II 

109TH CONGRESS 

1ST SESSION S. 2002 

To provide better protection against bovine spongiform encephalopathy and 

other prion diseases. 

IN THE SENATE OF THE UNITED STATES 

NOVEMBER 14, 2005 

Mr. DURBIN (for himself, Mr. AKAKA, and Mr. SCHUMER) introduced the following bill; which was read twice and referred to the Committee on Agriculture, Nutrition, and Forestry 

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: 

8 (1) BSE.—The term ‘‘BSE’’ means bovine 

9 spongiform encephalopathy. 

10 (2) COVERED ARTICLE.— 
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1 (A) IN GENERAL.—The term ‘‘covered ar2 ticle’’ means— 

3 (i) food or feed for a human or ani4 mal; 

5 (ii) a food or nutritional supplement; 

6 (iii) a medicine; 

7 (iv) a pituitary-derived hormone; 

8 (v) transplant material; 

9 (vi) a fertilizer derived from animals; 

10 (vii) a cosmetic; and 

11 (viii) any other article of a kind that 

12 is ordinarily ingested, implanted, or other13 wise taken into a human or animal. 

14 (B) EXCLUSIONS.—The term ‘‘covered ar15 ticle’’ does not include— 

16 (i) an unprocessed agricultural com17 modity that is readily identifiable as non18 animal in origin, such as a vegetable, 

19 grain, or nut; 

20 (ii) an article described in subpara21 graph (A) that, based on compelling sci22 entific evidence, the Secretary determines 

23 does not pose a risk of transmitting prion 

24 disease; or 
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1 (iii) an article regulated by the Sec2 retary that, as determined by the Sec3 retary— 

4 (I) poses a minimal risk of car5 rying prion disease; and 

6 (II) is necessary to protect ani7 mal health or public health. 

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

9 wasting disease. 

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

11 means— 

12 (A) a transmissible spongiform 

13 encephalopathy (including prion diseases that 

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

15 elk, and mink); and 

16 (B) any related disease, as determined by 

17 the Secretary in consultation with the Secretary 

18 of Agriculture. 

19 (5) SPECIFIED RISK MATERIAL.— 

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

21 risk material’’ means— 

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

23 eyes, tonsils, spinal cord, vertebral column, 

24 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; or 

7 (iii) any other material of a ruminant 

8 that may carry a prion disease, as deter9 mined by the Secretary in consultation 

10 with the Secretary of Agriculture, based on 

11 scientifically credible research. 

12 (B) MODIFICATION.—The Secretary, in 

13 consultation with the Secretary of Agriculture, 

14 may modify the definition of specified risk ma15 terial based on scientifically credible research. 

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

17 the Secretary of Health and Human Services. 

18 SEC. 3. PROTECTION OF BORDERS. 

19 (a) PROHIBITIONS.— 

20 (1) DISCLOSURE REQUIREMENT.—It shall be 

21 unlawful for any person to import a covered arti22 cle— 

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

24 contains animal-derived material, if the covered 

25 article does not exhibit or contain, or is not oth-
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1 erwise accompanied by, a statement in English 

2 that— 

3 (i) states that the covered article con4 tains animal-derived material; 

5 (ii) states the common English name 

6 of the animal from which the material in 

7 the article is derived; and 

8 (iii) if the animal from which the ma9 terial in the covered article is derived is a 

10 ruminant— 

11 (I) identifies the country of ori12 gin of the ruminant; and 

13 (II) states whether specified risk 

14 material from the ruminant is or may 

15 be part of the covered article; or 

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

17 does not contain animal-derived material, if the 

18 covered article does not exhibit or contain, or is 

19 not otherwise accompanied by, a statement in 

20 English that states that the covered article does 

21 not contain animal-derived material. 

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

23 unlawful for any person to import a covered article 

24 described in section 2(2)(A) if, as determined by the 

25 Secretary of Agriculture— 
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1 (A) the article contains animal-derived ma2 terial from a ruminant that was in any country 

3 at a time at which there was a risk of trans4 mission of BSE in the country; and 

5 (B) the country did not meet the guide6 lines on BSE established in the World Organi7 zation for Animal Health’s (OIE) Terrestrial 

8 Animal Health Code. 

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

10 date of enactment of this Act, the Secretary, in consulta11 tion with the Secretary of Agriculture, shall promulgate 

12 regulations that establish standards for compliance with 

13 this section, including— 

14 (1) the manner of disclosure that shall be con15 sidered to be in compliance with this subsection; 

16 (2) any manner of disclosure that shall be con17 sidered not to be in compliance with this subsection; 

18 and 

19 (3) definitions of the terms ‘‘animal-derived ma20 terial’’, ‘‘country of origin’’, and other terms used 

21 but not defined in this section. 

