II

104TH CONGRESS

1ST SESSION S. 515

To amend the Federal Meat Inspection Act and the Poultry Products Inspection Act to provide for improved public health and food safety through

the reduction of harmful substances in meat and poultry that present

a threat to public health, and for other purposes.

IN THE SENATE OF THE UNITED STATES

MARCH 7 (legislative day, MARCH 6), 1995

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

to the Committee on Agriculture, Nutrition, and Forestry

A BILL

To amend the Federal Meat Inspection Act and the Poultry

Products Inspection Act to provide for improved public

health and food safety through the reduction of harmful

substances in meat and poultry that present a threat

to public health, 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 ‘‘Family Food Protection Act of 1995’’.

6 (b) TABLE OF CONTENTS.—The table of contents of

7 this Act is as follows:
2

•S 515 IS

Sec. 1. Short title; table of contents.

Sec. 2. Findings.

TITLE I—MEAT INSPECTION

Sec. 101. References to the Federal Meat Inspection Act.

Sec. 102. Definitions.

Sec. 103. Inspection of meat and meat food products.

Sec. 104. Post mortem examination of carcasses and marking or labeling.

Sec. 105. Storage and handling regulations.

Sec. 106. Federal and State cooperation.

Sec. 107. Auxiliary provisions.

Sec. 108. Reducing adulteration of meat and meat food products.

TITLE II—POULTRY INSPECTION

Sec. 201. References to the Poultry Products Inspection Act.

Sec. 202. Definitions.

Sec. 203. Federal and State cooperation.

Sec. 204. Ante mortem and post mortem inspection, reinspection, and quarantine.

Sec. 205. Exemptions.

Sec. 206. Reducing adulteration of poultry and poultry products.

1 SEC. 2. FINDINGS.

2 Congress finds that—

3 (1) bacterial foodborne illness exacts a terrible

4 toll on United States citizens, taking approximately

5 9,000 lives each year and causing between 6,500,000

6 and 80,000,000 illnesses;

7 (2) meat and meat food products, and poultry

8 and poultry products, contaminated with pathogenic

9 bacteria are a leading cause of foodborne illness;

10 (3) foodborne illness related to meat and poul11 try cost Americans between $2,000,000,000 and

12 $4,000,000,000 each year in medical expenses and

13 lost wages;

14 (4) the number of illnesses and deaths associ15 ated with adulterated meat and poultry undermines
3

•S 515 IS

1 public confidence in the food supply of the United

2 States and tends to destroy both domestic and for3 eign markets for wholesome meat and poultry;

4 (5) the meat and poultry inspection system

5 costs United States taxpayers approximately

6 $600,000,000 per year but does not provide ade7 quate protection against foodborne illness because

8 the system does not test for and limit the presence

9 of disease-causing bacteria;

10 (6) the Federal Government must—

11 (A) set levels of disease-causing bacteria

12 above which meat and meat food products and

13 poultry and poultry products are determined to

14 be unsafe for human consumption and adulter15 ated; and

16 (B) remove the products from commerce

17 unless and until the products are made safe;

18 (7) beginning with the National Academy of

19 Sciences report entitled ‘‘Meat and Poultry: The Sci20 entific Basis for the Nation’s Program’’, the United

21 States Department of Agriculture has been urged to

22 shift from organoleptic inspection to inspection

23 based on the detection and limitation of disease24 causing bacteria;
4

•S 515 IS

1 (8) to sustain the confidence of the people of

2 the United States and justify the expenditure of tax

3 dollars, the inspection system must—

4 (A) be based on sound application of mod5 ern science;

6 (B) effectively protect human health;

7 (C) be open to public scrutiny;

8 (D) create incentives for high standards;

9 (E) provide for fines for failure to meet

10 standards; and

11 (F) assess severe penalties for intentional

12 violation of the law;

13 (9) a modern system of meat and poultry in14 spection should extend from farm to table and re15 quire livestock and poultry producers, handlers,

16 processors, distributors, transporters, and retailers

17 to assume responsibility for handling livestock, meat,

18 meat food products, poultry, and poultry products in

19 such a way as to limit contamination to a level that

20 will not endanger human health;

21 (10) to effectively protect human health, there

22 must be an orderly transition from the system of in23 spection in effect on the date of enactment of this

24 Act to a new system based on preventive controls

25 that are designed to limit the presence of disease-
5

•S 515 IS

1 causing bacteria on meat, meat food products, poul2 try, and poultry products, and the efficacy of the

3 new system must be demonstrated by pilot projects;

4 (11)(A) consumer confidence is further under5 mined by the ‘‘USDA Inspected and Passed’’ seal

6 that appears on every package of meat or a meat

7 food product and the ‘‘USDA Inspected for Whole8 someness’’ seal that appears on every package of

9 poultry and poultry products, a seal that misleads

10 consumers into believing the products are safe when

11 the products often are contaminated with disease12 causing bacteria; and

13 (B) the Federal Government should not affix a

14 seal that misleads consumers and may increase the

15 incidence of foodborne illness and death; and

16 (12)(A) all articles and other animals that are

17 subject to the Federal Meat Inspection Act (21

18 U.S.C. 601 et seq.) and the Poultry Products In19 spection Act (21 U.S.C. 451 et seq.) are in inter20 state or foreign commerce or substantially affect

21 commerce; and

22 (B) regulation by the Secretary of Agriculture

23 and cooperation by the States, consistent with this

24 Act and the amendments made by this Act, are nec25 essary to prevent or eliminate burdens on commerce
6

•S 515 IS

1 and to protect the health and welfare of consumers

2 of the United States.

3 TITLE I—MEAT INSPECTION

4 SEC. 101. REFERENCES TO THE FEDERAL MEAT INSPEC5 TION ACT.

6 Whenever in this title an amendment or repeal is ex7 pressed in terms of an amendment to, or repeal of, a sec8 tion or other provision, the reference shall be considered

9 to be made to a section or other provision of the Federal

10 Meat Inspection Act (21 U.S.C. 601 et seq.), except to

11 the extent otherwise specifically provided.

12 SEC. 102. DEFINITIONS.

13 (a) ADULTERATED.—Section 1(m)(1) (21 U.S.C.

14 601(m)(1)) is amended to read as follows:

15 ‘‘(1) if it bears or contains a poisonous or dele16 terious substance that may render it injurious to

17 health, except that, in the case of a substance that

18 is not an added substance, the article shall be con19 sidered adulterated under this subsection if there is

20 a reasonable probability that the quantity of the sub21 stance in the article will cause adverse health con22 sequences;’’.

23 (b) ADDED SUBSTANCE; OFFICIAL ESTABLISH24 MENT.—Section 1 is amended by adding at the end the

25 following:
7

•S 515 IS

1 ‘‘(w) The term ‘added substance’—

2 ‘‘(1) means a substance that is not an inherent

3 constituent of a food and whose intended use results,

4 or may reasonably be expected to result, directly or

5 indirectly, in the substance becoming a component

6 of, or otherwise affecting the characteristics of, the

7 food; and

8 ‘‘(2) includes—

9 ‘‘(A) a substance that is intentionally

10 added to any food; or

11 ‘‘(B) a substance that is the result of mi12 crobial, viral, environmental, agricultural, in13 dustrial, or other contamination.

14 ‘‘(x) The term ‘official establishment’ means an es15 tablishment at which inspection of the slaughter of cattle,

16 sheep, swine, goats, mules, and other equines, or the proc17 essing of meat and meat food products of the animals,

18 is maintained in accordance with this Act.’’.

19 SEC. 103. STORAGE AND HANDLING REGULATIONS.

20 The last sentence of section 24 (21 U.S.C. 624) is

21 amended by inserting before the period at the end the fol22 lowing: ‘‘, except that regulations issued under section 503

23 shall apply to a retail store or other type of retail estab24 lishment’’.
8

•S 515 IS

1 SEC. 104. FEDERAL AND STATE COOPERATION.

2 Section 301(c) (21 U.S.C. 661(c)) is amended—

3 (1) in paragraph (1)—

4 (A) in the first sentence—

5 (i) by inserting after ‘‘the Wholesome

6 Meat Act,’’ the following: ‘‘or by 30 days

7 prior to the expiration of the 2-year period

8 beginning on the date of enactment of the

9 Family Food Protection Act of 1995,’’;

10 and

11 (ii) by striking ‘‘title I and IV’’ and

12 inserting ‘‘titles I, IV, and V’’;

13 (B) by striking ‘‘titles I and IV’’ each

14 place it appears and inserting ‘‘titles I, IV, and

15 V’’; and

16 (C) by striking ‘‘title I and title IV’’ each

17 place it appears and inserting ‘‘titles I, IV, and

18 V’’; and

19 (2) in paragraph (3), by striking ‘‘titles I and

20 IV’’ each place it appears and inserting ‘‘titles I, IV,

21 and V’’.

