[Code of Federal Regulations]

[Title 40, Volume 23]

[Revised as of July 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 40CFR158.162]



[Page 94]

 

                   TITLE 40--PROTECTION OF ENVIRONMENT

 

         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

 

PART 158_DATA REQUIREMENTS FOR REGISTRATION--Table of Contents

 

              Subpart C_Product Chemistry Data Requirements

 

Sec.  158.162  Description of production process.



    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 on the formulation process, in accordance with Sec.  

158.165.

    (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, the necessary reaction 

conditions, and 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.