SUPPORTING STATEMENT

ENVIRONMENTAL PR OTECTION AGENCY

NESHAP for Pharmaceuticals Production (40 CFR Part 63, Subpart GGG) (Revision)

1. Identification of th e Information Collection

1(a) Title of the Information Collection

NESHAP for Pharmaceuticals Production (40 CFR Part 63, Subpart GGG) . This is a revised information collection request (ICR). The EP A ICR tracking number is 1781.05, and the OMB

Control Number 2060-0358.

1(b) Short Charac terization/Abstract

This ICR is prepared for a U.S. Envir onmental Protection Agency (EPA) rulemaking developed under authority of section 112 of th e Clean Air Act (CAA). The rulemaking amends title 40, chapter I, part 63, subpart GGG, National Emission Standards for Hazardous Air Pollutants from Pharmaceuticals Production, of the Code of Federal Regulations (CFR). The

current Pharmaceuticals Production NESHAP were proposed on April 2, 1997, and promulgated on September 21, 1998. These standards apply to facilities in the pharmaceuticals manufacturing operations that are major sources of hazardous ai r pollutants (HAP). Th e affected facilities encompass all pharmaceuticals manufacturing operati ons that include process vents, storage tanks, equipment components, and wastewater systems co mmencing 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 po llutants regulated under this subpart. The

amendments to the rule elimin ate the startup, shutdown, and malfunction exemption, remove the SSM plan requirement, add provision s to provide an affirmative defense against civil penalties for exceedances of emission standards caused by ma lfunctions, and a requirement for electronic submittal of performance test data, and correct an editorial error. The remaining portions of the NESHAP remain unchanged.

In general, all NESHAP sta ndards require initial notifica tions, performance tests, and periodic reports. Owners or operators are also required to maintain reco rds of the occurrence and duration of any malfunctions in the operation of an affected facili ty, or any period during which the monitoring system is inoperative. These notifi cations, reports, and re cords are essential in determining compliance and, in general, are requi red of all sources subject to NESHAP. This information is used by the Agency to identify sour ces subject to the standards to insure that the

maximum achievable control tec hnologies are being applied. Semiannual summary reports are also required.

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 fi ve years following the date of such measurements, maintenance reports, and records. All reports are se nt 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.2

Based on our consultations with industry repr esentatives, there is an average of one affected facility at each plant site and that each plant site has only one respondent (i.e., the owner/operator of the plant site).

We have determined that there are an estimat ed 27 respondents currently subject to this

rule. It is estimated that no additional sources wi ll become subject to the standard over the next three years.

All of the pharmaceutical production facilities in the United States are owned and operated by the pharmaceutical industry (the “Affected Public”) . None of the facilitie s in the United States are owned by state, local, tribal or the Fede ral government. They are all privately, owned for-profit businesses. The burde n to the “Affected Public” is listed below in Table 1: Annual Respondent Burden and Cost - NESHAP for Ph armaceutical Production (40 CFR Part 63, Subpart GGG) (Revision). The Federal government burde n associated with the review of reports submitted by the respondent is shown below in Table 2: Average Annual EPA Burden - NESHAP for Pharmaceutical Production (40 CF R Part 63, Subpart GGG) (Revision).

2. Need for and Use of the Collection

2(a) Need/Authority for the Collection

The EPA is charged under section 112 of th e Clean Air Act, as amended, to establish standards of performance for each category or su bcategory of major sources and area sources of HAP. These standards are applicable to new or existing sources of HAP and shall 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 reco rds; (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 peri ods, and in such manner as the Administrator shall prescribe) ; (E) keep records on control equipment parameters, production vari ables or other indirect data when direct monitoring of emi ssions is impractical; (F) submit compliance certifications in accordance with Section 114(a)(3); and (G) provide such other inform ation as the Administrator may reasonably require.

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

2(b) Practical Utility/Users of the Data3

The recordkeeping and reporting requirements in the standard ensure compliance with the applicable regulations which were promulgated in accordance with the Clean Air Act. In addition, the collected information is used for targeting in spections 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 standard. Con tinuous emission monitors are used to ensure compliance with the standard at al l times. During the performance tests, a record of the operating parameters under which compliance was achieved may be recorded and used to determine compliance in place of a c ontinuous emission monitor.

