Ecological Risk Assessment Process for 

Honey Bees

U.S. Environmental Protection Agency 1

Thomas Moriarty, 

Pesticide Reevaluation Division

Office of Pesticide Programs
Overview

• Overview of Pollinator Declines

• International and Domestic Efforts to Refine Exposure/Effects 

and Risk Assessment Methods

• Current Risk Assessment Process

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• Current Risk Assessment Process

• Problem Formulation and Protection Goals

• Apis vs. non-Apis Bees

• Charge Questions
Overview of Pollinator Declines and Factors 

Associated with Declines

• National Academy of Science 2006 report on the status of

pollinators in North America; reported that in general,

pollinators are in decline

• Parasites and Varroa Mites

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• Parasites and Varroa Mites

• Diseases

• Nutritional stress

• Pesticides

• Parallel declines in pollinators and insect-pollinated plants 

reported in Britain and the Netherlands. 

• .
Pollinator Declines • Declines in managed 

honey bee colonies

• Approximately 6 mill. 

in 1947 to roughly 

2.8 million in 2006

• Introduction of mites 

in 1980’s

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in 1980’s

• 2007 increase in 

average colony
Pollinator Declines

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Agricultural Practices

Disease/Parasites

Bacteria

Fungi

Nosema

Viruses

Urbanization

Pesticides Nutrition

Source: USDA Agricultural Research Service

Other 

Insects Parasites

Bee Management Practices
Domestic and International Efforts to Refine 

Risk Assessment Methods for Bees

• USDA Workshop

• Society of Environmental Toxicology and Chemistry (SETAC) 

Pellston

• International Commission for Plant-Bee Relationships (ICP-BR)

• European and Mediterranean Organization for Plant Protection 

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• European and Mediterranean Organization for Plant Protection 

(EPP0)

• Prevention of Colony Losses (COLOSS)

• Organization for Economic Cooperation and Development 

(OECD) Pesticide Effects on Insect Pollinator (PEIP) Workgroup

• European Food Safety Authority (EFSA)
EPA Risk Assessment Process

• Qualitative hazard Assessment

• Acute Contact Toxicity (850.3020)

• Individual bees

• Young adult bees

• Toxicity of Residues on Foliage Test (850.3030)

• RT25

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• RT25

• Field Pollinator Toxicity Test (850.3040)

• Colony-level

• NOAEC/LOAEC

• Interim Guidance on Honey Bee Data Requirements

• Effects 

• Acute oral/semi-field studies

• Exposure

• Residues in pollen/nectar
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Protection Goals

• Management or Protection goals are statements about the desired 

condition of ecological values of concern.

• Defined, in part, by the laws which provide statutory authority to regulate 

pesticides.

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• Generic Protection Goals reflect statutory and scientific objectives of a 

regulatory agency.

• Specific Protection Goals provide guidance at the risk assessment level.

• Inform decisions about the type of data which are considered

• Provide a basis for criteria used in determining need for additional refinements
Protection Goals

Relative to pesticide risk assessment for pollinators, specific 

protection goals may include:

• Pollination Services

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• Honey/hive products 

• Biodiversity
Assessment Endpoints

• Valued entity (receptor)

• Attribute or characteristic that is important to protect and is 

potentially at risk 

• Assessment endpoints should be:

• Ecologically relevant

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• Ecologically relevant

• Susceptible to potential stressor (pesticide)

• Relevant to management goals

• Measurement endpoints provide specific information that 

informs one or more assessment endpoint. 
Assessment Endpoints

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Apis versus non-Apis Bees

• Primary focus of the proposed risk assessment framework is on honey bees 

(Apis mellifera)

• EPA regularly makes use of surrogate species to represent a broader range of 

organisms/taxa.

• Surrogates selected based on their ability to thrive under laboratory/field study conditions

• Reasonably sensitive indicators of toxicity

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• Proposed process employs measurements of exposure and effects that are 

relevant to both Apis and non-Apis bees.

• Screening level exposure measures (dermal and oral) are relevant to both Apis and non-Apis 

species

• Screening-level toxicity endpoints, based on individual bees, are adequately reflective and 

protective for non-Apis bees. 

• Proposed process is consistent with process used for other taxa, and supports 

the identified specific protection goals, as well as the Agency’s generic 

protection goals.