Document ID: EPA-HQ-OECA-2006-0713-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-05-04T04:00Z

SUPPORTING STATEMENT

	ENVIRONMENTAL PROTECTION AGENCY

	

NESHAP for Pharmaceuticals Production (40 CFR part 63, subpart GGG)
(Renewal)

1.  Identification of the Information Collection

1(a)  Title of the Information Collection

NESHAP for Pharmaceuticals Production (40 CFR part 63, subpart GGG)
(Renewal)

1(b)  Short Characterization/Abstract

The National Emission Standards for Hazardous Air Pollutants (NESHAP)
for Pharmaceuticals Production was proposed on April 2, 1997 and
promulgated on September 21, 1998.  These standards apply to facilities
in pharmaceuticals productions that are major sources of hazardous air
pollutants (HAP).  The affected facilities encompass all pharmaceuticals
manufacturing operations that include process vents, storage tanks,
equipment components, and wastewater systems commencing construction, or
reconstruction after the date of that proposal.  This information is
being collected to assure compliance with 40 CFR part 63, subpart GGG. 
HAP emissions are the pollutants regulated under this subpart.

	In general, all NESHAP standards require initial notifications,
performance tests, and periodic reports.  Owners, or operators also are
required to maintain records of the occurrence and duration of any
startup, shutdown, or malfunction in the operation of an affected
facility, or any period during which the monitoring system is
inoperative.  These notifications, reports, and records are essential in
determining compliance and in general, are required of all sources
subject to NESHAP.  This information is used by the Agency to identify
sources subject to the standards to insure that the maximum achievable
control technologies are being applied.

	Any owner, or operator subject to the provisions of this part will
maintain a file of these measurements, and retain the file for at least
five years following the date of such measurements, maintenance reports,
and records.  All reports are sent to the delegated state, or local
authority.  In the event that there is no such delegated authority, the
reports are sent directly to the United States Environmental Protection
Agency (EPA) regional office.

	There is an annual average of 100 respondents that will be subject to
the standard, and it is estimated that there will be no new growth in
the industry over the next three years, though one of the existing
sources per year will become subject to the standard over the next three
years due to the reconstruction of an existing affected facility.  The
average annual cost to industry over the next three years of this
Information Collection Request (ICR) is estimated to be $14,485,933.

The Office of Management and Budget (OMB) approved the currently active
ICR without any “Terms of Clearance” (TOC).

The “Affected Public” as categorized in ICRAS is “Private Sector-
Business, or other for- profit.”  The burden for the “Affected
Public” may be found in Table 1: Annual Industry Burden for NESHAP for
Pharmaceuticals Production (40 CFR part 63, subpart GGG).  The burden
for the Federal Government is attributed entirely to work performed by
Federal employees, or government contractors and may be found in Table
2: Average Annual EPA Burden for NESHAP for Pharmaceuticals Production
(40 CFR part 63, subpart GGG).

2.  Need for and Use of the Collection

2(a)  Need/Authority for the Collection

The EPA is charged under section 112 of the Clean Air Act, as amended,
to establish standards of performance for each category, or subcategory
of major sources and area sources of hazardous air pollutants.  These
standards are applicable to new, or existing sources of hazardous air
pollutants and will require the maximum degree of emission reduction. 
In addition, section 114(a) states that the Administrator may require
any owner, or operator subject to any requirement of this Act to:

(A) Establish and maintain such records; (B) make such reports; (C)
install, use, and maintain such monitoring equipment, and use such audit
procedures, or methods; (D) sample such emissions (in accordance with
such procedures or methods, at such locations, at such intervals, during
such periods, and in such manner as the Administrator shall prescribe);
(E) keep records on control equipment parameters, production variables
or other indirect data when direct monitoring of emissions is
impractical; (F) submit compliance certifications in accordance with
Section 114(a)(3); and (G) provide such other information as the
Administrator may reasonably require.

	In the Administrator's judgment, HAP pollutant emissions from
pharmaceuticals production (predominately methanol, methylene chloride
and toluene) cause, or contribute to air pollution that may reasonably
be anticipated to endanger public health, or welfare.  Therefore, the
NESHAP was promulgated for this source category at 40 CFR part 63,
subpart GGG

2(b)  Practical Utility/Users of the Data

The control of emissions of HAP from pharmaceuticals production required
not only the installation of properly designed equipment, but also the
operation and maintenance of that equipment.  Emissions of HAP from
pharmaceuticals production is the result of operation of the affected
facilities.  The subject standards are achieved by the reduction of HAP
emissions using control technology and leak detection and repair
procedures.

The recordkeeping and reporting requirements in the standards ensure
compliance with the applicable regulations which where promulgated in
accordance with the Clean Air Act.  The collected information also is
used for targeting inspections and as evidence in legal proceedings.

