[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 2002 Introduced in Senate (IS)]








109th CONGRESS
  1st Session
                                S. 2002

 To provide better protection against bovine spongiform encephalopathy 
                       and other prion diseases.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           November 14, 2005

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

_______________________________________________________________________

                                 A BILL


 
 To provide better protection against bovine spongiform encephalopathy 
                       and other prion diseases.

    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 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;
                            (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.
                                 <all>