August 11, 2004

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, Maryland 20852

RE: Docket No. 2004N-0264, Federal Measures to Mitigate BSE Risks:

Considerations for Further Action

Dear Sir or Madam:

The Anamax Group of companies, headquartered in Green Bay, Wisconsin,
has three rendering facilities, a gelatin bone facility, a grease
processing facility, and a hide and skin processing facility. We employ
over 350 people and service five states in the upper Midwest.

We are concerned with the limited time given to prepare comments on such
a complicated issue and 36 questions to respond to, especially in areas
relating to economic and environmental impacts. We would request a
minimum of 90 days for a comment period for any proposed rules so that
appropriate background information can be collected.

We as a company and an industry have strongly supported all previous and
current controls developed as a "fire-wall" against the introduction or
spread of BSE in the U.S. We eliminated ovine products from our
rendering raw materials in 1992 and promoted the voluntary ruminant
protein to ruminant ban in 1996, and we supported the 1997 FDA feed
rule, 21CRF 589.2000. In fact, as you know, the industry continues to
exceed 99% compliance with the feed rule.

All avenues of precaution regarding BSE must be considered, but at this
time making any major changes to the current rule is not justified,
either scientifically or financially.

The current surveillance program should have the opportunity to be
analyzed after appropriate samples are collected to determine the extent
of BSE in the U.S. To implement new regulation now, and try to change in
the future when more is known would, as you know, be almost impossible.

Cost/Benefit analysis also needs to be completed to determine
appropriate mitigation steps for strengthening the current rule if
needed. An all-out SRM ban may sound good or feel good, but the actual
risk reduction is miniscule when compared with other options. The 2001
Harvard Risk Analysis stated that if 10 infected cattle with BSE were
imported into the U.S., on average only 3 new cases of BSE would occur.
This assumed a much higher rate of non-compliance with the feed ban. To
make a statement that 98% of risk can be eliminated by removing SRMs
from animal feed needs to be taken in context. There is very little
difference between 98% of 3 animals over 20 years and 50% of 3 animals
over 20 years as compared to the entire population of cattle in the U.S.

All options of partial SRM removal should be considered if the agency is
determined to have an SRM ban; i.e. removal of heads from all cattle
over 30 months and all dead stock.

The situation in North America is dramatically different than the
situation that occurred in the E.U. To use the E.U. as a template is not
warranted. We will try now to address the specific questions of the
A.N.P.R.

1\. Would there be value in establishing a specialized advisory
committee or standing subcommittee on BSE?

Yes, a format similar to the Beef Roundtable which seems to have worked
well in Canada. It includes academia, government and affected
industries.

3\. What information, especially scientific data, is available to
support or refute the assertion that removing SRMs from all animal feed
is necessary to effectively reduce the risks of cross-contamination of
ruminant feed or 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?

a\) We continue to hear about the large percentage of risk reduction by
removing SRM's from animal feed. It would be interesting to utilize the
Harvard Risk Assessment to establish the baseline level with 10 positive
animals that were introduced into the rendering process and calculate
the projected numbers with and without removal of SRM's. i.e. If the
projected number of animals that may develop BSE over the next 20 years
is 3 without removal of SRM's, there is very little difference removing
60% or 98% of the potential infectivity. A cost benefit analysis could
then be done to analyze different levels of "SRM" removal.

b\) Refer to audits of the compliance with the current rule.

4.  If SRMs are prohibited from animal feed, should the list of SRMs be
    the same as for human food? What information is available to support
    having two lists?

Refer to #3

5.  What methods are available for verifying that a feed or feed
    ingredient does not contain SRMs?

Glyceroltriheptanoate (GHT -- C7 fatty acid) This is a synthetic fatty
acid not found in nature. The EU is studying this as a potential marker
for rendered products. This could be added to the raw material of
prohibited material. After processing it would be a part of the fat
fraction and show up in the finished tallow and meat and bone meal. To
test for its presence in finished product, the extracted fat would be
run through a GC and analyzed for its presence. (See addendum 1.)

