[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 2007 Introduced in Senate (IS)]
108th CONGRESS
2d Session
S. 2007
To provide better protection against bovine spongiform encephalopathy
and other prion diseases.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
January 20, 2004
Mr. Durbin (for himself and Mr. Akaka) 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 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 followup inspections to
confirm that violations are corrected.
(3) Review of exclusion of certain portions of animals from
definition of protein derived from mammalian tissues.--On the
motion of the Secretary or on the petition of any person that,
citing scientifically credible evidence, demonstrates that
there is reason to believe that any of the portions of
mammalian animals excluded from the definition of protein
derived from mammalian tissues in section 589.2000(a) of title
21, Code of Federal Regulations, may carry prion disease, the
Secretary shall commence a proceeding to determine whether the
exclusion should be modified or stricken.
(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.
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