[Federal Register Volume 66, Number 75 (Wednesday, April 18, 2001)]
[Rules and Regulations]
[Pages 19858-19860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-9480]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[PA160-4113a; FRL-6959-6]


Approval and Promulgation of Air Quality Implementation Plans; 
Pennsylvania; Approval of VOC and NOX RACT Determinations 
for Merck and Company, Inc

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is taking direct final action to approve revisions to the 
Commonwealth of Pennsylvania's State Implementation Plan (SIP). The 
revisions were submitted by the Pennsylvania Department of 
Environmental Protection (PADEP) to establish and require reasonably 
available control technology (RACT) for Merck and Company, Inc.'s 
(Merck's) West Point facility located in Montgomery County, 
Pennsylvania. Merck's West Point facility is a major source of volatile 
organic compounds (VOC) and nitrogen oxides ( NOX). The 
intent of this action is to approve the Commonwealth's RACT 
determinations for VOC and NOX at Merck's West Point 
facility located in Montgomery County. EPA is approving this SIP 
revision in accordance with the Clean Air Act.

DATES: This rule is effective on June 4, 2001 without further notice, 
unless EPA receives adverse written comment by May 18, 2001. If EPA 
receives such comments, it will publish a timely withdrawal of the 
direct final rule in the Federal Register and inform the public that 
the rule will not take effect.

ADDRESSES: Written comments should be mailed to Makeba Morris, Chief, 
Permits and Technical Assessment Branch, Air Protection Division, 
Mailcode 3AP11, U.S. Environmental Protection Agency, Region III, 1650 
Arch Street, Philadelphia, Pennsylvania 19103. Copies of the documents 
relevant to this action are available for public inspection during 
normal business hours at the Air Protection Division, U.S. 
Environmental Protection Agency, Region III, 1650 Arch Street, 
Philadelphia, Pennsylvania 19103; the Air and Radiation Docket and 
Information Center, U.S. Environmental Protection Agency, 401 M Street, 
SW, Washington, DC 20460; and the Pennsylvania Department of 
Environmental Protection, Bureau of Air Quality Control, P.O. Box 8468, 
400 Market Street, Harrisburg, Pennsylvania 17105.

FOR FURTHER INFORMATION CONTACT: Melik A. Spain, 215.814.2299, at the 
EPA Region III address above, or by email at [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On July 2, 1997, the Commonwealth of Pennsylvania (the 
Commonwealth) submitted revisions to its SIP to establish RACT for 
several major sources of VOC and NOX. In this rulemaking 
action, EPA is approving the Commonwealth's VOC and NOX RACT 
determinations for Merck's West Point facility in Montgomery County. 
EPA will address the remainder of the Commonwealth's July 2, 1997 
submittal in separate rulemaking actions. The Commonwealth's submittal 
for Merck consists of an operating permit (#46-0005) which imposes VOC 
and NOX RACT requirements for this source. The operating 
permit was revised on June 23, 2000 to incorporate administrative 
amendments and was resubmitted to EPA on August 9, 2000. On February 1, 
2001, the Commonwealth submitted a clarifying supplement to its August 
9, 2000 submittal for Merck to indicate that its SIP revision request 
only pertains to the RACT-related provisions of Merck's operating 
permit. In accordance with Pennsylvania's SIP revision request, EPA is 
approving only the RACT-related requirements and

[[Page 19859]]

conditions contained in Merck's operating permit.
    Pursuant to sections 182(b)(2) and 182(f) of the Clean Air Act 
(CAA), Pennsylvania is required to implement RACT for all major VOC and 
NOX sources. The major source size is determined by its 
location, the classification of that area and whether it is located in 
the ozone transport region (OTR), which is established by the CAA. 
Under section 184 of the CAA, at a minimum, moderate ozone 
nonattainment area requirements, including RACT as specified in 
sections 182(b)(2) and 182(f), apply throughout the OTR. The entire 
Commonwealth of Pennsylvania is located within the OTR. Therefore, RACT 
is applicable statewide in Pennsylvania.