The notifications required in th e standard 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 cont rol devices are properly installed and operated, that leaks are being detected and repaired, and that the standards are being met. The performance test may also be observed.

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

determinations.

The information generated by the monitori ng, recordkeeping and reporting requirements described in this ICR is used by the Agency to ensure that facilities affected by the NESHAP continues to operate the control equipm ent in compliance w ith the regulation.

3. Non-duplication, Consultation s, and Other Collection Criteria

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

GGG.

3(a) Non-duplication

If the subject standards have not been delega ted, the information is sent directly to the appropriate EPA regional o ffice. Otherwise, the information is sent directly to the delegated state or local agency. If a state or local agency has adopted their 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 re port required by the Fede ral standards. Ther efore, no duplication

exists.

3(b) Public Notice Required Pr ior to ICR Submission to OMB

This is a rule-related ICR and comments we re solicited on the propos al package and the

proposed ICR, which included no revisions. This ICR contains revisions from the proposed ICR

to include burden associated with th e provisions for affirmative defense.

3(c) Consultations4

The Agency’s industry experts have been c onsulted, and the Agency’s internal data sources and projections of industr y growth over the next three year s have been considered. The primary source of information as reported by indus try, in compliance with the recordkeeping and reporting provisions in the standar d, is the Online Tracking Inform ation System (OTIS) which is operated and maintained by the EP A Office of Compliance. OTIS is the EPA database for the collection, maintenance, and retrieval of all complia nce data. The growth ra te for the industry is based on our consultations with the Ag ency’s internal industry experts.

Industry trade associations and other interest ed parties were provi ded an opportunity to

comment on the burden associated with the stan dard as it was being developed. During development of the original standards, we contacted the Pharmaceutical Research and Manufacturers of America (PhRMA), at (202) 835-3400, and Noramco Inco rporated, at (302)

652-3840.

The number of sources was obtained by inform ation gathered and public comments for pharmaceutical facilities subject to 40 CFR part 63, subpart GGG on the Residual Risk and Technology Review that was completed in Oc tober of 2008, by EPA’s Office of Air Quality Planning and Standards

3(d) Effects of Less Frequent Collection

Less frequent information collection would decrea se the margin of assurance that facilities are continuing to meet the standards. Requireme nts 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 informa tion required by these sta ndards was collected less frequently, the proper operation and maintenan ce of control equipment and the possibility of detecting violations would be less likely.

3(e) General Guidelines

None of these reporting or recordkeeping re quirements violate a ny of the regulations established by OMB at 5 CFR part 1320, section 1320.5.

These standards require the respondents to ma intain all records, including reports and notifications for at least five years. This is cons istent with the General Provisions as applied to the standards. EPA believes that the five-year records retention requirement is consistent with the Part 70 permit program and the five-year statute of lim itations on which the permit program is based. The retention of records for five years allows EP A to establish the compliance history of a source, any pattern of non-compliance, and to determine the appropriate le vel of enforcement action. EPA has found that the most flagrant violators have violations extending beyond the five years. Without the five-year record retention, EPA would be prevented from pursuing the violators due to

the destruction or nonexisten ce of essential records.

3(f) Confidentiality5

Any information submitted to the Agency for wh ich a claim of confidentiality is made will be safeguarded according to the Agency policies se t forth in title 40, chapte r 1, part 2, subpart B - Confidentiality of Business Info rmation (CBI) (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

None of the reporting or recordkeeping requirements contain sensitive questions.

4. The Respondents and the Information Requested

4(a) Respondents/SIC Codes

The respondents to the recordkeeping a nd reporting requirements are pharmaceutical production facilities. The North American Indus try Classification Syst em (NAICS) codes are listed below for each source category description.

Standard (40 CFR, part 63, subpart GGG) NAICS Codes

Pharmaceutical Preparation Manufacturing 325412

Medicinal and Botanical Manufacturing 325411

4(b) Information Requested

None of these reporting or recordkeeping re quirements violate a ny of the regulations established by OMB at 5 CFR part 1320, section 1320.5.

