50676 RULES AND REGULATIONS - US EPA...Nov 17, 1976 · Federal Water Pollution Control Act, as amended (33 U.S.C. 1251, 1311 and 1314 (b) and (c), 86 Stat. 816 et seq.; Pub. L. 92-500)

RULES AND REGULATIONS

Title 40-Protection of the EnvironmentCHAPTER I-ENVIRONMENTAL

PROTECTION- AGENCYSUBCHAPTER N-EFFUENT GUIDELINES AND

STANDARDS[FRL 644-1

PART 439-PHARMACEUTICAL MANU-FACTURING POINT SOURCE CATEGORY

Interim Final RulemakingNotice is hereby given that effluent lim-

itations and guidelines for existingsources to be achieved by the applicationof best practicable control technologycurrently available as set forth in in-terim final form below are promulgatedby the Environmental Protection Agency(EPA). The regulation set forth belowestablishes Paft 439, Pharmaceutic lManufacturing Point Source Category,and will be applicable to existing sourcesfor the fermentation products subcate-gory (Subpart A), the extraction prod-ucts subcategory (Subpart B), the chem-ical synthesis products subcategory(Subpart C), the mixing/compoundingand formulation subcategory (SubpartD), and the research subcategory (Sub-part E) of the pharmaceutical manufac-turing point source category pursuant tosections 301, and 304 (b) and (c), of theFederal Water Pollution Control Act, asamended (33 U.S.C. 1251, 1311 and 1314(b) and (c), 86 Stat. 816 et seq.; Pub. L.92-500) (the Act). In the near future,the Agency intends to publish in pro-posed form effluent limitations andguidelines for existing sources to beachieved by the application of best avail-able technology economically achievable,and standards of performance and pre-treatment standards for existing point-90ur~es and new point sources. A de-scription and discufsion of this legal au-thority is contained in Appendix A tothis preamble.

The pharmaceutical -manufacturingpoint source category was first studied todetermine whether separate limitationsare appropriate for different segmentswithin the category. This analysis in-eluded a determination of whether dif-ferenceg in raw'material used, productproduced, manufacturing process em-ployed, age, size, wastewater constituentsand other factors require development ofseparate limitations for different seg-ments of the point source category. Th.raw waste characteristics for this pointsource were then identified. The controland treatment technologies existingwithin thkcategory were identified interms of the quantity and the chemical,physical, and biological characteristics ofpollutants, and the effluent level result-ing from the application of each of thetechnologies. This information was thenevaluated in order to determine whatlevels of technology constitute the "bestpracticable control technology currently

'available." The data upon which theabove analysis was performed includedEPA permit applications, EPA samplingand inspections, consultant reports, andindustry submissions. A summary of themethod of study, the several factors con-

sidered in subcategorization and the con-clusions reached -ire set forth as Ap-pendix B to this preamble.Although the percent removal ap-proach used in this regulation representsa departure from the conventional pro-duction based limitations, it is the onlyfeasible alternative -using the presentdata base. This approach should not beconstrued as setting a precedent for fu-ture industrial limitations. There may be'modification of the format utilized in thisrulemaking when further analysis is con-ducted-of expected new data. While theregulation published in interim finalform today does not present a specificnumerical limitation, the effect of today'spublication is the same as if numbers forBOD5 and COD were presented. The per-mit- writer may arrive at effluent limitsfor BOD5 and COD by applying to theraw waste load for each plant a percentreduction known to be attainable, and avariability factor. This approach does notdisallow or mandate in-house pollutioncontrol practices; it merely assures thatthe total pollution loading from all facili-ties are reduced on an equitable basis.This regulation does not prohibit intro-duction of mycelia from fermentationprocesses in subcategory A into waste-water treatment systems, but the Agencyis restudying this practice.

Although the TSS maximum for theaverage of daily TSS values for any cal-endar month -is not specified for sub-categories A and C in this regulation, itis not the intent of the Agency to re-main mute on this parameter. AdditionalTSS data on these two subcategories will,be compiled as- expeditiously as possiblein order to amend the regulations -forsubcategories in regard to TSS. For sub-6ategories B, D and ,E the average ofdaily TSS values for any calendar monthshall not exceed 52 mg/I.

Although- daily maximum numbers forBOD5, COD and TSS are omitted in thisregulation, it is anticipated that the per-mit writer will review each facility on acase by case basis and supply appro-priate daily maximum limitations underauthority of section 402 of the FWPCAA,and in compliance with regulations pub-lished in 40 CFR Parts 124 and 125, Inthe same manner, those known pollut-ants at a site specific loiation but notidentified in this regulation may be as--signed appropriate effluent limitationvalues by the permit writer.

The report entitled "Development Doc-ument for Interim Final Effluent Limi-tations, Guidelines and 'Proposed NewSource Performance Standards for thePharmaceutical Manufacturing PointSource Category" details the analysis un-dertaken in support of the interim finalregulation set forth herein and is avail-able for inspection at the EPA PublicInformation Reference Unit, Room 2922(EPA Library), Waterside Mall, 401 MSt., S.W., Washington, D.C. 20460, at allEPA regional-offices and at State waterpollution-control offices. A supplementaryanalysis prepared for 'EPA of the pos-sible-economic effects of the regulationis also available for inspection at these

_locations. Copies of both of these docu-ments are being sent to persons or in-stitutions affected by the proposed reg-ulation or who have placed themselveson a mailing list for this purpose (seeEPA's Advance Notice of Public ReviewProcedures, 38 P.R. 212D2, August 6,1973). An additional limited number ofcopies of both reports are available. Per-sons wishing to obtain a copy may writethe Environmental Protection Agency,Effluent Guidelines Division, Washington,D.C. 20460, Attention: Distribution Of-ficer, WH-552.

When this regulation is promulgatedin final rather than interim form, revisedcopies of the Development Document willbe available from the Superintendent ofDocuments, Government Printing Ofice,Washington, D.C. 20402. Copies of theeconomic analysis document will beavailable through the National Tech-nical Information Service, Springfield,VA 22151.

Prior to this publication, many agen-cies and groups were consulted and giventhe opportunity to participate in the de-velopment of these limitations, guidelinesand standards. All participating agen-cies have been informed of project de-velopments. An initial draft of the De-velopment Document was sent to all par-ticipants and comments were solicited onthat report. A summary of these com-ments and the Agency's response andconsideration of these is contaunri inAppendix C to this preamble.

The Agency today promulgates regu-lations which are explicitly addressed tothe control of BOD5, COD and pH. TSSis controlled for subcategories B, D) andE.

The oxygen demanding properties ofthese wastes result from the presenceof both orgafiic and inorganic compoundsin the wastewaters. The release of oxy-gen demanding substances will be re-duced when the discharger employs rec-ommended technology. To meet the 1977levels, a discharger can either rely onin-plant treatment or an end of the pipetreatment. Another option availablewould be to use a combination of both.

The Agency has studied the economicand inflationary impact of the costs ofthese regulations and has made the fol-lowing conclusions. It was found thatonly a few plants may have significantdifficulty in implementing a treatmenttechnology based on biological treat-ment. None of the 58 plants that are af-fected by the 1977 regulations are ex-

,pected to close or curtail production.This analysis meets all of the require-ments of economic and inflationary im-pact statements and is hereby certifiedby the Administrator in accordance withExecutive Order No. 11821. '

The Agency is subject to an order ofthe United States District Court for theDistrict of Columbia entered in "NaturalResources Defense Council v Train" ot.al. (Civ. No. 1609-73) which requires thepromulgation of regulations for this in-dustry category no later than September1, 1976. This order also requires that suchregulations become effective immediately

FEDERAL REGISTER, VOL. 41, NO. 223-WEDNESDAY, NOVEMBER 17, 1976

50676

RULES AND REGULAIONS

upon publication. In addition, it is nec-essary to promulgate regulations-estab-lishing limitations on the discharge of-pollutants from point sources In thiscategory so that the process of issuingpermits to individual dischargers undersection 402 of this Act is not delayed.

- It has iot been practicable to -developand publish regulations for this categoryin proposed Iorm, to provide a 30 daycomment period, and to make any neces-sary revisions in light of the commentsreceived within the time constraints im-posed by the -court order referred toabove. Accordingly, the Agency has de-termined pursuant to -5 U.S.C. 553(b)that-notice and comment on the interimfnal regulations would be impracticableand contrary to the public interest. Goodcause is also found for -these -regulationsto become effective immediately uponpublication.

Interested persons are encouraged tosubmit written comments. Commentsshould be submitted in triplicate to theEnvironmental Protection Agency, 401M St., SW., -Washington, D.C. 20460, At-tention: Distribution Officer, "WH-552.Comments oni all aspects of the regula-tion are solicted. The Agency especiallysolicits comments and/or data on costof waste treatment, including processingof mycelia, solvents, and broths. In theevent cbmments are in the nature of crit-icisms as to the adequacy of data-whichare available, or which may be Teliedupon by the -Agency, comments shouldidentify and, if-possible, provide any ad-ditional data which may be'available andshould indicate why such data suggest

-amendment or modification of the regu-lation. In the ,event 'comments addressthe approach taken by the Agency in es-tablishing an effluent limitation or guide-line, EPA solicits suggestions as to whatalternative approach should be taken andwhy and how this, alternative better-satisfies the detailed-requirements of sec-tions 301 and 304(b) of the Act.

A copy of all public comments willbe available for inspection and-copyingat the EPA Public-Information ReferenceVUnit, Room 2922 (EPA Isibrary), Water-.

side Mall, 401 M Street, SW., Washing-ton, D.CI 20460. 'A copy of preliminarydraft contractor reports, the Develop-ment Document and economic study re-ferred-to above, and certain supplemen-tary. materials supporting the study ofthe industry concerned will also be main-tained at this location for public review-and copying. The ZPA information reg-ulation, 40 CER part 2, -provides that areasonable fee may be'charged for copy-

,ing.All comments received on or- before

January 17,'1977, and the availability ofthe" Development Document supportingthis nterim final regulation will-be con-sidered. Steps previously taken by theEnvironmental Protection Agency tofacilitate public response within this time-period axe outlined in the advance notice.concernini public review procedures pfib-lished on August 6, 1973 (38 FR 21202).'In 'the event that the final regulationdiffers substantially from the interim

final regulation set forth herein theAgency will consider modification 6f anypermits issued In accordance with thisinterim final regulation.

Section 8 of the FWPCA authorizes theSmall Business Administration, throughits economic disaster loan program, tomake loans to assist any mal businessconcern in effecting additions to or al-terations in their equipment, facilities, ormethods of operation so as to meet waterpollution control requirements under theFWPCA, If the concern Is likely to suffera substantial economic injury withoutsuch asslstance-

For further details on this Federal loanprogram write to EPA, Office of Analystsand Evaluatlon, WH-586, 401 AT St., SW.,Washington, D.C. 20460.

In consideration of the foregoing, 40CFR Part 439 Is hereby established as setforth below.

Dated: November 9, 1976.

• - JoHN QuAnLES,Acting Administrator.

Subpart A-Fermentation Products SubcategowySec.

39.10 Applicability; description of the fcr-minntatlon products subcategory.

439.11 Specialized definitions.439,12 Effluent limitations and guidelines

representing the degree of effluent'reduction attainable by the appU-cation of tho best praoticable con-trol technology currently available.

