Federal Register Vol. 48, No. 209 Thursday, Qctober 27, … Register / Vol. 48, No. 209 / Thursday, Qctober 27, 1983 / Rules and Regulations ENVIRONMENTAL PROTECTION ENVIRONMENTAL

Federal Register / Vol. 48, No. 209 / Thursday, Qctober 27, 1983 / Rules and Regulations

ENVIRONMENTAL PROTECTIONENVIRONMENTAL PROTECTIONAGENCY

40 CFR Part 439

[WH-FRL2443-2]

Pharmaceutical Manufacturing PointSource Category Effluent LimitationsGuidelines, Pretreatment Standards,and New Source PerformanceStandards

AGENCY: Environmental ProtectionAgency (EPA).ACTION: Final regulation.

SUMMARY: This regulation establisheseffluent limitations guidelines andstandards limiting the discharge ofpollutants into navigable waters byexisting and new sources that conductpharmaceutical manufacturingoperations, These regulations are issuedunder the Clean Water Act and theSettlement Agreement in NaturalResources Defense Council, Inc. v.Train, 8 ERC 2120 (D.D.C. 1976),modified, 12 ERC 1833 (D.C.C. 1979),modified by Orders dated October 26,1982, and August 2, 1983.

The purpose of this regulation is tospecify for certain pollutants "bestpracticable control technology currentlyavailable" (BPT) effluent limitationsguidelines, "best available technologyeconomically achievable" (BAT) effluentlimitations guidelines, "new sourceperformance standards" (NSPS), andpretreatment standards for existing andnew sources (PSES and PSNS,respectively) for the pharmaceuticalmanufacturing industry.DATES: In accordance with 40 CFR100.01 (45 FR 26048), this regulation shallbe considered issued for purposes ofjudicial review at 1:00 p.m. Eastern timeon November 10, 1983. This regulationshall become effective December 12,1983, except for provisions in thefollowing sections which allow facilitiesnot using or generating cyanide tocertify to that effect instead ofmonitoring for cyanide. Thesecertification provisions are contained inthe following sections: § § 439.14-439.17,439.24-439.27, 439.34-439.37, and 439.44-439.47. These certification provisionshave been submitted to the OfficeManagement and Budget (OMB) and arenot effective until OMB has approvedthem under the Paperwork ReductionAct.

The compliance date for the BATregulations is as soon as possible, but inany event, no later then July 1, 1984. Thecompliance date for new sourceperformance standards (NSPS) andpretreatment standards for new sources

(PSNS) is the date the new sourcebegins operations. The compliance datefor pretreatment standards for existingsources (PSES) is October 27, 1986.

Under Section 509(b)(1) of the CleanWater Act, judicial review of thisregulation can be made only by filing apetition for review in the United StatesCourt of Appeals within 90 days afterthe regulation is considered issued forpurposes of judicial review. UnderSection 509(b)(2) of the Clean WaterAct, the requirements in this regulationmay not be challenged later in civil orcriminal proceedings brought by EPA toenforce these requirements.ADDRESSES: The basis for this regulationis detailed in four major documents. SeeSUPPLEMENTARY INFORMATION (under"XIV. Availability of TechnicalInformation") for a description of eachdocument. Copies of the technical andeconomic documents may be obtainedfrom the National Technical InformationService, Springfield, Virginia 22161(Phone: (703) 487-4600). For additionaltechnical information, contact Dr. FrankH. Hund, Effluent Guidelines Division(WH-552), U.S. EnvironmentalProtection Agency, 401 M Street, SW.,Washington, D.C. 20460 (Phone (202)382-7182). For additional economicinformation, contact Mr. Joseph Yance,Office of Analysis and Evaluation (WH-586), U.S. Environmental ProtectionAgency, 401 M Street, SW., Washington,D.C. 20460 (Phone (202) 382-5379).

On January 3, 1984, the completepublic record for this rulemakingincluding the Agency's responses tocomments on the proposed regulation,will be available for review in EPA'sPublic Reference Unit, Room 2404 (Rear)(EPA Library), 401 M Street, SW.,Washington, D.C. The EPA publicinformation regulation (40 CFR Part 2)provides that a reasonable fee may becharged for copying.FOR FURTHER INFORMATION CONTACT:Dr. Frank Hund at the address listedabove or by calling (202) 382-7182.SUPPLEMENTARY INFORMATION:

Organization of this Notice

I. Legal authorityII. Scope of this rulemaking and prior

regulationsIII. Summary of legal backgroundIV. Summary of methodology and data

gathering effortsV. Summary of promulgated regulations and

changes from proposalVI. Costs, economic impacts, Executive Order

12291, Regulatory Flexibility Analysis,and Small Business Administration{SBA) loans

VII. Pollutants and subcategories notregulated

VIII. Non-water quality environmentalimpacts

IX. Best management practicesX. Upset and bypass provisionsXI. Variances and modifications .XII. Implentation of limitations and standarXIII. Public participation-responses to maj

commentsXIV. Availability of technical informationXV, Office of Management and Budget (OM

reviewXVI. List of subjects in 40 CFR Part 439

AppendicesA. Abbreviations, Acronyms and Other

Terms Used in this NoticeB. Toxic Pollutants Not Detected in the

Treated Effluents of Direct DischargersC. Toxic Pollutants Detected in Treated

Effluents of Direct Dischargers: (1) Frora Small Number of Sources, (21 Detectein Only Trace Amounts or (3) SufficieniControlled by Existing Technologies

D. Toxic Pollutants Not Detected in theEffluent of Indirect Dischargers

E. Toxic Pollutants Detected in the EffluentIndirect Dischargers Whose Toxicity axAmount (Taken Together) Is SoInsignificant as Not To justifyDeveloping Pretreatment Regulations

1. Legal Authority

This regulation is being promulgatedunder the authority of Sections 301, 30,306, 307, 308, and 501 of the Clean WatAct (the Federal Water Pollution ContiAct Amendments of 1972, 33 U.S.C. 12!et seq., as amended by the Clean WattAct of 1977, Pub. L. 95-217), also callec"the Act." It is also being promulgatedin response to the Settlement Agreemein Natural Resources Defense CouncilInc. v. Train, 8 ERC 2120 (D.D.C. 1976)9modified, 12 ERC 1833 (D.D.C. 1979),modified by Orders dated October 26,1982, and August 2, 1983.II. Scope of This Rulemaking and PrioiRegulations

A. Prior Regulations

EPA promulgated interim final BPTregulations for the pharmaceuticalmanufacturing point source category cNovember 17, 1976 (41 FR 50676; 40 CFPart 439, Subparts A-E). The fivesubcategories of the pharmaceuticalindustry (40 CFR Part 439) are:

• Subpart A-Fermentation ProductsSubcategory

* Subpart B-Extraction ProductsSubcategory

" Subpart C-Chemical SynthesisProducts Subcategory

" Subpart D-Miiing/Compounding aFormulation Subcategory

" Subpart E-Research SubcategQryThe 1976 BPT regulations set month

limitations for five-day biochemicaloxygen demand (BOD5) and chemicaloxygen demand (COD) based on perciremovals for all subcategories. No daimaximum effluent limitations were

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No. 209 / Thursday, October 27, 1983 / Rules and Regulations 49809

established for these two parameters.The pH was set within the range of 6.0to 9,0 standard units. The regulation alsoset maximum 30 day average totalsuspended solids (TSS) limitations forsubcategories B, D, and E only. No TSSvalues were established forsubcategories A and C. Subpart A(applicable to the fermentationoperations subcategory) was amended(42 FR 6814) on February 4, 1977, toimprove the language referring toseparable mycelia and solvent recovery.In addition, the amendment allowed theinclusion of spent beers (broths) in thecalculation of raw waste loads forSubpart A in those instances where thespent beer is actually treated in thewastewater treatment system. Theseregulations were never challenged andare presently in effect.

On November, 26, 1982, EPA proposedregulations applicable to the -pharmaceutical manufacturing pointsource category (47 FR 53584). At thattime, EPA: (a) Proposed to modify theexisting BPT TSS effluent limitations forSubparts B, D, and E; (b) proposed BPTTSS effluent limitations for Subparts Aand C; (c) proposed to modify theexisting BPT COD effluent limitationsfor Subparts A, B, C, D, and E; (d)proposed BPT cyanide effluentlimitations for Subparts A, B, C, and D;and (e) proposed BAT and BCT effluentlimitations, NSPS, PSES, and PSNS toapply uniformly to subcategories A, B,C, and D. EPA did not propose toestablish regulations controlling othertoxic pollutant discharges frompharmaceutical research for the reasonsdiscussed in Section VII of thispreamble (Pollutants and SubcategoriesNot Regulated).

With the few exceptions discussedbelow, the Agency is not modifying thepreviously promulgated BPT limitationsfor Subparts A through E. However, inorder to publish a complete set of allapplicable requirements, the BPTlimitations already in effect arereprinted in today's rule. Existing BPTlimitations not modified in today'srulemaking are not subject to legalchallenge.

B. Scope of this RulemakingThis final regulation, which was

proposed on November 26, 1982 (47 FR53584), establishes effluent limitationsguidelines and standards for existingand new pharmaceutical manufacturingfacilities. Pharmaeeutical manufacturersuse many different methods -and rawmaterials to create a wide range ofproducts. These products includemedicinal and feed grades of all organicchemicals having therapeutic value,whether obtained by chemical synthesis,

by fermentation, by extraction fromnaturally occurring plant or animalsubstances, or by refining a technicalgrade product.

The pharmaceutical products,processes, and activities covered by thisproposal include:

a. Biological products covered by theU.S. Department of Commerce, Bureauof the Census Standard IndustrialClassifications (SIC) Code No. 2831.

b. Medicinal chemicals and botanicalproducts covered by SIC Code No. 2833.

c. Pharmaceutical products covredby SIC Code No. 2834.

d. All fermentation, biological, andnatural extraction, chemical synthesis,and formulation products which areconsidered as pharmaceutically activeingredients by the Food and DrugAdministration, but are not covered bySIC Code Nos. 2831, 2833, or 2834. (Also,products of these types such as citricacid which are not regarded aspharmaceutical active ingredients willbe included if they are manufactured bya pharmaceutically manufacturer byprocesses, and result in wastewaters,which closely correspond to those of apharmaceutical product.)

e. Cosmetic preparation covered bySIC Code No. 2844 which function as askin treatment. (This group ofpreparations does not include productssuch as lipsticks or perfumes whichserve to enhance appearance or toprovide a pleasing odor, but do notprovide skin care. In general, this alsoexcludes deodorants, manicurepreparations, and shaving preparationswhich do not primarily function as askin treatment.)

f. Products with multiple end useswhich are attributable topharmaceutical manufacturing as a finalpharmaceutical product, component of apharmaceutical formulation, orpharmaceutical intermediate. Productswhich have non-pharmaceutical usesmay also be covered entirely by thispoint source category provided that theproduct(s) was (were) primarilyintended for'use as a pharmaceutical.

g. Pharmaceutical research whichincludes biological, microbiological, andchemical research, productdevelopment, clinical and pilot plantactivities. (This does not include farmswhich breed, raise, and/or hold animalsfor research at another site. This alsodoes not include ordinary feedlot orfarm operations utilizing feed whichcontains pharmaceutically activeingredients.)

A number of products and/oractivities such as surgical and medicalinstruments and medical laboratoryactivity are not part of the

pharmaceutical manufacturing category.A descriptive listing of the productsand/or activities which are specificallyexcluded from the pharmaceuticalmanufacturing category may be found inSection II of the Development Documentfor Effluent Limitations Guidelines, NewSource Performance Standards, andPretreatment Standards for thePharmaceutical Manufacturing PointSource Category.

EPA is promulgating BPT and BATeffluent limitations, NSPS, andpretreatment standards for existing andnew sources (PSES and PSNS,respectively) for the pharmaceuticalmanufacturing point source category.Concurrent with this regulation, EPA isproposing NSPS to control the dischargeof two conventional pollutants (BOD5and TSS) from the pharmaceuticalplants. As explained below, EPA willnot establish BCT limitations for thepharmaceutical industry untilpromulgation of the generalmethodology for determiningappropriate levels of conventionalpollutant control under BCT. We arealso postponing a final decision on BATlimitations and NSPS.for thenonconventional pollutant COD.

III. Summary of Legal Background

The Federal Water Pollution ControlAct Amendments of 1972 established acomprehensive program to "restore andmaintain the chemical, physical, andbiological integrity of the Nation'swaters," Section 101(a). To implementthe Act, EPA was to issue effluentlimitations guidelines, pretreatmentstandards, and new source performancestandards for industrial dischargers.

The Act included a timetable forissuing these standards. However, EPAwas unable to meet many of thedeadlines and, as a result, in 1976, itwassued by several environmental groups.In settling this lawsuit, EPA and theplaintiffs executed a "SettlementAgreement" which was approved by thecourt. This agreement required EPA todevelop a program and adhere to aschedule for controlling 65 "priority"pollutants and classes of pollutants. Incarrying out this program, EPA mustpromulgate BAT effluent limitationsguidelines, pretreatment standards, andnew source performance standards for21 major industries. See NaturalResources Defense Council, Inc. vTrain, 8 ERC 2120 (D.D.C. 1976),modified, 12 ERC 1833 (D.D.C. 1979),modified by Orders dated October 26,1982, and August 2, 1983. The 65 toxicpollutants and classes of pollutantspotentially include thousands of spechficpollutants. EPA selected i29 specific

Federal Register / Vol. 48,

49810 Federal Register I Vol. 48, No. 209 / Thursday, October 27, 1983 I Rules and Regulationstoxic pollutants for study in thisrulemaking and other industryrulemakings. Since initiation of thisrulemaking effort, three toxic pollutantshave been removed from the list of 129toxic pollutants:Dichlorodifluoromethane,frichlorofuloromethane, and bis-chloromethyl ether (46 FR 2266 and 46FR 10723)..Many of the basic elements of theSettlement Agreement wereincorporated into the Clean Water Actof 1977. Like the Agreement, the Actstressed control of toxic pollutants,including the 65 "priority" pollutants. Inaddition, to strengthen the toxic controlprogram, Section 304(e) of the Actauthorizes the Administrator toprescribe "best management practices"(BMPs) to prevent the release of toxicand hazardous pollutants from plant siterunoff, spillage or leaks, sludge or wastedisposal, and drainage from rawmaterial storage associated with, orancillary to, the manufacturing ortreatment process.

Under the Act, the EPA is to set anumber of different kinds of effluentlimitations. These are discussed indetail in the preamble to the proposedregulation and in the DevelopmentDocument. They are summarized brieflybelow:

1. Best Practicble ControlTechnology (BPT). BPT limitations aregenerally based on the average of thebest existing performance by plants ofvarious sizes, ages, and unit.processeswithin the industry or subcategory forcontrol of familiar (i.e., classical]pollutants.

In establishing BPT limitations, weconsider the total cost of applying thetechnology in relation to the effluentreduction derived, the age of equipmentand facilities involved, the processesemployed, process changes required,engineering aspects of the controltechnologies, and nonwater qualityenvironmental impacts (including energyrequirements). We balance the total costof applying the technology against theeffluent reduction.

2. Best A vailable Technology (BAT).BAT limitations, in general, representthe best existing performance in theindustrial subcategory or category. TheAct establishes BAT as the principalnational means of controlling the directdischarge of toxic and nonconventionalpollutants to waters of the UnitedStates.

In arriving at BAT, the Agencyconsiders the age of the equipment andfacilities involved, the processemployed, the engineering aspects of thecontrol. technologies, process changes,the cost of achieving such effluent

reduction, and nonwater qualityenvironmental impacts. The Agencyretains considerable discretion inassigning the weight to be accordedthese factors.

3. Best Conventional Pollutant ControlTechnology (BCT). The 1977Amendments to the Clean Water Actadded Section 301(b)(2)(E), establishing"best conventional pollutant controltechnology" (BCT) for discharge ofconventional pollutants from existingindustrial point sources. Section304(a)(4) designated the following asconventional pollutants: BOD, TSS, fecalcoliform, pH, and any additionalpollutants defined by the Administratoras conventional. The Administratordesignated oil and grease as"conventional" on July 30, 1979 (44 FR4450).

BCT is not an additional limitation butreplaces BAT for the control ofconventional pollutants. In addition toother factors specified in Section304(b)(4}(B), the Act requires that BCTlimitations be assessed in light of a twopart "cost-reasonableness" test.American Paper Institute v. EPA, 660 F.2d 954 (4th Cir. 1981). The first testcompares the cost for private industry toreduce its conventional pollutants withthe costs to publicly owned treatmentworks for similar levels of reduction intheir discharge of these pollutants. Thesecond test examines the costeffectiveness of additional industrialtreatment beyond BPT. EPA must findthat limitations are "reasonable" underboth tests before establishing them asBCT. In no case may BCT be lessstringent than BPT.

