161.75—Requirements for additional data.

(a) General policy. The data routinely required by part 161 may not be sufficient to permit EPA to evaluate every pesticide product. If the information required under this part is not sufficient to evaluate the potential of the product to cause unreasonable adverse effects on man or the environment, additional data requirements will be imposed. However, EPA expects that the information required by this part will be adequate in most cases for an assessment of the properties of pesticide.
(b) Policy on test substance. In general, where the technical grade of the active ingredient is specified as the substance to be tested, tests may be performed using a technical grade which is substantially similar to the technical grade used in the product for which registration is sought. In addition to or in lieu of the testing required in subparts C and D of this part the Administrator will, on a case-by-case basis, require testing to be conducted with:
(1) An analytical pure grade of an active ingredient, with or without radioactive tagging.
(2) The technical grade of an active ingredient.
(3) The representative technical grade of an active ingredient.
(4) An intentionally added inert ingredient in a pesticide product.
(5) A contaminant or impurity of an active or inert ingredient.
(6) A plant or animal metabolite or degradation product of an active or inert ingredient.
(7) The end-use pesticide product.
(8) The end-use pesticide product plus any recommended vehicles and adjuvants.
(9) Any additional substance which could act as a synergist to the product for which registration is sought.
(10) Any combination of substances in paragraphs (b) (1) through (9) of this section.

Code of Federal Regulations

[49 FR 42881, Oct. 24, 1984, as amended at 53 FR 15999, May 4, 1988; 58 FR 34203, June 23, 1993]