[Federal Register Volume 64, Number 42 (Thursday, March 4, 1999)]
[Rules and Regulations]
[Pages 10391-10394]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-5106]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 136 and 439

[FRL-6304-8]
RIN 2040-AA13


Pharmaceutical Manufacturing Category Effluent Limitations 
Guidelines, Pretreatment Standards, and New Source Performance 
Standards; Final Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; correction

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SUMMARY: EPA is correcting minor errors in the preamble and effluent 
limitations guidelines and standards for the pharmaceutical 
manufacturing point source category, which appeared in the Federal 
Register on September 21, 1998 (63 FR 50388).

EFFECTIVE DATE: These corrections shall become effective March 4, 1999. 
In accordance with 40 CFR 232, this rule will be considered promulgated 
for purposes of judicial review at 1:00 P.M. Eastern time on March 18, 
1999.


[[Page 10392]]


FOR FURTHER INFORMATION CONTACT: Dr. Frank H. Hund, Office of Water 
Engineering and Analysis Division (4303), U. S. Environmental 
Protection Agency, 401 M St., SW, Washington, DC, 20460, (202) 260-
7182, [email protected].

SUPPLEMENTARY INFORMATION: In a final rule published on September 21, 
1998 (63 FR 50388), EPA established final effluent limitations and 
standards for the pharmaceutical manufacturing point source category 
for the control of wastewater pollutants. The final rule contained 
minor typographical errors and errors in the rounding of several of the 
numerical limitations to a specific number of significant figures. This 
document corrects those errors.

Administrative Requirements

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 
action is not a ``significant regulatory action'' and is therefore not 
subject to review by the Office of Management and Budget. In addition, 
this action does not impose any enforceable duty, contain any unfunded 
mandate, or impose any significant or unique impact on small 
governments as described in the Unfunded Mandates Reform Act of 1995 
(Pub. L. 104-4). This rule also does not require prior consultation 
with State, local, and tribal government officials as specified by 
Executive Order 12875 (58 FR 58093, October 28, 1993) or Executive 
Order 13084 (63 FR 27655, May 10, 1998), or involve special 
consideration of environmental justice related issues as required by 
Executive Order 12898 (59 FR 7629, February 16, 1994).
    Because this action is not subject to the notice-and-comment 
requirements under the Administrative Procedure Act, 5 U.S.C. 553, or 
any other statute, it is not subject to the regulatory flexibility 
provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). 
This rule also is not subject to Executive Order 13045 (62 FR 19885, 
April 23, 1997) because EPA interprets E.O. 13045 as applying only to 
those regulatory actions that are based on health and safety risks, 
such that the analysis required under section 5-501 of the Order has 
the potential to influence the regulation. This rule is not subject to 
E.O. 13045 because it does not establish an environmental standard 
intended to mitigate health or safety risks. EPA's compliance with 
these statutes and Executive Orders for the underlying rule is 
discussed in the Federal Register notice of September 21, 1998. This 
action contains no information collection requirements. Therefore, no 
information collection request has been submitted to the Office of 
Management and Budget (OMB) for review and approval under the Paperwork 
Reduction Act of 1980, 44 U.S.C. 1501, et seq.
    The revisions in this final rule are not substantive. These 
revisions correct minor typographical errors and errors in the rounding 
of several numerical limitations. For this reason, EPA has determined 
that public participation in this action is unnecessary and constitutes 
good cause for issuing this rule without notice and comment. For the 
same reason, the Agency has determined that good cause exists to waive 
the requirement for a 30 day period before the amendments become 
effective and therefore the amendments will be immediately effective.
    The Congressional Review Act (CRA), 5 U.S.C. 801 et seq., as added 
by the Small Business Regulatory Enforcement Fairness Act of 1996, 
generally provides that before a rule may take effect, the agency 
promulgating the rule must submit a rule report, which includes a copy 
of the rule, to each House of the Congress and to the Comptroller 
General of the United States. Section 808 allows the issuing agency to 
make a rule effective sooner than otherwise provided by the CRA if the 
agency makes a good cause finding that notice and public procedure is 
impracticable, unnecessary or contrary to the public interest. This 
determination must be supported by a brief statement. 5 U.S.C. 808(2). 
As stated above, EPA has made such a good cause finding, including the 
reasons therefor, and established an effective date of March 4, 1999. 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 439

    Environmental protection, Incorporation by reference, Reporting and 
recordkeeping requirements, Water pollution control.

