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From: TSS ()
Subject: Re: Medical Waste and CJD 2003 guidelines CDC ?
Date: May 2, 2006 at 12:24 pm PST

In Reply to: Medical Waste and CJD 2003 guidelines CDC ? posted by TSS on May 2, 2006 at 7:34 am:

2910-D Fortune Circle West
Indianapolis, IN 46241
Phone: 317.484.4200
Fax: 317.484.4201
www.wr2.net
Comments on FDA Proposed Rulemaking - Docket No. 2002N-0273
From a public health standpoint, we are surprised and concerned that the
FDA would consider disposal of the brain and spinal cord of cattle over 30
months of age, the material it considers the highest risk SRM, through
landfill or incineration (page 44). It has been well demonstrated that there
is no reduction in potential infectivity of BSE contaminated material sent to
landfill. Incineration of animal material is an extremely inefficient process;
animal tissues do not make good fuel being 65% to 70% water. Further,
without specifying the conditions of temperature, residence time, and
agitation, there is no control over the efficiency of the proposed incineration.
The work of Paul Brown at NIH has clearly shown that the infectivity of
prions (in that case 256K scrapie agent) could survive a temperature of
600ºC for 15 minutes, conditions virtually never reached in routine
incinerators. Alkaline hydrolysis at elevated temperature* has been
demonstrated to destroy infectivity even of the most virulent strain of BSE.
i.e., 301V mouse –passaged BSE, and has been included in EU legislation
as a disposal method for all Category 1 material, including known BSEcontaminated
material.
We agree strongly with FDA’s concerns about cross contamination, not only
between ruminant feed processing lines and SRM destruction lines but also
between clean ruminant feed made from fresh animal and plant material
and ruminant feed contaminated with chicken droppings, non-ruminant feed
that could contain SRM, blood, and other waste products. While the
infectious dose quoted in Reference 13, 0.01gram of brain tissue from a
BSE infected animal, is frightening enough, a report that appeared after the
publication of the proposed rulemaking suggests that the actual infectious
dose may be as little as one-tenth that amount. While these possible
routes of infection of cattle are of serious concern, a potentially more direct
route of infection of humans has not been adequately considered or
discussed in connection with the banning of SRM from animal feed. It is an
unfortunate fact in this country that many poor people derive their major
protein intake from the eating of pet foods. Thus, the possible inclusion of
SRM in those products could pose a direct threat to human health. The
eating of pet foods by poor people was one of the primary reasons for the
banning from pet foods of material derived from animals euthanized with
barbiturates. SRMs included in per food could pose a similar significant
threat.
We are also uncomfortable with the elimination of the small intestine of
cattle younger than 30 months of age as SRM. Absorption in the small
intestine is the primary route of infection for the prions that cause Bovine
Spongiform Encephalopathy and it has been demonstrated that these
Waste Reduction by Waste Reduction, Inc.
* In the spirit of full disclosure, it must be noted that WR2 is the developer of the Alkaline Hydrolysis
Process and the manufacturer of Tissue Digestors™ for the use of the Process.
agents can localize and reproduce in the lymph nodes of the intestine
before they travel to the central nervous system. For that reason, we
believe that the small intestine of all cattle, or, at least, the terminal ileum of
all cattle, even those younger than 30 months of age, should be designated
as SRM and removed from the human and animal food chains. While we
realize that this would significantly increase the amount of SRM that
needed to be destroyed, we also believe that the necessary infrastructure
for that destruction, using scaled-up versions of current alkaline hydrolysis
technology, could rapidly be deployed either as fixed-base plants or as
large-scale mobile systems. While some of the numbers quoted in the
discussion section of the proposed rulemaking for the amount of SRM to be
generated seem very large, efficient use of as few as 100 alkaline
hydrolysis systems capable of processing 20,000 pounds per cycle and as
few as only three cycles per day could process the 2 billion pounds per year
reported on page 25 of the proposed rulemaking.
We must also question the cost estimates for disposal made by ERG. No
specific estimate for any of the proposed disposal methods is presented;
rather, a lump sum “low-end” estimate is given with no relation to any
method. We do not know how they derived any figures on the cost of
alkaline hydrolysis for their analysis as they did not contact us or, to the
best of our knowledge, any of the sites currently using large volume Tissue
Digestors™. Operating costs for these Digestors (not including labor and
amortization of capital equipment) range between $2.5 per 100 lbs and $4
per 100 lbs, far less than the $12 average cited. Further, considering that
the ERG survey had to have been made some months before the
publication of the proposed rulemaking, it could not have taken into account
the dramatic increase in natural gas costs to fuel the proposed incinerator
disposal pathway. Thus, even the apparently high estimates presented that
must include this as, perhaps, the primary disposal pathway are probably
much too low under present circumstances.
In summary, although we accept that the proposed rulemaking may be an
improvement over the present unregulated situation with regard to the use
of SRM in animal feeds, we do not believe it is inclusive enough nor goes
far enough. We believe the original proposal from FDA would provide
significantly greater protection of public health than the currently proposed
regulation.


http://www.fda.gov/OHRMS/DOCKETS/dockets/02n0273/02n-0273-EC232-Attach-1.pdf


tss



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