(i) Data Items

In this ICR, all the data recorded or reported is require d by the NESHAP for Pharmaceuticals Production (40 CFR Part 63, Subpart GGG).

A source must make the following reports:

Notifications

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

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

Notification of appli cability 63.9(a), 63.1260(b)

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

Notification of initial performance test, submittal of test plan, request of waiver of performance test 63.7(b)(1-2), 63.7(c), 63.7(f), 63.7(h), 63.9(e), 63.1257(b)(8), 63.1260(1)6

Notifications

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(e)(5), 63.9(g)(1), 63.10(e)(2), 63.1260(d)

Notification of 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 malfunctions 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 a nd repair (LDAR) 63.1260(j), 63.1255(h)

Reports of emissions averaging 63.1260(k)

Reports of malfunctions that re sult in an exceedances of the standard for the purpose of affirmative defense 63.1250(g)(4)

A source must keep the following records:

Recordkeeping

Recordkeeping requirements 63.10(a), 63.1259(a)

All reports and notificati ons 63.10(b)(1), 63.1259(a)(1)

Record of applicabil ity 63.10(b)(3), 63.1259(a)(2)

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

63.1259(a)(4)

Application for approval of cons truction/reconstruction 63.1259(a)(5)

Records of equipment operation 63.1259(b)

Records of operating scenarios 63.1259(c)

Records of LDAR programs 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 tr ansfer 63.1259(g)

Records of extensions 63.1259(h)7

Recordkeeping

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 monitori ng equipment that au tomatically records parameter data. Although personnel at the affected facility must st ill evaluate the data, internal automation has significantly reduced the burden a ssociated with monitoring and recordkeeping at a plant site.

Also, regulatory agencies, in cooperation with th e respondents, continue to create reporting systems to transmit data electronically. Howeve r, electronic reporting systems are not widely used. At this time, it is estimated that appr oximately 20 percent of the respondents are reporting electronically.

The amendments to the NESHAP require th at any performance tests performed after December 31, 2011 be submitted electronically to EPA’s Central Data Exchange by using the Electronic Reporting Tool (ERT) for test methods that are compatible with ERT. This new requirement to submit the data to the ERT is in addition to the other existing submission requirements for this data. (ii) Respondent Activities

Respondent Activities

Read instructions.

Plan compliance strategy (include s preparing implementation plans)

Perform initial performance test and re peat performance tests if necessary.

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

Write the notifications and reports listed above.

Enter information required to be recorded above.

Submit the required reports developing, acquirin g, installing, and uti lizing technology and systems for the purpose of collecting, validating, and verifying information.

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

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

Adjust the existing ways to comply with a ny previously applicable instructions and requirements.

Train personnel to be able to res pond to a collection of information.

Transmit, or otherwise disclose the information.8

Currently, sources are using monitoring equi pment that provides parameter data in an automated way (e.g., continuous pa rameter monitoring system). Although personnel at the source still need to evaluate the data, this type of monitoring equipment has significantly reduced the

burden associated with mon itoring and recordkeeping.

EPA is including in Table 3 (located at the e nd of this supporting statement) an estimate of the burden associated with performing an affirma tive defense. EPA is providing this as an illustrative example of the potential additional administrative burden a source may incur to assert in an Affirmative Defense in response to an action to enforce the standards set forth in the applicable subpart.

This illustrative estimate is not considered a duplicate estim ate of cost under the General Duty to Minimize Emissions clause under 63.6(e)(1)( i), which states: “At all times, the owner and operator must operate and maintain any affected source, including associated air pollution control equipment and monitoring equipment, in a manner consistent with safety and good air pollution control practices for minimizing emissions. Dete rmining whether such operation and maintenance procedures are being used will be based on inform ation available to the Administrator which may include, but is not limited to, mon itoring results, review of operat ion and maintenance procedures, review of operation and maintenance record s, and inspection of the source.”