    Dated: February 22, 1999.
J. Charles Fox,
Assistant Administrator for Water.

    The following corrections are made in FRL-6135-7, Final Effluent 
Limitations Guidelines and Standards for the Pharmaceutical 
Manufacturing Point Source Category, which was published in the Federal 
Register on September 21, 1998 (63 FR 50388).
    1. On page 50392 column 1 line 38 ``BO 5'' is corrected 
to read ``BOD 5''. 11
    2., 3., and 4. On page 50392 column 2 lines 3, 6, and 7 ``BO 
5'' in each instance is corrected to read ``BOB 
5''.
    5., 6., 7., and 8. On page 50394 in column 2 lines 15, 19, 55, and 
60, ``BOD 5'' in each instance is corrected to read ``BOD 
5''.
    9. On page 50398 column 1 line 47, the word ``plants'' is removed.
    10. On page 50402 column 1 line 48, ``passthrough'' is corrected to 
read ``pass through''.
    11. On page 50409 column 2 line 38, ``(July, 1998'' is corrected to 
read ``July, 1998''.
    12. On page 50410 column 3 line 31, ``are'' is corrected to read 
``were''.
    13. On page 50412 column 1 line 34, ``XI.B.9.g'' is corrected to 
read ``VI.B.9.G''.
    14. On page 50421 column 1 line 26, the word ``that'' is removed.
    15. On page 50421 column 2 lines 60 and 61, the phrase ``Mass 
loading at the relevant point of measurement)'' is removed.
    16. and 17. On page 50422 column 2 lines 44 and 49, remove the word 
``proposed.''
    18. On page 50422 column 3 line 21, remove the phrase ``being 
proposed today.''
    19. On page 50423 column 3 line 62, remove the phrase ``which the 
discharge occur'' and replace with ``which the discharge will occur''.
    20. On page 50426 column 1 line 5, the phrase ``part a 
determination'' is corrected to read ``part, a determination''.


Sec. 439.14  [Corrected]

    21. On page 50427 in the table for Sec. 439.14, the numerical value 
listed in the column entitled ``Average monthly discharge must not 
exceed'', corresponding to the entry ``24 Chloroform'' in the 
``Regulated parameter'' column is changed from ``0.01'' to ``0.013''.


Sec. 439.15  [Corrected]

    22. On page 50428 in the table continued from the previous page, 
the numerical value listed in the column entitled ``Maximum daily 
discharge'', corresponding to the entry ``17 Methyl Cellosolve'' in the 
``Regulated parameter'' column is changed from ``25.0'' to ``100.0''.
    23. On page 50428 in the table continued from the previous page, 
the numerical value listed in the column entitled ``Average monthly 
discharge must not exceed'', corresponding to the entry `` 17 Methyl 
Cellosolve'' in the ``Regulated parameter'' column is changed from 
``10.2'' to ``40.6''.

[[Page 10393]]

    24. On page 50428 in the table continued from the previous page, 
the numerical value listed in the column entitled ``Average monthly 
discharge must not exceed'', corresponding to the entry ``27 
Chloroform'' in the ``Regulated pollutant'' column is changed from 
``0.01'' to ``0.013''.


