I 

108TH CONGRESS 

2D SESSION H. R. 3714

To provide better protection against bovine spongiform encephalopathy and 

other prion diseases. 

IN THE HOUSE OF REPRESENTATIVES 

JANUARY 21, 2004

Ms. DELAURO (for herself and Ms. LEE) introduced the following bill; which 

was referred to the Committee on Agriculture, and in addition to the 

Committees on Energy and Commerce, and Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned 

A BILL

To provide better protection against bovine spongiform 

encephalopathy and other prion diseases.

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 ‘‘BSE and Other Prion 

5 Disease Prevention and Public Health Protection Act’’. 

6 SEC. 2. DEFINITIONS. 

7 In this Act: 
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1 (1) BSE.—The term ‘‘BSE’’ means bovine 

2 spongiform encephalopathy. 

3 (2) COVERED ARTICLE.—

4 (A) IN GENERAL.—The term ‘‘covered ar5 ticle’’ means—

6 (i) food or feed for a plant, animal, or 

7 human; 

8 (ii) a food or nutritional supplement; 

9 (iii) a medicine; 

10 (iv) a pituitary-derived hormone; 

11 (v) transplant material; 

12 (vi) a fertilizer; 

13 (vii) a cosmetic; and 

14 (viii) any other article of a kind that 

15 is ordinarily ingested, implanted, or other16 wise taken into a living organism. 

17 (B) EXCLUSIONS.—The term ‘‘covered ar18 ticle’’ does not include—

19 (i) an unprocessed agricultural com20 modity that is readily identifiable as non21 animal in origin, such as a vegetable, 

22 grain, or nut; 

23 (ii) an article described in subpara24 graph (A) that, based on compelling sci25 entific evidence, the Secretary determines 
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1 does not pose a risk of transmitting prion 

2 disease; or 

3 (iii) an article regulated by the Sec4 retary that, as determined by the Sec5 retary—

6 (I) poses a minimal risk of car7 rying prion disease; and 

8 (II) is necessary to protect indi9 vidual or public health. 

10 (3) CWD.—The term ‘‘CWD’’ means chronic 

11 wasting disease. 

12 (4) PRION DISEASE.—The term ‘‘prion disease’’ 

13 means—

14 (A) a transmissible spongiform 

15 encephalopathy (including prion diseases that 

16 affect humans, cattle, bison, sheep, goats, deer, 

17 elk, and mink); and 

18 (B) any related disease, as determined by 

19 the Secretary. 

20 (5) SPECIFIED RISK MATERIAL.—

21 (A) IN GENERAL.—The term ‘‘specified 

22 risk material’’ means—

23 (i) the skull, brain, trigeminal ganglia, 

24 eyes, tonsils, spinal cord, vertebral column, 

25 or dorsal root ganglia of—
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1 (I) cattle and bison 30 months of 

2 age and older; or 

3 (II) sheep, goats, deer, and elk 

4 12 months of age and older; 

5 (ii) the intestinal tract of a ruminant 

6 of any age; and 

7 (iii) any other material of a ruminant 

8 that may carry a prion disease, as deter9 mined by the Secretary, based on scientif10 ically credible research. 

11 (B) MODIFICATION.—The Secretary may 

12 modify the definition of specified risk material 

13 based on scientifically credible research (includ14 ing the conduct of ante-mortem and post15 mortem tests certified by the Secretary of Agri16 culture). 

17 (6) SECRETARY.—The term ‘‘Secretary’’ means 

18 the Secretary of Health and Human Services. 