Performance tests are required in order to determine an affected
facility’s initial capability to comply with the emission standards. 
Continuous emission monitors may be used to ensure compliance with the
standards at all times.  During the performance test a record of the
operating parameters under which compliance was achieved may be recorded
and used to determine compliance in place of a continuous emission
monitor. 

The notifications required in the standards are used to inform the
Agency, or delegated authority when a source becomes subject to the
requirements of the regulations.  The reviewing authority may then
inspect the source to ensure that the pollution control devices are
properly installed and operated, that leaks are being detected and
repaired, and that the standards are being met.  The performance test
also may be observed.

The required semiannual reports are used to determine periods of excess
emissions, identify problems at the facility, verify
operation/maintenance procedures and for compliance determinations.

3.  Nonduplication, Consultations, and Other Collection Criteria

The requested recordkeeping and reporting are required under 40 CFR part
63, subpart GGG.

3(a)  Nonduplication

 If the subject standards have not been delegated, the information is
sent directly to the appropriate EPA regional office.  Otherwise, the
information is sent directly to the delegated state, or local agency. 
If a state, or local agency has adopted its own similar standards to
implement the Federal standards, a copy of the report submitted to the
state, or local agency can be sent to the Administrator in lieu of the
report required by the Federal standards.  Therefore, no duplication
exists.

3(b)  Public Notice Required Prior to ICR Submission to OMB

An announcement of a public comment period for the renewal of this ICR
was published in the Federal Register 71 FR 58853 on October 5, 2006. 
No comments were received on the burden published in the Federal
Register. 

3(c)  Consultations

For this information collection, we referenced the most recent ICR, the
preparer of the active ICR, and accessed the most recent data available
on the Air Facility System (AFS) database as maintained by the Office of
Compliance.  We reviewed information available from the United States
Census Bureau via the internet, and other websites covering
pharmaceuticals production.  We consulted with Randy McDonald at EPA’s
Office of Air Quality Planning and Standards at 919-541-5402 and Ms. Sue
Wise with Merck at 908-423-3181. 

3(d)  Effects of Less Frequent Collection

Less frequent information collection would decrease the margin of
assurance that facilities are continuing to meet the standards. 
Requirements for information gathering and recordkeeping are useful
techniques to ensure that good operation and maintenance practices are
applied and emission limitations are met.  If the information required
by these standards was collected less frequently, the proper operation
and maintenance of control equipment and the possibility of detecting
violations would be less likely.

3(e)  General Guidelines

These reporting and recordkeeping requirements do not violate any of the
regulations  promulgated by OMB under 5 CFR part 1320, section 1320.5.

These standards require the respondents to maintain all records,
including reports and notifications for at least five years.  This is
consistent with the General Provisions as applied to the standards.  EPA
believes that the five year records retention requirement is consistent
the Part 70 permit program and the five year statute of limitations on
which the permit program is based.  The retention of records for five
years allows EPA to establish the compliance history of a source,
discern any pattern of non-compliance, and determine the appropriate
level of enforcement action.  EPA has found that the most flagrant
violators have violations extending beyond five years.  In addition, EPA
would be prevented from pursuing the violators due to the destruction or
nonexistence of essential records.

3(f)  Confidentiality

Any information submitted to the Agency for which a claim of
confidentiality is made will be safeguarded according to the Agency
policies set forth in title 40, chapter 1, part 2, subpart B -
Confidentiality of Business Information (see 40 CFR 2; 41 FR 36902,
September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43 FR
42251, September 20, 1978; 44 FR 17674, March 23, 1979).

3(g)  Sensitive Questions

The reporting, or recordkeeping requirements in the standard do not
include sensitive questions.

4.  The Respondents and the Information Requested

4(a)  Respondents/SIC Codes

The respondents to the recordkeeping and reporting requirements are
pharmaceuticals production manufacturing operations.  The United States
Standard Industrial Classification (SIC) codes for the respondents
affected by the standards are SIC 2833 and 2834, which correspond to the
North American Industry Classification System (NAICS) 325411 and 325412
for pharmaceuticals production manufacturing operations.

4(b)  Information Requested 

(i)  Data Items

In this ICR, all the data that is recorded or reported is required by
the NESHAP for Pharmaceuticals Production (40 CFR part 63, subpart GGG).