22 SEC. 105. AUXILIARY PROVISIONS.

23 Sections 402 and 403 (21 U.S.C. 672 and 673) are

24 amended by striking ‘‘title I or II’’ each place it appears

25 and inserting ‘‘title I, II, or V’’.
9

•S 515 IS

1 SEC. 106. REDUCING ADULTERATION OF MEAT AND MEAT

2 FOOD PRODUCTS.

3 The Act (21 U.S.C. 601 et seq.) is amended by add4 ing at the end the following:

5 ‘‘TITLE V—REDUCING ADULTER6 ATION OF MEAT AND MEAT

7 FOOD PRODUCTS

8 ‘‘SEC. 501. REDUCING ADULTERATION OF MEAT AND MEAT

9 FOOD PRODUCTS.

10 ‘‘(a) IN GENERAL.—On the basis of the best available

11 scientific and technological data, the Secretary shall issue

12 regulations to—

13 ‘‘(1) limit the presence of human pathogens and

14 other potentially harmful substances in cattle, sheep,

15 swine, or goats, or horses, mules, or other equines

16 at the time the animals are presented for slaughter;

17 ‘‘(2) ensure that appropriate measures are

18 taken to control and reduce the presence and growth

19 of human pathogens and other potentially harmful

20 substances on carcasses and parts of carcasses and

21 on meat or meat food products derived from the ani22 mals prepared in any official establishment;

23 ‘‘(3) ensure that all ready-to-eat meat or meat

24 food products prepared in any official establishment

25 preparing the meat or food product for distribution

26 in commerce are processed in such a manner as to
10

•S 515 IS

1 destroy any human pathogens and other potentially

2 harmful substances that are likely to cause

3 foodborne illness; and

4 ‘‘(4) ensure that meat and meat food products,

5 other than meat and meat food products referred to

6 in paragraph (3), prepared at any official establish7 ment preparing meat or a meat food product for dis8 tribution in commerce are labeled with instructions

9 for handling and preparation for consumption that,

10 when adhered to, will destroy any human pathogens

11 or other potentially harmful substances that are like12 ly to cause foodborne illness.

13 ‘‘(b) NONCOMPLIANCE.—

14 ‘‘(1) IN GENERAL.—Except as provided in para15 graph (2), a carcass or part of a carcass, or meat

16 or a meat food product, prepared at any official es17 tablishment preparing the article for distribution in

18 commerce, that is found not to be in compliance

19 with the regulations issued under paragraph (2), (3),

20 or (4) of subsection (a) shall be—

21 ‘‘(A) considered adulterated and deter22 mined to be condemned; and

23 ‘‘(B) if no appeal is made to the deter24 mination of condemnation, destroyed for human
11

•S 515 IS

1 food purposes under the supervision of a duly

2 authorized representative of the Secretary.

3 ‘‘(2) REPROCESSING OR LABELING.—A carcass

4 or part of a carcass, or meat or a meat food product

5 that is not in compliance with paragraph (2), (3), or

6 (4) of subsection (a), but that may by reprocessing

7 or labeling, or both, be made not adulterated, need

8 not be condemned and destroyed if after reprocess9 ing or labeling, or both, as applicable and as deter10 mined by the Secretary, under the supervision of a

11 duly authorized representative of the Secretary, the

12 carcass, part of a carcass, meat, or meat food prod13 uct is subsequently inspected and found to be not

14 adulterated.

15 ‘‘(3) APPEALS.—

16 ‘‘(A) ACTION PENDING APPEAL.—If an ap17 peal is made to a determination of condemna18 tion, the carcass, part of a carcass, meat, or

19 meat food product shall be appropriately

20 marked, segregated, and held by the official es21 tablishment pending completion of an appeal in22 spection.

23 ‘‘(B) CONDEMNATION SUSTAINED.—If the

24 determination of condemnation is sustained, the

25 carcass, part of a carcass, meat, or meat food
12

•S 515 IS

1 product if not so reprocessed or labeled, or

2 both, under paragraph (2) so as to be made not

3 adulterated, shall be destroyed for human food

4 purposes under the supervision of a duly au5 thorized representative of the Secretary.

6 ‘‘(c) HUMAN PATHOGENS AND OTHER HARMFUL

7 SUBSTANCES.—Not later than 1 year after the date of en8 actment of this title, the Secretary shall issue regulations

9 that—

10 ‘‘(1) require meat and meat food products in an

11 official establishment to be tested, in such manner

12 and with such frequency as the Secretary considers

13 necessary, to identify human pathogens, or markers

14 for the pathogens, and other potentially harmful

15 substances in the meat and meat food products;

16 ‘‘(2) require that the results of any test con17 ducted in accordance with paragraph (1) be reported

18 to the Secretary, in such manner and with such fre19 quency as the Secretary considers necessary;

20 ‘‘(3)(A) establish interim limits for human

21 pathogens and other potentially harmful substances

22 that, when found on meat or meat food products,

23 may present a threat to public health; and

24 ‘‘(B) in carrying out subparagraph (A)—
13

•S 515 IS

1 ‘‘(i) establish interim limits that are below

2 the industry mean as determined by the Sec3 retary for the pathogen or other potentially

4 harmful substance established through national

5 baseline studies; and

6 ‘‘(ii) reestablish the interim limits every

7 after the initial interim limits until the regu8 latory limits referred to in subsection (d)(2),

9 tolerances, or other standards are established

10 under this Act or other applicable law; and

11 ‘‘(4) prohibit or restrict the sale, transpor12 tation, offer for sale or transportation, or receipt for

13 transportation of any meat or meat food products

14 that—

15 ‘‘(A) are capable of use as human food;

16 and

17 ‘‘(B) exceed the regulatory limits, interim

18 limits, tolerances, or other standards estab19 lished under this Act or other applicable law for

20 human pathogens or other potentially harmful

21 substances.

22 ‘‘(d) RESEARCH AND REGULATORY LIMITS.—

23 ‘‘(1) RESEARCH ON FOOD SAFETY.—The Sec24 retary, acting through the Under Secretary of Agri-
14

•S 515 IS

1 culture for Food Safety, shall conduct or support ap2 propriate research on food safety, including—

3 ‘‘(A) developing and reevaluating appro4 priate limits for human pathogens or other po5 tentially harmful substances that when found

6 on meat and meat food products prepared in of7 ficial establishments may present a threat to

8 public health;

9 ‘‘(B) developing efficient, rapid, and sen10 sitive methods for determining and detecting

11 the presence of microbial contamination, chemi12 cal residues, and animal diseases that have an

13 adverse impact on human health;

14 ‘‘(C) conducting baseline studies on the

15 prevalence of human pathogens or other poten16 tially harmful substances in processing facili17 ties; and

18 ‘‘(D) conducting risk assessments to deter19 mine the human pathogens and other poten20 tially harmful substances that pose the greatest

21 risk to human health.

22 ‘‘(2) REGULATORY LIMITS FOR HUMAN PATHO23 GENS AND OTHER HARMFUL SUBSTANCES.—

24 ‘‘(A) IN GENERAL.—Not later than 1 year

25 after the date of enactment of this title, the
15

•S 515 IS

1 Secretary of Health and Human Services shall

2 establish regulatory limits, to the maximum ex3 tent scientifically supportable, for human patho4 gens and other potentially harmful substances,

5 including heavy metals, that, when found as a

6 component of meat or meat food products pre7 pared in official establishments, may present a

8 threat to public health.

9 ‘‘(B) RISK TO HUMAN HEALTH.—In estab10 lishing the regulatory limits, the Secretary of

11 Health and Human Services shall consider the

12 risk to human health, including the risk to chil13 dren, the elderly, individuals whose immune

14 systems are compromised, and other population

15 subgroups, posed by consumption of the meat

16 or meat food products containing the human

17 pathogen or other potentially harmful sub18 stance.

19 ‘‘(C) FUNDING.—The Secretary of Agri20 culture shall annually transfer to the Secretary

21 of Health and Human Services an amount, to

22 be determined by the Secretaries, to defray the

23 cost of establishing the regulatory limits.

24 ‘‘(e) SURVEILLANCE AND SAMPLING SYSTEMS.—
16

•S 515 IS

1 ‘‘(1) SURVEILLANCE SYSTEM.—In conjunction

2 with the Director of the Centers for Disease Control

3 and Prevention and the Commissioner of Food and

4 Drugs, the Secretary shall develop and administer

5 an active surveillance system for foodborne illness,

6 that is based on a representative sample of the pop7 ulation of the United States, to assess more accu8 rately the frequency and sources of human disease

9 in the United States associated with the consump10 tion of food products.

11 ‘‘(2) SAMPLING SYSTEM.—

12 ‘‘(A) IN GENERAL.—Not later than 2 years

13 after the date of enactment of this title, the

14 Secretary shall establish a sampling system,

15 using data collected under subsection (c)(2) and

16 other sources, to analyze the nature, frequency

17 of occurrence, and quantities of human patho18 gens and other potentially harmful substances

19 in meat and meat food products.

20 ‘‘(B) INFORMATION.—The sampling sys21 tem shall provide—

22 ‘‘(i) statistically valid monitoring, in23 cluding market basket studies, on the na24 ture, frequency of occurrence, and quantity

25 of human pathogens and other potentially
17

•S 515 IS

1 harmful substances in meat and meat food

2 products available to consumers; and

3 ‘‘(ii) such other information as the

4 Secretary determines may be useful in as5 sessing the occurrence of human pathogens

6 and other potentially harmful substances

7 in meat and meat food products.

8 ‘‘(C) NONCOMPLIANCE.—If a sample is

9 found to exceed regulatory limits, interim lim10 its, tolerances, or standards established under

11 this Act or other applicable law, the Secretary

12 shall take action to prevent violative products

13 from entering commerce or to remove the viola14 tive products from the market.