19 SEC. 3. PROTECTION OF BORDERS. 

20 (a) PROHIBITIONS.—

21 (1) DISCLOSURE REQUIREMENT.—It shall be 

22 unlawful for any person to import a covered arti23 cle—

24 (A) in the case of a covered article that 

25 contains animal-derived material, if the covered 
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1 article does not exhibit or contain, or is not oth2 erwise accompanied by, a statement in English 

3 that—

4 (i) states that the covered article con5 tains animal-derived material; 

6 (ii) states the common English name 

7 of the animal from which the material in 

8 the article is derived; and 

9 (iii) if the animal from which the ma10 terial in the covered article is derived is a 

11 ruminant—

12 (I) identifies the country of ori13 gin of the ruminant; and 

14 (II) states whether specified risk 

15 material from the ruminant is or may 

16 be part of the covered article; or 

17 (B) in the case of a covered article that 

18 does not contain animal-derived material, if the 

19 covered article does not exhibit or contain, or is 

20 not otherwise accompanied by, a statement in 

21 English that states that the covered article does 

22 not contain animal-derived material. 

23 (2) PROHIBITION OF IMPORTATION.—It shall be 

24 unlawful for any person to import a covered article 

25 described in section 2(2)(A) if the article contains 
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1 animal-derived material from a ruminant that was in 

2 any country at a time at which there was a risk of 

3 transmission of BSE in the country, as determined 

4 by the Secretary of Agriculture. 

5 (b) REGULATIONS.—Not later than 1 year after the 

6 date of enactment of this Act, the Secretary, in consulta7 tion with the Secretary of Agriculture, shall promulgate 

8 regulations that establish standards for compliance with 

9 this section, including—

10 (1) the manner of disclosure that shall be con11 sidered to be in compliance with this subsection; 

12 (2) any manner of disclosure that shall be con13 sidered not to be in compliance with this subsection; 

14 and 

15 (3) definitions of the terms ‘‘animal-derived ma16 terial’’, ‘‘country of origin’’, and other terms used 

17 but not defined in this section. 

18 (c) INTERIM GUIDANCE.—Until the date on which 

19 final regulations promulgated under subsection (b) become 

20 effective, the Secretary shall provide guidance and advice 

21 on general applicability of, and compliance with, this sec22 tion. 

23 (d) ENFORCEMENT.—For the purposes of admin24 istering the customs laws of the United States, the re25 quirement to comply with subsection (a)(1) shall be treat-
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1 ed as a requirement to mark an article under section 304 

2 of the Tariff Act of 1930 (19 U.S.C. 1304). 

3 SEC. 4. PROTECTION OF FOOD AND ANIMAL FEED SUP4 PLIES AND PUBLIC HEALTH. 

5 (a) COVERED ARTICLES.—

6 (1) PROHIBITION.—Except as provided in para7 graph (2)(B), it shall be unlawful for any person to 

8 introduce into interstate or foreign commerce a cov9 ered article if the covered article contains—

10 (A)(i) specified risk material from a rumi11 nant; or 

12 (ii) any material from a ruminant that was 

13 in any foreign country at a time at which there 

14 was a risk of transmission of BSE in the coun15 try, as determined by the Secretary of Agri16 culture; or 

17 (B) any material from a ruminant exhib18 iting signs of a neurological disease. 

19 (2) REGULATIONS.—

20 (A) SECRETARY OF AGRICULTURE.—Not 

21 later than 1 year after the date of enactment of 

22 this Act, the Secretary of Agriculture, in con23 sultation with the Secretary, shall promulgate 

24 regulations that establish standards for compli25 ance with this subsection, including—
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1 (i) requirements for the disposal of 

2 dead and nonambulatory ruminants on a 

3 farm or ranch so that the prion disease, if 

4 present in the animals, will not be recycled 

5 or expose other animals; 

6 (ii) requirements for the registration 

7 with the Food Safety and Inspection Serv8 ice of all renderers and all persons that en9 gage in the business of buying, selling, or 

10 transporting—

11 (I) dead, dying, disabled, or dis12 eased livestock; or 

13 (II) parts of the carcasses of live14 stock that die other than by slaughter; 

15 (iii) requirements for the handling, 

16 transportation, and disposal of dead, 

17 dying, disabled, and diseased livestock that 

18 are condemned on ante-mortem or post19 mortem inspection in accordance with any 

20 policy that is developed for the disposal of 

21 dead or nonambulatory ruminants on the 

22 farm; 

23 (iv) a prohibition on the use of pneu24 matic stunning devices to immobilize 

25 ruminants during slaughter; 
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1 (v) a requirement that slaughter2 houses institute best practices to prevent 

3 contamination of material intended for 

4 human consumption with specified risk 

5 material; and 

6 (vi) a prohibition on relabeling for 

7 human use any ruminant meat product 

8 that has been shown to include extraneous 

9 neurological tissue. 