EPA published its methodology forcarrying out the BCT analysis on August29, 1979 (44 FR 50732). In the casementioned above, the Court of Appealsordered EPA to correct data errorsunderlying EPA's calculation of the firsttest, and to apply the second cost test.(EPA had argued that a second cost testwas not required.)

A revised methodology for the generaldevelopment of BCT limitations wasproposed on October 29, 1982 (47 FR49176). BCT limits for this industry areaccordingly deferred until promulgationof the final methodology for BCTdevelopment.

4. New Source Performance Standards(NSPS). NSPS are based on the bestavailable demonstrated technology(BDT). New plants have the opportunityto install the best and most efficientproduction processes and wastewatertreatment technologies.

5. Pretreatment Standards for ExistingSources (PSES). PSES are designed toprevent the discharge of pollutants thatpass through, interfere with, or are

otherwise incompatible with theoperation of publicly owned treatmentworks (POTW). They must be achievedwithin three years of promulgation. Thelegislative history of the 1977 Actindicates that pretreatment standardsare to be technology-based, analogousto the best available technology forremoval of toxic pollutants. EPA hasgenerally determined that there is passthrough of pollutants if the nationwideaverage percentage of pollutantsremoved by a well operated POTWachieving secondary treatment is lessthan the percent removed by the BATmodel treatment system. The GeneralPretreatment Regulation, which-servesas the framework for categoricalpretreatment regulations, is found at 40CFR Phirt 403.

6. Pretreatment Standards for NewSources (PSNS}. Like PSES, PSNS aredesigned to prevent the discharge ofpollutants which pass through, interferewith, or are otherwise incompatible witlthe operation of a POTW. PSNS are tobe issued at the same time as NSPS.New indirect dischargers, like newdirect dischargers, have the opportunityto incorporate in their plant the bestavailable demonstrated technologies.The Agency considers the same factorsin promulgating PSNS as it considers inpromulgating PSES.

IV. Methodology and Data GatheringEfforts

The methodology and data gatheringefforts used in developing the proposedregulations were summarized in thepreamble to the proposedpharmaceutical manufacturing industryregulations (47 FR 53584, November 26,1982). In summary, before publishing thEpi-oposed regulation, the Agencyconducted a data collection, analyticalscreening, and analytical verificationprogram for the pharmaceuticalindustry. This program stressed theacquisition of data on the presence andtreatability of the 129 toxic pollutantsand classes of toxic pollutants discusseipreviously.

Based on the results of that program,comments on the proposed regulations,and additional data gathered orsubmitted since proposal, EPA identifieseveral distinct control and treatmenttechnologies that are in use or arecapable of being used to treatpharmaceutical wastewaters. For eachof these technologies, the Agency: (i)Compiled and analyzed historical andnewly-generated data on effluentquality; (ii) identified the reliability andconstraints; (iii) considered the non-water quality environmental fmpacts(including impacts on air quality, solid

49810 Federal Register / Vol. 48, No. 209 / Thursday, October 27, 1983 / Rules and Regulations

Federal Register / Vol. 48, No. 209 / Thursday, October 27, 1983 / Rules and Regulations 49811

waste generation, and energyrequirements); and (iv) estimated thecosts and economic impacts of applyingthe technology as a treatment andcontrol system. Costs and economicimpacts of the technology optionsconsidered are discussed in detail inEconomic Analysis of EffluentStandards and Limitations for thePharmaceutical Industry (U.S. EPA,September 1983). A more complete.description of the Agency's studymethodology, data gathering efforts, andanalytical procedures supporting theregulation can be found in theDe velopment Document for EffluentLimitations Guidelines, NewSourcePerformance Standard, andPretreatment Standards for thePharmaceutical Manufacturing PointSource Category (U.S. EPA, September1983).

To allow the Agency to respond fullyto comments on the proposed rules, theAgency engaged in additional datagathering activities after November of1982. A major effort involved gatheringinformation on the presence andvariability of toxic volatile organics(TVOs) in pharmaceutical raw wastesand treated effluents. In this regard, EPAobtained additonal data on thepercentages of process wastewaterdischarges that are contaminated withTVOs and on the levels of TVOscontained in the contaminated wastestreams. To broaden our data base onpass through of TVOs, we aiso sampleda publicly owned treatment works(POTW) receiving pharmaceuticaldischarges. The Agency also identifiedpharmaceutical plants where steamstripping or related technologies areemployed and sampled a steam stripperand flash tank used to remove TVOs.EPA incorporated this additonalinformation into our existing data baseand used the expanded data base toreach decisions on regulation of TVOdischarges from the pharmaceuticalindustry.

In some cases, industry comments onour proposed regulations includedeffluent data on the discharge of toxic,nonconventional, and conventionalpollutants. However, these data wereoften provided in a format that did notallow for proper analysis by the Agency.In those instances, we requestedadditional information in a format thatwould allow us to include the data whendeveloping the final regulations.

Detailed discussions of the results ofthese additional data gathering effortscan be found below and in the finalDevelopment Document.

V. Summary of Promulgated Regulationsand Changes From Proposal

The final regulations issued todaydiffer from the proposed regulations.The changes are the result of theAgency's review of comments on theproposal and our analysis of additionalinformatioA obtained to respond tocomments. The following includes areview of the proposed regulation, asummary of the changes from proposalto promulgation, and an explanation ofthe changes.

In brief, EPA is promulgating BPTeffluent limitations controlling thedischarge of TSS from plants coveredunder regulations for subcategories Aand C and is modifying existing BPTBOD5, COD, and TSS effluentlimitations for subcategories B, D, and E.We are also establishing BPT and BATeffluent limitations guidelines, NSPS,PSES, and PSNS controlling cyanidedischarges from pharmaceutical plants.

Concurrent with this regulation, EPAis proposing NSPS to control thedischarge of two conventional pollutants(BOD5, and TSS) from newpharmaceutical plants.

A. Subcategorization

On November 26, 1982, we proposedto exclude the research-onlysubcategory (E) from all but BPTregulations. We also collapsed theremaining four subcategories(fermentation-subcategory A,extraction-subcategory B, chemicalsynthesis-subcategory C, andiormulation-subcategory D) into onesubcategory for which one set of BATlimitations, NSPS, PSNS, and PSES wereproposed.

We received no comments on the.exclusion of the research onlysubcategory from further regulationunder BAT, NSPS, PSES, and PSNS.Therefore, for the reasons discussedlater in this preamble (see Section VIIPollutants and Subcategories NotRegulated), we have excluded theresearch only subcategory fromdevelopment of further regulationsbeyond BPT.

A number of commenters objected tothe proposed establishment of onepharmaceutical subcategory consistingof fermentation, chemical synthesis,extraction, and formulation plants. Theyexplained that there was no need tochange the 1976 BPT subcategorizationscheme. They maintained that high rawwaste generating facilities (fermentationand chemical synthesis plants) shouldbe regulated on a different basis thanlow raw waste generating facilities(extraction and formulation plants). Wereceived no comments supporting the

proposed change in thesubcategorization scheme.

In comments on the proposal, theAgency received new plant data whichwas added to the existing data base. Weanalyzed data on influent and effluentcharacteristics of all direct dischargersto determine if the proposed change insubcategorization was appropriate. Ouranalysis of the most recent data indicatethat the subcategorization scheme forthis industry should separatefermentation and chemical synthesisplants (subcategory A and C plants)from extraction and formulation plants(subcategory B and D plants).Specifically, our analyses show thatusually the influent and effluentconventional pollutant and CODconcentrations and discharge flows ofsubcategory A and C plants are similar;we also found that these characteristicsfor subcategory B and D plants aresimilar. However, we found that thecharacteristics of the subcategory A andC plant group are not similar to thecorresponding characteristics of thesubcategory B and D plant group. Ouranalyses indicate that toxic pollutantloads are similar for all foursubcategories.

We are also aware that permittingauthorities and the regulated industryare familiar with the originalsubcategorization scheme and theformat of the Code of FederalRegulations. Therefore, the Agency hasdecided to maintain the existing BPTsubcategorization scheme. However,because conventional pollutant rawwaste characteristics are similar forsubcategory A and C plants,conventional pollutant limitations andstandards for those plants should beidentical. For the same reason,conventional pollutant limitations andstandard for subcategory B plantsshould be identical to those forsubcategory D plants. A more detaileddiscussion of the industrysubcategorization scheme can be foundin Section IV of the DevelopmentDocument.

B. BPT for BOD5, TSS, and COD

The Agency proposed a BPT TSSlimitation for all subcategories of plantsbased on a long-term averageconcentration of 75 mg/l. This limitationwas intended to replace the overlystringent BVr TSS limitations forsubcategory B, D, and E plants and toestablish BPT TSS limitations for A andC subcategory plants. The originaloverly stringent BPT TSS limitationswere based on data from two plantswhose operations were notcharacteristic of the entire range of

49812 Federal Register I Vol. 48, No. 209 / Thursday, October 27, 1983 / Rules and Regulationsoperations employed at plants in the B,D, and E subcategories.

One commenter stated that a singlenumber concentration limit for TSS isnot appropriate for high raw waste loadplants but may be appropriate for lowraw waste load plants.

The existing BPT regulations, whichare based on the application ofbiological treatment, require that eachpharmaceutical plant, regardless ofsubcategory, achieve a 90 percentreduction in BOD5. A single numberconcentration limit for TSS is notconsistent with our BPT percentreduction BOD5 limitations, which whenconverted to long-term average BOD5effluent concentrations, vary from plantto plant over a wide range (e.g., fromabout 15 mg/l to almost 400 mg/1). Asingle nurfiber TSS limitation wouldrequire some plants to install moreadvanced treatment than thattechnology identified as BPT. It wouldalso mean that low raw waste loadplants would be able to operate theirtreatment systems inefficiently and stillcomply with the proposed single numberlimitation. After analyzing all availabledata, the Agency found that effluent TSSconcentrations from biological treatmentsystems usually are greater thancorresponding effluent BOD5concentrations. We found that themedian ratio of effluent TSSconcentrations to effluent BOD5concentrations after biological treatmentis 1.7 for both the subcategory A and Cand the subcategory B and D plantgroups. Consequently, the Agency isfinalizingBPT TSS limitations for allfive subcategories which are equal to amultiple of 1.7 times the existing BPTBOD5 limitations.

The Agency also proposed alternativeconcentration-based BOD5 and CODBPT limitations for all subcategories.These proposed revisions to BPT werenecessitated by the Agency's decisionnot to change the existing percentreduction-based BPT limitations eventhough the proposed BCT and BATlimitations were concentration based.Without the proposed modification inBPT BOD5 and COD limitations, someplants would have had concentration-based BCT and BAT limitations thatwere less stringent than the percentreduction-based BPT limitations. Thiscondition would have been inconsistentwith the requirements of the CleanWater Act. No comments were receivedon these alternative limitations.

The Agency has reviewed theavailable influent and effluent BOD5and COD data in the light of ourdecision to use the original BPTsubcategorization scheme. As a result,the Agency is finalizing alternative

BOD5 and COD concentration-basedlimitations for subcategories B, D, and E.Although we are not yet promulgatingfinal BCT limitations for BOD5 or BATlimitations for COD, available dataindicate that the alternative BOD5 andCOD limitations are appropriate forthese subcategories for another reason.These alternative limitations establishminimum concentration levelsconsistent with EPA's assessment of arealistic estimate of the lowestattainable long-term average BOD5 andCOD concentrations representative ofthe capability of the best practicablecontrol technology currently available intreating pharmaceutical industrywastewaters, Such alternativelimitations are not necessary forsubcategory A or C because availabledata indicate that raw waste loads are,sufficiently high at chemical synthesisand fermentation plants that limitationsas low as the alternative limitationsestablished for subcategories B, D, and Ewould not be required under BPT.

C. BPT and BAT Effluent Limitations,NSPS, PSES and PSNS for Cyanide

The Agency proposed BPT and BATeffluent limitations guidelines, NSPS,PSES, and PSNS based on in-plantcyanide destruction and biologicaltreatment. These proposed limitationsand standards assumed that monitoringwould occur at the end-of-pipe. ,Proposed PSES would have requiredcompliance by July 1, 1984. At proposal,the Agency requested additional data on-the performance of cyanide destructiontechnology in the pharmaceuticalindustry.

One commenter stated that theproposed cyanide limitations andstandards were not sufficientlyrepresentative of the production cycle of.the industry because the data whichwere used to derive the limits wereobtained during a period of less thannormal production. The commenter, at alater date, submitted three additionalsets of data to cover periods of normalproduction. Another commentercomplained that a PSES compliancedate of July 1, 1984, would beprohibitively difficult to achieve andsuggested that the Agency establish acompliance date of three years afterpromulgatfon as authorized by the CleanWater Act.

The new data measured both theperformance of in-plant cyanidedestruction systems directly and thecombination of in-plant and biologicaltreatment. EPA is finalizing BPT andBAT effluent limitations guidelines,NSPS, PSES, and PSNS for cyanidebased on these new submissions. Theregulations include provisions for

monitoring either in-plant after cyanidedestruction or end-of-pipe.

Section 307(b)(1) provides that PSESshall specify a time for compliance, notto exceed three years from the date ofpromulgation. This does not create apresumption that three years willnecessarily be allowed. However, theAgency has reviewed information on theinstallation of cyanide destructiontechnology at pharmaceutical plants.The readjustment of internal processingconditions to segregate contaminatedwaste streams may require more timethan for only the installation of end-of-pipe treatment equipment. Additionally,plants in this and other industries willbe installing the treatment equipmentsuggested as the model technology forthis regulation; this may result in delaysinengineering, ordering, installing, andoperating this equipment. For the abovereasons, EPA decided to specify the datefor compliance with pharmaceuticalindustry PSES as three years from thepromulgation date of final PSES forcyanide.

D. BAT Effluent Limitations, NSPS,PSES, and PSNS for Toxic VolatileOrganics (TVOs)

Toxic volatile organics (TVOs) arethose priority pollutants that are readilypurged from water because of their highvolatility. Many of these compounds areused as industrial solvents. Methylenechloride, benzene, toluene, andchloroform are four toxic volatileorganics .that are used as solvents in themanufacture of pharmaceuticalproducts.

1. Direct Dischargers:.BA T/NSPS. Atproposal, methylene chloride and allother toxic volatile organics wererecommended for exclusion from directdischarger regulations (BAT and NSPS)under the provisions of paragraph 8 ofthe Settlement Agreement. With theexception of methylene chloride, threehas been no change in our rationale fornot establishing effluent limitationsguidelines and standards for the TVOs.In the case of methylene chloride, westated that dischargers were controlledby effluent limitations reflecting the bestpracticable control technology currentlyavailable. We received no comments onour proposed exclusion of this toxicpollutant. However, a reexamination ofthe existing information on the use anddischarge of methylene chloride bydirect discharging pharmaceutical plantsindicates that, in fact, treatable levels ofmethylene chloride may remain evenafter the implementation of BPT (i.e.,biological treatment).

Available data show that in caseswhere the concentrations of methylene


No. 209 / Thursday, October 27, 1.983 J Rules and Regulations 49813

chloride discharged to biologicaltreatment systems are greater than 5mg/l, treatable concentrations ofmethylene chloride remain in theeffluent. Methylene chloride is used inabout 15 percent of all fermentation,chemical synthesis, and extractionprocesses and to a lesser extent informulation operations. Our data showthat 15 of the 51 direct dischargingpharmaceutical plants use methylenechloride in their manufacturingprocesses. For these reasons, wereconsidered our original paragraph 8determination.

We considered establishing morestringent BAT effluent limitationsguidelines for methylene chloride basedon in-plant steam stripping technologyin addition to biological treatment. Thistreatment technology would insure thatonly low effluent concentrations ofmethylene chloride would be,discharged. However, we found that thecosts of installing and operating steamstrippers to control methylene chlorideare not insignificant. We estimate thatnine direct discharging plants wouldincur average capital and average totalannual costs of $0.736 million and $0.712million (1982 dollars), respectively, perplant. We estimate that the installationof steam stripping technology wouldreduce current discharge levels ofmethylene chloride by 60,700 pounds peryear at these plants. This compares tothe 651,000 pounds per year ofmethylene chloride that are nowremoved by biological treatment, thebest practicable control technologycurrently available for this industry. Wealso determined that steam strippingtechnology is extremely energy intensiveand would increase energy use at thesenine direct dischargers by the equivalentof 94,300 barrels of oil per year. Weproject that the average methylenechloride removal cost resulting from theapplication of steam strippingtechnology would be $103 per pound,when assuming full value of therecovered solvent.

