

2 handling the food to immediately cease such ac3 tivities with respect to the food; or 

4 ‘‘(B) to which the food has been distrib5 uted, transported, or sold, to immediately cease 

6 distribution of the food; 

7 ‘‘(3) recall the food; 

8 ‘‘(4) in conjunction with the Secretary, provide 

9 notice of the finding of the Secretary— 

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

11 or may have been, distributed; and 

12 ‘‘(B) to State and local public health offi13 cials; or 

14 ‘‘(5) take any combination of the measures de15 scribed in this paragraph, as determined by the Sec16 retary to be appropriate in the circumstances. 

17 ‘‘(c) CIVIL AND CRIMINAL PENALTIES.— 

18 ‘‘(1) CIVIL SANCTIONS.— 

19 ‘‘(A) CIVIL PENALTY.—Any person that 

20 commits an act that violates the notification 

21 and recall standards under subsection (b) (in22 cluding a regulation promulgated or order 

23 issued under this Act) may be assessed a civil 

24 penalty by the Secretary of not more than 

25 $10,000 for each such act. 

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1 ‘‘(B) SEPARATE OFFENSE.—Each act de2 scribed in subparagraph (A) and each day dur3 ing which that act continues shall be considered 

4 a separate offense. 

5 ‘‘(2) OTHER REQUIREMENTS.— 

6 ‘‘(A) WRITTEN ORDER.—The civil penalty 

7 described in paragraph (1) shall be assessed by 

8 the Secretary by a written order, which shall 

9 specify the amount of the penalty and the basis 

10 for the penalty under subparagraph (B) consid11 ered by the Secretary. 

12 ‘‘(B) AMOUNT OF PENALTY.—Subject to 

13 paragraph (1)(A), the amount of the civil pen14 alty shall be determined by the Secretary, after 

15 considering— 

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

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

18 person; 

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

20 of the person; and 

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

22 the person under this Act. 

23 ‘‘(C) REVIEW OF ORDER.—The order may 

24 be reviewed only in accordance with subsection 

25 (d). 

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1 ‘‘(3) EXCEPTION.—No person shall be subject 

2 to the penalties of this subsection— 

3 ‘‘(A) for having received, proffered, or de4 livered in interstate commerce any food, if the 

5 receipt, proffer, or delivery was made in good 

6 faith, unless that person refuses to furnish (on 

7 request of an officer or employee designated by 

8 the Secretary)— 

9 ‘‘(i) the name, address and contact in10 formation of the person from whom that 

11 person purchased or received the food; 

12 ‘‘(ii) copies of all documents relating 

13 to the person from whom that person pur14 chased or received the food; and 

15 ‘‘(iii) copies of all documents per16 taining to the delivery of the food to that 

17 person; or 

18 ‘‘(B) if that person establishes a guaranty 

19 signed by, and containing the name and address 

20 of, the person from whom that person received 

21 in good faith the food, stating that the food is 

22 not adulterated or misbranded within the mean23 ing of this Act. 

24 ‘‘(d) JUDICIAL REVIEW.— 

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

2 penalty under subsection (c) shall be a final order 

3 unless the person— 

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

7 court of appeals for the circuit in which that 

8 person resides or has its principal place of busi9 ness or the United States Court of Appeals for 

10 the District of Columbia; and 

11 ‘‘(B) simultaneously serves a copy of the 

12 petition by certified mail to the Secretary. 

13 ‘‘(2) FILING OF RECORD.—Not later than 45 

14 days after the service of a copy of the petition under 

15 paragraph (1)(B), the Secretary shall file in the 

16 court a certified copy of the administrative record 

17 upon which the order was issued. 

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

19 the Secretary relating to the order shall be set aside 

20 only if found to be unsupported by substantial evi21 dence on the record as a whole. 

22 ‘‘(e) COLLECTION ACTIONS FOR FAILURE TO PAY.— 

23 ‘‘(1) IN GENERAL.—If any person fails to pay 

24 a civil penalty assessed under subsection (c) after 

25 the order assessing the penalty has become a final 

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1 order, or after the court of appeals described in sub2 section (d) has entered final judgment in favor of 

3 the Secretary, the Secretary shall refer the matter to 

4 the Attorney General, who shall institute in a United 

5 States district court of competent jurisdiction a civil 

6 action to recover the amount assessed. 

