158.325—Description of materials used to produce the product.
The following information must be submitted on the materials used to produce the product:
(a) Products not produced by an integrated system.
(1)
For each active ingredient that is derived from an EPA-registered product:
(ii)
All information that the applicant knows (or that is reasonably available to him) concerning the composition (and, if requested by the Agency, chemical and physical properties) of the ingredient, including a copy of technical specifications, data sheets, or other documents describing the ingredient.
(iii)
If requested by the Agency, the name and address of the producer of the ingredient or, if that information is not known to the applicant, the name and address of the supplier of the ingredient.
(b) Products produced by an integrated system.
(1)
The information required by paragraph (a)(1) of this section concerning each active ingredient that is derived from an EPA-registered product (if any).
(2)
The following information concerning each active ingredient that is not derived from an EPA-registered product:
(B)
The name and address of the person who produces the starting material or, if that information is not known to the applicant, the name and address of each person who supplies the starting material.
(C)
All information that the applicant knows (or that is reasonably available to him), concerning the composition (and if requested by the Agency, chemical or physical properties) of the starting material, including a copy of all technical specifications, data sheets, or other documents describing it.
(c) Additional information.
On a case-by-case basis, the Agency may require additional information on substances used in the production of the product.