To: BSE-L@uni-karlsruhe.de[Federal Register: January 21, 2003 (Volume 68, Number 13)]
[Proposed Rules]
[Page 2703-2711]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21ja03-17]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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[[Page 2703]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Ch. I
[Docket No. 01-068-1]
RIN 0579-AB43
Risk Reduction Strategies for Potential BSE Pathways Involving
Downer Cattle and Dead Stock of Cattle and Other Species
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Advance notice of proposed rulemaking.
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SUMMARY: We are soliciting public comment to help us develop approaches
to control the risk that dead stock and nonambulatory animals could
serve as potential pathways for the spread of bovine spongiform
encephalopathy, if that disease should ever be introduced into the
United States.
DATES: We will consider all comments that we receive on or before March
24, 2003.
ADDRESSES: You may submit comments by postal mail/commercial delivery
or by e-mail. If you use postal mail/commercial delivery, please send
four copies of your comment (an original and three copies) to: Docket
No. 01-068-1, Regulatory Analysis and Development, PPD, APHIS, Station
3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1231. Please state
that your comment refers to Docket No. 01-068-1. If you use e-mail,
address your comment to regulations@aphis.usda.gov. Your comment must
be contained in the body of your message; do not send attached files.
Please include your name and address in your message and ``Docket No.
01-068-1'' on the subject line.
You may read any comments that we receive on this docket in our
reading room. The reading room is located in room 1141 of the USDA
South Building, 14th Street and Independence Avenue SW., Washington,
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through
Friday, except holidays. To be sure someone is there to help you,
please call (202) 690-2817 before coming.
APHIS documents published in the Federal Register, and related
information, including the names of organizations and individuals who
have commented on APHIS dockets, are available on the Internet at
http://www.aphis.usda.gov/ppd/rad/webrepor.html.
FOR FURTHER INFORMATION CONTACT: Dr. Lisa Ferguson, Emergency Programs,
VS, APHIS, 4700 River Road, Unit 41, Riverdale, MD 20737-1237; (301)
734-8073.
SUPPLEMENTARY INFORMATION:
Background
We are soliciting comments to help us develop an approach to
control risks associated with disposal of nonambulatory and dead
livestock. These animals could serve as potential pathways for the
spread of bovine spongiform encephalopathy (BSE), if that disease
should ever be introduced into the United States.
It is well established that domestic and wild animals may contract
diseases--especially viral and bacterial diseases--from animals that
die on the farm and do not receive proper disposal. Direct exposure to
improperly buried dead stock \1\ and consumption of feed or grass
contaminated by run-off that passed over such animals are some of the
routes of potential exposure for these diseases.
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\1\ Dead stock are livestock that die or are killed before being
sent to slaughter; they are sometimes referred to as ``on-farm
deads.'' When used in this notice in reference to cattle, this term
refers to adult cattle over 24 months of age, since cattle that die
at a younger age present a greatly reduced likelihood of harboring
BSE infectivity.
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Bovine spongiform encephalopathy (BSE) is a disease of cattle and
is a member of a class called transmissible spongiform encephalopathies
(TSE's). Other TSE's also cause various diseases in animals and humans.
BSE was first documented in the United Kingdom in 1986 and has since
spread to approximately 21 other countries in Europe, and to Israel and
Japan. There has never been a case of BSE identified in the United
States. However, other types of TSE diseases have affected U.S.
livestock and wildlife, including scrapie in sheep and goats and
chronic wasting disease (CWD) in both captive and free-ranging elk and
deer.
In many ways, TSE diseases present a more difficult problem than
other animal diseases with regard to controlling the spread of disease
through dead stock. This is due to the nature of TSE diseases, the
general lack of live-animal tests for them, and the extreme hardiness
of TSE agents. These issues are discussed in some detail below.
Surveillance programs in European countries where BSE exist have
found that BSE is present in a higher percentage of nonambulatory and
dead livestock than in the general cattle populations. An animal at the
point of death from BSE is also generally in its most infectious state,
with a high concentration of the BSE agent in certain tissues. Studies
by the U.S. Department of Agriculture (USDA), independent researchers,
and the Harvard Center for Risk Analysis (discussed below) concur that
if BSE were introduced into the United States, dead stock that were
rendered and allowed into the animal feed chain would pose a risk of
spreading the disease. In January 2001, the Food and Agriculture
Organization of the United Nations issued a press release urging
countries to take steps to reduce BSE risks; one of the recommended
practices was correct disposal of dead stock. Diseases other than BSE
are also an issue in the disposal of dead stock.
The BSE agent is remarkably hardy and resistant to destruction by
standard cooking practices, sterilization procedures, and rendering
processes. Generally, the rendering processes used in the United States
will reduce the infectivity of a TSE agent in the rendered material by
a factor of 1 to 3 logs.\2\ The continuous rendering processes most
widely used in the United States reduce infectivity by 2 logs or less;
batch processing, used for less than 5 percent of rendered animals, can
reduce infectivity by 3 logs. Since some BSE agent survives rendering,
if BSE were to be present in a rendered product that is used in cattle
feed (in deliberate or accidental violation of the feed ban imposed by
the U.S. Food and Drug Administration (FDA)) it could lead to the
amplification and spread of
[[Page 2704]]
BSE among cattle consuming that feed. There is also a possibility that
animal feed containing a TSE agent from the rendered protein of one
species (e.g., scrapie in sheep) could cause development of disease in
animals of another species consuming that feed (e.g., cause BSE in
cattle). This is, in fact, the leading theory for how BSE originated in
the United Kingdom.
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\2\ A 1-log reduction is reduction by a factor of 10, 2 logs =
100, 3 logs = 1000, etc.
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Given this situation, the Animal and Plant Health Inspection
Service (APHIS) wants to take steps to limit the potential pathways
through which BSE could spread in U.S. animal populations, in case it
is introduced despite efforts to keep it out of the United States.