To provide the public with an estimate of the relative magnitude of the burden associated

with an assertion of the affirmative defens e position adopted by a source, EPA provides an administrative adjustment to this ICR that estim ates the costs of the no tification, recordkeeping and reporting requirements associated with the as sertion of the affirmative defense. EPA’s estimate for the required notific ation, reports and records, incl uding the root cause analysis, associated with a single incident totals approximately $3,141 and is based on the time and effort required of a source to review re levant data, interview plant em ployees, and document the events surrounding a malfunction that has ca used an exceedance of an emi ssion limit. The estimate also includes time to produce and retain the records a nd reports for submission to EPA. EPA provides

this illustrative estimate of this burden because these costs are only incu rred if there has been a

violation and a source chooses to take advantage of the affirmative defense.

Of the number of excess emission events reported by source operators, only a small number would be expected to result from a ma lfunction, and only a subset of excess emissions caused by malfunctions would result in the source c hoosing to assert the affirmative defense. Thus

we believe the number of instances in which source operators might be expected to avail

themselves of the affirmative defense will be ex tremely small. For this reason, we estimate no

more than 2 or 3 such occurrences for all sour ces within a given categor y over the 3-year period covered by this ICR. For the purpose of this estimate, we are adding two (2) instances of affirmative defense. We expect to gather inform ation on such events in the future and will revise

this estimate as better information becomes available.

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

5(a) Agency Activities9

EPA conducts the following activities in connect ion with the acquisiti on, analysis, storage,

and distribution of th e required information.

Agency Activities

Observe initial performance tests and re peat performance tests if necessary.

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

Audit facility records.
Input, analyze, and maintain data in the OTIS.

5(b) Collection Methodology and Management

Following notification of startup, the review ing authority might inspect the source to determine whether the pollution control devices are properly installed and ope rational. Performance test reports are used by the Agency to discern a source’s initial capability to comply with the emission standard, and note the operating condi tions under which compliance was achieved. Data and records maintained by the re spondents are tabulated and publis hed for use in compliance and enforcement programs.

Information contained in the re ports is entered into OTIS which is operated and maintained by the EPA Office of Compliance. OTIS is the EP A database for the collection, maintenance, and retrieval of compliance data for approx imately 125,000 industrial and government-owned facilities. EPA uses OTIS for tracking air pollution compliance and enforcement by local and state regulatory agencies, EPA regional offices, and EPA headquarters. EPA edit, store, retrieve and analyze the data.

The records required by this regulation must be retained by the owner or operator for five

years.

5(c) Small Entity Flexibility

The majority of the respondents are large en tities (i.e., large businesses). However, the impact on small entities (i.e., small businesse s) was taken into c onsideration during the development of the regulation. Due to technical considerations involving the process operations and the types of control equipment employed, th e recordkeeping and reporting requirements are the same for both small and large entities. Th e Agency considers these to be the minimum requirements needed to ensure compliance and, th erefore, cannot reduce them further for small

entities. To the extent that la rger businesses can use economies of scale to reduce their burden, the

overall burden will be reduced.

5(d) Collection Schedule10

The specific frequency for each information collec tion activity within this request is shown below in Table 1: Annual Respondent Burd en and Cost - NESHAP for Pharmaceuticals Production (40 CFR Part 63, Subpart GGG) (Revision).

6. Estimating the Burden and Cost of the Collection

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

The Agency may not conduct or sponsor, a nd a person is not required to respond to, a collection of information unless it displa ys 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 44, 266 (Total Labor Hours from Table 1). These hours are based on Agency studies and backgrou nd documents from the development of the regulation, Agency knowledge and experience w ith the NESHAP program, the previously approved ICR, and any comments received.

6(b) Estimating Respondent Costs

This ICR uses the following labor rates:

Managerial $114.49 ($54.52 + 110%) Technical $98.20 ($46.76 + 110%) Clerical $48.53 ($23.11 + 110%)

These rates are from the United States Depart ment of Labor, Bureau of Labor Statistics, September 2009, ”Table 2. Civilian Workers, by O ccupational and Industry group.” The rates are from column 1, ”Total compensation.” The rate s have been increased by 110 percent 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 collect ion activities in the subject standard are labor costs which are addresse d elsewhere in this ICR and the costs associated with continuous monitoring. The capital/startup co sts are one-time costs when a facility becomes subject to the regulation. The annual operation and maintenance costs ar e the ongoing costs to maintain the monitor and other costs such as photocopying and postage.11

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

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 27 $112,266

Total $0 $112,266

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 main tenance (O&M) costs for this ICR are $112,266. This is the

total of column G.

