Regulating Pesticides (1980) / Chapter Skim
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6. Evaluation of the Regulatory Options: Weighing the Risks and Benefits
6. Evaluation of the Regulatory Options: Weighing the Risks and Benefits
Pages 131-153
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From page 131... ...
DEVELOPING REGULATORY OPTIONS CURRENT APPROACH The development and evaluation of major regulatory options in pesticide preregistration decisions is the purpose of the REAR process. The primary 131
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From page 132... ...
The risks and benefits of using substitute chemicals are also analyzed and incorporated into the alternative actions. Final alternative actions (major regulatory options)
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From page 133... ...
Thus, the current methodology by which viable regulatory options are identified is somewhat vague. The basic approach to generating such options appears to be that of first listing on a use-by-use basis those options that would reduce potential exposures and then considering the attendant risks and benefits associated with them.
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From page 134... ...
RECOMMENDATIONS In developing regulatory options, the Committee recognizes the difficulties associated with balancing the need to maintain benefits of pesticide use, for example increased crop production, with the need to protect human health and ecosystems. At the same time, the Committee acknowledges that each compound that undergoes the RPAR process will have certain unique characteristics; hence, the development of relevant regulatory options may not be easily generalized.
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From page 135... ...
are usually described more quantitatively. In addition to narrative descriptions that discuss the trade-o~s between the risks and benefits associated with each major regulatory option, the draft guidance package provided by SPRY (and quoted above)
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From page 136... ...
At this stage, estimates are available of the risks in terms of human exposure estimates and the relative potency of the compound imposed by each use of the pesticide under each of the regulatory options. Corresponding estimates of the benefits yielded by each of the uses permitted by each option are also available.
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From page 137... ...
population from dietary exposure would be estimated as the sum of the amounts of the pesticide ingested by a typical consumer in the form of residues on all those foods, taking account of the carcinogenic activity of the pesticide. If an alternative option forbids the use of the pesticide on five of the foods, the dietary risk to a typical member of the population would be estimated as the total ingestion of residue on the five permitted foods plus the equivalent intake of alternative pesticides, if any, used on the five forbidden foods in response to this stricter regulation, again taking account of the carcinogenic activity of the pesticide.
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From page 138... ...
138 m Cat o au au Ct m o 4 C~ Ct o C)
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From page 139... ...
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From page 141... ...
m o Ct cn ·_ ~o o $ C = =i C b.o C ~ C V74 _ <.c, E E E E ~V, .= o ~ ._ o =.
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From page 144... ...
(Disregard the right-hand scales for the moment.) The left-hand scale, calibrated in micromoles per kilogram, measures lifetime doses of Pestide, including the Pestide-equivalent doses of alternative pesticides that are likely to be used under the various options.
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From page 145... ...
12 ~y 0 9 at, _ to to 0 6 it o In 3 ~ 0 c' o FIGURE 6.1 Equivalent lifetime doses and discounted costs of five options for regulating Pestide, with carcinogenic reference compound doses: certainty case (see text for discussion)
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From page 146... ...
This fact is shown by the horizontal line labeled Safex. With this chart in hand, the RPAR team or the Administrator might reason as follows: if Pestide is reregistered according to Option A, both the general population and the special exposure group would be exposed to lifetime doses greater than the one equivalent to the potential exposure to Visolin that led to the denial of its reregistration.
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From page 147... ...
In some cases, suitable comparison compounds can be found for which benefit-risk analyses have been conducted to determine the dose level where risks are considered to balance benefits. An example of such an instance might be the interim drinking water standard for trihalomethanes (U.S.
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From page 148... ...
A particularly helpful table is one that shows incremental changes, that is, one that shows the changes in costs, lifetime doses to which relevant population groups are exposed, and say, the number of fish killed as one moves from one option to the next most costly one. Table 6.4 illustrates such a table.
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From page 149... ...
Because the consequences of the alternative regulatory options are now uncertain, there are more data to be assimilated than can be presented on a single chart, so two are used. The first chart, Figure 6.2, compares the estimates of probable lifetime doses resulting from the various options with estimated ranges of their costs.
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From page 150... ...
The lower one is the familar Visolin cut-offi Notice that if this band were interpreted in the way it was on the previous chart, Option C would no longer be admissible, since there is some possibility that under it the members of the special exposure population will receive greater lifetime doses of Pestide than comparison with the Visolin decision indicates to be acceptable. But it is not entirely reasonable to compare the worst-case results of Pestide regulation with the probable-case results of Visolin regulation.
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From page 151... ...
Population A x Visolin Probable Case a O ,__1 1 0 2 151 o ._ _ 0.20 ^ au ._ 4J ._ _ 0.15 a' 0 ~ 0.10 us En o 111 J m 6 c:: lo: 8 4 6 8 10 DISCOUNTED COST ($ million) FIGURE 6.2 Equivalent probable lifetime doses and ranges of discounted costs of five options for regulating Pestide; carcinogenic reference compounds included (see text for discussion)
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From page 152... ...
_ 1 a) E 0.20 a-, ._ Y a, 0.15 E UJ an O 0.10 us J m is: 0.05 ~ o FIGURE 6.3 Equivalent max~mum-plausible lifetime doses and ranges of discounted costs of five options for regulating Pestide; carcinogenic reference compounds included (see text for discussion)
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From page 153... ...
In Endrin: Position Document 2/3, August 11 draft. Special Pesticide Review Division, Office of Pesticide Programs, U.S.
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