ECCW86.01
Authorised by: Ed Burnett
Effective Date:10.02.2014
Page 1 of 4
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
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
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.
Culture Collections, Public Health England, Porton Down, Salisbury, SP4 0JG, United Kingdom
T: +44 (0) 1980 612512 F: +44 (0) 1980 611315 E: culturecollections@phe.gov.uk W: www.phe-culturecollections.org.uk
ECCW86.01
Authorised by: Ed Burnett
Effective Date:10.02.2014
Page 2 of 4
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
8. ACDP Hazard Group1
1
2
Yes
No
3
If Yes, what Class:
4
If USA deposit use SALS Category
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.
9. Brief description of known associated pathogens or genetic modification of the cell line.
Culture Collections, Public Health England, Porton Down, Salisbury, SP4 0JG, United Kingdom
T: +44 (0) 1980 612512 F: +44 (0) 1980 611315 E: culturecollections@phe.gov.uk W: www.phe-culturecollections.org.uk
ECCW86.01
Authorised by: Ed Burnett
Effective Date:10.02.2014
Page 3 of 4
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
If answer to question 13 is either "possible" or "demonstrated" please provide additional details
here:
14.
What is the potential for sequences in the cell line being transferred to another related organism?
Negligible
Low
Medium
High
If answer to question 14 is either "medium" or "high" please provide additional details here:
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
If answer to question 15 is either "medium" or "high" please provide additional details here:
16.
Does this cell line have the ability to survive, establish and disseminate in the environment?
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: culturecollections@phe.gov.uk W: www.phe-culturecollections.org.uk
ECCW86.01
Authorised by: Ed Burnett
Effective Date:10.02.2014
Page 4 of 4
17.
ECACC may request further information in order to complete its risk assessment.
To whom should such requests be addressed?
Name
Address
Telephone
Fax
E-mail
Culture Collections, Public Health England, Porton Down, Salisbury, SP4 0JG, United Kingdom
T: +44 (0) 1980 612512 F: +44 (0) 1980 611315 E: culturecollections@phe.gov.uk W: www.phe-culturecollections.org.uk