7 ‘‘(2) LIMITATION ON REVIEW.—In a civil action 

8 under paragraph (1), the validity and appropriate9 ness of the order of the Secretary assessing the civil 

10 penalty shall not be subject to judicial review. 

11 ‘‘(f) PENALTIES PAID INTO ACCOUNT.—The Sec12 retary— 

13 ‘‘(1) shall deposit penalties collected under this 

14 section in an account in the Treasury; and 

15 ‘‘(2) may use the funds in the account, without 

16 further appropriation or fiscal year limitation— 

17 ‘‘(A) to carry out enforcement activities 

18 under food safety law; or 

19 ‘‘(B) to provide assistance to States to in20 spect retail commercial food establishments, 

21 such as an establishment that holds, stores, or 

22 transports food or food ingredients, or other 

23 food or firms under the jurisdiction of State 

24 food safety programs. 

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1 ‘‘(g) DISCRETION OF THE SECRETARY TO PROS2 ECUTE.—Nothing in this section, section 418, or section 

3 419 requires the Secretary to report for prosecution, or 

4 for the commencement of an action, the violation of this 

5 Act in a case in which the Secretary finds that the public 

6 interest will be adequately served by the assessment of a 

7 civil penalty under this section. 

8 ‘‘(h) REMEDIES NOT EXCLUSIVE.—The remedies 

9 provided in this section may be in addition to, and not 

10 exclusive of, other remedies that may be available. 

11 ‘‘SEC. 418. MANDATORY RECALL ACTION. 

12 ‘‘(a) MANDATORY ACTIONS.—If a person referred to 

13 in section 417(b) refuses to or does not adequately carry 

14 out the actions described in that section within the time 

15 period and in the manner prescribed by the Secretary, the 

16 Secretary shall— 

17 ‘‘(1) have authority to control and possess the 

18 food, including ordering the shipment of the food 

19 from a food establishment, such as an establishment 

20 that holds, stores, or transports food or food ingredi21 ents, to the Secretary— 

22 ‘‘(A) at the expense of such food establish23 ment; or 

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1 ‘‘(B) in an emergency (as determined by 

2 the Secretary), at the expense of the Secretary; 

3 and 

4 ‘‘(2) by order, require, as the Secretary deter5 mines to be necessary, the person to immediately— 

6 ‘‘(A) cease distribution of the food; and 

7 ‘‘(B) notify all persons— 

8 ‘‘(i) processing, distributing, or other9 wise handling the food to immediately 

10 cease such activities with respect to the 

11 food; or 

12 ‘‘(ii) if the food has been distributed, 

13 transported, or sold, to immediately cease 

14 distribution of the food. 

15 ‘‘(b) NOTIFICATION TO CONSUMERS BY SEC16 RETARY.—The Secretary shall, as the Secretary deter17 mines to be necessary, provide notice of the finding of the 

18 Secretary under paragraph (1)— 

19 ‘‘(1) to consumers to whom the food was, or 

20 may have been, distributed; and 

21 ‘‘(2) to State and local public health officials. 

22 ‘‘(c) NONDISTRIBUTION BY NOTIFIED PERSONS.—A 

23 person that processes, distributes, or otherwise handles 

24 the food, or to which the food has been distributed, trans25 ported, or sold, and that is notified under section 

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1 417(b)(2) or subsection (a)(2)(B) of this section shall im2 mediately cease distribution of the food. 

3 ‘‘(d) AVAILABILITY OF RECORDS TO SECRETARY.— 

4 Each person referred to in section 417 that processed, dis5 tributed, or otherwise handled food shall make available 

6 to the Secretary information necessary to carry out this 

7 subsection, as determined by the Secretary, regarding— 

8 ‘‘(1) persons that processed, distributed, or oth9 erwise handled the food; and 

10 ‘‘(2) persons to which the food has been trans11 ported, sold, distributed, or otherwise handled. 

12 ‘‘(e) INFORMAL HEARINGS ON ORDERS.— 

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

14 any person subject to an order under subsection (a) 

15 with an opportunity for an informal hearing, to be 

16 held as soon as practicable but not later than 2 busi17 ness days after the issuance of the order. 

