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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.