10 (B) SECRETARY.—Not later than 1 year 

11 after the date of enactment of this Act, the Sec12 retary, in consultation with the Secretary of Ag13 riculture, shall promulgate regulations that es14 tablish standards for compliance with this sub15 section, including a prohibition on the use of 

16 salvaged pet food and poultry litter in feed in17 tended for food producing ruminants. 

18 (C) INTERIM GUIDANCE.—Until the date 

19 on which final regulations promulgated under 

20 subparagraphs (A) and (B) become effective, 

21 the Secretary of Agriculture or the Secretary, 

22 as appropriate, shall provide guidance and ad23 vice on general applicability of, and compliance 

24 with, this subsection. 

25 (b) RUMINANT FEED.—
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1 (1) MONITORING AND EVALUATION.—The Sec2 retary shall—

3 (A) monitor the implementation of section 

4 589.2000 of title 21, Code of Federal Regula5 tions; and 

6 (B) annually conduct a formal evaluation 

7 of that section and the implementation of that 

8 section. 

9 (2) ENFORCEMENT PLAN.—

10 (A) IN GENERAL.—The Secretary shall de11 velop and implement a plan for enforcing sec12 tion 589.2000 of title 21, Code of Federal Reg13 ulations. 

14 (B) CONTENTS.—The plan shall include—

15 (i) a computer database that would 

16 allow for effective management of inspec17 tion data; 

18 (ii) a hierarchy of enforcement actions 

19 to be taken; 

20 (iii) timeframes for persons that are 

21 subject to that section to correct violations; 

22 and 

23 (iv) timeframes for follow-up inspec24 tions to confirm that violations are cor25 rected. 
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1 (3) REVIEW OF EXCLUSION OF CERTAIN POR2 TIONS OF ANIMALS FROM DEFINITION OF PROTEIN

3 DERIVED FROM MAMMALIAN TISSUES.—On the mo4 tion of the Secretary or on the petition of any per5 son that, citing scientifically credible evidence, dem6 onstrates that there is reason to believe that any of 

7 the portions of mammalian animals excluded from 

8 the definition of protein derived from mammalian 

9 tissues in section 589.2000(a) of title 21, Code of 

10 Federal Regulations, may carry prion disease, the 

11 Secretary shall commence a proceeding to determine 

12 whether the exclusion should be modified or stricken. 

13 (c) ANIMAL FEED PREPARATION AND FEEDING

14 PRACTICES.—

15 (1) SURVEY.—

16 (A) IN GENERAL.—During the 18-month 

17 period beginning on the date of enactment of 

18 this Act, the Secretary and the Secretary of Ag19 riculture shall jointly conduct a survey of ani20 mal feed preparation practices and animal feed21 ing practices to determine—

22 (i) the extent of compliance with this 

23 section; and 
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1 (ii) the extent to which ruminants are 

2 being fed feed that contains no ruminant3 derived material. 

4 (B) REPORTS.—

5 (i) INTERIM REPORT.—Not later than 

6 180 days after the date of enactment of 

7 this Act, the Secretary and the Secretary 

8 of Agriculture shall jointly submit to Con9 gress an interim report on the results of 

10 the surveys conducted under subparagraph 

11 (A). 

12 (ii) FINAL REPORT.—Not later than 

13 18 months after the date of enactment of 

14 this Act, the Secretary and the Secretary 

15 of Agriculture shall jointly submit to Con16 gress a final report on the results of the 

17 survey conducted under subparagraph (A). 