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

19 under paragraph (1), the Secretary shall consider 

20 the actions required by the order and any reasons 

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

22 not be recalled. 

23 ‘‘(f) POST-HEARING RECALL ORDERS.— 

24 ‘‘(1) AMENDMENT OF ORDER.—If, after pro25 viding an opportunity for an informal hearing under 

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1 subsection (e), the Secretary determines that there 

2 is a reasonable probability that the food that is the 

3 subject of an order under subsection (a), if con4 sumed, would present a threat to the public health, 

5 the Secretary, as the Secretary determines to be nec6 essary, may— 

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

8 the food or other appropriate action; 

9 ‘‘(B) specify a timetable in which the recall 

10 shall occur; 

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

13 ‘‘(D) provide notice of the recall to con14 sumers to whom the food 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 (e), 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 ‘‘(g) REMEDIES NOT EXCLUSIVE.—The remedies 

22 provided in this section shall be in addition to, and not 

23 exclusive of, other remedies that may be available. 

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1 ‘‘SEC. 419. FOREIGN INSPECTIONS; IMPORTS. 

2 ‘‘(a) AUTHORITY TO INSPECT.—The Secretary shall 

3 have the authority to visit any foreign country that im4 ports to the United States human or pet food. Such a visit 

5 shall be for the purpose of auditing the food safety or pet 

6 food programs of such foreign country or to conduct inves7 tigations in the event that a food or ingredient of a food 

8 is found to violate this Act. 

9 ‘‘(b) IMPORTS.— 

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

11 after the date of enactment of this section, the Sec12 retary shall establish a system under which a foreign 

13 government or foreign manufacturer, importer, dis14 tributor, or retailer that seeks to import food to the 

15 United States shall submit a request for certification 

16 to the Secretary. 

17 ‘‘(2) CERTIFICATION STANDARD.—A foreign 

18 government or foreign manufacturer, importer, dis19 tributor, or retailer requesting a certification to im20 port food to the United States shall demonstrate, in 

21 a manner determined appropriate by the Secretary, 

22 that food produced under the supervision of a for23 eign government or by the foreign manufacturer, im24 porter, distributor, or retailer has met standards for 

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1 tection that are at least equivalent to standards ap2 plicable to food produced in the United States. 

3 ‘‘(3) CERTIFICATION APPROVAL.— 

4 ‘‘(A) REQUEST BY FOREIGN GOVERN5 MENT.—Prior to granting the certification re6 quest of a foreign government, the Secretary 

7 shall review, audit, and certify the food safety 

8 program of a requesting foreign government 

9 (including all statutes, regulations, and inspec10 tion authority) as at least equivalent to the food 

11 safety program in the United States, as dem12 onstrated by the foreign government. 

13 ‘‘(B) REQUEST BY FOREIGN ESTABLISH14 MENT.—Prior to granting the certification re15 quest of a foreign manufacturer, importer, dis16 tributor, or retailer that seeks to import food to 

17 the United States, the Secretary shall certify, 

18 based on an onsite inspection, the food safety 

19 programs and procedures of a requesting for20 eign firm as at least equivalent to the food safe21 ty programs and procedures of the United 

22 States. 

23 ‘‘(4) LIMITATION.—A foreign government or 

24 foreign manufacturer, importer, distributor, or re25 tailer approved by the Secretary to import food to 

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1 the United States under this section shall be cer2 tified to export only the approved food products to 

3 the United States for a period not to exceed 5 years. 

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

5 Secretary may withdraw certification of any food 

6 from a foreign government or foreign manufacturer, 

7 importer, distributor, or retailer that seeks to import 

8 food to the United States— 

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

10 of human illness; 

11 ‘‘(B) following an investigation by the Sec12 retary that finds that the food safety programs 

13 and procedures of the foreign government or 

14 foreign manufacturer, importer, distributor, or 

15 retailer are no longer equivalent to the food 

16 safety programs and procedures in the United 

17 States; or 

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

19 States officials to conduct such audits and in20 vestigations as may be necessary to fulfill the 

21 requirements under this section. 