15 ‘‘(f) REVIEW AND CONSULTATION.—

16 ‘‘(1) REVIEW.—The Secretary shall review, at

17 least 2 years, all regulations, processes, procedures,

18 and methods designed to limit and control human

19 pathogens and other potentially harmful substances

20 present on or in carcasses and parts of carcasses

21 and in meat and meat food products. The ongoing

22 review shall include, as necessary, epidemiologic and

23 other scientific studies to ascertain the efficiency

24 and efficacy of the regulations, processes, proce25 dures, and methods.
18

•S 515 IS

1 ‘‘(2) CONSULTATION.—In carrying out para2 graphs (1) and (3) of subsection (c), subsection (d),

3 subsection (e)(1), and paragraph (1), the Secretary

4 shall consult with the Assistant Secretary for

5 Health, the Director of the Centers for Disease Con6 trol and Prevention, the Commissioner of Food and

7 Drugs, and the heads of such other Federal and

8 State public health agencies as the Secretary consid9 ers appropriate.

10 ‘‘SEC. 502. HAZARD CONTROLS.

11 ‘‘(a) REGULATIONS.—

12 ‘‘(1) ISSUANCE.—Not later than 1 year after

13 the date of enactment of this title, the Secretary

14 shall issue regulations that require an official estab15 lishment to—

16 ‘‘(A) adopt processing controls that are

17 adequate to protect public health; and

18 ‘‘(B) limit the presence and growth of

19 human pathogens and other potentially harmful

20 substances in carcasses and parts of carcasses

21 and on meat and meat food products derived

22 from animals prepared in the establishment.

23 ‘‘(2) CONTENT.—The regulations shall—

24 ‘‘(A) set standards for sanitation;
19

•S 515 IS

1 ‘‘(B) set interim limits for biological,

2 chemical, and physical hazards, as appropriate;

3 ‘‘(C) require processing controls to ensure

4 that relevant regulatory standards are met;

5 ‘‘(D) require recordkeeping to monitor

6 compliance;

7 ‘‘(E) require sampling to ensure that proc8 essing controls are effective and that regulatory

9 standards are being met; and

10 ‘‘(F) provide for agency access to records

11 kept by official establishments and submission

12 of copies of the records to the Secretary as the

13 Secretary considers appropriate.

14 ‘‘(3) PUBLIC ACCESS.—Public access to records

15 that relate to the adequacy of measures taken by an

16 official establishment to protect the public health,

17 and to limit the presence and growth of human

18 pathogens and other potentially harmful substances,

19 shall be subject to section 552 of title 5, United

20 States Code.

21 ‘‘(4) PROCESSING CONTROLS.—The Secretary

22 may, as the Secretary considers necessary, require

23 any person with responsibility for, or control over,

24 any animals or meat or meat food products intended

25 for human consumption to adopt processing controls,
20

•S 515 IS

1 if the processing controls are needed to ensure the

2 protection of public health.

3 ‘‘(b) ADVISORY BOARD.—

4 ‘‘(1) IN GENERAL.—On the issuance of regula5 tions under subsection (a), the Secretary shall con6 vene an advisory board on meat and poultry safety

7 to—

8 ‘‘(A) recommend improvements to the

9 meat and poultry inspection programs;

10 ‘‘(B) evaluate alternatives to the programs;

11 and

12 ‘‘(C) provide other relevant advice to the

13 Secretary.

14 ‘‘(2) COMPOSITION.—The advisory board shall

15 include representatives of consumers, processors,

16 producers, retail outlets, inspectors, plant workers,

17 public health officials, and victims of foodborne ill18 ness.

19 ‘‘(3) DUTIES.—The advisory board shall—

20 ‘‘(A) evaluate—

21 ‘‘(i) the meat and poultry inspection

22 programs; and

23 ‘‘(ii) the significance of the programs

24 in ensuring the proper operation of manda25 tory processing controls; and
21

•S 515 IS

1 ‘‘(B) make recommendations to the Sec2 retary described in paragraph (4).

3 ‘‘(4) REPORT.—The Secretary shall report to

4 Congress on the recommendations of the advisory

5 board for improving the meat and poultry inspection

6 programs, including—

7 ‘‘(A) the timing and criteria for any

8 changes in the programs;

9 ‘‘(B) alternative approaches for addressing

10 safety and quality issues; and

11 ‘‘(C) the minimum time needed to ensure

12 that processing controls effectively reduce

13 foodborne illness prior to any change in the

14 programs.

15 ‘‘(5) PROCEDURE.—The advisory board shall be

16 subject to the Federal Advisory Committee Act (5

17 U.S.C. App.).

18 ‘‘(c) LABELING.—Notwithstanding any other provi19 sion of this Act, if the Secretary discontinues carcass-by20 carcass inspection of meat, the ‘USDA Inspected and

21 Passed’ seal, or a similar seal, shall not be affixed to any

22 carcasses and parts of carcasses and to meat and meat

23 food products derived from the animals prepared in any

24 official establishment.
22

•S 515 IS

1 ‘‘SEC. 503. VOLUNTARY GUIDELINES FOR RETAIL ESTAB2 LISHMENTS.

3 ‘‘(a) STANDARDS.—

4 ‘‘(1) IN GENERAL.—In consultation with rep5 resentatives of States, the Conference for Food Pro6 tection, the Association of Food and Drug Officials,

7 and Federal agencies, the Secretary shall establish

8 minimum standards for the handling, processing,

9 and storage of meat and meat food products at re10 tail stores, restaurants, and similar types of retail

11 establishments (collectively referred to in this section

12 as ‘retail establishments’).

13 ‘‘(2) CONTENT.—The standards shall—

14 ‘‘(A) be designed to ensure that meat and

15 meat food products sold by retail establish16 ments are safe for human consumption;

17 ‘‘(B) be based on the principles of preven18 tive controls; and

19 ‘‘(C) include—

20 ‘‘(i) safe food product processing and

21 handling practices for retail establish22 ments, including time and temperature

23 controls on meat and meat food products

24 sold by the establishments;

25 ‘‘(ii) equipment handling practices, in26 cluding standards for the cleaning and
23

•S 515 IS

1 sanitization of food equipment and uten2 sils;

3 ‘‘(iii) minimum personnel hygiene re4 quirements; and

5 ‘‘(iv) requirements for the use of tem6 perature warning devices on raw meat and

7 meat food products to alert consumers to

8 inadequate temperature controls.

9 ‘‘(b) GUIDELINES.—

10 ‘‘(1) ISSUANCE.—Not later than 18 months

11 after the date of enactment of this title, the Sec12 retary, after notice and opportunity for comment,

13 shall issue guidelines for retail establishments that

14 offer meat and meat food products that include the

15 standards established under subsection (a).

16 ‘‘(2) COMPLIANCE.—Not later than 18 months

17 after the date of enactment of this title, the Sec18 retary shall issue a final regulation defining the cir19 cumstances that constitute substantial compliance by

20 retail establishments with the guidelines issued

21 under paragraph (1). The regulation shall provide

22 that there is not substantial compliance if a signifi23 cant number of retail establishments have failed to

24 comply with the guidelines.

25 ‘‘(3) REPORT.—
24

•S 515 IS

1 ‘‘(A) IN GENERAL.—Not later than 3 years

2 after the date of enactment of this title, the

3 Secretary shall issue a report to Congress on

4 actions taken by retail establishments to comply

5 with the guidelines. The report shall include a

6 determination of whether there is substantial

7 compliance with the guidelines.

8 ‘‘(B) SUBSTANTIAL COMPLIANCE.—If the

9 Secretary determines that there is substantial

10 compliance with the guidelines, the Secretary

11 shall issue a report and make a determination

12 in accordance with subparagraph (A) not less

13 than every 2 years.

14 ‘‘(C) NO SUBSTANTIAL COMPLIANCE.—If

15 the Secretary determines that there is not sub16 stantial compliance with the guidelines, the Sec17 retary shall (at the time the determination is

18 made) issue proposed regulations requiring that

19 retail establishments comply with the guide20 lines. The Secretary shall issue final regulations

21 imposing the requirement not later than 180

22 days after issuance of any proposed regulations.

23 Any final regulations shall become effective 180

24 days after the date of the issuance of the final

25 regulations.
25

•S 515 IS

1 ‘‘(c) ENFORCEMENT.—A State may bring, in the

2 name of the State and within the jurisdiction of the State,

3 a proceeding for the civil enforcement, or to restrain a vio4 lation, of final regulations issued pursuant to subsection

5 (b)(3)(C) if the food that is the subject of the proceeding

6 is located in the State.

7 ‘‘SEC. 504. LIVESTOCK TRACEBACK.

8 ‘‘(a) IN GENERAL.—

9 ‘‘(1) IDENTIFICATION.—For the purpose of un10 derstanding the nature of foodborne illness and

11 minimizing the risks of foodborne illness from car12 casses and parts of carcasses and meat and meat

13 food products distributed in commerce, the Secretary

14 shall, as the Secretary considers necessary, prescribe

15 by regulation that cattle, sheep, swine, and goats,

16 and horses, mules, and other equines presented for

17 slaughter for human food purposes be identified in

18 a manner prescribed by the Secretary to enable the

19 Secretary to trace each animal to any premises at

20 which the animal has been held for such period prior

21 to slaughter as the Secretary considers necessary to

22 carry out this Act.