The average annual cost for capital/startup a nd operation and maintenance costs to industry over the next three years of the ICR is estimated to be $112,266.

(iv) Affirmative Defense, Root Ca use Analysis, and Malfunction Costs.

EPA’s estimate for a affirmative defense and root cause analysis is based on general experience to calculate the time and effort required of a source to review relevant data, interview plant employees, and reconstruct th e events prior to a malfunction in order to determine primary and contributing causes. The level of effort also includes time to produce and retain the report in

document form so that the source will have it ava ilable should EPA or state enforcement agencies ever request to review it.

6(c) Estimating Agency Burden and Cost

The only costs to the Agency are those costs associated with anal ysis of the reported information. The EPA compliance and enforcem ent program includes activities such as: the examination of records maintained by the resp ondents; periodic insp ection of sources of emissions; and the publication and dist ribution of collected information.

The average annual Agency cost during the th ree years of the ICR is estimated to be $71,518.

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

Managerial $62.27 (GS-13, Step 5, $38.92 + 60%) Technical $46.21 (GS-12, Step 1, $28.88 + 60%) Clerical $25.01 (GS-6, Step 3, $15.63 + 60%)12

These rates are from the Office of Personne l Management (OPM), 2010 General Schedule, which excludes locality rate of pay. The rates ha ve been increased by 60 pe rcent to account for the benefit packages available to government employees. Details upon which this estimate is based appear below in Table 2: Average Annual EPA Burden - NESHAP for Pharmaceuticals Production (40 CFR Part 63, Subpart GGG) (Revision).

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 27 respondents will be subject to the standard. It is estimated that no new respondents per year will become subject. The overall average number of re spondents, as shown in the table below is 27 per

year.

The number of respondents is calculated us ing the following table which addresses the three years covered by this ICR.

Number of Respondents

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 0 27 0 0 27

2 0 27 0 0 27

3 0 27 0 0 27

Average 0 27 0 0 27

1 New respondent include sources w ith constructed, reconstructed a nd modified affect ed facilities.

To avoid double-counting respondents, column D is subtracted. As shown above, the average Number of Respondents over the three-year period of this ICR is 27.

The total number of annual re sponses per year is calculate d using the following table:

Total Annual Responses

(A)

Information Collection Activity (B)

Number of Respondents (C)

Number

of Responses (D) Number of Existing Respondents That Keep Records But

Do Not Submit Reports (E)

Total

Annual Responses E=(BxC)+D

Notification of construction/reconstruction 0 1 0 0

Notification of physical or operational changes 27 3 0 81

Notification of actual startup 0 1 0 0

Notification of initial performance test 0 1 0 0

Notification of applicability 0 1 0 013

Total Annual Responses

(A)

Information Collection Activity (B)

Number of Respondents (C)

Number

of Responses (D) Number of Existing Respondents That Keep Records But

Do Not Submit Reports (E)

Total

Annual Responses E=(BxC)+D

Notification of demonstration of CMS 0 1 0 0

Notification of compliance status 0 1 0 0

Pre-compliance report (emission averaging) 0 1 0 0

Malfunction 27 2 0 54

No deviations 24 2 0 48

Deviations 3 2 0 6

LDAR report 27 2 0 54

Emissions averaging report 3 2 0 6

Reports of malfunctions that result in an

exceedances of the standa rd for the purpose of

affirmative defense 27 0.025 0 0.7

Total Number of Annual Responses Total 250

The number of Total A nnual Responses is 250.

The total annual labor costs are $4,187,309. Details regardin g these estimates may be found below in Table 1: Annual Respondent Burd en and Cost - NESHAP for Pharmaceuticals Production (40 CFR Part 63, Subpart GGG) (Revision).

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 hours are 44,266. Details regardi ng these estimates may be found below in Table 1: Annual Respondent Burd en and Cost - NESHAP for Pharmaceuticals Production (40 CFR Part 63, Subpart GGG) (Revision).