After considering the relative toxicityof this pollutant in light of these costs,and all the other factors, we havedecided not to issue categoricalregulations limiting methylene bhloridedischarges from the pharmaceuticalindustry based on the addition oftreatment technology beyond biologicaltreatment. We have also decided not toestablish limitations based on biologicaltreatment because they would not effecta further removal of methylene chloride.Another factor, while not directly abasis for these decisions, confirmed thereasonableness of the weight weaccorded to cost and energy factors. We

determined that much of the methylenechloride which would be removed bysteam stripping will otherwise volatilizeduring biological treatment. Our dataindicate that the volatilized methylenechloride will not be at levels whichcreate a health risk.

Data on the capabilities of steamstripping and biological treatmenttechnologies to reduce the discharge ofmethylene chloride and on the cost ofinstalling and operating steam strippersto control toxic volatile organics ispresented in Section VII of theDevelopment Document. Thisinformation may be used by permitwriters in developing permit limitationsfor methylene chloride on a case-by-case basis where necessary.

2. Indirect Dischargers: PSES, PSNS.At proposal, we stated that we were *considering establishing pretreatmentstandards to control TVO'dischargesbecause available data indicated thatpass through of TVOs occurs at POTWs.A standard of 1.2 mg/I for total toxicvolatile organics was suggested in thepreamble to the proposed rules, pendingthe availability of adequate supportingdata on the performance of steamstripping technology.

One POTW and one State Agencycommented that pretreatment standardscontolling TVOs should be promulgated.Industry commenters questioned theneed for TVO pretreatment standards inview of the low concentrations of toxicvolatile organics in POTW effluents. IThey also questioned the achievabilityof a 1.2 mg/l discharge level with steamstripping technology.,

In the proposed regulation, 17 TVOswere listed as possible candidates forregulation by pretreatment standards.After reexamining all of the availabledata, we have concluded that, with theexception of methylene chloride andchloroform, these pollutants should beexcluded from regulation by theprovisions of paragraph 8 of theSettlement Agreement. Thirteen of thesepollutants have been excluded becausetheir amount and toxicity, takentogether, are so insignificant as not tojustify developing uniformly applicablepretreatment regulations (see AppendixE). Of the remaining, there are two(benzene and toluene) which, while notas insignificant, nonetheless are unlikelyto pass through POTWs.

To address the issue of pass through,EPA studied 50 well-operated POTWsthat use biological treatment todetermine the extent to which prioritypollutants are reduced by such POTWs.In the case of benzene and toluene, thedata indicate that direct dischargermedian percent reductions exceed

POTW median percent reductions byless than 5 percent (100 percent fordirect dischargers versus 99 percent forbenzene and 97 percent for toluene atPOTWs). In light of the fact that EPAhad less data in the POTW studies on.benzene and toluene than it had forsome other-pollutants and in light of thevariability in analyzing samples fororganic priority pollutants at theconcentrations typically found in end-of-pipe biological systems at POTWs andpharmaceutical plants, EPA believesthat differences of 5 percent or lessbetween the direct discharger andPOTW data for benzene and toluene areunlikely to reflect real differences intreatment efficiency. Therefore, EPA hasdetermined that benzene and toluene donot pass through POTWs.

However, a potential interferenceproblem could exist for these two toxicvolatile organics because of a potentialfire/explosion hazard. Benzene andtoluene water mixtures have low flashpoints. Relatively small concentrationsof these solvents in water mixtures(about 180 mg/l) can cause spontaneouscombustion in the vapor space abovethe water mixture under certainconditions. Our latest informationindicates that fire/explosions, while notimpossible, are unlikely. Benzene andtoluene levels above the minimumconcentrations required to causecombustion have not been reported indischarges from plants in thepharmaceutical industry. Because passthrough does not occur and interferenceis unlikely, there is no basis forestablishing nationally applicablecategorical pretreatment standards forbenzene or toluene. However, under thegeneral pretreatment regulation, 40 CFR403.5, an individual POTW mayestablish pretreatment standards ifbenzene and toluene discharges frompharmaceutical users result ininterference. Section VII of theDevelopment Document containssuggested pretreatment standards forbenzene and toluene, based on steamstripping, for consideration by POTWsestablishing standards under § 403.5.

At direct discharging pharmaceuticalmanufacturing plants, chloroform isreduced to levels that are below itstreatability through volatilization inbiological treatment systems. Therefore,we have excluded chloroform from BATregulations under the provisions ofparagraph 8(a)(iii) of the SettlementAgreement. As for indirect dischargers,we have found that POTWs to whichhigh concentrations of chloroform aredischarged achieve high chloroformremoval (greater than 95 percent).Therefore, POTWs receiving high

,Federal Register / Vol. 48,


concentrations of chloroform as a resultof pharmaceutical discharges areunlikely to experience pass through. Forthe above reasons, we have decided notto establish pretreatment standardscontrolling choloroform from-indirectdischarging pharmaceutical plants.

Through this process, the Agencydetermined that only methylene chloridewas a candidate for national PSES andPSNS regulations. We found that theinstallation and operation of steamstrippers to reduce methylene chloridedischarges to POTWs bypharmaceutical plants would result incosts that are not insignificant. Weestimate that 25 indirect dischargingplants would incur capital and totalannual costs of $0.748 million and $0.768million (1982 dollars), respectively, perplant. We project that one indirectdischarging pharmaceutical plant wouldclose if required to install steamstripping technology. Steam strippersare also equally energy intensive atindirect discharging plants as at directdischargers. We estimate that theoperation of steam strippers at the 25plants would increase energy usage bythe equivalent of 315,000 barrels of oilper year. For these reasons and becausewe concluded that regulation ofmethylene chloride at direct dischargersis inappropriate, we decided not toestablish categorical PSES and PSNS formethylene chloride.

Data on the capabilities of steamstripping technology to reduce thedischarge of methylene chloride and onthe cost of installing and operatingsteam strippers to control toxic volatileorganics is presented in Section VII ofthe Development Document. Thisinformation may be used bymunicipalities in developingpretreatment standards for methylenechloride on a case-by-case basis wherenecessary.

E. New Source Performance Standardsfor Conventional Pollutants

On November 26, 1982, EPA proposedconventional pollutant new sourceperformance standards that applieduniformly to subcategories A, B, C, andD. Proposed NSPS were based onadvanced biological treatment (i.e.,biological treatment systems with longerdetention times than those consideredas the basis of BPT). As discussedpreviously, we have determined thatseparate conventional pollutantlimitations are appropriate for thesubcategory A and C and thesubcategory B and D plant groups. Wehave also identified four pharmaceuticalplants where effluent filtration inaddition to advance biological treatmentis employed. Conventional pollutant

discharges from these plants aresignificantly lower than from plantswhere only advanced biologicaltreatment is employed. Consequently,the Agency is proposing NSPS based oneffluent filtration in combination withadvanced biological treatment. For amore detailed explanation of the basisof this decision, see the preamble to theproposed regulation that appearselsewhere in today's Federal Register.

F BA T Limitations and NSPS for COD

The Agency proposed-BAT CODconcentration limitations that applieduniformly to subcategories A, B, C, andD based on the same technologyidentified as the best conventionalpollutant control technology (BCT) (i.e.,add-on biological treatment). NSPS tocontrol COD were proposed based onadvanced biological treatment.

One commenter suggested thatlimitations and standards should bewritten for specific compounds, ifjustifiable, rather than regulatingadditional pollutants through control ofCOD. Two industry commentersmaintained that there are some chemicalsynthesis plants which have better thanthe proposed BCT treatment in-placethat cannot meet the proposedlimitations. Another commenter statedthat it was inappropriate to proposeCOD limitations based on advancedbiological treatment for substanceswhich biodegrade slowly or not at all.

The concentrations of many materialsthat are measured as or contribute toCOD are'reduced in biological systemsby biodegradation or by air strippingand sorption mechanisms; therefore,increased biological treatment systemcapacity can afford greater removal ofthese materials. There are somematerials, however, that contribute toCOD, such as dissolved inorganic saltsand some organics, which pass throughbiological treatment systems withoutbeing biodegraded, air stripped, orabsorbed. Available data indicate thateven after biological treatment systemexpansion, many subcategory A and Cplants would not meet the proposedCOD limitations. Additional informationon the identity of the pollutants thatcontribute to COD and on applicableCOD removal technologies is requiredbefore we can evaluate COD controloptions. Therefore, the Agency ispostponing a final decision onappropriate BAT limitations and NSPSfor the nonconventional pollutant CODuntil a later date. We are continuing ourinvestigation of appropriate CODremoval technologies and their costs.

VI. Costs, Economic Impacts, ExecutiveOrder 12291, Regulatory FlexibilityAnalysis, and Small BusinessAdministration (SBA) Loans

A. Cost and Economic Impact

The Agency's economic impactassessment of this regulation ispresented in Economic Analysis ofEffluent Standards and Limitations forthe Pharmaceutical Industry. This reportdetails the investment and annual costsfor the industry as a whole and for.plants covered by the final regulation.Plant costs are engineering estimates forthe effluent control systems described inthis preamble. The report assesses theimpact of effluent'control costs in termsof price changes, plant closures,employment effects, and balance oftrade effects.

EPA has identified 466 pharmaceuticalfacilities that are covered by thisregulation. An estimated 134 of theseplants are zero discharigers and are notexpected to incur costs. Of theremaining 332 discharging plants, EPAestimates that nine will incur totalinvestment costs for BPT, BAT, andPSES of $1.47 million, with annual costsof $0.65 million, including depreciation-and interest. These costs are expressedin 1982 dollars and are based on thedeterminations that plants will upgradetheir existing treatment systems tocomply with BPT, BAT, or PSES, asappropriate. No plant closures areprojected as a result of compliance costsfor this regulation and, hence, we expectno adverse employment effects onpharmaceutical manufacturingemployees. The maximum price increaseif all costs were passed on to consumersis less than 0.1 percent for the plantsaffected by the regulation. Balance oftrade effects are nil.

In order to measure the potentialeconomic impacts, a two-step analyticalprocedure was employed. First, theanalysis determined whether a plant'scompliance costs exceeded one percentof sales. If the costs did exceed onepercent, then the analysis consideredinformation on the firm's financialposition, its size, the relative importanceof its pharmaceutical line of business,patent protection, and other economicinformation relevant to assessing thelikely impact of the regulation on a firm.If the firm is in a position to pass thecosts on to the consumer, due to patentprotection, for example, then it isassumed that prices would increase andthe plant would remain in operation. Ifcosts cannot be passed on, then basedon the above information, adetermination was made as to whethera plant might close, a production line


might shut down, or production might beshifted from one plant to another. Forthe reasons discussed below and afterapplying this economic impactmethodology, the Administrator hasdetermined that the costs of thisregulation are justified.

1. BPT. BPT regulations for cyanideand TSS are expected to requireexpenditures at eight plants (cyanidedestruction at four plants, TSS control atfive plants, with one of these plantsrequiring both). Total investment and.annual costs are estimated to be $1.05million and $0.39 million, respectively(1982 dollars). The estimated change inprice for the affected plants is less than0.1 percent. No significant economicimpacts are projected as a result of BPT.

2. BAT. Only cyanide is limited underBAT. Cyanide limits are the same asunder BPT. Therefore, no incrementalimpacts are expected fromimplementation of BAT.

3. PSES. The standard is for thecontrol of cyanide. Only one out of the277 indirect discharging plants isexpected to incur costs; the estimatedcapital and annual costs are $0.42million and $0.26 million, respectively(1982 dollars). The expected pricechange is nil. No significant economicimpacts are expected from the PSEScyanide regulation.

4. NSPS and PSNS. Only pH andcyanide are limited under NSPS. Sincethe pH and cyanide limits are the sameas under BPT, no incremental impactswill result from implementation of finalNSPS. NSPS controlling BOD5 and TSSare being proposed today in acompanion notice.

Regulations for indirect dischargingnew sources (PSNS) are the same asthose for existing sources. Therefore, noincremental impacts are expected fromimplementation of PSNS.

B. Cost Effectiveness

EPA has conducted an analysis of theincremental removal cost per poundequivalent for each toxic pollutantcontrol option. A pound equivalent iscalculated by multiplying the number ofpounds of pollutant discharged by aweighting factor for that pollutant. Theweighting factor is equal to the aquaticlife water-quality criterion for astandard pollutant (copper), divided bythe aquatic life water-quality criterionfor the pollutant being evaluated. Theuse of "pound equivalent" givesrelatively more weight to removal ofmore highly toxic pollutants. Thus for agiven expenditure, the cost per poundequivalent removal would be lowerwhen a highly toxic pollutant is removedthan if a less toxic pollutant is removed.This analysis is included in the record of

this rulemaking in a document titled"Cost Effectiveness Analysis of EffluentStandards and Limitations for thePharmaceutical Industry."

C. Executive Order 12291Executive Order 12291 requires EPA

and other agencies to perform regulatoryimpact analyses of major regulations.Major rules are those which impose anannual cost on the economy of $100million or more or have certain othereconomic impacts. This regulation is nota major rule because its annualized costis less than $100 million and it meetsnone of the other criteria specified inSection I, paragraph (b) of the ExecutiveOrder. The economic impact analysisprepared for this rulemaking satisfiesthe requirement of the Executive Orderfor a non-major rule.

D. Regulatory Flexibility AnalysisPub. L. 96-354 requires EPA to prepare

an Initial Regulatory FlexibilityAnalysis for all regulations that have asignificant impact on a substantialnumber of small entities. This analysismay be conducted in conjunction withor as part of other Agency analyses.

Since no firms in the data base areprojected to experience significanteconomic impacts, there is nodisproportionate burden on smallbusinesses; therefore, a formalRegulatory Flexibility Analysis is notrequired.

E. SBA LoansThe Agency is continuing to

encourage small pharmaceuticalmanufacturers to use Small BusinessAdministration (SBA) financing asneeded for pollution control equipment.The three basic programs are: (1) TheSection 503 Program; (2) the RegularGuarantee Program; and (3) theGuaranteed Pollution Control BondProgram. All the SBA loan programs areopen only to businesses that have: (a)Net assets less than $6 million; (b) anaverage annual after-tax income of lessthan $2 million; and (c) fewer than 250employees. The estimated economicimpacts for this point source category donot include consideration of financingavailable through these programs.

The Section 503 Program, as amendedin July 1980, allows long-term loans tosmall and medium sized businesses.These loans are made by SBA approvedlocal development companies. For thefirst time these companies areauthorized to issue Government-backeddebentures that are bought by theFederal Financing Bank, an arm of theU.S. Treasury.

Through SBA's Regular GuaranteeProgram, loans are made available by

commercial banks and are guaranteedby the SBA. This program has interestrates equivalent to market rates.

For additional information on theRegular Guarantee and Section 503Programs, contact your district or localSBA Office. The coordinator at EPAheadquarters is Ms. Frances Dessellewho may by reached at (202) 382-5373.

For further information and specificson the Guaranteed Pollution ControlBond Program contact: U.S. SmallBusiness Administration, Office ofPollution Control Financing, 4040 NorthFairfax Drive, Rosslyn, Virginia 22203;(703) 235-2902.

VII. Pollutants and Subcategories NotRegulated

Paragraph 8 of the modifiedSettlement Agreement, approved by theDistrict Court for the District ofColumbia on March 9, 1979 (12 ERC1833), contains provisions authorizingthe exclusion from regulation, in certaininstances, of toxic pollutants andindustry subcategories.

A. Pollutants Excluded

Paragraph 8(a)(iii) of the modifiedSettlement Agreement allows theAdministrator to exclude fromregulation toxic pollutants not detectedby Section 304(h) analytical methods orother state-of-the-art methods. The toxicpollutants not detected in the effluentsof direct discharging pharmaceuticalplants and, therefore, excluded fromregulation in this industry, are listed inAppendix B of this notice.

Paragraph 8(a)(iii} also allowsexclusion of pollutants that are: (1)Detected in the effluent from a smallnumber of sources and uniquely relatedto those sources; (2) detected in onlytrace amounts not likely to cause toxiceffects; (3) sufficiently controlled byexisting technologies; or (4] detected inamounts too small to be effectivelycontrolled by technologies known to theAdministrator. Thirty-four differenttoxic pollutants were found in theeffluent of direct dischargingpharmaceutical plants during thescreening and verification program.Twenty-four of these pollutants (toxicmetals and volatile organics) were foundat treatable levels only in a smallnumber of instances. In those instances,these levels were attributable tomanufacturing activities that areuniquely related to the plants sampled.Another eight toxic pollutants (somephenols and phthalates) were found ator below the treatability limitconcentrations determined for existingphysical-chemical treatment methods bystudies conducted on wastewater from

vFederal Register / Vol. 48,

49816 Federal Register / Vol. 48, No. 209 / Thursday, October 27, 1983 I Rules and Regulationsseveral industry categories. The 32pollutants are listed in Appendix C tothis notice along with the particularreason for excluding them fromregulation. The two remaining toxicpollutants detected in the effluent ofdirect discharging pharmaceutical plantsare cyanide and methylene chloride.EPA is establishing BPT and BATlimitations and NSPS controlling thedischarge of cyanide. For the reasonsdiscussed above, EPA is not regulatingthe discharge of methylene chloridefrom direct discharging pharmaceuticalplants.

