[Federal Register Volume 69, Number 88 (Thursday, May 6, 2004)]
[Rules and Regulations]
[Pages 25324-25325]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-55508]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 439


Pharmaceutical Manufacturing Point Source Category

CFR Correction

    In Title 40 of the Code of Federal Regulations, Parts 425 to 699, 
revised as of July 1, 2003, the duplicated text from pages 401 and 408 
is removed and the following text is reinstated.



Text to be reinstated on page 401:


* * * * *

Appendix A to Part 439--Tables

    Authority: 33 U.S.C. 1311, 1314, 1316, 1317, 1318, 1342 and 
1361.

    Source: 48 FR 49821, Oct. 27, 1983, unless otherwise noted.

General


Sec.  439.0  Applicability.

    (a) This part applies to process wastewater discharges resulting 
from the research and manufacture of pharmaceutical products, which are 
generally, but not exclusively, reported under SIC 2833, SIC 2834 and 
SIC 2836 (1987 Standard Industrial Classification Manual).
    (b) Although not reported under SIC 2833, SIC 2834 and SIC 2836, 
discharges from the manufacture of other pharmaceutical products to 
which this part applies include (but are not limited to):
    (1) Products manufactured by one or more of the four types of 
manufacturing processes described in subcategories A, B, C or D of this 
part, and considered by the Food and Drug Administration to be 
pharmaceutical active ingredients;
    (2) Multiple end-use products (e.g., components of formulations, 
chemical intermediates, or final products) derived from pharmaceutical 
manufacturing operations and intended for use primarily in 
pharmaceutical applications;
    (3) Pharmaceutical products and intermediates not subject to other 
categorical limitations and standards, provided the manufacturing 
processes generate process wastewaters that are similar to those 
derived from the manufacture of pharmaceutical products elsewhere (an 
example of such a product is citric acid);
    (4) Cosmetic preparations that are reported under SIC 2844 and 
contain pharmaceutical active ingredients, or active ingredients that 
are intended for the treatment of a skin condition. (These preparations 
do not include products such as lipsticks or perfumes that serve to 
enhance appearance, or provide a pleasing odor, but do not enhance skin 
care. Also excluded are deodorants, manicure preparations, shaving 
preparations and non-medicated shampoos that do not function primarily 
as a skin treatment.)
    (c) The provisions of this part do not apply to wastewater 
discharges resulting from the manufacture of the following products, or 
as a result of providing one or more of the following services:
    (1) Surgical and medical instruments and apparatus reported under 
SIC 3841;
    (2) Orthopedic, prosthetic, and surgical appliances and supplies 
reported under SIC 3842;
    (3) Dental equipment and supplies reported under SIC 3843;
    (4) Medical laboratory services reported under SIC 8071;
    (5) Dental laboratory services reported under SIC 8072;
    (6) Outpatient care facility services reported under SIC 8081;
    (7) Health and allied services reported under SIC 8091, and not 
classified elsewhere;
    (8) Diagnostic devices other than those reported under SIC 3841;
    (9) Animal feed products that include pharmaceutical active 
ingredients such as vitamins and antibiotics, where the major portion 
of the product is non-pharmaceutical, and the resulting process 
wastewater is not characteristic of process wastewater from the 
manufacture of pharmaceutical products;
    (10) Food and beverage products fortified with vitamins or other 
pharmaceutical active ingredients, where the major portion of the 
product is non-pharmaceutical, and the resulting process wastewater is 
not characteristic of process wastewater from the manufacture of 
pharmaceutical products;
    (11) Pharmaceutical products and intermediates subject to the 
provisions of 40 CFR part 414, provided their manufacture results in 
less than 50 percent of the total flow of process wastewater that is 
regulated by 40 CFR part 414 at the facility.

[63 FR 50424, Sept. 21, 1998]


Sec.  439.1  General definitions.

    As used in this part:
    (a) The general definitions, abbreviations and methods of analysis 
in 40 CFR part 401 shall apply.
* * * * *



Text to be reinstated on page 408:


* * * * *

standards specified in Sec. Sec.  439.23 and 439.24.

