Innovative Proteins

North American Spray Dried Blood and Plasma Producers

Dockets Management Branch (HFA-305)

Department of Health and Human Services

Food and Drug Administration

5630 Fishers Lane, Rm. 1061

Rockville, MD 20852

Response to Advanced Notice of Proposed Rulemaking

\[Docket No. 2004N-0264\]

RIN 0910-AF46

Federal Measures to Mitigate BSE Risks: Considerations for Further
Action

##### Executive Summary

*There is no scientific evidence to suggest that BSE infectivity is
present in bovine blood. Banning the use of bovine blood or blood
fractions in ruminant rations will not reduce the risk of exposure of
humans or animals to BSE infectivity. Animal health will be compromised
if the use of bovine blood or blood proteins in ruminant feeds is
restricted.*

The North American Spray Dried Blood and Plasma Producers Association
(NASDBPP) (see **Appendix A**) is a group of companies located in North
America involved in the production and development of spray dried blood
and plasma products. These companies organized a working group within
the American Feed Industry Association (AFIA) with the purpose of
developing Manufacturing Standards to insure that the safety of blood
derived proteins is preserved. In addition, it is the intention of
NASDBPP to insure that data supporting the safe nature of these proteins
is communicated to industry and government officials. The NASDBPP is
committed to producing safe, high quality blood products for use as an
ingredient in feeds for commercial livestock and companion animals.

BSE infectivity has never been detected in blood or any component of
bovine blood. There is no epidemiological evidence that bovine blood or
blood component carries BSE infectivity. Spray dried blood and plasma
products are consumed orally, which is the least efficient method of
transmission (100,000 times less efficient compared to intracranial
injection). The NASDBPP developed Manufacturing Standards to insure that
our blood products do not become contaminated with high-risk tissues.
The Manufacturing Standards have been reviewed by internationally
recognized BSE experts. Finally, the NASDBPP have agreed to and
completed annual third party inspections to certify compliance to these
Manufacturing Standards.

It is critically important that regulatory policy developed to prevent
BSE from becoming established in the US cattle population is grounded on
sound science. The NASDBPP support APHIS, FSIS and FDA in their efforts
to develop policies to mitigate the risk of BSE.

The NASDBPP appreciate the opportunity to comment on the questions and
issues raised in the Advanced Notice of Proposed Rulemaking (ANPRM). We
will restrict our comments to those questions raised in the ANPRM that
we feel qualified to address.

## 

## Question 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?

# 

**Response -**

***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.***

# 

# A. BSE infectivity has never been detected in bovine blood. 

Bovine blood has never been implicated in bovine-to-bovine transmission
of either natural or experimental BSE (European Commission Scientific
Steering Committee (SSC), April 2000; SSC, October 2000). Despite
intensive research trials and detailed epidemiological evidence, no BSE
infectivity has been detected in bovine blood in either natural or
experimental cases (Bradley, 1993, 1999, 2000; Fraser et al., 1992;
Kimberlin and Wilesmith, 1994; Middleton and Barlow, 1993; Moon, 1996).

BSE infectivity has not been detected in the buffy coat, spleen or lymph
nodes from naturally or experimentally infected cattle when bioassayed
in susceptible mice or directly in calves (Wells, et al., 1994; 1998).
In an experiment initiated in 1996, buffy coat from a BSE infected cow
(the cow was experimentally infected and the blood cells were collected
32 months post exposure) was injected intracerebrally into recipient
calves. To date (over 7 years post exposure) the recipient calves have
not developed BSE (Dr. Ray Bradley, 2004, personal communication).

Following the discovery of BSE in the United States, the Secretary of
Agriculture appointed an international panel of BSE experts to review
the US BSE response and to make recommendations on the US national
program. The panel defined Specified Risk Materials (SRM) as those that
are considered to represent the greatest BSE exposure risk to humans and
animals because they contain infectivity at some point during the
disease incubation period. Blood was not identified as a SRM (Kihm et
al., 2004). Numerous international organizations include blood and
plasma products in Category IV; tissues with no detected infectivity
(DEFRA, 2001; OIE, 1998; SSC, 1997; WHO, 1997).

These data indicate that BSE infectivity is not present in bovine blood
of BSE infected cattle.