Paragraph 8(b)(ii) of the SettlementAgreement authorizes the Administratorto exclude from nationally applicablepretreatment standards a subcategory orcategory if the toxicity and amount ofincompatible pollutants (taken together)introduced by such point sources intoPOTWs is so insignificant as not tojustify developing a nationalpretreatment regulation. EPA hasreviewed available data from indirectdischargers and is excluding the 123toxic pollutants listed in Appendices Dand E from nationally applicablepretreatment standards. Appendix Dlists those toxic pollutants not detectedin the effluents of indirect dischargers.Appendix E lists those toxic pollutantswhich, although detected, were notsignificant enough, in terms of toxicityand amount of incompatible pollutants(taken together), to justify nationallyapplicable pretreatment standards. EPAis establishing PSES and PSNScontrolling the discharge of cyanide. Forthe reasons discussed previously, EPA isnot establishing nationally applicablepretreatment standards for methylenechloride or chloroform.

B. Subcategories Excluded

The Settlement Agreement did notrequire EPA to regulate the entirepharmaceutical industry. Subcategory E,Pharmaceutical Research, is notmentioned in the Settlement Agreement..Since pharmaceutical research does notinvolve production and wastewatergeneration in appreciable quantities ona regular basis, EPA now considers thissubcategory outside the province ofordinary industrial guidelinesdevelopment. Therefore, facilities whichconduct pharmaceutical research onlyare specifically excluded from alllimitations and standards in thisregulation other than the BPTlimitations. Research activities'conducted at mixed and singlesubcategory plants (A, B, C, and D only)will be covered by this regulationbecause the wastewaters from theseactivities were studied as part of thetechnical development of this regulation.

However, these activities contribute avery small portion of wastewater to thefinal effluent of the average productionfacility.

VIII. Non-Water Quality Aspects ofPollution Control

Eliminating or reducing one Form ofpollution may cause otherenvironmental problems. Sections 304(b)and 306 of the Act require EPA toconsider the non-water qualityenvironmental impacts (including energyrequirements) of certain regulations. Incompliance with these provisions, EPAhas considered the effect of theseregulations on air pollution, solid wastegeneration, and energy consumption.This regulation was reviewed by EPApersonnel responsible for non-waterquality programs. While it is difficult tobalance pollution problems against eachother'and against energy use, EPAbelieves that this regulation will bestserve often competing national goals.

The following non-water qualityenvironmental impacts (including energyrequirements) are associated with thefinal regulations. The Administrator hasdetermined that the impacts identifiedbelow are justified by the benefitsassociated with compliance with thelimitations and standards.

A. Solid Waste

EPA estimates that the total solidwaste generated to attain the new BPTTSS limitations will be approximately138,000 additional pounds per year ofwastewater treatment sludge. This isequal to an incremental increase ofabout 0.3 percent over that currentlygenerated by the pharmaceuticalindustry to meet existing BPT BOD5limitations. The solid wastes generatedthrough wastewater treatment at •pharmaceutical plants have not beenlisted as hazardous in regulationspromulgated by the Agency underSubtitle C of the Resource Conservationand Recovery Act (RCRA) (see 45 FR33066; May 19, 1980). Accordingly, itdoes not appear likely that thewastewater sludges generated bypharmaceutical plants under the newBPT TSS limitations will be subject tothe comprehensive RCRA programestablishing requirements for personshandling, transporting, treating, storing,and disposing of hazardous wastes. TheAgency's estimates of the costs of thisregulation include-the cost of handlingthese sludges as a non-hazardous waste.

No sludge will be generated as aresult of complying with the finalpretreatment standards, NSPS, or theBPT and BAT effluent limitations forcyanide.

B. Air Pollution

EPA does not believe that cyanideremoval mechanisms will cause thegeneration of air pollutants;additionally, we do not anticipate thatcompliance with the modified and newBPT TSS limitations will result in thegeneration of additional air pollutionfrom pharmaceutical plants.

C. Energy Requirements

EPA estimates that the achievementof the cyanide and the new modifiedTSS BPT effluent limitations willincrease energy consumption byapproximately 0.01 percent of presentfacility use for all plants. We estimatethat compliance with PSES to controlcyanide discharges to POTWs willincrease over-all energy use by 0.07percent at the affected indirectdischarging pharmaceutical plant.Because BAT limitations and NSPS forcyanide are identical to BPT cyanidelimitations and because PSNS areidentical to PSES, there will be noincremental increase in energy usageresulting from compliance with BATeffluent limitations,. NSPS, or PSNS.

IX. Best Management Practices

Section 304(e) of the Clean Water Actauthorizes the Administrator toprescribe what have been termed "bestmanagement practices" (BMPs). TheAgency is not promulgating BMPs forthe pharmaceutical industry at this time.However, the existing BPT regulationrequires that separable mycelia andsolvents not be included in the rawwaste load calculations that form thebasis of determinations of BPT effluentlimitations for BOD5 and COD. (See 40CFR Part 439; 41 FR 50676, November 17,1976). This rulemaking does not changethis requirement.

X. Upset and Bypass Provisions

A recurring issue of concern has beenwhether industry guidelines shouldinclude provisions authorizing.noncompliance with effluent limitationsduring periods of "upset" or "bypass."An upset, sometimes called an."excursion," is an unintentionalnoncompliance occurring for reasonsbeyond the reasonable control of thepermittee. It has been argued that anupset provision is necessary in EPA'seffluent limitations because such upsetswill inevitably occur even in properlyoperated control equipment. Becausetechnology-based limitations are torequire only what technology can.achieve, it is claimed that liability forsuch situations is improper. Whenconfronted with this issue, courts havedisagreed on whether an explicit upset


Federal Register I Vol. 48, No. 209 / Thursday, October 27, 1983 / Rules and Regulations 49817or excursion exemption is necessary orwhether upset or excursion incidentsmay be handled through EPA's exerciseof enforcement discretion. CompareMarathon Oil Company v. EPA, 564 F.2d1253 (9th Cir. 1977) with Weyerhaeuserv. Castle, supra, and Corn RefinersAssociation, et al. v. Costle, No. 78-1069(8th Cir., April 2, 1979). See alsoAmerican Petroleum Institute v. EPA,540 F.2d 1023 (loth Cir. 1976); CPCInternational Inc. v. Train, 540 F.2d 1320(8th Cir. 1976); FMC Corp. v. Train, 539F.2d 973 (4th Cir. 1976).

An upset is an unintentional episodeduring which effluent limits areexceeded; however, a bypass is an actof intentional noncompliance duringwhich wastewater treatment facilitiesare circumvented in emergencysituations. We have, in the past,included bypass provisions in NPDESpermits.

EPA has determined that both upsetand bypass provisions should beincluded in NPDES permits and haspromulgated NPDES regulations whichinclude upset and bypass permitprovisions. (See 40 CFR 122741, 45 FR14166 (April 1, 1983].] The upsetprovision establishes an upset as anaffirmative defense to prosecution forviolation of technology-based effluentlimitations. The bypass provisionauthorizes bypassing to prevent loss oflife, personal injury, or severe propertydamage. Consequently, althoughpermittees-in the pharmaceuticalmanufacturing industry will be entitledto the upset and bypass provisionsincorporated into NPDES permits, thisregulation does not address these issues.

XI. Variances and ModificationsThe BPT and BAT effluent limitations

and NSPS contained in this regulationmust be applied in all Federal and StateNPDES permits issued to directdischargers in the pharmaceuticalindustry. In addition, the pretreatmentstandards are directly applicable to anyindirect dischargers.

For the BPT effluent limitations, theonly exception to the binding limitationsis EPA's "fundamentally differentfactors" variance. (See E. I duPont deNemours and Co. v. Train, 430 U.S. 112(1977); Weyerhaeuser Co. v. Castle,supra.) This variance recognizes factorsconcerning a particular dischargerwhich are fundamentally different fromthe factors considered in thisrulemaking. Although this varianceclause was set forth in EPA's 1973 to1976 regulations for specific industries, itis now included in the general NPDESregulations and will not be included inthe specific pharmaceutical industryregulations. (See the NPDES regulations

at 40 CFR Part 125, Subpart D.) The BATlimitations in this regulation are alsosubject to EPA's "fundamentallydifferent factors" variance.

Indirect discharges subject to PSESand PSNS are eligible for credits fortoxic pollutants removed by POTWs.See 40 CFR 403.7; 48 FR 9404 (Jamiary28, 1981). New sources are not eligiblefor any other statutory or regulatorymodification. See E. L duPont deNemours & Co. v. Train, supra.

Indirect dischargers subject to PSEShave, in the past, been eligible for the"fundamentally different factors" (FDF)variance. See 40 CFR 403.13. However,on September 20, 1983, the U.S. Court ofAppeals for the Third Circuit held that"FDF variances for toxic pollutants areforbidden by the Act," and remanded§ 403.13 to EPA. National Association ofMetal Finishers, et al. v. EPA, Nos.'79-2256 et al. (3d Circuit, September 20,1983). EPA is considering the effect ofthat decision.

In a few cases, information whichwould affect these PSES may not havebeen available to EPA or affectedparties in the course of this rulemaking.As a result, it may be appropriate toissue specific categorical standards forsuch facilities, treating them as aseparate subcategory with more, or less,stringent standards as appropriate. Thiswill only be done if a different stahdardis appropriate because of unique aspectsof the factors listed in Section304(b)(2)(B) of, the Act: the age of.equipment and facilities involved, theprocess employed, the engineeringaspects of applying control techniques,non-water quality environmentalimpacts (including energy requirements],or the cost of required effluentreductions (but uot of ability to pay thatcost].

Indirect dischargers and otheraffected parties may petition theAdministrator to examine those factorsand determine whether these PSES areproperly applicable in specific cases orshould be revised. Such petitions mustcontain specific and detailed supportdata, documentation, and evidenceindicating why the relevant factorsjustify a more, or less, stringentstandard, and must also indicate whythose factors could not have beenbrought to the attention of the Agency inthe course of this rulemaking. TheAdministrator will consider suchrulemaking petitions and determinewhether a rulemaking should beinitiated.

XII. Implementation of Limitations andStandards

A. Relationship to NPDES Permits

The BPT and BAT limitations andNSPS in this regulation will be appliedto individual pharmaceutical plantsthrough NPDES permits issued by EPAor approved state agencies, underSection 402 of the Act. As discussed inthe preceding section of this preamble,these limitations must be applied in allFederal and State NPDES permitsexcept to the extent that variances andmodifications are expressly authorized.Other aspects of the interaction betweenthese limitations and NPDES permits arediscussed below.

One issue that warrants considerationis the effect of this regulation on thepowers of NPDES permit-issuingauthorities. The promulgation of thisregulation does not restrict the power ofany permitting authority to act in anymanner consistent with law or these orany other EPA regulations, guidelines, orpolicy. For example, even if thisregulation does not control a particularpollutant, the permit issuer may stilllimit such pollutant on a case-by-casebasis when limitations are necessary tocarry out the purposes of the Act. Inaddition, to the extent that state waterquality standards or other provisions ofState or Federal law require limitationof pollutants not covered by thisregulation (or require more stringentlimitations on covered pollutants), suchlimitations must be applied by thepermit issuing authority.

A second topic that warrantsdiscussion is the operation of EPA'sNPDES enforcement program, manyaspects of which were considered indeveloping this regulation. Weemphasize that although the CleanWater Act is a strict liability statute, theinitiation of enforcement proceedings byEPA is discretionary. We have exercisedand intend to exercise that discretion ina manner that recognizes and promotesgood-faith compliance efforts.

B. Indirect Dischargers

For indirect dischargers, PSES andPSNS are implemented under NationalPretreatment Program proceduresoutlined in 40 CFR 403. The table belowmay be of assistance in resolvingquestions about the operation of thatprogram. A brief explanation of some ofthe submissions indicated on the tablefollows.

A "request for categorydetermination" is a written request,submitted by an indirect discharger orits POTW, for a determination of whichcategorical pretreatment standard

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49818 Federal Register / Vol. 48, No. 209 / Thursday, October 27, 1983 I Rules and Regulations

applies to the indirect discharger. Thisassists the indirect discharger inknowing which PSES or PSNS limits itwill be required to meet. See 40 CFR403.6(a).

A "baseline monitoring report" is thefirst report an indirect discharger mustfile following promulgation of anapplicable standard. The baseline reportincludes an identification of the indirectdischarger, a description of itsoperations, a report on the flows ofregulated streams.and the results ofsampling analyses to determine levels ofregulated pollutants in those streams, astatement of the discharger'scompliance or noncompliance with thestandard, and a description of anyadditional steps required to achievecompliance. See 40 CFR 403.12(b).

A "report on compliance" is requiredof each indirect discharger within 90days following the date for compliancewith an applicable categoricalpretreatment standard. The report mustindicate the concentration of all

regulated pollutants in the facility'sregulated process wastestreams; theaverage and maximum daily flows of theregulated streams; and a statement ofwhether compliance is consistentlybeing achieved, and if not, whatadditional operation and maintenanceand/or pretreatment is necessary toachieve compliance. See 40 CFR403.12(d).

A "periodic compliance report" is areport on continuing compliance with allapplicable categorical pretreatmentstandards. It is submitted twice per year(June and December) by indirectdischargers subject to the standards.The report shall provide theconcentrations of the regulatedpollutants in its discharge to the POTW,the average and maximum daily flowrates of the facility, the methods used bythe indirect discharger to sample andanalyze the data, and a certification thatthese methods conform to the methodsoutlined in the regulations. See 40 CFR403.12(e).

INDIRECT DISCHARGES SCHEDULE FOR SUBMITTAL AND COMPLIANCE

Item event Applicable Date or time Measured Item submitted to'sources period

Request for category determi. Existing .............. 60 days ................. From effective of standard, or Director.nation, from Development document

availability.N ew ................... (') ..........................

Baseline monitoring report .......... All ...................... 180 days ............ From effective date of stand- Control authority.,ard or Final decision on cat-egory determination.

Report on compliance ................. Existing ............. 90 days ................ From date for final compliance.. Control authority.:'New .................. 90 days ................ From commencement dis-

charge to POTW,Periodic compliance reports . All ....................... June and Control authority."

December.

Director = (a) Chief Administrative Officer of a State water pollution control agency with an approved pretreatmentprogram; or (b) EPA Regional Water Division Director, if State does not have an approved pretreatment program.

Prior to commencement of discharge to POTW.Control Authority = (a) POTW if its pretreatment program has been approved: or (b) Director of State water pollution

control agency with an approved pretreatment program or (c) EPA Regional Administrator, if State does not have an approvedpretreatment program.

XIII. Public Participation-Responses toMajor Comments

Numerous agencies and groups haveparticipated in this study of thepharmaceutical industry. The Agencysolicited comments on the proposedrules and on the Development Documentand the economic analysis supportingthe proposal.

The comment period ended onJanuary 25, 1983. Comments weresubmitted by one trade association, 11individual companies, one state agency,two municipalities, and one engineeringconsultant representing industrialclients.

The Agency held a public hearing onthe proposal on January 17, 1983, inWashington D.C. A Technical Workshopwas held on January 18, 1983, inWashington, D.C.

Individual public comments receivedon the proposed regulation and ourresponses are presented in a report,"Summary of Comments and Responseson the November 1982 ProposedRegulations for the PharmaceuticalIndustry," September 1982, which is partof the public record of this rulemaking.A summary of the major comments thatare not discussed elsewhere in thispreamble and the Agency's responsesfollow.

1. Comment: Effluent limitationsshould be in the form of treatmentremoval efficiencies or mass limits ofpollutants with concentration limitationsbeing required only in specific cases atthe discretion of the local permit writerwhere the receiving water quality maybe a limiting factor.

Response: Effluent limitationsguidelines can be in the form of percent

reduction, concentration, or production-based mass limitations. Limitations canbe based solely on the performance ofapplicable treatment technologies.However, when the availableproduction dataJor an industrialcategory or subcategory can becorrelated with pollutant discharges,EPA can develop mass limitations basedon both treatment technologyperformance and production. This latterapproach, however, is not appropriatefor the pharmaceutical manufacturingpoint source category because of thelarge number of different productsinvolved, the constantly changing natureof the product mix, and the lack of anestablished correlation betweenpollutant discharge and production. Thedevelopment of percent reductionlimitations requires that influent as wellas effluent data descriptive of treatmenttechnology performance be availablewhereas concentration limitationsrequire only that effluent data beavailable. Oftentimes, influent datarelating to treatment systemperformance is either not available or isconsiderably less extensive anddescriptive than the effluent data. Bothof these considerations influenced theAgency's decision to proposeconcentration-based limitations for thepharmaceutical industry.

