BSE and Other Prion Disease Prevention and Public Health Protection Act

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S.2007

BSE and Other Prion Disease Prevention and Public Health Protection Act

(Introduced in Senate)

 

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SECTION 1. SHORT TITLE.

 

This Act may be cited as the `BSE and Other Prion Disease Prevention and

Public Health Protection Act'.

 

SEC. 2. DEFINITIONS.

 

In this Act:

 

(1) BSE- The term `BSE' means bovine spongiform encephalopathy.

 

(2) COVERED ARTICLE-

 

(A) IN GENERAL- The term `covered article' means--

 

(i) food or feed for a plant, animal, or human;

 

(ii) a food or nutritional supplement;

 

(iii) a medicine;

 

(iv) a pituitary-derived hormone;

 

(v) transplant material;

 

(vi) a fertilizer;

 

(vii) a cosmetics; and

 

(viii) any other article of a kind that is ordinarily ingested,

implanted, or otherwise taken into a living organism.

 

(B) EXCLUSIONS- The term `covered article' does not include--

 

(i) an unprocessed agricultural commodity that is readily

identifiable as nonanimal in origin, such as a vegetable, grain, or nut;

 

(ii) an article described in subparagraph (A) that, based on

compelling scientific evidence, the Secretary determines does not pose a

risk of transmitting prion disease; or

 

(iii) an article regulated by the Secretary that, as determined by

the Secretary--

 

(I) poses a minimal risk of carrying prion disease; and

 

(II) is necessary to protect individual or public health.

 

(3) CWD- The term `CWD' means chronic wasting disease.

 

(4) PRION DISEASE- The term `prion disease' means--

 

(A) a transmissible spongiform encephalopathy (including prion

diseases that affect humans, cattle, bison, sheep, goats, deer, elk, and

mink); and

 

(B) any related disease, as determined by the Secretary.

 

(5) SPECIFIED RISK MATERIAL-

 

(A) IN GENERAL- The term `specified risk material' means--

 

(i) the skull, brain, trigeminal ganglia, eyes, tonsils, spinal

cord, vertebral column, or dorsal root ganglia of--

 

(I) cattle and bison 30 months of age and older; or

 

(II) sheep, goats, deer, and elk 12 months of age and older;

 

(ii) the intestinal tract of a ruminant of any age; and

 

(iii) any other material of a ruminant that may carry a prion

disease, as determined by the Secretary, based on scientifically credible

research.

 

(B) MODIFICATION- The Secretary may modify the definition of specified

risk material based on scientifically credible research (including the

conduct of ante-mortem and post-mortem tests certified by the Secretary of

Agriculture).

 

(6) SECRETARY- The term `Secretary' means the Secretary of Health and

Human Services.

 

SEC. 3. PROTECTION OF BORDERS.

 

(a) PROHIBITIONS-

 

(1) DISCLOSURE REQUIREMENT- It shall be unlawful for any person to

import a covered article--

 

(A) in the case of a covered article that contains animal-derived

material, if the covered article does not exhibit or contain, or is not

otherwise accompanied by, a statement in English that--

 

(i) states that the covered article contains animal-derived

material;

 

(ii) states the common English name of the animal from which the

material in the article is derived; and

 

(iii) if the animal from which the material in the covered article

is derived is a ruminant--

 

(I) identifies the country of origin of the ruminant; and

 

(II) states whether specified risk material from the ruminant is

or may be part of the covered article; or

 

(B) in the case of a covered article that does not contain

animal-derived material, if the covered article does not exhibit or contain,

or is not otherwise accompanied by, a statement in English that states that

the covered article does not contain animal-derived material.

 

(2) PROHIBITION OF IMPORTATION- It shall be unlawful for any person to

import a covered article described in section 2(2)(A) if the article

contains animal-derived material from a ruminant that was in

any country at a time at which there was a risk of transmission of BSE in

the country, as determined by the Secretary of Agriculture.