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

23 final regulations promulgated under subsection (b) become 

24 effective, the Secretary shall provide guidance and advice 
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1 on general applicability of, and compliance with, this sec2 tion. 

3 (d) ENFORCEMENT.—For the purposes of admin4 istering the customs laws of the United States, the re5 quirement to comply with subsection (a)(1) shall be treat6 ed as a requirement to mark an article under section 304 

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

8 SEC. 4. PROTECTION OF FOOD AND ANIMAL FEED SUP9 PLIES AND PUBLIC HEALTH. 

10 (a) COVERED ARTICLES.— 

11 (1) PROHIBITION.—It shall be unlawful for any 

12 person to introduce into interstate or foreign com13 merce a covered article if the covered article con14 tains— 

15 (A)(i) specified risk material from a rumi16 nant; or 

17 (ii) any material from a ruminant that was 

18 in any foreign country at a time at which there 

19 was a risk of transmission of BSE in the coun20 try and the country did not meet the guidelines 

21 on BSE established in the World Organization 

22 for Animal Health’s (OIE) Terrestrial Animal 

23 Health Code, as determined by the Secretary of 

24 Agriculture; or 
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1 (B) any material from a ruminant exhib2 iting signs of a neurological disease. 

3 (2) REPORTING.—The Secretary of Agriculture 

4 will make publicly available quarterly reports con5 taining the number of noncompliance reports relat6 ing to regulations on specified risk materials and the 

7 reasons for noncompliance. 

8 (3) PUNITIVE OR RETALIATORY ACTION.—It 

9 shall be unlawful to take punitive or retaliatory ac10 tion against inspectors and other employees who re11 port cases of noncompliance. 

12 (4) REGULATIONS.— 

13 (A) SECRETARY OF AGRICULTURE.—Not 

14 later than 1 year after the date of enactment of 

15 this Act, the Secretary of Agriculture, in con16 sultation with the Secretary, shall promulgate 

17 regulations that establish standards for compli18 ance with this subsection, including— 

19 (i) requirements for the disposal of 

20 dead and nonambulatory ruminants on a 

21 farm or ranch so that the prion disease, if 

22 present in the animals, will not be recycled 

23 or expose other animals; 

24 (ii) requirements for the registration 

25 with the Food and Drug Administration of 
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1 all renderers and all persons that engage 

2 in the business of buying, selling, or trans3 porting— 

4 (I) dead, dying, disabled, or dis5 eased livestock; or 

6 (II) parts of the carcasses of live7 stock that die other than by slaughter; 

8 (iii) requirements for the handling, 

9 transportation, and disposal of dead, 

10 dying, disabled, and diseased livestock that 

11 are condemned on ante-mortem or post12 mortem inspection in accordance with any 

13 policy that is developed for the disposal of 

14 dead or nonambulatory ruminants on the 

15 farm; and 

16 (iv) a requirement that slaughter17 houses institute best practices to prevent 

18 contamination of material intended for 

19 human consumption with specified risk 

20 material. 

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

22 after the date of enactment of this Act, the Sec23 retary, in consultation with the Secretary of Ag24 riculture, shall promulgate regulations that es25 tablish standards for compliance with this sub-
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1 section, including a prohibition on the use of 

2 salvaged pet food, plate waste, poultry litter, 

3 and blood and blood products in animal feed in4 tended for food producing ruminants, with an 

5 exemption for the use of blood and blood prod6 ucts in bovine biologics. 

7 (b) ANIMAL FEED.— 

8 (1) MONITORING AND EVALUATION.—The Sec9 retary shall annually conduct a formal evaluation of 

10 the implementation of section 589.2000 of title 21, 

11 Code of Federal Regulations (or a successor regula12 tion), including an assessment of coordination be13 tween the Food and Drug Administration, the De14 partment of Agriculture, and State agencies. 