##### 

##### B. The Harvard-Tuskegee Risk Assessment demonstrates that feeding bovine blood will not spread BSE in the cattle population. 

The Harvard Center for Risk Analysis and the Center for Computational
Epidemiology at Tuskegee University released the findings of a major
3-year initiative (Harvard-Tuskegee Study) to develop a risk assessment
model that allows evaluation of the impact of various risks for exposure
of US cattle to BSE (Cohen et al., 2001). The report was extensive and
evaluated numerous risk factors associated with the introduction and
transmission of BSE.

In the report, the authors recognize that BSE infectivity has never been
detected in bovine blood. However, in tissues where BSE infectivity has
not been detected, the European Scientific Steering Committee recommends
that it should be assumed a minimum BSE infectivity of 10 oral ID~50~ /
kg (in BSE infected cattle; SSC, 2000). The Harvard-Tuskegee model
assumed this level of BSE infectivity was present in the blood of BSE
infected cattle. The model also assumed that heifer calves consumed
blood from birth while bull calves consumed blood from 7 months to
market. Finally, it was assumed that BSE infected cattle existed in the
U.S. cattle population. When these assumptions were included in the
model, blood contributed on average 0.11 new cases over a 20-year
period. The authors summarized:

*"...recycling (feeding) this material (blood) poses little risk of
exposing cattle to BSE."*

The outcome of the Harvard-Tuskegee model shows that when used as a feed
ingredient, blood does not contribute to the spread and amplification of
BSE in the cattle population.

##### C. The detection of TSE infectivity in the blood of other species does not mean BSE infectivity is present in bovine blood.

Pathology of TSE diseases differs significantly depending on the disease
and on the animal model being studied, especially with respect to
involvement of the lymphoreticular system (Barclay et al., 2002, Foster
et al., 1996, 2001; Wells et al., 1998; Wells, 2003). For this reason,
it is not appropriate to speculate that TSE infectivity found in the
blood of humans, rodents or sheep proves that BSE infectivity is present
in bovine blood. Differences in the distribution of TSE infectivity
among tissues of different species of animals make extrapolation among
species impossible (Dodd and Busch, 2002; Barclay et al., 2002; Šimák et
al., 2002).

The work by UK researchers (Houston et al., 2000; Hunter and Houston,
2002; Hunter et al., 2002) indicated that one sheep of 21 transfused has
developed BSE. The EU SSC (SSC, 2002) evaluated the data and concluded
(p 6):

> *"The TSE ad hoc Group considered that the finding of infectivity in
> the blood of sheep could not be extrapolated to BSE in cattle. Indeed,
> the most recent research results do not support the hypothesis that
> bovine blood or lean meat constitutes a risk for humans."*

Based on these data it is not appropriate to conclude that detection of
TSE infectivity in the blood of other specie proves that BSE infectivity
must also be present in the blood of BSE infected cattle.

D. By banning the use of air injection stunning the USDA has eliminated
the risk of neural emboli being disseminated in the blood and other
tissues.

Although bovine blood is not inherently infective with BSE,
contamination with specific risk material (primarily neural tissue) is
possible within the abattoir. Use of various stunning methods and the
risk associated with neural contamination of blood and other tissues
have been evaluated by several organizations, including the SSC (SSC,
2000, 2002). The SSC (2002) concluded "*Penetrative stunning without
pithing appears to be the safest of the three methods of stunning*
\[captive bolt without pithing, pithing, air injection stunning\] *in
regard to the production of CNS emboli.*" Recently, USDA FSIS published
an interim final rule that prohibited the use of air-injection pneumatic
stunners in the U.S.
(<http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/01-033IF.htm>). The USDA
concluded (page 1887):

> "*In general, studies have not demonstrated that penetrative captive
> bolt stunning without air injection results in CNS tissue macro-emboli
> in the blood or other tissues of stunned cattle.*"

By banning the use of air injection stunning the USDA has eliminated the
risk of neural emboli being disseminated in the blood and other tissues.

