[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3714 Introduced in House (IH)]






108th CONGRESS
  2d Session
                                H. R. 3714

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            January 21, 2004

 Ms. DeLauro (for herself and Ms. Lee) introduced the following bill; 
which was referred to the Committee on Agriculture, and in addition to 
the Committees on Energy and Commerce, and Ways and Means, for a period 
    to be subsequently determined by the Speaker, in each case for 
consideration of such provisions as fall within the jurisdiction of the 
                          committee concerned

_______________________________________________________________________

                                 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 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 cosmetic; 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.
    (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.--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.
                    (C) 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 follow-up 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.
    (c) 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.
    ``(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, 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.''
    (c) 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;
                    (C) 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;
                    (B) evaluate the effectiveness of practices in 
                effect as of the date of enactment of this Act to 
                protect the human blood supply from contamination from 
                blood infected with prion disease; and
                    (C) develop a coordinated strategy to identify 
                resources needed to increase inspections of imported 
                goods.
    (d) 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.
    (e) 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) genetics 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 2004 and 2005; 
        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>