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Pharmaceutical Regulations

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second most common categorical IU in NC 29 in 17 cities. grouped together ... be used as BPJ for bioengineering operations if products and wastewater ... – PowerPoint PPT presentation

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Title: Pharmaceutical Regulations


1
Pharmaceutical Regulations
  • Dana Rees Folley
  • DWQ Pretreatment, Emergency Response, and
    Collection Systems Unit (PERCS)
  • NC Pretreatment Consortium Annual Pretreatment
    Workshop
  • September 19, 2006

2
Pharmaceuticals - 40 CFR 439
  • second most common categorical IU in NC 29 in
    17 cities
  • grouped togethertown with 3 SIUs all 439town
    with 80 SIUs - 2 439s
  • 5 subcategories - 4 ways to make drugs, plus
    research

3
Pharmaceuticals - 40 CFR 439
  • Federal Categorical Regulation
  • 10/27/1983 - EPA published original Rule in
    Federal Register
  • Only regulated cyanide
  • IU could certify cyanide not used or generated
    then not considered categorical

4
Pharmaceuticals - 40 CFR 439
  • 5/2/95 - EPA published Proposed New Rule
    added ammonia and many organics parameters
  • 9/21/98 - EPA published Final Rule in Federal
    Register
  • BUT

5
Pharmaceuticals - 40 CFR 439
  • Revised Six Times!
  • Most typos and reorganization
  • But
  • 3/4/99 preamble wording changes limits
    changes due to rounding errors and typos
  • 3/13/03 - delete methyl cellulose altogether
  • 3/16/99, 9/2/99, 6/11/03, 5/6/04

6
Pharmaceuticals - 40 CFR 439
  • EPAs Pharmaceutical Web-sitehttp//www.epa.gov/w
    aterscience/guide/pharm/
  • All FR publications
  • Analytical Guidance
  • Permit Guidance
  • Pharmaceutical Info on PERCS Web-sitehttp//h2o.e
    nr.state.nc.us/percs/
  • Pharmaceutical Sections on Pretreatment Permit
    Writing and Headworks Analysis Pages 40 CFR 439
    7/1/05 version lots more

7
40 CFR 439 Applies to -
  • Research and manufacturing of pharmaceuticals,
    which are generally, but not exclusively,
    reported under SIC codes
  • 2833 medicinal chemicals and botanical products
  • 2934 pharmaceutical preparations
  • 2836 biological products, except diagnostic
    substances.

8
40 CFR 439 Applies to (cont.) -
  • Other products manufactured by 4 subcategory
    methods - fermentation, extraction, chemical
    synthesis, mixing, compounding and formulation -
    And
  • considered pharmaceutical active ingredient by
    FDA
  • Or
  • Multiple end-use products intended for use
    primarily in pharmaceutical application

9
40 CFR 439 Applies to (cont.) -
  • pharm products intermediates not subject to
    other categorical regs, provided manufacturing
    generates process wastewaters similar to those
    derived from manufacture of pharmaceuticals (ex.,
    citric acid)
  • Cosmetic preparations SIC 2844 containing
    pharmaceutical active ingredients, or active
    ingredients intended for treatment of a skin
    condition

10
40 CFR 439 Does Not Apply to
  • 439.0(b)(4) and 439.0(c)(1) (11) - various
    products that are excluded
  • Medical/dental/lab instruments, equipment,
    services
  • Food/Beverage/Animal feed with vitamins,
    antibiotics, pharmaceu-tically active, if mostly
    non-pharm and characteristics dif from 439
  • OCPSF Pharm CIUs where pharm portion lt50
  • 439.2(j) special definition of process
    wastewater that excludes more flows

11
40 CFR 439 Does Not Apply to
  • EPAs January 2006 Pharmaceutical Permit
    Guidance-More exclusions clarifications
  • Page 3-3, 8-1516 439 could be used as BPJ for
    bioengineering operations if products and
    wastewater characteristics are similar to 439
  • 8-16 Incidental Passivating Electropolishing
    during cleaning of Process Tanks - Not 433
  • Guidance on developing permit limits, monitoring
    requirements, case studies

12
40 CFR 439 Applicability
13
40 CFR 439 Applicability
  • Ask lots of questions!
  • Read regulation with SIU and have them explain
    terms in regular words and words used in the
    industry
  • and have them explain what they do and why they
    think they are or are not covered by which parts
  • Confirm with PERCS
  • Document in IUP Synopsis
  • Including why not covered

14
Each Subpart-5 Sets of Limits
  • BPT, BCT, BAT, NSPS For direct dischargers,
    i.e., pharmaceutical has their own NPDES permit
  • PSES - Pretreatment Standards for Existing
    Sources
  • PSNS - Pretreatment Standards for New Sources
  • Dont confuse with NSPS New Source Performance
    Standards

15
Each Subpart-5 Sets of Limits
  • PSES PSNS 439 Limits Identical
  • Only Issue When must comply
  • New Source Date 5/2/95
  • begin construction or significant change
    after this date New Source. See 403.3(m) for
    details.
  • Existing Sources must comply by 9/21/2001
  • New Sources must comply immediately upon start-up