A source must make the following reports:

Notifications and Reports	Standard Citation by Section

Change in area source status (as applicable)	63.1(c)(5)

Application and notification of construction/reconstruction	63.5(b)(4),
63.5(d), and 63.1260(c)

Notification of applicability	63.9(a), 63.1260(b)

Notification of initial startup	63.9(b), 63.9(d), and 63.1260(b)

Notification of initial performance test, submittal of test plan,
request for waiver of performance test	63.7(b)(1), 63.7(b)(2), 63.7(c),
63.7(f), 63.7(h) and 63.9(e), 63.1257(b)(8), 63.1260(l)

Notification of delay (reschedule) of initial performance test
63.7(b)(2)

Notification of CMS performance evaluation and results	63.8(e)(2),
63.9(g)(1), 63.9(e)(5), 63.10(e)(2), and 63.1260(d)

Notification to continue use of alternative to relative accuracy testing
has been exceeded	 63.9(g)(3) , 63.1260(d)

Notification of compliance status report (NOCSR)	63.9(h), 63.1260(f)

Initial performance test results	63.10(d)(2), 63.7(g), 63.1260(f)

Request for compliance extension and progress reports for compliance
extension (as applicable)	63.10(d)(4), 63.1250(f)(6), 63.1260(m)

Reports of startup, shutdown, and malfunction (SS&M)	63.10(d)(5), and
63.1260(i)

Pre-compliance report (as applicable)	63.1260(e)

Notification of process change	63.1260(h)

Periodic Reports	63.1260(g)

Reports of leak detection and repair (LDAR)	63.1260(j), 63.1255(h)

Reports of emissions averaging	63.1260(k)

A source must keep the following records:

Recordkeeping

Recordkeeping requirements	63.10(a), 63.1259(a)

All reports and notifications	63.10(b)(1), and 63.1259(a)(1)

Record of applicability	63.10(b)(3), and 63.1259(a)(2)

Records of SS&M and SS&M plan	63.1259(a)(3)

Records of sources with continuous monitoring systems (CMS)
63.10(c)(1)-(14), and 63.1259(a)(4)

Application for approval of construction/reconstruction	63.1259(a)(5)

Records of equipment operation	63.1259(b)

Records of operating scenarios	63.1259(c)

Records of LDAR program	63.1259(d), 63.1255(g)

Records of emissions averaging	63.1259(e)

Records of delay of repair	63.1259(f)

Records of wastewater stream or residual transfer	63.1259(g)

Records of extensions	63.1259(h)

Records of inspections	63.1259(i)

Records should be retained for 5 years	63.10(b)(1), 63.1259(a)(1)

Electronic Reporting

Some of the respondents are using monitoring equipment that
automatically records parameter data.  Although personnel at the
affected facility must still evaluate the data, internal automation has
significantly reduced the burden associated with monitoring and
recordkeeping at a plant site. 

Also, regulatory agencies in cooperation with the respondents continue
to create reporting systems to transmit data electronically.  However,
electronic reporting systems are still not widely used.  At this time,
it is estimated that approximately 20 percent of the respondents use
electronic reporting.

Respondent Activities	

Respondent Activities

Read instructions.

Plan compliance strategy (includes preparing implementation plans)

Perform initial performance test, Reference Methods 1, 2, 3, 4, 18, 25
and 26 test, and repeat performance tests if necessary.

Write the notifications and reports listed above.

Enter information required to be recorded above.

Submit the required reports developing, acquiring, installing, and
utilizing technology and systems for the purpose of collecting,
validating, and verifying information.

Develop, acquire, install, and utilize technology and systems for the
purpose of processing and maintaining information.

Develop, acquire, install, and utilize technology and systems for the
purpose of disclosing and providing information.

Currently, sources are using automated monitoring equipment that
provides parameter data.  Although personnel at the source still need to
evaluate the data, this type of monitoring equipment has significantly
reduced the burden associated with monitoring and recordkeeping.

5.  The Information Collected: Agency Activities, Collection
Methodology, and Information Management

5(a)  Agency Activities

EPA conducts the following activities in connection with the
acquisition, analysis, storage, and distribution of the required
information:

Agency Activities

Review notifications and reports, including performance test reports,
and excess emissions reports, required to be submitted by industry.

Audit facility records.

Input, analyze, and maintain data in the Air Facility System (AFS).

5(b)  Collection Methodology and Management

Following notification of startup, the reviewing authority could inspect
the source to determine whether the pollution control devices are
properly installed and operated.  Performance test reports are used by
the Agency to discern a source’s initial capability to comply with the
emission standard.  Data and records maintained by the respondents are
tabulated and published for use in compliance and enforcement programs. 
The semiannual reports are used for problem identification, as a check
on source operation and maintenance, and for compliance determinations.

Information contained in the reports is entered into the AFS which is
operated and maintained by EPA's Office of Compliance.  AFS is EPA’s
database for the collection, maintenance, and retrieval of compliance
data for approximately 125,000 industrial and government-owned
facilities.  EPA uses the AFS for tracking air pollution compliance and
enforcement by local and state regulatory agencies, EPA regional offices
and EPA headquarters.  EPA and its delegated Authorities can edit,
store, retrieve and analyze the data.