**E. Oral consumption is the least efficient method of transmission of
BSE.**

The route of exposure is a major factor determining the efficiency of
transmission of BSE. The least efficient method of transmission that has
been studied is oral exposure (Kimberlin et al, 1991). Intracerebral
injection has been found the most efficient method of transmission. It
has been estimated that oral exposure is up to 100,000 times less
effective than intracerebral injection. It is important to point out
that numerous attempts to detect BSE infectivity in bovine blood
involved intracerebral injection. All these attempts have failed to
detect BSE infectivity in blood of BSE infected cattle (European
Commission Scientific Steering Committee (SSC), April 2000; SSC, October
2000; Bradley, 1993, 1999, 2000; Fraser et al., 1992; Kimberlin and
Wilesmith, 1994; Middleton and Barlow, 1993; Moon, 1996).

Injected intracerebrally, BSE infectivity has never been detected in
bovine blood. Oral exposure is a method 100,000 times less effective in
transmitting BSE. Blood and blood products used in the feed industry are
consumed orally.

# Manufacturing Standards

As an Industry Group, the NASDBPP are committed to producing a safe,
wholesome and effective product. Based on the published scientific data,
we conclude that bovine blood does not contain infective levels of the
BSE agent. In April 2001, the companies in the United States and Canada
involved in the collection and processing of spray dried blood and
plasma established a series of Manufacturing Standards. These Standards
were established to insure that the blood based products we manufacture
do not become contaminated with High Risk Tissues such as brain, spinal
cord or distal ileum. These guidelines have been developed and reviewed
by internationally recognized BSE experts. Finally, the NASDBPP have
contracted with the Facilities Certification Institute (FCI), an
independent auditing firm, to annually inspect company facilities to
insure compliance with the Industry Guidelines.

These Guidelines have been published for public review (Russell, 2001).
In addition they have been presented (formally and informally) to
numerous government agencies in the United States and around the world.
See **Appendix B** for a more complete description of the NASDBPP
Manufacturing Standards.

# F. Summary

BSE infectivity has never been detected in bovine blood. The
International Review Team appointed by the Secretary of Agriculture did
not include blood in the list of SRM. The Harvard-Tuskegee Risk
Assessment demonstrates that feeding bovine blood will not spread BSE.
The presence of TSE infectivity in the blood of other specie does not
prove that BSE infectivity is present in bovine blood. By banning the
use of air injection stunning the USDA has eliminated the risk of neural
emboli being disseminated in the blood and other tissues. Bovine blood
products are fed orally and oral consumption is the least effective
method of transmission of BSE. Manufacturing Standards have been
developed to insure that spray dried blood and plasma products do not
become contaminated with high risk tissues.

In summary, 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.

**Question 26 -**

**How can training and educational materials be designed or improved to
meet the needs of multiple audiences with variable levels of scientific
training?**

**Response --**

***The Harvard-Tuskegee Report can serve as the basis for communicating
the true risks of BSE to the public.***

When explained logically, simply, and clearly, the public does not
demand zero-risk policy. In the past, zero-risk policies have been
attempted and found to result in greater harm than the risk that it was
intended to mitigate. A logical approach is to educate the public on the
true risk factors associated with BSE and to explain the logic
supporting a science based policy.

An example of a zero-risk policy that was found unreasonable is the
Delaney Clause. The Delaney Clause amended the Federal Food, Drug and
Cosmetic Act (FFDCA) in 1958 to prohibit the use of any food additives
in processed food that were found to induce cancer in humans or animals.
The clause states that no additive can be considered safe if "it is
found to induce cancer when ingested by man or animal, or if it is
found, after tests which are appropriate for the evaluation of the
safety of food additives, to induce cancer in man or animal."

The problems of the Delaney Clause were two-fold. First science
discovered potential carcinogenic effects of a large number of
substances, at least where laboratory animals were exposed to the
Maximum Tolerated Dose, an extremely high level of exposure. Second,
scientific knowledge advanced to where we could detect extremely minute
amounts of a substance. Rather than preventing significant exposures to
a few very hazardous substances, the Delaney Clause would preclude
minuscule exposures to a broad range of chemicals, even if that exposure
produced little or no actual harm.

