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Country's Decision or any other Communication
Record information and status
Record ID
107918
Status
Published
Date of creation
2015-03-24 08:03 UTC (german_bch@bvl.bund.de)
Date of last update
2017-04-12 13:27 UTC (german_bch@bvl.bund.de)
Date of publication
2017-05-16 10:12 UTC (222@bmel.bund.de)

This document is also available in the following languages:
General information
Country submitting the decision or communication
  • Germany
Competent National Authority(ies) responsible for the decision or communication
Federal Office of Consumer Protection and Food Safety
Mauerstrasse 39-42
Berlin
Germany, 10117
Phone:+49-(0)3018-445-6500
Fax:+49-(0)3018-445-6099
Email:german_bch@bvl.bund.de
Url:http://www.biosafety-bch.de (english language),BVL Homepage (English)
Title / Reference number of the decision or communication
6786-01-0213 (adv. 42010-0213); Decision regarding the deliberate release (field trial) of genetically modified Rhodococcus equi RG2837 issued by the German Competent Authority
Date of the decision
2012-06-04
Is the decision taken prior to entry into force of the Protocol?
No
Jurisdiction
  • Germany
Is this an amendment to a previous decision / communication?
No
Decision or communication details
Subject(s) of the decision
  • Decision on LMOs for intentional introduction into the environment (according Article 10 or domestic regulatory framework)
Was the decision triggered by a request for a transboundary movement of LMOs into the country?
No
Does the decision apply to transboundary movements of LMO(s) into the country?
No
Importer’s or Applicant’s contact details
Intervet
Intervet International B.V.
Wim de Körverstraat 35
Boxmeer
Netherlands, 5831 AN
Phone:+ 31 48 558 7600
Email:animal-health-communications@merck.com
Url:MERCK Animal Health
Result of the decision
  • Approval of the import/use of the LMO(s) with conditions
Conditions
[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"].
Reasons
To comply with requirements of Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act): reduce possibility of GMO spread/establishment.
Does the decision involve field trials?
Yes
Does the decision involve commercial release?
No
LMO identification
Rhodococcus equi Vaccine
Intervet Resistance to diseases and pests - Bacteria
Risk assessment
6786-01-0213 (adv. 42010-0213); Summary of the risk assessment of a deliberate release (field trial) of genetically modified Rhodococcus equi RG2837 issued by the German Competent Authority
Rhodococcus equi Vaccine
Intervet

Resistance to diseases and pests - Bacteria
Additional Information
Additional Information
type of decision: field trial
LMO: Rhodococcus equi RG2837
legal basis: Directive 2001/18/EC, Gentechnikgesetz (German Gene Technology Act)
scope: test of field performance of LMO/animal experiment for vaccine design
authorization valid from June 04, 2012 to December 31, 2014
locations: One release site; for details see German LMO/GMO location register ( http://apps2.bvl.bund.de/stareg_web/localeSwitch.do?language=en&page=/showflaechen.do?)
size: stables with 1800 m²; no more than 60 fowls per year, not more than 120 fowls during the whole trial will be treated with the vaccine containing LMO Rhodococcus equi RG2837