TSE Disease Surveillance
Data from APHIS animal disease surveillance programs can be used to
detect occurrences of disease, provide information for better policy
decisions, and better understand the diseases. Most surveillance
programs are based on data from live-animal tests; however, since such
tests are generally unavailable for TSE's, in this area APHIS generally
relies on observation of animals exhibiting signs of TSE's and tissue
samples from dead animals. Since 1990, animals targeted for BSE
surveillance by APHIS include cattle exhibiting signs of neurological
disease in the field (i.e., prior to being brought to slaughter),
cattle condemned at slaughter for neurologic reasons, rabies-negative
cattle submitted to public health laboratories,\3\ neurologic cases
submitted to veterinary diagnostic laboratories and teaching hospitals,
nonambulatory cattle (``downer cattle'') over 24 months of age at
slaughter, and adult cattle dying from unknown causes on farms. The
primary reason we target downer animals is that surveillance data from
European countries in which BSE has been detected indicate that downer
cattle have a greater incidence of BSE.\4\ If BSE enters the United
States, downer cattle testing programs are likely to first reveal it.
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\3\ We test rabies-negative cattle because these animals often
have clinical signs that could be consistent with BSE. If the public
health tests show the animal does not have rabies, the samples may
be forwarded to APHIS for BSE testing.
\4\ For instance, surveillance in Germany in 2001 showed that
animals subjected to normal slaughter had a BSE incidence of 0.002
percent, while fallen animals (in the United States, these would be
called dead stock, or animals not presented for slaughter for human
consumption) had an incidence of 0.02 percent, and emergency
slaughters (in the United States, animals presented for slaughter
for human consumption and found to show signs of neurological
illness) had an incidence of 0.48 percent. ``Final Report of a
Mission Carried Out in Germany from 28/05/2001 to 01/06/2001 in
Order to Evaluate the Implementation of Protective Measures Against
Bovine Spongiform Encephalopathy,'' available at
http://europa.eu.int/comm/food/fs/inspections/vi/reports/germany/vi_rep_germ_3302-2001_en.pdf
.
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APHIS' current approach to BSE surveillance takes into account
regional differences in the movement of animals, i.e., surveillance is
scaled to take into account where most cattle are raised and where they
are slaughtered. On this basis the United States is divided into eight
regions \5\ for BSE surveillance. For years, APHIS has calculated
regional surveillance goals for BSE to exceed international standards
recommended by the Office International des Epizooties, the world
organization for animal health. APHIS continues to increase postmortem
testing for BSE, with more than 19,990 cattle samples tested in fiscal
year 2002'up from 5,200 during fiscal year 2001. Overall, our
surveillance program targets the segment of the cattle population where
BSE would most likely be found if it were to occur, i.e., downer
animals and dead stock.
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\5\ These divisions were established essentially for
epidemiological surveillance reasons and are not intended for the
purposes of Chapter 1.3.4 of the International Animal Health Code,
i.e., ``defining geographical areas of different animal health
status within its territory for the purpose of international
trade.'' The regions were established because State-by-State
reporting did not provide very useful data, and caused
underestimation and overestimation of States' cattle populations,
due to the common practice of moving cattle interstate for feeding
and slaughter. Often an animal actually comes from one state (e.g.,
New Jersey) but is slaughtered in another state (e.g.,
Pennsylvania), so therefore slaughter surveillance on a State-by-
State basis would report the animal as originating from
Pennsylvania. To make our estimations and calculations as
scientifically sound as possible, we changed to a regional system,
with States grouped into regions based on typical animal populations
and their movement to regional slaughterhouses.
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Limiting Possible Pathways for Spread of BSE
By their nature, downer animals and dead stock include many animals
dead or dying from communicable diseases. They therefore represent a
significant pathway for spread of disease if they are not handled or
disposed of with appropriate safeguards. Over time, USDA and industry
have developed methods to mitigate, if imperfectly, the risks presented
by dead stock and downer animals affected by the older, better-known
animal diseases.
With regard to limiting the potential pathways through which BSE
could spread in U.S. animal populations if it were introduced, we
believe that dead stock and downer animals represent the most
significant potential pathway that has not been addressed in previous
efforts to reduce BSE risks. The remainder of this advance notice of
proposed rulemaking discusses why we think this is so and identifies
topic areas where we are seeking more information in order to develop
rulemaking on the subject of dead stock.
The Harvard Risk Analysis
In April 1998, in order to better characterize the potential for
BSE to be introduced and spread in the United States, and the potential
threat to human health should this happen, USDA commissioned the
Harvard Center for Risk Analysis to conduct a risk analysis (referred
to below as the Harvard study). The Harvard study was completed and
released on November 30, 2001.\6\ The summary of the Harvard study
stated its findings that the United States is highly resistant to any
introduction of BSE or a similar disease. It also found that BSE is
extremely unlikely to become established in the United States, and if
introduced, it is likely to be quickly eliminated following its
introduction.
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\6\ Evaluation of the Potential for Bovine Spongiform
Encephalopathy in the United States; Harvard University and Tuskegee
University, November 26, 2001. Available at
http://www.aphis.usda.gov/oa/bse/
.
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The Harvard study investigated potential pathways by which BSE or
other TSE's could enter U.S. cattle populations, using a quantitative
simulation model to characterize how the introduction of BSE would
spread over time, and the extent to which it could result in human
exposure to contaminated food products. The study's model quantified
some aspects of BSE's potential progress if introduced into the United
States--e.g., the number of animals that would be infected over time,
and the resulting quantity of the BSE agent in food that would
potentially be available for human consumption--but it did not quantify
the probability that BSE will be introduced, nor did it estimate how
many people would contract vCJD if BSE were introduced. The study
omitted quantitative treatment of both of these issues because the
available information is inadequate.
The Harvard study has helped APHIS identify those risk management
control options that most influence the introduction and spread of
disease, and to identify those sources of uncertainty that have the
greatest impact on our programs to control BSE risks. This information
can be used to help identify the most important control measures and to
prioritize data collection and research efforts.
The Harvard study finds that the United States is highly resistant
to the introduction of BSE. In addition, should BSE occur in this
country, measures taken by government and industry make
[[Page 2705]]
the United States robust against the spread of BSE to animals or
humans.
The report identified three pathways or practices that could
contribute most either to increased human exposure to the BSE agent or
to the spread of BSE if it should be introduced into the United States.
The three pathways are:
[sbull] Noncompliance with the FDA feed ban, including misfeeding
on the farm and the mislabeling of prohibited feed and feed products;
[sbull] Inclusion of high risk material, such as brain and spinal
cord, in edible products;
[sbull] Rendering of animals that die on the farm and use (through
illegal diversion or cross-contamination) of the rendered product in
ruminant feed.
