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Biological agent

Any micro-organism, cell culture, or human endoparasite, including any that have been genetically modified, which may cause infection, allergy, toxicity or other hazard to human health. Classified into four groups by infectivity and risk.

By jurisdiction

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UK HSE

“biological agent”Exact equivalent

Defined in COSHH 2002 regulation 2(1) as any micro-organism, cell culture, or human endoparasite, including genetically modified ones, that may cause infection, allergy, toxicity or other hazard to human health. Schedule 3 of COSHH sets out four hazard groups, from group 1 (unlikely to cause human disease) to group 4 (causes severe human disease, high individual risk).

RegulatoryControl of Substances Hazardous to Health Regulations 2002, regulation 2(1) and Schedule 3Source
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Irish HSA

“biological agent”Close equivalent

Defined in the Safety, Health and Welfare at Work (Biological Agents) Regulations 2013 (SI 2013/572), implementing EU Directive 2000/54/EC. Biological agents are classified into groups 1 to 4 by risk to humans. Employers must assess the risk and apply containment measures appropriate to the group.

Jurisdiction note: The Irish regulations implement the same EU Directive basis as the GB COSHH Schedule 3 but are a separate statutory instrument. The hazard group classification is identical in structure.
RegulatorySafety, Health and Welfare at Work (Biological Agents) Regulations 2013 (SI 2013/572)Source
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US OSHA

“biological hazard”Partial equivalent

OSHA addresses biological agents in specific standards including 29 CFR 1910.1030 (Bloodborne Pathogens), which defines bloodborne pathogens as pathogenic microorganisms in human blood that can cause disease. There is no single OSHA standard equivalent to COSHH Schedule 3 covering all four hazard groups of biological agents.

Jurisdiction note: OSHA addresses biological hazards through specific standards (bloodborne pathogens, anthrax, select agents) rather than a general four-group classification. COSHH Schedule 3 is more comprehensive.
Regulatory29 CFR 1910.1030Source

Practitioner note: Group classification drives the containment level. Confirm the group before specifying controls, because the risk assessment and the containment requirements both follow from it.

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