- Subpart Bl-Extracton Products Subcategory

43920 Applicabilitr, description of the ex-- traction products subcategory.

439.21 Specialized definitions.439.22 Eflluent limitations and guidelines

Tepresonting the degree of efmuentreduction attainable by the appll-cation of the best practicable con-trol technology currentlyavanlable.

Subpart C--Chemlcal Synthesis ProductsSubcategory

439.30 Applicability. description of thechemical synthesis product, sub-category.

,439.31 Specialized definitions.439.32 Effluent limitations and gutidelines

representing the degree of effluentreduction attainable by the appll-cation of the best practicable con-trol technology currently available.

Subpart D-Mixing/Compounding andFormulation Subcategory

439.40 Applicability; description of the mix-ng/compounding and formulation

subcategory.439.41 Specialized definitions.439.42 Effluent limitations and guidelines

representing the degree of effluentreduction attainable by the appi-cation of the best practicablo con-

trol technology currently avallable.Subpart E-Research Subcategory

See.439.50 Applicability; dczcrlption of the re-

search subcategory.439.51 Specialized definitions.439.52 Effluent limitations and guidelines,

* repr-snting the degree of eflluentreduction attainable by the appli-cation of the best practicable-con-trol technology currently.available.

Aomaoarrr: Secs. 301, 304 jb) and (a) and306(b) ,'Federal Water Pollution Control Act,as amended (33 U.S.C. 1251. 1311, 1314 (b)

and (c) and 1316(b), 86 Stat. 816 et seq.;Pub.L.92-500) (the Act).

SubpartA-Fermentaton Products,Subcategory

§ 439.10 Applicability; description ofthe fermentation products subcate-gory.

7he provisions of this subpart are ap-plicable to discharges resulting from themanufacture of pharmaceuticals byfermentation.§ 439.11 Specialized definitions.

For the purpose of this subpart:(a) Except as provided below, the gen-

eral definitions, abbreviations and meth-ods of analysis set forth in Part 401 ofthis chapter shall apply to this subpart.

(b) The term "product" shall meanpharmaceutical products derived fromfermentation processes.

§ 439.12 Effluent limitations and guide-lines representing the degree ofeffluent reduction attainable by theapplication of-the best practicablecontrol technology currently avail-able.

In establishing the limitations setforth in this section, EPA took into ac-count all Information it was able to col-lect develop and solicit with respect tofactors (such as age and size of plant,raw materials, manufacturing processes,products produced, treatment technologyavailable, energy-requirements and costs,which can affect the Industry -ubcate-gorization and effluent levels established.It is, however, possible that data whichwould affect these limitations have notbeen available and, as a result, these lim-Itations should be adjusted for certainplants In this industry. An individual dis-charger or other Interested persons maysubmit evidence to the Regional Admin-Istrator (or to the State, if the State hasthe authority to Issue NPDES permits)that factors relating tothe equipment orfacilities Involved, the process applied, orother such factors related to such dis-charger are fundamentally different fromthe factors considered In the establish-ment of the guidelines. On. the basis ofsuch evidence or other available infor-mation, the Regional Administrator (orthe State) will make a written findingthat such factors ate or are not funda-mentally different for that facility com-pared to those specified In the Develop-ment Document. If such fundamentallydifferent factors are found to exist, theRegional Administrator or the State shallestablish for the discharger effluent lim-itations In the NPDES permit either moreor less stringent than the limitations es-tablished herein,. to the extent dictatedby such fundamentally different factors.Such limitations must be approved bythe Administrator of the EnvironmentalProtection Agency. 7he Administratormay approve or disapprove such limita-tions, specify other, limitations, or ini-tiate proceedings to revise these regula-tions.

(a) The lfollowing limitations estab-lish the quantity or quality of pollutantsor pollutantpropertiles, controlled by this

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paragraph, which may be discharged bya fermentation products plant from apoint source subject to the provisions ofthis paragraph after application of thebest practicable control technology cur-rently available:

(1) The allowable effluent dischargelimitation for the daily average mass ofBOD5 in any calendar month shall beexpressed in mass per unit time and shallspecifically reflect not less than 90 per-cent reduction in the long term dailyaverage raw waste content of BOD5 mul-tiplied by a variability Factor of 3.0.

(2) The allowable effluent dischargelimitation for the daily average mass ofCOD in any calendar month shall be ex-pressed in mass per unit time and shallspecifically reflect not less than 74 per-cent reduction in the long term -dailyaverage raw waste content of COD mul-tiplied by a variability factor of 2.2.

(3) The long term daily average rawwaste load for the pollutant BOD5 andCOD is defined as the average daily-massof each pollutant influent to the waste-water treatment system over a 12 con-secutive month period within the mostrecent 36 months, which shall include thegreatest production effort.

(4) To assure equityin regulating dis-charges from the point sources coveredby this subpart of the point source cate-gory, calculation of raw waste loads ofBOD5 and COD for the purpose of deter-mining NPDES permit limitations (i.e.,the base numbers to which the percentreductions are applied) shall exclude anywaste load associated with mycelia, spentbeers (broths) and solvents in those rawwaste loads: Provided, That residualamounts of mycelia, spent beers and sol-vents remaining after the practice ofrecovery and/or separate disposal or re-use may be included in calculation of rawwaste loads. These practices of removal,disposal or reuse include physical separa-tion and removal of mycelia, recovery ofsolvents from waste streams, incinerationof concentrated solvent waste streams(including tar still bottoms) and brothconcentrated for disposal other than tothe treatment system. This regulationdoes not prohibit inclusion of such wastesin the raw waste loads in fact, nor doesit mandate any speciflc practice, butrather descripes the rationale for deter-mining the permit conditions. These lim-its may be achieved by any one of sev-eral or a combination thereof of pro-grams and iractices.

(5) The pH shall be within the rangeof 6.0-9.0 standard units.

Subpart B-Extraction ProductsSubcategory

§ 439.20 Applicability; description ofthe extraction products subcategory.

The provisions of this subpart are ap-

ods of analysis set forth in Part 401 ofthis chapter shall apply to this subpart.

(b) The term "product" shall meanbiological and natural extraction prod-ucts. This subcategory shall include bloodfractions, vaccines, serums, animal bilederivatives, endocrine products and iso-lation of medicinal products, such as al-kaloids, from botanical drugs and herbs.

§ 439.22 Effluent limitations and guide-lines representing the degree of efflu-ent reduction attainable by the appli-cation of the best practicable controltechnology currently available.

In establishing the limitations setforth in this section, EPA took-into ac-count all Information it ,was able to col-lect, develop and solicit with respect tofactors (such as age and size of plant,raw materials, manufacturing processes,products produced, treatment technologyavailable, energy requirements and costs)

"'hich can affect the industry subcate-gorization and effluent levels established:It is, however, possible that data whichwould affect these limitations have notbeen available and, as a result, these lim-itations should be adjusted for certainplants in this industry. An individualdischarger or other interested personsmay submit evidence to the Regional Ad-ministrator (or to the State, if the Statehas the authority to Issue NPDES per-mits) that factors relating to the equip-ment or facilities involved, *the processapplied, or other -uch factors related tosuch discharger are fundamentally dif-ferent from the factors cbnsidered in theestablishment of the guidelines. On thebasis of such evidence or other availableinformation, the Regional Administrator(or the State) will make a written findingthat stich factors are or are not funda-mentally different for that facility com-pared to those specified in the Develop-ment Document. If such fundamentallydifferent factors are found to exist, theRegional Administrator or the Stateshall establish 'for the discharger efflu-ent limitations in the NPDES permiteither more or less stringent than thelimitations established herein, to the ex-tent dictated bk such fundamentally dif-ferent factors. Such limitations must beapproved by the Administrator of theEnvironmental Protection' Agency. TheAdministrator may approve or disap-prove such limitations, specify other lim-itations, or initiate proceedings to revisethese regulations.

(a) -The following limitations estab-lish the quantity or quality of pollutantsor pollutant properties, controlled by thisparagraph, which may be dis6harged byan extraction products plant from apoint source subject to the provisions ofthis paragraph after application of thebest practicable control technology cur-rently available:

plicalne W d u g res wug, r rom the 1 h llwbedshag o hmanufacture of pharmaceuticals by ex-, (1) The allowable discharge for thetraction. pollutant parameters BOD5 and CODshall be expressed in mass per unit time§ 439,.21 Specialized definitions, and shall represent the specified waste-

For the purpose of this subpart: water treatment efficiency in termstof a(a) Except as provided below, the gen- • residual discharge associated with an in-

eral definitions, abbreviations and meth- fluent to the wastewater treatment plant

corresponding to the maximum produc-tion for a given pharmaceutical plant.

(2) The allowable effluent dischargelimitation for the daily average mass ofBOD5 n any calendar montL slall spe-cifically reflect not less than 00 percentreduction in tile long term daily averageraw waste content of BOD multipliedby a variability factor of 3.0.

(3) The allowable effluent dischargelimitation for the daily average mass ofCOD in any calendar month shall specIf.ically reflect not less than 74 percent re-duction in the long term daily averageraw waste content of COD multiplied bya variability factor of 2,2.

(4) The long term daily average rawwaste load for the pollutant BOD5 andCOD is defined as the average daily massof each pollutant influent to the waste-water treatment system over a 12 con-secutive month period within the mostrecent 36 months, which shall Includethe greatest production effort.

(5) To assure equity In regulating dis-charges from the point sources coveredby this subpart of the point source cate-gory, calculation of raw waste loads ofBOD5 and COD for the purpose of deter-mining NPDES permit limitations (i.e.,the base numbers to which the percentreductions are applied) shall exclude anywaste load associated with solvents inthose raw waste loads; Provided, Thatresidual amounts of solvents remainingafter the practice of recovery and/orseparate disposal or reuse may be in-cluded in calculation of raw waste load.These practices of removal, disposal orreuse include recovery of solvents fromwaste streams and incineration of con-centrated solvent Waste streams (includ-ing tar still bottoms). This regulationdoes not prohibit inclusion of such wastesin the raw waste loads in fact, nor doesit mandate any specific practice, butrather describes the rationale for deter-mining the permit conditions. These lim-its may be achieved by any one of severalor a combination thereof of programsand practices.

(6) The average of daily TSS valuesfor any calendar month shall not exceed52 mg/l.

(7) The pH shall be within the rangeof 6.0-9.0 standard units.Subpart C-Chemical Synthesis Products

Subcategory§439.30 Applicability de ription of

lhe chemical synhthesi p1anL.1 Nu1-category.

The provisions of this subpart are ap-plicable to discharges resulting from themanufacture of pharmaccutlealg bychemical synthesis.§ 439.31 Specializcd defititionq.


eral definitions, abbreviations and moth-ods of analysis set forth in Part 401 ofthis chapter shall apply to this subpart.

(b) The term "product" shall -meanchemical synthesis products.


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§ 439.32 Effluent limitations and guide-lines representing the degree of efflu-ent reduction attainable by the appli-cation of the best practicable controltechnology currently available.