15 (2) REGISTRATION OF BUSINESSES.—Not later 

16 than 1 year after the date of enactment of this Act, 

17 the Secretary shall promulgate regulations for the 

18 registration with the Food and Drug Administration 

19 of all animal feed manufacturers, transporters, on20 farm mixers, and other animal feed industry busi21 nesses that are subject to section 589.2000 of title 

22 21, Code of Federal Regulations (or a successor reg23 ulation). 

24 (3) PREVENTION OF ADMIXING.—Not later 

25 than 1 year after the date of enactment of this Act, 
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1 the Secretary, in consultation with the Secretary of 

2 Agriculture, shall promulgate regulations and an in3 spection plan to prevent admixing of ruminant and 

4 nonruminant feed by animal feed manufacturers, 

5 animal feed transporters, and producers that feed 

6 both ruminants and nonruminants on the same 

7 farm. 

8 (4) ENFORCEMENT PLAN.— 

9 (A) IN GENERAL.—The Secretary shall de10 velop and implement a plan for enforcing sec11 tion 589.2000 of title 21, Code of Federal Reg12 ulations (or a successor regulation). 

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

14 (i) a computer database that would 

15 allow for effective management of inspec16 tion data; 

17 (ii) a hierarchy of enforcement actions 

18 to be taken; 

19 (iii) timeframes for persons that are 

20 subject to that section to correct violations; 

21 and 

22 (iv) timeframes for followup inspec23 tions to confirm that violations are cor24 rected. 
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1 (5) 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 (or a successor regulation), may 

11 carry prion disease, the Secretary shall commence a 

12 proceeding to determine whether the exclusion 

13 should be modified or stricken. 

14 (6) LABELING REQUIREMENTS FOR ANIMAL

15 FEED.—Animal feed intended for export shall be 

16 subject to the labeling requirements for animal feed 

17 described in section 589.2000 of title 21, Code of 

18 Federal Regulations (or a successor regulation). 

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

20 HUMANS AND ANIMALS. 

21 (a) RUMINANT IDENTIFICATION PROGRAM.—Title I 

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

23 seq.) is amended by adding at the end the following: 
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1 ‘‘SEC. 25. RUMINANT IDENTIFICATION PROGRAM. 

2 ‘‘(a) IN GENERAL.—The Secretary shall accelerate 

3 the establishment of a ruminant identification program, 

4 so that, not later than 1 year after the date of enactment 

5 of this section, the program will be capable of tracing, 

6 within 48 hours after an animal is diagnosed with any re7 portable animal disease or any condition that can cause 

8 disease in humans, the movements of all exposed animals 

9 from birth to slaughter. 

10 ‘‘(b) REQUIREMENTS.— 

11 ‘‘(1) IN GENERAL.—Under the ruminant identi12 fication program, the Secretary shall identify cattle, 

13 sheep, goats, bison, deer, and elk and any other ru14 minant species intended for human consumption 

15 through a nationally recognizable uniform num16 bering system under which an identification number 

17 is assigned to— 

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

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

20 of animals, as determined by the Secretary. 

21 ‘‘(2) CONTINUATION OF EXISTING PRO22 GRAMS.—The program shall augment, and not sup23 plant, nationally recognized systems in existence on 

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

25 program for scrapie traceback and eradication in 

26 sheep and goats. 
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1 ‘‘(c) PROHIBITION OR RESTRICTION ON ENTRY.— 

2 The Secretary may prohibit or restrict entry into any 

3 slaughtering establishment inspected under this Act of any 

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

5 intended for human consumption that is not identified 

6 under the program. 

7 ‘‘(d) RECORDS.— 

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

9 that a producer required to identify livestock under 

10 the program maintain records, as prescribed by the 

11 Secretary, regarding the purchase, sale, and identi12 fication of livestock for such period of time as the 

13 Secretary prescribes. 

14 ‘‘(2) ACCESS.—A producer shall, at all reason15 able times, on notice by an authorized representative 

16 of the Secretary, allow the representative access to 

17 examine and copy the records described in para18 graph (1). 

19 ‘‘(e) PROHIBITIONS.—It shall be unlawful for a pro20 ducer to— 

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

22 or to the Secretary any information relating to any 

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

24 bison, deer, elk, or other ruminant intended for 
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1 human consumption, or carcasses thereof, are held; 

2 or 

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

4 means of identification prescribed by the Secretary 

5 for use in determining the premises at which any 

6 cattle, sheep, swine, goats, bison, deer, elk, or other 

7 ruminant intended for human consumption, or car8 casses thereof, are held.’’. 