FDA and FSIS are taking action to address the first two pathways.
FDA is enhancing its enforcement of the feed ban and is evaluating
whether further rulemaking is needed. FSIS published a notice in the
Federal Register on January 17, 2002 (67 FR 2399, Docket No. 01-027N)
announcing the availability of a BSE Current Thinking Paper that
discusses measures that it is considering implementing to minimize
human exposure to bovine materials that could potentially contain the
BSE agent. Measures under consideration by FSIS include prohibiting
certain high risk materials, such as brain and spinal cord, from
specified cattle for use as human food and prohibiting the
incorporation of CNS tissue in boneless beef products, including meat
from advance meat recovery (AMR) systems. Commenters on this advance
notice of proposed rulemaking may wish to explore whether there are
cross-cutting issues between safe disposal of these specified risk
materials and safe disposal options for downer and on-farm dead
animals.
Because APHIS has primary authority \7\ for animal disease risks
posed by both live and dead animals on the farm, including matters
where carcass disposal may pose animal health risks, APHIS is
publishing this advance notice of proposed rulemaking to open
discussion concerning the third pathway, rendered material from animals
that die on the farm and its possible inclusion in ruminant feed. We
are publishing this notice to fulfill the Secretary's statement, upon
release of the Harvard study, that ``USDA will publish an advance
notice of proposed rulemaking to consider disposal options for dead and
downer animals, because such cattle are considered an important
potential pathway for the spread of BSE in the animal chain.''
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\7\ Generally, APHIS does not directly regulate businesses
engaged in animal disposal through rendering, incineration, burial,
or other methods. However, such businesses could be affected if
APHIS regulates how the owners of animals may move or dispose of
dead stock; e.g., disposal businesses could choose to alter their
practices to provide the types of disposal APHIS requires the owners
of animals to employ. See the Animal Health Protection Act of 2002
(Subtitle E of the Farm Security and Rural Investment Act of 2002,
Pub. L. 107-171). Section 10406 states that the Secretary of
Agriculture may prohibit or restrict ``the movement in interstate
commerce of any animal, article, or means of conveyance if the
Secretary determines that the prohibition or restriction is
necessary to prevent the introduction or dissemination of any pest
or disease of livestock.'' Section 10409 states that the Secretary
``may carry out operations and measures to detect, control, or
eradicate any pest or disease of livestock * * * including animals
at a slaughterhouse, stockyard, or other point of concentration.''
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The Harvard study considers dead stock to be an especially
significant potential pathway for BSE. The base case for the Harvard
study's model examined what would happen if 10 animals infected with
BSE were imported into the United States, assuming current Government
regulations and controls are in place. In this scenario, it could be
likely that one or more of these animals will succumb to the disease on
the farm, or become sick enough to be killed rather than sent to
slaughter. The worst possible outcome at this point in the scenario
would be for an animal with BSE to be rendered, and for the rendered
product to be mixed into ruminant feed (in violation of the FDA feed
ban). Rendering an animal that has reached the clinical stage of BSE
introduces the maximum amount of infectivity into rendering and
potentially into feed. This could result in many more cattle
contracting BSE through consuming that contaminated feed, or consuming
feed that was cross-contaminated during production or storage, if the
feed ban was violated.
The Harvard study's model estimates that keeping this from
occurring, by prohibiting the rendering of animals that die on the farm
or by ensuring that no rendered product from such animals is ever mixed
with ruminant feed, would greatly reduce the potential for
contamination in the animal feed chain and reduce the average predicted
new cases of BSE following introduction of 10 infected cattle from 2.9
new cases to 0.68 new cases. The Harvard study found that safely
disposing of on-farm dead livestock is predicted to greatly reduce BSE
spread due to the high levels of BSE agent expected in animals that die
from BSE on the farm. It is important to keep such animals from
directly entering animal feed chains (e.g., through using rendered
products derived from them in feed), and it is important to dispose of
their carcasses in ways that keep other livestock and wildlife from
contacting them.
Note that the Harvard study by design considered risk factors for
BSE one at a time, not in combination. In other words, the prediction
that keeping rendered dead stock out of ruminant feed would lower new
cases of BSE following introduction of 10 infected cattle from 2.9 to
0.68 new cases does not take into account the marginal and cumulative
effects of other BSE risk reduction activities. Other actions by
Federal agencies and industry--e.g., more effective enforcement of the
feed ban and import restrictions applied to countries with BSE--will
also be acting to mitigate BSE risks, to a cumulative degree not
calculated by the Harvard study.
The Harvard study suggests prohibiting rendering of dead stock as
one way to mitigate this risk, but it does not go on to evaluate the
associated negative effects such a policy could have on preventing the
spread of BSE and other diseases. Eliminating rendering as a disposal
option for dead stock would mean owners would have to find other
disposal options, many of which pose their own risks of spreading
disease. These risks are discussed later in this document.
Issues in Disposal of Downer Cattle and Dead Stock
Downer Cattle
Downer cattle--animals that cannot rise from a recumbent position
due to injury or illness--may be sent for slaughter at plants inspected
by FSIS.\8\ Sometimes the FSIS antemortem inspection reveals that the
downer animal clearly is affected by a particular disease, but more
often diseases are revealed only when characteristic lesions (e.g., of
tuberculosis, swine erysipelas, or infectious anemia) are seen within
the carcass after slaughter. However, TSE diseases do not cause grossly
observable lesions, so FSIS inspectors instead observe the live downer
animals for signs of a CNS disorder. FSIS has the lead role in ensuring
that downer cattle presented for slaughter that exhibit clinical signs
of BSE are diverted from slaughter. Cattle with clinical signs of a CNS
disorder and cattle that died otherwise than by slaughter are already
prohibited from use as human food. All downer cattle presented for
slaughter are
[[Page 2706]]
automatically suspected of being affected with a disease or condition
that may require condemnation of the animal, in whole or in part, and
are identified as ``U.S. Suspects.'' Such cattle must be examined by an
FSIS veterinarian, and a record of the veterinarian's clinical findings
must accompany the carcass to postmortem inspection if the animal is
not condemned. Post mortem inspection on the carcasses of all cattle
classified as ``US Suspects,'' including downer cattle, must be
performed by a veterinarian rather than a food inspector, and the
results of this inspection must be recorded as well.
