Health
Scientific Committees
Scientific Steering Committee (former MDSC)
Outcome of discussions
Evaluation of
the "133°/20'/3 bars heat/pressure conditions" for the
production of gelatine regarding its equivalency with
commonly used industrial gelatine production processes in
terms of its capacity of inactivating/eliminating possible
TSE infectivity in the raw material. Report and Opinion
adopted by the Scientific Steering Committee at its meeting
of 21-22 January 1999
1.
The question.
On 28 October 1998, Directorate General
VI - Agriculture of the European Commission invited the
Scientific Steering Committee to evaluate an alternative
process for the production of gelatine from bones regarding
its equivalent efficacy in terms of eliminating TSE
agents.
The exact formulation of the question is
as follows:
"Is a treatment of all ruminant bone material which is
not derived from animals born, reared and slaughtered in
countries recognised BSE free or at negligible risk, to
heating to at least 133°C throughout its substance for a
minimum of 20 minutes at a pressure of three bars, with a
particle size prior to processing of not more than 50
millimetres
and complying with the updated report on MBM regarding
the steam requirement without air trapped,
an acceptable alternative to the production conditions
laid down in the opinion on the safety of gelatine,
namely:
a process which ensures that all bone material is finely
crushed and degreased with hot water and treated with
dilute hydrochloric acid (at minimum concentration of 4%
and pH<1.5) over a period of at least two days, followed
by an alkaline treatment of saturated lime solution
(pH>12.5) for a period of at least 20 days with a
sterilisation step of 138-140°C during 4
seconds".
The evaluation was referred by the
Scientific Steering Committee to the "Safety of Products"
working group of the TSE/BSE ad hoc Group of the Scientific
Steering Committee. Its report follows hereafter.
2. Background
The SSC (Scientific Steering Committee)
adopted at its plenary meeting of 26-27 March 1998, an
opinion on the safety of gelatine produced from ruminant
bones manufactured following the classic acid-alkaline
process.
This opinion elaborates on the sourcing
of the raw material and provides the example of an
"appropriate" production process for bone materials: bones
finely crushed and degreased with hot water and treated
with dilute hydrochloric acid (at a minimum concentration
of 4% and pH <1.5) over a period of at least two days,
followed by an alkaline treatment of saturated lime
solution (pH >12.5) for a period of 20 to 50 days with a
sterilisation step of 138-140°C during 4 seconds. Regarding
the sterilisation step, the SSC further noted that the
appropriate technique should be used, as its efficacy in
contributing to the inactivation of a TSE agent will also
depend upon the time needed to reach the temperature, the
duration of the cooling and the atmospheric pressure during
the process.
It was further stated: "Alternative
methods with demonstrated equivalent efficacy in terms of
eliminating BSE-agents may be acceptable. Such methods must
be evaluated and acknowledged on a case by case basis, also
against the BSE status of the source region or country and
the type of material used. For bones coming from high or
low risk countries, the alkaline step should be
included".
It is in this context that the question
was raised whether
"a treatment of all ruminant bone material which is not
derived from animals born, reared and slaughtered in
countries recognised BSE free or at negligible risk, to
heating to at least 133°C throughout its substance for a
minimum of 20 minutes at a pressure of three bars, with a
particle size prior to processing of not more than 50
millimetres
and complying with the updated report on MBM regarding
the steam requirement without air trapped, can be
considered as an acceptable alternative to the production
conditions laid down in the opinion on the safety of
gelatine".
A process which is currently applied by
the industry can be summarised as follows:
- Finely crushed bone chips are
degreased with hot water (85-90°C, pH = approximately 5,
during an average of 15 minutes);
- After centrifugation and pre-drying,
the bone chips are dried (rotating drier) in a stream of
hot air (over 400°C) and then calibrated (mean particle
size 15-20 mm);
- The calibrated bone chips are first
pre-heated with steam (115°C, 1.7 bars, 10 minutes) in an
autoclave;
- The pre-heated bone chips are
autoclaved and pressurised with steam at 133°C, 3 bars, 23
minutes and then after depressurisation the gelatine is
extracted with water; (10°C in most steps, 20
minutes);
- The steam heating (133°C/3bars/20
minutes) and water extraction is repeated eight times on
the residual bone chips;
The gelatine extraction yield is
decreased after each step. To obtain sufficient
concentration during the last 4 heatings, the extraction is
realised with the gelatine liquid obtained in previous
extraction steps.
- The extractions are finally purified
by filtration, centrifugation and are sterilised during 5
seconds at least 148°C.
3. Report from the Working Group.
The bone material used for this
particular preparation may potentially be
cross-contaminated with (dried) brain, spinal cord and bone
marrow
1
.
It has been reported that it becomes
more difficult to inactivate scrapie-infected brain-tissue
by heat after it has been dried (Asher et al, 1986; 1987).