9 (b) PROGRAMS.— 

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

11 the date of enactment of this Act— 

12 (A) the Secretary of Agriculture shall de13 velop programs to— 

14 (i)(I) waive diagnostic laboratory 

15 charges for the diagnosis of neurological 

16 disease in ruminants and mink; 

17 (II) provide compensation for each 

18 submission payable to the attending veteri19 narian to pay the costs of obtaining and 

20 processing neurological samples; and 

21 (III) develop a program to pay a fee 

22 to renderers or producers for each cattle 

23 head not already tested that is submitted 

24 to a certified lab for BSE testing; 
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1 (ii)(I) fund the development of the na2 tional animal health laboratory network; 

3 (II) expand the network to include all 

4 certified Federal, State, and university vet5 erinary diagnostic laboratories; and 

6 (III) facilitate the timely processing of 

7 samples from surveillance and epidemiolog8 ical investigation; 

9 (iii) require rapid prion disease 

10 screening tests on— 

11 (I) all cattle and bison 30 

12 months of age and older and all 

13 sheep, goats, deer, and elk 12 months 

14 of age and older presented for slaugh15 ter and intended for human consump16 tion; and 

17 (II) all such livestock of a young18 er age than either of the ages speci19 fied in subclause (I) if the Secretary 

20 determines, based on scientifically 

21 credible research, that screening of 

22 livestock of a younger age should be 

23 conducted; 

24 (iv) require rapid prion disease 

25 screening tests on all nonambulatory 
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1 ruminants, including all ruminants exhib2 iting neurological signs, when presented at 

3 a slaughterhouse or for disposal; 

4 (v) ensure that— 

5 (I) any ruminant tested for BSE 

6 is excluded from use in any animal 

7 feed until the test is confirmed nega8 tive in writing that clearly identifies 

9 the carcass with the negative test re10 sult; and 

11 (II) all ruminants exhibiting neu12 rological signs are excluded from the 

13 human food supply regardless of the 

14 results of the BSE test; 

15 (vi) expand, in conjunction with the 

16 Secretary of the Interior, the collection of 

17 animal tissue by Federal, State, tribal, and 

18 local agencies for testing for chronic wast19 ing disease; 

20 (vii) develop programs to require 

21 CWD herd certification and interstate 

22 movement restrictions for farm raised deer 

23 and elk; 
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1 (viii) develop a coordinated strategy to 

2 identify resources needed to increase in3 spections of imported goods; and 

4 (ix) allow qualified entities to conduct 

5 additional voluntary rapid prion disease 

6 screening tests; and 

7 (B) the Secretary shall develop programs 

8 to— 

9 (i) expand survey efforts for prion dis10 eases in humans, in conjunction with the 

11 National Prion Disease Pathology Re12 search Center at Case Western Reserve 

13 University; 

14 (ii) evaluate the effectiveness of prac15 tices in effect as of the date of enactment 

16 of this Act to— 

17 (I) protect the human blood sup18 ply from contamination from blood in19 fected with prion disease; and 

20 (II) prevent transmission of BSE 

21 through contaminated medical equip22 ment; and 

23 (iii) develop a coordinated strategy to 

24 identify resources needed to increase in25 spections of imported goods. 
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1 (2) DEFINITION OF QUALIFIED ENTITY.—For 

2 purposes of paragraph (1)(A)(ix), the term ‘‘quali3 fied entity’’ means a person or a State that— 

4 (A) uses rapid test technology approved by 

5 the Secretary of Agriculture for the detection of 

6 BSE in cattle; and 

7 (B) meets or exceeds standards established 

8 by the Secretary for— 

9 (i) laboratory sample collection and 

10 chain of custody; 

11 (ii) sample and laboratory methods 

12 quality control; and 

13 (iii) laboratory safety and quality. 

14 (c) LIAISON.—Each of the Secretary and the Sec15 retary of Agriculture shall establish liaison positions at 

16 each appropriate Undersecretary level to ensure adequate 

17 coordination and communication between the Department 

18 of Health and Human Services and the Department of Ag19 riculture regarding prion diseases. 