 

 

(b) REGULATIONS- Not later than 1 year after the date of enactment of this

Act, the Secretary, in consultation with the Secretary of Agriculture, shall

promulgate regulations that establish standards for compliance with this

section, including--

 

(1) the manner of disclosure that shall be considered to be in

compliance with this subsection;

 

(2) any manner of disclosure that shall be considered not to be in

compliance with this subsection; and

 

(3) definitions of the terms `animal-derived material', `country of

origin', and other terms used but not defined in this section.

 

© INTERIM GUIDANCE- Until the date on which final regulations

promulgated under subsection (b) become effective, the Secretary shall

provide guidance and advice on general applicability of, and compliance

with, this section.

 

(d) ENFORCEMENT- For the purposes of administering the customs laws of the

United States, the requirement to comply with subsection (a)(1) shall be

treated as a requirement to mark an article under section 304 of the Tariff

Act of 1930 (19 U.S.C. 1304).

 

SEC. 4. PROTECTION OF FOOD AND ANIMAL FEED SUPPLIES AND PUBLIC HEALTH.

 

(a) COVERED ARTICLES-

 

(1) PROHIBITION- Except as provided in paragraph (2)(B), it shall be

unlawful for any person to introduce into interstate or foreign commerce a

covered article if the covered article contains--

 

(A)(i) specified risk material from a ruminant; or

 

(ii) any material from a ruminant that was in any foreign country at

a time at which there was a risk of transmission of BSE in the country, as

determined by the Secretary of Agriculture; or

 

(B) any material from a ruminant exhibiting signs of a neurological

disease.

 

(2) REGULATIONS-

 

(A) SECRETARY OF AGRICULTURE- Not later than 1 year after the date of

enactment of this Act, the Secretary of Agriculture, in consultation with

the Secretary, shall promulgate regulations that establish standards for

compliance with this subsection, including--

 

(i) requirements for the disposal of dead and nonambulatory

ruminants on a farm or ranch so that the prion disease, if present in the

animals, will not be recycled or expose other animals;

 

(ii) requirements for the registration with the Food Safety and

Inspection Service of all renderers and all persons that engage in the

business of buying, selling, or transporting--

 

(I) dead, dying, disabled, or diseased livestock; or

 

(II) parts of the carcasses of livestock that die other than by

slaughter;

 

(iii) requirements for the handling, transportation, and disposal of

dead, dying, disabled, and diseased livestock that are condemned on

ante-mortem or post-mortem inspection in accordance with any policy that is

developed for the disposal of dead or nonambulatory ruminants on the farm;

 

(iv) a prohibition on the use of pneumatic stunning devices to

immobilize ruminants during slaughter;

 

(v) a requirement that slaughterhouses institute best practices to

prevent contamination of material intended for human consumption with

specified risk material; and

 

(vi) a prohibition on relabeling for human use any ruminant meat

product that has been shown to include extraneous neurological tissue.

 

(B) SECRETARY- Not later than 1 year after the date of enactment of

this Act, the Secretary, in consultation with the Secretary of Agriculture,

shall promulgate regulations that establish standards for compliance with

this subsection, including a prohibition on the use of salvaged pet food and

poultry litter in feed intended for food producing ruminants.

 

© INTERIM GUIDANCE- Until the date on which final regulations

promulgated under subparagraphs (A) and (B) become effective, the Secretary

of Agriculture or the Secretary, as appropriate, shall provide guidance and

advice on general applicability of, and compliance with, this subsection.

 

(b) RUMINANT FEED-

 

(1) MONITORING AND EVALUATION- The Secretary shall--

 

(A) monitor the implementation of section 589.2000 of title 21, Code

of Federal Regulations; and

 

(B) annually conduct a formal evaluation of that section and the

implementation of that section.

 

(2) ENFORCEMENT PLAN-

 

(A) IN GENERAL- The Secretary shall develop and implement a plan for

enforcing section 589.2000 of title 21, Code of Federal Regulations.