16
439 Subpart A - Fermentation
  • Process operations that utilize a chemical change
    induced by a living organism or enzyme,
    specifically bacteria, or the microorganisms
    occurring in uni-cellular plants such as yeasts,
    molds, or fungi to produce a specific product
  • PSES PSNS limit cyanide, ammonia, and 22
    organic compounds
  • Same limits as Subpart C

17
439 Subpart B - Extraction
  • Process operations that derive pharmaceutically
    active ingredients from natural sources such as
    plant roots and leaves, animal glands, and
    parasitic fungi by chemical and physical
    extraction
  • PSES PSNS limit 5 organic compounds
  • Same limits as Subpart D

18
439 Subpart C - Chemical Synthesis
  • Process operations that utilize a chemical
    reaction or series of chemical reactions in the
    manufacturing process of a specified product
  • PSES PSNS limit cyanide, ammonia, and 22
    organic compounds
  • Same limits as Subpart A

19
439 Subpart D Mixing, Compounding Formulation
  • Mixing, compounding, and formulating operations
    means processes that put (previously
    manufactured) pharmaceutical products into dosage
    forms
  • Includes ampules, tablets, capsules, vials,
    ointments, medicinal powders, solutions, and
    suspensions
  • both human and veterinary use
  • PSES PSNS limit 5 organic compounds
  • Same limits as Subpart B

20
40 CFR 439 Subpart E - Research
  • process wastewaters, products, or services
    resulting from research and product development
    activities
  • no PSES or PSNS yeah!!

21
Categorical versus Local Limits
  • Categorical-Technology Based
  • 439 pollutants and untreated concentrations
  • Pre-treatment technologies available, and
    expected effluent
  • Cost of installing operating close down too
    many CIUs?
  • If no, and CIU technology has higher removal rate
    than typical POTW, assign expected effluent as
    pretreatment categorical limit
  • Compare costs to environmental benefits, but not
    deciding factor

22
Categorical versus Local Limits
  • Local Limits Technically Based
  • How much and still protect stream, WWTP bugs,
    sludge, people
  • Ammonia,Cyanide Regular HWA/AT

23
Pharmaceutical Organics Headworks Analysis (POHWA)
  • Spreadsheet and Directions on PERCS HWA web-page
  • Download
  • Fill in blue outlined fields (ask PERCS for
    stream flows)
  • Complete Allocation Table, including other IUPS
    with Organics limits (ex. OCPSF)
  • Reduce IUP limits below categorical to resolve
    over allocation
  • Submit with IUP

24
Proposed New NC Benzene Water Quality Standard
  • NC Water Quality Standard for Class C Waters
    proposed as part of Triennial Review
  • Reduce from 71.4 ug/l to 51 ug/l
  • Benzene Class WS Waters - No change
  • DWQ Planning Section, Classification Standards
    Unit, Jeff Manning ext. 579
  • http//www.ncwaterquality.org/csu/TriRCurrent.html
    TRIENNIALReview
  • Triennial Review - changes for other
    (non-pharmaceutical) parameters, too.

25
40 CFR 439 Ammonia Limits
  • Subpart A Fermentation 439.16, .17
  • Subpart C Chemical Synthesis .36, .37
  • PSES and PSNS Ammonia limits not applicable to
    CIU if POTW nitrifies as defined in 439.1(I)
  • Discuss in IUP Synopsis
  • Still may need IUP Ammonia Limit to protect WWTP
    (CIU average discharge gt5 MAHL)
  • If have Limit, Composite POTW min. 1/6 months
    SIU up to POTW

26
40 CFR 439 Cyanide Limits
  • Subpart A Fermentation .16, .17
  • Subpart C Chemical Synthesis .36, .37
  • PSES and PSNS Cyanide limits not applicable if
    CIU certifies to POTW that manufacturing
    processes neither use or generate cyanide
  • Discuss in IUP Synopsis
  • If have Limit, Grab POTW min-1/6 months SIU
    up to POTW
  • Can composite preserved grabs over 24 hours
  • 1983 cyanide limits for Subpart B and D are
    withdrawn

27
439 Organic Pollutant Analysis
  • 9/21/98 Federal Register also modified 40 CFR 136
  • 40 CFR 136.3(a)Table IF Approved Methods for
    each parameter
  • New EPA Methods 1666, 1667, 1671
  • 40 CFR 141 Drinking Water Methods 502.2 and 524.2
  • ASTM Methods D3371, D3695, D4763
  • 40 CFR 136.3(b)(40) Lists Method Sources

28
439 Organic Pollutant Analysis
  • Subparts A and C 2 or 3 Approved Methods to
    cover all POCs
  • Subparts B and D 524.2 for acetone and methylene
    chloride, 1666 for three acetates
  • Only one lab does 1666 (main method)
  • 1666 expensive, plus more to do multiple
    methods
  • NC DWQ Lab Certification not available for most
    Table IF Methods