[68 FR 12273, Mar. 13, 2003]


Sec.  439.26  Pretreatment standards for existing sources (PSES).

    Except as provided in 40 CFR 403.7 and 403.13, any existing source 
subject to this subpart must achieve the

[[Page 25325]]

following standards by September 21, 2001:

                      Pretreatment Standards (PSES)
------------------------------------------------------------------------
                                                                Maximum
                                                     Maximum    monthly
                Regulated parameter                 daily \1\   average
                                                                  \1\
------------------------------------------------------------------------
Acetone...........................................       20.7        8.2
n-Amyl acetate....................................       20.7        8.2
Ethyl acetate.....................................       20.7        8.2
Isopropyl acetate.................................       20.7        8.2
Methylene chloride................................        3.0        0.7
------------------------------------------------------------------------
\1\ mg/L (ppm).


[68 FR 12273, Mar. 13, 2003]


Sec.  439.27  Pretreatment standards for new sources (PSNS).

    Except as provided in 40 CFR 403.7, any new source subject to this 
subpart must achieve the following pretreatment standards:

------------------------------------------------------------------------
                                                        Pretreatment
                                                        standards \1\
                                                   ---------------------
                                                                Average
                Regulated parameter                  Maximum    monthly
                                                      daily    discharge
                                                    discharge   must not
                                                                 exceed
------------------------------------------------------------------------
1 Acetone.........................................       20.7        8.2
2 n-Amyl acetate..................................       20.7        8.2
3 Ethyl acetate...................................       20.7        8.2
4 Isopropyl acetate...............................       20.7        8.2
5 Methylene chloride..............................        3.0        0.7
------------------------------------------------------------------------
\1\ Mg/L (ppm).


[63 FR 50431, Sept. 21, 1998; 64 FR 48104, Sept. 2, 1999]

Subpart C--Chemical Synthesis Products


Sec.  439.30  Applicability.

    This subpart applies to discharges of process wastewater resulting 
from the manufacture of pharmaceutical products by chemical synthesis.

[63 FR 50431, Sept. 21, 1998]


Sec.  439.31  Special definitions.

    For the purpose of this subpart:
    (a) Chemical synthesis means using one or a series of chemical 
reactions in the manufacturing process of a specified product.
    (b) Product means any pharmaceutical product manufactured by 
chemical synthesis.

[68 FR 12273, Mar. 13, 2003]


Sec.  439.32  Effluent limitations attainable by the application of the 
best practicable control technology currently available (BPT).

    Except as provided in 40 CFR 125.30 through 125.32, any existing 
point source subject to this subpart must achieve the following 
effluent limitations representing the application of BPT:
    (a) The limitation for BOD5 is the same as specified in 
Sec.  439.12(a).
    (b) The limitation for TSS is the same as specified in Sec.  
439.12(b).
    (c) The limitations for COD are the same as specified in Sec.  
439.12(c) and (d).
    (d) The limitations for cyanide are the same as specified in Sec.  
439.12(e), (f) and (g).

[63 FR 50431, Sept. 21, 1998, as amended at 68 FR 12273, Mar. 13, 
2003]


Sec.  439.33  Effluent limitations attainable by the application of the 
best conventional pollutant control technology (BCT).

    Except as provided in 40 CFR 125.30 through 125.32, any existing 
point source subject to this subpart must achieve the following 
effluent limitations representing the application of BCT: Limitations 
for BOD5, TSS and pH are the same as the corresponding limitations in 
Sec.  439.32.

[63 FR 50432, Sept. 21, 1998]


Sec.  439.34  Effluent limitations attainable by the application of 
best available technology economically achievable (BAT).

    Except as provided in 40 CFR 125.30 through 125.32, any existing 
point source subject to this subpart must achieve the following 
effluent limitations representing the application of BAT:
    (a) The limitations are the same as specified in Sec.  439.14(a).
    (b) The limitations for COD are the same as specified in Sec.  
439.12(c) and (d).
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[FR Doc. 04-55508 Filed 5-5-04; 8:45 am]
BILLING CODE 1505-01-D