From: Bernie Shire [bfshire@aamp.com]
Sent: Tuesday, October 12, 2004 4:02 PM
To: fdadockets@oc.fda.gov
Subject: Docket No. 2004N-0081 (RIN-0910-AF47)

								October 11, 2004

Department of Health & Human Services
Food and Drug Administration (FDA)
Division of Dockets Management
5630 Fishers Lane, Room 1061
Rockville, MD 20852

RE:  Docket NO. 2004N-0081:  RIN-0910-AF47:  Use of Materials Derived from
Cattle in Human Food and Cosmetics; and Recordkeeping Requirements for Human
Food and Cosmetics Manufactured From, Processed With, or Otherwise
Containing, Material from Cattle; Final Rule and Proposed Rule

The American Association of Meat Processors is submitting the following
comments on two issues:  the complete ban on the use of all non-ambulatory
disabled animals; and the complete ban of the use of the small intestine
from cattle of all ages, and the labeling of the intestines as a Specified
Risk Material, particularly in beef casings that are used in sausage and
other meat products.

AAMP Objects To Complete Ban on Non-Ambulatory Cattle

AAMP believes that the complete ban on the use of non-ambulatory disabled
cattle as a result of the discovery of a single cow with BSE in Washington
State in December, 2003, is not justified.  The Agency has levied this ban
on all cattle that would enter the food chain, including animals that are
under USDA, Aequal to@ state program inspection, and custom slaughter and
processing, animals that are not turned into meat to be sold wholesale, but
are slaughtered and processed for the animals= owners.

The Association can understand that FDA is following USDA in placing
restrictions on cattle that exhibit central nervous system (CNS) disorders
and other illnesses.  But AAMP cannot see or buy the reasoning to place
these same restrictions on animals that have injuries such as broken
extremities.  It is impossible to see any food safety issue connected with
animals that cannot walk because they have suffered broken legs or pelvic
problems due to birthing.  There is no scientific basis or need for such a
policy.

This is particularly true when animals suffer broken appendages due to
injuries that occur in feedlots, in trucks in which they are being
transported to slaughter, or to other locations.  There is no way to justify
the banning of such animals for slaughter just because the injuries took
place before ante mortem inspection.  An animal that suffers an identical
injury after ante mortem inspection on the way to the box is deemed fit for
slaughter when presented.  Yet there is no difference in the injury to the
animal.  There is no scientific documentation or evidence for FDA to make
this distinction.  While a good case could be made for not allowing animals
suffering from central nervous system (CNS) disease into the human food
supply, there is no way to make a similar argument for animals that have
suffered physical injuries, such as broken legs.

But there is a solution to this problem that makes much more sense than the
total downed cattle ban.  Why not allow slaughter plants to test their
cattle for BSE and hold them until they get the results of their tests?

In the past, there has been a limited amount of testing of animals for BSE B
about 20,000 animals annually, with a goal of 40,000 animals.  Yet the
Department of Agriculture re-designed its testing program, to greatly
increase the number of animals to be tested over the next 12 to 18 months to
about 268,000 annually.  Most of these animals will be those that are
already dead or are dying.  About 20,000 will be healthy animals who are
older (more than 30 months old), and who are headed for slaughter.  While
APHIS is saying there would be payment for cattle for testing, a spokesman
for the Agency said there is no indication as to how much would be paid per
animal, or an overall figure from the USDA budget.

But if testingBandBholding for BSE were to be allowed, in the end, it will
cost the public less in the marketplace.  If the test comes back negative,
it won=t result in an animal thrown away.  If cattle are destroyed, thrown
away for no reason, that will cost meat processors about $1,000 per animal.

