S. 2002Senate109th Congress (2005-2007)In Committee

BSE and Other Prior Disease Prevention and Public Health Protection Act

A bill to provide protection against bovine spongiform encephalopathy and other prion diseases.

Introduced November 14, 2005

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SenateIntro Referral Latest Action

Read twice and referred to the Committee on Agriculture, Nutrition, and Forestry. (text of measure as introduced: CR S12768-12770)

November 14, 2005

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SenateIntro Referral

Introduced in Senate

November 14, 2005

SenateIntro Referral

Sponsor introductory remarks on measure. (CR S12767-12768)

November 14, 2005

SenateIntro Referral

Read twice and referred to the Committee on Agriculture, Nutrition, and Forestry. (text of measure as introduced: CR S12768-12770)

November 14, 2005

Floor Debate

2 members

What members said about S. 2002 on the floor

2 Democrats
Richard J. Durbin
Sen. Richard J. DurbinD-IL · Nov 14, 2005

Mr. President, I am introducing a bill to strengthen our Nation's firewalls against prion diseases. This bill would prevent the spread of mad cow disease, or bovine spongiform encephalopathy, BSE. It…

Richard J. Durbin
Sen. Richard J. DurbinD-IL · Nov 14, 2005

Mr. President, I am introducing a bill to strengthen our Nation's firewalls against prion diseases. This bill would prevent the spread of mad cow disease, or bovine spongiform encephalopathy, BSE. It…

Ron Wyden
Sen. Ron WydenD-OR · Nov 14, 2005

Mr. President, the legislation I introduce today reauthorizes a very successful cooperative watershed restoration program that I originally sponsored, and that was originally enacted for the Forest…

Bill Text

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Introduced in SenateIssued November 14, 2005

II

109th CONGRESS

1st Session

S. 2002

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.

Short title

This Act may be cited as the BSE and Other Prion Disease Prevention and Public Health Protection Act.

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 human or animal;

(ii)

a food or nutritional supplement;

(iii)

a medicine;

(iv)

a pituitary-derived hormone;

(v)

transplant material;

(vi)

a fertilizer derived from animals;

(vii)

a cosmetic; and

(viii)

any other article of a kind that is ordinarily ingested, implanted, or otherwise taken into a human or animal.

(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 animal health 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 in consultation with the Secretary of Agriculture.

(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; or

(iii)

any other material of a ruminant that may carry a prion disease, as determined by the Secretary in consultation with the Secretary of Agriculture, based on scientifically credible research.

(B)

Modification

The Secretary, in consultation with the Secretary of Agriculture, may modify the definition of specified risk material based on scientifically credible research.

(6)

Secretary

The term Secretary means the Secretary of Health and Human Services.

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, as determined by the Secretary of Agriculture—

(A)

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; and

(B)

the country did not meet the guidelines on BSE established in the World Organization for Animal Health’s (OIE) Terrestrial Animal Health Code.

(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.

(c)

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).

4.

Protection of food and animal feed supplies and public health

(a)

Covered articles

(1)

Prohibition

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 and the country did not meet the guidelines on BSE established in the World Organization for Animal Health’s (OIE) Terrestrial Animal Health Code, as determined by the Secretary of Agriculture; or

(B)

any material from a ruminant exhibiting signs of a neurological disease.

(2)

Reporting

The Secretary of Agriculture will make publicly available quarterly reports containing the number of noncompliance reports relating to regulations on specified risk materials and the reasons for noncompliance.

(3)

Punitive or retaliatory action

It shall be unlawful to take punitive or retaliatory action against inspectors and other employees who report cases of noncompliance.

(4)

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 and Drug Administration 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; and

(iv)

a requirement that slaughterhouses institute best practices to prevent contamination of material intended for human consumption with specified risk material.

(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, plate waste, poultry litter, and blood and blood products in animal feed intended for food producing ruminants, with an exemption for the use of blood and blood products in bovine biologics.

(b)

Animal feed

(1)

Monitoring and evaluation

The Secretary shall annually conduct a formal evaluation of the implementation of section 589.2000 of title 21, Code of Federal Regulations (or a successor regulation), including an assessment of coordination between the Food and Drug Administration, the Department of Agriculture, and State agencies.

(2)

Registration of businesses

Not later than 1 year after the date of enactment of this Act, the Secretary shall promulgate regulations for the registration with the Food and Drug Administration of all animal feed manufacturers, transporters, on-farm mixers, and other animal feed industry businesses that are subject to section 589.2000 of title 21, Code of Federal Regulations (or a successor regulation).

(3)

Prevention of admixing

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 and an inspection plan to prevent admixing of ruminant and nonruminant feed by animal feed manufacturers, animal feed transporters, and producers that feed both ruminants and nonruminants on the same farm.

(4)

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 (or a successor regulation).

(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.

(5)

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 (or a successor regulation), may carry prion disease, the Secretary shall commence a proceeding to determine whether the exclusion should be modified or stricken.

(6)

Labeling requirements for animal feed

Animal feed intended for export shall be subject to the labeling requirements for animal feed described in section 589.2000 of title 21, Code of Federal Regulations (or a successor regulation).

5.

Surveillance of BSE and prion diseases in humans and animals

(a)

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:

25.

Ruminant identification program

(a)

In general

The Secretary shall accelerate the establishment of a ruminant identification program, so that, not later than 1 year after the date of enactment of this section, the program will be 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.

(c)

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

(2)

alter, detach, or destroy any records or means of identification prescribed by the Secretary for use in determining the premises at which any cattle, sheep, swine, goats, bison, deer, elk, or other ruminant intended for human consumption, or carcasses thereof, are held.

.