Effluent limitations guidelineswhether in the form of percentreduction, concentration, or production-based mass limits are to be used byNPDES permit writers in developingminimum permit requirements.Generally, effluent limitations areconverted into mass limitations bypermit writers. Permit writers mayincorporate more stringent limits such asthose required by water qualityconsiderations, but in no case may thepermit limits be less stringent (i.e., allowa greater pollutant discharge) than thosethat are indicated by an applicabletechnology-based effluent limitationsguideline.

2. Comment: On June 8, 1982, EPAissued a final rulemaking whichmodified effluent limitations guidelinesfor pH for all industrial dischargers. Thefinal rule required compliance 99percent of the time and limitedindividual excursions to 60 minutes. Webelieve that EPA has inadvertentlyfailed to include this change in theproposed pharmaceutical guidelines andtherefore request EPA to incorp6ratethis change into the guidelines.

Response: The applicability of thefinal rule cited.by the commenter (see 47FR 34534-34537, June 4, 1982) iscontingent on whether a permittee isrequired, or has the option, to monitor



continuously the pH of its wastewateras specified by the conditions of thepermittee's National Pollutant DischargeElimination System (NPDES) permit. Ifthe industrial discharger's NPDESpermit does not contain a requirementor an option for the permittee to monitorpH continuously, then the monthly andindividual excursion limitations of thatrule are not applicable. Thus, the ruleapplies only to those industrialdischargers with an NPDES permitrequirement or option to monitorcontinuously the pH of theirwastewater. The modified pH rule forcontinuous monitoring is currentlyapplicable to permittees having thisrequirement or option (see 40 CFR401.17). It is not necessary that thismodified rule be explicitly stated in allcategorical regulations.

3. Comment: Several commentersrequested additional time to commenton the grounds that EPA, in theseproposed rules and accompanyingdocuments, has for the first timereleased substantial portions of theinformation on which certain of theproposed rules are based, and hasmaterially revised other portions of theinformation on which other portions ofthe proposed rules are based.

Response: After consideration of theamount and complexity of the newinformation released in the proposedrulemaking and the fact that all of theinformation supporting the proposedregulations was available to the publicat the time that the proposed regulationswere published in the Federal Register,we concluded that a 60-day commentperiod was an adequate time period forcommenting on the proposedregulations. The Agency has allowedextensions of comment periods on someproposal regulations due to certainspecial circumstances surrounding thoserulemakings. However, no suchcircumstances were present in thepharmaceutical rulemaking. Therefore,the Agency concluded that an extensionof the comment peiod for thisrulemaking was not appropriate.

EPA-received several comments afterthe close of the official comment period.The Agency has evaluated andresponded to these comments.

4. Comment: One commenter statedthat TSS limits are inappropriate forplants discharging to rivers, such as theMississippi, presumably because'theyare naturally turbid. The commenterrecommended that permit writers beallowed to disregard or modify TSSlimitations.

Response: We have not made any,changes in response to this comment.Section 304 of the Act requires thateffluent limitations guidelines be based

on the application of control andtreatment technology. EPA may notconsider receiving water quality indeveloping such guidelines. Accordingly,BPT TSS limitations are based on theapplication of currently availabletechnology, not on water qualityconsiderations. Since receiving waterquality is not a factor which isconsidered in establishing categoricallimitations, it follows that it cannot beconsidered by the permit writer as abasis for a fundamentally differentfactors (FDF) variance.

5. Comment. One commenter objectedto the fact that "new sources" weredefined in terms of plants whoseconstruction commences after proposalof a new source performance standard,rather than after final promulgatih. Thecommenter noted that there may bechanges in the standard betweenproposal and final promulgation.

Response: The definition of "newsource" in Appendix A to the proposalis a shortened version of the definitionof new source established in EPA'sNPDES permit regulations (40 CFR 122.2,April 1, 1983, 48 FR 14146). To avoidconfusion, we have revised the.definition in Appendix A.

6. Comment: Since regulationscontrolling the discharge of BOD5 areincluded in the proposed regulation, wequestion the need for COD limitations.What additional pollutants is EPA tryingto'control with COD limitations? Weconsider these limitations to beduplicative in nature and unwarranted.

Response: Many materials that aremeasured as or contribute to CODbiodegrade slowly or not at all, whilethose materials which contribute toBOD5 are, by definition, biodegradable.Removal of COD in a biologicaltreatment system is accomplished tosome extent by biodegradation but alsoby incidental removal mechanisms suchas air stripping and sorption. Since theextent to which any of thesemechanisms operates to remove CODdepends in part on the size of thebiological treatment system, anyincrease in the capacity of a biologicaltreatment system should result ingreater removal of these materials. TheAgency recognizes that there are alsosome pollutants measured by COD, suchas salts and some solvents, which do notbiodegrade.

The 1976 BPT regulation requires allsubcategories to achieve a 74 percentreduction of COD from raw waste levelsand, in addition, specifies that separablesolvents be removed by in-plant controlmethods prior to measurement of rawwaste COD levels. The purpose of theexisting BPT COD limitations is to limitthe discharge of those materials which

biodegrade slowly or not at all by firstprohibiting the inclusion of certain non-biodegradable materials (e.g., somesolvents] in raw waste streams and byaccounting for the incidental removal ofCOD that occurs in biological treatmentsystems. More stringent BAT limitationsand NSPS for COD based on add-onbiological treatment were included inthe proposed regulation of November 26,1982. We intend to issue final BATlimitations and NSPS for COD for allsubcategories after reviewing additionaldata on the pollutants which constituteCOD in pharmaceutical plants and onthe cost of their removal. The Agencycontinues to believe that limitationscontrolling the discharge of COD areappropriate and not duplicative innature.

7. Comment: EPA has proposed toapply broad categorical limits for anindividual pollutant, cyanide, that maybe present in only a few operations. Byproposing a limit for cyanide, EPA willrequire all pharmaceutical plants toexpend resources -to monitor for cyanidewhether or not cyanide is used orgenerated in themanufacturing process.At a minimum, EPA's action will forcecertain dischargers to request afundamentally different factors (FDF)variance at the time of permit re-issuance to avoid unnecessarymonitoring requirements.

Response: EPA agrees with thecommenter that if cyanide is not used orgenerated in the manufacturing process,dischargers should not be required tomonitor for cyanide. Therefore, the finalregulations allow facilities not using orgenerating cyanide to certify to thateffect instead of monitoring for cyanide.Permit issuing authorities may find itnecessary to require that specificmonitoring programs be instituted atindividual plants if cyanidecontamination is suspected.

XIV. Availability of TechnicalInformation

The basis for this regulation isdetailed in four major documents.Analytical methods are discussed inSampling and Analysis Procedures forScreening of Industrial Effluents forPriority Pollutants (U.S. EPA, April1977). EPA's technical conclusions aredetailed in Development Document forEffluent Guidelines, New SourcePerformance Standards, andPretreatment Standards for thePharmaceutical Manufacturing PointSource Category (USEPA, September1983). The Agency's economic analysisis presented in Economic Analysis ofEffluent Standards and Limitations forthe Pharmaceutical Industry (USEPA,


September 1983). A summary of thepublic comments received on theproposed regulation is presented in areport "Summary of Responses toComment on the ProposedPharmaceutical Manufacturing IndustryRegulations," which is a part of thepublic record for this regulation. OnNovember 28, 1983, copies of thetechnical development document andthe economic analysis will be availablefor public review in EPA's PublicInformation Reference Unit, Room 2404(Rear) in the EPA Library, 401M Street,SW., Washington, D.C. Copies of thetechnical and economic documents mayalso be obtained from the NationalTechnical Information Service (NTIS),Springfield, Virginia 22161, (703) 487-4600. A notice will be published in theFederal Register announcing theavailability of these documents fromNTIS. (This should occur on or beforeDecember 27, 1983).

Additional information concerning theeconomic impact analysis may beobtained from Mr. Joseph Yance,Economic Analysis Staff (WH-586), U.S.Environmental Protection Agency, 401 MStreet, SW., Washington, D.C. 20460 orby calling (202) 382-5397. Technicalinformation may be obtained by writingto Dr. Frank Hund, Effluent GuidelinesDivision (WH-552), U.S. EnvironmentalProtection Agency, 401 M Street, SW.,Washington, D.C. 20460 or by calling(202) 382-7182.

XV. Office of Management and Budget(OMB) Review

This notice was submitted to theOffice of Management and Budget forreview as required by Executive Order12291. Any commments from OMB toEPA and any EPA response to thosecomments are available for publicinspection through contacting Dr. FrankHund at the address listed at thebeginning of this notice.

This regulation contains provisions in§ § 439.14-439.17, 439.24-439.27, 439.34-439.37, and 439.44-439.47 which allowfacilities not using or generating cyanideto certify to that effect instead ofmonitoring for cyanide. The informationcollection requirements in ths rule havebeen submitted to OMB underprovisions of the Paperwork ReductionAct of 1980, 44 U.S.C. 3501 et seq. Theyare not effective until OMB approvesthem and a technical amendment to thateffect is published in the FederalRegister.

XVI. List of Subjects in 40 CFR Part 439

Drugs, Waste treatment and disposal,Water pollution control.

Dated: September 30, 1983.William D. Ruckelshaus,Administrator.

Appendix A-Abbreviations, Acronyms,and Other Terms Used in this Notice

Act-The Clean Water Act.Agency-The U.S. Environmental

Protection Agency.BAT-The best available technology

economically achievable, under Section304(b)(2)(B) of the Act.

BCT-The best conventional pollutantcontrol technology, under Section304(b)(4) of the Act.

BMP-Best management practices,under Section 304(e) of the Act.

BPT-The best practicable controltechnology currently available, underSection 304(b)(1) of the Act.

Clean Water Act-The Federal WaterPollution Control Act Amentments of1972 (33 U.S.C. 1251 et seq.), as amendedby the Clean Water Act of 1977 (Pub. L.95-217).

Direct D.'ischarger-A facility wherewastewaters are discharged or may bedischarged into waters of the UnitedStates.

Indirect Discharger-A facility wherewastewat4rs are discharged or may bedischarged into a publicly ownedtreatment works.

New Sources-Industrial facilitieswhich are "new sources" under thedefinition in Section 306 of the Act.

NPDES Permit-A National PollutanfDischarge Elimination System permitissued under Section 402 of the Act.

NSPS-New source performancestandards, under Section 306 of the Act.

POTW or POTWs-Publicly ownedtreatment works.

PSES-Pretreatment standards forexisting sources of indirect discharges,under Section 307(b) of the Act.

PSNS-Pretreatment standards fornew sources of indirect discharges,under Section 307 (b) and (c) of the Act.

RCRA-Resource Conservation andRecovery Act (Pub. L. 94-580) of 1976, asamended, 42 U.S.C. 6901 et seq. .

Appendix B-Toxic Pollutants NotDetected in the Effluent of DirectDischargers

acenaphtheneacrylonitrilebenzidine1,1-dichloroethane1,2,4-trichlorobenzenehexachlorobenzenehexachloroethane1,1,2-trichlordethane1,1,2,2-tetrachloroethanechloroethanebis(2-chloroethyl) ether2-chloroethyl vinyl ether2-chloronapthalene

2,4,6rtrichlorophenolparachlorometa cresol2-chlorophenol1,3-dichlorobenzene1,4-dichlorobenzene3,3'-dichlorobenzidine1,1-dichloroethylene1,2-trans-dichloroethylene2,4-dichlorophenol1,2-dichloropropane1,3-dichloropropylene2,4-dinitrotoluene2,4-dimethyl phenol2,6-dinitrotoluene1,2-diphenlhydrazinefluoranthene4-chlorophenyl phenyl ether4-bromophenyl phenyl etherbis(2-chloroethoxy) methanemethyl bromidedichlorobromomethanechlorodibromethanehexachlorobutadienehexachlorocyclopentadieneisophoronenaphthalenenitrobenzene2-nitrophenol4,6-dinitro-o-cresolN-nitrosodimethylamineN-nitrosodiphenylamineN-nitrosodi-n-propylaminepentachlorophenolbutyl benzyl phthalatedi-n-octyl phthalatedimethyl phthalatebenzo(a)anthracenebenzo(ajpyrene -3,4-benzofluoranthenebenzo(k)fluoranthanechryseneacenaphthyleneanthracenebenzo(ghi)perylenefluorenephenanthrenedibeiizo[a,h)anthraceneindeno(1,2,3-c,d)pyrenepyrenealdrindieldrinchlordane4,4'-DDT4,4'-DDE4,4'-DDDalpha-endosulfanbeta-endosulfanendosulfan sulfateendrinendrin aldehydeheptachlorheptachlor epoxidealpha-BHCbeta-BHCgamma-BHC (lindane)delta-BHCPCB-1242PBC-1254

No. 209 / Thursday, October 27, 1983 / Rules and Regulations49820 Federal Register / Vol. 48,


PCB-1221PCB-1232PCB-1248PCB-1260PCB-1016toxapheneasbestos (fibrous)beryllium (total)2,3,7,8-tetrachloro-dibenzo-p-dioxin

(TCDD)

Appendix C-Toxic Pollutants Detectedin-Treated Effluents of DirectDischargers: (1) From a Small Number ofSources, (2) Detected in Only TraceAmounts, (3) Sufficiently Controlled byExistingTechnologies, or (4) Detected inAmounts Too Small to be EffectivelyControlled by Technologies Known tothe Administrator

Pollutant and basis for exclusion

A cro lein ............................................................ 1B enzene ............................................................ 3Brom oform ....................................................... 1Carbon tetrachloride .................................... 2

.1,2-dichloroethane .......................................... 31,1,1-trichloroethane .................. 3C hloroform ...................................................... 3Ethylbenzene .................................................. 3Bis(2-chloroisopropyl) ether ......................... 1M ethyl chloride .............................................. 34-nitrophenol ................................................. 32,4-dinitrophenol ............................................. 3Ph enol ............................................................... 3Bis(2-ethylhexyl) phthalate .......................... 4Di-n-butyl phthalate .................. 4Diethyl phthalate .......................................... 4Tetrachloroethylene ...................................... 2T oluene ............................................................ 3Trichloroethylene ......................................... 3V inyl chloride ................................................ 2A ntim ony ......................................................... 'A rsenic ............................................................ 4C adm ium ......................................................... 4C hrom ium ...................................................... 4C opper .............................................................. 4Lead .................................................................. 4M ercury ............................................................ 4N ickel ............................................................... 4Selenium : ......................................................... 4S ilver ............................................................. .. 4T hallium ..... : ..................................................... 4Z inc ............................................................... .. 4

Appendix D-Toxic Pollutants NotDetected in the Effluent of IndirectDischargers

acenaphthenebenzidine1,2,4-trichlorobenzenehexachlorobenzenehexachloroethane1,1,2-trichloroethane1,1,2,2-tetrachloroethanechloroethanebis(2-chloroethyl) ether2-chloroethyl ether2-chloronapthalene2,4,6-trichlorophenol

parachlorometa cresol2-chlorophenol1,3-dichlorobenzene1,4-dichlorobenzene3,3'-dichlorobenzidine2,4-dichlorophenol1,2-dichloropropane1,3-dichloropropylene2,4-dinitrotoluene2,6-dinitrotolueneI,2-diphenlhydrazinefluoranthene4-Chlorophenyl phenyl ether4-bromophenyl phenyl etherbis(2-chloroethoxy) methanemethyl bromidedichlorobromomethanechlorodibromethanehexachlorobutadienehexachlorocyclopentadieneisophoronenaphthalenenitrobenzene4-nitrophenol2,4-dinitro phenol4,6-dinitro-o-cresolN-nitrosodi-n-propylaminepentachlorophenolbutyl benzyl phthalatedi-n-octyl phthalatedimethyl phthalatebenzo(a)anthracenebenzo(a)pyrene3,4-benzofluoranthenebenzo(k)fluoranthanechryseneacenaphthyleneanthracenebenzo(ghi)perylenephenanthrenedibenzo(a,h)anthraceneindeno (1,2,3-c,d)pyrenepyrenealdrindieldrinchlordance4,4'-DDT4,4'-DDE4,4'-DDDalpha-endosulfanbeta-endsulfanendosulfan sulfateendrinendrin aldehydeheptachlorheptachlor epoxidealpha-BHCbeta-BHCgamma-BHC (lindane)delta-BHCPCB-1242PCB-1254PCB-1221PCB-1232PCB-1248PCB-1260PCB-1016toxapheneasbestos (fibrous)

beryllium2,3,7,8-tetrachloro-dibenzo-p-dioxin

(TCDD)

Appendix E-Toxic Pollutants Detectedin the Effluent of Indirect DischargersWhose Toxicity and Amount (TakenTogether) Are So Insignificant As NotTo Justify Developing PretreatmentRegulations*acrolein

*acrylonitrile

benzene*carbon tetrachloride*chlorobenzene

methyl chloride1,2-dichlorobenzene*1,2-dichloroethane*1,1, 1-trichloroethane*1,1-dichloroethane*ll-dichloroethylene*1,2-trans-dichloroethylene*ethylbenzene*bromoform*tetrachloroethylene

toluene* trichloroethylene

2,4-dimethylphenol2-nitrophenolN-nitrosodiphenylaminephenolbis(2-ethyl hexyl) phthalatediethyl phthalatefluoreneantimonyarseniccadmiumchromiumcopperleadmercurynickelseleniumsilverthalliumzinc

*Volatile organics identified at proposal aspotential candidates for categoricalpretreatment standards (47 FR 53584).

