[Federal Register Volume 64, Number 170 (Thursday, September 2, 1999)]
[Rules and Regulations]
[Pages 48103-48104]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22745]


-----------------------------------------------------------------------

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, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. 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).

II. 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. 99-22745 Filed 9-1-99; 8:45 am]
BILLING CODE 6560-50-P