HomeMy Public PortalAboutPharmaceutical Reduced or Surrogate Pollutants RequestREV 04-2021 1
PHARMACEUTICAL MANUFACTURING POINT SOURCE
REQUEST FOR SELF-MONITORING
REDUCED MONITORING or SURROGATE POLLUTANTS REQUEST
Pollutant(s) Neither Used nor Generated in Regulated Pharmaceutical Operations
Facility Name:
Premise Address:
Regulated Process: 40 CFR Part 439 Subpart PSES / PSNS (circle one)
REDUCED MONITORING FOR POLLUTANT NOT PRESENT
Regulated pollutants for
which reduced monitoring
is requested:
Technical evaluation: Attach a technical evaluation of the facility regarding the pollutants with
reduced monitoring (once/year) requested, demonstrating that they
should not be present.
As indicated in 40 CFR 439.4, permit limits and compliance monitoring are required for each regulated
pollutant generated or used at a pharmaceutical manufacturing facility, except where the regulated
pollutant is monitored as a surrogate parameter except for cyanide. Facilities that do not use a
regulated chemical and that can demonstrate a non-detect value for the regulated chemical from their
self-monitoring may certify that they do not use the regulated chemical.
Note that determining whether a pollutant is present should be on the basis of not only whether the
pollutant is in the process wastestream, but also whether a pollutant has the potential to enter the
wastestream. Therefore, the facility must evaluate the potential for the pollutant to enter the
wastestream through spills and other potentially infrequent events in addition to whether the pollutant
would be routinely expected to enter the wastestream or could be a by-product of pollutants in the
wastestream.
A facility may submit safety data sheets (SDSs) as evidence that a particular pollutant is not present in
the raw materials or other chemicals it uses at its premise. However, while SDSs are a valuable tool in
this demonstration, they do not identify all the pollutants present in a given material. Therefore, the SDS
cannot be relied on exclusively to determine whether a pollutant is present or not.
Sampling data: Attach sampling data from at least one sampling of the facility's regulated
process wastewater prior to any treatment.
Point at which samples were collected:
Date on which samples were collected:
Time(s) at which samples were collected:
Sample type (grab or composite):
Although a properly conducted technical evaluation showing that a pollutant is not present suggests that a facility
has met its burden for the sampling request, the Pretreatment Regulations require the facility to also conduct
monitoring to further demonstrate eligibility for the request. The amount of data that is sufficient to make a
decision to grant the request is not defined. The amount of data needed in individual cases is necessarily a site-
specific determination, because of the tremendous variations among facilities.
REV 04-2021 2
At a minimum, a facility must provide the results of one or more samples prior to any treatment. The samples
taken must be representative of all wastewater from all processes, including any seasonal or other variability in
the discharge. To verify that the pollutant is not present based solely on wastewater treatment, the data must
show one of the following:
1. There are no detectable levels of the pollutant . - or - 2. Any detectable levels of the pollutant are solely
attributable to the intake water, as demonstrated by data on the pollutant’s levels in the industry's influent water
and not to any activities at the industry's facility .
However, if a pollutant is present in the discharger’s wastewater, either prior to treatment or after treatment, data
on the pollutant levels in the influent water are necessary to demonstrate that the pollutant’s presence is due
solely to levels that exist in the intake water and not due to any of a facility’s activities. With the exception of
copper and lead, data from the water supplier may be used in place of data supplied by the industry, provided that
such data is representative of the IU’s intake water. Note that where the data prior to treatment shows that the
pollutant is present at levels above concentrations in the background intake water, the facility’s sampling request
will be denied.
In addition to the sample prior to treatment, the facility may also provide historical effluent data as further proof
that the pollutant is not present. This information will be useful as partial evidence of the pollutant’s non-presence.
However, effluent data should be viewed as secondary to the sample(s) taken prior to treatment.
If the permitted sampling point for the regulated process above also receives wastewater from other
sources, a sample must also be collected from this location and analyzed for the pollutants with reduced
or surrogate monitoring. Attach this sampling data, also, and indicate the same sampling details as
above.
