assessments, the summaries from Bryceland et al. (1997) are used. In
most cases, this did not
have a substantial impact on the risk assessment. Specific examples are discussed in various
sections of this risk assessment as appropriate.
The human health and ecological risk assessments presented in this document are not, and are not
intended to be, comprehensive summaries of all of the available information. The information
presented in the appendices and the discussions in chapters 2, 3, and 4 of the risk assessment are
intended to be detailed enough to support a review of the risk analyses; however, they are not
intended to be as detailed as the information generally presented
in Chemical Background
documents or other comprehensive reviews.
For the most part, the risk assessment methods used in this document are similar to those used in
risk assessments previously conducted for the Forest Service as well as risk assessments
conducted by other government agencies. Details regarding the specific methods used to prepare
the human health risk assessment are provided in SERA (2000).
Risk assessments are usually expressed with numbers; however, the numbers are far from exact.
Variability and
uncertainty may be dominant factors in any risk assessment, and these factors
should be expressed. Within the
context of a risk assessment, the terms
variability and
uncertainty signify different conditions.
Variability reflects the knowledge of how things may change. Variability may take several forms.
For this risk assessment, three types of variability are distinguished:
statistical,
situational, and
arbitrary.
Statistical variability reflects, at least, apparently random patterns in data. For
example, various types of estimates used in this risk assessment involve relationships of certain
physical properties to certain biological properties. In such cases, best or maximum likelihood
estimates can be calculated as well as upper and lower confidence
intervals that reflect the
statistical variability in the relationships.
Situational variability describes variations depending on
known circumstances. For example, the application rate or the applied concentration of a
herbicide will vary according to local conditions and goals. As discussed in the following section,
the limits on this variability are known and there is some information to indicate what the
variations are. In
other words,
situational variability is not random.
Arbitrary variability, as the
name implies, represents an attempt to describe changes that cannot be characterized statistically
or by a given set of conditions that cannot be well defined. This type of variability dominates
some spill scenarios involving either a spill of a chemical on to the surface of the skin or a spill of
a chemical into water. In either case, exposure depends on the amount of chemical spilled and the
area of skin or volume of water that is contaminated.
Variability reflects a knowledge or at least an explicit assumption about how things may change,
while
uncertainty reflects a lack of knowledge. For example, the
focus of the human health
dose-response assessment is an estimation of an “acceptable” or “no adverse effect” dose that will
not be associated with adverse human health effects. For sethoxydim and for most other
chemicals, however, this estimation regarding human health must be based on data from
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experimental animal studies, which cover only a limited number of effects. Generally, judgment is
the basis for the methods used to make the assessment. Although the judgments may reflect a
consensus (i.e., be used by many groups in a reasonably consistent manner), the resulting
estimations of risk cannot be proven analytically. In other words, the estimates regarding risk
involve uncertainty. The primary functional distinction between variability and uncertainty is that
variability is expressed quantitatively, while uncertainty is generally expressed qualitatively.
In considering different forms of variability, almost no risk estimate presented in this document is
given as a single number. Usually, risk is expressed as a central estimate and a range, which is
sometimes very large. Because of the need to encompass many different
types of exposure as
well as the need to express the uncertainties in the assessment, this risk assessment involves
numerous calculations.
Most of the calculations are relatively simple, and the very simple calculations are included in the
body of the document. Some of the calculations, however, are cumbersome. For those
calculations, a set of worksheets is included as an attachment to the risk assessment. The
worksheets provide the detail for the estimates cited in the body of the document. The
worksheets are divided into the following sections: general
data and assumptions, chemical
specific data and assumptions, exposure assessments for workers, exposure assessments for the
general public, and exposure assessments for effects on nontarget organisms. The worksheets are
included at the end of this risk assessment and further documentation for these worksheets are
included as Attachment 1. As detailed in Attachment 1, two versions of the worksheets are
available: one in a word processing format and one in a spreadsheet format. The worksheets that
are in the spreadsheet format are used only as a check of the worksheets that are in the word
processing format. Both sets of worksheets are provided with the
hard-text copy of this risk
assessment as well as with the electronic version of the risk assessment. Documentation for the
use of these worksheets is provided in a separate document that also accompanies this risk
assessment (SERA 2001).
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