18 (2) PREVENTION OF ADMIXING.—

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

20 after the date of enactment of this Act, the Sec21 retary, in consultation with the Secretary of Ag22 riculture, shall promulgate regulations requiring 

23 producers that feed both ruminants and 

24 nonruminants on the same farm to institute a 
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1 system to prevent admixing of ruminant feed 

2 and nonruminant feed. 

3 (B) RECORDKEEPING.—The regulations 

4 under subparagraph (A) shall require a pro5 ducer to maintain feed purchase invoices and 

6 related records for a minimum of 2 years. 

7 SEC. 5. SURVEILLANCE OF BSE AND PRION DISEASES IN 

8 HUMANS AND ANIMALS. 

9 (a) REPORTS ON SURVEILLANCE OF PRION DIS10 EASES.—The Secretary, in consultation with the Secretary 

11 of Agriculture, shall annually submit to Congress a report 

12 that describes—

13 (1) the surveillance programs to assess the 

14 prevalence of prion diseases in the United States; 

15 and 

16 (2) the surveillance of prion disease infectivity 

17 and the testing of cattle in the United States. 

18 (b) RUMINANT IDENTIFICATION PROGRAM.—Title I 

19 of the Federal Meat Inspection Act (21 U.S.C. 601 et 

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

21 ‘‘SEC. 25. RUMINANT IDENTIFICATION PROGRAM. 

22 ‘‘(a) IN GENERAL.—The Secretary shall establish a 

23 ruminant identification program that is capable of tracing, 

24 within 48 hours, after an animal is diagnosed with any 

25 reportable animal disease or any condition that can cause 
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1 disease in humans, the movements of all exposed animals 

2 from birth to slaughter. 

3 ‘‘(b) REQUIREMENTS.—

4 ‘‘(1) IN GENERAL.—Under the ruminant identi5 fication program, the Secretary shall identify cattle, 

6 sheep, goats, bison, deer, and elk and any other ru7 minant species intended for human consumption 

8 through a nationally recognizable uniform num9 bering system under which an identification number 

10 is assigned to—

11 ‘‘(A) each premises of a producer; and 

12 ‘‘(B) each individual animal or group or lot 

13 of animals, as determined by the Secretary. 

14 ‘‘(2) CONTINUATION OF EXISTING PRO15 GRAMS.—The program shall augment, and not sup16 plant, nationally recognized systems in existence on 

17 the date of enactment of this section, such as the 

18 program for scrapie traceback and eradication in 

19 sheep and goats. 

20 ‘‘(c) PROHIBITION OR RESTRICTION ON ENTRY.—

21 The Secretary may prohibit or restrict entry into any 

22 slaughtering establishment inspected under this Act of any 

23 cattle, sheep, goats, bison, deer, elk, or other ruminant 

24 intended for human consumption that is not identified 

25 under the program. 
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1 ‘‘(d) RECORDS.—

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

3 that a producer required to identify livestock under 

4 the program maintain records, as prescribed by the 

5 Secretary, regarding the purchase, sale, and identi6 fication of livestock for such period of time as the 

7 Secretary prescribes. 

8 ‘‘(2) ACCESS.—A producer shall, at all reason9 able times, on notice by an authorized representative 

10 of the Secretary, allow the representative access to 

11 examine and copy the records described in para12 graph (1). 

13 ‘‘(e) PROHIBITIONS.—It shall be unlawful for a pro14 ducer to—

15 ‘‘(1) falsify or misrepresent to any other person 

16 or to the Secretary any information relating to any 

17 premises at which any cattle, sheep, swine, goats, 

18 horses, mules, or other equines, or carcasses thereof, 

19 are held; or 

20 ‘‘(2) alter, detach, or destroy any records or 

21 other means of identification prescribed by the Sec22 retary for use in determining the premises at which 

23 any cattle, sheep, swine, goats, horses, mules, or 

24 other equines, or the carcasses thereof are held.’’
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1 (c) PROGRAMS.—Not later than 1 year after the date 