Sec. 439.16  [Corrected]

    25. On page 50429 in the table continued from the previous page, 
the numerical value listed in the column entitled ``Average monthly 
discharge must not exceed'' corresponding to the entry ``10 Methyl 
Cellosolve'' in the ``Regulated parameter'' column is changed from 
``9.7'' to ``59.7''.
    26. On page 50429 in the table continued from the previous page, 
the numerical value listed in the column entitled ``Average monthly 
discharge must not exceed'' corresponding to the entry `` 13 Benzene'' 
in the ``Regulated parameter'' column is changed from ``0.6'' to 
``0.7''.
    27. On page 50429 in the table continued from the previous page, 
the numerical value listed in the column entitled ``Average monthly 
discharge must not exceed'', corresponding to the entry ``14 Toluene'' 
in the ``Regulated parameter'' column is changed from ``0.1'' to 
``0.2''.


Sec. 439.17  [Corrected]

    28. On page 50429 in the table in Sec. 439.17, the numerical value 
listed in the column entitled ``Average monthly discharge must not 
exceed'', corresponding to the entry ``14 Toluene'' in the ``Regulated 
parameter'' column is changed from ``0.1'' to ``0.2''.


Sec. 439.26  [Corrected]

    29. On page 50431 in the last line in column 1, the date ``October 
22, 2001'' is replaced by ``September 21, 2001''.
    30. On page 50431 in the table in Sec. 439.26, change the entry 
``Ethyl acetate'' in ``Regulated parameter'' column to ``3 Ethyl 
acetate''.


Sec. 439.34  [Corrected]

    31. On page 50432 in the table in Sec. 439.34, the numerical value 
listed in the column entitled ``Maximum daily discharge'', 
corresponding to the entry ``14 Methyl Cellosolve'' in the ``Regulated 
parameter'' column is changed from ``25.0'' to ``100.0''.
    32. On page 50432 in the table in Sec. 439.34, the numerical value 
listed in the column entitled ``Average monthly discharge must not 
exceed'', corresponding to the entry ``14 Methyl Cellosolve'' in the 
``Regulated parameter'' column is changed from ``10.2'' to ``40.6''.
    33. On page 50432 in the table in Sec. 439.34, the numerical value 
listed in the column entitled ``Maximum daily discharge'', 
corresponding to the entry ``16 Triethyl amine'' in the ``Regulated 
parameter'' column is changed from ``250.3'' to ``250.0''.
    34. On page 50432 in the table in Sec. 439.34, the numerical value 
listed in the column entitled ``Average monthly discharge must not 
exceed'' corresponding to the entry ``16 Triethyl amine'' in the 
``Regulated parameter'' column is changed from ``101.5'' to ``102.0''.
    35. On page 50432 in the table in Sec. 439.34, the numerical value 
listed in the column entitled ``Average monthly discharge must not 
exceed'' corresponding to the entry ``24 Chloroform'' in the 
``Regulated parameter'' column is changed from ``0.01'' to ``0.013''.


Sec. 439.35  [Corrected]

    36. On page 50433 in the table in Sec. 439.35, the entry listed in 
the column entitled ``Regulated parameter'', ``18 Methyl Sulfoxide'' is 
changed to read ``18 Dimethyl Sulfoxide''.
    37. On page 50433 in the table in Sec. 439.35, the numerical value 
listed in the column entitled ``Maximum daily discharge'' corresponding 
to the entry ``23 Xylenes'' in the ``Regulated parameter'' column is 
changed from ``0.02 to ``0.03''.
    38. On page 50433 in the table in Sec. 439.35, the numerical value 
listed in the column entitled ``Average monthly discharge must not 
exceed'' corresponding to the entry ``27 Chloroform'' in the 
``Regulated parameter'' column is changed from ``0.01'' to ``0.013''.
    39. On page 50433 in the table in Sec. 439.35, the numerical value 
listed in the column entitled ``Average monthly discharge must not 
exceed'' corresponding to the entry ``29 Chlorobenzene'' in the 
``Regulated parameter'' column is changed from ``0.05'' to ``0.06''.