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\8\ Any FSIS-inspected facility may slaughter downer cattle if
the animal passes ante mortem inspection. Although some slaughter
facilities will not accept downers for slaughter, FSIS does not
restrict or approve where downers may be slaughtered.
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Downer cattle presented for slaughter that pass antemortem
inspection may be slaughtered and, if passed on postmortem inspection,
the meat and meat products from such cattle can be used for human food.
However, surveillance for BSE in Europe has shown that downer cattle
infected with BSE often cannot be found by looking for the typical
clinical signs associated with BSE, because the signs of BSE often
cannot be differentiated from the signs of the many other diseases and
conditions affecting downer cattle. Thus, if BSE were present in the
United States, downer cattle infected with BSE could potentially be
offered for slaughter and, if the clinical signs of the disease were
not detected, pass antemortem inspection. These cattle could then be
slaughtered for human or animal food. Although the muscle tissue from
BSE-infected downer cattle has not been found to contain the BSE agent,
other tissues could contain the BSE agent and the muscle tissue could
be cross-contaminated during slaughter and processing.
As noted above, FSIS is considering placing restrictions on
specified risk materials from certain categories of slaughtered cattle,
including downer cattle, to address this scenario. We are seeking
suggestions on actions APHIS could take to prevent downer animals
potentially affected by BSE (should it be introduced) from spreading
the disease; i.e., actions that could be taken on the farm or at other
stages prior to slaughter. We are looking for actions we could take
now, rather than actions to be taken if and when BSE is ever
introduced. Commenters may wish to describe how risk factors should be
considered when sending downer cattle to slaughter, e.g., age, physical
condition, source and type of cattle, etc.
Commenters should bear in mind that we currently rely on collecting
samples from downer animals, at slaughter and other locations, as a key
part of BSE surveillance. We would like commenters to address how APHIS
could continue to obtain samples for testing from downer cattle, since
such cattle are an important part of our surveillance program for BSE.
Dead Stock
In addition to comments regarding downer animals, we seek comments
regarding dead stock. Disposal methods for dead stock is the most
important issue addressed by this advance notice of proposed
rulemaking. Dead stock are a potential source of infection for many
animal diseases, including BSE. Past experience with disease outbreaks
in livestock has demonstrated the need for carcass disposal methods
that are cost-effective, safe, fast, complete, and environmentally
acceptable.
If an animal dies on the farm, or becomes so sick or injured that
it must be destroyed on the farm, it immediately loses most or all of
its economic value. It is prohibited from being sold for human food. It
might be sold to be rendered, or to be processed as pet food, but in
most cases the fee for picking up and transporting a dead animal
exceeds the salvage value (i.e., the payment for its value as rendered
product or pet food). Thus, producers have a strong business reason for
finding ways to dispose of dead stock as cheaply as possible.
This incentive to find cheap means of disposal for dead stock is
directly in conflict with certain public interest needs. We will note,
but not directly address in this advance notice of proposed rulemaking,
that dead stock disposal can have significant impacts on environmental
quality and on the capacity of existing solid waste management disposal
systems (landfills, incinerators, etc.). We are also aware that there
are varying costs associated with different methods of dead stock
disposal, but we have not analyzed these costs because we have
insufficient data, and we request commenters to submit data on these
costs. The focus of this advance notice of proposed rulemaking is on
how dead stock disposal relates to the public interest in controlling
animal disease risks.
Many animal health programs depend on collecting good data about
how livestock become sick and die. This data collection would obviously
become even more important if BSE were introduced into the United
States. When dead stock is treated as an economic burden and disposed
of as cheaply as possible, this data collection suffers. The cheapest
methods for dead stock disposal include ignoring the carcass (possible
in some cattle range situations) or burying it on-site. Both of these
means are legal in some States, and in other States that have specific
disposal requirements, the requirements are often loosely enforced.
Some producers have disposed of dead stock creatively and illegally by
abandoning it on public or private land in ravines, rivers, culverts,
dumpsters, and other locations. In all of these situations, information
about the animal and its possible cause of death is unlikely to make
its way to State or Federal animal health authorities.
In addition to making it harder to collect animal health data,
inappropriate disposal of dead stock increases the possibility that
humans, livestock, or wildlife will come into contact with pathogens
associated with the dead stock. Human and animal health concerns, along
with environmental quality concerns, are the major reasons existing
State laws on carcass disposal were enacted.
While State laws regarding dead stock disposal vary widely, most
have the following features in common. They establish a time limit
within which disposal must take place--usually 24 or 48 hours after
death. They limit disposal methods to those authorized by law, and
sometimes rank the methods in the order the State prefers they be used.
Typically, this is the preferred order:
Rendering at a licensed and approved rendering facility. This
method maximizes the government's ability to monitor and regulate dead
stock disposal, by working with relatively few companies that pick up
and render the dead stock. However, as discussed below, dead stock
pickup by renderers has become less available in many areas and has
become more expensive. (In the past renderers would pick up dead cattle
for free, or pay the producer for the dead animals; now there is
typically a fee of $20 or more for this service, when it is available
at all.) There are also TSE risk issues associated with rendering, and
with the renderers' ability to segregate higher-risk materials and
divert them to products that are not for use in humans or animals.
However, the existence of markets for use of rendered products for
industrial purposes that present no risk of contact with animal or
human products does provide a possible avenue for disposal of rendered
products from animals that may be infected with a TSE. Such products
may be diverted into production of paints, adhesives, or other
products. Rendered fat products and meat and bone meal (MBM) may also
be used as either a primary fuel or a fuel supplement for heat and
power production (especially co-combustion in coal-fired plants), or as
an ingredient in cement (MBM is currently used in
[[Page 2707]]
cement production in Belgium, France, Germany, Japan, and possibly
other countries.) Naturally, diversion of large quantities of rendered
products into new uses raises significant economic issues, and many
diversion uses may not currently make sense in purely economic terms,
as other nations that practice such diversion have found.\9\ For
example, MBM, when burned, generates only about half the energy
obtained from burning coal, yet MBM sells for about 12 times the price
of coal.