 The records required by this regulation must be retained by the
owner/operator for five years.

5(c)  Small Entity Flexibility

A majority of the affected facilities are large entities (e.g., large
businesses).  However, the impact on small entities (i.e., small
businesses) was taken into consideration during the development of the
regulation.  Due to technical considerations involving the process
operations and the types of control equipment employed, the
recordkeeping and reporting requirements are the same for both small and
large entities.  The Agency considers these requirements the minimum
needed to ensure compliance and, therefore, cannot reduce them further
for small entities.  To the extent that larger businesses can use
economies of scale to reduce their burden, the overall burden will be
reduced.

5(d)  Collection Schedule

The specific frequency for each information collection activity within
this request is shown in  Table 1: Annual Industry Burden for NESHAP for
Pharmaceuticals Production (40 CFR part 63, subpart GGG).  

6.  Estimating the Burden and Cost of the Collection

Table 1 documents the computation of individual burdens for the
recordkeeping and reporting requirements applicable to the industry for
the subpart included in this ICR.  The individual burdens are expressed
under standardized headings believed to be consistent with the concept
of burden under the Paperwork Reduction Act.  Where appropriate,
specific tasks and major assumptions have been identified.  Responses to
this information collection are mandatory.

The 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.

6(a)  Estimating Respondent Burden

The average annual burden to industry over the next three years from
these recordkeeping and reporting requirements is estimated to be
163,525 hours.  These hours are based on Agency studies and background
documents from the development of the regulation, Agency knowledge and
experience with the NESHAP program, the previously approved ICR, and any
comments received.

6(b)  Estimating Respondent Costs

(i)  Estimating Labor Costs 

 

This ICR uses the following labor rates: 

Managerial	$105.36 ($50.17 + 110%)   

Technical	$92.09   ($43.85 + 110%)

Clerical	$45.15   ($22.50 + 110%)

These rates are from the United States Department of Labor, Bureau of
Labor Statistics, September 2006, “Table 2. Civilian Workers, by
occupational and industry group.”  The rates are from column 1,
“Total compensation.”  The rates have been increased by 110% to
account for the benefit packages available to those employed by private
industry.

(ii)  Estimating Capital/Startup and Operation and Maintenance Costs

 The type of industry costs associated with the information collection
activities in the subject standards are both labor costs that are
addressed elsewhere in this ICR and the costs associated with continuous
monitoring.  The capital/startup costs are one-time costs when a
facility becomes subject to the regulation.  The annual operation and
maintenance costs are the ongoing costs to maintain the monitors and
other costs such as photocopying and postage.]

(iii)  Capital/Startup vs. Operation and Maintenance (O&M) Costs

Capital/Startup vs. Operation and Maintenance (O&M) Costs

(A)

Continuous Monitoring Device	(B)

Capital/Startup Cost for One Respondent	(C)

Number of New Respondents 	(D)

Total Capital/Startup Cost, 

(B X C)	(E)

Annual O&M Costs for One Respondent	(F)

Number of Respondents with O&M	(G)

Total O&M,

(E X F)

Data-logger and Thermocouple	$4,400	0	$0	$4,158	100	$415,800

The total capital/startup costs for this ICR are zero.  This is the
total of column D in the above table. 

The total operation and maintenance (O&M) costs for this ICR are
$415,800.  This is the total of column G. 

The average annual cost for capital/startup and operation and
maintenance costs to industry over the next three years of the ICR is
estimated to be $415,800.  The continuous monitoring costs that are
included in this section consist only of those capital/start-up and O&M
costs that a source incurs as a result of the standard.  Some continuous
monitoring costs may not be included in this section.  For instance, if
a particular industry typically utilizes a control device that must have
a continuous monitor (e.g., temperature, pressure drop, etc.) to
function properly, and the recordation of additional measurements beyond
the minimum are required by the standard, then there is no
capital/startup, or O & M cost, but there is a labor cost to record the
additional readings.  Such a cost would not appear in this section, but
in the industry burden Section 6 (d) below.

6(c)  Estimating Agency Burden and Cost

The only costs to the Agency are those costs associated with analysis of
the reported information.  EPA's overall compliance and enforcement
program includes activities such as the examination of records
maintained by the respondents, periodic inspection of sources of
emissions, and the publication and distribution of collected
information. 

The average annual Agency cost during the three years of the ICR is
estimated to be $242,257.  Details upon which this estimate is based
appear in Table 2: Average Annual EPA Burden for NESHAP for
Pharmaceuticals Production (40 CFR part 63, subpart GGG), attached.