In 1996, the Food Quality Protection Act amended the Federal
Insecticide, Fungicide and Rodenticide Act and the FFDCA. The amendments
recognized the need to establish policy allowing tolerable levels of
exposure to carcinogenic substances. Issues surrounding the BSE
situation should be handled in a similar fashion. If the public can
understand and accept explanation of the risk associated with minuscule
exposure to known carcinogens, the public will likely accept the
explanation of the risks associated with BSE.

The Harvard-Tuskegee Report addressed risk factors associated with the
spread of BSE in the U.S. cattle population and the risk of human
exposure to BSE infectivity. Using this analysis as a framework would
provide the platform for a logical discussion of the risks to the public
from BSE.

**Question 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?**

**Response --**

***Currently in 9 CFR 589.2000, FDA has provisions for exemption from
regulations where approved deactivations or detection technologies are
developed: this provision should remain in the regulations.***

The North American Spray Dried Blood and Plasma Producers fully supports
the concepts for providing for new technologies that will overcome the
risks associated with BSE. Currently in 9 CFR 589.2000, FDA has
provisions for exemption from regulations where approved deactivations
or detection technologies are developed. Specifically, it states,

> "(2) Renderers described in paragraph (c)(1) of this section will be
> exempted from the requirements of paragraphs (c)(1)(i) and (c)(1)(ii)
> of this section if they:

(i) Use exclusively a manufacturing method that has been validated by
    the Food and Drug Administration to deactivate the agent that causes
    transmissible spongiform encephalopathy (TSE) and whose design has
    been made available to the public;

(ii) Use routinely a test method that has been validated by the Food and
     Drug Administration to detect the presence of the agent that causes
     TSE's and whose design has been made available to the public.
     Renderers whose products test positive for agents that cause TSE's
     must comply with paragraphs (c)(1)(i) and (c)(1)(ii) of this
     section. Records of the test results shall be made available for
     inspection by the Food and Drug Administration; or

(iii) Use exclusively a method for controlling the manufacturing process
      that minimizes the risk of the TSE agent entering the product and
      whose design has been made available to the public and validated
      by the Food and Drug Administration.

We believe this provision should remain in the regulations.

## References

21 CFR 589.2000. 1997. Federal Register. Substances Prohibited from use
in animal food or feed: Animal proteins prohibited in ruminant feed;
Final rule.

Barclay, R.G., E.F. Houston, S.I. Halliday, C.F. Farquhar and M. L.
Turner. 2002. Comparative analysis of normal prion protein expression on
human, rodent, and ruminant blood cells by using a panel of prion
antibodies. Transfusion. 42:517-526.

Bradley, R. 2000. Proceedings of the Food and Drug Administration Joint
Meeting or the Transmissible Spongiform Encephalopathies Advisory
Committee and Vaccines and Related Biological Products Advisory
Committee. Bethesda Md., 27 July, 2000.

Bradley, R. 1999. BSE transmission studies with particular reference to
blood. Dev. Biol. Stand. 99:35-40.

Bradley, R. 1993. The research program on transmissible spongiform
encephalopathies in Britain with special reference to Bovine Spongiform
Encephalopathy. In: Transmissible Spongiform Encephalopathies -- Impact
on Animal and Human Health. Brown F. (ed.) Dev. Biol. Stand. Basel,
Karger, 80: 157 - 170.

Cohen, J. T., Duggar, K., Gray, G. M., Kreindel, S., Abdelrahman, H.,
HabteMariam, T., Oryang, D., Tameru, B. 2001. Evaluation of the
Potential for Bovine Spongiform Encephalopathy in the United States.
<http://www.hcra.harvard.edu/pdf/madcow.pdf>. Accessed 29 March 2004.

Dept for Environment Food and Rural Affairs. 2001. BSE information**:**
Transmission of BSE (Infectivity in Tissues). Accessed: 2004. Available
at:
http://www.defra.gov.uk/animalh/bse/bse-science/level-4-transmis.html#infect.

Dodd, R. Y., and M. P. Busch. 2002. Animal models of bovine spongiform
encephalopathy and vCJD infectivity in blood: two swallows do not a
summer make. Transfusion. 42:509-512.

Federal Food, Drug and Cosmetic Act (FFDCA), 1958. Section 409 on food
additives; Section 512 relating to animal drugs in meat and poultry;
Section 712 on color additives.

