Biohazard Risk Assessment - Culture Collections · Web viewHazard Group 3. A biological agent that...
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ECCW86.01 Authorised by: Ed Burnett Effective Date:10.02.2014 Page 1 of 5 Biohazard Risk Assessment To be completed prior to acceptance of a Cell Line into a European Collection of Cell Cultures (ECACC) repository For ECACC use only Type of Deposit: Accession Accession Number: Tracking Number: ACDP Hazard Group: 2 ECACC Risk Assessments: Signature Date: For completion by Depositor. Complete all questions (1-17) if the Cell Line has an associated pathogen or is genetically modified. Otherwise complete questions 1-7 & 17. Name of Depositor Title Signature Dat e 1 . Cell Line Name Culture Collections, Public Health England, Porton Down, Salisbury, SP4 0JG, United Kingdom T: +44 (0) 1980 612512 F: +44 (0) 1980 611315 E: [email protected] W: www.phe- culturecollections.org.uk
Transcript of Biohazard Risk Assessment - Culture Collections · Web viewHazard Group 3. A biological agent that...
ECCW86.01 Authorised by: Ed Burnett Effective Date:10.02.2014
Page 1 of 4
Biohazard Risk AssessmentTo be completed prior to acceptance of a Cell Line into a European Collection of Cell Cultures (ECACC) repository
For ECACC use only
Type of Deposit: Accession
Accession Number: Tracking Number:
ACDP Hazard Group: 2
ECACC Risk Assessments:
Signature Date:
For completion by Depositor. Complete all questions (1-17) if the Cell Line has an associated pathogen or is genetically modified. Otherwise complete questions 1-7 & 17.
Name of Depositor
Title
Signature Date
1
.
Cell Line Name
2
.
Tissue type
3
.
Species
4
.
Morphology
5. Is cell line known to contain or secrete a virus or virus-like particles? Yes No Culture Collections, Public Health England, Porton Down, Salisbury, SP4 0JG, United Kingdom
T: +44 (0) 1980 612512 F: +44 (0) 1980 611315 E: [email protected] W: www.phe-culturecollections.org.uk If Yes, is the virus of a known pathogenic type or potentially pathogenic to animals or humans?
Please give details of any virus or virus-like particles known to be associated with the cell line in the box provided below (#6). If No, indicate the reason by giving details in the box provided below (#6) of any tests performed.
ECCW86.01 Authorised by: Ed Burnett Effective Date:10.02.2014
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6. Does the cell line contain/produce a biologically active substance that could potentially causing harm to humans (e.g. toxin, cytokine, hormone, allergen, oncogene or virus) . Yes No
7. Is the Cell Line Genetically Modified Yes No If Yes, what Class:
8. ACDP Hazard Group1 1 2 3 4 If USA deposit use SALS Category
9. Brief description of known associated pathogens or genetic modification of the cell line.
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Culture Collections, Public Health England, Porton Down, Salisbury, SP4 0JG, United KingdomT: +44 (0) 1980 612512 F: +44 (0) 1980 611315 E: [email protected] W: www.phe-culturecollections.org.uk
ACDP Advisory Committee on Dangerous Pathogens
Hazard Group 1. A biological agent unlikely to cause human disease.
Hazard Group 2. A biological agent that can cause human disease and may be a hazard to employees, it is unlikely to spread to the community and there is usually effective prophylaxis and effective treatment available.
Hazard Group 3. A biological agent that can cause severe human disease and presents a serious hazard to employees. It may present a risk of spreading to the community, but there may be a prophylaxis or treatment available.
Hazard Group 4. A biological agent that causes severe human disease and is a serious hazard to employees. It is likely to spread to the community and there is usually no effective prophylaxis or treatment available.
ECCW86.01 Authorised by: Ed Burnett Effective Date:10.02.2014
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10. Are you including any Risk Assessment performed at your site? Yes / No. *If Yes, please attach.
11. If you are sending ampoules to ECACC are they glass ampoules or plastic vials? Plastic
12. Does this require a Specified Animal Pathogens Order Yes No
*If yes please refer to the DEFRA Web site where you can download a licence application.
www.defra.gov.uk
13. What is the likelihood that the associated pathogen or genetic modification can confer
pathogenic traits in the host organism? Negligible Possible Demonstrated
14. What is the potential for sequences in the cell line being transferred to another related organism?
Negligible Low Medium High
15. In the light of your knowledge of this cell line and its origination, what is your assessment of its potential to cause harm to human health in the event of exposure?
Negligible Low Medium High
16. Does this cell line have the ability to survive, establish and disseminate in the environment?
Culture Collections, Public Health England, Porton Down, Salisbury, SP4 0JG, United KingdomT: +44 (0) 1980 612512 F: +44 (0) 1980 611315 E: [email protected] W: www.phe-culturecollections.org.uk
If answer to question 13 is either "possible" or "demonstrated" please provide additional details here:
If answer to question 14 is either "medium" or "high" please provide additional details here:
If answer to question 15 is either "medium" or "high" please provide additional details here:
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Yes No
17. ECACC may request further information in order to complete its risk assessment.
To whom should such requests be addressed?
Name
Address
Telephone Fax
Culture Collections, Public Health England, Porton Down, Salisbury, SP4 0JG, United KingdomT: +44 (0) 1980 612512 F: +44 (0) 1980 611315 E: [email protected] W: www.phe-culturecollections.org.uk