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\9\ ``In Germany all fallen animals and all animals unfit for
human consumption must be disposed of at rendering plants. The
renderers collect the animals. All fallen and sick bovines over 24
months are BSE tested * * * If the results of the test have not come
through then the whole carcass must be processed into MBM under the
standard procedure at 133[deg]C and 3 bar. Since the introduction of
the MBM feed ban all MBM must be burnt either in waste incinerators,
power stations, or as fuel for cement producers * * * Since the
introduction of the MBM feed ban rendering operations run at a loss.
Federal and Land Governments are still discussing the coverage of
the extra costs brought about by the BSE crisis. The Federal
Government has so far resisted the wish of the Land Governments that
the Federal Government should pay all BSE follow-up costs including
the disposal costs of MBM.''--British Embassy Bonn Office
Agriculture Note: September 2001, available at
http://www.britischebotschaft.de/en/embassy/agriculture/Agni-Note-Fallen%20Stock.htm
.
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Although many industrial products are produced mainly from rendered
fats and oils, rather than rendered protein, some products utilize
rendered protein. In other cases, a percentage of rendered protein can
be included as a harmless additive with the rendered fat or oil
product. If such diversion into non-food uses is effectively
accomplished, it could provide a safe means of dead stock disposal for
animals that might spread TSE's if disposed of in other ways.
Composting of dead stock in a properly designed and sized dead
animal composter. Composting of dead stock allows the end product to be
recycled back to the land as a fertilizer. Poultry and swine industries
use this technology effectively. Composting is used to dispose of some
cattle and other large species, but large-scale cost-effective
approaches are still under development. Composting requires careful
planning and monitoring to be successful. Issues include moisture and
temperature control and proper admixture of plant matter (often straw
or old feedstuffs) to raise the carbon-nitrogen level to a point where
proper composting can occur. Composting also takes time; decomposition
of a mature cattle carcass takes about 6 to 8 months. The remaining
bony matter is soft and easily broken for land application or other
final disposal. One successful composting approach uses a three-bin
system, which is best located downwind from nearby residences and away
from waterways and ponds. Permanent composting facilities have
significant start-up costs of $5,000 or more. Composting operations
must also take steps to control the potential risk of disease spread by
wild and feral animals.
Composting is problematic with regard to BSE infectivity; it may be
effective, or it may reduce but not destroy infectivity. Composting
does not usually raise material temperatures over 160 [deg]F, a
temperature the BSE agent is known to survive for long periods. Further
research is needed to characterize the effectiveness of composting with
regard to BSE. The United Kingdom's Department for Environment, Food,
and Rural Affairs is currently preparing a risk assessment, to be
completed in the near future, that may help resolve this question.
Dead stock disposal in an approved sanitary landfill. Most
municipal landfills are permitted to accept dead animals but may limit
their numbers. To minimize pathogen contamination of groundwater,
modern sanitary landfills are designed and operated to prevent leaching
into groundwater or surface waters. Drawbacks include limited capacity
and expense--many landfills charge over $100 a head to dispose of
cattle. However, properly operated landfills will keep infectious
material away from livestock.
Incinerating dead stock. Incineration is very effective but is
costly and energy intensive, and it may pollute the environment if the
incinerator is not operated and maintained properly. Incinerators
generally must be licensed by a State government. Open burning of dead
animals is not allowed in most States without a permit.
A subset of incineration technology that is gaining popularity is
on-site disposal using either complete mobile incinerators or air
curtain trench burners. There are cost and air quality issues
associated with both of these technologies, and they are usually
considered most suitable for short-term disposal projects (such as
depopulating a herd) rather than long-term use. However, air curtain
trench burners in particular have been gaining use in recent years for
on-site disposal of diseased animals. They have been used in Great
Britain for disposal of animals during the recent foot-and-mouth
disease outbreak, and they have been used in Montana and Colorado to
dispose of elk implicated in CWD outbreaks. When properly used, this
technology produces ash that presents no disease risk when disposed of
properly.
Air curtain trench burners are essentially giant blowers that
direct powerful airstreams onto trenches in which carcasses are burned
on firewood fuel. This superheats the fire to temperatures steadily
above 1,000 [deg]C., resulting in total carcass incineration in
approximately 20 minutes. (Cadaver incineration times will vary with
factors such as fat content, moisture content, firebox or pit
temperature, type of wood waste used, etc.) Site selection is important
for air curtain trench burners, and soil type, underground water table,
and prevailing wind direction should be carefully considered. High
water table areas and sandy soil types should be avoided. Stable
vertical trench walls with minimum entry of underground water into the
burn area are needed for steady high incineration temperatures.
Burial on premises. Many States specify requirements for owners who
bury their dead stock on their own premises. Typically, State laws
limit the number of animals that may be buried, require adequate
topsoil covering the animals (usually 2 or 3 feet), and attempt to
restrict burials in areas where runoff passing over the animals would
contaminate groundwater or aquifers.
Tissue digestion. Because this is a new and relatively expensive
technology, most State laws do not yet recognize or recommend it as a
means of dead stock disposal. Tissue digesters are essentially large
``pressure cooker'' devices that use boiling sodium hydroxide solutions
to degrade proteins and fats and result in a sterile liquid suitable
for municipal sewage systems, and a sterile, crumbling calcium
phosphate residue from the bones and teeth of the animals. Research has
shown this method to very effectively reduce levels of TSE infectivity.
A typical digester costs several hundred thousand dollars, could
process several cattle cadavers simultaneously, and takes several hours
to complete a processing cycle. Currently, most digesters in the United
States are located at major veterinary research centers or veterinary
teaching hospitals.
Preferred Methods for Dead Stock Disposal
APHIS is seeking comments on which approaches for safe disposal of
dead stock should be encouraged or required. The primary issue we would
like commenters to address is how to develop a combination of
regulatory requirements, incentives, and cooperative relationships with
production and disposal industries that
[[Page 2708]]
will result in sustainable procedures for the safe disposal of dead
stock.
Commenters are also asked to consider the costs associated with any
such solutions, and any trade-offs that might result by requiring
particularly stringent disposal methods to protect against BSE, when
easier disposal methods might be adequate protection against other
animal diseases. Such comments could also address whether moving to a
disposal system designed with BSE in mind might reduce the availability
of other types of disposal services which might be needed in situations
where it is necessary to dispose of large quantities of carcasses that
do not present a BSE risk (e.g., an FMD or pseudorabies outbreak).