Food Quality Protection Act of 1996 (FQPA), 1996. Pub. L. No. 104-170,
110 Stet. 1489.

Foster, J., Bruce, M., McConnell, I., Chree, A. and Fraser, H., 1996.
Detection of BSE infectivity in brain and spleen of experimentally
infected sheep. Veterinary Record. 138:546-548.

Foster, J., Parnham, D., Hunter, N. and Bruce, M. 2001. Distribution of
the prion protein in sheep terminally affected with BSE following
experimental oral transmission. Journal of General Virology.
82:2319-2326.

Fraser, H., Bruce, M., Chree, A, McConnell, I., and Wells, G. 1992.
Transmission of bovine spongiform encephalopathy and scrapie to mice. J.
of General Virology. 73:1891-1897.

Houston, F., Foster, J., Chong, A., Hunter, N. and Bostock, C., 2000.
Transmission of BSE by blood transfusion in sheep. The Lancet.
356:999-1000.

Hunter, N., Foster, J., Chong, A., McCutcheon, S., Parnaham, D., Eaton,
S., MacKenzie, C. and Houston, F., 2002. Transmission of prion diseases
by blood transfusion. Journal of General Virology. 83:2897-2905.

Hunter, N., and F. Houston. 2002. Can prion diseases be transmitted
between individuals via blood transfusion: evidence from sheep
experiments. Dev. Biol. (Basel). 108:93-98.

Kihm, U., W. Hueston, D. Matthews, S.C. MacDiarmid and D. Hein. 2004.
Report on Measures Relating to BSE in the United States.
http://www.aphis.usda.gov./lpa/issues/bse/BSE_tr_ban_ltr%20_enc_2.pdf.

Kimberlin, R.H. 1991. An overview of bovine spongiform encephalopathy.
Develop. Biol. Standard. 75:75-82.

Kimberlin, R. H. and Wilesmith, J. W., 1994. Bovine Spongiform
Encephalopathy. Epidemiology, low dose exposure and risk. Annals New
York Academy of Sciences. 724 : 210-220.

Middleton, D. and Barlow, R. 1993. Failure to transmit bovine spongiform
encephalopathy to mice by feeding them with extraneural tissues of
affected cattle. Veterinary Record. 132:545-547.

Moon, Harley W. 1996. Bovine Spongiform Encephalopathy: Hypothetical
risk of emergence as a zoonotic foodborne epidemic. J. of Food
Protection. 59 : 1106-1111.

OIE. 1998. Supporting document for the OIE International Animal Health
Code chapter on BSE. OIE Paris Pp 87-121.

Russell, L.E. 2001. Reasons that blood products are safe. Feed
Management. 52(8):25-28.

Scientific Steering Committee. 2000. Opinion on: The Safety of Ruminant
Blood With Respect to TSE Risks. Adopted by the Committee 13-14 April,
2000. <http://europa.eu.int/comm/food/fs/sc/ssc/out74_en.pdf>. Accessed
30 March, 2004.

Scientific Steering Committee. 2002. Opinion on the implications of the
recent papers on transmission of BSE by blood transfusion in sheep
(Houston et al., 2000; Hunter et al., 2002). Adopted by the Scientific
Steering Committee at its meeting of 12-13 September 2002.
<http://europa.eu.int/comm/food/fs/sc/ssc/out280_en.pdf>. Accessed 12
April, 2004.

Scientific Steering Committee. 2000. Opinion on: The Implications of the
Houston et al Paper in The Lancet of 16 September 2000 on the
Transmission of BSE by Blood Transfusion in Sheep. (The Lancet,
356:999-1000; 955-956; 1013). Adopted by the Committee 26-27 October,
2000.

Scientific Steering Committee. 1997. Scientific opinion of the SSC of
the EC on the listing of specified risk materials: a scheme for
assessing relative risks to man. Adopted 9 December 1997. EC, DGXXIV,
Brussels. Pp 20.

Šimák, J. K. Holada, F. D\'Agnillo, J. Janota, and J. G. Vostal. 2002.
Cellular prion protein is expressed on endothelial cells and is released
during apoptosis on membrane microparticles found in human plasma.
Transfusion. 42:334-342.