In establishing the limitations set forthin this section, EPA took into account allinformation it-was'able to collect, developand solicit with respect to factors (such-as age and size of plant, raw materials,manufacturing processes, products pro-duced,. treatmfent technology available,energy requirements and costs) whichcan affect the industry subeategorization-and effluent levels establlhed. It is, how-ever, possible that data which would af-fect these limitations have not beenavailable and, as a result, these limilta-tions should be adjusted for certainplants in this industry. An- individualdischarger -or other interested personmay submit evidence to-the Regional Ad-ministrator (or to the State, if the Statehas the authority to issue NPDES per-mits) that factors relating to the equip-ment or facilities involved, the processapplied, or other such factors related to-such discharger are fundanientally dif-ferent from the factors considered in theestablishment of the guidelines. On thebasis of such evidence or other availableinformation, the Regional Administrator(ofthe State) will make a written find-Ing that such factors are or are not fun-damentally different for that facilitycompared to those specified in the fDe-velopment Document. If such funda-mentally different factors are found toexist, the Regional Administrator or theState shall establish for the dischargereffluentliinitations in the NPDES permiteither more or -less stringent thfin thelimitations established herein, to the ex-terit dictated by such fundamentally dif-ferent factors. Such limitations must beapproved by the Administrator of theEnvironmental Protection Agency. TheAdministrator may approve or disap-'prove such limitations, specify other lim-itations, or initiate proceedings to revisethese regulations.

(a) The following limitations establishthe quantity or quality of pollutants orpollutant properties, controlledby thisparagraph, which may be discharged bychemical synthesis, plants 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 specified waste-water treatment efficiency in terms of aresidual discharge associated with aninfluent to. the wastewaster treatmentplant corresponding to the maximumproduction for a given pharmaceuticalplant.' (2) The-allowable effluent discharge

limitation for.the daily average mass ofBOD5 in any calendar month shallspecifically reflect not less than 90 per-cent reduction in the long term dailyaverage raw waste content of BOD5 mul-tiplied by a variability factor of 3.0.

(3) The allowable effluent dischargelimitation Xor the daily average mass ofCOD in any calendar month shall specif-ically reflect not less than 74 percentreduction in the long term daily averageraw waste coxitent of COD multiplied bya variability factor of 2.2.

(4) The long term daily average rawwaste load for the pollution BOD5 andCOD is defined as the average daily massof each pollutant influent to the waste-water treatment system over a 12 con-secutive month period within the mostrecent 36 months, which shall include thegreatest production effort.

(5) To assure equity in regulating dis-charges from the point sources coveredby this subpart of the point source cate-gory, calculation of raw waste loads ofBOD5 and COIlfor the purpoce of deter-mining NPDES permit limitations (le.,the base numbers to which the percentreductions are applied) shall exclude anywaste load associated with solvents inthose raw waste loads: Provided, Thatresidual amounts of solvents remainingafter the practice of recovery and/orseparate disposal or reuse may be in-cluded in calculation of raw waste loads.These practices of removal, disposal orreuse include recovery of solvents fromwaste streams and ncineration of con-centrated solvent waste streams (includ-ing tar still bottoms). This regulationdoes not prohibit inclusion of such wastesin the raw waste loads in fat, nor does Itmandate any specific practice, but iatherdescribes the rationale for determiningthe permit conditions. These limits maybe achieved by any one of several or acombination thereof of programs andpractices.

(6) The pH shall be within the rangeof 6.0 to 9.0 standard units.

Subpart D-Mixing/Compounding andFormulation Subcategory

§439.40 Applicability; description ofthe inxing/conipounding and for-mulation subcategory.

The provisions of this subpart areapplicable to discharges resulting fromnmixing/compounding and formulationoperations of pharmaceutical products.§ 439.41 Specialized defrwtions.


eral definitions, abbreviations and meth-ods of analysis set forth in Part 401 ofthis chapter shall apply to this subpart.

(b) The term "product" shall meanproducts from plants which blend, mix,compound, and formulate pharmaceuti-cal Ingredlnts. Pharmaceutical prepara-tions for human and veterinary use suchas ampuls, tablets, capsules, vials, oint-,ments, medicinal powders, solutions andsuspensions are included.-§ 439.42 Effluent limitations and guide-

lines representing the degree of eflu-ent reduction attainable by the ap-plication of the best practicable con-trol technology currently available.

In establishing the limitations set forthin this section, EPA took into account all

50679

Information it was able to collect, de-velop and solicit with respect to factors(such as age and size of plant, raw mate-rials, manufacturing processes, prod-ucts produced, treatment technologyavailable, energy requirements and costs)which can affect the Industry subcate-gorizatlon and effluent levels established.It is, however, possible that data whichwould affect these limitations.have notbeen available and, as a result, these lim-itations should be adjusted for certainplants in this Industry. An Individualdischarger or other Interested personmay submit evidence to the RegionalAdministrator (or to the State, if theState has the authority.to issue NPDESpermits) that factors relating to theequipment or facilities Involved, theprocess applied, or other such factorsrelated to such discharger are funda-mentally different from the factors con-sidered in the establishment of theguidelines. On the basis of such evidenceor other hvailable.information, the Re-gional Administrator (or the State) willmake a written fihding that such factorsare or are not fundamentally differentfor that facility compared to those spec-ified in the Development Document. Ifsuch fundamentally different factors arefound to exLt the Regional Adminis-trator or the State shall establish for thedischarger effluent limitations in theNPDES permit either more or less strin-gent than the limitations establishedherein, to the extent dictated by suchfundamentally different factors. Suchlimitations nust be approved by the Ad-ministrator of the Environmental Pro-tection Ageney. The Administrator mavapprove or disapprove such limitations,specify other limitations, or initiate pro-ceedings to revise these regulations.

(a) The following limitations establishthe quitntity 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 after ap-plication of the best practicable controltechnology currently available:

(1) Tihe allowable .discharge for thepollutant paranieters BOD5 and CODshall be expressed In mass per unit timeamd shall represent the specified waste-water treatment efficiency in terms of aresidual discharge associated with an in-fluent to the wastewater treatment plantcorresponding to the maximum produc-tion for a given pharmaceutical plant.

(2) -The allowable effluent dischargelimitation for the daily average mass ofBeD5 in any calendar month shall spe-cifically reflect not less than 90 percentreduction in the long term daily averageraw waste content of BOD5 multipliedby a variability factor of 3.0.

(3) The allowable effluent dischargelimitation for the daily average mass ofCOD In any calendar month shall spe-cifically reflect not less than 74 percentreduction In the long term daily averageraw waste content of COD multiplied bya variability factor of 2.2.

FEDERAL 1GISH1U ,VOL 41, NO. 223-WEDNESDAY, NOVEMBER 17, 1976


(4) The long term daily average rawwaste load for the pollutant BOD5 andCOD is defined as the average daily massof each pollutant influent to the waste-water treatment system over a 12 con-secutive month period within the mostrecent 36 months, which shall includethe greatest production effort.

(5) To assure equity in regulating dis-charges from the Point sources coveredby this subpart of the point source cate-gory, calculation of raw waste loads ofBOD5 and COD for the purpose of deter-mining NPDES permit limitations (i.e.,the base numbers to which the percentreductions are applied) shall exclude anywaste load associated with solvents inthose raw waste loads; Provided, Thatresidual amounts of solvents remainingafter the practice of recovery andT/orseparate disposal or reuse may be in-cluded in calculation of raw waste loads.These practices of removal, disposal orreuse include recovery of solvents fromwaste streams and incineration of con-centrated solvent wastestreams (includ-ing tar still bottoms). This regulationdoes not prohibit inclusion of such wastesin the raw waste loads in fact, nor doesIt mandate any specific practice, butrather describes the rationale for deter-mining the permit conditions. These lim-its may be achieved by any one of severalor a combination thereof of programsand practices.

(6) The average of daily TSS valuesfor any calendar month shall not exceed52 mg/i.

(7) The pH shall be within the rangeof 6.0 to 9.0 standard units.

Subpart E-Research Subcategory§ 439.50 Applicability; description of

tih research subcategory.The provisions of this subpart are ap-

plicable to discharges resulting frompharmaceutical research.§ 439.51 'Specialized definitions.


eral definitions, abbreviations and meth-ods of analysis set forth in Part 401 ofthis chapter shall' apply to this subpart.

(b) The term "product" shall meanproducts or service resulting frompharmaceutical research, which includesmicrobiological, biological and chemicaloperations.§ 439.52 Effluent limitations and guide-,

lines representing the degree of efflu-ent reduction attainable by the ap-plication of the best practicable con-trol-technology currently available.

In establishing the limitations .setforth in this section, EPA took into ac-count all information it was able to "col-lect, develop and solicit with respect tofactors (such as age and size of plant,raw materials, manufacturing processes,products produced, treatment technblogyayailable, energy requirements andcosts) which can affect the industry'sub-categorlzation and eflluent levels estab-lished. It Is, however, possible that, datawhich would affect these limitations have

not been available and, as a result, theselimitations should be adjusted for certainplants in this industry. An individualdischarger or other interested personsmay submit evidence to the RegionalAdministrator (or to the State, if the

-State has the authority to issue NPDESpermits) that factors relating to theequipment or facilities involved, theprocess applied, or other such factorsrelated to such discharger are funda-mentally different from the factors con-sidered in the establishment of the guide-lines. On the basis of such evidence orother available information, the Re-gional Administrator (or the State) willmake a written finding that suchfactors are or are not fundamentallydifferent for that facility compared tothose specified in the DevelopmentDocument. If such fundamentally differ-ent factors are found to exist, the Re-gional Administrator or the State shallestablish for the discharger' effluentlimitations in the I'PDES permit eithermore or less stringent than the limita-tions established herein, to the extentdictated by such fundamentally differentfactors. Such limitations must be ap-proved by the Administratefr of the En-vironmental Protection Agency. TheAdministrator may approve or disap-3irove such limitations, specify otherlimitations, or initiate proceedings to re-vise these regulations.

(a) The following lidtations estab-lish the quantity or quality of pollut-ants or pollutant properties, controlledby this paragraph, which may be dis-charged by a pharmaceutical researchoperation from a point source subject tothe provisions of this paragraph afterapplication of the best practicable con-trol technology currently available:

(1) The allowable discharge for thepollutant parameters BOD5, and CODshall be expressed in mass per unit timeand shall represent the specified waste-water treatment efficiency in terms ofa residual discharge associated with aninfluent to the wastewater treatmentplant coresponding to the maximum re-search effort for a given pharmaceuticalplant. -

(2) The allowable effluent dischargelimitation for the daily average mass ofBOD5 in any calendar month shall spe-cifically- reflect not less than 90 percentreduction in the long term daily averageraw waste content of BOD5 multipliedby a variability factor of 3.0.

(3) The allowable effluent dischargelimitation for the daily average mass ofCOD in any calendar month shall spe-cifically reflect not less than 74 percentreduction in the longterm daily aver-age raw'waste content of COD multi-plied by a variability factor of 2.2.

(4) The long term daily average rawwaste load for the pollutant BeOD5 andCOD is defined as the average daily massof each pollutant influent to the waste-water treatment system over a 12 con-secutive month period within the mostrecent 36 months.