There have been some preliminary guesses as to what the ban on
non-ambulatory animals will cost.  An economist for the National Cattlemen=s
Beef Association puts the cost of the ban on downer animals at $55 million,
not including those that would normally have been condemned due to disease
or other maladies.  The rule prohibiting specified risk materials (SRMs) for
animals over 30 months from USDA is estimated to cost between $17 million
and $59 million, while the cost of removing these materials is probably $100
million more.  So we=re already over $200 million.  But we think this is a
gross underestimate.  In Pennsylvania alone, there is thought to be 25,000
downers a year processed.  At a cost of $1,000 an animal, this would be a
loss of $25 million in just one state.

Slaughter Ban will Result in Fewer AGood@ Tests for BSE

The basis for USDA=s BSE testing program, which FDA seems intent on
following, had been that non-ambulatory animals with the greatest chance of
having the disease are brought to the slaughterhouse to be killed, and then
tested.  AAMP believes the interim final rule preventing slaughtering of all
non-ambulatory animals for food purposes will result in fewer animals being
tested for BSE, especially those with the greatest chance of being infected
with the disease.  The result will be that there will be very little chance
of finding animals that might have BSE.  The fact that non-ambulatory cattle
were being brought to slaughter in the first place, as well as undergoing
tests for BSE, had actually helped USDA to find animals that might be sick
and not be fit to use as food.

The likelihood of animals undergoing tests for BSE back on the farm or
ranch, or at the rendering plant is very slight.  If the case involving the
cow with BSE in Washington State is a good example, we don=t think that
producers want to put themselves in the position of having an animal tested
there, with a tentative or a definite positive and face a potential
Adepopulation@ of their entire herds.  USDA should allow cattle to be tested
for BSE at the slaughter plant, so that a lot of money won=t be wasted, or
lost by the animal=s owner or the slaughter plant, and FDA should support
such a policy.  As far as we can determine, there is no money in federal
budget to compensate slaughterers, processors or producers for animals that
can no longer be sent to slaughter because they are non-ambulatory or
because they exhibit signs or symptoms of central nervous system (CNS)
disease.  If there is no compensation for these animals, AAMP is concerned
that if no compensation or indemnification is offered, non-ambulatory cattle
farms will Afind their way@ elsewhere for burial, without, of course, being
tested for BSE.  In fact, even if compensation would be offered, we are
concerned that non-ambulatory cattle would still be destroyed, so producers
may seek to avoid the bad publicity from finding a BSE-infected animal.

Restrictions on Custom Animals Can=t Be Defended

AAMP also believes that the restrictions being put on using non-ambulatory
injured animals in custom slaughter and processing cannot be defended.
Again, there are no reasons for this prohibition that can be argued
scientifically.  According to USDA, the policy against using custom
non-ambulatory injured animals in the food supply is based on the
adulteration provisions in the Federal Meat Inspection Act.  But custom
animals
are also exempt from the provisions in the Act requiring ante mortem and
post mortem inspection.  There is no reason for FDA to follow along with
that same policy for the products that it regulates.

At the same time, a custom-exempt animal, raised by a farmer and brought to
a custom-exempt establishment for slaughter or processing, still belongs to
the farm, not the establishment.  The cattle cannot be condemned because it
was injured on the way to the slaughterhouse.  This policy would also seem
to raise a constitutional issue as to whether the government can confiscate
the farmer=s property due to this reason.

Also, in designated states, there hasn=t been good communications between
Department of Agriculture and custom-exempt plants.  There are two kinds of
custom-exempt plants: those who also do some slaughtering and processing
under inspection, and those who don=t.  In the case of custom plants that
have no connection to inspection, the Agency hasn=t updated  these plants as
frequently as state inspection programs do with Atheir@ custom plants.  The
federal agency hasn=t told custom plants about the ban on the slaughter of
non-ambulatory animals for food purposes to the same degree that state
inspection programs have.

So we wonder who would decide if an injured cow was adulterated, and how
would it be decided?  AAMP believes that the Agency would have problems
enforcing condemnations of recently injured animals in custom plants in
designated states.