Furthermore, the annual public reporting and re cordkeeping burden for this collection of information is estimated to average 177 hours per response.

The total annual capital/startup and Opera tion and Maintenance (O&M) costs to the regulated entity are $112,266.

(ii) The Agency Tally14

The average annual Agency burden and cost over next three years is estimated to be 1,587 labor hours at a cost of $71,518. See below Tabl e 2: Average Annual EPA Burden and Cost – NESHAP for Pharmaceuticals Production ( 40 CFR Part 63, Subpart GGG) (Revision).

6(f) Reasons for Change in Burden

There is an increase in the labor hour burden in this ICR compared to the previous ICR due

to the inclusion of the new re quirements of the amendments to the NESHAP. EPA provides an adjustment to this ICR that estimates the cost s of the notification, r ecordkeeping, and reporting requirements associated with the assertion of th e affirmative defense. EPA’s estimate for the required notification, reports and records, includi ng the root cause analysis, associated with a single incident totals approximate ly $3,141 and is based on the time and effort required of a source to review relevant data, interview plant em ployees, and document the events surrounding a

malfunction that has caused an exceedance of an emi ssion limit. The estimate also includes time to produce and retain the records and reports for su bmission to EPA. For the purpose of estimating the annual burden, EPA is attributing a total of 2 instances of affirmative defense over a three year period across all sources in the category. EPA is using this frequency of 2 events in three years because, of the number of excess emission even ts reported by source operators, only a small number would be expected to result from a ma lfunction, and only a subset of excess emissions caused by malfunctions would result in the source c hoosing to assert the affirmative defense. Thus

we believe the number of instances in which source operators might be expected to avail themselves of the affirmative defense will be extremely small.

6(g) Burden Statement

The annual public reporting and recordkeeping bur den for this collection of information is estimated to average 177 hours per response. Burd en means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provi de information to or for a Federal agency. This includes the time needed to review instructions ; to develop, acquire, install, and utilize tec hnology and systems for the purposes of collecting, valida ting, and verifying information, processing and maintaining informa tion, and disclosing and providing information; to adjust the existing ways to comply with any pr eviously applicable instru ctions and requirements; to train personnel to be able to respond to a collection of informa tion; to search data sources; to complete and review the collection of informati on; and to transmit or otherwise disclose the

information.

An agency may not conduct or sponsor, a nd 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 fo r minimizing respondent burden, including the use of automated collection techniqu es, EPA has established a public docket for this ICR under Docket ID Number EPA-HQ-OECA-2009-0381. An electronic vers ion 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 i ndex listing of the cont ent of the docket,15

and to access those documents in the public docket that are available electronically. When in the system, select “search” than 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 Avenue, N.W., Washington, DC. The EP A Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday thro ugh Friday, excluding legal holidays. The telephone number for the Reading Room is (202) 566-1744, and the telephone number for the Enforcement and Compliance Docket and Informa tion Center Docket is (202) 566-1752. Also, you can send comments to the Office of Info rmation and Regulatory Affairs, Office of Management and Budget, 725 17th Street, N.W., Washington, DC 20503, Attention: Desk Officer

for EPA. Please include the EPA Docket ID Number EPA-HQ-OECA-2009-0381 and OMB Control Number 2060-0358 in any correspondence.

Part B of the Supporting Statement

This part is not applicable because no stat istical methods were used in collecting this