20 (d) TASK FORCE.— 

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

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

23 the Secretary of Agriculture shall jointly establish a 

24 task force on prion diseases to provide recommenda-
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1 tions to Congress on the status of all surveillance 

2 and research programs. 

3 (2) MEMBERSHIP.—The Task Force shall in4 clude representatives of— 

5 (A) the Food Safety and Inspection Serv6 ice; 

7 (B) the Animal and Plant Health Inspec8 tion Service; 

9 (C) the Agricultural Research Service; 

10 (D) the Food and Drug Administration; 

11 (E) the Centers for Disease Control and 

12 Prevention; 

13 (F) the National Institutes of Health; 

14 (G) the Customs Service; 

15 (H) the National Prion Research Program; 

16 (I) the Public Health Service; and 

17 (J) any other Federal Agency the assist18 ance of which the President determines is re19 quired to carry out this subsection. 

20 (3) EXISTING TASK FORCE.—The Secretary 

21 may expand or amend an existing task force to per22 form the duties of the task force under this section. 

23 (4) DUTIES.—The task force shall— 

24 (A) evaluate, with respect to prion dis25 eases, the need for structural changes in and 
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1 among Federal agencies that exercise jurisdic2 tion over food safety and other aspects of public 

3 health protection; 

4 (B) prioritize prion disease resource and 

5 prion disease research needs at all Federal 

6 agencies that exercise jurisdiction over matters 

7 relating to prion diseases, including— 

8 (i) genetic markers for all species af9 fected by prion disease; 

10 (ii) in vivo diagnostic tests; 

11 (iii) human blood supply diagnostic 

12 tests; 

13 (iv) therapies for humans and ani14 mals; 

15 (v) processing techniques that dena16 ture the prion protein in carcasses and 

17 other materials; and 

18 (vi) development of stunning devices 

19 that are humane, protect worker safety, 

20 and do not allow contamination of meat 

21 products; and 

22 (C) perform such other duties pertaining 

23 to surveillance and research of prion disease as 

24 the Secretary may specify. 
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1 (5) PRELIMINARY RECOMMENDATIONS.—Not 

2 later than 180 days after the date of enactment of 

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

4 preliminary recommendations of the task force. 

5 (6) FINAL RECOMMENDATIONS.—Not later than 

6 1 year after the date of enactment of this Act, the 

7 task force shall submit to Congress the final rec8 ommendations of the task force. 

9 SEC. 6. ENFORCEMENT. 

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

11 other Federal agencies, as appropriate, shall cooperate 

12 with the Attorney General in enforcing this Act. 

13 (b) DUE PROCESS.—Any person subject to enforce14 ment action under this section shall have the opportunity 

15 for an informal hearing on the enforcement action as soon 

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

17 enforcement action is taken. 

18 (c) REMEDIES.—In addition to any remedies avail19 able under other provisions of law, the head of a Federal 

20 agency may enforce this Act by— 

21 (1) seizing and destroying an article that is in22 troduced into interstate or foreign commerce in vio23 lation of this Act; or 
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1 (2) issuing an order requiring any person that 

2 introduces an article into interstate or foreign com3 merce in violation of this Act— 

4 (A) to cease the violation; 

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

6 (ii) to refund the purchase price to the 

7 purchaser; 

8 (C) to destroy the article or forfeit the ar9 ticle to the United States for destruction; or 

10 (D) to cease operations at the facility at 

11 which the article is produced until the head of 

12 the appropriate Federal agency determines that 

13 the operations are no longer in violation of this 

14 Act. 

15 SEC. 7. AUTHORIZATION OF APPROPRIATIONS. 

16 (a) AUTHORIZATION OF APPROPRIATIONS.—There 

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

18 (1) $100,000,000 for each of fiscal years 2007 

19 and 2008; and 

20 (2) such sums as are necessary for each subse21 quent fiscal year. 

22 (b) ALLOCATION OF FUNDS.— 

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

24 for each fiscal year under subsection (a)— 
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1 (A) 30 percent shall be available to the 

2 Secretary; and 

3 (B) 70 percent shall be available to the 

4 Secretary of Agriculture. 

5 (2) MODIFICATION OF ALLOCATIONS.—The 

6 President may alter the allocation of funding under 

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

8 against prion disease. 

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