If the product is produced by an integrated system, the applicant must submit information on the production (reaction) processes used to produce the active ingredients in the product. The applicant must also submit information about the formulation process, in accordance with § 158.335.
(a) Information must be submitted for the current production process for each active ingredient that is not derived from an EPA-registered product. If the production process is not continuous (a single reaction process from starting materials to active ingredient), but is accomplished in stages or by different producers, the information must be provided for each such production process.
(b) The following information must be provided for each process resulting in a separately isolated substance:
(1) The name and address of the producer who uses the process, if not the same as the applicant.
(2) A general characterization of the process (e.g., whether it is a batch or continuous process).
(3) A flow chart of the chemical equations of each intended reaction occurring at each step of the process, and of the duration of each step and of the entire process.
(4) The identity of the materials used to produce the product, their relative amounts, and the order in which they are added.
(5) A description of the equipment used that may influence the composition of the substance produced.
(6) A description of the conditions (e.g., temperature, pressure, pH, humidity) that are controlled during each step of the process to affect the composition of the substance produced, and the limits that are maintained.
(7) A description of any purification procedures (including procedures to recover or recycle starting materials, intermediates or the substance produced).
(8) A description of the procedures used to assure consistent composition of the substance produced, e.g., calibration of equipment, sampling regimens, analytical methods, and other quality control methods.
Title 40 published on 2012-07-01
The following are only the Rules published in the Federal Register after the published date of Title 40.
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This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.