This cost is based on the average hourly labor rate as follows:

	Managerial	$58.18  (GS-13, Step 5, $36.36 + 60%)   

	Technical	$43.17  (GS-12, Step 1, $26.98 + 60%)

	Clerical	$23.36  (GS-6, Step 3, $14.60 + 60%)

These rates are from the Office of Personnel Management (OPM) “2007
General Schedule” which excludes locality rates of pay.  The rates
have been increased by 60% to account for the benefit packages available
to government employees.  These rates can be obtained from the OPM web
site, http//www.opm.gov/oca/payrates/ index/htm.  

6(d)  Estimating the Respondent Universe and Total Burden and Costs

Based on our research for this ICR, on average over the next three
years, approximately 100 existing respondents will be subject to the
standard.  It is estimated that no additional respondents per year will
become subject, although one existing source will become subject to new
source standards through reconstruction.  There will be no net increase
in the number of sources due to this change.  The overall average number
of respondents, as shown in the table below is 100 per year.

The number of respondents is calculated using the following table that
addresses the three years covered by this ICR:

Number of Respondents

	Respondents That Submit Reports	Respondents That Do Not Submit Any
Reports

	Year	(A)

Number of New Respondents 1	(B)

Number of Existing Respondents	(C)

Number of Existing Respondents That Keep Records But Do Not Submit
Reports	(D)

Number of Existing Respondents That Are Also New Respondents	(E)

Number of Respondents

(E=A+B+C-D)

1	1	99	0	1	100

2	1	99	0	1	100

3	1	99	0	1	100

Average	1	99	0	1	100

1 New respondents only include sources with reconstructed affected
facilities, so there is no net change in the number of respondents
(i.e., a reconstructed existing facility becomes a new affected
facility).  

Column D is subtracted to avoid double-counting respondents.  As shown
above, the average Number of Respondents over the three year period of
this ICR is 100.

The total number of annual responses per year is calculated using the
following table: 

Total Annual Responses

(A)

Information Collection Activity	(B)

Number of Respondents per year	(C)

Number of Occurrences per Respondent per year	(D)

Number of Existing Respondents That Keep Records But Do Not Submit
Reports	(E)

Total Annual Responses 

E=(BxC)+D

    a. Read rule and instructions	0	1	0	0

    b. Required Activities

 

        i. Initial Performance Test 

 

           New	0	1	0	0

        ii. Initial Performance Test 

 

            Reconstructed	1	1	0	1

       iii. Initial Performance Test

             Wastewater	0	1

0

        iii. Initial CMS performance

 

            Evaluation	0	1	0	  =product(b9,c9)  0 

        iv. Repeat Performance Test	0.2	1	0	0.2

    c. Write Reports

 

          i. Notification of Construction/

 

             Reconstruction	1	1	0	1

          ii. Notification of Process Change	100	3

300

         iii. Notification of Actual

 

              Startup	0	1	0	0

          iv. Performance Test

                Notification	1	1	0	1

          v. Notification of Applicability 	0	1	0	0

          vi. Notification of Demonstration                 of CMS      
                   	0	1	0	  =product(b24,c24)  0 

          vii. Notification of Compliance

 

               Status 	0	1

0 

        viii. Emissions Averaging Plan	0	1

0

          ix. Semi-annual Summary

 

               Report

 

               a. No Deviations	90	2	0	180

               b. Deviations	10	2	0	20

               c. SS&M Report	100	2	0	200

               d. LDAR Report	100	2	0	200

               e. Emission Averaging 

 

                   Report	10	2	0	20

Total Number of Annual Responses

923  =SUM(e2:e38)   

The number of Total Annual Responses is 923.  The total annual labor
costs are $14,485,933.  Details regarding these estimates may be found
in Table 1: Annual Industry Burden for NESHAP for Pharmaceuticals
Production (40 CFR part 63, subpart GGG), attached.

6(e)  Bottom Line Burden Hours Burden Hours and Cost Tables

The detailed bottom line burden hours and cost calculations for the
respondents and the Agency are shown in Tables 1 and 2, respectively,
and summarized below. 

(i) Respondent Tally

The total annual labor costs are $14,485,933.  Details regarding these
estimates may be found in Table 1: Annual Industry Burden for NESHAP for
Pharmaceuticals Production (40 CFR part 63, subpart GGG), attached. 
Furthermore, the annual public reporting and recordkeeping burden for
this collection of information is estimated to average 177 hours per
response.

The total annual capital/startup and O&M costs to the regulated entity
are $415,800.  The cost calculations are detailed in Section 6(b)(iii),
Capital/Startup vs. Operation and Maintenance (O&M) Costs.