23 ‘‘(2) PROHIBITION OR RESTRICTION ON

24 ENTRY.—The Secretary may prohibit or restrict

25 entry into any slaughtering establishment inspected
26

•S 515 IS

1 under this Act of any cattle, sheep, swine, or goats,

2 or horses, mules, or other equines not identified as

3 prescribed by the Secretary.

4 ‘‘(b) RECORDS.—

5 ‘‘(1) IN GENERAL.—The Secretary may require

6 that a person required to identify livestock pursuant

7 to subsection (a) maintain accurate records, as pre8 scribed by the Secretary, regarding the purchase,

9 sale, and identification of the livestock.

10 ‘‘(2) ACCESS.—A person subject to paragraph

11 (1) shall, at all reasonable times, on notice by a duly

12 authorized representative of the Secretary, afford

13 the representative access to the place of business of

14 the person and an opportunity to examine the

15 records of the person and copy the records.

16 ‘‘(3) DURATION.—Any record required to be

17 maintained under this subsection shall be main18 tained for such period of time as the Secretary pre19 scribes.

20 ‘‘(c) FALSE INFORMATION.—No person shall falsify

21 or misrepresent to the Secretary or any other person any

22 information concerning the premises at which any cattle,

23 sheep, swine, or goats, or horses, mules, or other equines,

24 or carcasses thereof, were held.
27

•S 515 IS

1 ‘‘(d) MAINTENANCE OF RECORDS.—No person shall,

2 without authorization from the Secretary, alter, detach, or

3 destroy any records or other means of identification pre4 scribed by the Secretary for use in determining the prem5 ises at which were held any cattle, sheep, swine, or goats,

6 or horses, mules, or other equines, or the carcasses there7 of.

8 ‘‘(e) HUMAN PATHOGENS OR OTHER HARMFUL SUB9 STANCES.—

10 ‘‘(1) IDENTIFICATION OF SOURCE.—If the Sec11 retary finds any human pathogen or any other po12 tentially harmful substance in any cattle, sheep,

13 swine, or goats, or horses, mules, or other equines

14 at the time they are presented for slaughter or in

15 any carcasses, parts of carcasses, meat, or meat food

16 products prepared in an official establishment and

17 the Secretary finds that there is a reasonable prob18 ability that human consumption of any meat or meat

19 food product containing the human pathogen or

20 other potentially harmful substance presents a

21 threat to public health, the Secretary may take such

22 action as the Secretary considers necessary to deter23 mine the source of the human pathogen or other po24 tentially harmful substance.
28

•S 515 IS

1 ‘‘(2) ACTION.—If the Secretary identifies the

2 source of any human pathogen or other potentially

3 harmful substance referred to in paragraph (1), the

4 Secretary may prohibit or restrict the movement of

5 any animals, carcasses, parts of carcasses, meat,

6 meat food products, or any other article from any

7 source of the human pathogen or other potentially

8 harmful substance until the Secretary determines

9 that the human pathogen or other potentially harm10 ful substance at the source no longer presents a

11 threat to public health.

12 ‘‘(f) PRODUCERS AND HANDLERS.—

13 ‘‘(1) USE OF METHODS.—The Secretary shall

14 use any means of identification and recordkeeping

15 methods utilized by producers or handlers of cattle,

16 sheep, swine, or goats, or horses, mules, or other

17 equines whenever the Secretary determines that the

18 means of identification and recordkeeping methods

19 will enable the Secretary to carry out this section.

20 ‘‘(2) COOPERATION.—The Secretary may co21 operate with producers or handlers of cattle, sheep,

22 swine, or goats, or horses, mules, or other equines,

23 in which any human pathogen or other potentially

24 harmful substance described in subsection (e)(1) is

25 found, to develop and carry out methods to limit or
29

•S 515 IS

1 eliminate the human pathogen or other potentially

2 harmful substance at the source.

3 ‘‘SEC. 505. NOTIFICATION AND RECALL OF NONCONFORM4 ING ARTICLES.

5 ‘‘(a) NOTIFICATION.—Any person preparing car6 casses or parts of carcasses, meat, or meat food products

7 for distribution in commerce who obtains knowledge that

8 provides a reasonable basis for believing that any car9 casses or parts of carcasses or any meat or meat food

10 products—

11 ‘‘(1) are unsafe for human consumption, adul12 terated, or not produced in accordance with section

13 501(a); or

14 ‘‘(2) are misbranded;

15 shall immediately notify the Secretary, in such manner

16 and by such means as the Secretary may by regulation

17 prescribe, of the identity and location of the articles.

18 ‘‘(b) RECALL.—

19 ‘‘(1) IN GENERAL.—If the Secretary finds, on

20 notification or otherwise, that any carcasses or parts

21 of carcasses or any meat or meat food products—

22 ‘‘(A) are unsafe for human consumption,

23 adulterated, or not produced in accordance with

24 section 501(a); or

25 ‘‘(B) are misbranded;
30

•S 515 IS

1 the Secretary shall by order require any person en2 gaged in the processing, handling, transportation,

3 storage, importation, distribution, or sale of the arti4 cles to immediately cease any distribution of the ar5 ticles, and to recall the articles from commercial dis6 tribution and use, if the Secretary determines that

7 there is a reasonable probability that the product is

8 unsafe for human consumption, adulterated, or mis9 branded, unless the person is engaged in a voluntary

10 recall of the articles that the Secretary considers

11 adequate.

12 ‘‘(2) ORDER.—The order shall—

13 ‘‘(A) include a timetable during which the

14 recall shall occur;

15 ‘‘(B) require periodic reports by the person

16 to the Secretary describing the progress of the

17 recall; and

18 ‘‘(C) require notice to consumers to whom

19 the articles were, or may have been, distributed

20 as to how the consumers should treat the arti21 cle.

22 ‘‘(c) INFORMAL HEARING.—

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

24 person subject to the order with an opportunity for

25 an informal hearing, to be held not later than 5 days
31

•S 515 IS

1 after the date of issuance of the order, on the ac2 tions required by the order.

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

4 an opportunity for the hearing, the Secretary deter5 mines that inadequate grounds exist to support the

6 actions required by the order, the Secretary shall va7 cate the order.

8 ‘‘(d) JUDICIAL RECALL.—A district court of the

9 United States may order any person engaged in the proc10 essing, handling, transportation, storage, importation, dis11 tribution, or sale of any carcass, part of a carcass, meat,

12 or meat food product to recall the carcass, part of a car13 cass, meat, or meat food product if the court finds that

14 there is a reasonable probability that the carcass, part of

15 a carcass, meat, or meat food product is unsafe for human

16 consumption, adulterated, or misbranded.

17 ‘‘SEC. 506. REFUSAL OR WITHDRAWAL OF INSPECTION.

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

20 to carry out this Act, refuse to provide, or withdraw, in21 spections under title I with respect to any official estab22 lishment if the Secretary determines, after opportunity for

23 a hearing is accorded to the applicant for, or recipient of,

24 the service that the applicant or recipient, or any person
32

•S 515 IS

1 connected with the applicant or recipient, has repeatedly

2 failed to comply with this Act.

3 ‘‘(b) INSPECTIONS PENDING REVIEW.—The Sec4 retary may direct that, pending opportunity for an expe5 dited hearing in the case of any refusal or withdrawal of

6 inspections and the final determination and order under

7 subsection (a) and any judicial review of the determination

8 and order, inspections shall be denied or suspended if the

9 Secretary considers the action necessary in the public in10 terest in order to protect the health or welfare of consum11 ers or to ensure the safe and effective performance of offi12 cial duties under this Act.

13 ‘‘(c) JUDICIAL REVIEW.—

14 ‘‘(1) IN GENERAL.—The determination and

15 order of the Secretary with respect to refusal or

16 withdrawal of inspections under this section shall be

17 final and conclusive unless the applicant for, or re18 cipient of, inspections files an application for judicial

19 review not later than 30 days after the effective date

20 of the order.

21 ‘‘(2) INSPECTIONS PENDING REVIEW.—Inspec22 tions shall be refused or withdrawn as of the effec23 tive date of the order pending any judicial review of

24 the order unless the Secretary or the Court of Ap25 peals directs otherwise.
33

•S 515 IS

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

2 order shall be—

3 ‘‘(A) in the United States Court of Appeals

4 for the circuit in which the applicant for, or the

5 recipient of, inspections has the principal place

6 of business of the applicant or recipient or in

7 the United States Court of Appeals for the Dis8 trict of Columbia Circuit; and

9 ‘‘(B) based on the record on which the de10 termination and order are based.

11 ‘‘(4) PROCESS.—Section 204 of the Packers

12 and Stockyards Act, 1921 (7 U.S.C. 194), shall be

13 applicable to appeals taken under this section.

14 ‘‘(d) ADDITIONAL AUTHORITY.—This section shall be

15 in addition to, and not derogate from, any provision of

16 this Act for refusal, withdrawal, or suspension of inspec17 tions under title I.

18 ‘‘SEC. 507. CIVIL PENALTIES.

19 ‘‘(a) IN GENERAL.—

20 ‘‘(1) ASSESSMENT.—A person who violates this

21 title, a regulation issued under this title, or an order

22 issued under subsection (b) or (d) of section 505

23 may be assessed a civil penalty by the Secretary of

24 not more than $100,000 for each day of violation.
34

•S 515 IS

1 ‘‘(2) SEPARATE VIOLATION.—Each offense de2 scribed in paragraph (1) shall be considered to be a

3 separate violation.

