[Federal Register Volume 70, Number 92 (Friday, May 13, 2005)]
[Rules and Regulations]
[Pages 25666-25670]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-9477]



[[Page 25665]]

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Part III





Environmental Protection Agency





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40 CFR Part 63



National Emission Standards for Pharmaceuticals Production; Final Rule 
and Proposed Rule

  Federal Register / Vol. 70, No. 92 / Friday, May 13, 2005 / Rules and 
Regulations  

[[Page 25666]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[OAR-2004-0023; FRL-7911-3]
RIN 2060-AM52


National Emission Standards for Pharmaceuticals Production

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule; amendments.

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SUMMARY: EPA is taking direct final action to amend the national 
emission standards for pharmaceuticals production. The direct final 
rule amendments include provisions for planned routine maintenance of 
wastewater tanks, alternative monitoring provisions for caustic 
scrubbers and condensers, and references general standards for 
containers. We are making the amendments by direct final rule, without 
prior proposal, because we view the revisions as noncontroversial and 
anticipate no adverse comments.

DATES: The direct final rule amendments are effective on July 12, 2005, 
without further notice, unless EPA receives adverse written comment by 
June 13, 2005, or if a public hearing is requested by May 23, 2005. If 
EPA receives such comments, it will publish a timely withdrawal in the 
Federal Register indicating which provisions will become effective and 
which provisions are being withdrawn due to adverse comment.

ADDRESSES: Submit your comments, identified by Docket ID No. OAR-2004-
0023, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Agency Web site: http://www.epa.gov/edocket. EDOCKET, 
EPA's electronic public docket and comment system, is EPA's preferred 
method for receiving comments. Follow the on-line instructions for 
submitting comments.
     E-mail: [email protected].
     Fax: (202) 566-1741.
     Mail: EPA Docket Center, Environmental Protection Agency, 
Mailcode: 6102T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460. 
Please include a duplicate copy, if possible.
     Hand Delivery: Air and Radiation Docket, Environmental 
Protection Agency, 1301 Constitution Avenue, NW., Room B-108, 
Washington, DC 20460. Such deliveries are only accepted during the 
Docket's normal hours of operation, and special arrangements should be 
made for deliveries of boxed information.
    We request that a separate copy also be sent to the contact person 
listed below (see FOR FURTHER INFORMATION CONTACT).
    Instructions: Direct your comments to Docket ID No. OAR-2004-0023. 
EPA's policy is that all comments received will be included in the 
public docket without change and may be made available online at http://www.epa.gov/edocket, including any personal information provided, 
unless the comment includes information claimed to be Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Do not submit information that you consider to 
be CBI or otherwise protected through EDOCKET, regulations.gov, or e-
mail. The EPA EDOCKET and the federal regulations.gov websites are 
``anonymous access'' systems, which means EPA will not know your 
identity or contact information unless you provide it in the body of 
your comment. If you send an e-mail comment directly to EPA without 
going through EDOCKET or regulations.gov, your e-mail address will be 
automatically captured and included as part of the comment that is 
placed in the public docket and made available on the Internet. If you 
submit an electronic comment, EPA recommends that you include your name 
and other contact information in the body of your comment and with any 
disk or CD-ROM you submit. If EPA cannot read your comment due to 
technical difficulties and cannot contact you for clarification, EPA 
may not be able to consider your comment. Electronic files should avoid 
the use of special characters, any form of encryption, and be free of 
any defects or viruses. For additional information about EPA's public 
docket visit EDOCKET on-line or see the Federal Register of May 31, 
2002 (67 FR 38102).
    Docket: All documents in the docket are listed in the EDOCKET index 
at http://www.epa.gov/edocket. Although listed in the index, some 
information is not publicly available, i.e., CBI or other information 
whose disclosure is restricted by statute. Certain other material, such 
as copyrighted material, is not placed on the Internet and will be 
publicly available only in hard copy form. Publicly available docket 
materials are available either electronically in EDOCKET or in hard 
copy at the Air and Radiation Docket, EPA/DC, EPA West, Room B102, 1301 
Constitution Ave., NW., Washington, DC. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the Air Docket is (202) 566-
1742.