(5) To assure equity in regulating dis-charges from. the point sources covered

by this subpart of the point source cate-gory, calculation of raw waste loads ofBOD5 and COD for the purpose of de-termining NPDES permit limltatlonu(i.e., the base numbers to which the per-cent reductions are applied) shall ex-elude any waste load associated withsolvents in those raw waste loads; Pro-vided, That residual amounts of solventsremaining after the practice of recoveryand/or separate disposal or reuse may beincluded in calculation of raw wvastoloads. These practices of removal, dL-posal or reuse include recoverey of sol-vents from waste streams and incinera-tion of concentrated solvent wvaotstreams (including tar still bottomsn),This regulation does not prohibit .in-clusion of such wastes in the raw wasteloads in fact, nor does It mandate anyspecific practice, but rather describethe rationale fdr determining the per-mit conditions, These limits may beachieved by any one of several or a com-bination thereof piograms and prac-tices.

(6) The average of daily TSS valuesfor any calendar month shall not ei:-ceed 5a mg/l.

(7) The pH shall be vthin the rangeof 6.0 to 9.0 standard units.

A'pENDrx A-zoa L Au rorrrv

ExSTING PoNr sovr.crSection 301(b) of tho Act requires tho

achievement by not later than July 1, 177,of effluent limitations for point rource ,other than publicly owned treatment works,which require the application of the bestpracticable control technology currentlyavailable as defined by the Administratorpursuant to section 304(b) of the Act. Section301(b) also rcquircs thc achievement by notlater than July 1, 1983, of effluent limitatiomnfor point sources, other than publicly ownedtreatment works, which require tho applica-tion of best available technology economlcallyachievable which will result in reasonablefurther progres toward the national goal ofeliminating the discharge of all pollutants, Aldetermined in accordance with regulationsissued by the Administrator pursuant tosection 304(b) of'the Act.SSection 304(b) of the Act requires the

Administrator to publish regulations provid-ing guidelines for effluent limitations settingforth the degree of effluent reduction attain-able through the application of the boatpracticable control technology currtntlyavailable and the degree of effluent reductionattainable through the application of the bestcontrol measures and practices achievable in-cluding treatment techniques, jroccs 'andprocedural Innovations, operating methodsand other alternatives. The regulation hereinsets forth effluent limitations and guideline,pursuant to sections 301 and 304(b) of theAct, for the fermentation products subeato-gory (Subpart A), the extraction productssubcategory (Subpart B), the chemical syn-thesis products subcategory (Subpart. 0),the mixing/compounding and formulationsubcategory (Subpart D), and tho researchsubcategory (Subpart E) of the pharmaceu-tical manufacturing point source category.

Section 304(c) of the Act rcquires theAdministrator to issue to the States and ap-propriate water pollution control agonclc In-formation on the processes, procedures oroperating methods which result in the clin-nation or reduction of the discharge ot pol-lutants to Implement standards of perform-ance under section 300 of the Act. Tho repOrt


50680

entitled -"Development Document for In-terim Final Effluent Limitations, Guidelinesand New Source Performance Standards forthe Pharmaceutical Manufacturing PointSource CategorV' provides, pursuant to sec-tion 304(c) of the Act, information on suchprocesses, procedures or operating methods.

Ammnox E-TZcmaCsn S n Y Aud BASISFOR IIEGUL&ATONS

This Appendix summarizes the basis ofInterim final effluent limitations and guide-lines for existing sources.

(1) GENERAL z=RnODOLOGY

The effluentlimitations and guidelines setforth berein were developed in the followingmanner. The" point source category was firststudied for the purpose of determiningwhether separate limitations are appropriatefor different segments within the category.This analysis Included a determination ofwhether differences in raaw materials, prod-ucts, manufacturing process employed, age,size, wastewater constituents and other fac-tors require development of separate limita-tions for different segments of the pointsource category. The raw waste characteristicsfor each such segment were then identified.This included an analysis of the source, flowand volume of water used In the process em-ployed, the sources of waste and wastewatersin the operation and the constituents of allwastewaters. The constituents of the waste-:waters which should be subject to effluentlimitations were identified..

The existing control and treatment tech-nologies within each segment were examined.This Included an identification of each dis--tinct control and treatment technology, In-eluding both- in-plant and end-of-procestechnologies, which exists or is capable ofbeing designed for each segment. It also in-eluded an identification of, In tdrms of theamount of constituents and the chemical,physical, and biological characteristics ofpollutants, the effluent level resulting fromthe application of -each of the technologies.Problems with each treatment and controltechnology were also identified. In addition,the nonwater quality environmental impact,such as the effects of the application of thesetechnologies upon other pollution problems,Including air, solid waste, noise and radiationwere examined. The energy requirements ofeach ontrol and treqtment technology weredetermined as well as the cost of-the appli-cation of such technologies.

The information outlined above was thenevaluated in order to determine what levelsof technology constitute the -'%est practic-able control technology currently available."In identifying such technologies, various fac-tors were considered. These included the totalcost of application of technology, the ageof equipment and facilities Involved, theprocess employbd, the englneering.aspects ofthe application of various types of controltechniques, process changes, nonwater qual-Ity environmental impact -(including energyrequirements), -potential benefits to beachieved by reducing pollution from thispoint source category and other factors.

The data upon which the above analysisWas performed -included EPA permit appli-cations, EPA sampling and inspections, con-sultant reports. and industry submissions.

(2) Summary of conclusions with respectto -the fermentation products subcategory'(Subpart A), the extraction products sub-category (Subpart ]B, the chemical synthesisproducts subcategory (Subpart C), the mix-ing/Qompounding and formulation subcate-gory (Subpart ),. and the research sub-category (Subpart E) -of the pharmaceuticalmanufacturing point source category.

(I) Subcategori ftion. For the purpose ofestablishing effluent limitations and guide-

lines, the pharmaceutical Industry was dl- ment plants. Tho average eliciencies of thevided into subcategories. Factors such as type best treatment plants within a subcategoryof product, raw waste loads, water require- were established as the removal technologyments, type of manufacturing process, treat- that should be applied to these subcategories.ability of wastewaters. and other means 'were The average values from an array of elevenused to establish effluent limitations and plants Identified as the best wastewaterguidelines for each of the specific subcate- Uratment plants for all subcategories weregorles. In general, the largest distingulaing--as follows:factors are product yield, procezAng and Percenttreatability based on production volumo and 3eDS removal. -------------------- 91specific water requirements. This broad ba-o COD removaL_ . 74subcategorlzation scheme simplifles the ap- I-.luent W ..... _ 274plcatlon of effluent limitations and guide-lines for a complex mni of pharmaceutical lhMg/l for subcategories A and .C, 17.3production activity. For example, an Inher- Mg/ for subcategories 3B, D and Ei.ent waste to thefermentation products mau- ho eleven exemplary plants were Identifiedufacturing operations (Subcategory A) is the from the following profile of biological treat-generation of considerable amounts of my- nlent system=. Only those plants that hadcelia. This waste is not found In the manu- high treatment efficiencies and for-whichfacturing operations of the other four sub- repreaentative historical data were availablecategories. (identified by asterisks) were used in de-

(il) Waste cheracterfstie. The lmorn afg- voloplng the effluent limitations. Further-niflcant wastewater pollutants and pollutant More, this BODS reduction (percent re-properties resulting from the pharmaceutical =oval) may be accomplished by any numberIndustry include pH, total supended solids, of treatment steps Or any kind of wastewaterBED5, COD, TO0, metals, organlo solvents, treatment technology (physical, chemical,and waste medicinal chemicals. BOD$, COD, bloloZIcal or any.combination of these).and TOO, which are primary measurements However, the Agency decided to lower thefor organic pollution. are evident In waste- BODS pcent removal from 9& to go in thiswaters from the pharmaceutical manufactur- ODtercfnt re on irder to e n thIng point source category. nterim ling' regulation In order to lessen th~e

potential economic impact in the form of(lII) Origin of wastewatcr pollutants. -capital investment in subcategories A and

Sources of wastewater pollutants in the phar- 0. The decision to extend the 90 percent re-maceutical industry Include aquCous iW&L"tm duction to all subcategories was based on thefrom fermenters, reactors, filtration system!, indu,1ry characteristic of complex manu-decanting systems, solvent extraction unlte, facting facilities covered by more thanion exchang regeneraton, distillation vac- one subcategory and treatment of combineduum. exhaust scrubbers, caustic rcrubbers, in wich that attributble to adestruction of waste or returned produots specifsi proceh could not readily boe

process equipment cleanouts, production identifiedarea washdowns, refining area washdowna, In order to arrive at the 52 ragil maximumformulation equipment cleanup, and spll. value for the average of daily Tss values forwashdowns. Unlike many other point source any calendar month for subcategories 13, Dcategories, the regulations could not be er- and B, exemplary plants number 14, 2- andtablished on a unit of production batis due 23 were averaged and a variability factor ofto the non-continuous nature of proceZes, 3.0 was applied. This variability factor repre-the different process routes to produce the Ints the 99 percent probability to long termzmne or imflar produots the variety of re- average ratio.fining options for a given product or class For subcategories A and C, the maximumof products, the differing converalon eficien- valuo for the average of daily TS values forces of raw materials to final products, the any calendar month has not been presentedlow absolute yields of some active Ingredi- at this time. Several plants that are Used asents, and the physical form of final products.Therefore, the removal efficiencies of the up- exemplary plants for BOD5 and COD removalplicable and practical technology were ap- efficiencies do not qualify as exemplaryplied. In this particular regulation, the de- plants for the purpose of determining finalgree of effluent reduction for BOD$ and COD TSS concentrations for subcategories A andshall have the same meaning as percent re- C. For example, Plant 02 cannotbe consideredmoval or percent removal eMclency, an exemplary plant for the 7WS calculation.

Inudetermining efficienclea to be used, the This plant may or may not be lacking in sec-historical data from existing plants in the ondary settling and NEIO has reported thatpoint source category were evaluated to dis- this plant has had dialculty meeting Its '5s$cover the best operating gastewater treat- permit limits In the past.

BhoLooacAL TnrrTHxr Pasx;r Psaocaua~c DA

,3OD5 COD TS8 In

P~nt No. M r ~oval reMOval cfluent Numter tlixr0 Ceai) (zallIbain eamples

Du0 CC5400 ...... . A 50 C' 4 119%- --. ACD 9-14' ..... _ _ 97 91 910 --- --- --- _ _O CIO 52 2=1G*. BE 55 9

DE 54 - -28 10621'- ... ...... AC 94 147 se0

A2 --- 93 so em6 se2--- --- A 70 380 4- DE 63 75 is 5

]8D 52 3 o22l28......... I 91 73 2 .- -- AI3CDB 92 177 360

---- _C 91 23 362 360I1. .. . . . . .. .0 91 85 J[ 10-- 13 33 57 U7

. . so 47_ _ 225 ------------------ AO 46 FS 2

FEDERAL RWGISTER,..VOL 41, NO. 2.23-WEDNESDAY, NOVEMBER 17, 1976

50681RULES AND REGULATIONS


As noted above, In most industries, processwastewater pollutants are generally propor-tional to the level of production; however,specification of a percent removal of BOB5across the wastewater treatment system is amore appropriate basis for this point sourcecategory than limitations and standardsbased on a unit of production. The CODparameter is a secondary control mechanism;the COD percent removal is that which canbe expected to occur in the biological waste-water treatment system. However, this doesnot preclude the use of a physical/chemicalwastewater treatment system to attain theequivalent COD reduction.The variability factor is applied to the long

term daily average effluent residual to arriveat the allowable effluent discharge limitationsfor the daily average mass of BOD5 In anycalendar month for a given pharmaceuticalplant. This factor for BODs is 3.0; the CODvariability factor is 2.2. Both the BOD5 andCOD variability factors represent the ratioof the 99 percent probability to long termdaily average.