29
439 Organic Pollutant Analysis
30
439 Organic Pollutant Analysis
  • 136.3(d)(f) allows Alternative Methods
  • EPA August 1999 Guidance allows transfer of
    analytes to another method (Table IF or
    Alternative)
  • Must show that will adapt Alternative Method
    and/or Analyte Transfer to meet QA/QC of
    applicable Table IF Method
  • POTWs choice to allow Alternative Method or
    Analyte Transfer to be explored
  • Lab must submit documentation to NC DWQ Lab
    Certification Unit for approval

31
439 Organic Pollutant Analysis
  • Example A few NC labs approved by NC DWQ Lab
    Cert to use 6210D from Standard Methods for the
    3 Subpart BD acetates, with conditions
  • One also approved to modify 6210D for acetone and
    methylene chloride
  • 6210D is now 6200B in Standard Methods 20th
    edition
  • Other Alternative Method Options
  • 40 CFR 136 Methods 601, 602, 604, 612, 624, 625,
    1624, and 1625
  • Solid Waste Method 8260B
  • Maybe others?

32
439 Organic Pollutant Analysis
  • Analytical Methods for Determination of
    Pollutants in Pharmaceutical Manufacturing
    Industry, EPA July 1998
  • Methods 1666, 1667, and 1671
  • Analytical Method Guidance for the Pharmaceutical
    Manufacturing Point Source Category, EPA August
    1999
  • Alterative methods and analyte transfer
    procedures
  • Solutions to matrix problems
  • Choosing the best method
  • Questions and answers

33
439 Organic Pollutant Analysis
  • NC DWQ Lab Certification not available for most
    Table IF Methods
  • Available for some but not all Alterative Methods
  • Pretreatment Permits typically require Certified
    Lab (Part II, 4)
  • POTWs must include special test method language
    in IUP
  • Updated Example IUP Language on Permit Writing
    Page

34
439 Organic Pollutant Analysis
  • David Livingston
  • NC DWQ Laboratory Certification Unit
  • 919-733-3908, ext. 272
  • david.livingston_at_ncmail.net
  • http//h2o.enr.state.nc.us/lab/index.htm

35
Surrogate Organic Pollutants 40 CFR 439.1(o)
  • Allows monitoring for one pollutant to serve as
    surrogate for a group of other specific
    pollutants
  • Must receive same level of pretreatment as
    surrogate and be in same treatability class as
    surrogate See Table 2 of Appendix A
  • Violation of limit for surrogate means are
    considered to violate limits for all pollutants
    represented by that surrogate

36
Surrogate Organic Pollutants 40 CFR 439.1(o)
  • Where more than one surrogate is available in
    treatability class, must use surrogate with
    highest concentration at that CIU
  • Optional but must be approved by POTW
  • Example Subpart B D Method 1666 for three
    acetates plus Method 524.2 for acetone and
    methylene chloride
  • Acetone can be Surrogate for all three acetates,
    so dont need Method 1666

37
Organic Pollutants Not Usedor Generated 40 CFR
439.4
  • Determination based on
  • Review of all raw materials in use
  • Assessment of process chemistry, products and
    by-products resulting from each manufacturing
    process
  • Submit to POTW for approval
  • Annual reconfirmation sample still required -
    by POTW or SIU
  • Updated Example IUP Language on Permit Writing
    Page

38
Organics Sampling
  • Limit in IUP Min once per year by POTW SIU
    sampling-up to POTW
  • Pollutant neither used or generatedAnnual
    re-confirmation sample by POTW or SIU (POTWs
    choice)
  • Grab or Composite - POTWs choice, must be
    representative of CIUs discharge without
    jeopardizing the integrity of the volatile
    organic compounds found in the sample
  • Can collect series of grabs in 24 hour period and
    composite them in lab if Method allows

39
Costs of Organics Sampling
  • Organic sampling may cost 1,000 or more
  • POTW Cost Recovery
  • Permitting Fees
  • Sample Collection Fees
  • Sample Analysis Fees
  • Administration Fees

40
Organics Sampling in LTMP/STMP
  • May be required if SIU discharges a significant
    amount
  • Case by Case Basis

41
439 IUP Limits
  • Concentration based 439 limits apply directly if
    sample location contains NO dilution wastestreams
    see 403.6(e)
  • Otherwise, Combined Wastestream Formula (CWF)
    uses process to total flow ratio to adjust 439
    limit down
  • if CWF limit below detection, cannot apply CWF.
    Instead, SIU must provide process only sample
    location
  • Can convert to Equivalent Mass Limits per 40 CFR
    403.6(c)(5)

42
Potential Impact to Other Industrial Users
  • Directly-None
  • Indirectly-YES!
  • New HWA and New MAHLs may bring new things to
    light
  • Identify New Pollutants of Concern (POCs)
  • May need data from other industrial users
  • Collection system data

43
Overwhelmed?
44
Thank You!
  • Dana Folley
  • NC DWQ PERCS
  • (919) 733-5083 ext. 523
  • dana.folley_at_ncmail.net
  • http//h2o.enr.state.nc.us/percs/
  • http//www.epa.gov/ost/guide/
  • http//www.epa.gov/waterscience/guide/pharm/

45
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