FOR FURTHER INFORMATION CONTACT: Mr. Randy McDonald, Organic Chemicals 
Group, Emission Standards Division (Mail Code C504-04), U.S. EPA, 
Research Triangle Park, North Carolina 27711, telephone number (919) 
541-5402, electronic mail address [email protected].

SUPPLEMENTARY INFORMATION: Regulated Entities. The regulated category 
and entities affected by this action include:

----------------------------------------------------------------------------------------------------------------
                                                                                        Examples of regulated
              Category                     NAICS codes              SIC codes                  entities
----------------------------------------------------------------------------------------------------------------
Industry...........................  325411 and 325412.....  2833 and 2834.........   Producers of
                                                                                      finished dosage forms of
                                                                                      drugs (e.g., tablets,
                                                                                      capsules, and solutions),
                                                                                      active ingredients, or
                                                                                      precursors.
                                     Typically 325199......  Typically 2869........   Producers of
                                                                                      material whose primary use
                                                                                      is as an active ingredient
                                                                                      of precursor.
----------------------------------------------------------------------------------------------------------------

    This table is not intended to be exhaustive, but rather provides a 
guide for readers likely to be interested in the revisions to the 
regulation affected by this action. To determine whether your facility, 
company, business, organization, etc., is regulated by this action, you 
should carefully examine all of the applicability criteria in 40 CFR 
63.1250. If you have questions regarding the applicability of the 
direct final rule amendments to a particular entity, consult the person 
listed in the preceding FOR FURTHER INFORMATION CONTACT section. 
Worldwide Web (WWW). In addition to being available in the docket, an 
electronic copy of the direct final rule amendments will also be 
available on the WWW through EPA's Technology Transfer Network (TTN). 
Following signature by the EPA Administrator, a copy of the direct 
final rule amendments will be posted on the TTN's policy and guidance 
page for

[[Page 25667]]

newly proposed or promulgated rules at http://www.epa.gov/ttn/oarpg. 
The TTN provides information and technology exchange in various areas 
of air pollution control.
    Comments. We are publishing the direct final rule amendments 
without prior proposal because we view the amendments as 
noncontroversial and do not anticipate adverse comments. We consider 
the changes to be noncontroversial because the only effect is to 
provide alternative monitoring requirements and extend planned routine 
maintenance provisions for storage tanks to wastewater tanks. In the 
Proposed Rules section of this Federal Register, we are publishing a 
separate document that will serve as the proposal in the event that 
timely adverse comments are received.
    If we receive such adverse comments on the amendments, we will 
publish a timely withdrawal in the Federal Register informing the 
public which provisions will become effective and which provisions are 
being withdrawn due to adverse comment. We will address all public 
comments in a subsequent final rule based on the proposed rule. Any of 
the distinct amendments in the direct final rule for which we do not 
receive adverse comment will become effective on the date set out 
above. We will not institute a second comment period on the direct 
final rule amendments. Any parties interested in commenting must do so 
at this time.
    Judicial Review. Under section 307(b)(1) of the Clean Air Act 
(CAA), judicial review of the direct final rule amendments is available 
only by filing a petition for review in the U.S. Court of Appeals for 
the District of Columbia by July 12, 2005. Under section 307(d)(7)(B) 
of the CAA, only an objection to the direct final rule amendments that 
was raised with reasonable specificity during the period for public 
comment can be raised during judicial review. Moreover, under section 
307(b)(2) of the CAA, the requirements established by the direct final 
rule amendments may not be challenged separately in any civil or 
criminal proceedings brought by EPA to enforce these requirements.
    Outline. The information presented in this preamble is organized as 
follows:

I. Why are we publishing the amendments as a direct final rule?
II. What amendments are we making to the rule?
III. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination with 
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children from 
Environmental Health and Safety Risks
    H. Executive Order 13211: Actions that Significantly Affect 
Energy Supply, Distribution, or Use
    I. National Technology Transfer Advancement Act
    J. Congressional Review Act

I. Why Are We Publishing the Amendments as a Direct Final Rule?

    We are publishing the amendments without prior proposal because we 
view the changes as noncontroversial and anticipate no adverse comment. 
The amendments to the final rule improve consistency with other 
standards by referencing generic type standards for containers; 
extending the planned routine maintenance provisions from storage tanks 
to wastewater tanks; and allowing alternative monitoring for scrubbers 
and condensers. The amendments do not alter the stringency of the 
standards, have no adverse health or environmental impacts, and will 
not increase costs.