If USDA continues to insist that the provisions of this interim final rule
are also applicable to custom plants, we predict that most injured animals
will be slaughtered illegally on farms, under unsanitary conditions, and
will hinder, rather than help, public health.  In fact, Ashade tree@
slaughter operations are taking place right now.

We wonder if the government would accept the practice of all Acustom@
animals being tested, with the cost being borne by the owner of the animal
who is paying the slaughter plant who is providing the service in killing
and processing it.

FDA has also aligned itsself with USDA and has made public statements in
defense of the ban on non-ambulatory animals due to:
(1) Auncertainty@ about what causes BSE in animals and that purely physical
injuries, as well as central nervous system (CNS) can=t be ruled out; (2) a
Agreat deal of opposition@ to the use of non-ambulatory animals in the food
supply even before the BSE cow appeared on December 23 of last year.  FDA
says that Congress and consumer activist groups have voiced opposition to
using such cattle.

It is our feeling that Agency regulations are supposed to be based on
comments from stakeholder groups, and not on the Agency=s feelings about
what certain members of Congress and consumer groups might Athink@,
Abelieve@ or Awant.@

AAMP notes that FDA and USDA are supporting a provision in the Federal Meat
Inspection Act that allows animals that have been condemned to be set apart
and held for treatment.  Under this section of the law, non-ambulatory
Abob-veal@, for example, can be retained and warmed up until the animals can
walk and then be fit for slaughter.  AAMP supports this provision and action
by the Agency.

Plants Need Financial Reimbursement from Government

Our Association is also concerned about the lack of financial reimbursement
from USDA, FDA and Aequal to@ state inspection programs to producers,
slaughterers and processors who experience economic loss as the result of
government condemnation of all non-ambulatory injured cattle.  By failing to
provide financial assistance to such establishments, the slaughter and
producing industries are forced to pay a severe monetary penalty for
something that has happened that is beyond the control of the firms that are
involved.  USDA needs to offer financial reimbursement to cover huge
additional expenses that plants are incurring, including additional labor
costs, handling of the cattle and storage costs.

In the state of Washington, legislation has been approved that would offer
temporary business and occupation tax breaks for companies there that
slaughter cattle for processing and wholesaling.  The same thing should be
done across the United States for cattle that are inspected by USDA, state
programs, or custom slaughter and processing.

Designation of Vertebral Column as SRM not Warranted

In its comments, the American Association of Meat Processors raised some
concerns about the Agency=s designation of the vertebral column in cattle as
Specified Risk Materials (SRMs).  Our Association believes that FSIS should
remove its designation of the major parts of the vertebral column of cattle
as an SRM.  As we understand it, the reason USDA made this designation
initially is that the dorsal root ganglia of cattle are attached to the
bones of the vertebral column, and aren=t removed along with the
loosely-attached spinal cord.  But setting the vertebral column as an SRM
because of the attachment of the ganglia is not justified.

In our comments to FSIS, we noted the Agency has the authority to require
inspected establishments to fully remove the spinal cord and the ganglia
next to it before the carcass leaves slaughter.  We think that would be
better than declaring the major parts of the vertebral column as inedible.

Initially, USDA had published information on its web site indicating that
steaks could safely be cut and separated from the major parts of the
vertebral column, without contamination of the meat as SRM.  At the time,
that was the best information available, and the USDA-FSIS Technical Service
Center in Omaha, NE concurred with the information.  But more recently, FSIS
says that steaks should not be cut from the vertebral column.  So AAMP,
other trade associations and university meat science departments, who
initially published the same advice and guidelines, are reevaluating the
guidance.  But that doesn=t mean we think the USDA advice is correct, or
scientifically justified.

The Harvard Study said that the estimates are likely to overstate true human
exposure because they represent the amount of infectivity presented for
human consumption but do not take into account waste or actual rate of
consumption.  For example, the reported quantity for potential exposure to
infectivity in bone-in beef reflects the presence of spinal cord and dorsal
root ganglia in a fraction of cuts like T-bone steaks,
although the spinal cord and the dorsal root ganglia may never be consumed
in these cuts of meat.