6\. If SRMs are prohibited from animal feed, what requirements
(labeling, marking, denaturing) should be implemented to prevent
cross-contamination between SRM-free rendered material and material
rendered from SRMs?

a\) Packing House -- Physical denaturent for SRM (packers
responsibility)

b\) Transportation -- Physical denaturent for SRM

c\) Renderer -- Physical denaturent for SRM in raw material, add GHT in
process

7\. What would be the economic and environmental impacts of prohibiting
SRMs from use in animal feed?

Economic:

Utilize the new Informa (Sparks) Study.

Environmental:

"Certified disposal" options would need to be established. Without these
in place there would be multiple health and safety issues that would
develop.

8\. What data are available on the extent of direct human exposure
(contact, ingestion) to animal feed, including pet food? To the degree
such exposure may occur, is it a relevant concern for supporting SRM
removal from all animal feed?

This is a question that would be best answered by PFI. Utilize EU/UK
information and see if any correlation between farmers, packing houses,
renderers, feed mill operators and vCJD. Something to keep in mind is
that in the UK where BSE and vCJD are prevalent, the incidence of vCJD
was about 1 case for every 8,000 BSE positive cattle that were
slaughtered and entered the food chain.

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 SRMs 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?

a\) Scientific analysis needs to be done.

b\) Should FDA prohibit SRMs from being used in animal feeds, and if
appropriate markers or detection systems could be developed, there would
not be a need for totally separate facilities. A "certified"
clean-out/flush-out procedure could be developed to allow this option
with separated storage facilities for the finished products. Raw
material transportation equipment should be able to have separation on
the same vehicle; i.e., compartments and also a clean-out procedure
needs to be approved to allow the back-haul of non-prohibited material.

10\. What would be the economic and environmental impacts of requiring
dedicated facilities, equipment, storage, and transportation?

Economic -- The costs would be high. The Informa (Sparks) Study of 2001
gives some estimates for the economic impacts of a regulation requiring
dedicated facilities, equipment, storage, and transportation, but it
should be updated to reflect 2004 costs.

Environmental -- Necessity to require dedicated "certified disposal"
options

11\. What information, especially scientific data, is available to
demonstrate that cleanout would provide adequate protection against
cross-contamination if SRMs are excluded from all animal feed?

This would need to be tested to develop certified processes. The major
concern I have regarding the ability to clean out is related to raw
material handling. Equipment utilized to haul SRM and non-SRM material
needs to have an approved method of cleaning to allow this option. Again
the issue of risk needs to be analyzed.

12\. What information, especially scientific data, supports banning all
mammalian and avian MBM in ruminant feed?

There is no scientific data to support banning all mammalian and avian
MBM from ruminant feeds. To utilize the EU approach because of the
history of what happened in Europe would be ludicrous, the circumstances
are totally different.

13\. If SRMs are required to be removed from all animal feed, what
information, especially scientific data, is available to support all
mammalian and avian MBM from ruminant feed, or to otherwise amend the
existing ruminant feed rule?

There is no scientific data to support the removal of mammalian and
avian MBM from ruminant feed.

14\. What would be the economic and environmental impacts of prohibiting
all mammalian and avian MBM from ruminant feed?

Utilize the Informa (Sparks) Report - 51 billion pounds per year would
fill landfills in 4 years. A large portion would be disposed of outside
of the acceptable, environmentally friendly options.

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?

At this time there has been no information to link the feeding of blood
meal or blood products to any transmission of BSE. In fact, eliminating
blood and blood products would be a major detriment to the cattle
industry.

16\. What information is available to show that plate waste poses a risk
of BSE transmission in cattle and other ruminants?

There is no information to show that plate waste is a risk in the
transmission of BSE. If there need to be tests to determine "species" of
animal proteins it may be necessary to prohibit plate waste from
non-ruminant proteins to eliminate "false positives".

19\. Is there any information, especially scientific data, showing that
tallow derived from the rendering of SRMs, dead stock, and
non-ambulatory disable cattle poses a significant risk of BSE
transmission if the insoluble impurities level in the tallow is less
than 0.15%?

