[Code of Federal Regulations]
[Title 40, Volume 20]
[Revised as of July 1, 2002]
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.