Technical Memorandum

innovative environmental solutions, inc.

To: 	   Jaime Pagan/EPA, Melanie King/EPA				Date: April 30, 2009

From:     Tom McGrath

c:	   Jim McCarthy, Jeff Panek

Subject:  Data used to develop the MACT Floor for gas-fired IC Engines

The tables below include emissions data for gas-fired internal combustion engines extracted from the file  “Emission Factors from RICE EDB-All HP-All Loads.xls.” The Excel file was provided by EPA on 4/29/09.  The tabulated data are intended to replicate the MACT floors for formaldehyde and carbon monoxide (CO) presented in EPA Docket document EPA-HQ-OAR-2008-0708-0006.pdf  “Subcategorization and MACT Floor Determination for Stationary Reciprocating Internal Combustion Engines ≤500 HP at Major Sources.”

As noted below, I was not able to exactly replicate the MACT Floor for 4SLB units; thus, it would be appreciated if you or your subcontractor Alpha-Gamma could review the 4SLB data and note discrepancies between the tabulated data below and their analysis.  In addition, verification of the MACT Floor data for 4SRB and 2SLB engines would be appreciated.

4SRB Gas-Fired IC Engines MACT Floor Data

Table 1 presents the formaldehyde emissions data used to develop the MACT floor for gas-fired SI non-emergency 4SRB engines 50 to 500 HP.  The MACT floor for this engine subcategory is the level achieved by 4SRB engines 50 to 500 HP operating without add-on (i.e. post-combustion) controls.  Table 1 has data from 13 tests of engines between 50 and 500 hp.  The proposed MACT floor is based on the average of the best performing 12% of engines (or 2 tests).  These data are shaded and result in a MACT floor of 2 ppbvd formaldehyde at 15% O2.

2SLB Gas-Fired IC Engines MACT Floor Data

Table 2 presents the formaldehyde emissions data used to develop the MACT floor for gas-fired SI non-emergency 2SLB engines.  The MACT floor for this engine subcategory is the level achieved by 2SLB engines 50 to 500 HP operating without add-on (i.e. post-combustion) controls.  Data from 16 tests of engines between 50 and 500 hp are presented.  EPA took the average of the best performing 12 percent (or 2 tests) of engines, found the corresponding CO tests and averaged those tests as well. These CO data are in Table 3 and the average of these two data is the proposed MACT floor of 85 ppmvd of CO at 15 percent O2.

4SLB Gas-Fired IC Engines MACT Floor Data

Table 4 presents the formaldehyde emissions data used to develop the MACT floor for gas-fired SI non-emergency 4SLB engines.  The MACT floor for this engine subcategory is the level achieved by 4SLB engines 50 to 500 HP operating without add-on (i.e. post-combustion) controls.  Data from 36 tests of engines greater than 500 hp are presented (Note – Docket document EPA-HQ-OAR-2008-0708-0006.pdf references 34 rather than 36 tests).  EPA took the average of the best performing 12 percent (or 4 tests) of engines, found the corresponding CO tests and averaged those tests. These CO data are in Table 5.  Only two of the four best performing formaldehyde engines had CO emissions data.   The average of these two data is 82 ppmvd of CO at 15 percent O2.  (Note – Docket document EPA-HQ-OAR-2008-0708-0006.pdf  lists a MACT floor of 85 rather than 82 ppmv CO at 15% O2).  Table 1.  MACT Floor Formaldehyde Emissions Data for Gas-Fired 4SRB Engines:  50 < hp < 500.