II. What Amendments Are We Making to the Rule?

    The direct final rule makes four amendments to the final rule. One 
amendment adds a reference to an existing generic standard as a 
compliance alternative for large wastewater containers. A second 
amendment applies the same planned routine maintenance provisions for 
storage tanks to wastewater tanks. A third amendment is to allow 
monitoring of the condenser product side temperature in lieu of the 
exit gas temperature. The fourth amendment is to allow monitoring of 
caustic strength of the scrubber effluent as an alternative to 
measuring pH. In addition to the amendments, we are correcting a 
citation error.
    The National Emission Standards for Containers in subpart PP to 40 
CFR part 63 were developed for administrative convenience and 
consistency and apply when other subparts reference subpart PP. The 
level of control required by subparts PP and GGG to 40 CFR part 63 are 
equivalent as both standards require vapor-tight containers. We are 
aware that there are some facilities subject to subpart GGG to 40 CFR 
part 63 that have containers subject to other maximum achievable 
control technology (MACT) standards that are permitted to meet subpart 
PP to 40 CFR part 63 with respect to those containers. Therefore, we 
are amending the wastewater provisions in the final rule to reference 
subpart PP to 40 CFR part 63 as a compliance option for large 
containers to allow such sources the option of complying with a single 
subpart for containers otherwise subject to different MACT standards.
    The final rule allows for 240 hours per year for use of storage 
tanks during periods of planned routine maintenance when the 
requirements for control devices do not apply. This provision allows 
for maintenance of the control device without emptying and cleaning the 
storage tank. During the initial implementation phase of the final 
rule, we became aware that the same problems of material management 
apply to wastewater tanks as well as storage tanks. Applying the 
planned routine maintenance provisions to storage of wastewater 
eliminates the need to empty and clean wastewater tanks with each 
downtime. This also eliminates emissions associated with cleaning and 
degassing the wastewater tank. Therefore, we are extending the planned 
routine maintenance provisions for storage tanks to wastewater tanks. 
The same issue of material management for stored wastewater was 
addressed in subpart FFFF to 40 CFR part 63 by providing the same 
planned routine maintenance provisions.
    Also, we are including provisions for alternative monitoring for 
condensers and scrubbers. The new provisions allow for monitoring of 
the product side temperature for condensers and provisions for 
monitoring the caustic strength of the effluent for scrubbers. Again, 
in the initial implementation phase of the final rule, we were informed 
by several affected sources that alternative monitoring for condensers 
and scrubbers should be allowed. Those alternative monitoring 
provisions have been approved in precompliance reports for the final 
rule and are also included in subpart FFFF to 40 CFR part 63.
    Finally, we are clarifying that for the final rule, a process 
change means the startup of a new process. As clarification in the 
preamble to the proposed national emission standards for hazardous air 
pollutants (NESHAP) for Pesticide Active Ingredient Production (PAI) 
(67 FR 17503), we stated that a process change means the startup of a 
new operating scenario associated with a new process. As in the 
proposed PAI rule, the final rule requires the owner or operator to 
prepare operating scenarios that describe the equipment, emissions, 
controls, and monitoring for each process. A new operating scenario 
must

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be prepared each time the owner or operator makes a change to produce a 
new product. A new operating scenario must also be prepared for any 
change to an existing process that is not within the scope of a current 
operating scenario. As in the proposed PAI rule, we are clarifying that 
for the final rule, a process change means the startup of a new 
process.

III. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), the 
Agency must determine whether the regulatory action is ``significant'' 
and, therefore, subject to Office of Management and Budget (OMB) review 
and the requirements of the Executive Order. The Executive Order 
defines ``significant regulatory action'' as one that is likely to 
result in a rule that may:
    (1) Have an annual effect on the economy of $100 million or more or 
adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or tribal governments or 
communities;
    (2) Create a serious inconsistency or otherwise interfere with an 
action taken or planned by another agency;
    (3) Materially alter the budgetary impact of entitlements, grants, 
user fees, or loan programs or the rights and obligations of recipients 
thereof; or
    (4) Raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
the Executive Order.
    It has been determined that the final rule amendments are not a 
``significant regulatory action'' under the terms of Executive Order 
12866 and are, therefore, not subject to OMB review.