Seven years ago, Great Britain banned bone-in beef after studies indicated
that in experimentally-inoculated cattle, the dorsal root ganglia contained
the prion that is thought to cause BSE.  But two years later, Britain lifted
the ban on the sale of bone-in beef because scientists researching how the
disease is transmitted concluded that the potential risk to humans from
bone-in beef was insignificant.  The Harvard study also reported that
bone-in beef was a less-likely route for human exposure to BSE.  What USDA
is saying about this issue is quite unclear and confusing.

The elimination of the use of backbones in ground bones will reduce by 50
percent on average the production of ground bones by companies that do this
work.  Eliminating the use of neck bones for commerce is also costly to
companies that are involved in this processing.

Why Are Small Processors Forced to AInspect@ Packers?

The American Association of Meat Processors had also expressed concerns
about USDA policy that is forcing further processors to take steps to make
sure that packers and slaughterers are complying with the interim final
rules on BSE.  According to the way the regulation is written, it is against
the law for a packing or slaughtering plant to sell product containing
Specified Risk Materials (SRMs) unless the product is marked that it
contains such materials, and that there is a means for them to be removed.

So it still makes no sense that further processors, including many AAMP
members, buy USDA-inspected meat with the mark of inspection on it, and then
have to face the possibility that FSIS would mark the product as being Aover
30 months of age@ if the processing plant can=t obtain verification letters.
The Agency is directing these processors to obtain verification letters from
packers, the same as when processors were forced to verify that suppliers
were complying with the E. coli O157:H7 regulations by having verification
letters, even though the product carried a mark of inspection.  This
inspection mark on a meat product says that it has been inspected by a USDA
inspector and Apassed,@ which means that the product was produced in
accordance with the regulations published by FSIS.  So, what is the point of
having the mark of inspection if
it doesn=t mean what it says it does?  There is no justification for
requiring the mark of inspection to be Averified@ by a letter stating that
the supplier followed the USDA meat inspection regulations.

Mark of Inspection Should Not Be ATentative@

AAMP took issue with this policy during one of USDA=s five small/very small
plant BSE seminars this past winter when the issue was raised by FSIS policy
staff.  Dr. Daniel Engeljohn, FSIS Executive Associate for Policy Analysis
and Formulation, said that the USDA mark of inspection on some products the
Department inspected can be Atentative.@  The new definition of the mark of
inspection as Atentative@ came in response to a question posed by AAMP
concerning letters processors are being asked to provide from suppliers
indicating that the products they receive contain no SRMs.

While Dr. Dan Engeljohn from said this policy is necessary because a lot of
product over 30 months of age is being shipped from packers to further
processors, it is our feeling there is very little over-30-month bone-in
product being moved.  It seems to us this debate is a way for USDA to avoid
the main issue.  If the large packers and suppliers are following the rules
and the product is passed, then the mark of inspection should be applied,
and letters of guarantee would not be needed.  In addition to raising this
issue in our comments on the interim final rulemaking, AAMP has also asked
for a written explanation of what should be an USDA proposal prior to
implementation, with a written explanation from FSIS about it, not as a
policy change or public policy already carried out.  FDA should not follow
along and mimick this USDA policy.

Carcasses with SRMs Should Not Leave Establishments

It is our opinion that carcasses containing SRMs should not be allowed to
leave an official slaughter establishment, especially with the marks of
inspection on them.  That policy is contrary to the whole idea of meat
inspection, and raises questions about the significance of the marks of
inspection.  Does Ainspected and passed@ mean anything anymore?  If it
doesn=t, then USDA could save inspected establishments a lot of headaches,
and the taxpayers of the United States a lot of money, by stopping meat and
poultry inspection.

