![](media/image1.png){width="0.8125in" height="1.625in"}UNITED STATES
ANIMAL HEALTH ASSOCIATION

**8100 Three Chopt Road, Suite 203**

**P. O. BOX K227**

**RICHMOND, VIRGINIA 23288**

**804- 285-3210 FAX 804-285-3367**

> **E-Mail: usaha@usaha.org**

**Web Site: www.usaha.org**

PRESIDENT

### DONALD H. LEIN

### CORNELL UNIVERSITY

### ANIMAL HEALTH DIAGNOSTIC

### LABORATORY

### BOX 5786

### ITHACA, NY 14852-5786

607-253-3911

FAX 607-253-3907

DHL10@cornell.edu

### 

PRESIDENT-ELECT

##### RICHARD D. WILLER

ARIZONA DEPARTMENT OF

AGRICULTURE

1688 WEST ADAMS

PHOENIX, AZ 85007

602-542-4293

FAX 602-542-4290

rick.willer@agric.state.az.us

FIRST VICE-PRESIDENT

##### BRET D. MARSH

INDIANA STATE BOARD OF

ANIMAL HEALTH

805 BEACHWAY DRIVE, SUITE 50

INDIANAPOLIS, IN 46224-7785

317-227-0300

FAX 317-227-0330

bmarsh@boah.state.in.us

SECOND VICE-PRESIDENT

##### LEE M. MYERS

GEORGIA DEPARTMENT OF

AGRICULTURE

19 M. L. KING, JR. DRIVE

CAPITOL SQUARE, ROOM 106

ATLANTA, GA 30334-4201

404-656-3671

FAX 404-657-1357

lmyers@agr.state.ga.us

THIRD VICE-PRESIDENT

##### JAMES W. LEAFSTEDT

NATIONAL PORK BOARD

P. O. BOX 139

ALCESTER, SD 57001-0139

605-934-2587

FAX 605-934-2587

SECRETARY

##### J. LEE ALLEY

8249 MOSSY OAK DRIVE

MONTGOMERY, AL 36117

334-277-7788

FAX 334-277-7788

JalleyEAlley@knology.net

TREASURER

##### J. W. BRYAN

CLEMSON UNIVERSITY

109-C BARRE HALL

P. O. BOX 340303

CLEMSON, SC 29634-0303

864-650-4585

FAX 864-656-1033

jbryn@clemson.edu

IMMEDIATE PAST PRESIDENT

ROBERT E. FROST

**108th Annual Meeting -- Sheraton Greensboro Hotel, Greensboro, NC --
October 21-28, 2004**

August 13, 2004 Page 2

The USAHA commends FDA for taking a very aggressive regulatory
compliance position towards the current ruminant feed ban. We believe
there has been no FDA rule with a higher level of compliance than this
feed rule and applaud the agency's continuing education and compliance
effort. The USAHA is committed to support the agency's effort to enforce
the current ruminant feed ban.

The USAHA strongly supports the effort of USDA's enhanced BSE
surveillance plan that started June 1, 2004 and is concerned about FDA's
rush to propose changes without the benefit of the 18 month enhanced
surveillance study that relies heavily on renderers, 3 D and 4 D
establishments for samples. Canada's heightened enhanced BSE
surveillance efforts began soon after the discovery of a native born BSE
case in Canada in May 2002 and results to date have found no further
cases of this disease in that country. **The USAHA believes that any
additional mitigation measures must be based on sound science and a
clear need determined from a comprehensive risk/benefit analysis before
additional FDA actions are proposed.** This action would follow the
recommendations of the International Review Team (IRT) commissioned by
USDA following the discovery of the Washington State BSE case in a
Canadian born dairy cow in December 23, 2003. The IRT stressed the
importance of enhanced surveillance in high risk animals (4-D) of the
U.S. cattle population to determine what other controls would be
necessary based on the enhanced surveillance results. FDA's proposed SRM
ban will seriously harm efforts to get that data. The FDA's proposed
all-SRM ban looks at reducing an already miniscule risk further at
tremendous cost to industry and disease surveillance. It is estimated
that over \$2 billion will be lost to revenue of the cattle producer and
industry, downstream lost revenue and disposal cost. Both the National
Renderers Association's Sparks Companies 2001 report: The Rendering
Industry: Economic Impact of Future Feeding Regulations and the
Harvard-Tuskegee Risk Model Study have abundant economic and risk
analysis data at a fraction of the costs that an all-SRM ban would
generate. The approaches include some controls suggested by FDA in the
January 26, 2004 announcement, such as dedicated feed mills and
equipment, registration of all handlers/distributors of prohibited
mammalian protein and third party certification of those farms and
consideration for banning poultry litter.

