[Code of Federal Regulations]
[Title 40, Volume 28]
[Revised as of July 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR439.1]

[Page 399-400]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 439_PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY
--Table of Contents
 
Sec. 439.1  General definitions.

    As used in this part:
    (a) The general definitions, abbreviations and methods of analysis 
in 40 CFR part 401 shall apply.

[[Page 400]]

    (b) Bench-scale operation means the laboratory testing of materials, 
methods, or processes on a small scale, such as on a laboratory 
worktable.
    (c) Cyanide (T) means the parameter total cyanide.
    (d) In-plant monitoring point means a location within a plant, where 
an individual process effluent can be exclusively monitored before it is 
diluted or mixed with other process wastewaters en route to the end-of-
pipe.
    (e) Maximum daily means the highest allowable discharge of 
wastewater pollutants during a calender day or any 24 hour period that 
reasonably represents a calender day for purposes of sampling.
    (f) Maximum monthly average means the highest allowable average of 
daily discharges of wastewater pollutants over a calendar month, and is 
calculated as the sum of all daily values measured during a calendar 
month divided by the number of daily values measured during that month.
    (g) mg/L means milligrams per liter or parts per million (ppm)
    (h) Minimum level means the level at which an analytical system 
gives recognizable signals and an acceptable calibration point.
    (i) Nitrification capability means the capability of a POTW 
treatment system to oxidize ammonia or ammonium salts initially to 
nitrites (via Nitrosomonas bacteria) and subsequently to nitrates (via 
Nitrobacter bacteria). Criteria for determining the nitrification 
capability of a POTW treatment system are: bioassays confirming the 
presence of nitrifying bacteria; and analyses of the nitrogen balance 
demonstrating a reduction in the concentration of ammonia or ammonium 
salts and an increase in the concentrations of nitrites and nitrates.
    (j) Non-detect (ND) means a concentration value below the minimum 
level that can be reliably measured by the analytical method.
    (k) Pilot-scale operation means processing equipment being operated 
at an intermediate stage between laboratory-scale and full-scale 
operation for the purpose of developing a new product or manufacturing 
process.
    (l) POTW means publicly owned treatment works (40 CFR 403.3).
    (m) Process wastewater, as defined at 40 CFR 122.2 and for the 
purposes of this part, does not include the following:
    (1) Trimethyl silanol, any active anti-microbial materials, process 
wastewater from imperfect fermentation batches, and process area spills. 
Discharges containing such materials are not subject to the limitations 
and standards of this part.
    (2) Non-contact cooling water, utility wastewaters, general site 
surface runoff, groundwater (e.g., contaminated groundwaters from on-
site or off-site groundwater remediation projects), and other non-
process water generated on site. Discharges of such waters and 
wastewaters are not subject to the limitations and standards of this 
part.
    (n) Non-conventional pollutants means parameters that are neither 
conventional pollutants (40 CFR 401.16), nor ``toxic'' pollutants (40 
CFR 401.15).
    (o) Surrogate pollutant means a regulated parameter that, for the 
purpose of compliance monitoring, is allowed to serve as a surrogate for 
a group of specific regulated parameters. Plants would be allowed to 
monitor for a surrogate pollutant(s), when the other parameters for 
which it stands are receiving the same degree of treatment as the 
surrogate pollutant(s) and all of the parameters discharged are in the 
same treatability class(es) as their respective surrogate pollutant(s). 
Treatability classes have been identified in Appendix A of this part for 
both steam stripping and biological treatment technologies, which are 
the respective technology bases for PSES/PSNS and BAT/NSPS limitations 
controlling the discharge of regulated organic parameters.
    (p) Xylenes means a combination of the three isomers: o-xylene, m-
xylene, and p-xylene.

[63 FR 50425, Sept. 21, 1998; 64 FR 48104, Sept. 2, 1999, as amended at 
68 FR 12270, Mar. 13, 2003]