Information provided for informational purposes only

Note: This information is provided for reference purposes only. Although the information provided here was accurate and current when first created, it is now outdated.

Staff Paper #13
TRAC 7/13-14/98
Elements of OPP's Preliminary Risk Assessments

The elements of OPP's human health and environmental preliminary risk assessments documents are listed below:

A. Human health assessment.

1. Hazard assessment. Assessment of hazard/toxicity to human and domestic animals.

a. Acute toxicity
b. Subchronic toxicity
c. Chronic toxicity
d. Carcinogenicity
e. Developmental toxicity
f. Reproductive toxicity
g. Mutagenicity
h. Metabolism
i. Domestic animal safety
j. Dermal penetration
k. Neurotoxicity

2. Dose Response Assessment. Decision on the appropriate No Observable Effect Levels (NOEL) for use in risk assessment.

a. Reference dose (acute and chronic).

b. Occupational/residential.

c. Carcinogenicity classification and risk quantification.

d. Other toxic endpoints.

3. Exposure Assessment. Estimate of exposure of the general population to pesticide residues in food and water, and to pesticides in the workplace.

a. Dietary exposure (residue and consumption components).

b. Occupational exposure.

4. Risk Characterizations. Risks to humans are characterized based on a consideration of dietary, occupational, and residential risk assessments and exposure estimates.

a. Dietary risk.

b. Occupational and residential risk characterizations.

5. FQPA Considerations. Determination of safety for infants, children, and U.S. population.

B. Environmental assessment.

1. Ecological toxicity data. Assessment of hazard/toxicity of plants and animals.

2. Environmental fate characteristics. Assessment of what might become of a pesticide once it is introduced into the environmental (e.g., degradation, transport to ground/surface water).

3. Exposure and risk characterization. Risks to the environment are characterized based on a consideration of toxicity and the potential for an animal or plant to be exposed.


FOUR OPTIONS FOR REFINING RISK ASSESSMENTS

STAFF PAPER #13 (continued)

OPTION 1--Registrant Consultation, Federal Register Notice and Public Comment

In this option, the preliminary risk assessment would be sent to the registrant, same as in the current process (Option 3), and refinements to the risk assessment would be made. At that point the refined risk assessments would be shared with the public for comment through a notice of availability in the Federal Register, with a summary of the comments provided by the registrant and any changes to the risk assessment made by the Agency in response to those comments. Additional refinements to the risk assessments would then be made based on information and/or data submitted by any of the stakeholders, and a risk assessment would be released.

OPTION 2--Federal Register Notice and Public Comment

In this option, the Agency would issue a notice of availability in the Federal Register of the preliminary risk assessment for a chemical and provide opportunities for review and comment to all stakeholders at the same time. Refinements to the risk assessment would be made based upon the information/data received from all stakeholders, and the assessment would be released.

OPTION 3 (current process)

Under the current process, the Agency develops an initial risk assessment for a chemical and then sends the assessment to the registrant(s) of the chemical. The Agency typically meets with the registrant(s) and receives comments on the risk assessment. The Agency reviews all comments and makes any refinements that are appropriate and supported with data.

OPTION 4--Registrant Consultation for Error Correction Only, Federal Register Notice and Public Comment

In this option, the preliminary risk assessment would be shared with the registrant for the correction of errors only. The Agency would review the comments on any errors and make appropriate corrections. The Agency would issue a notice of availability of the risk assessment in the Federal Register, along with a discussion of any comments received on errors, for review and comment by all stakeholders. Refinements to the risk assessment would be made based on information/data received from all stakeholders, and the Agency would release the draft risk assessment for individual chemicals.


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updated August 3, 1999