[Federal Register Volume 68, Number 112 (Wednesday, June 11, 2003)]
[Rules and Regulations]
[Pages 34831-34832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14744]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 439

[FRL-7510-6]
RIN 2040-AD85


Partial Withdrawal of Direct Final Rule; Effluent Limitations 
Guidelines, Pretreatment Standards, and New Source Performance 
Standards for the Pharmaceutical Manufacturing Point Source Category

AGENCY: Environmental Protection Agency (EPA).

ACTION: Partial withdrawal of direct final rule and revisions.

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[[Page 34832]]

SUMMARY: Because EPA received adverse comment, we are withdrawing 
certain portions of the direct final rule for the Effluent Limitations 
Guidelines, Pretreatment Standards, and New Source Performance 
Standards for the Pharmaceutical Manufacturing Point Source Category. 
The direct final rule published on March 13, 2003 (68 FR 12265) made 
three amendments to the final regulations published on September 21, 
1998 (63 FR 50424) and non-substantive editorial and format changes. We 
stated in the direct final rule that if we received adverse comment by 
May 12, 2003, we would publish a timely notice of withdrawal in the 
Federal Register. We subsequently received adverse comment on the 
direct final rule. We will address that comment in a subsequent final 
action based on the parallel proposal also published on March 13, 2003 
(68 FR 12276). As stated in the parallel proposal, we will not 
institute a second comment period on this action.

DATES: As of June 11, 2003, EPA withdraws amendments to Sec. Sec.  
439.17 (a) and (b), 439.27(a) and (b), 439.37(a) and (b), and 439.47(a) 
and (b) published at 68 FR 12265, on March 13, 2003. Revisions to the 
introductory text and paragraph (a) of Sec. Sec.  439.17 and 439.37 are 
effective on June 11, 2003. The remaining provisions published on March 
13, 2003 will be effective on June 11, 2003.

FOR FURTHER INFORMATION CONTACT: Mr. Frank Hund, Engineering and 
Analysis Division (4303T), USEPA Office of Science and Technology, 1200 
Pennsylvania Ave., NW., Washington, DC, 20460; telephone: 202-566-1027; 
e-mail: [email protected].

SUPPLEMENTARY INFORMATION: EPA published a direct final rule (68 FR 
12265) and parallel proposed rule (68 FR 12276) on March 13, 2003, to 
make minor amendments to the final rule establishing effluent 
guidelines and standards for the Pharmaceutical Manufacturing Point 
Source Category (40 CFR part 439) published on September 21, 1998. In 
this direct final rule, EPA clarified the date on which a discharger 
subject to the New Source Performance Standards (NSPS) and the 
Pretreatment Standards for New Sources (PSNS) would be subject to 
effluent limitations and pretreatment standards established in the 1998 
regulation. In addition, EPA re-established a minimum concentration for 
the monthly average BOD5 limitation that EPA inadvertently 
omitted from the Best Practicable Control Technology (BPT) requirements 
in two subcategories of the 1998 regulation and corrected an error in 
EPA's pass-through analysis from the 1998 rule by deleting methyl 
Cellosolve (2-methoxyethanol) from the pretreatment standards in two 
subcategories and from Appendix A, Table 2, ``Surrogate Parameters for 
Indirect Dischargers.'' Finally, the Agency made other non-substantive 
editorial and format changes such as removing redundancies, and adding 
definitions.
    The partial withdrawal of the direct final rule involves 
withdrawing language in (a) and (b) from Sec. Sec.  439.17, 439.27, 
439.37, and 439.47 of the direct final rule regarding the compliance 
schedule for new source dischargers who commenced operations after 
November 21, 1988 and prior to November 20, 1998. Today's action also 
revises the introductory text and paragraph (a) in Sec. Sec.  439.17 
and 439.37 to be consistent with the remaining amendments of the direct 
final rule. EPA has received comment concerning the applicability of 
the 10-year protection period provided in section 306(d) of the Clean 
Water Act for new source facilities. EPA will address those comments in 
a subsequent final action based on the parallel proposal. The 
provisions for which we did not receive adverse comment will become 
effective on June 11, 2003, as provided in the preamble to the direct 
final rule.

List of Subjects in 40 CFR Part 439

    Environmental protection, Drugs, Reporting and recordkeeping 
requirements, Waste treatment and disposal, Water pollution control.

    Dated: June 5, 2003.
G. Tracy Mehan, III,
Assistant Administrator, Office of Water.

0
For reasons set out in the preamble, part 439, title 40, chapter I of 
the Code of Federal Regulations is amended as follows:

PART 439--PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY

0
1. The authority citation for part 439 continues to read as follows:

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

0
2. Section 439.17 is amended by revising the introductory text and 
paragraph (a) to read as follows:


Sec.  439.17  Pretreatment standards for new sources (PSNS).

    Except as provided in 40 CFR 403.7, any new source subject to this 
subpart must achieve the same standards as specified in Sec.  439.16.
    (a) Sources that discharge to a POTW with nitrification capability 
(defined at Sec.  439.2(i)) are not required to achieve the 
pretreatment standard for ammonia (as N).
* * * * *

0
3. Section 439.37 is amended by revising the introductory text and 
paragraph (a) to read as follows:


Sec.  439.37  Pretreatment standards for new sources (PSNS).

    Except as provided in 40 CFR 403.7, any new source subject to this 
subpart must achieve the same standards as specified in Sec.  439.36.
    (a) Sources that discharge to a POTW with nitrification capability 
(defined at Sec.  439.2(i)) are not required to achieve the 
pretreatment standard for ammonia (as N).
* * * * *

[FR Doc. 03-14744 Filed 6-10-03; 8:45 am]
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