Wells, G.A.H. 2003. Pathogenesis of BSE. Vet Res. Communications. 27
(Suppl. 1):25-28.

Wells, G.A.H., M. Dawson, S.A.C. Hawkins, R.B. Green, I. Dexter, M.E.
Francis, M.M. Simmons, A. R. Austin, M.W. Horigan. 1994. Infectivity in
the ileum of cattle challenged orally with bovine spongiform
encephalopathy. Vet. Record. 135:40-41.

Wells, G. A., S. A. Hawkins, A. R. Austin, S. J. Ryder, S. H. Done, R.
B. Green, I. Dexter, M. Dawson and R. H. Kimberlin. 2003. Studies on the
transmissibility of the agent of bovine spongiform encephalopathy to
pigs. J. Gen. Virol. 84:1021-1031.

Wells, G., Hawkins, S., Green, R., Austin, A., Dexter, I., Spencer, Y.,
Chaplin, M., Stack, M., and Dawson, M. 1998. Preliminary observations on
the pathogenesis of experimental bovine spongiform encephalopathy (BSE):
an update. Veterinary Record. 142:103-106.

WHO. 1997. Report of a WHO Consultation on Medicinal and Other Products
in Relation to Human and Animal TSE, Geneva, 24-26 March 1997. WHO
Geneva.

######   {#section-4 .unnumbered}

###### Appendix A. North American Spray Dried Blood and Plasma Producers {#appendix-a.-north-american-spray-dried-blood-and-plasma-producers .unnumbered}

######  {#section-5 .unnumbered}

APC, Inc.

2425 SE Oak Tree Court

Ankeny, IA 50021

California Spray Dry

P.O. Box 5035

Stockton, CA 95205

DuCoa

7720 Buckwood Drive

Smithville, MO 64089

Harimex, Inc.

3010, 715 Fifth Ave. S.W.

Calgary, Alberta T2P 2X6

Hemotech

601 Carlson Pkwy., Suite 400

Minnetonka, MN 55305

Land O'Lakes

P.O. Box 64406

MS 7405

St. Paul, MN 55164

Merrick's

654 Bridge Street

P.O. Box 99

Union City, WI 53962

Proliant, Inc.

2425 SE Oak Tree Court

Ankeny, IA 50021

Sanimal, Inc.

9900 6e Rue

Montreal, Quebec H1C 1G2

###### Appendix B. Manufacturing Standards {#appendix-b.-manufacturing-standards .unnumbered}

Careful collection and processing methods are important to insure that
an inherently safe product like blood does not become contaminated with
prohibited tissues during collection and subsequent processing. The
NASDBPP has developed Manufacturing Standards to insure a consistent,
safe product is produced.

# Blood is collected from registered abattoirs in the United States or Canada under Federal Inspection. All source animals have been passed ante-mortem inspection as fit for slaughter for human consumption prior to entry into the slaughter facility. Animals showing symptoms of neurological diseases are not allowed to enter the abattoir.

All source facilities process only single species: bovine, porcine or
avian. Blood is not collected from abattoirs processing more than one
species. This allows blood to be collected with strict species
identification. Most importantly this eliminates the potential for
accidental sourcing of blood from sheep, goats, deer or mink, species
naturally susceptible to TSE diseases.

Some stunning methods have been shown to result in contamination of
blood with central nervous tissue (Anil et al., 1999; Garland et al,
1996; Munro, 1997; Schmidt et al, 1999; Taylor, 1996). Neural
contamination has not been shown associated with captive bolt stunning.
The GMPs developed by the NASDBPP prohibit sourcing of bovine blood from
animals stunned by methods shows to result in contamination with neural
emboli.

Blood is collected from animals immediately after stunning while the
carcass is whole (i.e. before decapitation) reducing the risk of
contamination with tissues such as brain, spinal cord or cerebrospinal
fluid. Blood is either collected from individual animals or on a
stainless steel pan designed to eliminate contamination with other
tissues or extraneous material. Immediately after collection the blood
is removed from the collection area in a dedicated closed system to a
processing and storage area. This area is dedicated to handling of blood
only with no other tissues allowed in the area. At the abattoir, blood
is stored in dedicated insulated storage tanks prior to transportation
to the processing facility.