However, it seems (Gelatine Delft, 1998) that the
degreasing step, which precedes the drying of the bones,
and carried out at a pilot scale which represent the
commercial degreasing process under laboratory
conditions
2
, reduces the brain protein levels by a factor 300-800.
It may be expected that, under operational conditions, this
reduction is higher because the same laboratory experiments
at pilot scale resulted in degreased bone with a fat
content of 6%, compared with 3% in the commercial
process.
The Working Group considers that the
extrapolation of data on inactivation/reduction of the TSE
agent during the process of rendering animal waste into
meat-and-bone meal, to a similar heat treatment of bones
can not be done automatically with a high degree of
certainty. This means, that if the question has to be
answered in detail, experiments using as exact conditions
as possible should be performed. Otherwise one has to
extrapolate several parameters, including the effects of
water content
3
, lipid content, particle size, heat penetration and so
forth. These parameters may have both a stabilising and
destabilising effect on the stability of the agent and may
change the temperature or time settings of the
treatment.
The experiments on which the reduction
factor for 133C/20min/3bar is based, involves treatment for
MBM production of raw material with a certain average
composition and water content. If the raw material
exclusively bone material (which may previously have been
dried), heat penetration may be changed. (Thus a longer
pre-heating phase or heating time may be required.) The
water content may not be adequate for efficient
inactivation.
During the common production process of
meat-and-bone meal from fresh material, the steam is
generated by the water naturally present in the tissues.
The water content during such process is estimated at
approximately 60%. The maximum water content of bones is
about 25-30%.
Although dried bone chips have a water
content of only around 10%, it is evident that they become
hydrated during the manufacturing process. Gelatine could
not be extracted unless the bone material has at this stage
a sufficiently high water content. (According to GSB, 1998,
the water content is approx.25% after the pre-heating step
and approx. 50% after the first heat and pressure
treatment). This means that there is little doubt that
steam could be generated and that heat penetration into the
15-20 mm bone chips during the 133°C steam process does
occur.
Therefore, whilst awaiting results from
TSE inactivation experiments, the Working Group considers
that the 133C/20min/3bar conditions, if applied withall
relevant parameters listed in the Updated Scientific Report
presented on 24-25 September to the Scientific Steering
Committee on the safety of meat and bone meal derived from
mammalian animals fed to non-ruminant food-producing farm
animals (e.g., maximum particle size, enough water and
saturated steam
4
, core temperature reached in all parts of the material
for at least 20 min
5
, etc.), would result in a reduction of potential BSE
infectivity which is close to or equivalent to the
reduction realised during the production process of
meat-and-bone meal from a fresh mixture of materials
containing bones, meat and other animal offals. According
to the SSC opinion of 26-27 March 1998, this process is
accepted to result in an infectivity reduction of at least
3 log
10, whereas the reduction of the acidulation +
liming process of the typical gelatine production process
is approx 2.84 log
10. (INVERESK Research, 1998).
4. Opinion of the Scientific Steering Committee
a) The SSC wishes to propose that any
future request for the evaluation of production processes
in terms of their equivalency in TSE infectivity
inactivation/elimination with other already documented and
validated processes, should be accompanied with the results
of a validation study and/or a supporting report on the TSE
inactivation/elimination capacity of the process.
b) The SSC recognised that it becomes
more difficult to inactivate scrapie-infected brain-tissue
by heat after it has been dried, that the raw material used
for the production of meat-and-bone meal and for gelatine
has a different composition (e.g., water, fat and protein
content) and different physical characteristics and that
there may be different heat transfer and inactivation
conditions during production. In general, there is an
uncertain comparability of "133°/20'/3 bars"
heat/pressure/time conditions during the processing of
fresh animal waste into meat-and-bone and (fresh or dried)
bone material into gelatine.
In the absence of a scientific and
comprehensive report on or the results of a validation
study on the TSE infectivity inactivating capacity of such
processing conditions and the intended end-use of the
produced gelatine being for human (and possibly animal)
consumption, the uncertainties about the residual risk
should therefore be reduced to the minimum possible.
The SSC is also concerned that an
acceptance of the equivalent inactivation of TSE
infectivity in the present process for the production of
gelatine with the process described in the SSC opinion of
26-27 March 1998 may trigger the submission for approval of
a number of other production processes for which no
validation has been carried out.
Given these concerns, the SSC cannot
conclude that "133°/20'/3 bars" heat/pressure/time
conditions as described in the report of the Working Group
would result in an equivalent safe product compared with
the acid-alkaline industrial gelatine production process
described in its opinion on the Safety of Gelatine of 26-27
March 1998.
