03-14744. 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.

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 §§ 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 §§ 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: [phone]; e-mail: [e-mail].

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 §§ 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 §§ 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.

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

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.

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

§ 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 § 439.16.

(a) Sources that discharge to a POTW with nitrification capability (defined at § 439.2(i)) are not required to achieve the pretreatment standard for ammonia (as N).

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

§ 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 § 439.36.

(a) Sources that discharge to a POTW with nitrification capability (defined at § 439.2(i)) are not required to achieve the pretreatment standard for ammonia (as N).

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