Test ID	Engine Specifications	Test Method	O2 (%)	ppb @ 15% O2

	Manufacturer	Model	hp	Load

Run 1 	Run 2	Run 3	Run 1 	Run 2	Run 3	Avg

11.2	Ingersoll Rand	8SVG	440	100%	CARB 430	5.0	5.0	5.0	1,247	1,896	1,900 1,681

7.4	Waukesha	MM425	54	100%	CARB 430	0.3	0.3	0.3	1,756	1,802	2,323	1,960

11.3	Ingersoll Rand	8SVG	440	100%	CARB 430	16.7	16.7	16.7	8,596	5,352 5,543	6,497

7.1	NR	MM605	60	100%	CARB 430	3.3	3.3	3.3	5,793	14,733	1,797	7,441

7.5	NR	MM336	77	100%	CARB 430	6.0	6.0	6.0	11,060	3,679	8,359	7,699

7.12	Waukesha	1197	208	100%	CARB 430	5.7	5.7	5.7	10,752	3,990	8,462 7,735

7.7	Waukesha	1197	208	100%	CARB 430	2.7	2.7	2.7	7,894	7,401	8,069	7,788

7.3	Waukesha	1197	159	100%	CARB 430	4.6	4.6	4.6	12,296	10,580	9,787 10,888

7.10	Waukesha	145	74	100%	CARB 430	7.1	7.1	7.1	13,031	10,795	8,906 10,911

7.11	Waukesha	145	74	100%	CARB 430	2.4	2.4	2.4	9,169	11,956	12,090 11,072

7.8	Waukesha	1197	208	100%	CARB 430	6.0	6.0	6.0	12,845	17,696	18,694 16,412

7.6	NR	MM335	77	100%	CARB 430	7.0	7.0	7.0	16,872	17,471	17,225	17,189

7.2	NR	MM605	60	100%	CARB 430	4.5	4.5	4.5	38,375	35,569	18,125	30,690

Table 2.  MACT Floor Formaldehyde Emissions Data for Gas-Fired 2SLB Engines:  50 < hp < 500.

Test ID	Engine Specifications	Test Method	O2 (%)	ppb @ 15% O2

	Manufacturer	Model	hp	Load (%)

Run 1 	Run 2	Run 3	Run 1 	Run 2	Run 3	Avg

CSU-1.4.1	Cooper Bessemer	GMB-4VTF	440	95	FTIR	14.70	NR	NR	15,333	NR	NR 15,333

CSU-1.14.1	Cooper Bessemer	GMB-4VTF	440	100	FTIR	14.60	NR	NR	15,776	NR NR	15,776

CSU-1.6.1	Cooper Bessemer	GMB-4VTF	440	100	FTIR	14.34	NR	NR	16,091	NR	NR 16,091

CSU-1.1.1	Cooper Bessemer	GMB-4VTF	440	100	FTIR	14.6	NR	NR	16,693	NR	NR 16,693

CSU-1.9.1	Cooper Bessemer	GMB-4VTF	440	100	FTIR	14.50	NR	NR	16,725	NR	NR 16,725

CSU-1.5.1	Cooper Bessemer	GMB-4VTF	440	100	FTIR	15.10	NR	NR	17,173	NR	NR 17,173

CSU-1.10.1	Cooper Bessemer	GMB-4VTF	440	100	FTIR	14.63	NR	NR	17,369	NR NR	17,369

CSU-1.16.1	Cooper Bessemer	GMB-4VTF	440	100	FTIR	14.60	NR	NR	18,002	NR NR	18,002

CSU-1.11.1	Cooper Bessemer	GMB-4VTF	440	95	FTIR	15.20	NR	NR	18,002	NR	NR 18,002

CSU-1.13.1	Cooper Bessemer	GMB-4VTF	440	100	FTIR	14.60	NR	NR	18,166	NR NR	18,166

CSU-1.15.1	Cooper Bessemer	GMB-4VTF	440	100	FTIR	14.70	NR	NR	18,274	NR NR	18,274

CSU-1.12.1	Cooper Bessemer	GMB-4VTF	440	95	FTIR	15.30	NR	NR	18,365	NR	NR 18,365

CSU-1.8.1	Cooper Bessemer	GMB-4VTF	440	95	FTIR	15.60	NR	NR	19,021	NR	NR 19,021

CSU-1.3.1	Cooper Bessemer	GMB-4VTF	440	69	FTIR	16.08	NR	NR	22,443	NR	NR 22,443

CSU-1.2/7.1	Cooper Bessemer	GMB-4VTF	440	68	FTIR	15.8	NR	NR	24,112	NR	NR 24,112

7.14	Clark	MA-4	150	100	CARB 430	14.2	14.2	14.2	33,744	27,704	28,655 30,034

Table 3.  MACT Floor Carbon Monoxide Emissions Data for Gas-Fired 2SLB Engines:  50 < hp < 500.

Test ID	Engine Specifications	Test Method	O2 (%)	ppmv  @ 15% O2

	Manufacturer	Model	hp	Load (%)

Run 1 	Run 2	Run 3	Run 1 	Run 2	Run 3	Avg

CSU-1.4.1	Cooper Bessemer	GMB-4VTF	440	95	FTIR	14.70	NR	NR	75	NR	NR	75

CSU-1.14.1	Cooper Bessemer	GMB-4VTF	440	100	FTIR	14.60	NR	NR	95	NR	NR	95

Table 4.  MACT Floor Formaldehyde Emissions Data for Gas-Fired 24LB Engines:  50 < hp < 500.