Part 439 of Title 40 is revised to readas follows:

PART 439-PHARMACEUTICALMANUFACTURING POINT SOURCECATEGORY

General Provisions

Sec.439 Applicability.439.1 General definitions.439.2 Monitoring requirements.

Subpart A-Fermentation ProductsSubcategory439.10 Applicability; description of the

fermentation products subcategory.439.11 Specialized definitions.439.12 Effluent limitations representing the

degree of effluent reduction attainable by

49822 Federal Register / Vol. 48, N.29ITusaOtbr2,18 ue n euain

Sec.the application of the best practicablecontrol technology currently available(BPT).

439.13 Effluent limitations representing thedegree of effluent reduction attainable bythe application of the best conventionalpollutant control technology (BCT).[Reserved]

439.14 Effluent limitations representing thedegree of effluent reduction attainable bythe application of the best availabletechnology economically achievable(BAT).

439.15 New source performance standards(NSPS).

439.16 Pretreatment standards for existingsources (PSES):

439.17 Pretreatment standards for newsources (PSNS).

Subpart B-Extraction ProductsSubcategory439.20 Applicability; description of the

• extraction products subcategory.439.21 Specialized definitions.439.22 Effluent limitations representing the

degree of effluent reduction attainable bythe application of the best practicablecontrol technology currently available(BPT).

439.23 Effluent limitations representing thedegree of effluent reducton attainable bythe application of the best conventionalpollutant control technology (BCTJ.[Reserved]



439.26 Pretreatment standards for existingsources (PSES).

439.27 Pretreatment standards for newsources (PSNS).

Subpart C-Chemical Synthesis ProductsSubcategory

439.30 Applicability; description of thechemical synthesis products subcategory.

439.31 Specialized definitions.439.32 Effluent limitations representing the

degree of effluent reduction attainable bythe application of the best practicablecontrol technology currently available(BPT].

439.33 Effluent limitations representing thedegree of effluent reduction attainable bythe application of the best conventionalpollutant control technology (BCT).[Reserved]

439.34 Effluent limitations representing thedegree of effluent reduction attainable by"the application of the best availabletechnology economically achievable(BAT).

439.35 New source performance standards(NSPS}.


439.37 Pretreatment standards for newsources (PSNS}.

Subpart D-Mixing/Compounding andFormulation Subcategory

Sec..439.40 Applicability; description of the

mixing/compounding and formulationsubcategory.


degree of effluent reduction attainable bythe application of the best practicablecontrol technology currently available(BPT).

439.43 Effluent limitations representing thedegree of effluent reduction attainable bythe application of the best conventionalpollutant control technology (BCT].[Reserved]




439.47 Pretreatment standards for newsources (PSNS].

Subpart E-Research Subcategory

439.50 Applicability; description of theresearch subcategory.


degree of effluent reduction attainable bythe application of the best'practicablecontrol technology currently available(BPT).

439.53 Effluent limitations representing thedegree of effluent reduction attainable bythe application of the best conventionalpollutant control technology (BCT].[Reserved]

439.54 Effluent limitations representing thedegree of effluent reduction attainable bythe application of the best availabletechnology economically achievable(BAT). [Reserved]

439.55 New source performance standards(NSPS). [Reserved]

439.56 Pretreatment standards for existingsources (PSES). [Reserved)

439.57 Pretreatment standards for newsources (PSNS}. [Reserved]

Authority: Sec. 301, 304 (b), (c), (e), and (g),306 (b) and (c), 307 (b) and (c), and 501 of theClean Water Act (the Federal WaterPollution Control Act Amendments of 1972,as amended by the Clean Water Act of 1977)(the "Act"); 33 U.S.C. 1311, 1314 [b), (c), (e),and (g), 1316 (b) and (c), 1317 (b) and (c), and'1361; 86 Stat. 816, Pub. L. 92-500; 91 Stat. 1567,Pub. L. 95-217. "

General Provisions

§ 439 Applicability.

This part applies to anypharmaceutical manufacturing facilitywhich discharges or may dischargeprocess wastewater pollutants to thewaters of the United States, or whichintroduces or may introduce processwastewater pollutants into a publiclyowned treatment works.

§ 439.1 General definitions.In addition to the definitions set forth

in 40 CFR Part 401, the followingdefinitions apply to this part:

(a) The term "maximum 30 dayaverage" shall mean the maximumaverage of daily values for 30consecutive days.

(b) The term "cyanide destructionunit" shall mean a treatment systemdesigned specifically to remove cyanide.

§ 439.2 Monitoring requirements.Unless otherwise noted, self-

monitoring will be conducted at the finaleffluent discharge point.

Subpart A-Fermentation ProductsSubcategory§ 439.10 Applicability; description of thefermentation products subcategory.

The provisions of this subpart areapplicable to discharges resulting fromthe manufacture of pharmaceuticals byfermentation.

§ 439.11 Specialized definitions.- For the purpose of this subpart:

(a) Except as provided below, the,general definitions, abbreviations, andmethods of analysis set forth in 40 CFRPart 401 and 439.01 shall apply to thissubpart.(b) The term "product" shall mean

pharmaceutical products derived fromfermentation processes.

§ 439.12 Effluent limitations representingthe degree of effluent reduction attainableby the application of the best practicablecontrol technology currently available(BPT).

Except as provided in 40 CFR 125.30through 125.32, any existing point sourcesubject to this subpart must achieve thefollowing effluent limitationsrepresenting the degree of effluentreduction attainable by the applicationof the best practicable controltechnology currently available (BPT).

(a) The following limitations establishthe quantity or quality of pollutants orpollutant properties, controlled by thisparagraph, which may be discharged bya fermentation products plant from apoint source subject to the provisions ofthis paragraph after application of thebest practicable control technologycurrently available:

(1) The allowable effluent dischargelimitation for the daily average mass ofBOD5 in any calendar month shall beexpressed in mass per unit time andshall specifically reflect not less than90% reduction in the long term dailyaverage raw waste content of BOD5multiplied by a variability factor of 3.0.

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(2) The allowable effluent dischargelimitation for the daily average mass ofCOD in any calendar month shall beexpressed in mass per unit time andshall specifically reflect not less than 74percent reduction in the long term dailyaverage raw waste content of CODmultiplied by a variability factor of 2.2.

(3) The long term daily average rawwaste load for the pollutants BOD5 andCOD is defined as the average dailymass of each pollutant discharged in theinfluent to the wastewater treatmentsystem over a 12 consecutive monthperiod within the most recent 36 months,which shall include the greatestproduction effort.

(4) To assure equity in regulatingdischarges from the point sourcescovered by this subpart of the pointsource category, calculation of rawwaste loans of BOD5 and COD for thepurpose of determining NPDES permitlimitations (i.e., the base numbers towhich the percent reductions areapplied) shall exclude any waste loadassociated with separable mycelia andsolvents in those raw waste loads,except that residual amounts of myceliaand solvents remaining after thepractice of recovery and/or separatedisposal or reuse may be included in thecalculation of the raw waste loads.These practices of removal, disposal, orreuse include physical separation andremoval of separable mycelia, recoveryof solvents from waste streams,incineration of concentrated solventwaste streams (including jar stillbottoms), and broth concentration fordisposal other than to the treatmentsystem. This regulation does not prohibitinclusion of such waste in the raw wasteloads in fact, nor does it mandate anyspecific practice, but rather describesthe rationale for determining the permitconditions. These limits may be.achieved by any of several or acombination thereof of programs andpractices.

(5) The pH shall be within the range of6.0-9.0 standard units.

(6) The allowable effluent dischargelimitation for the daily average mass ofTSS in any calendar month shall be 1.7times the flOD5 limitation determined inparagraph (a)(1) of this section.

(7) For those plants using orgenerating cyanide in the manufacturingprocess, the allowable effluentdischarge for cyanide is shown below.

BPT Effluent limitations

Average ofPollutant or pollutant property Maximum for daily values

ayIdy for 30any1 day consecutive

days

Milligrams per liter (mg/I)

Total cyanide ............................... 33.5 9.4

(ii) If all cyanide-containing wastestreams are diverted to a cyanidedestruction unit and the effluent fromthe cyanide destruction unit isdischarged to a biological treatmentsystem, self-monitoring must beconducted after cyanide treatment andbefore dilution with other streams.Alternatively self-monitoring may beconducted at the final effluent dischargepoint, if the daily maximum cyanidelimitation is multiplied by 0.18, themaximum 30 day average cyanidelimitation is multiplied by 0.35, and bothlimitations are adjusted based on thedilution ratio of the cyanide-contaminated waste stream flow to thetotal process wastewater dischargeflow. However, if all cyanide-containingwaste streams are not treated in acyanide destruction unit or if theeffluent from the cyanide destructionunit is not discharged to a biologicaltreatment system, self-monitoring mustbe conducted at the final effluentdischarge point and the daily maximumcyanide limitation must be multiplied by0.18, the maximum 30 day averagecyanide limitation must be multiplied by0.35, and both limitations must beadjusted based on the dilution ratio ofthe cyanide-contaminated waste streamflow to the total process wastewaterdischarge flow. Permittees not using orgenerating cyanide must certify to thepermit-issuing authority that they arenot using or generating this compound.

(b) Dilution to meet the above effluentlimitations may not be practiced.§ 439.13 Effluent limitations representingthe degree of effluent reduction attainableby the application of the best conventionalpollutant control technology (BCT).[Reserved]§ 439.14 Effluent limitations representingthe degree of effluent reduction attainableby the application of the best availabletechnology economically achievable (BAT).

(a) Except as provided in 40 CFR125.30 through 125.32, any existing pointsource subject to this subpart wherecyanide is used or generated in themanufacturing process must achieve' thefollowing effluent limitationsrepresenting the degree of effluentreduction attainable by the application

of the best available technologyeconomically achievable (BAT).(1)

BAT Effluent limitations

Average ofPollutant or pollutant property Maximum for defy values

y for 30any I day consecutivedays


Total cyanide ............... 94............... 33.5 9.4COD ............................................... .C (')

Reserved.

(2) If all cyanide-containing wastestreams are diverted to a cyanidedestruction unit and the effluent fromthe cyanide destruction unit isdischarged to a biological treatmentsystem, self-monitoring must beconducted after cyanide treatment andbefore dilution with other streams.Alternatively, self-monitoring may beconducted at the final effluent dischargepoint, if the daily maximum cyanidelimitation is multiplied by 0.18, themaximum 30 day average cyanidelimitation is multiplied by 0.35, and bothlimitations are adjusted based on thedilution ratio of the cyanide-contaminated waste stream flow to thetotal process wastewater dischargeflow. However, if all cyanide-containingwaste streams are not treated in acyanide destruction unit or if theeffluent from the cyanide destructionunit is not discharged to a biologicaltreatment system, self-monitoring mustbe conducted at the final effluentdischarge point and the daily maximumcyanide limitation must be multiplied by0.18, the maximum 30 day averagecyanide limitation must be multiplied by0.35, and both limitations must beadjusted based on the dilution ratio ofthe cyanide-contaminated waste streamflow to the total process wastewaterdischarge flow. Permittees not using orgenerating cyanide must certify to thepermit-issuing authority that they arenot using or generating this compound.

(b) Dilution in order to meet the aboveeffluent limitations may not bepracticed.§ 439.15 New source performancestandards (NSPS).

(a) The following standards ofperformance establish the quantity orquality of pollutants or pollutantproperties, controlled by this section,which may be discharged by a newsource subject to the provisions of thissubpart.

49824 Federal Register / Vol. 48, No. 209 / Thursday, October 27, 1983 J Rules and Regulations

NSPS

Average ofPollutant or pollutant property Maximum for daily values

ap y day for 30.any I day consecutive

days


Total cyanide .... ............. 33.5 9.4BOD5 ...................... () 11)Tss ............................................... .,(')COD ............................................... ... ( ) (2)pH. ......................... (2) (2)

' Reserved.2 Within the range of 6.0 to 9.0 at all times,

(2) If all cyanide-containing wastestreams are diverted to a cyanidedestruction unit and the effluent fromthe cyanide destruction unit isdischarged to a biological treatmentsystem, self-monitoring must beconducted after cyanide treatment andbefore dilution with other streams.Alternatively, self-monitoring may beconducted at the final effluent dischargepoint, if the daily maximum cyanidestandard is multiplied by 0.18, themaximum 30 day average cyanidestandard is multiplied by 0.35, and bothstandards are adjusted based on thedilution ratio of the cyanide-contaminated waste stream flow to thetotal process wastewater dischargeflow. However, if all cyanide-containingwaste streams are not treated in acyanide destruction unit or if theeffluent from the cyanide destructionunit is not discharged to a biologicaltreatment system, self-monitoring mustbe conducted at the final effluentdischarge point and the daily maximumcyanide standard must be multiplied by0.18, the maximum 30 day averagecyanide standard must be multiplied by0.35, and both standards must beadjusted based on the dilution ratio ofthe cyanide-contaminated waste streamflow to the total process wastewaterdischarge flow. Only facilities wherecyanide is used or generated in themanufacturing process are subject tocyanide standards. Permittees not usingor generating cyanide must certify to thepermit-issuing authority that they arenot using or generating this compound.

(b) Dilution in order to meet the abovestandards may not be practiced.

§ 439.16 Pretreatment standards forexisting sources (PSES).

(a) Except as provided in 40 CFR 403.7and 403.13, any existing source subjectto this subpart that introduces pollutantsinto a publicly owned treatment worksmust comply with 40 CFR Part 403 andby October 27, 1986, where cyanide isused or generated in the manufacturingprocess, must achieve the followingpretreatment standards for existingsources (PSES).

PSES

Average ofPollutant or pollutant property Maximum for daily valuesfor 30an ay consecutive

days


Total cyanide............................... 33.5 9.4

(2) If all cyanide-containing wastestreams are diverted to a cyanidedestruction unit, self-monitoring forcyanide must be conducted aftercyanide treatment and before dilutionwith other streams. Alternatively, self-monitoring may be conducted at thefinal effluent discharge point, if thecyanide standard is adjusted based onthe dilution ratio of contaminated wastestream flow to the total processwastewater discharge flow. However, ifall cyanide-containing waste streamsare not treated, self-monitoring must beconducted at the final effluent dischargepoint and the cyanide standard must beadjusted based on the dilution ratio ofcontaminated waste stream flow to thetotal process wastewater dischargeflow. Indirect dischargers not using orgenerating cyanide must certify to thepublicly owned treatment works thatthey are not using or generating thiscompound.

(b) Dilution in order to meet the abovestandards may not be practiced.§ 439.17 Pretreatment standards for newsources (PSNS).

(a) Except as provided in 40 CFR403.7, any new source subject to thissubpart that introduces pollutants into apublicly owned treatment works mustcomply with 40 CFR Part 403 and wherecyanide is used or generated in themanufacturing process, must achieve thefollowing pretreatment standards fornew sources (PSNS).(1)

PSNS

Average ofPollutant or pollutant property Maximum daily values

for any 1 for 30day consecutive

days


Total Cyanide ................................ 33.5 9.4

(2) If all cyanide-containing wastestreams are diverted to a cyanidedestruction unit, self-monitoring forcyanide must be conducted aftercyanide treatment and before dilutionwith other streams. Alternatively, self-monitoring may be conducted at thefinal effluent discharge point, if thecyanide standard is adjusted based onthe dilution ratio of contaminated wastestream flow to the total process

wastewater discharge flow. However, ifall cyanide-containing waste streamsare not treated, self-monitoring must beconducted at the final effluent dischargepoint and the cyanide standard must beadjusted based on the dilution ratio ofcontaminated waste stream flow. to thetotal process wastewater dischargeflow. Indirect dischargers not using orgenerating cyanide must certify to thepublicly owned treatment works thatthey are not using or generating thiscompound.


Subpart B-Extraction ProductsSubcategory

§ 439.20 Applicability; description of theextraction products subcategory.

The provisions of this subpart areapplicable to discharges resulting fromthe manufacture of pharmaceuticals byextraction.