The following USAHA responses are provided to certain specific questions
posed in the proposed rule.

1: [Would there be value in establishing a specialized advisory
committee or standing subcommittee on BSE?]{.underline} The USAHA's
structure; representing federal/state government agencies, academia,
animal industry organizations, and veterinary diagnostic laboratories
and the development of committees to work on several diseases, eg,
brucellosis, tuberculosis, pseudorabies, pullorum disease, etc. that
constantly advises agencies on programs would be an excellent forum for
a BSE committee. The committees work at several levels; technical,
producer/management and scientific levels. All regulatory diseases
require review and must be dynamic to meet scientific advances and
management change.

August 13, 2004 Page 3

3: [What information, especially scientific data, is available to
support or refute the assertion that removing SRM's from all animal feed
is necessary to effectively reduce the risks of cross contamination of
ruminant feed or of feeding errors on the farm? What information is
available on the occurrence of on-farm feeding errors or
cross-contamination of ruminant feed with prohibited
material?]{.underline} The USAHA is aware that there is on-going review
of on-farm practice by USDA's APHIS and the Harvard Center for Risk
Analysis. These on farm interviews will provide data to answer these
questions. FDA's own inspection data indicates violations are low.
Inspections of facilities are limited and the agency needs to increase
their field force or use other federal or state or private agencies to
increase education, inspection, review and provide data of cross
contamination.

7\. [What would be the economical and environmental impacts of
prohibiting SRM's from use in all animal feed?]{.underline} The USAHA
feels that FDA must conduct a risk assessment and economic cost/benefit
analysis of the impact of removing all Specified Risk Material (SRM)
from the animal feed supply. We feel that their action will create
significant economic problems throughout the entire feed, rendering,
livestock and extended industries. The resulting disposal of SRM's and
4-D animals will pose significant environmental impacts without an
extensive government plan and support for safe and significant disposal
options and the availability of these animals for diagnostic
surveillance of BSE and other diseases. Unless removal of all SRM's can
show significant reduction of future BSE infectivity risk to our
nation's cattle population from the level of risk now present under the
current ruminant protein feed ban, USAHA believes such significant
economic disruptions would not be justified. USAHA would encourage FDA
to propose a number of the risk reduction alternatives as suggested in
the Harvard Risk Assessment Model. Such an approach would permit the
industries to comment on what alternatives might provide the greatest
risk reduction at the lowest cost. Any mitigations resulting in economic
and environmental disruption to the affected industry sections need
appropriate government and public support which might be necessary to
develop or address various SRM and animal protein utilization
alternatives such as bioenergy.

9\. [What information, especially scientific data, is available to show
that dedicated facilities, equipment, storage, and transportation are
necessary to ensure that cross contamination is prevented? If FDA were
to prohibit SRM's from being used in animal feed, would there be a need
to require dedicated facilities, equipment, storage and transportation?
If so, what would be the scientific basis for such a
prohibition?]{.underline} The USAHA would prefer requiring dedicated
facilities and equipment in lieu of a SRM ban. The FDA needs to develop
a risk reduction model based on the agency inspection experience on
cross contamination. This current data is limited, but indicates very
good industry compliance.

12,13,14. [Questions concerning banning all mammalian and avian MBM in
ruminant feed.]{.underline} USAHA is unaware of any data to justify such
a ban. FDA was not concerned in both its 1997 final rule preamble and
its 1998 video teleconference proceeding about all mammalian and avian
MBM in ruminant feed.

August 13, 2004 Page 4

15\. [Is there scientific evidence to show that the use of bovine blood
or blood products in feed poses a risk of BSE transmission in cattle and
other ruminants?]{.underline} There is no scientific evidence that
demonstrates that the use of bovine blood or blood products in feed
poses a risk of BSE transmission on cattle and other ruminants. The
USAHA is aware of transmission of BSE in sheep via a large quantity of
blood transfused from an experimentally infected sheep; also of the two
suspected human cases of vCJD possibly transmitted through blood
transfusion. We have not found reported evidence that BSE can be
transferred to cattle through transfusion of blood or blood products or
through feeding of blood or blood products. The observations of
scientists believe there is a difference in the pathogenesis of the
disease in different species; sheep infected orally with BSE show
widespread deposition of prions in the lymphoreticular system (LRS),
similar to vCJD human patients, whereas in cases of human CJD and cattle
BSE, peripheral pathogenesis does not appear to involve the LRS (Hunter
et al).^1^