information.Table 1: Annual Respondent Burden and Cost - NESHAP for Pharmaceuticals Production (40 CFRPart 63, Subpart GGG) (Revision)(A) (B) (C) (D) (E) (F) (G) (H)Personhours peroccurrenceNo. ofoccurrencesper respondentper yearPerson hoursper respondentper year(C=AxB)Respondentsper yearaTechnicalpersonhours peryearManagementperson hoursper year(Ex0.05)Clericalperson hoursper year(Ex0.1)Total CostPer year b1. Applications N/A2. Surveys and studies N/A3. Reporting requirementsNew sourcescA. Read rule and instructions 1 1 1 0 0 0 0 $0B. Required activitiesi. Initial performance testsNew 480 1 480 0 0 0 0 $0Reconstructed 160 1 160 0 0 0 0 $0Wastewater 160 1 160 0 0 0 0 $0ii. Quality control plan for CMS 60 1 60 0 0 0 0 $0iii. Develop record system 40 1 40 0 0 0 0 $0iv. Train personnel 40 1 40 0 0 0 0 $0v. Repeat performance testd60 1 60 0 0 0 0 $0C. Write reportsi. Notification of construction/reconstruction 2 1 2 0 0 0 0 $0ii. Notification of physical or operational changese8 3 24 27 648 32.4 64.8 $70,488iii. Notification of actual startup 2 1 2 0 0 0 0 $0iv. Notification of initial performance test 2 1 2 0 0 0 0 $0v. Notification of applicability 2 1 2 0 0 0 0 $0vi. Notification of demonstration of CMS 2 1 2 0 0 0 0 $0vii Notification of compliance status 120 1 120 0 0 0 0 $0viii. Pre-compliance report (emission averaging) 180 1 180 0 0 0 0 $0ix. Startup, shutdown, malfunctionf40 2 80 27 2,160 108 216 $234,959x. Semiannual summary reporta. No deviationsg8 2 16 24 384 19.2 38.4 $41,771b. Deviationsh24 2 48 3 144 7.2 14.4 $15,664xi. Leak detection and repair (LDAR) reporti432 2 864 27 23,328 1,166.4 2,332.8 $2,537,562xii. Emissions averaging reportj20 2 40 3 120 6 12 $13,053xiii. Affirmative defensen30 0.7 20 1 12 8 0 $2,094Subtotal for Reporting Requirements30,821.6Burden item17Assumptions:aWe have assumed that the average number of respondents thatwill be subject to this rule will be 27. There will be no new additional sources during the next three years of this ICR.bThis ICR uses the following labor rates: $114.49 per hour for Executive, Administrative, and Managerial labor; $98.20 per hour for Technical labor, and $48.53 per hour for Clericallabor. These rates are from the United States Department of Labor, Bureau of Labor Statistics, September, 2009, Table 2. Civilian Workers, by Occupational and Industry group. The ratesare from column 1, Total Compensation. Therates have been increased by 110 percent to account for the benefit packages available to those employed by private industry.cWe have assumed that there will be no new or reconstructed facilities during the next three years of this ICR.dWe have assumed that 20 percent of respondents would have to repeat performance tests due to failure.eWe have assumed that each source will require an average of three processing changes each year tocomplete this task over thenext three years of this ICR.fWe have assumed that each respondent willtake 40 hours two times per year to complete the startup, shutdown, malfunction reports.gWe have assumed that 90 percent of respondents will each take eight hour two times per year to complete the no deviation report.hWe have assumed that 10 percent of respondents will each take 24 hours two times per year to complete the deviation report.iWe have assumed that it will take each respondent 432hour two times per year tocomplete the LDAR report.jWe have assumed that ten percent of respondents will each take20 hours two times per year to complete the emissions averaging report.kWe have assumed that it will take each respondent 1 hour 365times per year to record the operating parameters for control devices.lWe have assumed that it will take each respondent 2hours 26 times per year torecord the SSM plans.mWe have assumed that it will takeeach respondent 16 hours one time per year to record the calibration of CMS.nAssumes 2 affirmative defense reports for entire industry during the 3-yrICR period. Formulas are not followed for person-hours per year. For affirmative defense hours required assumes 18 hours technical, 12 hours management, 0clerical for each instance ofaffirmative defense.