22 ‘‘(6) RENEWAL OF CERTIFICATION.—The Sec23 retary shall audit a foreign government and a for24 eign manufacturer, importer, distributor, or retailer 

25 that seeks to import food to the United States at 

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1 least every 5 years to ensure the continued compli2 ance with the standards set forth in this section. 

3 ‘‘(7) REQUIRED ROUTINE INSPECTION.—The 

4 Secretary shall routinely inspect food and food ani5 mals (via a physical examination) before it enters 

6 the United States to ensure that it is— 

7 ‘‘(A) safe; 

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

9 in the United States; and 

10 ‘‘(C) otherwise meets requirements under 

11 this Act. 

12 ‘‘(8) RECORDS INSPECTION.— 

13 ‘‘(A) IN GENERAL.—The responsible party 

14 or importer shall permit an authorized person 

15 to have access to records required to be main16 tained under this section during an inspection 

17 pursuant to section 704. 

18 ‘‘(B) DEFINTIONS.—For purposes of this 

19 paragraph— 

20 ‘‘(i) the term ‘authorized person’ 

21 means an officer or employee of the De22 partment of Health and Human Services, 

23 who has— 

24 ‘‘(I) appropriate credentials, as 

25 determined by the Secretary; and 

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1 ‘‘(II) been duly designated by the 

2 Secretary to have access to the 

3 records required under this section; 

4 and 

5 ‘‘(ii) the term ‘responsible party’ 

6 means, with respect to an article of food, 

7 any person responsible for the manufac8 turing, processing, packaging, or holding 

9 for such food for consumption in the 

10 United States. 

11 ‘‘(9) ENFORCEMENT.—The Secretary is author12 ized to— 

13 ‘‘(A) deny importation of food from any 

14 foreign government that does not permit United 

15 States officials to enter the foreign country to 

16 conduct such audits and inspections as may be 

17 necessary to fulfill the requirements under this 

18 section; 

19 ‘‘(B) deny importation of food from any 

20 foreign government or foreign manufacturer, 

21 importer, distributor, or retailer that does not 

22 consent to an investigation by the Administra23 tion when food from that foreign country or 

24 foreign firm is linked to a food-borne illness 

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1 outbreak or is otherwise found to be adulterated 

2 or mislabeled; and 

3 ‘‘(C) promulgate rules and regulations to 

4 carry out the purposes of this section, including 

5 setting terms and conditions for the destruction 

6 of products that fail to meet the standards of 

7 this Act. 

8 ‘‘(10) DETENTION AND SEIZURE.—Any food 

9 imported for consumption in the United States may 

10 be detained, seized, or condemned pursuant to sec11 tion 418.’’. 

12 SEC. 3. ENSURING EFFICIENT AND EFFECTIVE COMMU13 NICATIONS DURING A RECALL. 

14 The Secretary shall, during an ongoing recall of 

15 human or pet food shall— 

16 (1) work with companies, relevant professional 

17 associations, and other organizations to collect and 

18 aggregate information pertaining to the recall; 

19 (2) use existing networks of communication in20 cluding electronic forms of information dissemina21 tion to enhance the quality and speed of communica22 tion with the public; and 

23 (3) post information regarding recalled prod24 ucts on the Internet website of the Food and Drug 

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1 Administration in a consolidated, searchable form 

2 that is easily accessed and understood by the public. 

3 SEC. 4. ENSURING THE SAFETY OF PET FOOD. 

4 (a) PROCESSING AND INGREDIENT STANDARDS.— 

5 Not later than 18 months after the date of enactment of 

6 this Act, the Secretary of Health and Human Services (re7 ferred to in this section as the ‘‘Secretary’’), in consulta8 tion with the Association of American Feed Control Offi9 cials, and other relevant stakeholder groups, including vet10 erinary medical associations, animal health organizations, 

11 and pet food manufacturers, shall by regulation estab12 lish— 

13 (1) processing and ingredient standards with 

14 respect to feed, pet food, animal waste, and ingre15 dient definitions; and 

16 (2) updated standards for the labeling of pet 

17 food that includes nutritional information and ingre18 dient information. 