Commenters should bear in mind that our current BSE surveillance
includes collecting samples from cattle that die on-farm. We would like
commenters to address how APHIS could continue to obtain and increase
our samples for testing from dead stock.
When dead stock are disposed of unsafely, it is because safe
disposal is unavailable, expensive, or inconvenient. One approach to
dead stock disposal could be to require certain methods of disposal
(e.g., incineration, landfill burial, digestion, or composting, at
licensed facilities) under Federal or State laws. But requiring certain
disposal methods does not automatically make them available,
inexpensive, or convenient. Also, some disposal methods have been very
useful for disposing of small numbers of animal carcasses, but their
use for the disposal of large numbers of carcasses may result in an
increased disease risk to other livestock producers in an area. The
short term savings from these methods can easily result in an increased
cost later on, which could have been reduced or eliminated if the right
techniques had been used initially.
As discussed above, different disposal methods result in different
levels and types of risk that cattle could contract BSE from a disposed
animal. There are very effective and usually expensive disposal methods
that reliably inactivate any infectious agent, including BSE, in a
destroyed cadaver. These methods include incineration (on-farm or at a
remote incinerator) and tissue digestion. Other disposal methods are
known to be partially effective in deactivating the BSE agent, thus
reducing but not eliminating risk. These methods include rendering
(known to reduce BSE infectivity, with the extent of reduction related
to the process used) and composting (apparently reduces infectivity,
but to what degree is not well characterized). In both of these
methods, an important element may be diversion of the end-product to
uses that will not bring it into contact with animal feed. Other
methods such as open burning, burial, and landfill disposal have great
variations in their effectiveness due to the great variations in how
they are implemented at different times and places.
An important aspect of disposal methods is that they can achieve
the desired end either by deactivating the BSE agent or by isolating
it. The BSE agent in dead stock need not be inactivated if it is
reliably kept from contact with animals that it might infect. Another
aspect to consider regarding disposal methods is the extent to which
they create further disposal problems downstream. Incineration reduces
animals to a small volume of ash, but the ash must be spread somewhere.
Tissue digesters produce innocuous liquid waste and some calcium
phosphate. Burial and landfill disposal do not immediately reduce the
volume of the animal and create enduring concerns about scavengers and
leaching into the water table. Rendering greatly reduces the volume of
the processed product by removing water content and places the end-
product in containers, but it has labeling and use concerns because the
product may still be infectious.
We are seeking comments to help us balance these considerations in
developing good dead stock disposal practices. We have better
information on the issues associated with rendering, compared to other
disposal methods, because rendering businesses are few in number and
uniform in operation compared to the great variety of businesses
operating landfills, incinerators, and composting services. While the
following discussion directly addresses some issues associated with
rendering, we hope commenters will help us develop similar data
regarding other disposal methods.
Here are some of the questions regarding whether rendering is a
useful disposal method for dead stock that could harbor TSE's: Since
rendering does not completely destroy TSE agents, can we be sure
rendered products from possibly-infected dead stock would all be used
in ways that would not spread TSE's? Given the capacity and
distribution of rendering plants, is rendering of dead stock a viable
option nationwide, or are there areas where it is practically
unavailable? If rendering is a desirable disposal method, what sorts of
requirements, partnerships, or incentives could increase its use?
There are approximately 100 million cattle in the United States,
including beef, dairy, and other categories. Over a million post-
weaning calves and adult cattle die or are killed each year before
being sent to slaughter. The National Renderers Association estimates
that about 44 percent of these carcasses were sent for rendering last
year but notes that this percentage is declining, as the profitability
of rendering dead stock declines. North American renderers process more
than 50 billion pounds of animal and poultry material each year,
including dead stock, offal, and waste from slaughter and packing
plants, and animal waste from food processing, supermarket, and
restaurant industries. Rendering reduces the volume of this material by
64 percent, mostly by reducing the water content, which makes the
resultant products much easier to package and transport--whether for
sale, or for disposal. The value of rendered products in the United
States in 1998 was approximately $3.2 billion, and consisted of 9
billion pounds of protein concentrate (largely meat and bone meal, or
MBM) and 9 billion pounds of animal fat such as tallow.
Historically, the bulk of rendered products has been used by the
feed industry, which adds MBM and high-energy fats to feed mixes for
cattle, swine, poultry, and pets. MBM is an attractive feed supplement
because it is high in protein, calcium, and phosphorus. The chief
supplements that compete with MBM are soybean meal and corn gluten
meal. Neither of these plant-based supplements has significant levels
of calcium or phosphorus, although corn gluten meal has a higher crude
protein content than MBM (60 percent compared to 50 percent). Wholesale
prices for MBM and soybean meal have traditionally tracked each other
closely, but with MBM commanding a slight premium presumably due to its
better mineral content. From January 1988 through February 1996,
ruminant MBM sold for an average of $16.05 per ton above the price of
soybean meal, but since March 1996, the average price of ruminant MBM
has been $1.20 below the price of soybean meal. This price reduction
probably results largely from the FDA feed ban, although greater
production of soy and corn may also be a factor.
Steady decreases in the price brought by MBM, coupled with
increases in transportation and processing costs, act to reduce
renderers' traditional role as the primary means for producers to
dispose of dead stock. In the past, renderers paid farmers for their
dead stock, but recovered that cost by selling the byproducts at a
profit. Farmers got rid of their dead animals without cost or
[[Page 2709]]
difficulty. Now, however, the rendered product derived from a dead
stock cow is worth perhaps $20; to cover collection and processing
costs and profit, renderers charge the owner a pickup fee of from $15
to $35 for each animal. This causes producers to seek cheaper means of
disposal. It has also caused some renderers to stop offering dead stock
pickup when they do not find it cost effective; renderer pickup is very
difficult to arrange in Ohio and Michigan, among other places.
We have not yet been able to obtain accurate national figures to
indicate the fall-off in renderer pickup of dead stock, but we do have
illustrative data from one State, California. The California Department
of Food and Agriculture recently required renderers to submit annual
reports on how much of their raw material came from dead stock. These
reports show that between fiscal years 1999-2000 and 2000-2001, the
number of dead stock (poultry excluded) that was collected by renderers
declined by 20 percent--from 686,434 head to 553,974 head.
To help commenters focus their comments on the role of rendering in
dead stock disposal, we are providing certain basic information about
how rendering industries are regulated, their business situation, and
certain rendering industry initiatives relevant to dead stock disposal.