There is no scientific data that supports any risk of BSE transmission
in tallow that is below 0.15% impurity. The industry has successfully
defended this position in 1997 in the EU and there is much research that
supports this position.

20\. Can SRMs be effectively removed from dead stock and non-ambulatory
disable cattle so that the remaining materials can be used in animal
feed, or is it necessary to prohibit the entire carcass from dead stock
and non-ambulatory disable cattle from use in all animal feed?

To answer this question there first needs to be a definition of what is
dead stock and what is SRM. Will the species be an issue? Will the age
be an issue? The ability to remove SRM's is dependent on the definition.
If removal of the head satisfies the need, that could be accomplished
easily. If it is more than that, removal of SRM's is impractical.
Another issue to keep in mind is that weather will also have a major
affect on the ability of processors to remove SRMs, hot weather will
cause deterioration and freezing weather could preclude the ability to
process correctly.

21\. What methods are available for verifying that a feed or feed
ingredient does not contain materials from dead stock and non-ambulatory
disabled cattle?

We know of no method to verify the presence of dead stock or
non-ambulatory material in feed.

22\. What would be the economic and environmental impacts of prohibiting
materials from dead stock and non-ambulatory disabled cattle from use in
animal feed?

Utilize Informa (Sparks) Study

23\. What other innovative solutions could be explored?

With current technology and knowledge it would seem that energy
generation would be the preferred alternative for the use of rendered
by-products. A major concern is that government regulatory agencies are
not in agreement as to the use of products for combustion in energy
producing applications. EPA needs to approve various methods of
incorporating the use of animal proteins as an acceptable fuel.

24\. When and under what circumstances should the program transition
from voluntary to mandatory?

A national identity system should be implemented as soon as possible. An
issue to keep in mind is that for this system to work it must close the
loop and mandatory disposal options need to be part of the system.

25\. What species should be covered, both initially and in the longer
term? Specifically, should the initial emphasis be on cattle, or also
cover other species? If so which? Which species should be covered by the
program when it is fully implemented? What priority should be given to
including different species?

Definitely start with cattle and see what the costs/benefits are. Take
some time to analyze benefits for other species.

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

The first concern is to make sure that whatever programs or rules come
into affect, that proper training occurs with all of the stake holders
involved, especially the regulatory groups. Information should be
disseminated so that a low level of knowledge can understand the
procedures. It is also critical that the general public be educated. A
proactive message that we have BSE in the U.S. but it is not a human
health issue needs to be disseminated.

27\. How can Federal Government increase access to these materials?

Make the information understandable and utilize the internet.

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?

Yes, the door must always be part way open to utilize new technology or
information regarding TSE's.

31\. Are there other related legal issues on which FDA should focus?

None that we know of.

Thank you for the opportunity to comment on this A.N.P.R. It is a very
complicated and intertwined issue that needs to be handled in a logical,
science-based approach.

Sincerely,

Michael J Langenhorst

President

Anamax Corporation

Addendum 1

DRAFT to EFPRA STG

Report part I:

**[Recommended method for marking products produced of category 1 and 2
material with glyceroltriheptanoate (GTH).]{.underline}**

**Abstract:**

From May 1st 2003 products produced from category 1 and 2 material
should be marked according to Regulation (EC) No 1774/2002. To establish
a suitable marking method for the traceability of MBM and fat, the price
and non-removability are important and a reliable detection method with
a low detection limit will be required.

An analytical approach for the use of glyceroltriheptanoate (GTH) as a
suitable marker was successfully developed. The detection limit of the
technique used for analysis was set at \< 5 mg/kg GTH on fat basis. If
in practice a dosage of 100 g GTH/ton animal product (this is about 500
g GTH/ton on fat basis) will be added, the additional price of the
marker will be € 0.25/ton. GTH is recommended as a very suitable marker
for all category 1 and 2 products.