 

(B) CONTENTS- The plan shall include--

 

(i) a computer database that would allow for effective management of

inspection data;

 

(ii) a hierarchy of enforcement actions to be taken;

 

(iii) timeframes for persons that are subject to that section to

correct violations; and

 

(iv) timeframes for followup inspections to confirm that violations

are corrected.

 

(3) REVIEW OF EXCLUSION OF CERTAIN PORTIONS OF ANIMALS FROM DEFINITION

OF PROTEIN DERIVED FROM MAMMALIAN TISSUES- On the motion of the Secretary or

on the petition of any person that, citing scientifically credible evidence,

demonstrates that there is reason to believe that any of the portions of

mammalian animals excluded from the definition of protein derived from

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

Regulations, may carry prion disease, the Secretary shall commence a

proceeding to determine whether the exclusion should be modified or

stricken.

 

© ANIMAL FEED PREPARATION AND FEEDING PRACTICES-

 

(1) SURVEY-

 

(A) IN GENERAL- During the 18-month period beginning on the date of

enactment of this Act, the Secretary and the Secretary of Agriculture shall

jointly conduct a survey of animal feed preparation practices and animal

feeding practices to determine--

 

(i) the extent of compliance with this section; and

 

(ii) the extent to which ruminants are being fed feed that contains

no ruminant-derived material.

 

(B) REPORTS-

 

(i) INTERIM REPORT- Not later than 180 days after the date of

enactment of this Act, the Secretary and the Secretary of Agriculture shall

jointly submit to Congress an interim report on the results of the surveys

conducted under subparagraph (A).

 

(ii) FINAL REPORT- Not later than 18 months after the date of

enactment of this Act, the Secretary and the Secretary of Agriculture shall

jointly submit to Congress a final report on the results of the survey

conducted under subparagraph (A).

 

(2) PREVENTION OF ADMIXING-

 

(A) IN GENERAL- Not later than 1 year after the date of enactment of

this Act, the Secretary, in consultation with the Secretary of Agriculture,

shall promulgate regulations requiring producers that feed both ruminants

and nonruminants on the same farm to institute a system to prevent admixing

of ruminant feed and nonruminant feed.

 

(B) RECORDKEEPING- The regulations under subparagraph (A) shall

require a producer to maintain feed purchase invoices and related records

for a minimum of 2 years.

 

SEC. 5. SURVEILLANCE OF BSE AND PRION DISEASES IN HUMANS AND ANIMALS.

 

(a) REPORTS ON SURVEILLANCE OF PRION DISEASES- The Secretary, in

consultation with the Secretary of Agriculture, shall annually submit to

Congress a report that describes--

 

(1) the surveillance programs to assess the prevalence of prion diseases

in the United States; and

 

(2) the surveillance of prion disease infectivity and the testing of

cattle in the United States.

 

(b) RUMINANT IDENTIFICATION PROGRAM- Title I of the Federal Meat

Inspection Act (21 U.S.C. 601 et seq.) is amended by adding at the end the

following:

 

`SEC. 25. RUMINANT IDENTIFICATION PROGRAM.

 

`(a) IN GENERAL- The Secretary shall establish a ruminant identification

program that is capable of tracing, within 48 hours, after an animal is

diagnosed with any reportable animal disease or any condition that can cause

disease in humans, the movements of all exposed animals from birth to

slaughter.

 

`(b) REQUIREMENTS-

 

`(1) IN GENERAL- Under the ruminant identification program, the

Secretary shall identify cattle, sheep, goats, bison, deer, and elk and any

other ruminant species intended for human consumption through a nationally

recognizable uniform numbering system under which an identification number

is assigned to--

 

`(A) each premises of a producer; and

 

`(B) each individual animal or group or lot of animals, as determined

by the Secretary.