Therefore, for gelatine derived from
ruminant bones, the Scientific Steering Committee's Opinion
on the Safety of Gelatine adopted on 26-27 March 1998 and
updated on 3 April 1998, remains valid. At present, the
only preliminary conclusion can be that ruminant bones from
animals certified fit for human consumption, to be used for
production of gelatine with the alternative system
described in the above Section 2 (Background), will have to
come from BSE-free or BSE-negligible risk countries.
c) The industry is invited to organise
an independent experiment showing that the series of
successive "133°C/20'/ 3 bars" steps for the production of
gelatine, results in a BSE infectivity reduction which is
at least equivalent to the reduction obtained during the
"133°C/20'/3 bars" production process defined in the SSC
opinion of 26-27 March 1998 and in the Updated Scientific
Report of 24-25 September 1998 on the safety of
meat-and-bone meal and which accept an infectivity
reduction of at least 3 log
10. These experiments should be carried out
under conditions similar to the ones in the real industrial
processes. The inactivation should be assessed at least for
the series as a whole of successive "133°C/20'/ 3 bars"
steps and preferably also for the production process as a
whole. The data should clearly show that also dry
contaminated material can be reduced in infectivity.
4. Literature references
Asher,D.M. et al (1986) Practical inactivation of
scrapie agent on surfaces. Abstracts of the IXth
International Congress of Infectious and Parasitic
Diseases, Munich, 20-26 July.
Asher, D.M. et al (1987) Attempts to disinfect
surfaces contaminated with etiological agents of the
spongiforrn encephalopathies. Abstracts of the VIIth
International Congress of Virology, Edmonton, 9-14 August,
p. 147.
E.C. (European Commission), 1998a. Opinion of the
Scientific Steering Committee on the Safety of Gelatine.
Adopted on 26-27 March 1998.
E.C. (European Commission), 1998b. Opinion of the
Scientific Steering Committee on the safety of meat and
bone meal from mammalian animals, naturally or
experimentally susceptible to Transmissible Spongiform
Encephalopathies. Adopted on 26-27 March 1998.
E.C. (European Commission), 1998c. Updated
Scientific Report presented on 24-25 September to the
Scientific Steering Committee on the safety of meat and
bone meal derived from mammalian animals fed to
non-ruminant food-producing farm animals. Adopted on 24-25
September 1998
Gelatine Delft Company, 1998. Information on the
results of laboratory tests carried out at pilot-scale on
the efficacy of the degreasing step with respect to the
reduction of brain material possibly present in raw bone
material. Provided in the letter of 4.12.1998 of Taylor,
D., member of the Working Group, to the SSC
secretariat.
GSB (Gelatine Smits Beheer BV, 1998). Gelatine heat
pressure process. Letter of 9.12.98 to Prof.Dr.A.Osterhaus,
member of the Scientific Steering Committee. 4 pp
(Commercial - in confidence).
Inveresk Research, 1998. Validation of the clearance
of scrapie from the manufacturing process of gelatine.
Final report. Inverest Project N° 855028. Inveresk Report
N° 14682. Tranent (Scotland), 41 pp.
Literature references listed in E.C., 1998a, 1998b and
1998c.
SEAC (Spongiform Encephalopathy Advisory Committee,
1998. November 1998 Reoprt tro the (UK) Ministers: A
review of infectivity in bone marrow and dorsla root
ganglia in cattle infected with BSE. 4 pp.
Wells, G.A.H., Hawkins, S.A.C., Green, R.B., Austin,
A.R., Dexter, I., Spencer, Y.I., Chaplin, M.J., Stack,
M.J., Dawson, M., 1998. Preliminary observations on the
pathogenesis of experimental bovine spongiform
encephalopathy (BSE): an update. Veterinary Record,
Vol.142: pp 103-106.
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1
Preliminary results of the still ongoing BSE
pathogenesis experiment in cattle (Wells et al, 1998) are
not fully conclusive: the (mice) tests for infectivity of
bone marrow were only positive in the group killed at 38
months after infection with BSE, when clinical disease was
evident in the cattle, and not at an earlier (2 to 36
months) or later (40 months) time after exposure to BSE.
The current SEAC conclusion (SEAC, 1998) is that "the
positive result at 38 months cannot be discounted and may
indicate that infectivity in bone marrow occurs
occasionally, when clinical signs are apparent and there
are already very high levels of infectivity in the central
nervous system." It is noted that BSE infectivity in bovine
bone-marrow has been detected in only one still ongoing
experiment, and only after the onset of clinical
signs.
2
Ten grams of pig-brain thoroughly mixed with 1 kg of
bone-chips typically used by gelatine manufactures (average
particle size: 12 mm, maximum: 20 mm).
3
For example, for meat-and-bone meal the water content
is approximately 60%.
4
"Saturated steam" means that all air is evacuated and
replaced by steam in the whole sterilisation
chamber.
5
The working group wishes to stress that this period of
20 minutes should be continuous, without
interruptions.
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