**Introduction:**

Regulation 1774/2002 requires that products produced from category 1 and
2 material are marked in order to be capable to detect the material as
such. The markers have to be permanent which means non-removable by
simple means. So heat resistance to sterilisation under rendering
conditions (up to 159°C) and light resistance are very important. When
the markers can be destroyed, the situation is worse than having no
marker.

A draft Commission Regulation is written by Sanco i.e. 2442/2003, which
is amending among others Regulation (EC) No 1774/2002. This regulation
describes category 1 and 2 materials and derived products to be kept
separate and identifiable during collection and transportation.

The marking of (derived) products of category 1 and 2 as described in
concept 2442/2003 (written by Sanco) is very difficult and complicated.
The way of marking depends on the category and the specific application
of the end product.

There are also doubts if the purposed markers, based on colour and
smell, are suitable in rendering products. First it is a question
whether the colouring will be visible in rendered products, this because
many products do have a very dark colour (i.e. blood meal, meat meal and
fat). And second the use of smell in practice might be irritating or
even harmful for the staff which is working at the rendering plant. This
might also cause problems to the people which live in the neighbourhood
of the rendering plant.

This recommended method is intended to provide a reliable method for
marking and detecting animal products produced from category 1 and 2
material with use of glyceroltriheptanoate. GTH has the same properties
as fat, so this doesn't have negative influences on product properties,
incineration and on the applications of fat of category 2.

[Glyceroltriheptanoate:]{.underline}

(Supplier e.g. Sasol Benelux N.V., tradename: Special Oil 107)

This is a fat/oil with three C7-fatty acids esterified with glycerol.
These C7 fatty acids are normally not found in nature. Heptanoic acid
can also be found in low levels (10-20 mg/kg) in fat after bacterial
deterioration. Therefore, an analytic technique should be developed to
analyse direct the intact GTH instead of heptanoic acid after
saponification. It is a clear transparent liquid without any
characteristic smell. The price of glyceroltriheptanoate supplied by
Sasol is € 2.50/kg.

Product information about the Special Oil 107 is added as Appendix A (of
report part I).

GTH can be detected with gas chromatography. As the
glyceroltriheptanoate is trapped in the fat fraction, it can be found in
the separated fat and in the fat fraction of the meal.

**Technical approach:**

The objectives of this project were as follows:

-   To develop, demonstrate and report an analytical approach of marking
    category 1 and 2 material. A standard operation procedure for
    determination of glyceroltriheptanoate is developed, see ANAL-10237.
    This is more extensively written in report part II.

```{=html}
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-   The validation of the developed approach in two steps. First with
    artificial additions of GTH to fat and meal samples obtained from a
    rendering plant. And second with GTH (100 mg/kg raw material)
    additions in practice to animal raw material under practical
    circumstances. At several days, samples of MBM and fat are taken for
    examination. This validation is described in report part III.

**Results and discussion:**

Marking of products produced of category 1 and 2 material can be done
with comparative low amounts of GTH. The product can be added before
processing and still can be detected after the extreme heat treatment.
GTH has the same properties as fat, so this doesn't have negative
influences on incineration and on the applications of fat of category 2.

It was possible to detect less than 5 mg GTH/kg on fat basis. When 100
gram Sasol/ton raw material is added (this means approximately 500 mg
GTH/kg on fat basis), this can easily be detected with the developed gas
chromatography method. With a price of € 2.50/kg Sasol the additional
costs will be € 0.25/ton raw material.

It is possible to add it at the raw materials which can be done under
supervision of the veterinary authorities. In this way the meal and the
fat is marked. If necessary it is even possible to add the GTH directly
at the slaughterhouse before the category 1 and 2 materials will be
transported to a rendering plant.

**Conclusion:**

The marking of category 1 and 2 material with glyceroltriheptanoate
(GTH) seems a very realistic option. The detection limit of the
technique used for analysis was set at \< 5 mg/kg GTH on fat basis.

**Recommendation:**

Our recommendation is to add 0.1 kg GTH/ton raw animal products as a
marker of all category 1 and 2 materials.

**Acknowledgements:**

This work was technically supported by EFPRA's Standing Technical
Working Group, October 2003.

**References:**

-   Regulation (EC) No. 1774/2002

-   EN SANCO/2442/2003

Veghel, October 10th 2003.

ing. S. van den Hoven

dr. R. Margry

ir. P. Derks

![](media/image1.png){width="2.2in" height="0.9in"}

26.13.006e/03.01

##### SPECIAL OIL 107

### Food Additive

#### Description

Special Oil 107 is a triglyceride derived from enanthic acid
(n-heptanoic acid).

+-------------------------+--------------+-----------+----------------+
| ## Characteristics      | ## Value     | ## Unit   | ## Method      |
+-------------------------+--------------+-----------+----------------+
| Acid value              | max. 0,3     | mg KOH/g  | DGF C-V 2      |
+-------------------------+--------------+-----------+----------------+
| Saponification value    | 385 -- 395   | mg KOH/g  | DGF C-V 3      |
+-------------------------+--------------+-----------+----------------+
| Hydroxyl value          | max. 10      | mg KOH/g  | DGF C-V 17a    |
|                         |              |           | (94)           |
+-------------------------+--------------+-----------+----------------+
| Enanthic acid           | mind. 95     | \%        | AN-SAA 960     |
| triglyceride            |              |           |                |
+-------------------------+--------------+-----------+----------------+
| Hazen colour            | max. 150     | APHA      | ISO 6271       |
+-------------------------+--------------+-----------+----------------+

+-------------------------+--------------+-----------+----------------+
| ##                      | ## Value     | ## Unit   | ## Method      |
| General Characteristics |              |           |                |
+-------------------------+--------------+-----------+----------------+
| Viscosity at 20 °C      | 10 -- 25     | mPa·s     | DGF C-IV 7     |
+-------------------------+--------------+-----------+----------------+
| Setting point           | \< - 20      | °C        | DGF C-IV 3d    |
+-------------------------+--------------+-----------+----------------+
| Refraction at 20 °C     | 1,4445 --    | nD~20~    | DIN 51423      |
|                         | 1,4465       |           |                |
+-------------------------+--------------+-----------+----------------+

## Application

Being an add-numbered (C~7~) triglyceride, Special Oil 107 is mainly
used as a tracer in the manufacture of other fats. Thus, a
gaschromatographic analyse enables the fat product to be identified,
which is often necessary for revenue or customs purposes.

The usage level is dependent upon the final application and is, to some
extent, controlled by official regulations. A level of 1 -- 3 % has been
put forward as a guideline. According to Regulation EEC No. 2571/97\* 11
kg of enanthic acid triglyceride have to be added to one metric ton of
concentrated butter.

Special Oil 107 as cold-resistant release agent: Due to its very low
setting point, Special Oil 107 can be applied even in cases where
conventional release agents loose their separating effect, becauce of
cold conditions. This is particular interest in the chocolate and
confectionery industry for cooling belts on which very sticky, sugary
products are cooled.

**SASOL Germany GmbH**

Oleochemicals

Arthur-Imhausen-Str. 92, 58453 Witten, Germany

Phone: +49 (0)2302/925-369 Fax: +49 (0)2302/925-358

## 

## 

## Packaging

plastic multitainers of 25 kg net

non-returnable iron drums of 190 kg net

containers of 950 kg

tank wagons

\* Regulation (EEC) No. 2571/97 of the Commission of 15. Dec. 1997
regarding the sale of butter at reduced prices and the granting of a
subsidy for dairy cream, butter and butterfat for the manufacture of
bakery goods, ice cream and other foodstuffs. Special Oil 107 compiles
with the specification outlined in Annex II of the Regulation.

We reserve the right to make any changes according to technological
progress or further developments. The customer is not released from the
obligations to conduct careful inspection and testing of incoming goods.
Reference to trade names used by other companies is neither a
recommendation, nor is it intended or suggested that similar products
could not be used. All our business transactions shall be governed
exclusively by our General Sales Conditions.