Title 40

SECTION 158.320

158.320 Product identity and composition.

§ 158.320 Product identity and composition.

Information on the composition of the pesticide product must be furnished. The information required by paragraphs (a), (b), and (f) of this section must be provided for each product. In addition, if the product is produced by an integrated system, the information on impurities required by paragraphs (c) and (d) of this section must be provided.

(a) Active ingredient. The following information is required for each active ingredient in the product:

(1) If the source of any active ingredient in the product is an EPA-registered product:

(i) The chemical and common name (if any) of the active ingredient, as listed on the source product.

(ii) The nominal concentration of the active ingredient in the product, based upon the nominal concentration of active ingredient in the source product.

(iii) Upper and lower certified limits of the active ingredient in the product, in accordance with § 158.350.

(2) If the source of any active ingredient in the product is not an EPA-registered product:

(i) The chemical name according to Chemical Abstracts Society (CAS) nomenclature, the CAS Registry Number, and any common names.

(ii) The molecular, structural, and empirical formulae and the molecular weight or weight range.

(iii) The nominal concentration.

(iv) Upper and lower certified limits of the active ingredient in accordance with § 158.350.

(v) The purpose of the ingredient in the formulation.

(b) Inert ingredients. The following information is required for each inert ingredient (if any) in the product:

(1) The chemical name of the ingredient according to Chemical Abstracts Society nomenclature, the CAS Registry Number, and any common names (if known). If the chemical identity or chemical composition of an ingredient is not known to the applicant because it is proprietary or trade secret information, the applicant must ensure that the supplier or producer of the ingredient submits to the Agency (or has on file with the Agency) information on the identity or chemical composition of the ingredient. Generally, it is not required that an applicant know the identity of each ingredient in a mixture that he uses in his product. However, in certain circumstances, the Agency may require that the applicant know the identity of a specific ingredient in such a mixture. If the Agency requires specific knowledge of an ingredient, it will notify the applicant in writing.

(2) The nominal concentration.

(3) Upper and lower certified limits in accordance with § 158.350.

(4) The purpose of the ingredient in the formulation.

(c) Impurities of toxicological significance associated with the active ingredient. For each impurity associated with the active ingredient that is determined by EPA to be toxicologically significant, the following information is required:

(1) Identification of the ingredient as an impurity.

(2) The chemical name of the impurity.

(3) The nominal concentration of the impurity in the product.

(4) A certified upper limit, in accordance with § 158.350.

(d) Other impurities associated with the active ingredient. For each other impurity associated with an active ingredient that was found to be present in any sample at a level ≥0.1 percent by weight of the technical grade active ingredient the following information is required:

(1) Identification of the ingredient as an impurity.

(2) The chemical name of the impurity.

(3) The nominal concentration of the impurity in the final product.

(e) Impurities associated with an inert ingredient. [Reserved]

(f) Ingredients that cannot be characterized. If the identity of any ingredient or impurity cannot be specified as a discrete chemical substance (such as mixtures that cannot be characterized or isomer mixtures), the applicant must provide sufficient information to enable EPA to identify its source and qualitative composition.

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