19 (b) EARLY WARNING SURVEILLANCE SYSTEMS AND

20 NOTIFICATION DURING PET FOOD RECALLS.— 

21 (1) IN GENERAL.—Not later than 180 days 

22 after the date of enactment of this Act, the Sec23 retary shall by regulation establish an early warning 

24 and surveillance system to identify contaminations of 

25 the pet food supply and outbreaks of illness from pet 

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1 food. In establishing such system, the Secretary 

2 shall— 

3 (A) use surveillance and monitoring mech4 anisms similar to, or in coordination with, those 

5 mechanisms used by the Centers for Disease 

6 Control and Prevention to monitor human 

7 health, such as the Foodborne Diseases Active 

8 Surveillance Network (FoodNet) and PulseNet; 

9 (B) consult with relevant professional asso10 ciations and private sector veterinary hospitals; 

11 and 

12 (C) work with Health Alert Networks and 

13 other notification networks to inform veterinar14 ians and relevant stakeholders during any recall 

15 of pet food. 

16 (2) AUTHORIZATION OF APPROPRIATIONS.— 

17 There are authorized to be appropriated to carry out 

18 paragraph (1) such sums as may be necessary. 

19 SEC. 5. SENSE OF THE SENATE. 

20 (a) FINDINGS.—Congress finds that— 

21 (1) the safety and integrity of the United 

22 States food supply is vital to the public health, to 

23 public confidence in the food supply, and to the suc24 cess of the food sector of the Nation’s economy; 

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1 (2) illnesses and deaths of individuals and com2 panion pets caused by contaminated food— 

3 (A) have contributed to a loss of public 

4 confidence in food safety; and 

5 (B) have caused significant economic loses 

6 to manufactures and producers not responsible 

7 for contaminated food items; 

8 (3) the task of preserving the safety of the food 

9 supply of the United States faces tremendous pres10 sures with regard to— 

11 (A) emerging pathogens and other con12 taminants and the ability to detect all forms of 

13 contamination; and 

14 (B) an increasing volume of imported food, 

15 without adequate monitoring and inspection; 

16 (4) the United States is increasing the amount 

17 of food that it imports such that — 

18 (A) from 2003 to the present, the value of 

19 food imports has increased from 

20 $45,600,000,000 to $64,000,000,000; and 

21 (B) imported food accounts for 13 percent 

22 of the average Americans diet including 31 per23 cent of fruits, juices, and nuts, 9.5 percent of 

24 red meat and 78.6 percent of fish and shellfish; 

25 and 

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1 (5) the number of full time equivalent Food and 

2 Drug Administration employees conducting inspec3 tions has decreased from 2003 to 2007. 

4 (b) SENSE OF THE SENATE.—It is the sense of the 

5 Senate that— 

6 (1) it is vital for Congress to provide the Food 

7 and Drug Administration with additional resources, 

8 authorities, and direction with respect to ensuring 

9 the safety of the food supply of the United States; 

10 (2) additional Food and Drug Administration 

11 inspectors are required if we are to improve Food 

12 and Drug Administration’s ability to safeguard the 

13 food supply of the United States; and 

14 (3) because of the increasing volume of inter15 national trade in food products the Secretary of 

16 Health and Human Services should make it a pri17 ority to enter into agreements, including memoranda 

18 of understanding, with the trading partners of the 

19 United States with respect to food safety. 

20 SEC. 6. ANNUAL REPORT TO CONGRESS. 

21 The Secretary of Health and Human Service shall, 

22 on an annual basis, submit to the Committee on Health, 

23 Education, Labor, and Pensions and the Committee on 

24 Appropriations of the Senate and the Committee on En25 ergy and Commerce and the Committee on Appropriations 

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1 of the House of Representatives a report that includes, 

2 with respect to the preceding 1-year period— 

3 (1) the number and amount of food products 

4 imported into the United States, aggregated by 

5 country, and type of food, if any; 

6 (2) a listing of the number of inspectors of im7 ported food products and the number of inspections 

8 performed on such products; and 

9 (3) aggregated data on the findings of such in10 spections, including data related to violations of the 

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

12 201 et seq.), and enforcement mechanisms used to 

13 follow-up on such findings and violations. 

Æ 

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