2 of enactment of this Act—

3 (1) the Secretary of Agriculture shall develop 

4 programs to—

5 (A)(i) waive diagnostic laboratory charges 

6 for the diagnosis of neurological disease in 

7 ruminants and mink; 

8 (ii) provide compensation for each submis9 sion payable to the attending veterinarian to 

10 pay the costs of obtaining and processing neu11 rological samples; and 

12 (iii) develop a program to pay a fee to ren13 derers for each cattle head not already tested 

14 that is submitted to a certified lab for BSE 

15 testing; 

16 (B)(i) fund the development of the national 

17 animal health laboratory network; 

18 (ii) expand the network to include all cer19 tified Federal, State, and university veterinary 

20 diagnostic laboratories; and 

21 (iii) facilitate the timely processing of sam22 ples from surveillance and epidemiological in23 vestigation; 

24 (C) require rapid prion disease screening 

25 tests on—
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1 (i) all cattle and bison 30 months of 

2 age and older and all sheep, goats, deer, 

3 and elk 12 months of age and older pre4 sented for slaughter and intended for 

5 human consumption; and 

6 (ii) all such livestock of a younger age 

7 than either of the ages specified in clause 

8 (i) if the Secretary determines, based on 

9 scientifically credible research, that screen10 ing of livestock of a younger age should be 

11 conducted; 

12 (D) require rapid prion disease screening 

13 tests on all nonambulatory ruminants, including 

14 all ruminants exhibiting neurological signs, 

15 when presented at a slaughterhouse or for dis16 posal; 

17 (E) ensure that any ruminant tested for 

18 BSE is excluded from use in any animal feed 

19 until the test is confirmed negative in a writing 

20 that clearly identifies the carcass with the nega21 tive test result and that all ruminants exhib22 iting neurological signs are excluded from the 

23 human food supply regardless of the results of 

24 the BSE test; 
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1 (F) establish standards for the collection, 

2 chain of custody, and storage of appropriate 

3 neurological samples for BSE testing; 

4 (G) assess consumer response to the first 

5 BSE case and further develop a communication 

6 strategy to address public concern regarding 

7 the safety of ruminant products; 

8 (H) expand, in conjunction with the Sec9 retary of the Interior, the collection of animal 

10 tissue by Federal, State, tribal, and local agen11 cies for testing for chronic wasting disease; 

12 (I) develop programs to require CWD herd 

13 certification and interstate movement restric14 tions for farm raised deer and elk; and 

15 (J) develop a coordinated strategy to iden16 tify resources needed to increase inspections of 

17 imported goods; and 

18 (2) the Secretary shall develop programs to—

19 (A) develop, in conjunction with the Na20 tional Prion Disease Pathology Research Center 

21 at Case Western Reserve University, processes 

22 to expand survey efforts for prion diseases in 

23 humans; 

24 (B) evaluate the effectiveness of practices 

25 in effect as of the date of enactment of this Act 
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1 to protect the human blood supply from con2 tamination from blood infected with prion dis3 ease; and 

4 (C) develop a coordinated strategy to iden5 tify resources needed to increase inspections of 

6 imported goods. 

7 (d) LIAISON.—Each of the Secretary and the Sec8 retary of Agriculture shall establish liaison positions at 

9 each appropriate Undersecretary level to ensure adequate 

10 coordination and communication between the Department 

11 of Health and Human Services and the Department of Ag12 riculture regarding prion diseases. 

13 (e) TASK FORCE.—

14 (1) IN GENERAL.—As soon as practicable after 

15 the date of enactment of this Act, the Secretary and 

16 the Secretary of Agriculture shall jointly establish a 

17 task force on prion diseases to provide recommenda18 tions to Congress on the status of all surveillance 

19 and research programs. 

20 (2) MEMBERSHIP.—The Task Force shall in21 clude representatives of—

22 (A) the Food Safety and Inspection Serv23 ice; 

24 (B) the Animal and Plant Health Inspec25 tion Service; 
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1 (C) the Agricultural Research Service; 

2 (D) the Food and Drug Administration; 

3 (E) the Centers for Disease Control and 

4 Prevention; 

5 (F) the National Institutes of Health; 

6 (G) the Customs Service; 

7 (H) the National Prion Research Program; 

8 (I) the Public Health Service; and 

9 (J) any other Federal Agency the assist10 ance of which the President determines is re11 quired to carry out this subsection. 