 

`(2) CONTINUATION OF EXISTING PROGRAMS- The program shall augment, and

not supplant, nationally recognized systems in existence on the date of

enactment of this section, such as the program for scrapie traceback and

eradication in sheep and goats.

 

`© PROHIBITION OR RESTRICTION ON ENTRY- The Secretary may prohibit or

restrict entry into any slaughtering establishment inspected under this Act

of any cattle, sheep, goats, bison, deer, elk, or other ruminant intended

for human consumption that is not identified under the program.

 

`(d) RECORDS-

 

`(1) IN GENERAL- The Secretary may require that a producer required to

identify livestock under the program maintain records, as prescribed by the

Secretary, regarding the purchase, sale, and identification of livestock for

such period of time as the Secretary prescribes.

 

`(2) ACCESS- A producer shall, at all reasonable times, on notice by an

authorized representative of the Secretary, allow the representative access

to examine and copy the records described in paragraph (1).

 

`(e) PROHIBITIONS- It shall be unlawful for a producer to--

 

`(1) falsify or misrepresent to any other person or to the Secretary any

information relating to any premises at which any cattle, sheep, swine,

goats, horses, mules, or other equines, or carcasses thereof, are held; or

 

`(2) alter, detach, or destroy any records or other means of

identification prescribed by the Secretary for use in determining the

premises at which any cattle, sheep, swine, goats, horses, mules, or other

equines, or the carcasses thereof are held.'.

 

© PROGRAMS- Not later than 1 year after the date of enactment of this

Act--

 

(1) the Secretary of Agriculture shall develop programs to--

 

(A)(i) waive diagnostic laboratory charges for the diagnosis of

neurological disease in ruminants and mink;

 

(ii) provide compensation for each submission payable to the attending

veterinarian to pay the costs of obtaining and processing neurological

samples; and

 

(iii) develop a program to pay a fee to renderers for each cattle head

not already tested that is submitted to a certified lab for BSE testing;

 

(B)(i) fund the development of the national animal health laboratory

network;

 

(ii) expand the network to include all certified Federal, State, and

university veterinary diagnostic laboratories; and

 

(iii) facilitate the timely processing of samples from surveillance

and epidemiological investigation;

 

© require rapid prion disease screening tests on--

 

(i) all cattle and bison 30 months of age and older and all sheep,

goats, deer, and elk 12 months of age and older presented for slaughter and

intended for human consumption; and

 

(ii) all such livestock of a younger age than either of the ages

specified in clause (i) if the Secretary determines, based on scientifically

credible research, that screening of livestock of a younger age should be

conducted;

 

(D) require rapid prion disease screening tests on all nonambulatory

ruminants, including all ruminants exhibiting neurological signs, when

presented at a slaughterhouse or for disposal;

 

(E) ensure that any ruminant tested for BSE is excluded from use in

any animal feed until the test is confirmed negative in a writing that

clearly identifies the carcass with the negative test result and that all

ruminants exhibiting neurological signs are excluded from the human food

supply regardless of the results of the BSE test;

 

(F) establish standards for the collection, chain of custody, and

storage of appropriate neurological samples for BSE testing;

 

(G) assess consumer response to the first BSE case and further develop

a communication strategy to address public concern regarding the safety of

ruminant products;

 

(H) expand, in conjunction with the Secretary of the Interior, the

collection of animal tissue by Federal, State, tribal, and local agencies

for testing for chronic wasting disease;

 

(I) develop programs to require CWD herd certification and interstate

movement restrictions for farm raised deer and elk; and

 

(J) develop a coordinated strategy to identify resources needed to

increase inspections of imported goods; and

 

(2) the Secretary shall develop programs to--

 

(A) develop, in conjunction with the National Prion Disease Pathology

Research Center at Case Western Reserve University, processes to expand

survey efforts for prion diseases in humans;

 

 

 

karl theis jr

 

 

http://groups.msn.com/exposureofthetruth

 

 

 

 

 

 

 

 

 

 

 

 

 

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