B. Paperwork Reduction Act

    This action does not impose any new information collection burden. 
This action gives a source owner or operator the option of using vapor 
balancing to comply with the standards. Since it is only an option, 
this action will not increase the information collection burden. The 
OMB has previously approved the information collection requirements 
contained in the existing regulations under the provisions of the 
Paperwork Reduction Act, 44 U.S.C. 3501 et seq., and has assigned OMB 
control number 2060-0358 (EPA ICR No. 1781.01).
    Copies of the Information Collection Request (ICR) document(s) may 
be obtained from Susan Auby, by mail at the Office of Environmental 
Information, Collection Strategies Division; U.S. EPA (2822T); 1200 
Pennsylvania Ave., NW., Washington, DC 20460, by e-mail at 
[email protected], or by calling (202) 566-1672. A copy may also be 
downloaded off the Internet at http://www.epa.gov/icr. Include the ICR 
or OMB number in any correspondence.
    Burden means the total time, effort, or financial resources 
expended by persons to generate, maintain, retain, or disclose or 
provide information to or for a Federal agency. This includes the time 
needed to review instructions; develop, acquire, install, and utilize 
technology and systems for the purposes of collecting, validating, and 
verifying information, processing and maintaining information, and 
disclosing and providing information; adjust the existing ways to 
comply with any previously applicable instructions and requirements; 
train personnel to be able to respond to a collection of information; 
search data sources; complete and review the collection of information; 
and transmit or otherwise disclose the information.
    An Agency may not conduct or sponsor, and a person is not required 
to respond to a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

C. Regulatory Flexibility Act

    The EPA has determined that it is not necessary to prepare a 
regulatory flexibility analysis in connection with the final rule.
    For purposes of assessing the impacts of today's amendments on 
small entities, a small entity is defined as: (1) A small business as 
defined by the Small Business Administration's regulations at 13 CFR 
121.201; (2) a small governmental jurisdiction that is a government of 
a city, county, town, school district or special district with a 
population of less than 50,000; and (3) a small organization that is 
any not-for-profit enterprise which is independently owned and operated 
and is not dominant in its field.
    After considering the economic impacts of today's direct final rule 
amendments on small entities, EPA has concluded that this action will 
not have a significant economic impact on a substantial number of small 
entities. In determining whether a rule has a significant economic 
impact on a substantial number of small entities, the impact of concern 
is any significant adverse economic impact on small entities, since the 
primary purpose of the regulatory flexibility analyses is to identify 
and address regulatory alternatives ``which minimize any significant 
economic impact of the proposed rule on small entities.'' 5 U.S.C. 603 
and 604. Thus, an agency may conclude that a rule will not have a 
significant economic impact on a substantial number of small entities 
if the rule relieves regulatory burden, or otherwise has a positive 
economic effect on all of the small entities subject to the rule. The 
final rule amendments add several compliance options granting greater 
flexibility to small entities subject to the final rule that may result 
in a more efficient use of resources for them and, therefore, impose no 
additional regulatory costs or requirements on owners or operators of 
affected sources.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public 
Law 104-4, establishes requirements for Federal agencies to assess the 
effects of their regulatory actions on State, local, and tribal 
governments and the private sector. Under section 202 of the UMRA, the 
EPA generally must prepare a written statement, including a cost-
benefit analysis, for proposed and final rules with ``Federal 
mandates'' that may result in expenditures by State, local, and tribal 
governments, in the aggregate, or by the private sector, of $100 
million or more in any 1 year. Before promulgating an EPA rule for 
which a written statement is needed, section 205 of the UMRA generally 
requires the EPA to identify and consider a reasonable number of 
regulatory alternatives and adopt the least-costly, most cost-
effective, or least burdensome alternative that achieves the objectives 
of the rule. The provisions of section 205 do not apply when they are 
inconsistent with applicable law. Moreover, section 205 allows the EPA 
to adopt an alternative other than the least-costly, most cost 
effective, or least-burdensome alternative if the Administrator 
publishes with the final rule an explanation why that alternative was 
not adopted. Before the EPA establishes any regulatory requirements 
that may significantly or uniquely affect small governments, including 
tribal governments, it must have developed under section 203 of the 
UMRA a small government agency plan. The plan must provide for 
notifying potentially affected small governments to have meaningful and 
timely input in the development of EPA regulatory proposals with 
significant Federal intergovernmental mandates, and

[[Page 25669]]

informing, educating, and advising small governments on compliance with 
the regulatory requirements.
    The EPA has determined that the final rule amendments do not 
contain a Federal mandate that may result in expenditures of $100 
million or more for State, local, and tribal governments, in the 
aggregate, or the private sector in any 1 year. The final rule 
amendments provide a source owner or operator with additional options 
to comply with the standards. Therefore, the final rule amendments are 
not subject to the requirements of sections 202 and 205 of the UMRA.

