**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]{.underline} 71 [FR]{.underline}
58853 on October 5, 2006. No comments were received on the burden
published in the [Federal Register.]{.underline}

**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]{.underline} 36902, September 1, 1976; amended by 43
[FR]{.underline} 40000, September 8, 1978; 43 [FR]{.underline} 42251,
September 20, 1978; 44 [FR]{.underline} 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                       63.5(b)(4),
  construction/reconstruction                           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   63.7(b)(1),
  of test plan, request for waiver of performance test  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         63.7(b)(2)
  performance test                                      

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

  Notification to continue use of alternative to        63.9(g)(3) ,
  relative accuracy testing has been exceeded           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 63.10(d)(4),
  for compliance extension (as applicable)              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 63.10(c)(1)-(14),
  (CMS)                                                 and 63.1259(a)(4)

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

  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]{.underline}

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.

(ii) **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.      |          |          |          |         |        |      |
| O        |          |          |          |         |        |      |
| peration |          |          |          |         |        |      |
| and      |          |          |          |         |        |      |
| Mai      |          |          |          |         |        |      |
| ntenance |          |          |          |         |        |      |
| (O&M)    |          |          |          |         |        |      |
| Costs**  |          |          |          |         |        |      |
+==========+==========+==========+==========+=========+========+======+
| \(A\)    | \(B\)    | \(C\)    | \(D\)    | \(E\)   | \(F\)  | \    |
|          |          |          |          |         |        | (G\) |
| Co       | Capital  | Number   | Total    | Annual  | Number |      |
| ntinuous | /Startup | of New   | Capital  | O&M     | of     | T    |
| Mo       | Cost for | Res      | /Startup | Costs   | Respo  | otal |
| nitoring | One      | pondents | Cost,    | for One | ndents | O&M, |
| Device   | Re       |          |          | Res     | with   |      |
|          | spondent |          | (B X C)  | pondent | O&M    | (E X |
|          |          |          |          |         |        | F)   |
+----------+----------+----------+----------+---------+--------+------+
| Dat      | \$4,400  | 0        | \$0      | \$4,158 | 100    | \    |
| a-logger |          |          |          |         |        | $415 |
| and      |          |          |          |         |        | ,800 |
| Ther     |          |          |          |         |        |      |
| mocouple |          |          |          |         |        |      |
+----------+----------+----------+----------+---------+--------+------+

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:

+-----+-----------+--------+--------------+------------+------------+
| **  |           |        |              |            |            |
| Num |           |        |              |            |            |
| ber |           |        |              |            |            |
| of  |           |        |              |            |            |
| R   |           |        |              |            |            |
| esp |           |        |              |            |            |
| ond |           |        |              |            |            |
| ent |           |        |              |            |            |
| s** |           |        |              |            |            |
+=====+===========+========+==============+============+============+
|     | Re        |        | Respondents  |            |            |
|     | spondents |        | That Do Not  |            |            |
|     | That      |        | Submit Any   |            |            |
|     | Submit    |        | Reports      |            |            |
|     | Reports   |        |              |            |            |
+-----+-----------+--------+--------------+------------+------------+
| Y   | \(A\)     | \(B\)  | \(C\)        | \(D\)      | \(E\)      |
| ear |           |        |              |            |            |
|     | Number of | Number | Number of    | Number of  | Number of  |
|     | New       | of     | Existing     | Existing   | R          |
|     | Re        | Ex     | Respondents  | R          | espondents |
|     | spondents | isting | That Keep    | espondents |            |
|     | ^1^       | Respo  | Records But  | That Are   | (          |
|     |           | ndents | Do Not       | Also New   | E=A+B+C-D) |
|     |           |        | Submit       | R          |            |
|     |           |        | Reports      | espondents |            |
+-----+-----------+--------+--------------+------------+------------+
| 1   | 1         | 99     | 0            | 1          | 100        |
+-----+-----------+--------+--------------+------------+------------+
| 2   | 1         | 99     | 0            | 1          | 100        |
+-----+-----------+--------+--------------+------------+------------+
| 3   | 1         | 99     | 0            | 1          | 100        |
+-----+-----------+--------+--------------+------------+------------+
| A   | 1         | 99     | 0            | 1          | 100        |
| ver |           |        |              |            |            |
| age |           |        |              |            |            |
+-----+-----------+--------+--------------+------------+------------+

