Regulating Pesticides (1980) / Chapter Skim
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3. Selecting and Scheduling Compounds
3. Selecting and Scheduling Compounds
Pages 46-64
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From page 46... ...
have proved inadequate to the task at hand. A single RPAR procedure namely, that for chlorobenzilate occupied an RPAR team of 13 oPP professionals for a significant part of their time for 3 years.
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From page 47... ...
CURRENT APPROACH To facilitate the following discussion, it will be useful to distinguish between the total pool of pesticide registrations up for review, those formulations selected as candidates for the RPAR process, and those actually chosen for formal RPAR consideration. The total pool of registrations is the roughly 35,000 registered pesticide formulations that EPA iS required to review under the 1972 amendments to F'FRA.
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From page 48... ...
In 1975 the RPAR process replaced the SCR program, and most compounds on the suspect list were included on an initial list of RPAR candidates. Chlorobenzilate, for example, was judged to be carcinogenic in the Mrak report, was included in the SCR program's suspect chemical list, and was accepted as one of the original RPAR candidates when the SCR program was replaced by the RPAR procedure.
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From page 49... ...
However, the procedures for determining the order in which the RPAR candidates receive attention or are inserted into the RPAR process (once it is determined that they exceed the risk criteria) are not clearly and explicitly defined.
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From page 50... ...
The question is whether similar delays will again arise in the future or whether data necessary for future RPAR assessments are now being generated. Lacking a sufficiently defined and formalized internal system for identifying and ranking RPAR candidates, oPP may be more susceptible to external and even capricious influences.
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From page 51... ...
. The purpose of the preliminary toxicity analysis is to determine whether evidence suggestive of acute or chronic toxic activity that may present unique hazard exists.
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From page 52... ...
Thus, it is apparent that consideration must be given in the preliminary toxicity assessment to the possibility of potentially hazardous impurities entering commercial preparations. On the basis of the preliminary toxicity assessment, each formulation should be placed in one of three classes: Class A, apparently a potential toxic hazard (an RPAR candidate)
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From page 53... ...
Accordingly, all cu~ently active registrahons involving tbese compounds sbould be renewed ~db~itb. In contrast tbe Class A ~nd B co~ounds do re-he ~r~er attention.
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From page 54... ...
The order in which these compounds receive attention should be directly related to their exposure potential. Other things being equal, those compounds to which many people (or many members of other significant nontarget species)
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From page 55... ...
The preliminary toxicity analysis has already been discussed in the section on Pre-RPAR Classification of Compounds. The purpose of the preliminary exposure analysis would be to identify those active ingredients to which significant numbers of people are exposed.
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From page 56... ...
More important, the suggested ranking system would enhance greatly the likelihood that oPP's limited resources will be devoted systematically to regulating those compounds posing the greatest hazards to human health and the environment. Although the ranking system would become a subject of controversy, it would serve an important function by broadening the preliminary screening to include all active ingredients and by reducing the influence of unwarranted pressure on oPP's decisions.
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From page 57... ...
The committee would have two functions and would be disbanded when those functions had been discharged. The first would be to classify the 500-odd active ingredients used in pesticide formulations into the three classes described earlier: Class A apparently a potential toxic hazard (an RPAR candidate)
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From page 58... ...
THE PROBLEM The purpose of the benefit-risk assessments is to determine, for each use of an RPAR pesticide, how various regulatory options are likely to influence the level of risks and benefits arising from pest control activities. The public health, environmental, and economic ejects of any regulation depend not only on the extent to which the regulation changes the use of the pesticide in question, but also on the changes it induces in alternative methods of pest control and in the public health, environmental, and economic ejects of the alternative control measures.
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From page 59... ...
possible for a regulation to have an adverse effect on public health if, for example, it induces more widespread use of a substitute chemical that is more toxic than the one being regulated. Even aside from this extreme possibility, a regulation may be unwarranted if it stimulates the use of alternative pesticides that are nearly as harmful to public health or the environment and that have substantially greater economic costs.
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From page 60... ...
RECOMMENDATIONS It follows from the forgoing discussion that assessment of the consequences of any regulatory option requires information about the public health, environmental, and economic effects of the regulated pesticides and comparable information about the effects of its principal alternatives. To generate this information for chemical alternatives, the Committee recommends that as soon as one of the high-priority compounds is assigned to the RPAR process, the RPAR team should identify all of the compound's uses and the alternative pesticides for each use.
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From page 61... ...
. The initiating compound should not necessarily be reregistered in this instance, since one or more of the Class A or Class B alternatives may be available and the advantages of the RPAR compound over the alternative may be insufficient to justify the additional risks entailed.
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From page 62... ...
Consequently, the question of continued availability of the crucial Class A alternatives determined by conducting ancillary RPAR'S must be addressed before oPP can reach a correct decision on the initiating compound (Table 3.1, Step 4~. Finally, there remains only the situation in which (for a specific use)
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From page 63... ...
. As soon as the qualified RPAR evaluations for the crucial Class A alternatives are completed and the appropriate assumptions for the Class B alternatives are adopted, oPP can reach a sound final decision as to which toxic compounds to reregister for the use in question (Table 3.1, Step 5~.
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From page 64... ...
Health Risk and Economic Impact Assessment of Suspected Carcinogens: Interim Procedures and Guidelines. 41 Federal Register (102)
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