E. Executive Order 13132: Federalism

    Executive Order 13132 (64 FR 43255, August 10, 1999) requires the 
EPA to develop an accountable process to ensure ``meaningful and timely 
input by State and local officials in the development of regulatory 
policies that have federalism implications.'' ``Policies that have 
federalism implications'' is defined in the Executive Order to include 
regulations that have ``substantial direct effects on the States, on 
the relationship between the national government and the States, or on 
the distribution of power and responsibilities among the various levels 
of government.''
    The final rule amendments do not have federalism implications. They 
will not have substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132. The final rule 
amendments provide a source owner or operator with another option to 
comply with the standards and, therefore, impose no additional burden 
on sources. Thus, Executive Order 13132 does not apply to the final 
rule amendments.
    In the spirit of Executive Order 13132 and consistent with EPA 
policy to promote communications between the EPA and State and local 
governments, the EPA specifically solicits comment on the final rule 
amendments from State and local officials.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    Executive Order 13175 (65 FR 67249, November 9, 2000) requires the 
EPA to develop an accountable process to ensure ``meaningful and timely 
input by tribal officials in the development of regulatory policies 
that have tribal implications.'' The final rule amendments do not have 
tribal implications, as specified in Executive Order 13175. The final 
rule amendments provide a source owner or operator with another option 
to comply with the standards and, therefore, impose no additional 
burden on sources. Thus, Executive Order 13175 does not apply to the 
final rule amendments.
    The EPA specifically solicits additional comment on the final rule 
amendments from tribal officials.

G. Executive Order 13045: Protection of Children From Environmental 
Health and Safety Risks

    Executive Order 13045 (62 FR 19885, April 23, 1997) applies to any 
rule that: (1) Is determined to be ``economically significant'' as 
defined under Executive Order 12866, and (2) concerns an environmental 
health or safety risk that the EPA has reason to believe may have a 
disproportionate effect on children. If the regulatory action meets 
both criteria, the EPA must evaluate the environmental health or safety 
effects of the planned rule on children, and explain why the planned 
regulation is preferable to other potentially effective and reasonably 
feasible alternatives considered by the EPA.
    The EPA interprets Executive Order 13045 as applying only to those 
regulatory actions that are based on health or safety risks, such that 
the analysis required under section 5-501 of the Executive Order has 
the potential to influence the regulation. Today's final rule 
amendments are not subject to Executive Order 13045 because they are 
based on technology performance, not health or safety risks. 
Furthermore, the final rule amendments have been determined not to be 
``economically significant'' as defined under Executive Order 12866.

H. Executive Order 13211: Actions That Significantly Affect Energy 
Supply, Distribution, or Use

    The final rule amendments are not subject to Executive Order 13211 
(66 FR 28355, May 22, 2001) because they are not a significant 
regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, 12(d) (15 U.S.C. 272 note), 
directs the EPA to use voluntary consensus standards in its regulatory 
activities unless to do so would be inconsistent with applicable law or 
otherwise impractical. Voluntary consensus standards are technical 
standards (e.g., materials specifications, test methods, sampling 
procedures, and business practices) that are developed or adopted by 
voluntary consensus standards bodies. The NTTAA directs the EPA to 
provide Congress, through OMB, explanations when the Agency decides not 
to use available and applicable voluntary consensus standards.
    No new standard requirements are cited in the direct final rule 
amendments. Therefore, the EPA is not proposing or adopting any 
voluntary consensus standards in the direct final rule amendments.

J. Congressional Review Act

    The Congressional Review Act, 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. The EPA will submit a report containing the direct final 
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 direct final rule in the Federal Register. 
The direct final rule is not a ``major rule'' as defined by 5 U.S.C. 
804(2). The direct final rule amendments are effective on July 12, 
2005.