4 ‘‘(3) NOTICE AND OPPORTUNITY FOR HEAR5 ING.—No penalty may be assessed against a person

6 under this section unless the person is given notice

7 and an opportunity for a hearing on the record be8 fore the Secretary in accordance with sections 554

9 and 556 of title 5, United States Code.

10 ‘‘(4) AMOUNT.—The amount of the civil penalty

11 shall be assessed by the Secretary by written order,

12 taking into account the gravity of the violation, the

13 degree of culpability, and any history of prior of14 fenses. The amount may be reviewed only as pro15 vided in subsection (b).

16 ‘‘(b) REVIEW.—

17 ‘‘(1) IN GENERAL.—A person against whom a

18 violation is found and a civil penalty assessed by

19 order of the Secretary under subsection (a) may ob20 tain review of the order in the United States Court

21 of Appeals for the circuit in which the party resides

22 or has a place of business or in the United States

23 Court of Appeals for the District of Columbia Cir24 cuit by filing a notice of appeal in the court not later

25 than 30 days after the date of the order and by si-
35

•S 515 IS

1 multaneously sending a copy of the notice by cer2 tified mail to the Secretary.

3 ‘‘(2) RECORD.—The Secretary shall promptly

4 file in the court a certified copy of the record on

5 which the violation was found and the penalty as6 sessed.

7 ‘‘(3) FINDINGS.—The findings of the Secretary

8 shall be set aside only if found to be unsupported by

9 substantial evidence on the record as a whole.

10 ‘‘(c) CIVIL ACTION TO RECOVER ASSESSMENT.—

11 ‘‘(1) IN GENERAL.—If a person fails to pay an

12 assessment of a civil penalty after the penalty has

13 become a final and unappealable order, or after the

14 appropriate Court of Appeals has entered final judg15 ment in favor of the Secretary, the Secretary shall

16 refer the matter to the Attorney General, who shall

17 institute a civil action to recover the amount as18 sessed in any appropriate district court of the Unit19 ed States.

20 ‘‘(2) SCOPE OF REVIEW.—In a recovery action

21 under paragraph (1), the validity and appropriate22 ness of the order of the Secretary imposing the civil

23 penalty shall not be subject to review.
36

•S 515 IS

1 ‘‘(d) DISPOSITION OF AMOUNTS.—All amounts col2 lected under this section shall be paid into the Treasury

3 of the United States.

4 ‘‘(e) EQUITABLE RELIEF.—

5 ‘‘(1) RELATIONSHIP TO OTHER ACTIONS.—

6 Nothing in this Act requires the Secretary to report

7 for criminal prosecution, or for the institution of an

8 injunction or other proceeding, a violation of this

9 Act, if the Secretary believes that the public interest

10 will be adequately served by assessment of civil pen11 alties.

12 ‘‘(2) MODIFICATION OF PENALTY.—The Sec13 retary may compromise, modify, or remit, with or

14 without conditions, any civil penalty assessed under

15 this section.

16 ‘‘SEC. 508. WHISTLEBLOWER PROTECTION.

17 ‘‘(a) IN GENERAL.—No person subject to this Act

18 may harass, prosecute, hold liable, or discriminate against

19 any employee or other person because the person—

20 ‘‘(1) is assisting or demonstrating an intent to

21 assist in achieving compliance with any Federal or

22 State law (including a rule or regulation);

23 ‘‘(2) is refusing to violate or assist in the viola24 tion of any Federal or State law (including a rule or

25 regulation); or
37

•S 515 IS

1 ‘‘(3) has commenced, caused to be commenced,

2 or is about to commence a proceeding, has testified

3 or is about to testify at a proceeding, or has assisted

4 or participated or is about to assist or participate in

5 any manner in such a proceeding or in any other ac6 tion to carry out the functions or responsibilities of

7 any agency, office, or unit of the Department of Ag8 riculture.

9 ‘‘(b) PROCEDURES AND PENALTIES.—The proce10 dures and penalties applicable to prohibited acts under

11 subsection (a) shall be governed by the applicable provi12 sions of section 31105 of title 49, United States Code.

13 ‘‘(c) BURDENS OF PROOF.—The legal burdens of

14 proof with respect to prohibited acts under subsection (a)

15 shall be governed by the applicable provisions of sections

16 1214 and 1221 of title 5, United States Code.’’.

17 TITLE II—POULTRY INSPECTION

18 SEC. 201. REFERENCES TO THE POULTRY PRODUCTS IN19 SPECTION ACT.

20 Whenever in this title an amendment or repeal is ex21 pressed in terms of an amendment to, or repeal of, a sec22 tion or other provision, the reference shall be considered

23 to be made to a section or other provision of the Poultry

24 Products Inspection Act (21 U.S.C. 451 et seq.), except

25 to the extent otherwise specifically provided.
38

•S 515 IS

1 SEC. 202. DEFINITIONS.

2 (a) ADULTERATED.—Section 4(g)(1) (21 U.S.C.

3 453(g)(1)) is amended to read as follows:

4 ‘‘(1) if it bears or contains a poisonous or dele5 terious substance that may render it injurious to

6 health, except that, in the case of a substance that

7 is not an added substance, the article shall be con8 sidered adulterated under this subsection if there is

9 a reasonable probability that the quantity of the sub10 stance in the article will cause adverse health con11 sequences;’’.

12 (b) ADDED SUBSTANCE.—Section 4 is amended by

13 adding at the end the following:

14 ‘‘(cc) The term ‘added substance’—

15 ‘‘(1) means a substance that is not an inherent

16 constituent of a food and whose intended use results,

17 or may reasonably be expected to result, directly or

18 indirectly, in the substance becoming a component

19 of, or otherwise affecting the characteristics of, the

20 food; and

21 ‘‘(2) includes—

22 ‘‘(A) a substance that is intentionally

23 added to any food; or

24 ‘‘(B) a substance that is the result of mi25 crobial, viral, environmental, agricultural, in26 dustrial, or other contamination.’’.
39

•S 515 IS

1 SEC. 203. FEDERAL AND STATE COOPERATION.

2 The first sentence of section 5(c)(1) (21 U.S.C.

3 454(c)(1)) is amended—

4 (1) by inserting after ‘‘the Wholesome Poultry

5 Products Act,’’ the following: ‘‘or by 30 days prior

6 to the expiration of the 2-year period beginning on

7 the date of enactment of the Family Food Protection

8 Act of 1995,’’; and

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

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

11 through 10, 12 through 22, and 30 through 37’’.

12 SEC. 204. EXEMPTIONS.

13 Section 15(a)(1) (21 U.S.C. 464(a)(1)) is amended

14 by inserting before the semicolon at the end the following:

15 ‘‘, except that regulations issued under section 32 shall

16 apply to a retail store or other type of retail establish17 ment’’.

18 SEC. 205. REDUCING ADULTERATION OF POULTRY AND

19 POULTRY PRODUCTS.

20 The Act (21 U.S.C. 451 et seq.) is amended by add21 ing at the end the following:

22 ‘‘SEC. 30. REDUCING ADULTERATION OF POULTRY AND

23 POULTRY PRODUCTS.

24 ‘‘(a) IN GENERAL.—On the basis of the best available

25 scientific and technological data, the Secretary shall issue

26 regulations to—
40

•S 515 IS

1 ‘‘(1) limit the presence of human pathogens and

2 other potentially harmful substances in poultry at

3 the time the poultry are presented for slaughter;

4 ‘‘(2) ensure that appropriate measures are

5 taken to control and reduce the presence and growth

6 of human pathogens and other potentially harmful

7 substances on poultry or poultry products prepared

8 in any official establishment;

9 ‘‘(3) ensure that all ready-to-eat poultry or

10 poultry products prepared in any official establish11 ment preparing the poultry or poultry products for

12 distribution in commerce are processed in such a

13 manner as to destroy any human pathogens and

14 other potentially harmful substances that are likely

15 to cause foodborne illness; and

16 ‘‘(4) ensure that poultry and poultry products,

17 other than the poultry and products referred to in

18 paragraph (3), prepared at any official establish19 ment preparing the poultry or poultry products for

20 distribution in commerce are labeled with instruc21 tions for handling and preparation for consumption

22 that, when adhered to, will destroy any human

23 pathogens or other potentially harmful substances

24 that are likely to cause foodborne illness.

25 ‘‘(b) NONCOMPLIANCE.—
41

•S 515 IS

1 ‘‘(1) IN GENERAL.—Except as provided in para2 graph (2), poultry or a poultry product prepared at

3 any official establishment preparing the poultry or

4 poultry product for distribution in commerce, that is

5 found not to be in compliance with the regulations

6 issued under paragraph (2), (3), or (4) of subsection

7 (a) shall be—

8 ‘‘(A) considered adulterated and deter9 mined to be condemned; and

10 ‘‘(B) if no appeal is made to the deter11 mination of condemnation, destroyed for human

12 food purposes under the supervision of an in13 spector.