(A) (B) (C) (D) (E) (F) (G) (H)Personhours peroccurrenceNo. ofoccurrencesper respondentper yearPerson hoursper respondentper year(C=AxB)Respondentsper yearaTechnicalpersonhours peryear(E=CxD)Managementperson hoursper year(Ex0.05)Clericalperson hoursper year(Ex0.1)Total CostPer year b4. Recordkeeping requirementsi. Records for operating parameters for controlDeviceskii. Records of SS&Ml2 26 52 27 1,404 70.2 140.4 $152,724iii. Calibration of CMSm16 1 16 27 432 21.6 43.2 $46,992iv. LDAR See 3CSubtotal for Recordkeeping Requirements38,487 1,931.8 3,847.5 $4,187,309TOTAL LABOR BURDEN AND COST (rounded)$4,187,309492.8 985.5 $1,072,00213,444.744,266Burden item1 365 365 27 9,85518Table 2: Average Annual EPA Burden - NESHAP for Pharmaceuticals Production (40 CFR Part 63, Subpart GGG) (Revision)Activity(A)EPA personhours peroccurrence(B)No. ofoccurrencesper plant peryear(C)EPApersonhours perplant peryear(C=AxB)(D)Plantsperyeara(E)Technicalpersonhours peryear(E=CxD)(F)Managementperson-hoursper year(Ex0.05)(G)Clericalpersonhours peryear(Ex0.1)(H)Cost, $b1. Required activitiesi. Initial performance testc2 1 2 0 0 0 0 $0ii. Repeat performance testd24 1 24 0 0 0 0 $02. Report review – one timei. Notification of construction/reconstruction 2 1 2 0 0 0 0 $0ii. Notification of actual startup 2 1 2 0 0 0 0 $0iii. Notification of initial CMS demonstration 2 1 2 0 0 0 0 $0iv. Initial notification 2 1 2 0 0 0 0 $0v. Notification of compliance status report 40 1 40 0 0 0 0 $0vi. Pre-compliance reportea. With emissions averagingf20 1 20 0 0 0 0 $0b. Without emissions averaging 4 1 4 0 0 0 0 $03. Report review – on-goingi. Semiannual summary reporta. No deviationsg2 2 4 24 96 4.8 9.6 $4,975.16b. Deviationsh8 2 16 3 48 2.4 4.8 $2,487.58ii. Notification of physical/operational changei8 3 24 27 648 32.4 64.8 $33,582.28iii. SSM reportj2 2 4 27 108 5.4 10.8 $5,597.05iv. LDAR reportk8 2 16 27 432 21.6 43.2 $22,388.18v. Emission averaging reportl8 2 16 3 48 2.4 4.8 $2,487.58Subtotals Labor Burden and cost 1,380 69 138 $71,517.83TOTAL ANNUAL BURDEN AND COST (rounded)1,587 $71,518Assumptions:aWe have assumed that the average number of respondents thatwill be subject to this rule will be 27. There will be no new additional sources during the next three years of this ICR.bThis cost is based on the followinglabor rates which incorporates a 1.6 benefits multiplication factor to account for government overhead expenses: $62.27 Managerial rate (GS-13, Step5, $38.92 x 1.6), $46.21 Technical rate (GS-12, Step 1, $28.88 x1.6), and $25.01 Clerical rate (GS-6, Step 3, $15.63 x 1.6).These rates are from the Office of Personnel Management(OPM) 2010 General Schedule which excludes locality rates of pay.cWe have assumed that there will be no new or reconstructed facilities during the next three years of this ICR.19dWe have assumed that 20 percent of respondents would have to repeat performance tests due to failure.eWe have assumed that 50 percent of new facilities will submit a pre-compliance report.fWe have assumed that 10 percent of existing facilities will have to comply with emission averaging requirements; new facilities are not allowed to use emissions averaging.gWe have assumed that 90 percent ofrespondents will each take two hours two times per year to complete this report.hWe have assumed that 10 percent of respondents will have to report deviation.iWe have assumed that each respondent will be required to review the physical/operational changes for each facility three times per year over the next three-year period of this ICR.jWe have assumed that each respondent will report actions taken during startup, shutdown, ormalfunction that are consistent.kWe have assumed that each respondent will have tocomply with the LDAR report two times per year.lWe have assumed that 10 percent of respondents will have to review the emission averaging report.Table 3: Single Affirmative Defense Burden EstimatePersonnelNumber ofPersonnelTimeRequirement(hours)TotalHoursHourly Rate($/hr) TotalTechnical Personnel3 6 18 98.20 $ 1,768ManagerialPersonnel2 6 12 114.49 $ 1,374Total5 30 $3,141