[Congressional Record Volume 151, Number 150 (Monday, November 14, 2005)]
[Senate]
[Pages S12767-S12770]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DURBIN (for himself, Mr. Akaka, and Mr. Schumer):
  S. 2002. A bill to provide protection against bovine spongiform 
encephalopathy and other prion diseases; to the Committee on 
Agriculture, Nutrition, and Forestry.
  Mr. DURBIN. 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 
also addresses other forms of prion disease that affect humans and 
animals.
  For many years, we thought that we didn't have BSE in the United 
States. But now we have to assume that the disease does exist in our 
cattle, though it has been detected only twice.
  In June 2005, U.S. Department of Agriculture, USDA, officials 
announced that a Texas cow had tested positive for BSE.
  It is troubling that the USDA and Food and Drug Administration, FDA, 
investigation could not pin down how the cow became infected. Reports 
compiled for the Texas Animal Health Commission and obtained by The 
Dallas Morning News showed that 85 percent of the cattle traced in the 
investigation had already been sent for slaughter.
  We should not settle for half-measures in BSE control. Yet nearly two 
years after USDA and FDA announced efforts to strengthen our nation's 
firewalls against BSE, critical gaps remain in our defenses.
  Just last week, the Government Accountability Office released a study 
that found that testing of cattle feed is at times too slow to prevent 
cattle from eating feed that might be contaminated.
  Poultry litter, plate waste, and pet food can still be fed to cattle, 
creating loopholes in the ruminant feed ban.
  In addition, the USDA Office of the Inspector General has raised 
concerns about the design of USDA's surveillance program, including 
whether the Agency is appropriately selecting animals for testing and 
testing an adequate number of older cattle.
  To fully protect animal and public health, I am reintroducing my bill 
to strengthen our Nation's firewalls against prion diseases like BSE. 
My bill would close loopholes in the ruminant feed ban. It would ensure 
that all older cattle are tested for BSE. In addition, my bill would 
improve enforcement of the feed ban and take steps to ensure that meat 
intended for human

[[Page S12768]]

consumption is free of tissues that could harbor infectious prions.
  The bill also would require the Secretary of Health and Human 
Services to assess the risk of transmission of human prion diseases 
through blood and surgical equipment and strengthen surveillance of 
prion diseases in humans.
  I urge my colleagues to support this bill.
  I ask unanimous consent that the text of the bill be printed in the 
Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 2002

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     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 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.

     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, 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).

     SEC. 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

[[Page S12769]]

     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).

     SEC. 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:

     ``SEC. 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;

[[Page S12770]]

       (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.

     SEC. 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.

     SEC. 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.
                                 ______