§ 158.130 Purposes of the registration data requirements.

(a) General. The data requirements for registration are intended to generate data and information necessary to address concerns pertaining to the identity, composition, potential adverse effects and environmental fate of each pesticide.

(b) Product chemistry—(1) Product composition. Data on product composition are needed:

(i) To support the conclusions expressed in the statement of formula;

(ii) To compare to the composition of materials used in required testing under this part; and

(iii) To determine whether a product is “identical or substantially similar”to another product, a determination that involves the comparison of product composition.

(2) Nominal concentration and certified limits. The nominal concentration of a product, defined as that concentration that is expected to be present in a product as a result of the production or formulation process, is used to gauge the acceptability of the certified limits, which define the outer limits of the range of the product's ingredients. The certified limits are used to enforce the composition of the product and to ensure the accuracy of hazard assessments.

(3) Physical and chemical characteristics. The physical and chemical characteristics of an active ingredient or product are used:

(i) To confirm or provide supportive information on the identity and composition of the product;

(ii) To assess the hazards of the ingredient or product; and

(iii) To trigger or evaluate certain other studies required by this part.

(c) Product performance. Requirements to develop data on product performance provide a mechanism to ensure that pesticide products will perform as intended and that unnecessary pesticide exposure to the environment will not occur as a result of the use of ineffective products. Specific performance standards are used to validate the efficacy data in the public health areas, including disinfectants used to control microorganisms infectious to man in any area of the inanimate environment and those pesticides used to control vertebrates (such as rodents, birds, bats and skunks) that may directly or indirectly transmit diseases to humans.

(d) Toxicology-humans and domestic animals. Data required to assess hazards to humans and domestic animals are derived from a variety of acute, subchronic and chronic toxicity tests, and tests to assess mutagenicity and pesticide metabolism.

(1) Acute studies. Determination of acute oral, dermal and inhalation toxicity is usually the initial step in the assessment and evaluation of the toxic characteristics of a pesticide. These data provide information on health hazards likely to arise soon after, and as a result of, short-term exposure. Data from acute studies serve as a basis for classification and precautionary labeling. For example, acute toxicity data are used to calculate farmworker reentry intervals and to develop precautionary label statements pertaining to protective clothing requirements for applicators. They also provide information used in establishing the appropriate dose levels in subchronic and other studies; provide initial information on the mode of toxic action(s) of a substance; and determine the need for child resistant packaging. Information derived from primary eye and primary dermal irritation studies serves to identify possible hazards from exposure of the eyes, associated mucous membranes and skin.