[only the most relevant conditions have been translated into
English]
II.3. The release of the genetically modified (GM) bacterial
strain, i.e. the rectal admin-istration of the vaccine to foals, is
permitted only after the competent inspection au-thority has
received any written agreements between the operator and the
entities authorised to dispose of the premises and the animals in
question that are required for compliance with the provisions of
this notification. These agreements are to be lodged with the
competent inspection authority at least three working days prior to
the release. The exact dates of the release are to be reported to
the competent in-spection authority at least three working days
prior to the release. If it proves unfea-sible to start the release
trial on the indicated day, a shorter notification period can be
agreed between the competent inspection authority and the
operator.
Prior to the start of the deliberate release the operator must be
able to demonstrate to the competent inspection authority that he
has at his disposal the facilities required for storage, transport
and disposal of the GM bacterial material and the contaminated
waste material.
If the operator does not intend to make use of the approval of the
deliberate release for all of the remaining approval period, the
competent inspection authority and the Bundesamt für
Verbraucherschutz und Lebensmittelsicherheit, BVL [Federal Office
of Consumer Protection and Food Safety] are to be informed thereof.
Pursuant to § 16a GenTG, the BVL is to be notified of the actual
implementation of the release at latest three working days prior to
commencement.
II.4. The report required under § 21 (4) GenTG is to be forwarded
to the BVL following completion of the project, at latest by 31
January 2015.
The interim reports on the release of GM bacteria during the
respective trial year are to be forwarded to the BVL by 31 January
of the year after the release year.
These reports are to include the results of the tests for faecal
shedding of the GM bacteria by the trial animals as well as the
results of the planned tests of soil samples for occurrence of GM
bacteria to be carried out by the operator under Provision
II.8.
When preparing the reports, due consideration shall be given to the
Commission De-cision of 29 September 2003 for establishing a format
for presenting the results of deliberate releases of genetically
modified higher plants into the environment for pur-poses other
than placing on the market (2003/701/EC). In doing so, the
structure giv-en in the Report Form is to be used. The sub-items
under Nos. 6.1. and 6.2. are to be adapted to the circumstances of
a release of the GM bacteria.
Any intended modification to or unintended change of the deliberate
release that be-comes known which could have consequences for the
evaluation of the conditions according to § 16 (1) of the GenTG
shall be reported to the BVL.
If the operator receives new information concerning risks to the
legal assets and in-terests mentioned in § 1 No. 1 of the GenTG, he
is obliged, insofar as it relates to the release, to report it
immediately to the BVL.
II.7. As long as the horses participating in the trial are kept at
the site of the release (stable building), the stable building and
its immediate surroundings are to be controlled on a daily basis.
Attention shall be paid to abnormalities in the interactions
between the GMO and the trial horses and, where applicable, other
organisms which could come into contact with the GM bacteria. If
necessary, risk-minimising measures are to be taken.
All observations, including the absence of abnormalities and any
interferences in the experiment, are to be recorded and presented
in the interim report.
II.8. The operator plans to transfer the foals back to the main
stud, at the earliest, six weeks after the last vaccination. Until
such time the horses are to be held exclusively in the stable
building proposed in the application for use for the release trial,
which they may not leave at any time in between. Given the
possibility that individual ani-mals may excrete small amounts of
the GM vaccine strain during that time, before returning to the
main stud the horses are to be examined for shedding of the GM
bacteria by the method described in the application. The competent
inspection au-thority is to be informed of the results of these
tests before the animals are moved to the main stud. Only animals
shown not to excrete the GM vaccine strain are to be permitted to
leave the release site and be transported to the main stud. The
compe-tent inspection authority shall be informed of the dates and
times at which horses which have tested negative are to be
transferred to the main stud.
II.9. The concrete floor in front of the stable building is to be
controlled on a regular basis for the discharge of manure and
faeces from the stable. Where necessary, the dis-charge is to be
removed and disposed of in the proper manner and the affected floor
area is to be disinfected.
II.10. Faeces or manure produced during the peak shedding period
(in the first two days after vaccination) is to be removed in the
meantime and straw and litter are to be re-placed. Contaminated
straw, litter and manure are to be transferred to sealed
con-tainers and transported off site to an authorised specialist
contractor for incineration. If the containers are not
co-incinerated they are to be disinfected after use.
II.11. After each group of foals has left the stable, the straw,
litter and manure are to be transferred to closed containers and
transported off site to an authorised specialist contractor for
incineration. If the containers are not co-incinerated they are to
be dis-infected after use.
II.12. The operator plans to conduct one cleaning operation in each
year after all trial hors-es have left the release site. In the
process, after complete removal of all straw, litter and manure,
the stable, the entire concrete floor inside and in front of the
building as well as all equipment used are to be first cleaned with
water and subsequently disin-fected with Halamid® (chloramine-T) in
standard concentration. The applicant shall ensure complete
disinfection of the entire area with Halamid®. The applicant shall
al-so ensure that the cleaning water is disinfected prior to
disposal.
II.13. The operator has a duty to ensure that all staff who have
access to the trial site are sufficiently qualified and instructed.
The operator plans to instruct all staff who have access to the
trial site on the charac-teristics of the vaccine strain in
writing, by providing a product brochure. In addition, the operator
has a duty to verbally inform all staff who have access to the
trial site about the content of the brochure and about the possible
health hazards caused by the R. equi bacterium in general, and
which could therefore result from handling very large amounts of
the GM vaccine strain. The content and dates and times of
instruc-tion shall be recorded in writing and confirmed by the
instructed persons by signa-ture.
As a preventive measure, members of staff with known
immuno-compromised sta-tus and members of staff who are scheduled
to receive or who are already receiving immuno-suppressant therapy
should not participate directly in the trial in order to avoid
contact with very large amounts of the GM vaccine strain.
II.14. The metal wiremesh fence surrounding the 110 m x 180 m
grounds on which the sta-ble building is located is to be
signposted as follows: "Das Betreten des Geländes durch Un-befugte
ist nicht gestattet" ["No entry to unauthorised persons"].
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