tolerances when such are not necessary to protect the public health. For the purposes 
of this law the term ‘‘pesticide chemical’’ means any substance which is an *‘economic 
poison’’ under the Federal Insecticide, Fungicide, and Rodenticide Act and is used 
in the production, storage, or transportation of raw agricultural commodities. Any person 
who has submitted an application for the registration of an economic poison under the 
Federal Insecticide, Fungicide, and Rodenticide Act in the Department of Agriculture 
may file with the Department of Health, Education, and Welfare a petition proposing a 
tolerance or an exemption. The petitionmust be supported by certain information including 
the identity and composition of the pesticide chemical, methods for analysis, complete 
information on the use, full reports of investigations made with respect to the residues 
produced and, of course, information on the toxicity of the chemical. The applicant also 
submits a copy of the petition to the Department of Agriculture and when the Secretary of 
Agriculture issues a Certificate of Usefulness, then the Secretary of Health, Education, 
and Welfare has 90 days to act upon the petition and issue a regulation. He may set the 
tolerance at zero if the data do not justify a greater tolerance. 
Provision is made for referral of the petition to an advisory committee if either 
the petitioner or the Secretary desires such referral within the 90-day period. After 
publication of an order, any person adversely affected may file objections and request a 
public hearing. Finally, provision is made for court review under certain circumstances 
involving an actual controversy. 
The technical review and evaluation of petition protocols are the responsibility of 
the scientific staff. This is a most serious and important responsibility, which can only 
be discharged adequately by well-trained and experienced scientists. 
In establishing a tolerance regulation, the law admonishesthat, among other relevant 
factors, appropriate consideration should be given to the other ways in which the con- 
sumer may be affected by the same pesticide chemical or by other related substances 
that are poisonous or deleterious. 
In appraising petitions our first concern is todetermine if the tolerance proposed is, 
in fact, a safe level. Next, we ask whether the tolerance level sought is necessary for 
effective use of the pesticide chemical on the particular crop or crops. We think that the 
tolerance should not be set at any higher figure than is necessary even though a higher 
figure would be safe. We believe that this policy is sound and is wholly consistent with 
the intent of the law. 
The problems in reviewing petition data include consideration of the chemistry of 
the pesticide: Are we certain of its composition and chemical identity? Are we sure 
that the residue present at harvesttime is the same compound that was applied to the 
crop--or have there been chemical changes--oxidation, for instance? Is the substance 
systemic--does it translocate into the tissues of the plant? If so, are there metabolites? 
Are the methods ofanalysis adequate todetect and measure residues that may be present? 
Will the methods detect oxidation products or metabolites? Do the data adequately 
validate the methods employed in securing the residue data? 
And then, a method may be entirely suitable for measuring residues remaining from 
test applications under controlled conditions. But we must consider the adequacy of 
methods in terms of their ability to detect and measure the residues in question in the 
presence of possible interfering substances. Unless we have methods capable of and 
practicable for enforcing tolerances, such tolerances can hardly be regarded as safe. 
Accordingly we are including an appraisal of methods of analysis as a part of our review 
of petitions. This may include actual try-out ofthe methods in our field laboratories. 
A very important part of the petition review involves the evaluation of the toxicity 
tests. This requires a meticulous study of the detailed data and an appraisal of the 
appropriateness of the experimental design and the validity of the conclusions. Are we 
satisfied that the toxicity data relate to the residues in question? 
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