14 ‘‘(2) REPROCESSING OR LABELING.—Poultry or

15 a poultry product that is not in compliance with

16 paragraph (2), (3), or (4) of subsection (a), but that

17 may by reprocessing or labeling, or both, be made

18 not adulterated, need not be condemned and de19 stroyed if after reprocessing or labeling, or both, as

20 applicable and as determined by the Secretary,

21 under the supervision of an inspector, the poultry or

22 poultry product is subsequently inspected and found

23 to be not adulterated.

24 ‘‘(3) APPEALS.—
42

•S 515 IS

1 ‘‘(A) ACTION PENDING APPEAL.—If an ap2 peal is made to a determination of condemna3 tion, the poultry or poultry product shall be ap4 propriately marked, segregated, and held by the

5 official establishment pending completion of an

6 appeal inspection.

7 ‘‘(B) CONDEMNATION SUSTAINED.—If the

8 determination of condemnation is sustained, the

9 poultry or poultry product if not reprocessed or

10 labeled, or both, under paragraph (2) so as to

11 be made not adulterated, shall be destroyed for

12 human food purposes under the supervision of

13 a duly authorized representative of the Sec14 retary.

15 ‘‘(c) HUMAN PATHOGENS AND OTHER HARMFUL

16 SUBSTANCES.—Not later than 1 year after the date of en17 actment of this section, the Secretary shall issue regula18 tions that—

19 ‘‘(1) require poultry and poultry products in an

20 official establishment to be tested, in such manner

21 and with such frequency as the Secretary considers

22 necessary, to identify human pathogens, or markers

23 for the pathogens, and other potentially harmful

24 substances in the poultry and poultry products;
43

•S 515 IS

1 ‘‘(2) require that the results of any test con2 ducted in accordance with paragraph (1) be reported

3 to the Secretary, in such manner and with such fre4 quency as the Secretary considers necessary;

5 ‘‘(3)(A) establish interim limits for human

6 pathogens and other potentially harmful substances

7 that, when found on poultry or poultry products,

8 may present a threat to public health; and

9 ‘‘(B) in carrying out subparagraph (A)—

10 ‘‘(i) establish interim limits that are below

11 the industry mean as determined by the Sec12 retary for the pathogen or other potentially

13 harmful substance established through national

14 baseline studies; and

15 ‘‘(ii) reestablish the interim limits every

16 two years after the initial interim limits until

17 the regulatory limits referred to in subsection

18 (d)(2), tolerances, or other standards are estab19 lished under this Act or other applicable law;

20 and

21 ‘‘(4) prohibit or restrict the sale, transpor22 tation, offer for sale or transportation, or receipt for

23 transportation of any poultry or poultry products

24 that—
44

•S 515 IS

1 ‘‘(A) are capable of use as human food;

2 and

3 ‘‘(B) exceed the regulatory limits, interim

4 limits, tolerances, or other standards estab5 lished under this Act or other applicable law for

6 human pathogens or other potentially harmful

7 substances.

8 ‘‘(d) RESEARCH AND REGULATORY LIMITS.—

9 ‘‘(1) RESEARCH ON FOOD SAFETY.—The Sec10 retary, acting through the Under Secretary of Agri11 culture for Food Safety, shall conduct or support ap12 propriate research on food safety, including—

13 ‘‘(A) developing and reevaluating appro14 priate limits for human pathogens or other po15 tentially harmful substances that when found

16 on poultry and poultry products prepared in of17 ficial establishments may present a threat to

18 public health;

19 ‘‘(B) developing efficient, rapid, and sen20 sitive methods for determining and detecting

21 the presence of microbial contamination, chemi22 cal residues, and animal diseases that have an

23 adverse impact on human health;

24 ‘‘(C) conducting baseline studies on the

25 prevalence of human pathogens or other poten-
45

•S 515 IS

1 tially harmful substances in processing facili2 ties; and

3 ‘‘(D) conducting risk assessments to deter4 mine the human pathogens and other poten5 tially harmful substances that pose the greatest

6 risk to human health.

7 ‘‘(2) REGULATORY LIMITS FOR HUMAN PATHO8 GENS AND OTHER HARMFUL SUBSTANCES.—

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

10 after the date of enactment of this section, the

11 Secretary of Health and Human Services shall

12 establish regulatory limits, to the maximum ex13 tent scientifically supportable, for human patho14 gens and other potentially harmful substances,

15 including heavy metals, that, when found as a

16 component of poultry or poultry products pre17 pared in official establishments, may present a

18 threat to public health.

19 ‘‘(B) RISK TO HUMAN HEALTH.—In estab20 lishing the regulatory limits, the Secretary of

21 Health and Human Services shall consider the

22 risk to human health, including the risk to chil23 dren, the elderly, individuals whose immune

24 systems are compromised, and other population

25 subgroups, posed by consumption of the poultry
46

•S 515 IS

1 or poultry products containing the human

2 pathogen or other potentially harmful sub3 stance.

4 ‘‘(C) FUNDING.—The Secretary of Agri5 culture shall annually transfer to the Secretary

6 of Health and Human Services an amount, to

7 be determined by the Secretaries, to defray the

8 cost of establishing the regulatory limits.

9 ‘‘(e) SURVEILLANCE AND SAMPLING SYSTEMS.—

10 ‘‘(1) SURVEILLANCE SYSTEM.—In conjunction

11 with the Director of the Centers for Disease Control

12 and Prevention and the Commissioner of Food and

13 Drugs, the Secretary shall develop and administer

14 an active surveillance system for foodborne illness,

15 that is based on a representative sample of the pop16 ulation of the United States, to assess more accu17 rately the frequency and sources of human disease

18 in the United States associated with the consump19 tion of poultry and poultry products.

20 ‘‘(2) SAMPLING SYSTEM.—

21 ‘‘(A) IN GENERAL.—Not later than 2 years

22 after the date of enactment of this section, the

23 Secretary shall establish a sampling system,

24 using data collected under subsection (c)(2) and

25 other sources, to analyze the nature, frequency
47

•S 515 IS

1 of occurrence, and quantities of human patho2 gens and other potentially harmful substances

3 in poultry and poultry products.

4 ‘‘(B) INFORMATION.—The sampling sys5 tem shall provide—

6 ‘‘(i) statistically valid monitoring, in7 cluding market basket studies, on the na8 ture, frequency of occurrence, and quantity

9 of human pathogens and other potentially

10 harmful substances in poultry and poultry

11 products available to consumers; and

12 ‘‘(ii) such other information as the

13 Secretary determines may be useful in as14 sessing the occurrence of human pathogens

15 and other potentially harmful substances

16 in poultry and poultry products.

17 ‘‘(C) NONCOMPLIANCE.—If a sample is

18 found to exceed regulatory limits, interim lim19 its, tolerances, or standards established under

20 this Act or other applicable law, the Secretary

21 shall take action to prevent violative products

22 from entering commerce or to remove the viola23 tive products from the market.

24 ‘‘(f) REVIEW AND CONSULTATION.—
48

•S 515 IS

1 ‘‘(1) REVIEW.—The Secretary shall review, at

2 least every 2 years, all regulations, processes, proce3 dures, and methods designed to limit and control

4 human pathogens and other potentially harmful sub5 stances present on or in poultry and poultry prod6 ucts. The ongoing review shall include, as necessary,

7 epidemiologic and other scientific studies to ascer8 tain the efficiency and efficacy of the regulations,

9 processes, procedures, and methods.

10 ‘‘(2) CONSULTATION.—In carrying out para11 graphs (1) and (3) of subsection (c), subsection (d),

12 subsection (e)(1), and paragraph (1), the Secretary

13 shall consult with the Assistant Secretary for

14 Health, the Director of the Centers for Disease Con15 trol and Prevention, the Commissioner of Food and

16 Drugs, and the heads of such other Federal and

17 State public health agencies as the Secretary consid18 ers appropriate.

19 ‘‘SEC. 31. HAZARD CONTROLS.

20 ‘‘(a) REGULATIONS.—

21 ‘‘(1) ISSUANCE.—Not later than 1 year after

22 the date of enactment of this section, the Secretary

23 shall issue regulations that require an official estab24 lishment to—
49

•S 515 IS

1 ‘‘(A) adopt processing controls that are

2 adequate to protect public health; and

3 ‘‘(B) limit the presence and growth of

4 human pathogens and other potentially harmful

5 substances in poultry and poultry products pre6 pared in the establishment.

7 ‘‘(2) CONTENT.—The regulations shall—

8 ‘‘(A) set standards for sanitation;

9 ‘‘(B) set interim limits for biological,

10 chemical, and physical hazards, as appropriate;

11 ‘‘(C) require processing controls to ensure

12 that relevant regulatory standards are met;

13 ‘‘(D) require recordkeeping to monitor

14 compliance;

15 ‘‘(E) require sampling to ensure that proc16 essing controls are effective and that regulatory

17 standards are being met; and

18 ‘‘(F) provide for agency access to records

19 kept by official establishments and submission

20 of copies of the records to the Secretary as the

21 Secretary considers appropriate.

22 ‘‘(3) PUBLIC ACCESS.—Public access to records

23 that relate to the adequacy of measures taken by an

24 official establishment to protect the public health,

25 and to limit the presence and growth of human
50

•S 515 IS

1 pathogens and other potentially harmful substances,

2 shall be subject to section 552 of title 5, United

3 States Code.

4 ‘‘(4) PROCESSING CONTROLS.—The Secretary

5 may, as the Secretary considers necessary, require

6 any person with responsibility for, or control over,

7 any poultry or poultry products intended for human

8 consumption to adopt processing controls, if the

9 processing controls are needed to ensure the protec10 tion of public health.