^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**             |        |        |                 |       |
+=========================+========+========+=================+=======+
| \(A\)                   | \(B\)  | \(C\)  | \(D\)           | \(E\) |
|                         |        |        |                 |       |
| Information Collection  | Number | Number | Number of       | Total |
| Activity                | of     | of     | Existing        | A     |
|                         | Respo  | Occur  | Respondents     | nnual |
|                         | ndents | rences | That Keep       | Resp  |
|                         | per    | per    | Records But Do  | onses |
|                         | year   | Resp   | Not Submit      |       |
|                         |        | ondent | Reports         | E=(B  |
|                         |        | per    |                 | xC)+D |
|                         |        | year   |                 |       |
+-------------------------+--------+--------+-----------------+-------+
| a\. Read rule and       | 0      | 1      | 0               | 0     |
| instructions            |        |        |                 |       |
+-------------------------+--------+--------+-----------------+-------+
| 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               | 0     |
+-------------------------+--------+--------+-----------------+-------+
| iv\. Repeat Performance | 0.2    | 1      | 0               | 0.2   |
| Test                    |        |        |                 |       |
+-------------------------+--------+--------+-----------------+-------+
| c\. Write Reports       |        |        |                 |       |
+-------------------------+--------+--------+-----------------+-------+
| i\. Notification of     |        |        |                 |       |
| Construction/           |        |        |                 |       |
+-------------------------+--------+--------+-----------------+-------+
| Reconstruction          | 1      | 1      | 0               | 1     |
+-------------------------+--------+--------+-----------------+-------+
| ii\. Notification of    | 100    | 3      |                 | 300   |
| Process Change          |        |        |                 |       |
+-------------------------+--------+--------+-----------------+-------+
| iii\. Notification of   |        |        |                 |       |
| Actual                  |        |        |                 |       |
+-------------------------+--------+--------+-----------------+-------+
| Startup                 | 0      | 1      | 0               | 0     |
+-------------------------+--------+--------+-----------------+-------+
| iv\. Performance Test   |        |        |                 |       |
+-------------------------+--------+--------+-----------------+-------+
| Notification            | 1      | 1      | 0               | 1     |
+-------------------------+--------+--------+-----------------+-------+
| v\. Notification of     | 0      | 1      | 0               | 0     |
| Applicability           |        |        |                 |       |
+-------------------------+--------+--------+-----------------+-------+
| vi\. Notification of    | 0      | 1      | 0               | 0     |
| Demonstration of CMS    |        |        |                 |       |
+-------------------------+--------+--------+-----------------+-------+
| vii\. Notification of   |        |        |                 |       |
| Compliance              |        |        |                 |       |
+-------------------------+--------+--------+-----------------+-------+
| Status                  | 0      | 1      |                 | 0     |
+-------------------------+--------+--------+-----------------+-------+
| viii\. Emissions        | 0      | 1      |                 | 0     |
| Averaging Plan          |        |        |                 |       |
+-------------------------+--------+--------+-----------------+-------+
| 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  |        |        |                 | 923   |
| Responses               |        |        |                 |       |
+-------------------------+--------+--------+-----------------+-------+

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        \(A\)             \(B\)        \(C\)        \(D\)         \(E\)       \(F\)         \(G\)         \(H\)           
  ^(a)^**                                                                                                                                

                       Respondent        Number of    Hours        Number        Technical   Management    Clerical      Total Annual    
                                                                                                           Hours                         

                       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      N/A                                                                                                               
  Studies                                                                                                                                

  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 60                1            60           0             0.00        0.00          0.00          0.00            
  Plan for CMS                                                                                                                           

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

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

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

  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          8                 3            24           100           2,400.00    120.00        240.00        244,495.20      
  Changes^d^                                                                                                                             

  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  2                 1            2            0             0.00        0.00          0.00          0.00            
  Applicability                                                                                                                          

  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           180               1            180          0             0.00        0.00          0.00          0.00            
  averaging)^e^                                                                                                                          

  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      20                2            40           10            400.00      20.00         40.00         40,749.20       
  Averaging Report                                                                                                                       

  Subtotal Reporting                                                                                       113,730.40    10,074,832.22   

  4\. Recordkeeping                                                                                                                      
  Requirements                                                                                                                           

  i\. Records of                                                                                                                         
  operating                                                                                                                              

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

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

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

  iv\. LDAR            Included in                                                                                                       
                       3.c.xi.                                                                                                           

  Subtotal                                                                                                 49,795.00     4,411,101.00    
  recordkeeping                                                                                                                          

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

                      per occurance     Per          Hours per    of            per year    Hours Per    per year   Cost^a^
                                        Respondent                Respondents                                       

                                                     Respondent                             year                    

  1\. Required                                                                                                      
  Activities^b^                                                                                                     

  i\. Initial         2                 1            2            1             2.00        0.10         0.20       95.21
  Performance Test^c^                                                                                               

  ii\. Repeat         24                1            24           0.2           4.80        0.24         0.48       228.51
  Performance Test^d^                                                                                               

  2\. Report Review -                                                                                               
  One Time                                                                                                          

  i\. Notification of                                                                                               
  Construction/                                                                                                     

  Reconstruction^c^   2                 1            2            1             2.00        0.10         0.20       95.21

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

  iii\. Notification                                                                                                
  of Initial                                                                                                        

  CMS Demonstration   2                 1            2            0             0.00        0.00         0.00       0.00

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

  v\. Notification of                                                                                               
  Compliance                                                                                                        

  Status Report       40                1            40           0             0.00        0.00         0.00       0.00

  vii\. Precompliance                                                                                               
  Report^e^                                                                                                         

  a\. w/ Emissions    20                1            20           0             0.00        0.00         0.00       0.00
  Averaging^f^                                                                                                      

  b\. w/o Emissions   4                 1            4            0             0.00        0.00         0.00       0.00
  Averaging^f^                                                                                                      

  3\. Report Review -                                                                                               
  On-going                                                                                                          

  i\. Semiannual                                                                                                    
  Summary                                                                                                           

  Report                                                                                                            

  a\. No              2                 2            4            90            360.00      18.00        36.00      17,138.16
  Deviations^g^                                                                                                     

  b\. Deviations^g^   8                 2            16           10            160.00      8.00         16.00      7,616.96

  ii\. Notification                                                                                                 
  Physical/                                                                                                         

  Operational         8                 3            24           100           2,400.00    120.00       240.00     114,254.40
  change^h^                                                                                                         

  iii\. SS&M          2                 2            4            100           400.00      20.00        40.00      19,042.40
  Report^i^                                                                                                         

  iv\. LDAR Report^j^ 8                 2            16           100           1,600.00    80.00        160.00     76,169.60

  v\. Emission        8                 2            16           10            160.00      8.00         16.00      7,616.96
  Averaging Report^f^                                                                                               

  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.                                                                                                   

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