SUPPORTING STATEMENT ENVIRONMENTAL PROTECTION AGENCY NESHAP for Pharmaceuticals Production (40 CFR Part 63, Subpart GGG) ( Revision )
1. Identification of the 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 (I CR). The EPA ICR tracking number is 1781.05 , and the OMB Control Number 2060

- 0358

. 1(b) Short Characterization/Abstract This I CR is prepared for a U.S. Environmental Protection Agency (EPA) rulemaking developed under authority of section 112 of the Clean Air Act (CAA). The rulemaking amends title 40, chapter I, part 63, subpart GGG, National Emission Standards for Hazardous Air Pollutants from Pharmaceuticals P roduction, 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 appl y to facilities in the pharmaceuticals manufacturing operations 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 s ys tems commencing construction or rec onstruction 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. The amendments to the rule eliminate the startup, shutdown, and malfunction exemption, remove the SSM plan requirement, add provisions to provide an affirmative defense against civil penalties for exceedances of emission standards caused b y malfunctions, and a requirement for electronic submittal of performan ce test data, and correct an editorial error. The remaining portions of the NESHAP remain unchanged. In general, all NESHAP standards require initial notifications, performance tests, and periodic reports. Owners or operators are also required to maintain records of the occurrence and duration of an y malfunction s in the operation of an affected facility , or an y period during which the monitoring sy stem is inoperative. These notifications, reports, and records are essential in determining compliance an d, 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. 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 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.2

Based on our consultations with industry representatives, 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 estimated 27 respondents currentl y s ubject to this rule. It is estimated that no additional sources will become subject to the standard over the next three ye ars. All of the pharmaceutical production facilities in the United States are owned and operated by the pharmaceutical industry (the “Affec ted Public”). None of the facilities in the United States are owned b y state, local, tribal or the Federal government. They are all privately, owned for

- profit businesses. The burden to the “Affected Public” is listed below in Table 1: Annual Respondent Burden and Cost

- NESHAP for Pharmaceutical Production (40 CFR Part 63, Subpart GGG ) (Re vision). The Federal government burden 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 CFR Part 63, Subpart GGG ) (Re vision).
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 perf

ormance for each category or subcategory

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 Ad ministrator 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 reasonabl y require.
In the Admi nistrator's judgment, HAP pollutant emissions from pharmaceuticals production (predominately methanol, methyl ene chloride and toluene) cause, or contribute to air pollution that may

reasonably

be anticipated to endanger 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 whic h were promulgated in accordance with the Clean Air Act. Ina ddition, the collected information is used for targeting inspections and as evidence in legal proceedings. Performance tests are required in order to determine an affected facility’s i nitial ca pability to comply

with the emission standard. Continuous emission monitors are used to ensure compliance with the standard at all times. During the performance tests, a record of the operating parameters under which compliance was achieved may be record ed and used to determine compliance in place of a continuous emission monitor. The notifications required in the standard are used to inform the Agency or delegated authority when a source becomes subject to the requirements of the regulations. The revie wing authority may then inspect the source to ensure that the pollution control devices are properl y 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 operation/maintenance procedures, and for compliance determinations. The information generated by the monitoring, recordkeeping and reporting requirements described in this I CR is used by the Agency

to ensure that facilities affected by the NESHAP continues to operate the control equipment in compliance with the regulation.
3. Non
- duplication, Consultations, and Other Collection Crite ria 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 delegated, the information is sent directly to the appropriate EPA regional office. Otherwise, th e information is sent directl y to the delegated state or local agency
. If a state or local agency h as adopted their own similar standards to implement the Federal standards, a cop y of the report submitted to the state or local agency can be sent to the Administrator in lieu of the report required b y the Federal standards. Therefore, no duplication exists. 3(b) Public Notice Required Prior to ICR Submission to OMB This is a rule

- related ICR and comments were solicited on the proposal package and the prop osed ICR, which included no revisions. This ICR contains revisions from the proposed ICR to include burden associated with the provisions for affirmative defense.
3(c) Consultations4