11 ‘‘(b) ADVISORY BOARD.—On the issuance of regula12 tions under subsection (a), the Secretary shall convene an

13 advisory board on meat and poultry safety in accordance

14 with section 502(b) of the Federal Meat Inspection Act.

15 ‘‘(c) LABELING.—Notwithstanding any other provi16 sion of this Act, if the Secretary discontinues carcass-by17 carcass inspection of poultry, the ‘USDA Inspected for

18 Wholesomeness’ seal, or a similar seal, shall not be affixed

19 to any poultry and poultry products derived from the poul20 try prepared in any official establishment.

21 ‘‘SEC. 32. VOLUNTARY GUIDELINES FOR RETAIL ESTAB22 LISHMENTS.

23 ‘‘(a) STANDARDS.—

24 ‘‘(1) IN GENERAL.—In consultation with rep25 resentatives of States, the Conference for Food Pro-
51

•S 515 IS

1 tection, the Association of Food and Drug Officials,

2 and Federal agencies, the Secretary shall establish

3 minimum standards for the handling, processing,

4 and storage of poultry and poultry products at retail

5 stores, restaurants, and similar types of retail estab6 lishments (collectively referred to in this section as

7 ‘retail establishments’).

8 ‘‘(2) CONTENT.—The standards shall—

9 ‘‘(A) be designed to ensure that poultry

10 and poultry products sold by the retail estab11 lishments are safe for human consumption;

12 ‘‘(B) be based on the principles of preven13 tive controls; and

14 ‘‘(C) include—

15 ‘‘(i) safe food product processing and

16 handling practices for retail establish17 ments, including time and temperature

18 controls on poultry and poultry products

19 sold by the establishments;

20 ‘‘(ii) equipment handling practices, in21 cluding standards for the cleaning and

22 sanitization of food equipment and uten23 sils;

24 ‘‘(iii) minimum personnel hygiene re25 quirements; and
52

•S 515 IS

1 ‘‘(iv) requirements for the use of tem2 perature warning devices on raw poultry or

3 poultry products to alert consumers to in4 adequate temperature controls.

5 ‘‘(b) GUIDELINES.—

6 ‘‘(1) ISSUANCE.—Not later than 18 months

7 after the date of enactment of this section, the Sec8 retary, after notice and opportunity for comment,

9 shall issue guidelines for retail establishments that

10 offer poultry and poultry products that include the

11 standards established under subsection (a).

12 ‘‘(2) COMPLIANCE.—Not later than 18 months

13 after the date of enactment of this section, the Sec14 retary shall issue a final regulation defining the cir15 cumstances that constitute substantial compliance by

16 retail establishments with the guidelines issued

17 under paragraph (1). The regulation shall provide

18 that there is not substantial compliance if a signifi19 cant number of retail establishments have failed to

20 comply with the guidelines.

21 ‘‘(3) REPORT.—

22 ‘‘(A) IN GENERAL.—Not later than 3 years

23 after the date of enactment of this section, the

24 Secretary shall issue a report to Congress on

25 actions taken by retail establishments to comply
53

•S 515 IS

1 with the guidelines. The report shall include a

2 determination of whether there is substantial

3 compliance with the guidelines.

4 ‘‘(B) SUBSTANTIAL COMPLIANCE.—If the

5 Secretary determines that there is substantial

6 compliance with the guidelines, the Secretary

7 shall issue a report and make a determination

8 in accordance with subparagraph (A) not less

9 than every 2 years.

10 ‘‘(C) NO SUBSTANTIAL COMPLIANCE.—If

11 the Secretary determines that there is not sub12 stantial compliance with the guidelines, the Sec13 retary shall (at the time the determination is

14 made) issue proposed regulations requiring that

15 retail establishments comply with the guide16 lines. The Secretary shall issue final regulations

17 imposing the requirement not later than 180

18 days after issuance of any proposed regulations.

19 Any final regulations shall become effective 180

20 days after the date of the issuance of the final

21 regulations.

22 ‘‘(c) ENFORCEMENT.—A State may bring, in the

23 name of the State and within the jurisdiction of the State,

24 a proceeding for the civil enforcement, or to restrain a vio25 lation, of final regulations issued pursuant to subsection
54

•S 515 IS

1 (b)(3)(C) if the food that is the subject of the proceeding

2 is located in the State.

3 ‘‘SEC. 33. LIVESTOCK TRACEBACK.

4 ‘‘(a) IN GENERAL.—

5 ‘‘(1) IDENTIFICATION.—For the purpose of un6 derstanding the nature of foodborne illness and

7 minimizing the risks of foodborne illness from poul8 try and poultry products distributed in commerce,

9 the Secretary shall, as the Secretary considers nec10 essary, prescribe by regulation that poultry pre11 sented for slaughter for human food purposes be

12 identified in a manner prescribed by the Secretary to

13 enable the Secretary to trace each poultry to any

14 premises at which the poultry has been held for such

15 period prior to slaughter as the Secretary considers

16 necessary to carry out this Act.

17 ‘‘(2) PROHIBITION OR RESTRICTION ON

18 ENTRY.—The Secretary may prohibit or restrict

19 entry into any slaughtering establishment inspected

20 under this Act of any poultry not identified as pre21 scribed by the Secretary.

22 ‘‘(b) RECORDS.—

23 ‘‘(1) IN GENERAL.—The Secretary may require

24 that a person required to identify poultry pursuant

25 to subsection (a) maintain accurate records, as pre-
55

•S 515 IS

1 scribed by the Secretary, regarding the purchase,

2 sale, and identification of the poultry.

3 ‘‘(2) ACCESS.—A person subject to paragraph

4 (1) shall, at all reasonable times, on notice by a duly

5 authorized representative of the Secretary, afford

6 the representative access to the place of business of

7 the person and an opportunity to examine the

8 records of the person and copy the records.

9 ‘‘(3) DURATION.—Any record required to be

10 maintained under this subsection shall be main11 tained for such period of time as the Secretary pre12 scribes.

13 ‘‘(c) FALSE INFORMATION.—No person shall falsify

14 or misrepresent to the Secretary or any other person any

15 information concerning the premises at which any poultry

16 were held.

17 ‘‘(d) MAINTENANCE OF RECORDS.—No person shall,

18 without authorization from the Secretary, alter, detach, or

19 destroy any records or other means of identification pre20 scribed by the Secretary for use in determining the prem21 ises at which were held any poultry.

22 ‘‘(e) HUMAN PATHOGENS OR OTHER HARMFUL SUB23 STANCES.—

24 ‘‘(1) IDENTIFICATION OF SOURCE.—If the Sec25 retary finds any human pathogen or any other po-
56

•S 515 IS

1 tentially harmful substance in any poultry at the

2 time the poultry is presented for slaughter or in any

3 poultry or poultry products prepared in an official

4 establishment and the Secretary finds that there is

5 a reasonable probability that human consumption of

6 any poultry or poultry product containing the human

7 pathogen or other potentially harmful substance pre8 sents a threat to public health, the Secretary may

9 take such action as the Secretary considers nec10 essary to determine the source of the human patho11 gen or other potentially harmful substance.

12 ‘‘(2) ACTION.—If the Secretary identifies the

13 source of any human pathogen or other potentially

14 harmful substance referred to in paragraph (1), the

15 Secretary may prohibit or restrict the movement of

16 any poultry or poultry products, or any other article

17 from any source of the human pathogen or other po18 tentially harmful substance until the Secretary de19 termines that the human pathogen or other poten20 tially harmful substance at the source no longer pre21 sents a threat to public health.

22 ‘‘(f) PRODUCERS AND HANDLERS.—

23 ‘‘(1) USE OF METHODS.—The Secretary shall

24 use any means of identification and recordkeeping

25 methods utilized by producers or handlers of poultry
57

•S 515 IS

1 whenever the Secretary determines that the means

2 of identification and recordkeeping methods will en3 able the Secretary to carry out this section.

4 ‘‘(2) COOPERATION.—The Secretary may co5 operate with producers or handlers of poultry in

6 which any human pathogen or other potentially

7 harmful substance described in subsection (e)(1) is

8 found, to develop and carry out methods to limit or

9 eliminate the human pathogen or other potentially

10 harmful substance at the source.

11 ‘‘SEC. 34. NOTIFICATION AND RECALL OF NONCONFORM12 ING ARTICLES.

13 ‘‘(a) NOTIFICATION.—Any person preparing poultry

14 or poultry products for distribution in commerce who ob15 tains knowledge that provides a reasonable basis for be16 lieving that any poultry or poultry products—

17 ‘‘(1) are unsafe for human consumption, adul18 terated, or not produced in accordance with section

19 30(a); or

20 ‘‘(2) are misbranded;

21 shall immediately notify the Secretary, in such manner

22 and by such means as the Secretary may by regulation

23 prescribe, of the identity and location of the articles.