§ 439.21 Specialized definitions.For the purpose of this subpart:(a) Except as provided below, the

general definitions, abbreviations, andmethods of analysis set forth in 40 CFRPart 401 and 439.01 shall apply to thissubpart.

(b) The term "pioduct" shall meanbiological and natural extractionproducts. This subcategory shall includeblood fractions, vaccines, serums,animal bile derivatives, endocrineproducts, and isolation of medicinalproducts, such as alkaloids, frombotanical drugs and herbs.


Except as provided in 40 CFR 125.30through 125.32, any existing point sourcesubject to this subpart must achieve thefollowing effluent limitationsrepresenting the degree of effluentreduction attainable by the applicati6nof the best practicable controltechnology currently available (BPT).

(a) The following limitations establishthe quantity or quality of pollutants orpollutant properties, controlled by thisparagraph, which may be discharged byan extraction products plant from apoint source subject to the provisions ofthis paragraph after application of thebest practicable control technologycurrently available:(1) The allowable discharge for the

pollutant parameters BOD5 and CODshall be expressed in mass per unit timeand shall represent the specifiedwastewater treatment efficiency in

Federal Register'/ Vol. 48, No. 209 / Thursday, October 27, 1983 / Rules and Regulations 49825

terms of a residual discharge associatedwith an influent to the wastewatertreatment plant corresponding to themaximum production period for a givenpharmaceutical plant as defined inparagraph (a)(4) of this section.

(2) The allowable effluent dischargelimitation for the daily average mass ofBOD5 in any calendar month shallspecifically reflect not less than 90percent reduction in the long term dailyaverage raw waste content of BOD5multiplied by a varialbility factor of 3.0.However, a plant shall not be requiredto attain a maximum 30 day averageBOD5 effluent limitation of less than theequivalent of 45 mg/l.

(3) The allowable effluent dischargelimitation for the daily average mass ofCOD in any calendar month shallspecifically reflect not less than 74percent reduction in the long term dailyaverage raw waste content of CODmultiplied by a variability factor of 2.2.However, a plant shall not be requiredto attain a maximum 30 day averageCOD effluent limitation of less than theequivalent of 220 mg/l.

(4) The long term daily average rawwaste load for the pollutants BOD5 andCOD is defined as the average dailymass of each pollutant discharged in theinfluent to the wastewater treatmentsystem over a 12 consecutive monthperiod within the most recent 36 months,which shall include the greatestproduction effort.

(5) To assure equity in regulatingdischarges from the point sourcescovered by this subpart of the pointsource category, calculation of rawwaste loads of BOD5 and COD for thepurpose of determining NPDES permitlimitations (i.e., the base numbers towhich the percent reductions areapplied) shall exclude any waste loadassociated with solvents in those rawwaste loads, except that residualamounts of solvents remaining after thepractice of recovery and/or separatedisposal or reuse may be included in thecalculation of the raw waste loads.Those practices of removal, disposal, orreuse include recovery of solvents fromwaste streams and incineration ofconcentrated solvent waste streams(including tar still bottoms). This'egulation does not prohibit inclusion ofsuch wastes in the raw waste loads infact, nor does it mandate any specificpractice, but rather describes therationale for determining the permitconditions. These limits may beachieved by any one of several or acombination thereof of programs andpractices.

(6) The allowable effluent dischargelimitation for the daily mass of TSS inany calendar month shall be 1.7 timesthe BOD5 limitation determined inparagraph (a)(2) of this section.

(7] The pH shall be within the range of6.0-9.0 standard units.


i]

BPT effluent limitations

Average ofPollutant of pollutant property Maximum daily values


days


Total cyanide .................................. 33.5 9,4

(ii) If all cyanide-containing wastestreams are diverted to a cyanidedestruction unit and the effluent fromthe cyanide destruction unit isdischarged to a biological treatmentsystem, self-monitoring must beconducted after cyanide treatment andbefore dilution with other streams.Alternatively, self-monitoring may beconducted at the final effluent dischargepoint, if the daily maximum cyanidelimitation is multiplied by 0.18, themaximum 30 day average cyanidelimitation is multiplied by 0.35, and bothlimitations are adjusted based on thedilution ratio of the cyanide-contaminated waste stream flow to thetotal process wastewater dischargeflow. However, if all cyanide-containingwaste streams are not treated in acyanide destruction unit or if theeffluent from the cyanide destructionunit is not discharged to a biologicaltreatment system, self-monitoring mustbe conducted at the final effluentdischarge point and the daily maximumcyanide limitation must be multiplied by0.18, the maximum 30 day averagecyanide limitation must be multiplied by0.35, and both limitations must beadjusted based on the dilution ratio ofthe cyanide-contaminated waste streamflow to the toial process wastewaterdischarge flow. Permittees not using orgenerating cyanide must certify to thepermit-issuing authority that they arenot using or generating this compound.

(b) Dilution to meet the above effluentlimitations may not be practiced.

§ 439.23 Effluent limitations representingthe degree of effluent reduction attainableby the application of the best conventionalpollutant control technology (BCT).[Reserved)

§ 439.24 Effluent limitations representingthe degree of effluent reduction attainableby the application of the best availabletechnology economically achievable (BAT).

(a) Except as provided in 40 CFR125.30 through 125.32, any existing pointsource subject to this subpart wherecyanide is used or generated in themanufacturing process must achieve thefollowing effluent limitationsrepresenting the degree of effluentreduction attainable by the applicationof the best available technologyeconomically achievable (BAT).

(M)

BAT effluent limitations


forany for 30day consecutive

days

Milligrams per litor (mg/I)

Total Cyanide ............................. 33.5 9.4COD ................................................. . . i) ()

Reserved.

(2) If all cyanide-containing wastestreams are diverted to a cyanidedestruction unit and the effluent fromthe cyanide destruction unit isdischarged to a biological treatmentsystem, self-monitoring must beconducted after cyanide treatment andbefore dilution with other streams.Alternatively, self-monitoring may beconducted at the final effluent dischargepoint, if the daily maximum cyanidelimitation is multiplied by 0.18, themaximum 30 day average cyanidelimitation is multiplied by 0.35, and bothlimitations are adjusted based on thedilution ratio of the cyanide-contaminated waste stream flow to thetotal process wastewater dischargeflow. However, if all cyanide-containingwaste streams are not treated in acyanide destruction unit or if theeffluent from the cyanide destructionunit is not discharged to a biologicaltreatment system, self-monitoring mustbe conducted at the final effluentdischarge point and the daily maximumcyanide limitation must be multiplied by0.18, the maximum 30 day averagecyanide limitations must be multipliedby 0.35, and both limitations must beadjusted based on the dilution ratio ofthe cyanide-contaminated waste stream

No. 209 / Thursday, October 27, 1983 / Rules and Regulations

flow to the total process wastewaterdischarge flow. Permittees not using orgenerating cyanide must certify to thepermit-issuing authority that they arenot using or generating this compound.

(b) Dilution in order to meet the aboveeffluent limitations may not bepracticed.

§ 439.25 New source performancestandards (NSPS).


(1)

NSPS



days


Total cyanide .................................. 335 9.4BOD5 ........................................... .. .(i) (1)TSS ............................................... () (1)CO D ............................................. .... ( (i)pH .................................................... (2) (2)

Reserved.Within the range of 6.0 to 9.0 at all times.

(2) If all cyanide-containing wastestreams are diverted to a cyanidedestruction unit and the effluent fromthe cyanide destruction unit isdischarged to a biological treatmentsystem, self-monitoring must beconducted after cyanide treatment andbefore dilution with other streams.Alternatively, self-monitoring may beconducted at the final effluent dischargepoint, if the daily maximum cyanidestandard is multiplied by 0.18, themaximum 30 day average cyanidestandard is multiplied by 0.35, and bothstandards are adjusted based on thedilution ratio of the cyanide-contaminated waste stream flow to thetotal process wastewater dischargeflow. However, if all cyanide-containingwaste streams are not treated in acyanide destruction unit or if theeffluent from the cyanide destructionunit is not discharged to a biologicaltreatment system, self-monitoring mustbe conducted at the final effluentdischarge point and the daily maximumcyanide standard must be multiplied by0.18, the maximum 30 day averagecyanide standard must be multiplied by0.35, and both standards must beadjusted based on the dilution ratio ofthe cyanide-contaminated waste streamflow to the total process wastewaterdischarge flow. Only facilities wherecyanide is used or generated in themanufacturing process are subject tocyanide standards. Permittees not using

or generating'cyanide must certify to thepermit-issuing authority that they arenot using or generating this compound.




(1)

PSES



days


Total Cyanide ................................. 33.5 9.4

(2) If all cyanide-containing wastestreams are diverted to a cyanidedestruction unit, self-monitoring forcyanide must be conducted aftercyanide treatment and before dilutionwith other streams. Alternatively, self-monitoring may be conducted at thefinal effluent discharge point, if thecyanide standard is adjusted based onthe dilution ratio of contaminated wastestream flow to the total processwastewater discharge flow. However, ifall cyanide-oontaining waste streamsare not treated, self-monitoring must beconducted at the final effluent dischargepoint and the cyanide standard must beadjusted based on the dilution ratio ofcontaminated waste stream flow to thetotal process wastewater dischargeflow. Indirect dischargers not using orgenerating cyanide must certify to thepublicly owned treatment works thatthey are not using or generating thiscompound.


§ 439.27 Pretreatment standards for newsources (PSNS).

(a) Except as provided in 40 CFR403.7, any new source subject to thissubpart that introduces pollutants into apublicly owned treatment works mustcomply with 40 CFR Part 403 and wherecyanide is used or generated in themanufacturing process, must achieve thefollowing pretreatment standards fornew sources (PSNS).

PSES



days


Total Cyanide ................................. 33.5 9.4

(2) If all cyanide-containing wastestreams are diverted to a cyanidedestruction unit, self-monitoring forcyanide must be conducted aftercyanide treaiment and before dilutionwith other streams. Alternatively, self-monitoring may be conducted at thefinal effluent discharge point, if thecyanide standard is adjusted based onthe dilution ratio of contaminated wastestream flow to the total processwastewater discharge flow. However, ifall cyanide-containing waste streamsare not treated, self-monitoring must beconducted at the final effluent dischargepoint and the cyanide standard must beadjusted based on the dilution ratio ofcontaminated waste stream flow to thetotal process wastewater dischargeflow. Indirect dischargers not using orgenerating cyanide must certify to thepublicly owned treatment works thatthey are not using or generating thiscompound.


Subpart C-Chemical SynthesisProducts Subcategory

§ 439.30 Applicability; description of thechemical synthesis products subcategory.

The provisions of this subpart areapplicable to discharges resulting fromthe manufacture of pharmaceuticals bychemical synthesis.


general definitions, abbreviations, andmethods of analysis set forth in 40 CFR401 and 439.01 of this chapter shallapply to this subpart.

(b) The term "product" shall meanpharmaceutical products derived fromchemical synthesis processes. ,

§ 439.32 Effluent limitations representingthe degroe of effluent reduction attainableby the application of the best practicablecontrol technology currently available(BPT).

Except as provided in 40 CFR 125.30through 125.32, any existing point sourcesubject to this subpart must achieve thefollowing effluent limitationsrepresenting the degree of effluentreduction attainable by the application

I I

49826 Federal Register / Vol. 48,


of the best practicable controltechnology currently available (BPT).

(a) The following limitations establishthe quantity or quality of pollutants orpollutant properties, controlled by thisparagraph, which may be discharged bya chemical synthesis plant from a pointsource subject to the provisions of thisparagraph after application of the bestpracticable control technology currentlyavailable:

(1) The allowable discharge for thepollutant parameters BOD5 and CODshall be expressed in mass per unit timeand shall represent the specifiedwastewater treatment efficiency interms of a residual discharge associatedwith an influent to the wastewatertreatment plant corresponding to themaximum production period for a givenpharmaceutical plant as defined inparagraph (a)(4) of this section.

(2) The allowable effluent dischargelimitation for the daily average mass ofBOD5 in any calendar month shallspecifically reflect not less than 90percent reduction in the long term dailyaverage raw waste content of BOD5multiplied by a variability factor of 3.0.

(3) The allowable effluent dischargelimitation for the daily average mass ofCOD in any calendar month shallspecifically reflect not less than 74percent reduction in the long term dailyaverage raw waste content of CODmultiplied by a variability factor of 2.2.

(4) The long term daily average rawwaste load for the pollutant parametersBOD5 and COD is defined as theaverage daily mass of each pollutantdischarged in the influent to thewastewater treatment system over a 12consecutive month Deriod within themost recent 36 months, which shallinclude the greatest production effort.

(5) To assure equity in regulatingdischarges from the point sourcescovered by this subpart of the pointsource category, calculation of rawwaste loads of BOD5 and COD for thepurpose of determining NPDES permitlimitations (i.e., the base numbers towhich the percent reductions areapplied) shall exclude any waste loada~sociated with solvents in those rawwaste loads, except that residualamounts of solvents remaining after thepractice of recovery and/or separatedisposal or reuse may be included in thecalculation of the raw waste loads.These practices of removal, disposal, orreuse include recovery of solvents fromwaste streams and incineration ofconcentrated solvent waste streams(including tar still bottoms). Thisregulation does not prohibit inclusion ofsuch wastes in the raw waste loads infact, nor does it mandate any specificpractice, but rather describes the

rationale for determining the permitconditions. These limits may beachieved by any one of several or acombination thereof of programs andpractices.

(6) The pH shall be within the range of6.0 to 9.0 standard units.

(7) The allowable effluent dischargelimitation for the daily average mass ofTSS in any calendar month shall be 1.7times the BOD5 limitation determined inparagraph (a)(2) of this section.


(i)




days

Milligrams per liter (mg/'

Total cyanide ................................. . 33-5 9.4

(ii) If all cyanide-containing wastestreams are diverted to a cyanidedestruction unit and the effluent fromthe cyanide destruction unit isdischarged to a biological treatmentsystem, self-monitoring must beconducted after cyanide treatment andbefore dilution with other streams.Alternatively, self-monitoring may beconducted at the final effluent dischargepoint, if the daily maximum cyanidelimitation is multiplied by 0.18, themaximum 30 day average cyanidelimitation is multiplied by 0.35, and bothlimitations are adjusted based on thedilution ratio of the cyanide-contaminated waste stream flow to thetotal process wastewater dischargeflow. However, if all cyanide-containingwaste streams are not treated in acyanide destruction unit or if theeffluent from the cyanide destructionunit is not discharged to a biologicaltreatment system, self-monitoring mustbe conducted at the final effluentdischarge point and the daily maximumcyanide limitation must be multiplied by0.18, the maximum 30 day averagecyanide limitation must be multiplied by0.35, and both limitations must beadjusted based on the dilution ratio ofthe cyanide-contaminated waste streamflow to the total process wastewaterdischarge flow. Permittees not using orgenerating cyanide must certify to thepermit-issuing authority that they arenot using or generating this compound.


§ 439.33 Effluent limitations representingthe degree of effluent reduction attainableby the application of the best conventionalpollutant control technology (BCT).[Reserved]


(a) Except as provided in 40 CFR125.30 through 125.32, any existing pointsource subject to this subpart wherecyanide is used or generated in themanufacturing process must achieve thefollowing effluent limitationsrepresenting the degree of effluentreduction attainable by the applicationof the best available technologyeconomically achievable (BAT).


Average ofPollutant' or pollutant property Mxmm daily values

for any I for 30day consecutive

days


Total cyanide . " . .............. 33.5 9.4COD ................................................ . . (')

Reserved.

(2) If all cyanide-containing wastestreams are diverted to a cyanidedestruction unit and the effluent fromthe cyanide destruction unit isdischarged to a biological treatmentsystem, self-monitoring must beconducted after cyanide treatment andbefore dilution with other streams.Alternatively, self-monitoring may beconducted at the final effluent dischargepoint, if the daily maximum cyanidelimitation is multiplied by 0.18, themaximum 30 day average cyanidelimitation is multiplied by 0.35, and bothlimitations are adjusted based on thedilution ratio of the cyanide-contaminated waste stream flow to thetotal process wastewater dischargeflow. However, if all cyanide-containingwaste streams are not treated in acyanide destruction unit is not 'discharged to a biological treatmentsystem, self-monitoring must beconducted at the final effluent.dischargepoint and the daily maximum cyanidelimitation must be multiplied by 0.18, themaximum 30 day average cyanidelimitation must be multiplied by 0.35,and both limitations must be adjustedbased on the dilution ratio of the cyanide-contaminated waste stream flow to thetotal process wastewater dischargeflow. Permittees not using or generatingcyanide must certify to the permit-issuing authority that they are not usingor generating this compound

Federal Register / Vol. 48,

49828 Federal Register I Vol. 48, No. 209 I Thursday, October 27, 1983 / Rules and Regulations(b) Dilution in order to meet the above

effluent limitations may not bepracticed.