The current USDA policy that allows official slaughter establishments to
ship carcasses containing SRMs to official processing establishments, under
the assumption that the further processing plants will remove the SRMs, is
wrong.  Since SRMs can=t be eaten under USDA regulation, a carcass
containing inedible parts should not carry inspection marks.  Otherwise, the
confidence of the American public in marks of inspection as an indicator of
meat safety, will deteriorate.  This kind of vague inspection measure could
compromise public health protection.  There should be a regulatory provision
that would prohibit the shipment of cattle carcasses containing SRMs to
another inspected establishment.  This would prevent the possibility of SRMs
reaching consumers due to error or negligence at a processing plant.

We also told FSIS previously that the Agency should also insure that
carcasses containing SRMs are not shipped to uninspected establishments,
such as retail stores or restaurants.  There is nothing in the final rule
mentioning such a prohibition.  Some FSIS officials have made comments that
carcasses containing SRMs could be sent to retail outlets, who would be
responsible for removing them.  We don=t think that such an expectation is
realistic.  A huge field force of compliance officers (which doesn=t exist)
would be needed to enforce such action by retail stores or restaurants.  The
prohibition should be included in the final rulemaking.

AMR Limitations Hurt Plants

The limitations that USDA has placed on Advanced Meat Recovery, such as
eliminating the use of backbones in this process, has hurt meat plants that
carry it out, including a number of small meat establishments.  On average,
the amount of finely textured beef (FTB) produced by these plants has been
reduced by 65 percent because of the limitations placed by the Agency.  We
will talk about the cost to such plants in our separate comments on the FSIS
Preliminary Regulatory Impact Analysis (PRIA).

Concerns About Rulemaking on BSE

AAMP also has concerns about the rulemaking process.  We notice that notices
are more detailed and lengthier than the interim final rules on BSE.
Notices carry the weight and power of regulatory requirements.  They are
only good until early 2005.  But we are concerned that for years to come,
inspectors will equate them with regulations.

Also, interpretations and explanations in notices often go far beyond the
regulations, as in the case of the notices relating to BSE.  The rulemaking
should be more inclusive, that would contain all the permanent regulatory
provisions.  This approach would eliminate the negative impression that
internal documents, such as notices and directives, are being used to
circumvent the open notice-and-comment rulemaking process.

Concern About the Complete Ban of the Small Intestines

In this proposed rulemaking, FDA bans cattle materials from not only the
distal ileum of the small intestine of all cattle, but the entire small
intestine itself.  There is no reason to do this, because only the distal
ileum is associated with BSE as a risk material, in the view of numerous
international regulatory authorities.  But both FDA and USDA ban the entire
bovine small intestine, because in the opinion of both agencies, it would be
"easier" and "safer" to do that than to take a chance that part of the
animal organ might get into product.

The American Association of Meat Processors would also like to ask the Food
and Drug Administration why there is also a policy banning the importation
of the beef casings from countries that are considered to be "BSE free".  We
understand that instead a political decision has been made to continue the
ban until at least after November 2, the date of the general election.
Decisions concerning the banning of cattle material should be made based on
real science, not "political science."

This policy is hurting the small meat processing industry severely, and
needs to be changed as soon as possible.  Plants that would be especially
affected negatively by this FDA policy include those who manufacture sausage
and similar products that are enclosed in beef casings.  This policy will
hurt plants that make such products as ring bologna, knockwurst and other
kinds of sausages, especially speciality items.  The small plants will be
affected severely, because they are the only kinds of establishments that
make many of these products.

We appreciate the opportunity to comment on these FDA interim final rules
concerning BSE.




						Sincerely,


						Bernard F. Shire
						Director, Legislative & Regulatory Affairs
						American Association of Meat Processors
						PO Box 269, One Meating Place
						Elizabethtown, PA 17022
						Tel:  717 367 1168
						Fax:  717 367 9096
						E-mail:  bfshire@aamp.com





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