(ii) The Agency Tally

The average annual Agency burden and cost over next three years is
estimated to be 5,852 labor hours at a cost of $242,257.  See Table 2:
Average Annual EPA Burden for NESHAP for Pharmaceuticals Production (40
CFR part 63, subpart GGG), attached.

 

6(f)  Reasons for Change in Burden

The increase in burden from the most recently approved ICR is due to
adjustments, as follows. 

Adjustments common to both Tables:

1.  The number of sources should be 100.  In the previous ICR, it was
assumed that there was no growth in the industry, but that one existing
source would become subject to new source standards through
reconstruction.  If this occurs, then there is no net increase in the
number of the sources, because the existing source simply becomes a
reconstructed source.  The same assumptions on growth and reconstruction
were made for this ICR, but the number of sources had to be adjusted
from 101 to 100 to account for the previous error. 

2.  The labor rates were adjusted to account for the latest labor rates
available.

Additional adjustments to Table 1:

1.  The burden for the following items should be zero, because this
burden is for new, greenfield construction only.  The sources in this
ICR which are subject to new source standards are reconstructed;
therefore, these one-time burdens associated with new, greenfield
construction do not apply (i.e., the existing source, prior to its
reconstruction would have already performed these actions):

a.  Read Instruction

b.  Quality Control Plan for CMS

c.  Develop Record System

d.  Train Personnel

e.  Notification of Actual Startup

f.  Notification of Demonstration of CMS

e.  Notification of Compliance Status Report

2.  The burdens for “Notification of Anticipated Startup” and
“Quarterly Reports of Excess Emissions” were removed, as they are
not requirements in the NESHAP. 

3.  The burden for “Semiannual Reports” was divided into “No
Deviations” and “Deviations” as the burden varies considerably
depending on which level of detail must be submitted.  Assumptions were
made on the percentage of sources submitting each, based on experience
with ICRs for similar source categories. 

4.  The number of occurrences per respondent per year for “Startup,
Shutdown and Malfunction” (SS&M) reports was corrected to two times
per year.  Additionally, the number of respondents per year submitting
SS&M reports was corrected to correlate with the number of sources
keeping records of SS&M.

5.  Burden items for “Emissions Averaging Reports” and
“Calibration of CMS” and “LDAR” records were added to the Table,
as these burden items were omitted in the previous ICR. 

6.  The burden item for “Records of Operating Conditions Exceeding
Last Performance Test” was deleted, as this is included in the burden
for “Records of Operating Parameters for Control Devices”. 

Additional adjustments to Table 2:

1.  The burdens for “Notification of Anticipated Startup” and
“Quarterly Reports of Excess Emissions and CMS Performance” were
removed, as they are not requirements in the NESHAP.

2.  The burden for the following items should be zero, because this
burden is for new, greenfield construction only.  The sources in this
ICR which are subject to new source standards are reconstructed,
therefore these one-time burdens associated with new, greenfield
construction do not apply (i.e., the existing source, prior to its
reconstruction would have already performed these actions):

a.  Review Notification of Demonstration of CMS

b.  Review Initial Notification of Compliance Status

c.  Notification of Actual Startup

3.  The burden associated with the “Initial Notification” was
reduced, as it was overstated in the previous ICR, based on experience
with ICRs for similar source categories.

4.  The burden associated with the “Notification of Compliance Status
Report” was increased, as it was understated in the previous ICR,
based on experience with ICRs for similar source categories.

5.  Burden items for “SS&M Report”, “LDAR Report”, and
“Emissions Averaging Report” were added as they were omitted in the
previous ICR. 

6.  The burden associated with reviewing “Semiannual Reports” was
divided into “No Deviations” and “Deviations” as the burden
varies considerably depending on which level of detail must be reviewed.
 Assumptions were made on the percentage of sources submitting each,
based on experience with ICRs for similar source categories.

The decrease in Capital/Startup cost is because the one reconstructed
source would not be required to buy a new thermocouple to meet the data
collection requirements.  The source would have already bought the
thermocouple to meet the existing source standards and will continue to
use that thermocouple to meet the more stringent new source standards. 
The increase in Operation and Maintenance (O&M) Costs, as calculated in
section 6(b)(iii), compared with the costs in the previous ICR is
because the O&M costs are ongoing costs born by all of the affected
facilities, not just new sources.

	6(g)  Burden Statement

The annual public reporting and recordkeeping burden for this collection
of information is estimated to average 177 hours per response.  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 valid OMB
Control Number.  The OMB Control Numbers for EPA’s regulations are
listed at 40 CFR part 9 and 48 CFR chapter 15.