Test ID	Engine Specifications	Test Method	O2 (%)	ppb @ 15% O2

	Manufacturer	Model	hp	Load

Run 1 	Run 2	Run 3	Run 1 	Run 2	Run 3	Avg

29.33x	Cooper Bessemer	LSV-16	4,200	98	FTIR	9.6	NR	NR	ND (326)	NR	NR	ND (326)

3.12	Dresser-Rand	KVS-412	2,000	90	CARB 430	9.9	9.9	9.9	2,575	2,575 2,575	2,575

29.41x	Ingersoll Rand	KVS-412	2,000	91	FTIR	8.3	NR	NR	4,683	NR	NR	4,683

25.2	Ingersoll Rand	KVR 616	5,500	70	CARB 430	13.8	13.75	13.6	3,571 7,274	3,482	4,775

21	Waukesha	7042-GL	1,000	100	CARB 430	9.28	9.30	9.30	12,313	6,709	8,479 9,167

3.7	Dresser-Rand	KVS-412	2,000	100	CARB 430	12.1	12.1	12.1	10,057	10,057 10,057	10,057

29.38x	Cooper Bessemer	LSV-16	4,200	99	FTIR	9.3	NR	NR	15,869	NR	NR 15,869

29.34x	Cooper Bessemer	LSV-16	4,200	101	FTIR	9.4	NR	NR	15,956	NR	NR 15,956

29.37x	Cooper Bessemer	LSV-16	4,200	98	FTIR	9.5	NR	NR	17,131	NR	NR 17,131

29.35x	Cooper Bessemer	LSV-16	4,200	87	FTIR	9.9	NR	NR	18,934	NR	NR 18,934

29.36x	Cooper Bessemer	LSV-16	4,200	85	FTIR	11	NR	NR	19,667	NR	NR	19,667

29.44x	Ingersoll Rand	KVS-412	2,000	89	FTIR	11.3	NR	NR	20,527	NR	NR 20,527

29.46x	Ingersoll Rand	KVS-412	2,000	92	FTIR	11.3	NR	NR	25,444	NR	NR 25,444

29.51x	Ingersoll Rand	KVS-412	2,000	87	FTIR	11.1	NR	NR	26,670	NR	NR 26,670

29.49x	Ingersoll Rand	KVS-412	2,000	88	FTIR	11.4	NR	NR	26,767	NR	NR 26,767

29.50x	Ingersoll Rand	KVS-412	2,000	88	FTIR	11.2	NR	NR	27,736	NR	NR 27,736

29.45x	Ingersoll Rand	KVS-412	2,000	82	FTIR	11.4	NR	NR	28,444	NR	NR 28,444

29.48x	Ingersoll Rand	KVS-412	2,000	84	FTIR	11.6	NR	NR	30,578	NR	NR 30,578

29.52x	Ingersoll Rand	KVS-412	2,000	80	FTIR	11.3	NR	NR	30,852	NR	NR 30,852

29.47x	Ingersoll Rand	KVS-412	2,000	85	FTIR	11.5	NR	NR	31,006	NR	NR 31,006

CSU-2.4.1	Waukesha	3521 GL	736	100	FTIR	9.80	NR	NR	33,371	NR	NR	33,371

CSU-2.9.1	Waukesha	3521 GL	736	100	FTIR	9.69	NR	NR	33,806	NR	NR	33,806

CSU-2.6.1	Waukesha	3521 GL	736	100	FTIR	9.10	NR	NR	33,833	NR	NR	33,833

CSU-2.14.1	Waukesha	3521 GL	736	100	FTIR	9.81	NR	NR	33,939	NR	NR	33,939

CSU-2.11.1	Waukesha	3521 GL	736	100	FTIR	9.81	NR	NR	33,955	NR	NR	33,955

CSU-2.1.1	Waukesha	3521 GL	736	100	FTIR	9.80	NR	NR	34,128	NR	NR	34,128

CSU-2.10.1	Waukesha	3521 GL	736	100	FTIR	9.80	NR	NR	34,383	NR	NR	34,383

CSU-2.16.1	Waukesha	3521 GL	736	100	FTIR	9.82	NR	NR	34,840	NR	NR	34,840

CSU-2.3.1	Waukesha	3521 GL	736	70	FTIR	9.81	NR	NR	34,960	NR	NR	34,960

CSU-2.12.1	Waukesha	3521 GL	736	100	FTIR	9.90	NR	NR	34,987	NR	NR	34,987

CSU-2.15.1	Waukesha	3521 GL	736	100	FTIR	9.90	NR	NR	35,102	NR	NR	35,102

CSU-2.2.1	Waukesha	3521 GL	736	70	FTIR	9.82	NR	NR	36,637	NR	NR	36,637

CSU-2.13.1	Waukesha	3521 GL	736	100	FTIR	10.44	NR	NR	36,742	NR	NR	36,742

CSU-2.8.1	Waukesha	3521 GL	736	100	FTIR	10.50	NR	NR	37,203	NR	NR	37,203

CSU-2.7.1	Waukesha	3521 GL	736	70	FTIR	9.20	NR	NR	37,907	NR	NR	37,907

CSU-2.5.1	Waukesha	3521 GL	736	100	FTIR	10.51	NR	NR	42,046	NR	NR	42,046

Table 5.  MACT Floor Carbon Monoxide Emissions Data for Gas-Fired 4SLB Engines:  50 < hp < 500.