(b)

Programs

(1)

In general

Not later than 1 year after the date of enactment of this Act—

(A)

the Secretary of Agriculture shall develop programs to—

(i)
(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 or producers for each cattle head not already tested that is submitted to a certified lab for BSE testing;

(ii)
(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;

(iii)

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 subclause (I) if the Secretary determines, based on scientifically credible research, that screening of livestock of a younger age should be conducted;

(iv)

require rapid prion disease screening tests on all nonambulatory ruminants, including all ruminants exhibiting neurological signs, when presented at a slaughterhouse or for disposal;

(v)

ensure that—

(I)

any ruminant tested for BSE is excluded from use in any animal feed until the test is confirmed negative in writing that clearly identifies the carcass with the negative test result; and

(II)

all ruminants exhibiting neurological signs are excluded from the human food supply regardless of the results of the BSE test;

(vi)

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;

(vii)

develop programs to require CWD herd certification and interstate movement restrictions for farm raised deer and elk;

(viii)

develop a coordinated strategy to identify resources needed to increase inspections of imported goods; and

(ix)

allow qualified entities to conduct additional voluntary rapid prion disease screening tests; and

(B)

the Secretary shall develop programs to—

(i)

expand survey efforts for prion diseases in humans, in conjunction with the National Prion Disease Pathology Research Center at Case Western Reserve University;

(ii)

evaluate the effectiveness of practices in effect as of the date of enactment of this Act to—

(I)

protect the human blood supply from contamination from blood infected with prion disease; and

(II)

prevent transmission of BSE through contaminated medical equipment; and

(iii)

develop a coordinated strategy to identify resources needed to increase inspections of imported goods.

(2)

Definition of qualified entity

For purposes of paragraph (1)(A)(ix), the term qualified entity means a person or a State that—

(A)

uses rapid test technology approved by the Secretary of Agriculture for the detection of BSE in cattle; and

(B)

meets or exceeds standards established by the Secretary for—

(i)

laboratory sample collection and chain of custody;

(ii)

sample and laboratory methods quality control; and

(iii)

laboratory safety and quality.

(c)

Liaison

Each of the Secretary and the Secretary of Agriculture shall establish liaison positions at each appropriate Undersecretary level to ensure adequate coordination and communication between the Department of Health and Human Services and the Department of Agriculture regarding prion diseases.

(d)

Task force

(1)

In general

As soon as practicable after the date of enactment of this Act, the Secretary and the Secretary of Agriculture shall jointly establish a task force on prion diseases to provide recommendations to Congress on the status of all surveillance and research programs.

(2)

Membership

The Task Force shall include representatives of—

(A)

the Food Safety and Inspection Service;

(B)

the Animal and Plant Health Inspection Service;

(C)

the Agricultural Research Service;

(D)

the Food and Drug Administration;

(E)

the Centers for Disease Control and Prevention;

(F)

the National Institutes of Health;

(G)

the Customs Service;

(H)

the National Prion Research Program;

(I)

the Public Health Service; and

(J)

any other Federal Agency the assistance of which the President determines is required to carry out this subsection.

(3)

Existing task force

The Secretary may expand or amend an existing task force to perform the duties of the task force under this section.

(4)

Duties

The task force shall—

(A)

evaluate, with respect to prion diseases, the need for structural changes in and among Federal agencies that exercise jurisdiction over food safety and other aspects of public health protection;

(B)

prioritize prion disease resource and prion disease research needs at all Federal agencies that exercise jurisdiction over matters relating to prion diseases, including—

(i)

genetic markers for all species affected by prion disease;

(ii)

in vivo diagnostic tests;

(iii)

human blood supply diagnostic tests;

(iv)

therapies for humans and animals;

(v)

processing techniques that denature the prion protein in carcasses and other materials; and

(vi)

development of stunning devices that are humane, protect worker safety, and do not allow contamination of meat products; and

(C)

perform such other duties pertaining to surveillance and research of prion disease as the Secretary may specify.

(5)

Preliminary recommendations

Not later than 180 days after the date of enactment of this Act, the task force shall submit to Congress any preliminary recommendations of the task force.

(6)

Final recommendations

Not later than 1 year after the date of enactment of this Act, the task force shall submit to Congress the final recommendations of the task force.

6.

Enforcement

(a)

Cooperation

The Secretary and the heads of other Federal agencies, as appropriate, shall cooperate with the Attorney General in enforcing this Act.

(b)

Due process

Any person subject to enforcement action under this section shall have the opportunity for an informal hearing on the enforcement action as soon as practicable after, but not later than 10 days after, the enforcement action is taken.

(c)

Remedies

In addition to any remedies available under other provisions of law, the head of a Federal agency may enforce this Act by—

(1)

seizing and destroying an article that is introduced into interstate or foreign commerce in violation of this Act; or

(2)

issuing an order requiring any person that introduces an article into interstate or foreign commerce in violation of this Act—

(A)

to cease the violation;

(B)
(i)

to recall any article that is sold; and

(ii)

to refund the purchase price to the purchaser;

(C)

to destroy the article or forfeit the article to the United States for destruction; or

(D)

to cease operations at the facility at which the article is produced until the head of the appropriate Federal agency determines that the operations are no longer in violation of this Act.

7.

Authorization of appropriations

(a)

Authorization of appropriations

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

(1)

$100,000,000 for each of fiscal years 2007 and 2008; and

(2)

such sums as are necessary for each subsequent fiscal year.

(b)

Allocation of funds

(1)

In general

Of the funds made available for each fiscal year under subsection (a)—

(A)

30 percent shall be available to the Secretary; and

(B)

70 percent shall be available to the Secretary of Agriculture.

(2)

Modification of allocations

The President may alter the allocation of funding under paragraph (1) as needed to better protect the public against prion disease.