Although the BPT regulation published Inthe FEDmAL Rr0csa and supported by thisdocument does not indicate the maximum'day limitations for BOD5. COD and TSS, itis expected that the permit writers will han-dle this issue on a case by case basis. Simi-larly, those known pollutants, but not identi-fled in this regulation, at a site specific loca-tion may be assigned appropriate effluentlimitation values by the permit writer usingauthority of section 402 of the FWPCAA, andin compliance with regulations published in40 CFR Parts 124 and 125. The constituentscontained in the process wastewater varywith the chemical or product produced.Suspended solids are present as a result ofmost production processes. These may gen-erally be removed by sedimentation basins,clarifiers, filters, centrifuges and evaporation.

(iv) Treatment and control technology.Wastewater treatment and control tech-nologies have been studied for this pointsource category to determine the best prac-ticable control technology currently avail-able.

The following discussion of treatmenttechnology provides the basis for the effluent.limitations and guidelines. This discussiondoes not preclude the selection of otherwastewater treatment alternatives Whichprovide equivalent or better levels of treat-ment. *

Pharmaceutical wastewaters vary in quan-tity and quality depending on the type ofmanufacturing activities. The wastes fromsubcategories B, D, and E are more readilytreatable than wastes Trom subcategories Aand, C, but wastes from all subcategories canbe adequately treated in properly designedfacilities. The results of an industry surveyindicate that a variety of in-plant abatementtechniques are utilized by pharmaceuticalplants and overall, in-plant wastewater con-trol measures are being practiced through-out the industry. Therefore, these techniquescan be incorporated as part of the technologyavailable to meet the limitations. The surveyhas shown that biological treatment meth-ods are the most prevalent end-of-pipe waste-water treatment systems utilized by theindustry.

rn-PLAN POLVOTION ABATEMflNT

It is within the manufacturing facilityitself that maximum reduction, reuse, andelimination of wastewaters can be accom-plished. In-plant practices are the majorfactor in determining the overall effort re-quired in end-of-pipe wastewater treatmentA complete evaluation of the effectiveness ofin-plant processing practices -in reducIngwastewater pollution requires detai ed infor-mation on the wastewater flows and polu-

tion concentrations from all types of proc-essing units. Information of a general natureindicates that substantial wastewater pollu-tion reduction through in-plant control ispossible. Specific in-plant techniques thatare important in controlling waste dischargevolumes and pollutant quantities in thepharmaceutical manufacturing point sourcecategory are discussed below:

HOUSssczzPfls AIMS GENER&L PzsACrzCn

In general, operating and housekeepingpractices within the pharmaceutical industryare excellent. The competitive nature of theindustry, combined with strict regulationsfrom the Food and Drug Administration, re-quire most producers to operate their plantsin the most efficient manner possible. Thereare numerous examples of good housekeepingpractices utilized throughout the industry.A few of the better practices used by exem-plary plants are described In the followingdiscussion.

1. All of the plants visited in subcategory D(mixIng/compounding and formulation)carried out their routine cleaning most effi-ciently by vacuum cleaning. Most facilitiesutilized "house" vacuum systems equippedwith bag filtert. This practice has resultedin a substantial reduction in the concentra-tion of pollutants and volume of wastewatergenerated.

2. The use of portable equipment in con-junction with central wash areas is a com-mon practice in many plants throughout theindustry. This practice provides better con-trol over the possibility of haphazard dump-ing of "tail ends" of potentially harmful pol-luting material to the sewer.

3. Quality control laboratories are an in-tegral part of the pharmaceutical industry,and solvent and toxic substance disposalpractices wlthin the laboratories are furtherevidence of the apparent industry-wide com-mitment to good housekeeping. Standardpractice throughout the industry is to collecttoxic wastes and flammable solvents, espe-cially low-bolling-point solvents like ethylether, in special waste containers locatedwithin the laboratories. Disposal of thesewastes varies within the industry, but themost prevalent practice is to have the wastesdisposed of byeu-private contractor or byon-site incineration.

4. Spills of both liquid and solid chemicals,not only inside production areas, but in gen-eral plant areas such as roads and loadingdocks, can lead to water pollution. In mostof the pharmaceutical plants visited, a com-prehensive spill prevention and cleanup pro-gedures program was an integral part of theplant's good housekeeping procedure. Sev-eral plants visited during the survey had ex-cellent spill prevention programs and havesignificantly reduced the amount of waterused for spill cleanup through the use ofvacuum collection devices and "squeegees".

5. Stormwater runoff from manufacturingareas, under certain circumstances, containssignificant-quantities of pollutants. One ex-emplary technique for controlling such dis-charges, observed at sbveial plants during thesurvey visits, consisted of containment. andmonitoring of stormwater for pH. If thestormwater pH exceeds present limits it Isthen automatically diverted to the wastetreatment facility. Uncontaminated storm-water is discharged without further treat-ment.

6. The survey indicated that disposal ofoff-specification batches to thq sewer systemIs'not a wide-spread practice because of thehigh value of the product. Most of the sub-category D plants visited reprocessed theiroff-specification)liquid formulation batchesand either discharged the off-specificationsolid products to a landfill or reformulated

*them when possible. Plants in other sub-

categories, when reproceeslng is not pe.,lble.either incinerate off-specification batohes orcollect them in drums and dispozo of themvia , private disposal contractor.

PnoCsEs TncOWOLOGMany of the newer pharmaceutical plant!i

are being designed with reduction of wateruse as part of the overall planning and plantdesign criteria. Improvements which havebeen implemented In existing plants are pri-marily dedicated to better control of manu-facturing processes and other activities ,ilthregard to their environmental aspects. Lx-amples of the kinds of changes which havebeen implemented within plants surveyedare:

1. The use of barometric condensero elnresult in significant water contamination,depending upon the nature of the materlalientering the discharge water stream. Thiscould be substantially reduced by subtl-tuting a heat exchanger for water sprays. Aan alternative, several plants are using sur-face condensers to reduce hydraulic or or-ganic loadg.

2. Water-sealed vacuum pumps often cre-ate water pollutionl problems. Several plantsare using a sealing water recirculatlon syo-tam as a means of greatly reducing theamount ot water being discharged, Theosystems often require the recycled water to.be cooled.

3. The recovery of vaste solvents is a com-mon practice among plants using solvontiin their manufacturing processes (qubcatc-gory A-fermentation producta; subcategoryC-chemical synthesis products; and to alesser extent subcategory B--biologlcal prod-ucts). However, several plants have insti-tuted further measures to reduce the nmountof waste solvent discharge. Such measures,include incineration of solvents that cannotbe recovered economically and "bottoms"from solvent recovery units, and design andconstruction of solvent recovery columns tostrip solvents beyond the economical re-covery point.

4. One plant producing a largo amount oforganic arsenic eliminated the discharge ofthis toxic substance by recovering the ar-senlc. Arsenic-laden waste stroams are seg-regated and concentrated before being ro-used. Non-recoverable arsenic residues aredrummed and shipped to an approved land-fill.

5. Several techniques have been employedby various subcategory A plants In an effortto reduce the volume of fermentation wastesdischarged to end-of-plp6 treatment systen.These include concentration of "spent beer"wastes by evaporation, and dowatering anddrying of waste mycella. The resulting dryproduct In some Instances has sufficient eco-nomic value as an animal feed supplementto offset a part of the drying cost.

6. One plant has installed automatic CODmonitoring instrumentation, and others haveutilized pH and TOO monitoring to permitearly detection of process upsots which mayresult in excessive discharges to soewers.

7. Several plants in subcategory B (Bio-logical Extraction Products) segregate thespent eggs used in virus production. Thewaste plasma and blood fractions used Inblood fractionation procedures arc llkoivioseparated. They are dispozed.of by inolnera-tion at all plants inspected on'field survey.

8. Substitution 'of chemicals In this in-dustry may be possible; however, tho re-search program required to obtain rDA ap-proval can cost as much as the original stud-ies to obtain approval of the product,

noYc=x/nnusE rnArcn=

Recycle/rouse can be accomplished eitherby returning wastewater to its origina uso,or by using it to satisfy a demand for lower

FEDERAL REGISTER, VOL 41, NO. 223-WEDNESDAY, NOyEMBER 17, 1976

50682


-quality water. The recycle/reuse practiceswithin the pharmaceutical Industry are var-ied and only a few,examples are describedbrieflybelow:

I. MinImizing the use of once-throughcooling water by recycling through coolingtowers Isusedin-umerous plants and resultsin -tremendously decreased total wastewater-discharge. - 7

2. Dilute waste- srubber waters are col-lected by one pharmaceutical plant and areused to wash equipment Although this prac-tice Is not applicable to all segments of theindustry, it can lead to a substantial reduc-tion In water usage and should be consideredIn situations whereit:does not pose a seriousthreat of product contamination.

3. Several plants reuse waste delonlzedrinse water for cooling, tower makeup.

4. Waste cooling water-from one plant wascollected In a pond and held as a sourceof water for fireprotection.

AT-SOURCE

The.surv.ey indicated that at-source in-plant abatementumeasures to protect down-stream biological treatment plants werepracticed by a n Lmber of plants within thispoint source category. Those manufacturingplants utizing at-source pretreatment wereusually found in subcategories A and C. 'Theparticular pretreatment processes utilized-are discussed below:

cyA-NIDE EzSRucriox

The purpose of the cyanide treatment is toreduce high levels of cyanide from raw wastestreams by alkaline chlorination prior todischarging the waste Into an activatedsludge treatment system. The treatment ofcyanide wastes by alkaline chlorination in-volves- the addition of chlorine to a waste of

. high pH. Sufficient alkallnity, usually Ca(OH)2 or NaOH, Is added prior -to chlorina-tion to bring the waste to ,a pHof about 11. -Violentagitation must sccomp any the chlorl-nation-to prevent the byanide salt from pre-cipitating out prior to oxidation and by-drolysis. About 7 to 9 pounds each of causticsoda and chlorine are normally required tooxidize one pound of CN to N2 and C02.However, variation can be expected, depend-ing on the COD -nd alkalinity of the waste.Destruction of 99.7 percent of cyanide hasbeenschievedby one plant.

Cyanide removal can also be accomplishedby electrolytic destruction and by ozoniza-tion.