List of Subjects in 40 CFR Part 63

    Environmental protection, Administrative practice and procedure, 
Air pollution control, Hazardous substances, Intergovernmental 
relations, Reporting and recordkeeping requirements.

    Dated: May 6, 2005.
Stephen L. Johnson,
Administrator.

0
For the reasons set out in the preamble, part 63 of title 40, chapter I 
of the Code of Federal Regulations is amended as follows:

PART 63--[AMENDED]

0
1. The authority citation for part 63 continues to read as follows:

    Authority: 42 U.S.C. 7401, et seq.

Subpart GGG--[Amended]

0
1. Section 63.1253 is amended by adding two sentences to the end of 
paragraph (e) to read as follows:


Sec.  63.1253  Standards: Storage tanks.

* * * * *

[[Page 25670]]

    (e) * * * The owner or operator may submit an application to the 
Administrator requesting an extension of this time limit to a total of 
360 hours in any 365-day period. The application must explain why the 
extension is needed, it must specify that no material will be added to 
the storage tank between the time the 240-hour limit is exceeded and 
the control device is again operational, and it must be submitted at 
least 60 days before the 240-hour limit will be exceeded.
* * * * *
0
2. Section 63.1256 is amended by:
0
a. Adding paragraph (b)(10); and
0
b. Revising paragraph (d)(1)(i).
    The revisions and addition read as follows:


Sec.  63.1256  Standards: Wastewater.

* * * * *
    (b) * * *
    (10) The emission limits specified in Sec.  63.1256 (b)(2) and (h) 
for control devices used to control emissions from wastewater tanks do 
not apply during periods of planned routine maintenance of the control 
device(s) of no more than 240 hours in any 365-day period. The owner or 
operator may submit an application to the Administrator requesting an 
extension of this time limit to a total of 360 hours in any 365-day 
period. The application must explain why the extension is needed, it 
must specify that no affected wastewater will be added to the tank 
between the time the 240-hour limit is exceeded and the control device 
is again operational, and it must be submitted at least 60 days before 
the 240-hour limit will be exceeded. Wastewater tanks shall not be 
sparged with air or other gases without an operational control device.
* * * * *
    (d) * * *
    (1) * * *
    (i) Except as provided in paragraph (d)(3)(iv) of this section, if 
the capacity of the container is greater than 0.42 m\3\, the cover and 
all openings (e.g., bungs, hatches, sampling points, and pressure 
relief valves) shall be controlled in accordance with the requirements 
of either paragraph (d)(1)(i)(A) or (d)(1)(i)(B) of this section.
    (A) The requirements specified in Sec.  63.1258(h); or
    (B) The requirements of subpart PP of this part for containers 
using level 2 controls that meet the definitions in Sec.  63.923(b)(1) 
or (2).
* * * * *

0
3. Section 63.1258 is amended by:
0
a. Amending paragraph (b)(1)(ii) introductory text to add a sentence 
before the last sentence; and
0
b. Revising paragraph (b)(1)(iii) introductory text.
    The revisions read as follows:


Sec.  63.1258  Monitoring requirements.

* * * * *
    (b) * * *
    (1) * * *
    (ii) * * * As an alternative to measuring pH, you may elect to 
continuously monitor the caustic strength of the scrubber effluent. * * 
*
* * * * *
    (iii) Condensers. For each condenser, the owner or operator shall 
establish the maximum condenser outlet gas temperature or product side 
temperature as a site specific operating parameter which much be 
measured and recorded at least every 15 minutes during the period in 
which the condenser is functioning in achieving the HAP removal 
required by this subpart.
* * * * *

0
4. Section 63.1259 is amended by revising the last two sentences in 
paragraph (a)(3) introductory text to read as follows:


Sec.  63.1259  Recordkeeping requirements.

    (a) * * *
    (3) * * * The owner or operator shall keep the startup, shutdown, 
and malfunction records specified in paragraphs (a)(3)(i) through (iii) 
of this section. Reports related to the plan shall be submitted as 
specified in Sec.  63.1260(i).
* * * * *
[FR Doc. 05-9477 Filed 5-12-05; 8:45 am]
BILLING CODE 6560-50-P