II. Summary of the SIP Revision

    Merck's West Point plant is a biological and pharmaceutical, 
research and support facility located in Upper Gwynedd, Montgomery 
County, Pennsylvania. The facility generates its own power using a 
combination of oil or natural gas-fired boilers and a gas turbine. The 
facility's RACT-subject units also include a rotary kiln incinerator 
and a waste heat incinerator. These combustion sources account for the 
majority of the facility's NOX emissions. Merck's operations 
include site engineering, graphic arts services, and pharmaceutical and 
biological manufacturing. Merck formulates aqueous and solvent-based 
pharmaceutical products, in addition to live and attenuated vaccines 
and sterile pharmaceutical products. These operations account for the 
majority of the facility's VOC emissions.
    The Commonwealth has imposed requirements including the use of low 
NOX burners on Merck's oil and natural gas fired boilers and 
a water injection system on its gas turbine to control NOX 
emissions. As of December 31, 1996, Merck permanently shut down the 
rotary kiln incinerator, but the Commonwealth did establish 
NOX RACT for the incinerator in its operating permit based 
upon the use of low NOX burners and a target tray wet 
scrubber. The Commonwealth also imposed, among other conditions, the 
use of low NOX burners as RACT for the waste heat 
incinerator.
    The Commonwealth's RACT determinations for Merck's VOC emitting 
operations from pharmaceutical manufacturing include the use of tray 
area local ventilation systems and a catalytic oxidizer with a minimum 
90% VOC destruction efficiency, as well as a condenser designed to 
control emissions from the drying process with a minimum 90% 
efficiency. The Commonwealth has imposed VOC RACT on Merck's biological 
manufacturing operations including the use of liquid nitrogen cooling 
coils and gasket-fitted access doors. The Commonwealth has imposed 
limitations on the VOC content of the inks, vanishes, coatings and 
adhesives of Merck's graphic arts operations as RACT.
    The details of Merck's NOX and VOC emitting operations 
and the Commonwealth's RACT determinations are found in Operating 
Permit No. OP-46-0005 issued by PADEP on January 13, 1997 and revised 
on June 23, 2000. That permit is included in the docket for this 
rulemaking and copies may be obtained from the EPA Regional Office 
listed in the ADDRESSES section of this document.
    EPA has reviewed that RACT-related provisions of operating permit 
No. OP-46-0005 issued by the Commonwealth of Pennsylvania to Merck for 
its West Point facility and concurs with PADEP's RACT determinations to 
control NOX and VOC from this facility.

III. Final Action

    EPA is approving the Commonwealth's SIP revision submittal of July 
2, 1997, as amended August 9, 2000 and the February 1, 2001 
supplementary information clarifying the RACT-related provisions of 
operating permit, No. OP-46-0005. The operating permit (OP-46-0005) was 
issued to Merck and Company, Inc., by the Pennsylvania Department of 
Environmental Protection on January 13, 1997, and was revised on June 
23, 2000. EPA is publishing this rule without prior proposal because we 
view this as a noncontroversial amendment and anticipate no adverse 
comment. However, in the ``Proposed Rules'' section of today's Federal 
Register, EPA is publishing a separate document that will serve as the 
proposal to approve the SIP revision if adverse comments are filed. 
This direct final rule will be effective on June 4, 2001 without 
further notice unless we receive adverse comment by May 18, 2001. If 
EPA receives adverse comment, EPA will publish a timely withdrawal in 
the Federal Register informing the public that the rule will not take 
effect. EPA will address all public comments in a subsequent final rule 
based on the proposed rule. EPA will not institute a second comment 
period on this action. Any parties interested in commenting must do so 
at this time.

IV. Administrative Requirements

A. General Requirements

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 
action is not a ``significant regulatory action'' and therefore is not 
subject to review by the Office of Management and Budget. This action 
merely approves state law as meeting federal requirements and imposes 
no additional requirements beyond those imposed by state law. 
Accordingly, the Administrator certifies that this rule will not have a 
significant economic impact on a substantial number of small entities 
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because 
this rule approves pre-existing requirements under state law and does 
not impose any additional enforceable duty beyond that required by 
state law, it does not contain any unfunded mandate or significantly or 
uniquely affect small governments, as described in the Unfunded 
Mandates Reform Act of 1995 (Public Law 104-4). This rule also does not 
have a substantial direct effect on one or more Indian tribes, on the 
relationship between the Federal Government and Indian tribes, or on 
the distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified by Executive Order 13175 (65 
FR 67249, November 9, 2000), nor will it 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 (64 FR 43255, August 10, 1999), because it 
merely approves a state rule implementing a federal standard, and does 
not alter the relationship or the distribution of power and 
responsibilities established in the Clean Air Act. This rule also is 
not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), 
because it is not economically significant. In reviewing SIP 
submissions, EPA's role is to approve state choices, provided that they 
meet the criteria of the Clean Air Act. In this context, in the absence 
of a prior existing requirement for the State to use voluntary 
consensus standards (VCS), EPA has no authority to disapprove a SIP 
submission for failure to use VCS. It would thus be inconsistent with 
applicable law for EPA, when it reviews a SIP submission, to use VCS in 
place of a SIP submission that otherwise satisfies the provisions of 
the Clean Air Act. Thus, the requirements of section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 
note) do not apply. As required by

[[Page 19860]]

section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in 
issuing this rule, EPA has taken the necessary steps to eliminate 
drafting errors and ambiguity, minimize potential litigation, and 
provide a clear legal standard for affected conduct. EPA has complied 
with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining 
the takings implications of the rule in accordance with the ``Attorney 
General's Supplemental Guidelines for the Evaluation of Risk and 
Avoidance of Unanticipated Takings' issued under the executive order. 
This rule does not impose an information collection burden under the 
provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et 
seq.).