MERCURY REMOVAL

-Mercury zemoval can be accomplished bytechniques such as sulfide precipitation, Ionexchange, reduction, or adsorpton One man-ufacturing plant insubcategory C producese. product reuirling the use of mercury. Thewaste'fromn this process contains about 25rng/l of -mercury. In order to protect thebiological treatment system utilized to treatthe plant's chenical wastes, the mercury-contaminated -wastewater Is'pretreated. Pre-treatment consists of exposing the waste tonine -under the proper chemical conditionsto permit the nalgamation of the twometals. The mercury concentration has beenreduced to less than 5 mg/L The contents ofthe holding.tank are mixed -with other chemi-cal wastes to further reduce the mercuryconcentration before it is discharged to acti- -vated sludge treatment. The mercury-zincsludge Is disposed of by a private -disposalcontractor.

A555IO=I aEMOVAL

Two plants In subcategory C use ammoniacompounds in their manufacturing processesresulting in waste streams containing 25 to3.0 percont ammonia. A iteam stripping col-man Is utilized to reduce this concentrationto about 0.6 percent after which it is mixed

with other chemical waste streams to diluteIt before treatment by an activated sludgesystem. The stripped ammonia Is returned tothe process and reused.

UxCELIA REMOVAL

Based on survey Information from morethan a dozen fermentation plants, It was de-termined that many pharmaceutical fermen-'tation plants separate the mycelium by fil-tratlon. In addliton, some pharmaceuticalfermentation product manufacturers bavedeveloped an animal feed supplement marie:ofor their dried and concentrated waste fer-mentation broths and waste mycellum. Thezein-plant abatement measures reduce the rawwaste load that otherwise would appear aspa-t of the influent to the biological, waUte-water treatment plant.

SOLTET- REMO"VAL

Recovery of solvents is a common practiceof the refining process for a number of anti-biotic products In subcategory A as well assynthetic chemicals In subcategory C. iE-clent recovery Is important In terms of man-ufacturing cost, as well as reduced wastetreatment requirements. Some strongstrength solvent wastes are incinerated to re-duce the influent raw waste load to thewastewater treatment plant.

szwE SEcREGATION"

In order to provide effclent treatment ofthe wastes originating within a-pharmeceu-tical'plant segregation of concentrated wastestreams frequently simplifies waste treatmentproblems. Wastewaters were often zegregatedasfollows:

1. Strong waste streams.2. Weak waste streams.3. Contaminated stormwater from. process

areas and tank farms.4. Special wastes such as spent caustics,

spent acids, wasto solvents, and metal-bear-ing wastes.

5. Non-contact cooling water.6. Stormwater drainage streamsSegregation and incineration of strong

wasto streams are being practiced by manypharmaceutical plants; however, potential forfurther segregation still exists. For example,some plants might find that the most cost-effective waste treatment program would In-clude Incineration of extremely concentratedwastes, and biological treatment of inter-mediate strength wastes.

Separation of stormwater runoff is prac-ticed through the industry and, as discussedpreviously, this practice often facilitates theisolation and treatment of contaminatedrun-off. The Isolation of wastes containingpollutants that may require specializedtreatment such as metals, arsenic, ammoniaand -cyanide is also a demonstrated practicein the pharmaceutical industry which per-mlts effective removal of such pollutants.

Segregation of non-contact cooling waterIs also practiced within the industry. Thispractice not only reduces the quantity of'wastewater that must be treated, but also fa-cilities water reuse either prior to or aftertreatment.

END-OF-PIPE CONLo L,TECHi2OLOG

In the pharmaceutical manufacturingpoint source category, end-of-pipe controltechnology relles heavily upon the use ofbiological treatment methods. Pretreatmentmost often consists of equalization basins tominimize shock organl loads, neutralizationfor pH control and clarLiers to remove soldThe control of pH Is ometime accomplishedin separate basins provided for the purpoce,but It can be .done In equalization basins. Inone plant the addition ofmeutralizing chemi-cas Is done on the basis of monitoring thepH In the activated sludge process Itself.

506&3

Other pretreatment methods observed Ili-elude cooling of waste and use of roughingfilters to reduce organic loadings. Effluentpolishing was utilized by many plants, andsystems observed included polishing ponds,cascades and rand filters. Odor control andphosphate removal systen were also ob-served. One pharmaceutical plant nanufac-turing subcategory A and C products utilizedthermal oxidation and A liquid evaporationproce-z to treat its *astewaters. No activatedcarbon adsorption systems were observed forpharmaceutical wastewaters; however, thereare literature references Indicating that thistechnology is being used in this indur.

Though the present practice is to select abiloglical treatment-method as an end-of-pipe treatment, other treatment techniquesare emerging with go6d potential. Evapora-tion and the thermal oxidation of strongwaste streams are becoming more attractivefor thos wastevaters which have signiflc ntfuel value. In some cases, high fuel require-menta would discourage the use of such tech-nlqucs. Other techniques, including reverseom06% ultrafltration, ozonlzation, and ion -exchange, are being studied and have goodpotential. For treating strong pharmaceuticalwatewater, an activated sludge system usingpure oxygen Is utilized by a pharmaceuticalplant.

17r cOST MODEL

The following Is a brief discussion of thetreatment technology available and the ra-tionale for selection of the unit processesincluded.

RATION5ALE FORSELEaCTION OF Musrr TPXz~AT=rsXfMOCE.SS SUBCAITGORIES A. 3, C, D, AND Z

The raw waste loads for subcategoriesA and C are significantly higher thanother subcategories. The high raw wasteloads found In subcategory A are a directresult of the low conversion of raw materialsto crude final product. With produ t yieldsIn the range 1 to 5 percent, it follows that95 to 99 percent of the rawmaterials chargedto a fermentator become waste products. Insubcategory C, refractory raw materials arefrequently used In chemical reactors to syn-thes ze complex chemical compounds. Un-reacted materials and by-prducts in sub-category C frequently generate a muchharsher raw waste load than is found in sub-category B. which handles naturally occur-ring substances. Subcategory D raw wasteloads tend to be weak in that formulationand packaging operations tend to be dryprocesses or closely monitored wet processes.The value of the -product and FDA regula-tions preclude the possibility of high rawwast loads from this subcategory. Subcate-gory E raw waste loads are low due to thefact that the size of the operation is smallerin terms of production since it is researchoriented.

Equalization facilities are provided In orderto minimize short-interval (eg., hourly)fluctuations In the organic loading.to thetreatment plant, as well as to absorb slugleads from reactor cleanouts and accidentalspills, and to minimize the usage of neutral-ization chemicals. On the basis of averageflow, two-day detention time Is provided forsubcategory B, D. and E flows. The largedetention time is provided .to allow for thehydraulic and organic variability inherent inmanufacturing facilities operating less than24. hours per day and, seven days per week.The added detention time will provide forcontinuous seven days per week operation, ofthe -waste-water treatment facities..

In subcategories A and C the equalizationfunction has been combined with aeration inthe four-day aeration'bas1w, which are ar-ranged In at least two ceils with provisionfor optional series or parallel flow.

FEDERAL REGISTER, VOL 41, NO. 223---VEDNESDAY, NOVEMBER 17, 1976


Depending on the Individual plant's prod-uct mix, it may be necessary to neutralize thewastewater after equalization to make itmore amenable to biological treatment.Neutralization facilities are provided forsubcategory A and C wastes; however, neu-tralization Is not required for subcategory B,D ard E wastes.

Primary clarification units are included forsubcategories A and C; however, they are notincluded In subcategory B, D, and Z facil-ities because the TSS RWL data indicated itwould not be necessary to remove TSS beforebiological treatment.

For all subcategories, a single-stage acti-vated sludge process was selected because ofits demonstrat~i ability to efficiently treatpharmaceutical wastes. Although a single-stage activated sludge treatment system hasbeen selected for the purpose of developingcost models and if properly operated will al-low compliance with these regulations, amulti-stage activated sludge treatment sys-tem merits consideration for subcategories Aand C. Single-stage processes have providedefficient treatment; however, use of a multi-stage systenfbr subcategories A and C maybe desirable for the followiing reasons:

I. Greater overall removal of BOD.2. Increased stability and more consistent

performance.3. Greater stability against shock loads.4. Ability to nitrify In the second stage,

resulting in some NH3 removal.Activated sludge facilities require sludge

disposal. In the biological process, for everypound of BODS removed from a wastewater,approximately 0.6 pound of TSS (biologicalsolids) -is produced which must be removedfrom the system. Suspended solids may bepresent as a result of most pharmaceuticalprocesses. Theta may generally be rpmovedby-sedimentation clarification, filtration andcentrifugatlon.

The BPT treatment model proposes sludgedisposal by landfilling of the dewatereddigested biological 'sludge with the pos-sibility of utilizing wet sludge in nearbyfarming operations. If practiced correctly,landfilling of the digested biological sludgedoes not create health hazards or nuisanceconditions. Sludge incineration is a viablealternative, but not included In the treat-ment model due to high fuel requirementsand high cost. Sludge incineration Is prac-ticed by some plants where sludge is in.cinerated along with other solid waste andstrong waste streams with high fuel value,reducing the auxiliary fuel requirement toa minimal level. High inert content wastessuch as filter cakes which contain heavymetals or corrosives should be placed in %chemical waste landfill. Characteristics of achemical -waste landfill are described in EPA'Publication. Landfilli Disposal of HazardousWastes; A Review of Literature and KnownApproaches (EPA/530/SW-165). This piub-lication is available from Solid Waste In-formation, U.S. EPA, Cincinnati, Ohio 45268.

A summary of the general design basisused to size the unit processes is presentedn the Development Document.

Good in-process control Is a significantpollution abatement technique for all prod-ucta processed in the pharmaceutical pointsource category. Practices such as mini-mization and containment of spills andleaks, segregation of.waste streams, recoveryof solvents, monitoring process wastewater,water conservation, whter reuse, wastewaterequalization and good housekeeping, are'necessary to eliminate or reduce the volumeof process wastewater requiring treatment.

Some pharmaceutical manufacturing proc-eases are essentially dry, requiring no addi-tional effluent treatment bebause the existingtechnology *averts the discharge of processwv tbwater pollutants under normal operat-Ing conditions.

- If thermal processing (incineration) Is thechoice for disposal, provisions must be madeto ensure against entry of hazardous pol-lutants into the atmosphere. Consideration*should also be given to recovery of materialsof value in the wastes.

For those waste materials considered tobe nonhazardous where land disposal is thachoice for disposal, proper sanitary landfilltechnology must be followed. The principlesset forth in the EPA's Land Disposal of SolidWastes Guidelines 40 CPR Part 241 may beused as guidance for acceptable land dis-posal techniques.

(v) Cost estimates for control of waste-water pollutants. Capital and annual' costswere computed for subdategorles A throughE on the basis of- the hydraulic andbiological loakling for a wastewater treat-ment plant applicable to the respective sub-categories.

Cost information was obtained directlyfrom industry, engineering firms, equip-ment suppliers, government sources, andliterature. Costs are based on actual Indus-trial installations or engineering estimatesfor projected facilities as supplied by con-tributIng companies. In the absence of suchinformation, cost estimates have been de-veloped from either plant-supplied costs forsimilar waste treatment installations atplants making other similar chemicals or-general cost estimates for treatment- tech-nology.

(VI) Energy requirements and non-waterquality environmental impacts. Energy re-quirements associated with treatment andcontrol technologies are not significant whencompared to the total energy requirementsfor this Industry. The percent of totaloperating energy used for wastewater treat-ment ranged from 3.8 to 7.4 in plants manu-facturing lroducts in the A and C subcate-gories. A major use of treatment plantenergy is for sludge incineration: 32 percentof the energy consumed by wastewater treat-ment plant operation was required for sludgeincineration in one case; 78 percent inanother case.