	To comment on the Agency's need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a public docket for this ICR under Docket ID Number
EPA-HQ-OECA-2006-0713.  An electronic version of the public docket is
available at http://www.regulations.gov/ which may be used to obtain a
copy of the draft collection of information, submit, or view public
comments, access the index listing of the contents of the docket, and to
access those documents in the public docket that are available
electronically.  When in the system, select “search,” then key in
the docket ID number identified in this document.  The documents are
also available for public viewing at the Enforcement and Compliance
Docket and Information Center in the EPA Docket Center (EPA/DC), EPA
West, Room 3334, 1301 Constitution Ave., NW, Washington, DC.  The EPA
Docket Center 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 Reading Room is (202) 566-1744, and the telephone number for the
docket center is (202) 566-1927.  Comments also may be submitted to the
Office of Information and Regulatory Affairs, Office of Management and
Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk
Officer for EPA.  Please include the EPA Docket ID Number EPA-HQ-
OECA-2006-0713 and OMB Control Number 2060-0358 in any correspondence.

Part B of the Supporting Statement

This part is not applicable because no statistical methods were used in
collecting this information.

	Table 1 - Annual Respondent Burden and Cost - NESHAP for
Pharmaceuticals Production 

	40 CFR Part 63, Subpart GGG

	Burden Item (a)       	(A)	(B)	(C)	(D)	(E)	(F)	(G)	(H)

Respondent 	Number of	Hours 	 Number	Technical 	Management	Clerical
Hours	Total Annual 

Hours	Occurences	Per	of 	hours	Hours Per	per year	Cost a

per	Per	Respondent	Respondents	per year	year	@ $45.15

	Occurrence	Respondent	Per Year	per year	@$92.09	@$105.36

	Year	(C=AxB)

(E=CxD)	(F=E*0.05)	(G=E*0.10)

1. Applications	N/A

2. Surveys and Studies	N/A

3. Reporting Requirements

	     New Sources b

	    A. Read Instructions	1	1	1	0	0.00 	0.00 	0.00 	0.00

	    B. Required Activities

	        i. Initial Performance Test - 

	New	480	1	480	0	0.00 	0.00 	0.00 	0.00

	Reconstructed	160	1	160	1	160.00 	8.00 	16.00 	16,299.68

	                  Wastewater	160	1	160	0	0.00 	0.00 	0.00 	0.00

	        ii. Quality Control Plan for CMS 	60	1	60	0	0.00 	0.00 	0.00 
0.00

	       iii. Develop Record System	40	1	40	0	0.00 	0.00 	0.00 	0.00

	       iv. Train Personnel	40	1	40	0	0.00 	0.00 	0.00 	0.00

	       iv. Repeat Performance Test c	60	1	60	0.2	12.00 	0.60 	1.20 
1,222.48

	     C. Write Reports

	         i. Notification of Construction/

	            Reconstruction	2	1	2	1	2.00 	0.10 	0.20 	203.75

	        ii. Notification of Physical or 

	            Operational Changesd	8	3	24	100	2,400.00 	120.00 	240.00 
244,495.20

	       iii. Notification of Actual

	            Startup	2	1	2	0	0.00 	0.00 	0.00 	0.00

	       iv. Notification of Initial 

	            Performance Test	2	1	2	1	2.00 	0.10 	0.20 	203.75

	        v. Notification of Applicability 	2	1	2	0	0.00 	0.00 	0.00 
0.00

	       vi. Notifcation of Demonstration

	            of CMS	2	1	2	0	0.00 	0.00 	0.00 	0.00

	      vii. Notification of Compliance

	            Status 	120	1	120	0	0.00 	0.00 	0.00 	0.00

	     viii.Precompliance Report

	           (emissions averaging)e	180	1	180	0	0.00 	0.00 	0.00 	0.00

	    ix. Startup, Shutdown 

	         and Malfunction 	40	2	80	100	8,000.00 	400.00 	800.00 
814,984.00

	      x . Semiannual Summary

	           Report f

	               a. No Deviations 	8	2	16	90	1,440.00 	72.00 	144.00 
146,697.12

	               b. Deviations 	24	2	48	10	480.00 	24.00 	48.00 
48,899.04

	      xi. LDAR Report g	432	2	864	100	86,400.00 	4,320.00 	8,640.00 
8,801,827.20

	     xii. Emissions Averaging Report	20	2	40	10	400.00 	20.00 	40.00 
40,749.20

	Subtotal Reporting

	113,730.40 	10,074,832.22

	4. Recordkeeping Requirements

	        i. Records of operating 

	           parameters for control devices h	1	365	365	100	36,500.00 
1,825.00 	3,650.00 	3,718,364.50

	        ii. Records of SS&M 	2	26	52	100	5,200.00 	260.00 	520.00 
529,739.60

	       iii. Calibration of CMS i	16	1	16	100	1,600.00 	80.00 	160.00 
162,996.80

	        iv. LDAR	Included in 3.c.xi. 

