[Code of Federal Regulations]
[Title 40, Volume 27]
[Revised as ofJuly 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR439.2]

[Page 402-403]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 439--PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY--Table of Contents
 
Sec. 439.2  General monitoring requirements.

    (a) Permit compliance monitoring is required for each regulated 
pollutant generated or used at a pharmaceutical manufacturing facility, 
except where the regulated pollutant is monitored as

[[Page 403]]

a surrogate parameter. Permit limits and compliance monitoring are not 
required for regulated pollutants that are neither used nor generated at 
the facility. Except for cyanide, for which an alternate monitoring 
requirement is established in subparts A and C of this part, a 
determination that regulated pollutants are neither used nor generated 
should be based on a review of all raw materials in use, and an 
assessment of the process chemistry, products and by-products resulting 
from each of the manufacturing processes. This determination along with 
a recommendation of any surrogate must be submitted with permit 
applications for approval by the permitting authority, reconfirmed by an 
annual chemical analysis of wastewater from each monitoring location, 
and measurement of a non-detect value for each regulated pollutant or 
its surrogate. Permits must specify that such determinations will be 
maintained in the facility's permit records with their discharge 
monitoring reports and will be available to regulatory authorities upon 
request.
    (b) Unless noted otherwise, self-monitoring will be conducted at the 
point where the final effluent is discharged.

[68 FR 12271, Mar. 13, 2003]