NOTE: The permitted sampling point's data must not show the presence of the pollutants with reduced or
surrogate monitoring, regardless of whether the source is suspected to be from the regulated process or from
other wastewater sources. This point is where ongoing verification of the absence of the pollutants will occur.
REV 04-2021 3
SURROGATE MONITORING FOR REGULATED POLLUTANT
Regulated pollutants for
which surrogate monitoring
is requested:
______________________________________________________________
______________________________________________________________
_______________________________________________
Technical evaluation: Attach a technical evaluation of the facility regarding the pollutants with
surrogate monitoring requested, demonstrating that equivalent treatment
provides an appropriate degree of control.
As indicated in 40 CFR 439.4, permit limits and compliance monitoring are required for each regulated pollutant
generated or used at a pharmaceutical manufacturing facility, except where the regulated pollutant is monitored
as a surrogate parameter except for cyanide. Facilities that do not use a regulated chemical and that can
demonstrate a non-detect value for the regulated chemical from their self-monitoring may certify that they do not
use the regulated chemical.
Facilities discharging more than one regulated organic pollutant must demonstrate an appropriate degree of
control for a specified group of pollutants. See 40 CFR 439.1 (o) and Appendix A, for the purpose of identifying
surrogates, pollutants are grouped according to treatability classes. Table 8-2 presents the treatability classes
identified for steam stripping, which is the PSES/PSNS technology basis for organic pollutants limitations.
Facilities may monitor for a surrogate pollutant(s) only if they demonstrate that all other pollutants recei ve the
same degree of treatment. All pollutants must go through the same treatment system to use the surrogates listed
on Table 8-2. Facilities must maintain documentation, including flow information and sampling results, that all the
pollutants in that treatability class received equivalent treatment.
If a facility uses a technology other than steam stripping and would like to use surrogates, the facility must show
equivalent reduction for the pollutant and provide data to show that the pollutant covered by the surrogate will be
treated to the same extent that the surrogate is treated.
Table 8-2: Steam Stripping Surrogates for Indirect Dischargers
Group Compound Surrogate (yes/no)
High Methylene Chloride
Toluene
Chloroform
Xylenes
n-Heptane
n-Hexane
Chlorobenzene
Benzene
Yes
Yes
Yes
No
No
No
No
No
Medium Acetone
Ammonia as N
Ethyl Acetate
Tetrahydrofuran
Triethylamine
MIBK
Isopropyl Acetate
Diethylamine
1,2 – Dichloroethane
n-Amyl Acetate
Isopropyl Ether
n-Butyl Acetate
Methyl Formate
Isobutyraldehyde
o-Dichlorobenzene
Yes
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
Sampling data: Attach sampling data from at least one sampling of the facility's regulated process
wastewater using equivalent treatment.
Point at which samples were collected:
Date on which samples were collected:
Time(s) at which samples were collected:
Sample type (grab or composite):
Certification: I certify under penalty of law that this document and all attachments were prepared
under my direction or supervision in accordance with a system designed to assure that
REV 04-2021 4
qualified personnel properly gather and evaluate the information submitted. Based on
my inquiry of the person or persons who manage the system, or those persons directly
responsible for gathering the information, the information submitted is, to the best of my
knowledge and belief, true, accurate, and complete. I am aware that there are sig nificant
penalties for submitting false information, including the possibility of fine and
imprisonment for knowing violations.
Name of Authorized Facility Representative:
Title:
Signature:
Date:
What happens next: Assuming that the facility has followed the requirements for requesting the reduced or
surrogate monitoring, MSD must determine whether to grant the request. The regulations do
not in any way require MSD to grant the request at any time. If MSD does not believe that the
industry has demonstrated to its satisfaction that a pollutant is not present, MSD cannot grant
the request. Even where the industry has demonstrated that a specific pollutant is not present,
MSD has the discretion to require monitoring.
MSD will base its decision on the materials submitted by the facility as well as its own historical
familiarity with the facility’s participation in the pretreatment program. MSD will also review
information contained in the facility's permit applications, baseline and periodic monitoring
reports, and data obtained through facility inspections.
How long is the request
valid:
If the request is granted, it is valid only for the duration of the permit. To continue
the request for the period of the next permit, the facility must reapply for reduced or
surrogate monitoring, including the submission of appropriate monitoring data.