12 (3) EXISTING TASK FORCE.—The Secretary 

13 may expand or amend an existing task force to per14 form the duties of the task force under this section. 

15 (4) DUTIES.—The task force shall—

16 (A) evaluate, with respect to prion dis17 eases, the need for structural changes in and 

18 among Federal agencies that exercise jurisdic19 tion over food safety and other aspects of public 

20 health protection; 

21 (B) prioritize prion disease resource and 

22 prion disease research needs at all Federal 

23 agencies that exercise jurisdiction over matters 

24 relating to prion diseases, including—
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1 (i) genetics markers for all species af2 fected by prion disease; 

3 (ii) in vivo diagnostic tests; 

4 (iii) human blood supply diagnostic 

5 tests; 

6 (iv) therapies for humans and ani7 mals; 

8 (v) processing techniques that dena9 ture the prion protein in carcasses and 

10 other materials; and 

11 (vi) development of stunning devices 

12 that are humane, protect worker safety, 

13 and do not allow contamination of meat 

14 products; and 

15 (C) perform such other duties pertaining 

16 to surveillance and research of prion disease as 

17 the Secretary may specify. 

18 (5) PRELIMINARY RECOMMENDATIONS.—Not 

19 later than 180 days after the date of enactment of 

20 this Act, the task force shall submit to Congress any 

21 preliminary recommendations of the task force. 

22 (6) FINAL RECOMMENDATIONS.—Not later than 

23 1 year after the date of enactment of this Act, the 

24 task force shall submit to Congress the final rec25 ommendations of the task force. 
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1 SEC. 6. ENFORCEMENT. 

2 (a) COOPERATION.—The Secretary and the heads of 

3 other Federal agencies, as appropriate, shall cooperate 

4 with the Attorney General in enforcing this Act. 

5 (b) DUE PROCESS.—Any person subject to enforce6 ment action under this section shall have the opportunity 

7 for an informal hearing on the enforcement action as soon 

8 as practicable after, but not later than 10 days after, the 

9 enforcement action is taken. 

10 (c) REMEDIES.—In addition to any remedies avail11 able under other provisions of law, the head of a Federal 

12 agency may enforce this Act by—

13 (1) seizing and destroying an article that is in14 troduced into interstate or foreign commerce in vio15 lation of this Act; or 

16 (2) issuing an order requiring any person that 

17 introduces an article into interstate or foreign com18 merce in violation of this Act—

19 (A) to cease the violation; 

20 (B)(i) to recall any article that is sold; and 

21 (ii) to refund the purchase price to the 

22 purchaser; 

23 (C) to destroy the article or forfeit the ar24 ticle to the United States for destruction; or 

25 (D) to cease operations at the facility at 

26 which the article is produced until the head of 
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1 the appropriate Federal agency determines that 

2 the operations are no longer in violation of this 

3 Act. 

4 SEC. 7. AUTHORIZATION OF APPROPRIATIONS. 

5 (a) AUTHORIZATION OF APPROPRIATIONS.—There 

6 are authorized to be appropriated to carry out this Act—

7 (1) $100,000,000 for each of fiscal years 2004 

8 and 2005; and 

9 (2) such sums as are necessary for each subse10 quent fiscal year. 

11 (b) ALLOCATION OF FUNDS.—

12 (1) IN GENERAL.—Of the funds made available 

13 for each fiscal year under subsection (a)—

14 (A) 30 percent shall be available to the 

15 Secretary; and 

16 (B) 70 percent shall be available to the 

17 Secretary of Agriculture. 

18 (2) MODIFICATION OF ALLOCATIONS.—The 

19 President may alter the allocation of funding under 

20 paragraph (1) as needed to better protect the public 

21 against prion disease.

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