^1^ Hunter N, et al Transmission of prion diseases by blood transfusion,
Journal of General Virology (2002): 83,2897-2905

The European Commission Scientific Steering Committee (SSC) has never
implicated bovine blood in bovine-to-bovine transmission of either
natural or experimental BSE. The Harvard-Tuskegee Risk Assessment
demonstrates that feeding bovine blood will not spread BSE in cattle
populations. The banning of air injection stunning during slaughter of
cattle has eliminated the risk of neural embolic material being
disseminated in blood or tissue. Bovine blood products are fed orally
and oral consumption is the least effective method of transmission of
BSE. Bovine blood products are collected only from cattle that pass USDA
antemortem inspection. The Office International Epizootics (OIE) and WHO
classify bovine blood and plasma with tissues indicating no detected
infectivity. The IRT did not recommend removal of current feeding
exemption for bovine blood or blood products. The USAHA believe there is
no scientific evidence to show that the use of bovine blood or blood
products in feed pose a risk of BSE transmission in cattle and other
ruminants. The USAHA is also concerned that blood products utilized in
milk and colostrum replacers not lose their current exemption under the
Mammalian to Ruminant Feed Ban 21 CFR589.2000. There products play an
important role in the control of Johne's disease and other enteric, and
neonatal infections in the newborn calf.

22\. [What would be the economic and environmental impact of prohibiting
materials from dead stock and non-ambulatory cattle from use in all
animal feed?]{.underline} The USAHA is very concerned that if the above
material is banned from all animal feed without a comprehensive plan
being developed for the disposal and utilization of both banned SRM's
and dead stock, the rendering industry and 3-D and 4-D establishments
will have no economic incentive to continue SRM and dead stock
processing. **It is paramount that FDA and USDA cooperate with industry
to develop a comprehensive national 4-D and SRM disposal and utilization
plan that will provide the necessary economic incentive for producers to
submit 4-D animals for animal health monitoring and surveillance
purposes and provide for the development of alternative market outlets
for such rendered material if it is banned in all animal feed.**

August 13, 2004 Page 5

24\. [When and under what circumstances should the recently announced
National Animal Identification System (NAIS) transition from voluntary
to mandatory?]{.underline} The USAHA support the recommendations of the
U.S. Animal Identification Plan (USAIP) Cattle Species Working Group
which requested to develop recommendations for implementation of a
national animal identification program capable of tracking all animal
movement within 48 hours of an animal health event or emergency. A
"critical mass" level of participation in order to assure successful
trace back of any diseased animal within 48 hours should be set and
monitored by state animal health agencies and USDA/APHIS. This will be
determined in an initial voluntary phase. USDA should be prepared to
fund the implementation of a required animal identification program in
2007.

25\. [What species should be covered, both initially and in the longer
term?]{.underline} The USAHA would recommend that all cloven-hoofed
species of livestock used for food purposes be included initially in
NAIS by 2007. These are species that are most capable of spreading a
highly contagious foreign animal disease such as Foot and Mouth Disease.
The USAHA would recommend that all species of livestock, including
pleasure and recreation species, be required to meet NAIS requirements
within the next 5 years.

28\. [Should FDA include exemptions to any new requirements to take into
account the future development of new technologies or test methods that
would establish that feed does not present a risk of BSE to
ruminants?]{.underline} The USAHA fully supports this approach as is now
practiced in the current BSE feed rule. This is an excellent example of
use of a standing committee on BSE discussed in Question 1.

34,35,36. Questions related to issues of equivalence. The USAHA
recommends that FSIS and FDA not exempt foreign countries from any
provisions of the SRM rule that might be adopted in the U.S., regardless
of the "BSE Status" claimed by the exporting country. The OIE plan for
BSE control and trade issues should be studied and followed.

The USAHA appreciates the opportunity to submit these comments to FDA on
this advanced notice of proposed rule making. We offer our service to
form a BSE committee similar to several of our other disease committees
to work with federal and state agencies, industry and scientific
community concerning the national BSE program. If we can be of
additional assistance, please contact us.

Sincerely,

![](media/image2.png)

Donald H. Lein, DVM, PhD

President, United States Animal Health Association