(1}

NSPS



days

Milligrams per liter (mgll)

Total cyanide .................................. 33.5 9.4BOD ......................... () (')TSS.. .......................... (') (')CO D ........... .. ....................... (') (1)pH .............................. .................. . (2) (2)

'Reserved.2 Within the range of 6.0 to 9.0 at all times.

(2) If all cyanide-containing wastestreams are diverted to a cyanidedestruction unit and the effluent fromthe cyanide destruction unit isdischarged to a biological treatmentsystem, self-monitoring must beconducted after Cyanide treatment andbefore dilution with other streams.Alternatively, self-monitoring may beconducted at the final effluent dischargepoint, if the daily maximum cyanidestandard is multiplied by 0.18, themaximum 30 day average cyanidestandard is multiplied by 0.35, and bothstandards are adjusted based on thedilution ratio of the cyanide-contaminated waste stream flow to thetotal process wastewater dischargeflow. However, if all cyanide-containingwaste streams are not treated in acyanide destruction uniteor if theeffluent from the cyanide destructionunit is not discharged to a biologicaltreatment system, self-monitoring mustbe conducted at the final effluentdischarge point and the daily maximumcyanide standard must be multiplied by0.18, the maximum 30 day averagecyanide standard must be multiplied by0.35, and both standards must beadjusted based on the dilution ratio ofthe cyanide-contaminated waste streamflow to the total process wastewaterdischarge flow. Only facilities wherecyanide is used or generated in themanufacturing process are subject tocyanide standards. Permittees not usingor generating cyanide must certify to thepermit-issuing authority that they arenot using or generating this compound.

(b) Dilution in order to'meet the abovestandards may not be practiced.



(1)

PSESMxum Average of

Pollutant or pollutant property Maximum daily valuesfor any I for 30

day consecutivedays


Total Cyanide ................................. 33.5 9.4

(2) If all cyanide-containing wastestreams are diverted to a cyanidedestruction unit, self-monitoring forcyanide must be conducted aftercyanide treatment and before dilutionwith other streams. Alternatively, self-monitoring may be conducted at thefinal effluent discharge point, if thecyanide standard is adjusted based onthe dilution ratio of contaminated wastestream flow to the total processwastewater discharge flow. Howe,,er, ifall cyanide-containing waste streamsare not treated, self-monitoring must beconducted at the final effluent dischargepoint and the cyanide standard must beadjusted based on the dilution ratio ofcontaminated waste stream flow to thetotal process wastewater dischargeflow. Indirect dischargers not using orgenerating cyanide must certify to thepublicly owned treatment Works thatthey are not using or generating thiscompound.



(a) Except as provided in 40 CFR403.7, any new source subject to thissubpart that introduces pollutants into apublicly owned treatment works mustcomply with 40 CFR Part 403 and wherecyanide is used or generated in themanufacturing process, must achieve thefollowing pretreatment standards fornew sources (PSNS).

PSNS

- Average ofPollutant or pollutant property Maximum daily values


days

Milligrams per ther (mg/A)

Total Cyanide ................................. 33.5 9.4

(2) If all cyanide-containing wastestreams are diverted to a cyanidedestruction unit, self-monitoring forcyanide must be conducted aftercyanide treatment and before dilutionwith other streams. Alternatively, self-monitoring may be conducted at thefinal effluent discharge point, if thecyanide standard is adjusted based onthe dilution ratio of contaminated wastestream flow to the total processwastewater discharge flow. However, ifall cyanide-containing streams are nottreated, self-monitoring must beconducted at the final effluent dischargepoint and the cyanide standard must beadjusted based on the dilution ratio ofcontaminated waste stream flow to thetotal process wastewater dischargeflow. Indirect dischargers not using orgenerating cyanide must certify to thepublicly owned treatment works thatthey are not using or generating thiscompound.


Subpart D-Mixing/Compounding andFormulation Subcategory

§ 439.40 Applicability; description of themixing/compounding and formulationsubcategory.

The provisions of this subpart areapplicable to discharges resulting frommixing/compounding and formulatonoperations of pharmaceutical products.


general definitions, abbreviations, andmethods of analysis set forth in 40 CFRPart 401 and 439.01 of this chapter shallapply to this subpart.

(b) The term "product" shall meanproducts from plants which blend, mix,compound, and formulatepharmaceutical ingredients.Pharmaceutical preparations for humanand veterinary use such as ampules,tablets, capsules, vials, ointments,medicinal powders, solutions, andsuspensions are included.





(a) The following limitations establishthe quantity or quality of pollutants orpollutant properties, controlled by thisparagraph, which may be discharged bya mixing/compounding and formulationplant from a point source subject to theprovisions of this paragraph afterapplication of the best practicablecontrol technology currently available:


(2) The allowable effluent dischargelimitation for the daily average mass of

w BOD5 in any calendar month shallspecifically reflect not less than 90percent reduction in the long term dailyaverage raw waste content of BOD5multiplied by a variability factor 3.0.However, a plant shall not be requiredto attain a maximum 30 day averageBOD5 effluent limitation of less than theequivalent of 45 mg/l.

(3) The allowable effluent dischargelimitation for the daily average mass ofCOD in any calendar month shallspecifically reflect not less than 74percent reduction in the long term dailyaverage raw waste content of CODmultiplied by a variability factor of 2.2.However, a plant shall not be requiredto attain a maximum 30 day averageCOD effluent limitation of less than theequivalent of 220 mg/l.

(4) The long term daily average rawwaste load for the pollutant parametersBOD5 and COD is defined as theaverage daily mass of each pollutantdischarged in the influent to thewastewater treatment system over a 12consecutive month period within the.most recent 36 months, which shallinclude the greatest production effort.

(5) To assure equity in regulatingdischarges from the point sourcescovered by this subpart of the pointsource category, calculation of rawwaste loads of BOD5 and COD for the

purpose of determining NPDES perlimitations (i.e., the base numbers towhich the percent reductions areapplied) shall exclude any waste loadassociated with solvents in those rawwaste loads except that residualamounts of solvents remaining after thepractice of recovery and/or separatedisposal or reuse may be included in thecalculation of the raw waste loads.These practice.s of removal, disposal, orreuse include recovery of solvents fromwaste streams and incineration ofconcentrated solvent waste streams(including tar still bottoms). Thisregulation does not prohibit inclusion ofsuch wastes in the raw waste loads infact, nor does it mandate any specificpractice, but rather describes therationale for determining the permitconditions. These limits may beachieved by any one of several or acombination thereof of programs andpractices.

(6) The allowable effluent discharge.limitation for the daily average mass ofTSS in any calendar month shall be 1.7times the BOD5 limitation determined in(2) above.



(i) See table below:

BPT effluent limitations

Average ofPollutant or pollutant property *Maximum daily values


days

Milligrams per liter (mg/l)

Total cyanide ................................ 33.5 9.4

(ii) If all cyanide-containing wastestreams are diverted to a cyanidedestruction unit and the effluent fromthe cyanide destruction unit isdischarged to a biological treatmentsystem, self-monitoring must beconducted after cyanide treatment andbefore dilution with other streams.Alternatively, self-monitoring may beconducted at the final effluent dischargepoint, if the daily maximum cyanidelimitation is multiplied by 0.18, themaximum 30 day average cyanidelimitation is multiplied by 0.35, and bothlimitations are adjusted based on thedilution ratio of the cyanide-contaminated waste stream flow to thetotal process wastewater dischargeflow. However, if all cyanide-containingwaste streams are not treated in acyanide destruction unit or if theeffluent from the cyanide destructionunit is not discharged to a biological

treatment system, self-monitoring mustbe conducted at the final effluentdischarge point and the daily maximumcyanide limitation must be multiplied by0.18, the maximum 30 day averagecyanide limitation must be multiplied by0.35, and both limitations must beadjusted based on the dilution ratio ofthe cyanide-contaminated waste streamflow to the total process wastewaterdischarge flow. Permittees not using orgenerating cyanide must certify to thepermit-issuing authority that they arenot using or generating this compound.




(a) Except as provided in 40 CFR125.30 through 125.32, any existing pointsource subject to, this subpart wherecyanide is used or generated in themanufacturing process must achieve thefollowing effluent limitationsrepresenting the degree of effluentreduction attainable-by the applicationof the best available technologyeconomically achievable (BAT).

(1)




days

Milligrams per litr (ag/)

Total cyanide ........................ ...... 33.5 9.4CO D ............................ ..................... . (') (')

(2) If all cyanide-containing wastestreams are diverted to a cyanidedestruction unit and the effluent fromthe cyanide destruction unit isdischarged to a biological treatmentsystem, self-monitoring must beconducted after cyanide treatment andbefore dilution with other streams.Alternatively, self-monitoring may beconducted at the final effluent dischargepoint, if the daily maximum cyanidelimitation is multiplied by 0.18, themaximum 30 day average cyanidelimitation is multiplied by 0.35, and bothlimitations are adjusted based on thedilution ratio of the cyanide-contaminated waste stream flow to thetotal.process wastewater dischargeflow. However, if all cyanide-containingwaste streams are not treated in a


cyanide destruction unit or if theeffluent from the cyanide destructionunit is not discharged to a biologicaltreatment system, self-monitoring mustbe conducted at the final effluentdischarge point and the daily maximumcyanide limitation must be multiplied by0.18, the maximum 30 day averagecyanide limitation must be multiplied by0.35, and both limitations must beadjusted based on the dilution ratio ofthe cyanide-contaminated waste streamflow to the total process wastewaterdischarge flow. Permittees not using orgenerating cyanide must certify to thepermit-issuing authority that they arenot using or generating this compound.

(b) Dilution in order to meet the aboveeffluent limitations may not bepracticed.



(1)

NSPS

Average ofPollutant or pollutant property Maximum daily valuesfor any I for 30

day consecutivedays


Total cyanide ................................. . 33.5 9.4BOD5 ................... (1)TSS .............................................. ... () ()COD ....................... (.) (I)pH........................................ (1)()

'Reserved.Within the range of 6.0 to 9.0 at all times.

(2) If all cyanide-containing wastestreams are diverted to a cyanidedestruction unit and the effluent fromthe cyanide destruction unit isdischarged to a biological treatmentsystem, self-monitoring must beconducted after cyanide treatment andbefore dilution with other streams.Alternatively, self-monitoring may beconducted at the final effluent dischargepoint, if the daily maximum cyanidestandard is multiplied by 0.18, themaximum 30 day average cyanidestandard is multiplied by 0.35, and bothstandards are adjusted based on thedilution ratio of the cyanide-contaminated waste stream flow to thetotal process wastewater dischargeflow. However, if all cyanide-containingwaste streams are not treated in acyanide destruction unit or if theeffluent from the cyanide destructionunit is not discharged to a biologicaltreatment system, self-monitoring must

be conducted at the final effluentdischarge'point and the daily maximumcyanide standard must be multiplied by0.18, the maximum 30 day averagecyanide standard must be multiplied by0.35, and both standards must beadjusted based on the dilution ratio ofthe cyanide-contaminated waste streamflow to the total process wastewaterdischarge flow. Only facilities wherecyanide is used or generated in themanufacturing process are subject tocyanide standards. Permittees not usingor generating cyanide must certify to thepermit-issuing authority that they arenot using or generating this compound.


§439.46 Pretreatment standards forexisting sources (PSES);

(a) Except as provided in 40 CFR 403.7and 403.13, any existing source subjectto this subpart that introduces pollutants

- into a publicly owned treatment worksmust comply with 40 CFR Part 403 andby October 27, 1986, where cyanide isused or generated in the manufacturingprocess, must achieve the followingpretreatment standards for existingsources (PSES).(1)

PSES



days


Total cyanide ............... 33.5 94

(2] If all cyanide-containing wastestreams are diverted to a cyanidedestruction unit, self-monitoring forcyanide must be conducted aftercyanide treatment and before dilutionwith other streams. Alternatively, self-monitoring may be conducted at thefinal effluent discharge point, if thecyanide standard is adjusted based onthe dilution ratio of contaminated wastestream flow to the total processwastewater discharge flow. However, ifall cyanide-containing waste streamsare not treated, self-monitoring must beconducted at the final effluent dischargepoint and the cyanide standard must beadjusted based on the dilution ratio ofcontaminated waste stream flow to thetotal process wastewater dischargeflow. Indirect dischargers not using orgenerating cyanide must certify to thepublicly owned treatment works thatthey are not using or generating thiscompound.



(a) Except as provided in 40 CFR 403.7any new source subject to this subpartthat introduces pollutants into a publiclyowned treatment works must complywith 40 CFR Part 403 and where cyanideis used or generated in themanufacturing process, must achieve thefollowing pretreatment standards fornew sources (PSNS).

(1)

PSNS



days

Milligrams per liter (mg/)

Total cyanide ............................ 33.5 9.4

(2) If all cyanide-containing wastestreams are diverted to a cyanidedestruction unit, self-monitoring forcyanide must be conducted aftercyanide treatment and before dilutionwith other streams. Alternatively, self-monitoring may be conducted at thefinal effluent discharge point, if thecyanide standard is adjusted based onthe dilution ratio of contaminated wastestream flow to the total processwastewater discharge flow. However, ifall cyanide-containing waste streamsare not treated, self-monitoring must beconducted at the final effluent dischargepoint and the cyanide standard must beadjusted based on the dilution ratio ofcontaminated waste stream flow to thetotal process wastewater dischargeflow. Indirect dischargers not using orgenerating cyanide must certify to thepublicly owned treatment works thatthey are not using or generating thiscompound.


Subpart E-Research Subcategory

§ 439.50 Applicability; description of theresearch subcategory.

The provisions of this subpart areapplicable to discharges resulting frompharmaceutical research.


general definitions, abbreviations, andmethods of analysis set forth in in 40CFR Part 401 and 439.01 shall apply tothis subpart.

(b) The term "product" shall meanproducts or services resulting frompharmaceutical research, which includes


microbiological, biological, andchemical operations.



(a) The following limitations establishthe quantity or quality of pollutants orpollutant properties, controlled by thisparagraph, which may be discharged bya pharmaceutical research operationfrom a point source subject to theprovisions of this paragraph afterapplication of the best practicablecontrol technology currently available:


(2) The allowable effluent dischargelimitation for the daily average mass ofBOD5 in any calendar month shallspecifically reflect not less than 90percent reduction in the long term dailyaverage raw waste content of BOD5multiplied by a variability factor of 3.0.

However, a plant shall not be requiredto attain a maximum 30 day averageBOD5 effluent limitation of less than theequivalent of 45 mg/l.

(3) .The allowable effluent dischargelimitation for the daily average mass ofCOD in any calendar month shallspecifically reflect not less than 74percent reduction in the long term dailyaverage raw waste content of CODmultiplied by a variability factor of 2.2.However, a plant shall not be requiredto attain a maximum 30 day averageCOD effluent limitation of less than theequivalent of 220 mg/l.

(4) The long term daily average rawwaste load for the pollutant parametersBOD5 and COD is defined as theaverage daily mass of each pollutantinfluent to the wastewater treatmentsystem over a 12 consecutive monthperiod within the most recent 36 months,which shall include the greatestproduction effort.

(5) To assure equity in regulationdischarges from the point sourcescovered by this subpart of the pointsource category, calculation of raw-waste loads of BOD5 and COD for thepurpose of determining NPDES permitlimitations (i.e., the base numbers towhich the percent reductions areapplied) shall exclude any waste loadassociated with solvents in those rawwaste loads, except that residualamounts of solvents remaining after thepractice of recovery and/or separatedisposal or reuse may be included in thecalculation of the raw waste loads.These practices of removal, disposal, orreuse include recovery of solvents fromwaste streams and incineration of

concentrated solvent waste streams(including tar still bottoms). Thisregulation does not prohibit inclusion ofsuch wastes in the raw waste loads infact, nor does it mandate any specificpractice, but rather describes therationale for determining the permitconditions. These limits may beachieved by any one of several or acombination thereof of programs andpractices.

(6) The allowable effluent dischargelimitation for the daily average mass ofTSS in any calendar month shall be 1.7times the BOD5 limitation determined inparagraph (a)(2) of this section.




§ 439.54 Effluent limitations representingthe degree of effluent reduction attainableby the application of the best availabletechnology economically achievable (BAT).[Reserved]

§ 439.55 New source performancestandards (NSPS). [Reserved]

§ 439.56 Pretreatment standards forexisting sources (PSES). [Reserved]

§ 439.57 Pretreatment standards for newsources (PSNS). [Reserved]

[FR Doc. 83-28778 Filed 10-28-83; 8:45 am]

BILLING CODE 6560-50--M

Documents

Federal Register Vol. 48, No. 209 Thursday, Qctober 27, … Register / Vol. 48, No. 209 / Thursday, Qctober 27, 1983 / Rules and Regulations ENVIRONMENTAL PROTECTION ENVIRONMENTAL