B. Submission to Congress and the Comptroller General

    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. Section 804 exempts from section 801 the following types 
of rules: (1) Rules of particular applicability; (2) rules relating to 
agency management or personnel; and (3) rules of agency organization, 
procedure, or practice that do not substantially affect the rights or 
obligations of non-agency parties. 5 U.S.C. 804(3). EPA is not required 
to submit a rule report regarding today's action under section 801 
because this is a rule of particular applicability establishing source-
specific requirements for one named source.

C. Petitions for Judicial Review

    Under section 307(b)(1) of the Clean Air Act, petitions for 
judicial review of this action must be filed in the United States Court 
of Appeals for the appropriate circuit by June 18, 2001. Filing a 
petition for reconsideration by the Administrator of this final rule 
does not affect the finality of this rule for the purposes of judicial 
review nor does it extend the time within which a petition for judicial 
review may be filed, and shall not postpone the effectiveness of such 
rule or action. This action approving Pennsylvania's source-specific 
RACT requirements to control VOCs and NOX from Merck and 
Company Inc.'s West Point facility in Montgomery County may not be 
challenged later in proceedings to enforce its requirements. (See 
section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by 
reference, Nitrogen dioxide, Ozone.

    Dated: March 19, 2001.
William C. Early,
Acting Regional Administrator, Region III.

    40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

    1. The authority citation for Part 52 continues to read as follows:

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

Subpart NN--Pennsylvania

    2. Section 52.2020 is amended by adding paragraph (c)(154) to read 
as follows:


Sec. 52.2020  Identification of plan.

* * * * *
    (c) * * *
    (154) Revisions to the Pennsylvania Regulations, Chapter 129.91 
pertaining to VOC and NOX RACT for Merck and Company Inc.'s 
West Point facility, submitted by the Pennsylvania Department of 
Environmental Protection on July 2, 1997, as amended August 9, 2000.
    (i) Incorporation by reference.
    (A) Letter submitted on July 2, 1997 by the Pennsylvania Department 
of Environmental Protection transmitting VOC and NOX RACT 
determinations in the form of an operating permit (OP-46-0005) for 
Merck and Company Inc.'s West Point facility located in Montgomery 
County Pennsylvania.
    (B) Letter submitted on August 9, 2000 by the Pennsylvania 
Department of Environmental Protection transmitting VOC and 
NOX RACT determinations in the form of an operating permit 
(OP-46-0005) for Merck and Company Inc.'s West Point facility located 
in Montgomery County Pennsylvania.
    (C) Letter submitted on February 1, 2001 by the Pennsylvania 
Department of Environmental Protection providing supplementary 
clarifying information regarding Merck's operating permit (OP-46-0005), 
in which Pennsylvania specified the portions of the permit, as listed 
in paragraph (c)(154)(i)(D) of this section, which it did not wish to 
have incorporated into the Pennsylvania State Implementation Plan.
    (D) Operating Permit for Merck and Company, Incorporated (OP 46-
0005) issued on January 13, 1997, as revised and effective on June 23, 
2000, except for the expiration date and the requirements of Conditions 
5. C., 5. D.1., 5.F.2., 5.F.3., 5.F.4., 5.F.5., 6.C., 6.D.3., 7.C., 
7.D.2., 8.B., 8.D., 9.B., 10.B., 10.F., 11.A., 11.C., 12.B., 12.C., 
13.A., 13.B., 13.C., the annual NOX limits in 13.D., 
14.A.1., 14.A.2., 14.A.3., 14.B., the words ``opacity and'' in 14.C., 
14.D.1., 14.D.2., 15.A.1., 15.B., 15.C.1.i., 15.C.1.ii., 15.C.2., 
15.D.1., 15.D.2., 15.D.3. 15.D.4., 15.E., 15.F., 16., 17.B., 17.D., 
17.F.1., 17.F.2., the ``2.4 tons per year as a 12-month rolling sum 
calculated monthly'' portion of condition 17.F.4., 18.A.2., 18.B., 19., 
20., 21.B., 21.C., 22., 23., 24., 25., 26., 27., and Appendix A.
    (ii) Additional Material.
    (A) Remainder of the July 2, 1997 submittal pertaining to Merck and 
Company, Inc.'s West Point facility located in Montgomery County.
    (B) Remainder of the August 9, 2000 submittal pertaining to Merck 
and Company, Inc.'s West Point facility located in Montgomery County.
    (C) Remainder of the February 1, 2001 submittal pertaining to Merck 
and Company, Inc.'s West Point facility located in Montgomery County.

[FR Doc. 01-9480 Filed 4-17-01; 8:45 am]
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