Persons interested in obtaining more information on rendering
industries may wish to visit the National Renderers Association website
at http://www.renderers.org.
Renderers generally must be licensed by each State in which they do
business. Licensing and operating requirements for renderers vary from
State to State. With regard to Federal regulations, renderers, like any
business, must comply with numerous regulations regarding employment,
worker safety, environmental quality, and so on. Renderers of livestock
species subject to the FMIA are required to register their businesses
with the FSIS, in accordance with 21 U.S.C. 643 and 9 CFR 320.5.
(Renderers who do business solely at official slaughter, packing, or
other establishments inspected by FSIS are exempt from this
registration requirement.) Renderers are also subject to FDA
regulations at 21 CFR 589.2000--the ``feed ban'' regulations--that
impose requirements on renderers that produce products for use in
animal feed. The FDA regulations include requirements for labeling,
recordkeeping, separation of raw materials based on species type, and
related matters to ensure mammalian protein (with certain exceptions)
does not go into ruminant feed.
The rendering industry and individual renderers have taken several
actions affecting dead stock disposal and TSE issues. Starting in 1991,
most renderers elected not to pick up dead sheep, due to the possible
scrapie/BSE link, as a means of keeping sheep dead stock protein out of
ruminant feed. That industry-elected action became irrelevant in 1997
with the FDA ruminant feed ban, but dead sheep pickup is still not
happening because: (1) Many contracts from product end-users specify
that no adult ovine protein is allowed in the product, and (2) the same
economic conditions that make it marginal for renderers to pick up any
dead stock (cattle, swine, etc.) make it a low priority for renderers
to resume picking up sheep. However, renderers have stated that they
could reinstitute sheep pickup if it becomes economically viable to do
so.
Rendering industry representatives cooperated with FDA in
developing the feed ban regulations and have monitored compliance with
the ban within the rendering industry. Beginning in April 2001, the
Animal Protein Producers Industry (the biosecurity arm of the rendering
industry) started an inspection audit of all animal protein producers
to ascertain compliance with the FDA feed ban. This was a third-party
audit performed by an independent auditing firm, Cook & Thurber of
Madison, WI.
Currently, a major concern of renderers is identifying markets for
MBM and other rendered protein products that contain ruminant protein.
Year 2000 production of MBM was nearly 6.7 billion pounds, of which 5
billion pounds, or 75 percent, contained ruminant protein. All of the
ruminant protein MBM production has been diverted from use in ruminant
feed, with most going to swine, poultry, and pet feed. Export markets
for MBM have also increased more than four-fold in the past 10 years,
to 979 million pounds in the year 2000. However, oversupply of MBM
compared to the demand for its allowed uses continues to drive MBM
prices down. The industry believes it would be physically possible for
independent rendering plants to install separate processing lines that
would allow them to reduce the amount of MBM containing ruminant
protein, and increase the amount of ruminant-free MBM, by roughly 1.5
billion pounds a year. However, the capital expenditure and operating
costs to do this would mean that renderers would lose money with each
year additional separate processing lines are operated, given
prevailing prices for MBM.
Renderers continue to seek new, non-feed markets for their rendered
product. However, the market opportunities seem to be much greater for
rendered fat and oil product lines than for rendered protein product
lines. For example, there is a growing market for biodiesel fuels that
can be produced from animal (as well as plant) fats and oils. The
USDA's Foreign Agricultural Service has reported that, to address MBM
disposal in Europe, ``New uses are being pursued, such as burning MBM
in power plants to produce electricity or burning it in kilns to
produce construction materials such as cement.''\10\
---------------------------------------------------------------------------
\10\ ``International Agricultural Trade,'' February 5, 2002,
p.3. Foreign Agricultural Service, USDA.
---------------------------------------------------------------------------
We are interested in receiving comments that discuss whether
rendering can be an effective means for safely disposing of dead stock
in a manner that minimizes risks of spreading BSE and other animal
diseases. We hope that commenters will address the full range of
technical, economic, regional, environmental, and practical business
issues associated with this question. At this time, APHIS believes that
the key issues associated with using rendering as a safe means of
disposal for dead stock are:
[sbull] Should dead stock ruminants be segregated at rendering from
material being rendered for animal feed use?
[sbull] If so, can the rendering industry successfully implement
this degree of raw material and product segregation and labeling? What
would the cost implications be?
[sbull] If the cost of rendering dead stock exceeds the value of
the rendered product, who should pay the excess cost? The producer,
State or local government, Federal Government, or someone else?
[sbull] What could be done through cooperation between industry and
government to decrease the cost of picking up dead stock for rendering
(e.g., harmonization of licensing and regulations, creation of regional
pickup centers, etc.)?
Compliance, Enforcement, and Incentive Issues
We are also interested in receiving comments on ways to ensure
compliance with any dead stock disposal requirements that may
eventually be established through rulemaking. Vigorous enforcement,
with civil and criminal penalties for violators, is one means to
encourage compliance. However, there are obvious limits to APHIS'
ability to directly monitor and enforce dead stock disposal
[[Page 2710]]
requirements. Our inspectors cannot directly observe, or even be aware
of, all the thousands of animal disposal incidents that occur each day.
In addition to enforcement and penalties, there may be a role for
incentives to help achieve compliance in dead stock disposal practices.
One possible incentive may be a program to help owners pay for the
cost of dead stock disposal under certain circumstances. In a January
2002 report \11\ about strengthening regulatory efforts to prevent BSE
in the United States, the Government Accounting Office (GAO) noted that
USDA sometimes subsidizes animal disposal costs in order to obtain
sufficient tissue samples for its BSE surveillance program. The report
notes that ``In 1998 USDA implemented a cooperative program with the
rendering industry to ensure that carcasses of animals condemned at
slaughter for signs of neurological disease are held until test results
are completed. Under this program, USDA may share the expenses to store
or dispose of carcasses during the testing period.''
---------------------------------------------------------------------------
\11\ ``MAD COW DISEASE: Improvements in the Animal Feed Ban and
Other Regulatory Areas Would Strengthen U.S. Prevention Efforts,''
GAO-02-183, Government Accounting Office, January 2002.
