[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]
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Regulated parameters Treatability class
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Benzene
Toluene \1\
Xylenes
n-Heptane.................................................. High strippability.
nHexane
Chloroform \1\
Methylene chloride \1\
Chlorobenzene
Methyl cellosolve
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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
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\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