Water pollution; effluent guidelines for point source categories: Pharmaceuticals manufacturing; correction,

[Federal Register: September 2, 1999 (Volume 64, Number 170)]

[Rules and Regulations]

[Page 48103-48104]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr02se99-17]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 439

[FRL-6431-8]

RIN 2040-AA13

Pharmaceutical Manufacturing Category Effluent Limitations Guidelines, Pretreatment Standards, and New Source Performance Standards; Correcting Amendments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Correcting amendments.

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

DATES: These corrections shall become effective September 2, 1999. In accordance with 40 CFR 23.2, this rule will be considered promulgated for purposes of judicial review at 1:00 p.m. Eastern Time on September 16, 1999.

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, hund.frank@epamail.epa.gov.

SUPPLEMENTARY INFORMATION:

1. Background

   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 omitted a clarifying abbreviation and contained four incorrect subsections. This notice inserts a clarifying abbreviation, deletes four incorrect subsections, changes the parenthetical letters identifying two subsections and deletes the parenthetical letters identifying two other subsections. The clarifying abbreviation ``Mg/L'' (milligrams per liter) is necessary to avoid confusion with the abbreviation ``Mg `` (megagrams) which is used in the preamble section devoted to the discussion of the MACT rule which was promulgated at the same time as the pharmaceuticals effluent guidelines rule. The subsection deletions are in the Pretreatment Standards for New Sources (PSNS) sections of the rule. These subsections contained a cite from the regulations concerning new source direct dischargers which is inconsistent

   [[Page 48104]]

   with the definition of new source contained in section 403.3(k) of the general pretreatment regulations. As a result of today's correction, the PSNS sections of the pharmaceuticals effluent guidelines will be consistent with the general pretreatment regulations. The PSNS sections will also be consistent with PSNS sections in other recently promulgated effluent guidelines rules. Today's correction also ``renumbers'' (by revising or deleting) the labels for the PSNS sections. For example, if paragraph (d) is deleted, paragraph (e) is renamed as (d).

2. Administrative Requirements

   Under Executive Order 12886 (58 FR 51735, October 4, 1993), this 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. 533, 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 it is not economically significant as defined under E.O. 12866. Further, 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. This rule is not subject to the National Technology Transfer and Advancement Act of 1995 (Pub. L. 104-113) because it does not involve any technical standards. This action contains no information collection requirements. Therefore, it is not subject to the Paperwork Reduction Act of 1980, 44 U.S.C. 1501, et seq. EPA's compliance with these statutes and Executive Orders for the underlying rule is discussed in the Federal Register notice of September 21, 1998.

   The revisions in this final rule are not substantive. These revisions add a clarifying abbreviation, delete four incorrect subsections of the rule, change parenthetical letters identifying two subsections and delete parenthetical letters identifying two other subsections. 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. Therefore, the amendments are effective immediately.

   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 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. Section 808(2). As stated previously, EPA has made such a good cause finding, including the reasons therefor, and established an effective date of September 2, 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, Reporting and recordkeeping requirements, Water pollution control.

   Dated: August 25, 1999. J. Charles Fox, Assistant Administrator for 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:

      Authority: Secs. 301, 304, 306, 307, 308, 402 and 501 of the Clean Water Act, as amended; 33 U.S.C. 1311, 1314, 1316, 1317, 1318, 1342, and 1361.

   2. Section 439.1 is amended by adding paragraph (n) to read as follows:

      Sec. 439.1 General definitions.

      * * * * *

      (n) The abbreviation Mg/L means milligrams per liter or parts per million (ppm).

      Sec. 439.17 [Amended]

   3. Section 439.17 is amended by removing paragraph (d) and redesignating paragraph (e) as (d).

   4. Section 439.27 is amended by removing paragraph (b) and removing the paragraph designation from paragraph (a) and revising the newly designated introductory text before the table to read as follows:

      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: * * * * *

      Sec. 439.37 [Amended]

   5. Section 439.37 is amended by removing paragraph (d) and redesignating paragraph (e) as (d).

      Sec. 439.47 [Amended]

   6. Section 439.47 is amended by removing the paragraph designation from paragraph (a) and by removing paragraph (b).

      [FR Doc. 99-22745Filed9-1-99; 8:45 am]

      BILLING CODE 6560-50-P