Other nonwater quality aspects, such asnoise ievels," will not be perceptibly affected.Most pharmaceutical plants generate fairlyhigh noise levels [ (85-95) dB] within the bat-tery limits because of equipment such aspumps, compressors, steam jets, flare stacks,etc. Equipment associated with in-process orend-of-pipe control systems would not addsignificantly to these levels.I (vii) Economic and Inflationary Impactanalysis.

Executive Order 11821 (November 27, 1974)requires that major proposals for legislationand promulgation of regulations and rules byAgencies of the executive branch be accm-panied by a statement certifying that the in-flationary impact of the proposal has beenevaluated. The Administrator has directedthat all regulatory actions that are likely toresult In (1) annualized costs of more than$100 million, (2) additional costs of produc-tion more than 5% of the selling price, or(3) an energy consumption Increase equiva-lent to 25,000 barrels of oil per day will re--quire a certified inflationary impact state-ment. The analysis indicates that the totalinvestment required to meet this regulationis $30.03 million with an annual cost of $9.11million.

The interim final effluent limitations andguidelines for 1977 will have a minor effect onprices. Price increases of less than 1 percent(range of 0.022 to 0.29 percent) are pro-jected. No plant closures are projected as aresult- of this regulation; doiiestic Indus-trial capacity will not be affected. The rela-tively small price effects are not expected tocause any important international trade ef-fects.

For subcategory n (Rraearcb), the. 6dilrOltreatment cost represents only 0.03 percent 9ftotal industry researchand development ex-penditures; domestic regvarch and dovolbp-ment efforts should not be affected by thirregulation. Thus the limits presented In thesecriteria have not been exceeded. However, thisanalysis satisfies all the requirementg for aoinflationary impact statement anti It Is here-by certified that the economic and inflation-ary effects of this proposal, have been care-fully evaluated in accordance with EeoutlvoOrder 11821.

A ADprzrD C--StuarAr.Y OV PUDMIcPARTICPATIOU

Prior to this publication, the agencles andgroups listed below wore consulted and givenan opportunity to participate In the develop-ment of effluent limitations, guidelines andstandards of performance propozod for tilepharhaceutical manufacturing point sourcocategory. All participating agencies have beoninformed of project developments. An Initialdraft of the Development Document was sotitto all participants and comments were solic-ited on that report. The following are theprinclifal agencies and groups consulted:Ffluent Standards rnd Water Quality Infor-mation Advisory Committee (establishedunder section 518 of the Act); all State andU.S. Territory Pollution Control Agencies;Academy of Pharmaceutical Sciences, Na-tional Institutes of Health; Monsanto Com-pany; Pfizer, Inc.; U.S. Department of Health,Education, and Welfare: EX, DuPont do No-mours and Company; Allied Chemical Cor-poration; American Cyanarldo CorporationLederlo Laboratories; National EcologicalResearch Center, Dow Chemical CompanyNational Association of PharmaceutialManufacturers; Abbott Laboratories; Officeof Environmental Affairs; BASF WyandotteCorporation; Ohio River Valley SanitationCommission; The Conservation Foundation;Businessmen for the Public Interest; En-vironmental Defense Fund, Inc.; Natural Re-sources Defense Council; American Society ofCivil Engineers; Water Pollution Control Fed-oration; National Wildlife Federation; Ameri-can Hospital Association; Smith, Btuctlln,and Associates, Inc.; Enviroengineoring, Inc.;U.S. Army Environmental Hygiene AgencyValden Research; American Pharmaceutical

Association; Pharmaceutical ManufacturersAssociation; Manufacturing Chemists Aejo-elation; New England Interstate Water Pol-lution Control Commission; Arnerlcan So-ciety of Mechanical Engineers; AmericanMedical Association, Public Health Division;U.S. Water Resouces Council; U.S. Depart-ment of Defense; U.S. Department of Inte-rior; Eli Lilly and Company; Merck and Com-pany, Inc.; and Parke, Davis and Company.

The following organizations responded withcomments for the pharmaceutical manufac-turing point source category: Effluent Stand-ards and Water Quality Information AdvisoryCommittee; Abbott Laboratories; Eli Lillyand Company; Merck and Company, Inc.;North Carolina Department of Natural andEconomic Resources; United States Depart-ment of Defense; Pharmaceutical Manufac-turers Association; and United States De-partment of Interior.

The primary issues raled by commenteraduring the development of the Interim finaleffluent llmitationa and guidelines and theresponse to these comments are as follow2

(1) A commenter did notbeliove that EPAhad the power under section 301 to promul-gate effluent limitations for existing sourcesby regulation. EPA's authority, the com-menter felt, Is to publish, guidelines undersection 304(b), which shall be consulted ,bythe perinit issuing huthbrlty.

'N meurous'roviewing courtb have upheolthe position that EPA has the authority and


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responsibility to issue national effluentlimitations and guidelines pursuant to sec-ti6ns-301 and 304.

(2) In the contractor's draft developmentdocument It was suggested that some of thewaste disposal problems be turned over to aprivate 4isposal contractor, Commenterastated that this is an ineffective way of solv-ing problems unless the contractor is coveredby the sane guidelines. They said that suchcontractors should be covered under thecategory of-"miscellaneous chemicals indus-try., - I. The suggestionithat contract disposal sys-

ters are available was mot meant to implythat the generator of the wastes is relievedof the responsibility for proper disposal. '

(3) Several commenters questioned therationale used to develop recommended efflu-ent limitations and standards of perform-ance for the Aiscellaneous Chemicals Indus-try presentedin February 1975 draft Develop-ment Document because the data base wasinadequate and the data obtained -was Im-properly interpreted. Specifically, the widerange in the amount of wastes produced perunit of product -for any representative listof pharmaceutical products made by mediumto large pharmaceutical plants is convincingevidence that the-nature of the product andthe process rather than production level isthe dominant factor. The commenter statedthat it Is practically and administratively Im-possible to set quantitative standards foreither allowable RWL's or discharges of pol-lutants per unit of production. Some ra-tional -basis for a requlred-percentoge re-duction of RWL is a better means of reg-ulation.. In response to the several points outlinedin this comment the Agency has completelyrevised the BET effluent limitations andguidelines. In most cases the actual limita-tons are based on wastewater treatment ef-ficiencles presertly being achieved by thebetter lants within the category. Estimateswere made of raw -waste load reductions pos-sible by the -us of identified in-plant andend-of-pipe treatment technologies. The ef-fluent reduction capabilities of the Identi-fied BPT end-of-pipe treatment were specl-fled on the basis of percent removal across thewatewater treatment plants for each of thefive subpategories to eliminate difficulties en-countered in the poor correlations betweenRWLs and production. I

(4) Comments were received that statedthat RWL's for each subcategory were Identi-fied for only one set of products and oneproduction schedule. Further, RWL's weredetermined on s collective basis for eachsubcategory-RWL's for the individual prod-ucts were not deterinned. Consequenty, the.commenters concluded that there Is no wayto determine IMWL's for individual productsor assess their individual- treatability. Fur-thermore, in the commenters' opinion, sub-categorization serves no purpose since thereIs as much variation of the various param-eters-wlthin a subcategory as there is be-tween subcategories.- This -comment was made when the draftdocument utilized production based limita-tions. Since then, this document has beenrevised and currently uses a percent removalconcept across the category. The problemsdelineated in the comment have been accom-

* modatedwith the revised approach.,(5) One commenter complained that the

process information given Is far more thannecessary to delineate waste sources, quanqti-ties and characteristics. - -.These regulations do not reveal proprietary

- -or confidential data. However, the Agencymust publish enoug process background in-formation in the Development Document to

- show wastes and waftewatea 'are generated.

Furthermore, It Is incumbent on the Agencyto Indicate. where possible, how in-plantpollution abttement methods can reduceend-of-pipe raw waste loads. Frequently, thssituation requires a descriptlon of the pro-duction of crude product or refining optionsin a general way.

(6) A commentr stated that exemplaryIs not defined in the document and thecorn-mentor is concerned that exemplary partsare those that are high performance treat-ment plants with no recognition given to theindividual circumstances affecting eachplant.

A definition will be Incorporated Into theDevelopment Document supporting this par-ticular point source category. To the extentpossible, a full range of plants will be ex-amined in each subcategory.- (7) A commenter indicated that the pro-posed treatment .effclencles for BPT forBOD5, COD and TOC are either prematureand unnecessary or unreasonably high. Anindustry handling a far more complex wastothan the average POTW receives should notbe expected to provide substantially greaterBODS removal.

To require pharmaceutical wastewatertreatment plants to achieve higher treat-ment efficlencles than POTWs Is not unrea-sonable because the operators of POTWo donot know what wastes to expect from day today and may have less sophisticated equip-ment. On the other hand a pharmaceuticalmanufacturer has the design and operationalcapability to control waste loading and/orthe amount of pollution abatement equip-ment In place. As product mix changes overthe years. the pharmaceutical company canchange its equipment configurations andwastewater treatment proccz:= to handlenew sita tions.

(8) A common criticism expre:s d bY'cv-eral commenters was that atandards of per-formance should be based on 99 percent prob-ability of occurrence rather than the 95percent proposed in the February 1976 draftDevelopment Document.

The regulation has been modified to incor-porate this suggestion. To mltigato the pos-sibility of adverse wastewater treatmentplant operations, a diversion basin is in-eluded in the cost model to handie the prob-ability of encountering high resulto 2 percentof the time.

(9) A comment stated that it would notbe fair to base eifluent limitations for a"vertical production" plant on data derivedfrom plants where only one discreto reactionin a "horizontal production" sequence isperformed, unless the "vertical production"plant is allowed to claim each of its manu-factured derivatives and manufactured rawmaterials as products on which additionalallocations of effluent waste loads may bebased. '

Under the production based limitations,this commenter had a valid concern. How-ever, under the percent removal conceptseach plant Is judged on its unique raw wastoload for a 12 consecutive month periodwithin the most recent 36 months whichshall include the greatest production effort.Hence, the Inequities between horizontal andvertical production from plant to plant axenot germane. If an individual manufactur-ing plant changed its Internal operations anddrastically altered Its raw waste load. a per-mit modification would probably be required.

(10) A commenter indicated that the Feb-ruary 1075 draft Development Document isunclear as to whether animal and feed sup-plements which are produced using fermen-.tation products technology are appropriatelyincluded among these products in ubcate-gory A.

Antibiotics which arme produced by thefermentation process and have an end use as

50W5

additive3 to animal feed products are In-cluded In subategroy A. By-product my-cellum from spent beer Is not considered partof the product base used to calculate allow-able discharge of pollutants per day.

(11) According to one commenter, ther-mal oxidation is only one of several methodsof disposing of C2 wastes and since onlyone plant uses this method, he felt that itIs patently unrealistic to recommend thermaloxidation as BPT for subcategory C2.