Sec. 439.36  [Corrected]

    40. On page 50434 in the table in Sec. 439.36, the numerical value 
listed in the column entitled ``Average monthly discharge must not 
exceed'' corresponding to the entry ``10 Methyl Cellosolve'' in the 
``Regulated parameter'' column is changed from ``54.7'' to ``59.7''.
    41. On page 50434 in the table in Sec. 439.36, the numerical value 
listed in the column entitled ``Average monthly discharge must not 
exceed'' corresponding to the entry ``14 Toluene'' in the ``Regulated 
parameter'' column is changed from ``0.1'' to ``0.2''.


Sec. 439.37  [Corrected]

    42. On page 50435 in the table continued from the previous page, 
the numerical value listed in the column entitled ``Average monthly 
discharge must not exceed'' corresponding to the entry ``14 Toluene'' 
in the ``Regulated parameter'' column is changed from ``0.1'' to 
``0.2''.

Appendix A to Part 439--Tables

    43. On page 50437 Table 1 should appear as follows with certain 
Regulated Parameters identified with footnote designations.

          Table 1.--Surrogate Parameters for Direct Dischargers
               [Utilizing biological treatment technology]
------------------------------------------------------------------------
             Regulated parameters                  Treatability class
------------------------------------------------------------------------
Amyl alcohol.................................   Alcohols.
Ethanol \1\
Isopropanol \1\
Methanol \1\
Phenol
Isobutyraldehyde \1\.........................  Aldehydes.
n-Heptane \1\................................  Alkanes.
n-Hexane \1\
Diethylamine \1\.............................  Amines.
Triethylamine
Benzene......................................  Aromatics.
Toluene \1\

[[Page 10394]]

 
Xylenes \1\
Chlorobenzene
o-Dichlorobenzene
Chloroform \1\...............................   Chlorinated Alkanes.
Methylene chloride \1\
1,2-Dichloroethane \1\
Ethyl acetate \1\............................  Esters.
Isopropyl acetate
n-Amyl acetate
n-Butyl acetate
Methyl formate
Tetrahydrofuran \1\..........................  Ethers.
Isopropyl ether
Acetone \1\..................................  Ketones.
4-Methyl-2-pentanone (MIBK)
Ammonia (aqueous)............................  Miscellaneous. \2\
Acetonitrile
Methyl Cellosolve
Dimethyl Sulfoxide
------------------------------------------------------------------------
\1\ These parameters may be used as a surrogate to represent other
  parameters in the same treatability class.
\2\ Surrogates have not been identified for the ``Miscellaneous''
  treatability class.

    44. On page 50437 Table 2 should appear as follows with certain 
Regulated Parameters with footnote designations:

                             Table 2.--Surrogate Parameters for Indirect Dischargers
                                [Utilizing steam stripping treatment technology]
----------------------------------------------------------------------------------------------------------------
                    Regulated parameters                                      Treatability class
----------------------------------------------------------------------------------------------------------------
Benzene
Toluene \1\
Xylenes
n-Heptane..................................................  High strippability.
nHexane
Chloroform \1\
Methylene chloride \1\
Chlorobenzene
Methyl cellosolve
----------------------------------------------------------------------------------------------------------------
Ammonia (aqueous) \1\
Diethyl amine
Triethyl amine
Acetone \1\
4-Methyl-2-pentanone (MIBK)
n-Amyl acetate
n-Butyl acetate \1\........................................  Medium strippability.
Ethyl acetate
Isopropyl acetate
Methyl formate
Isopropyl ether
Tetrahydrofuran \1\
1,2-Dichloroethane
o-Dichlorobenzene
----------------------------------------------------------------------------------------------------------------
\1\ These paramaters may be used as a surrogate to represent other parameters in the same treatability class.

[FR Doc. 99-5106 Filed 3-3-99; 8:45 am]
BILLING CODE 6560-50-P