---------------------------------------------------------------------------
Similar programs haves used State, Federal, and industry subsidies
to obtain surveillance samples and to encourage responsible dead stock
disposal. For example, when cattle with neurological signs of illness
are identified at ante mortem inspection in several States, the costs
of sample collection and carcass disposal are shared between State
government, Federal agencies, and renderers. We are seeking more data
on the rationale and operations of these and similar programs,
especially including any studies of their overall costs and benefits.
We hope to assemble enough data to evaluate the costs and benefits
associated with possible dead stock disposal programs that could be
designed to maximize benefits to the general public, cattle producers,
disposal industries, and others. One possible design for a voucher-
subsidized ``multi-benefit'' dead stock disposal program is discussed
below.
Consider a program where the Federal or State Government issues
qualifying producers a certain number of ``stock disposal vouchers''
each year. If one of the producer's animals dies on-farm, or becomes so
ill or injured the producer decides to euthanize it, the producer could
use a voucher to cover some or all of the costs of disposing of the
animal. The government that issued the vouchers may make arrangements
with incinerator operators or other disposal businesses that will honor
the vouchers. Dead stock transporters may also be involved in the
voucher system. In all cases, businesses may benefit from increased
formal disposal of dead stock that, without the voucher system, might
be buried on-farm. Solid waste disposal systems may benefit as fewer
animals are taken to limited landfill spaces and more animals are
incinerated. Public health and environmental values may benefit from
fewer casual or illegal animal disposals that pollute groundwater and
spread disease.
Such a voucher system could also benefit USDA disease surveillance
programs if it includes a requirement to allow USDA to examine and
collect samples from the animals for which vouchers are used. USDA
staff or accredited veterinarians could be used to examine animals
prior to euthanasia and to collect samples from dead animals prior to
their disposal.
As an alternative to a predefined voucher system for dead stock
disposal, Federal or State agencies could concentrate on identifying,
and paying disposal costs for, downer animals that would be euthanized
on the farm. This approach might offer a bounty or reward payment for
owners who report certain types of animals in their herds--e.g., adult
cattle showing certain signs indicative of CNS conditions. The Federal
or State agency could then examine the animal, euthanize it, take
samples if the examination showed a reason to do so, and arrange to
dispose of the cadaver. The owner would receive a small bounty payment
and would avoid any disposal costs he might otherwise have faced if he
euthanized the animal without government assistance.
The above are just two examples of a design for a ``multi-benefit''
dead stock disposal program; we encourage commenters to suggest others.
If your comment suggests a system for dead stock disposal, please
include your thoughts on what businesses, levels of government, or
other parties should be involved. We are particularly interested in
hearing comments on whether such programs should be organized on the
county or State level, a regional level, or a national level, and what
role the Federal Government should play.
Dead Stock Disposal for Species Other Than Cattle
While this notice primarily addresses disposal of cattle, there are
obviously related issues for other species. In particular, commenters
may wish to address disposal of sheep and goats with regard to scrapie,
disposal of captive elk and deer with regard to CWD, and disposal of
all types of livestock with regard to communicable non-TSE diseases. We
hope commenters will help us to understand what dead stock disposal
issues are common to all of these species, what issues are of
particular importance to different types of producers, and the possible
costs to involved parties (including producers and taxpayers) of
addressing these issues.
Summary of Issues Open for Comment
[sbull] What is the preferred approach and associated costs to
affected parties for controlling risks associated with disposal of
nonambulatory and dead livestock?
[sbull] Are there any cross-cutting issues between safe disposal of
specified risk materials such as brain and spinal cord and safe
disposal options for downer and on-farm dead animals?
[sbull] Are there practical ways to cull higher-risk downer cattle,
e.g. cattle that may have a non-obvious CNS condition, before they are
sent to slaughter? How should risk factors such as age, physical
condition, and the source and type of cattle be considered when sending
downer cattle to slaughter? What would such culling cost affected
parties?
[sbull] Since APHIS currently relies on collecting samples from
downer animals, at slaughter and other locations, as a key part of BSE
surveillance, how could we continue to obtain samples for testing from
downer cattle if they are not sent to slaughter?
[sbull] What carcass disposal methods are safe, fast, complete, and
environmentally acceptable? What combination of regulatory
requirements, incentives, and cooperative relationships with production
and disposal industries would result in sustainable procedures for the
safe disposal of dead stock, and what are the costs associated with
such solutions?
[sbull] Can rendering be an effective means for safely disposing of
dead stock in a manner that minimizes risks of spreading BSE and other
animal diseases? Under what conditions? What are the associated
technical, economic, regional, environmental, and practical business
issues?
[sbull] What are equitable ways to share the costs of dead stock
disposal, to concentrate and increase economic opportunities and social
benefits that can be associated with responsible dead stock disposal?
[sbull] What businesses, levels of government, or other parties
should be involved in dead stock disposal? Should such programs be
organized on the
[[Page 2711]]
county or State level, a regional level, or a national level, and what
role should the Federal Government play?
[sbull] Is there a need to particularly address disposal of sheep
and goats with regard to scrapie, and disposal of captive elk and deer
with regard to CWD? What dead stock disposal issues are common to all
species, and what issues are of particular importance to different
types of producers?
Done in Washington, DC, this 15th day of January 2003.
Bill Hawks,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 03-1210 Filed 1-17-03; 8:45 am]
BILLING CODE 3410-34-P
http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-1210.htm
BAN ALL DOWNERS/SRMS/MRMS FROM ALL SPECIES FROM BEING FED
TO ANY OTHER SPECIES.
NO SCRAPIE SHEEP/GOATS OR CWD/TSE DEER/ELK TO BE RENDERED,
ONLY INCINERATED!
RAPID BSE/TSE TEST _ALL_ DOWNERS!
RAPID BSE/TSE TEST 1 MILLION CATTLE ANNUALLY FOR FIVE YEARS!
MAKE CJD/TSE REPORTABLE NATIONALLY!
# Docket No. 02N-0273 – Substances Prohibited From Use In Animal Food Or
Feed (TSS SUBMISSION) - TSS 1/18/03 (0)
http://www.vegsource.com/talk/madcow/messages/9912338.html
USA GBR II SHOULD BE CHANGED TO GBR III IMMEDIATELY !
GBR BSE RISK ASSESSMENT SHOULD BE CHANGED TO INCLUDE _ALL_ TSEs !
TSS
