II

108TH CONGRESS

2D SESSION S. 2007

To provide better protection against bovine spongiform encephalopathy and

other prion diseases.

IN THE SENATE OF THE UNITED STATES

JANUARY 20, 2004

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

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

and Forestry

A BILL

To 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 plant, animal, or

4 human;

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;

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 living organism.

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

3 Secretary—

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

6 (II) is necessary to protect indi7 vidual 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.

18 (5) SPECIFIED RISK MATERIAL.—

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

20 risk material’’ means—

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

22 eyes, tonsils, spinal cord, vertebral column,

23 or dorsal root ganglia of—

24 (I) cattle and bison 30 months of

25 age and older; or
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1 (II) sheep, goats, deer, and elk

2 12 months of age and older;

3 (ii) the intestinal tract of a ruminant

4 of any age; and

5 (iii) any other material of a ruminant

6 that may carry a prion disease, as deter7 mined by the Secretary, based on scientif8 ically credible research.

9 (B) MODIFICATION.—The Secretary may

10 modify the definition of specified risk material

11 based on scientifically credible research (includ12 ing the conduct of ante-mortem and post13 mortem tests certified by the Secretary of Agri14 culture).

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

16 the Secretary of Health and Human Services.

17 SEC. 3. PROTECTION OF BORDERS.

18 (a) PROHIBITIONS.—

19 (1) DISCLOSURE REQUIREMENT.—It shall be

20 unlawful for any person to import a covered

21 article—

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

23 contains animal-derived material, if the covered

24 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 the article contains

25 animal-derived material from a ruminant that was in
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1 any country at a time at which there was a risk of

2 transmission of BSE in the country, as determined

3 by the Secretary of Agriculture.

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

5 date of enactment of this Act, the Secretary, in consulta6 tion with the Secretary of Agriculture, shall promulgate

7 regulations that establish standards for compliance with

8 this section, including—

9 (1) the manner of disclosure that shall be con10 sidered to be in compliance with this subsection;

11 (2) any manner of disclosure that shall be con12 sidered not to be in compliance with this subsection;

13 and

14 (3) definitions of the terms ‘‘animal-derived ma15 terial’’, ‘‘country of origin’’, and other terms used

16 but not defined in this section.

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

18 final regulations promulgated under subsection (b) become

19 effective, the Secretary shall provide guidance and advice

20 on general applicability of, and compliance with, this sec21 tion.

22 (d) ENFORCEMENT.—For the purposes of admin23 istering the customs laws of the United States, the re24 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

13 that was in any foreign country at a time

14 at which there was a risk of transmission

15 of BSE in the country, as determined by

16 the Secretary of Agriculture; 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 followup 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.

Æ