1.This Act may be cited as
the BSE and Other Prion Disease
Prevention and Public Health Protection Act
.
2.In this Act:
(1)The
term BSE means bovine spongiform encephalopathy.
(2)
(A)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)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)The
term CWD means chronic wasting disease.
(4)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)
(A)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)The
Secretary, in consultation with the Secretary of Agriculture, may modify the
definition of specified risk material based on scientifically credible
research.
(6)The
term Secretary means the Secretary of Health and Human
Services.
3.
(a)
(1)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
importationIt 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)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)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)For
the purposes of administering the customs laws of the United States, the
requirement to comply with subsection (a)(1) shall be treated as a requirement
to mark an article under section 304 of the Tariff Act of 1930 (19 U.S.C.
1304).
4.Protection of
food and animal feed supplies and public health
(a)
(1)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)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 actionIt shall be unlawful to take punitive or
retaliatory action against inspectors and other employees who report cases of
noncompliance.
(4)
(A)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)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)
(1)Monitoring and
evaluationThe 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
businessesNot 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)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)
(A)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)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 tissuesOn 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 feedAnimal feed intended for export
shall be subject to the labeling requirements for animal feed described in
section 589.2000 of title 21, Code of Federal Regulations (or a successor
regulation).
5.Surveillance of
BSE and prion diseases in humans and animals
(a)Ruminant
identification programTitle I of the Federal Meat Inspection Act
(21 U.S.C. 601 et seq.) is amended by adding at the end the following:
25.Ruminant
identification program
(a)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)
(1)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 programsThe 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 entryThe 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)
(1)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)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)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)
(1)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 entityFor 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)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)
(1)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)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)The Secretary may expand or amend an existing task force to
perform the duties of the task force under this section.
(4)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
recommendationsNot 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)Not later than 1 year after the date of enactment
of this Act, the task force shall submit to Congress the final recommendations
of the task force.
6.
(a)The
Secretary and the heads of other Federal agencies, as appropriate, shall
cooperate with the Attorney General in enforcing this Act.
(b)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)In
addition to any remedies available under other provisions of law, the head of a
Federal agency may enforce this Act by—
(1)seizing and
destroying an article that is introduced into interstate or foreign commerce in
violation of this Act; or
(2)issuing an order
requiring any person that introduces an article into interstate or foreign
commerce in violation of this Act—
(A)to cease the
violation;
(B)(i)to recall any article
that is sold; and
(ii)to refund the purchase price to
the purchaser;
(C)to destroy the
article or forfeit the article to the United States for destruction; or
(D)to cease
operations at the facility at which the article is produced until the head of
the appropriate Federal agency determines that the operations are no longer in
violation of this Act.
7.Authorization of
appropriations
(a)Authorization
of appropriationsThere 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)
(1)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
allocationsThe President may alter the allocation of funding
under paragraph (1) as needed to better protect the public against prion
disease.