Thermal oxidation for dispsing, of sub-category C2 wastes has been abandoned inthe revised BPT cost model for subcategory0 which now include3 pharmaceutical prod-ucts and processes formerly covered Insubcategory C2. Since the cost model is usedonly for developing the economic analysis,this change in the BET cost model shouldnot be Interpreted as discouraging this poe-lution abatement alternative.

(12) Several commenters were displeasedwith the long-term average TSS concentra-tions of 20 rg/i recommended by Roy F.Weston, Inc. the contractor for the 1975 draftDevelopment Document for subcategories B.C2, D, and E. They expressed the opinion thatthia concentration Is unnecessarily severeconsidering the highly expensive operatingand capital costs of polymer addition forcurpended rollds; flocculation and final el_-cllcatlon facilities.

The proposed BPT TSS limitations for allsubcategories were determined by averagingthe effluent TSS results from the same groupof plants selected for the calculation of theaverage of the best wastewater treatmentplanta based on percent removal of BODSand by transfer technology. The values arebased upon the more resent work of a follow-on con mcto;, Jacobs Engineering.

(13) A number of commenters have re-quLted an advance copy of the DdelapmentDocument and guldelinea. Mos cdmplalnedthat the 30 day comm ent period is not suf-flclent.

It Is the Agency's position to keep theregulation writing process as open as poa-able by identifying issues and Indicatingavailable options in advance. To this end dis-cusslons with Industry representatives arebeing held in advance of this publication inthe F=mLs Rcs-T he use of interim finalregulations is necessitated by the court daterequiring the publication of a regulation forthis industry.

(14) A commenter expressed the opinionthat technology transfer is only useful inidentifying technology being used in one in-dustry that might have an application inanother Industry, but It is not a suitable basisfor establishing effluent limitations.

Technology transfer has been utilized inprevious guideline documents as a rationalefor specific waste abatement practices. How-ever. limitations prescribed are based on theapplication of such transferred technology tothe waste waters of the specific Industrialcategory being regulated.

(15) Another commenter noted that otherparameters besides BOD. COD and.'SS (suchas TEN) should have limits applied to them.

The time constraints imposed upon theAgency preclude an exhaustive testing andsampling program for parameters such asTEN at this time. The Agency will continueto study this point source category and sup-plement parameters in the regulation on an"as needed" basis when aufflclent data isavailable.

(16) A commenter stated that the MIT andBAT in most Instances would be Insufficientto protect the water quality of the lowerflow orth Carolina streams Involved and themore stringent water-quality determiiedstandards would apply.

The effluent limitations and guidelines pre-sented herein are based on the practicability

FEDERAL REGISTER, VOL 41, NO. 223-WEDNESDAY, NOVEMBER 17, 1976 -


and availability of control and treatmenttechnologies. More stringent standards maybe applied to a point source, pursuant to sec-tion 303 of the Act, when necessary to pre-serve water quality.

(17) One commenter urged that the U.S.EPA publication "Waste Treatment andDisposal Methods for the Pharmaceutical In-dustry" by.E. J. Struzeski, Jr.. should be-usedin the decision making process when theproposed guidelines are prepared.

This reference publication has been re-viewed by both project personnel in theAgency and contractor personnel. Importantelements have been extracted and utilizedin this regulatory effort.

(18) One commenter requested that sub-categorization which includes Clas E, Micro-biological, Biological and Chemical Researchshould be deleted and the combination offermentation and synthesized organic chem-icals should be included as a subcategory.

The Agency is requiring the pharniaceu-tical point source category to install treat-ment only slightly more sophisticated thanis required of municipal dischargers for sub-category E, Research (Microbiological; Bio-logical and Chemical). The slight incrementIs due to the need to effectively treat testanimal and laboratory wastewaters. TheAgency has reviewed the option of combiningsubeategory A (Fermentation Products) andsubcategory C (Chemical Synthesis Prod-ucts). After considerable deliberation a deci-sion has been reached to keep these subcate-gorics separate, since subcategory A has adistinctly different raw waste lead in theform of mycelia which is non-existent insubcategory C.

(19) A commenter suggested that dualmedia filtration should not be mandatory,as its application depends on the specificwaste.

It should be understood that the treat-ment system used in a particular situation isthe choice of the individual plant manage-ment. Dual-media filtration is well-knownand demonstrated technology, currently usedin the petroleum refining, grain milling andother industries for effluent solids controlThe basic characteristics of the solids in thiseffluent are amenable to treatment in thisway. The Agency has no Intention of makingdual-media filtration mandatory.

(20) Solvent incineration, or recoveryshould be mandatory at all pharmaceuticalplants according to one comment.

The Agency .does not have the power toforce mandatory solvent incineration or ol--vent recovery at all pharmaceutical plants.Furthermore, the Agency simply indicates thetechnology available to achieve BPT limita-tions and leaves the waste treatment options.to the individual plant managers.

(21) A commenter recommended that themetallic ion concentration in any pharma-ceutical waste should not be over 2 mg/L

The Agency has scheduled an intensivereview of potentially toxic chemicals whichinclude pneallic ions.

(22) A commenter noted that segregationof wastes should not be imposed, as thereare cases in which these stream flows arenecessary to reduce the concentration of theorganic load.

In most cases, it may be advisable to segre-gate process streams in order to decrease thehydraulic load and thereby decrease the sizeand cost of pollution control equipment atstrategic points within the process or at thefront end of a treatment train. It should bestressed that the Agency does not mandatesegregation ofwastewater streams.

(23) A commenter stated that secondarytreatment should not, be limited to the ac-tIvated sludge process- Industries equippedwith biofilters should be permitted t* oper-

ate, even If they would not attain the recom-mended parameters.

Bio-fiters, or for that matter other biolog-ical methods, are not meant to be excluded.Activated sludge is presented to provide abaseline cost for the proposed regulations forBPT.

(24) A commentor implied that additionalevaluation of the performance of activatedsludge plants treating fermenter's slopsshould be gathered. The 93 percent reduc-tion in these wastes will be very difficult toattain by activated sludge.

The Agency does have evidence that ac-tivated sludge plants treating fermenter'sslops can attain 94 percent reduction ofBOD5 even though this regulation only spec-ilies 90 percent BODS removal by the waste-water treatment system.

(25) A commenter stated that considera-tion should be given to the fact that thereare some pharmaceutical wastewaters which-are not properly treated by the activatedsludge process. This problem has been experi-enced in plant operations.

The activated sludge plant used in costmodel Is an example of the type of treatmentthat can treat the wastewater generated inthe manufacture of pharmaceutical products.It is currently in use in this category. EPAhas f6und that eleven of the twenty bio-logical treatment plants visited treated mul-tiple subcategory wastes.. The conclusionreached after examining the reductions ob-tainable with present technology is that 94percent BOD5 reduction can be reached.Nevertheless, the Agency has selected a 90percent BOD5 reduction for this interim finalregulation in order to reduce potential eco-nomic impact. Results from these surveysshould identify additional technology thatcan be used to meet or surpass the effluenlimitations. The biological treatment systemmodel used for cost estimating purposes isaccepted and used by the manufacturers of-pharmaceutical products. Of course, thismodel is not required technology, the in-dividual plant personnel are responsible forselecting the most effective treatment sys-tem applicable In their own case.

(26) A commenter pointed out that con-sideration should be given to the fact- thatsynthesized chemical production wastewatersare strong, difficult to treat, and frequentlyInhibitory to biological treatment systems.

In spite of the possibility that subcategoryC wastes may have strong and difficult wastesto treat, the data show that an adequatelydesigned and consistently operated stand-alone treatment plant can achieve 91 percentBODff reduction and a combination subcate-gory A and C wastewater treatment plant canachieve 96 percent BOD5 reduction. It s thejudgment of the Agency that the stand-alone subcategory C plants can apply thenecessary technology to achieve the 3 percentimprovement required to meet the 94 percentBOD5 reduction. Combination plants are al-ready achieving the 94 percent reductionlevel. Hence, a 90 percent BOD5 reductionused for this category is reasonable.

(27) One commentor felt that salt concen-tration in the wastewaters Is a matter of im-portance n some cases and should be dis-cussed more extensively.

The questions of salt concentration is ac-knowledged and Is a part of the continuingstudy of this subcategory for BAT and NSPSeffluent limitations to be proposed In thefuture.

(28) A commenter stated that designcriteria indicated In the Contractor'3 report Isbased on an overall basis. The pharmaceuti-cal industry needs individual and pilot plantstudies to develop design criteria for the spe-cihc wastes.

It should be clearly understood that thetreatment system is presented only as a cootmodel for an average pharmaceutical waste-water treatment plant for the identliled sub-category. The Agency does not hold out thecost model configuration as a univeroaltreatment plant, applicable to every plantwastewater within the mibcategory. It is ac-knowledged that a good design procedurewould involve pilot plant studic ln ,om"cases in order to develop dcsIgn criteria.

(29) The statement that the wastowater,from the pharmaceutical Industry withincategories A and 01 may be amenable tosludge incineration because of large quantl-ties of sludge produced should be roviowedaccording to another commenter.

The Agency Is developing additional datain this respect and will expand the dimuts lonof this point at a future date. In any case theindividual company would be faced with acost trade-off between reducing the volumeof sludge versus transportation, storag andhandling costs of the larger qumatity ofsludge on an "as Is" basis.

(30) A commonter indicated that consid-oration should be given to the actual hydrau-lic and organic load of the exemplary plantaselected, and then baso their perforrnaneoin terms of these loads.

The contractor is familiar with thb ind ofanalysis and has supplied a table In the rv-vised Development Document which Indi-cates which treatment units Pro slzed on hy-draulic load rnd which use organlo load,

-1 (31) One commonter rcm.rt:ed that equal-ization and neutralikation ehould be Itrdonly in those cases where it is neessary, andnot Included as a required regulation.

Neutralization facilitle3 are Included Inthe cost models for subcategories A and Li,but omitted for B, D and E. In the cao ofequalization facilities, subcategorli A nudC employ combined equalization and ara-tion basins with four days residence time, Vorsubcategories B, D and E separato equaliza-tion basins are provided in the cost modelfor each subcategory. It should bo empha-sized that these recommendations are notmandatory. The management for each plantis free to choose the method of achieving anoverall waste load reduction of 90 percentfor BOD5 used In this reulation,

A number of other comments were re-ceived and were considered not be appli-cable to the subcategories being promul-gated today and have been omitted fromthe preceding discussion. Appropriateconsideration and responses will be madeat the time of publication of the re~ula-tions applicable to BAT, NSPS and pre-treatment (new and existing sources).

Interested persons ara encouraged tosubmit written comments. Commentsshould be submitted In triplicate to theEnvironmental Protection Agency, 401M St., 8W., Washington, D.C. 2040, At-tention: Distribution Officer, WH-502.

All comments received on or-beforo

January 17, 1977, and the availability ofthe, Development Document supportingthis interim final regulation will be con-sidered. Steps previously taken by theEnvironmental Protection Agency to fa-ciltate public response within this timeperiod are outlined in the advance noticeconcerning public review procedurespublished on August 0, 1973 (38 FR21202). ,,

IF1MDoc.7&-3380 Filied 11-:1-16,;1"45 amI

FEDERAL REGISTER, VOL. 41, NO. 223-WEDNESDAY, NOVEMBER. 17, 1976

50686