24 ‘‘(b) RECALL.—
58

•S 515 IS

1 ‘‘(1) IN GENERAL.—If the Secretary finds, on

2 notification or otherwise, that any poultry or poultry

3 products—

4 ‘‘(A) are unsafe for human consumption,

5 adulterated, or not produced in accordance with

6 section 30(a); or

7 ‘‘(B) are misbranded;

8 the Secretary shall by order require any person en9 gaged in the processing, handling, transportation,

10 storage, importation, distribution, or sale of poultry

11 or poultry products to immediately cease any dis12 tribution of the poultry or poultry products, and to

13 recall the poultry or poultry products from commer14 cial distribution and use, if the Secretary determines

15 that there is a reasonable probability that the prod16 uct is unsafe for human consumption, adulterated,

17 or misbranded, unless the person is engaged in a

18 voluntary recall of the poultry or poultry products

19 that the Secretary considers adequate.

20 ‘‘(2) ORDER.—The order shall—

21 ‘‘(A) include a timetable during which the

22 recall shall occur;

23 ‘‘(B) require periodic reports by the person

24 to the Secretary describing the progress of the

25 recall; and
59

•S 515 IS

1 ‘‘(C) require notice to consumers to whom

2 the articles were, or may have been, distributed

3 as to how the consumers should treat the arti4 cle.

5 ‘‘(c) INFORMAL HEARING.—

6 ‘‘(1) IN GENERAL.—The order shall provide any

7 person subject to the order with an opportunity for

8 an informal hearing, to be held not later than 5 days

9 after the date of issuance of the order, on the ac10 tions required by the order.

11 ‘‘(2) VACATION OF ORDER.—If, after providing

12 an opportunity for the hearing, the Secretary deter13 mines that inadequate grounds exist to support the

14 actions required by the order, the Secretary shall va15 cate the order.

16 ‘‘(d) JUDICIAL RECALL.—A district court of the

17 United States may order any person engaged in the proc18 essing, handling, transportation, storage, importation, dis19 tribution, or sale of poultry or a poultry product to recall

20 the poultry or product if the court finds that there is a

21 reasonable probability that the poultry or poultry product

22 is unsafe for human consumption, adulterated, or mis23 branded.
60

•S 515 IS

1 ‘‘SEC. 35. REFUSAL OR WITHDRAWAL OF INSPECTION.

2 ‘‘(a) IN GENERAL.—The Secretary may, for such pe3 riod or indefinitely as the Secretary considers necessary

4 to carry out this Act, refuse to provide, or withdraw, in5 spections under this Act with respect to any official estab6 lishment if the Secretary determines, after opportunity for

7 a hearing is accorded to the applicant for, or recipient of,

8 the service that the applicant or recipient, or any person

9 connected with the applicant or recipient, has repeatedly

10 failed to comply with this Act.

11 ‘‘(b) INSPECTIONS PENDING REVIEW.—The Sec12 retary may direct that, pending opportunity for an expe13 dited hearing in the case of any refusal or withdrawal of

14 inspections and the final determination and order under

15 subsection (a) and any judicial review of the determination

16 and order, inspections shall be denied or suspended if the

17 Secretary considers the action necessary in the public in18 terest in order to protect the health or welfare of consum19 ers or to ensure the safe and effective performance of offi20 cial duties under this Act.

21 ‘‘(c) JUDICIAL REVIEW.—

22 ‘‘(1) IN GENERAL.—The determination and

23 order of the Secretary with respect to refusal or

24 withdrawal of inspections under this section shall be

25 final and conclusive unless the applicant for, or re26 cipient of, inspections files an application for judicial
61

•S 515 IS

1 review not later than 30 days after the effective date

2 of the order.

3 ‘‘(2) INSPECTIONS PENDING REVIEW.—Inspec4 tions shall be refused or withdrawn as of the effec5 tive date of the order pending any judicial review of

6 the order unless the Secretary or the Court of Ap7 peals directs otherwise.

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

9 order shall be—

10 ‘‘(A) in the United States Court of Appeals

11 for the circuit in which the applicant for, or the

12 recipient of, inspections has the principal place

13 of business of the applicant or recipient or in

14 the United States Court of Appeals for the Dis15 trict of Columbia Circuit; and

16 ‘‘(B) based on the record on which the de17 termination and order are based.

18 ‘‘(4) PROCESS.—Section 204 of the Packers

19 and Stockyards Act, 1921 (7 U.S.C. 194), shall be

20 applicable to appeals taken under this section.

21 ‘‘(d) ADDITIONAL AUTHORITY.—This section shall be

22 in addition to, and not derogate from, any provision of

23 this Act for refusal, withdrawal, or suspension of inspec24 tions under this Act.
62

•S 515 IS

1 ‘‘SEC. 36. CIVIL PENALTIES.

2 ‘‘(a) IN GENERAL.—

3 ‘‘(1) ASSESSMENT.—A person who violates any

4 of sections 30 through 37, a regulation issued under

5 any of the sections, or an order issued under sub6 section (b) or (d) of section 34 may be assessed a

7 civil penalty by the Secretary of not more than

8 $100,000 for each day of violation.

9 ‘‘(2) SEPARATE VIOLATION.—Each offense de10 scribed in paragraph (1) shall be considered to be a

11 separate violation.

12 ‘‘(3) NOTICE AND OPPORTUNITY FOR HEAR13 ING.—No penalty may be assessed against a person

14 under this section unless the person is given notice

15 and an opportunity for a hearing on the record be16 fore the Secretary in accordance with sections 554

17 and 556 of title 5, United States Code.

18 ‘‘(4) AMOUNT.—The amount of the civil penalty

19 shall be assessed by the Secretary by written order,

20 taking into account the gravity of the violation, the

21 degree of culpability, and any history of prior of22 fenses. The amount may be reviewed only as pro23 vided in subsection (b).

24 ‘‘(b) REVIEW.—

25 ‘‘(1) IN GENERAL.—A person against whom a

26 violation is found and a civil penalty assessed by
63

•S 515 IS

1 order of the Secretary under subsection (a) may ob2 tain review of the order in the United States Court

3 of Appeals for the circuit in which the party resides

4 or has a place of business or in the United States

5 Court of Appeals for the District of Columbia Cir6 cuit by filing a notice of appeal in the court not later

7 than 30 days after the date of the order and by si8 multaneously sending a copy of the notice by cer9 tified mail to the Secretary.

10 ‘‘(2) RECORD.—The Secretary shall promptly

11 file in the court a certified copy of the record on

12 which the violation was found and the penalty as13 sessed.

14 ‘‘(3) FINDINGS.—The findings of the Secretary

15 shall be set aside only if found to be unsupported by

16 substantial evidence on the record as a whole.

17 ‘‘(c) CIVIL ACTION TO RECOVER ASSESSMENT.—

18 ‘‘(1) IN GENERAL.—If a person fails to pay an

19 assessment of a civil penalty after the penalty has

20 become a final and unappealable order, or after the

21 appropriate Court of Appeals has entered final judg22 ment in favor of the Secretary, the Secretary shall

23 refer the matter to the Attorney General, who shall

24 institute a civil action to recover the amount as-
64

•S 515 IS

1 sessed in any appropriate district court of the Unit2 ed States.

3 ‘‘(2) SCOPE OF REVIEW.—In a recovery action

4 under paragraph (1), the validity and appropriate5 ness of the order of the Secretary imposing the civil

6 penalty shall not be subject to review.

7 ‘‘(d) DISPOSITION OF AMOUNTS.—All amounts col8 lected under this section shall be paid into the Treasury

9 of the United States.

10 ‘‘(e) EQUITABLE RELIEF.—

11 ‘‘(1) RELATIONSHIP TO OTHER ACTIONS.—

12 Nothing in this Act requires the Secretary to report

13 for criminal prosecution, or for the institution of an

14 injunction or other proceeding, a violation of this

15 Act, if the Secretary believes that the public interest

16 will be adequately served by assessment of civil pen17 alties.

18 ‘‘(2) MODIFICATION OF PENALTY.—The Sec19 retary may compromise, modify, or remit, with or

20 without conditions, any civil penalty assessed under

21 this section.

22 ‘‘SEC. 37. WHISTLEBLOWER PROTECTION.

23 ‘‘(a) IN GENERAL.—No person subject to this Act

24 may harass, prosecute, hold liable, or discriminate against

25 any employee or other person because the person—
65

•S 515 IS

1 ‘‘(1) is assisting or demonstrating an intent to

2 assist in achieving compliance with any Federal or

3 State law (including a rule or regulation);

4 ‘‘(2) is refusing to violate or assist in the viola5 tion of any Federal or State law (including a rule or

6 regulation); or

7 ‘‘(3) has commenced, caused to be commenced,

8 or is about to commence a proceeding, has testified

9 or is about to testify at a proceeding, or has assisted

10 or participated or is about to assist or participate in

11 any manner in such a proceeding or in any other ac12 tion to carry out the functions or responsibilities of

13 any agency, office, or unit of the Department of Ag14 riculture.

15 ‘‘(b) PROCEDURES AND PENALTIES.—The proce16 dures and penalties applicable to prohibited acts under

17 subsection (a) shall be governed by the applicable provi18 sions of section 31105 of title 49, United States Code.

19 ‘‘(c) BURDENS OF PROOF.—The legal burdens of

20 proof with respect to prohibited acts under subsection (a)

21 shall be governed by the applicable provisions of sections

22 1214 and 1221 of title 5, United States Code.’’.

Æ

S 515 IS—2

S 515 IS—3
66

•S 515 IS

S 515 IS—4

S 515 IS—5

S 515 IS—6