Blood or plasma is then shipped to off-site spray drying facilities in
either dedicated tankers or in tankers certified not to have contained
prohibited tissues. This eliminates the potential for contamination of
blood with prohibited tissues.

The spray drying facilities are off-site from the abattoir and are
dedicated to processing blood or other non-prohibited tissues.
Prohibited tissues are not processed at these plants eliminating the
possibility of any contamination.

### 

**Third Party Verification**

The NASDBPP has contracted with Facility Certification Institute to
verify member companies are compliant with Manufacturing Standards. On
site audits are performed annually.

## North American Spray Dried Blood and Plasma Producers

Guidelines for Blood Collection and Spray Dried Blood and Plasma
Processing

1.  Blood is collected only from bovine, porcine and avian species in
    facilities in the United States and Canada which are registered to
    ship interstate or inter-province and are continuously inspected by
    USDA/FSIS or Canadian Food Inspection Agency, or a state or
    provincial inspection authority that has been determined to be
    equivalent by USDA/FSIS or Canadian Food inspection Agency and
    slaughter animals for human consumption.

2.  Blood is collected only from animals inspected ante-mortem by
    USDA/FSIS or Canadian Food Inspection Agency, or a state or
    provincial inspection authority that has been determined to be
    equivalent by USDA/FSIS or Canadian Food inspection Agency and
    passed as fit for slaughter for human consumption.

3.  All collection facilities are dedicated to one species: bovine,
    porcine or avian.

4.  Bovine blood is collected from facilities certified to stun animals
    using captive bolt. Bovine blood will not be collected from
    abattoirs stunning with captive bolt followed by injection of
    compressed air or captive bolt followed by pithing (see Definitions
    for complete description of this term).

5.  Blood is collected while the animal is whole prior to decapitation
    and evisceration and in an area where cross contamination cannot
    occur from exposed internal organs or tissues including nervous
    tissue or other prohibited tissues (see Definitions for complete
    description of this term).

6.  Blood is transferred immediately from the collection area to a
    dedicated area for processing.

7.  At the abattoir, blood is stored in insulated dedicated storage
    tanks.

8.  Spray drying facilities are isolated and remote from the slaughter
    facility or any facility that handles prohibited tissue.

9.  All transfer lines, pumps and tankers used to transport liquid blood
    or plasma are dedicated only to blood products or are thoroughly
    washed (see Definitions for complete description of this term). All
    non-dedicated equipment is inspected and documented as being
    thoroughly cleaned (see Definitions for complete description of this
    term) prior to use with blood products.

10. Spray drying facilities do not co-process, store or utilize any
    prohibited tissues.

11. Packaging material will be new. If not new, packaging material will
    be certified to not have contained prohibited tissues or feed
    containing prohibited tissues. Bulk shipments will be made in
    dedicated containers or trailers. If the container or trailer is not
    dedicated, it will be thoroughly cleaned. If the container or
    trailer can not be thoroughly cleaned or the previous material can
    not be confirmed, then the product will be clearly labeled 'Do not
    feed to cattle or other ruminants'.

12. These guidelines are regularly re-evaluated in light of new
    scientific evidence with regard to natural or experimental BSE.

#### Definitions

**Prohibited tissues**. Prohibited tissues shall mean any protein
containing portion of mammalian animals, excluding: Blood and blood
products; gelatin; inspected meat products which have been cooked and
offered for human food and further heat processed for feed (such as
plate waste and used cellulosic food casings); milk products (milk and
milk proteins); and any product whose only mammalian protein consists
entirely of porcine or equine protein.

**Thoroughly washed or thoroughly cleaned.** To use clean-out procedures
or other means adequate to prevent carry-over of products that contain
or may contain protein derived from mammalian tissues (prohibited
material as defined above) into animal protein or feeds that may be used
for ruminants.

Also, to maintain written procedures specifying the clean-out procedures
or other means and specifying the procedures for separating products
that contain or may contain protein derived from mammalian tissue
(prohibited material as defined above) from all other protein products
from the time of receipt until the time of shipment.

**Pithing.** Insertion of an elongated rod shaped instrument into the
cranium through the stun wound.