Test ID	Engine Specifications	Test Method	O2 (%)	ppb @ 15% O2

	Manufacturer	Model	hp	Load

Run 1 	Run 2	Run 3	Run 1 	Run 2	Run 3	Avg

29.33x	Cooper Bessemer	LSV-16	4,200	98	FTIR	9.6	NR	NR	106	NR	NR	106

3.12	Dresser-Rand	KVS-412	2,000	90	CARB 430	9.9	9.9	9.9	No Data

29.41x	Ingersoll Rand	KVS-412	2,000	91	FTIR	8.3	NR	NR	59	NR	NR	59

25.2	Ingersoll Rand	KVR 616	5,500	70	CARB 430	13.8	13.75	13.6	No Data


[Federal Register Volume 78, Number 249 (Friday, December 27, 2013)]
[Proposed Rules]
[Pages 78796-78797]
[FR Doc No: 2013-30881]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 314 and 601

[Docket No. FDA-2013-N-0500]
RIN 0910-AG94

Supplemental Applications Proposing Labeling Changes for Approved
Drugs and Biological Products; Correction and Extension of Comment
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; correction and extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA) is correcting, and
extending the comment period for, the proposed rule that appeared in
the Federal Register of November 13, 2013. In the proposed rule, FDA
requested comments on the proposal to revise and clarify procedures for
application holders of an approved drug or biological product to change
the product labeling to reflect certain types of newly acquired
information in advance of FDA's review of the change. The proposed rule
published without a reference or a link to the accompanying Regulatory
Impact Analysis. The Agency is taking this action to correct this
omission and to extend the comment period in response to requests for
an extension to allow interested persons additional time to submit
comments on the proposed rule.

DATES: FDA is extending the comment period on the proposed rule
published November 13, 2013, at 78 FR 67985, and on information
collection issues under the Paperwork Reduction Act of 1995. Submit
either electronic or written comments on the proposed rule by March 13,
2014. Submit comments on information collection issues under the
Paperwork Reduction Act of 1995 by February 11, 2014 (see the
``Paperwork Reduction Act of 1995'' section of the proposed rule).

ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-0500 and/or Regulatory Information Number (RIN) 0910-AG94, by any of
the following methods, except that comments on information collection
issues under the Paperwork Reduction Act of 1995 must be submitted to
the Office of Information and Regulatory Affairs, Office of Management
and Budget (OMB) (see the ``Paperwork Reduction Act of 1995'' section
of the proposed rule.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2013-N-0500 and RIN 0910-AG94 for this rulemaking.
All comments received may be posted without change to http://www.regulations.gov, including any personal information provided. For
additional information on submitting comments, see the ``Request for
Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the ``Search'' box and follow the prompts and/or go to the
Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.

FOR FURTHER INFORMATION CONTACT: Janice L. Weiner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6304, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of November 13, 2013 (78 FR 67985), FDA
published a proposed rule with a 60-day comment period to request
comments on the proposal to revise and clarify procedures for
application holders of an approved drug or biological product to change
the product labeling to reflect certain types of newly acquired
information in advance of FDA's review of the change. Comments on the
proposal to permit holders of abbreviated new drug applications to
distribute revised product labeling that differs in certain respects,
on a temporary basis, from the labeling of its reference listed drug
upon submission of a ``changes being effected'' supplement will inform
FDA's rulemaking.
    The proposed rule published without reference or a link to the
accompanying Regulatory Impact Analysis. Accordingly, the following
corrections are made to FR Doc. 2013-26799, appearing on page 67985, in
the Federal Register of November 13, 2013:
    1. On page 67996, in the first column, at the end of section IV.
Analysis of Impacts, the following is added as a third full paragraph:
``The full discussion of economic impacts is available in docket FDA-
2013-N-0500 and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (Ref. 3).''
    2. On page 67997, in the third column, the following is added as a
third reference: ``3. Preliminary Regulatory Impact Analysis, Initial
Regulatory Flexibility Analysis, and Unfunded Mandates Reform Act
Analysis for Supplemental Applications Proposing Labeling Changes for
Approved Drugs and Biological Products, available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.''
    The Agency has received requests for a 60-day extension of the
comment period for the proposed rule. These requests conveyed concern
that the current 60-day comment period does not allow sufficient time
to develop a meaningful or thoughtful response to the proposed rule.
    FDA has considered the requests and is extending the comment period
for the proposed rule for 60 days, until March 13, 2014. FDA also is
extending the comment period for information collection issues under
the Paperwork

Reduction Act of 1995 for 60 days, until February 11, 2014. The Agency
believes that a 60-day extension allows adequate time for interested
persons to submit comments without significantly delaying rulemaking on
these important issues.

II. Request for Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: December 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30881 Filed 12-26-13; 8:45 am]
BILLING CODE 4160-01-P