	Subtotal recordkeeping

	49,795.00 	4,411,101.00

	Total Hours and Cost

	163,525.40 	14,485,933.22 

a Assume that all tasks are to be performed by managerial, 

	 

   technical and clerical personnel. 

	  This ICR uses the following labor rates: $105.36 for Managerial
labor, $92.09 for Technical labor, and $45.15 for Clerical labor. 

	  These rates are from the United States Department of Labor Bureau of
Labor Statistics, September 2006, “Table 10. Private industry, by
occupational

  and industry group.”  The rates have been increased by 110% to
account for the benefit packages available to those employed by private
industry. 

b Assume that there will be one reconstructed facility each year for the
next three years.

c Assume that 20 percent of sources required to conduct a performance
test will repeat performance testing each year due to failure.

	d Assume each source will require an average of three processing
changes per facility each year over the next three year period of this
ICR.

	e Assumes 10 percent of existing facilities will comply with emissions
averaging requirements; new facilities are not allowed to use emissions
averaging. 

f All affected sources must sumbit Semiannual Reports. It is estimated
that 10% will have deviations. 

	g Assumes that it will take respondents 432 hours to write the leak
detection and repair report

h Assume that all sources are required to keep records of operating
parameters for control devices

i Assume that 10 percent of source are required to keep records of
operating conditions exceeding last performance tests. 

	



	Table 2 - Annual Agency Burden and Cost - NEHSAP for Pharmaceuticals
Production

40 CFR Part 63, Subpart GGG

Burden Item	(A)	(B)	(C)	(D)	(E)	(F)	(G)	(H)

	Person Hours	Annual Occurrence	Annual Person	Total Number	Technical
Hours	Managerial 	Clerical Hours	Total Annual 

	per occurance	Per Respondent	Hours per	of Respondents	per year	Hours
Per	per year	Costa

	Respondent

	year

1. Required Activitiesb 

     i. Initial Performance Testc	2	1	2	1	2.00	0.10	0.20	95.21

   ii. Repeat Performance Testd	24	1	24	0.2	4.80	0.24	0.48	228.51

2. Report Review - One Time

     i. Notification of Construction/

        Reconstructionc	2	1	2	1	2.00	0.10	0.20	95.21

   ii. Notification of actual startup	2	1	2	0	0.00	0.00	0.00	0.00

  iii. Notification of Initial

       CMS Demonstration	2	1	2	0	0.00	0.00	0.00	0.00

  iv.  Initial Notification	2	1	2	0	0.00	0.00	0.00	0.00

   v.  Notification of Compliance

       Status Report	40	1	40	0	0.00	0.00	0.00	0.00

  vii. Precompliance Reporte

   a.  w/ Emissions Averagingf	20	1	20	0	0.00	0.00	0.00	0.00

   b.  w/o Emissions Averagingf	4	1	4	0	0.00	0.00	0.00	0.00

3. Report Review - On-going

    i. Semiannual Summary

       Report

         a. No Deviationsg	2	2	4	90	360.00	18.00	36.00	17,138.16

         b. Deviationsg	8	2	16	10	160.00	8.00	16.00	7,616.96

    ii. Notification Physical/

        Operational changeh	8	3	24	100	2,400.00	120.00	240.00	114,254.40

       iii. SS&M Reporti	2	2	4	100	400.00	20.00	40.00	19,042.40

       iv. LDAR Reportj	8	2	16	100	1,600.00	80.00	160.00	76,169.60

       v. Emission Averaging Reportf	8	2	16	10	160.00	8.00	16.00
7,616.96

Total

242,257.41

Subtotal Hours

	5,088.80	254.44	508.88

	Total Hours

	5,852.12

	a The cost is based on an hourly labor rate of $42.45 for technical
labor, $53.22 for managerial labor,and $22.96 for clerical labor.

	  These rate are from the Office of Personnel Management (OPM) " 2007
General Schedule", which exludes locality rates of pay. 

	b Includes review of test plan and test results

	c  Assume that there will be one reconstructed facility each year for
the next three years. 

d Assume that 20 percent of sources required to conduct a performance
test will repeat performance testing each year due to failure.

	e Assumes 50 percent of new facilities will submit a precompliance
report.

	f Assumes 10 percent of existing facilities will comply with emissions
averaging requirements; 

	  new facilities are not allowed to use emissions averaging.

g Assumes 90 percent of facilities will have no deviations, 10 percent
will have deviations

h Assume each source will require an average of three processing changes
per facility each year over the next three year period of this ICR

i  Assumes all facilities will report actions taken during startup,
shutdown, or malfunction that are consistent

	    with the SS&M plan

j  Assumes all facilities will report the specified information for
processes subject to the equipment leak standards. 

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