T he Agency ’s industry

experts have been consulted, and the Agency ’s internal data sources and projections of industry growth over the next three years have been considered. The primary source of information as reported b y industry , in compliance with the recordkeeping and reporting provisions in the standard, is the Online Tracking Information System (OTI S) which is operated and maintained by the EPA Office of Compliance. OTIS is the EPA database for the collection, maintenance, and retrieval of all compliance data. The growth rate for the industry is based on our consultations with the Agency ’s internal industry experts. Industry trade associations and other interested parties were provided an opportunity to comment on the burden associated with the standard as it was being developed. During development of the original s tandards, w e contacted the Pharmaceutical Research and Manufacturers of America (PhRMA), at (202) 835

- 3400, and Noramco Incorporated, at (302) 652

- 3840. The number of sources was obtained b y information gathered and public comments for pharmaceutical faci lities subject to 40 CFR part 63, subpart GGG on the Residual Risk and Technology

Review that was completed in October of 2008, by EPA’s Office of Air Quality Planning and Standards 3(d) Effects of Less Frequent Collection Less frequent information coll ection 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 emis sion limitations are met. If the information required b y these standards was collected less frequentl y, the proper operation and maintenance of control equipment and the possibility of detecting violations would be less likely

. 3(e) General Guidelines None of these reporting or recordkeeping requirements violate any of the regulations established by

OMB at 5 CFR part 1320, section 1320.5. These standards require the respondents to maintain all records, including reports and notifications for at least f

ive years. T his is consistent with the General Provisions as applied to the standards. E PA believes that the five

- ye ar records retention requirement is consistent with the Part 70 permit program and the five

- ye ar statute of limitations on which the permi t program is based. The retention of records for five years allows EPA to establish the compliance history of a source, any p attern of non - compliance, and to determine the appropriate level of enforcement action. E PA has found that the most flagrant viol ators have violations extending beyond the five years. Without the five

- ye ar record retention, EPA would be prevented from pursuing the violators due to the destruction or nonexistence of essential records. 3(f) Confidentiality5

Any i nformation submitte d to the Agenc y fo r which a claim of confidentiality i s made will be safeguarded according to the Agency policies set forth in title 40, chapter 1, part 2, subpart B

- Confidentiality

of Business Information (CBI) (see 40 CFR 2; 41 FR 36902, September 1, 1 976; amended b y 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 Informa tion Requested 4(a) Respondents/SIC Codes The respondents to the recordkeeping and reporting requirements are pharmaceutical production facilities. The North American Industry Classification Sy stem (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 requirements violate an y 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 required by the NESHAP for Pharmaceuticals Production (40 CFR Part 63, Subpart GGG ).
A source must make the f ollowing 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 applicability 63.9(a), 63.1260(b) Notification of in itial 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

(reschedu le) 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 malfunction s 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), 63.125 5(h) Reports of emissions averaging 63.1260(k) Reports of malfunctions that result 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 notifications 63.10(b)(1), 63.1259(a)(1) Record of applicability 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 construction/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 63.1 259(f) Records of wastewater stream or residual transfer 63.1259(g) Records of extensions 63.1259(h)7 Recordkeeping Records of inspections 63.1259(i) Records should be retained for 5 ye ars 63.10(b)(1), 63.1259(a)(1) Electronic Reporting Some of the respondents are using monitoring equipment that automatically records parameter data. Although personnel at the affected facility must still evaluate the data, internal automation has significantly reduced the burden associated with monitoring and recordkeeping at a plant site. Also, regulatory

a gencies, in cooperation with the respondents, continue to create reporting sy stems to transmit data electronically . However, electronic reporting s ys tems are not widel y used. At this time, it is estimated that approximately 20 percent of the respondents are reporting electronically

. The amendments to the NESHAP require that any performance tests performed after December 31, 2011 be submitted electronicall y to EPA’s Central Data Exchange b y 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 (includes preparing implementation plans) Perform initial performance test and repeat performance tests if necessary

. Perform initial performance test, Reference Methods 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, acquiring, installing, and utilizing technology and sy stems for the purpose of collecting, validating , and verifying information. Develop, acquire, install, and utilize technology and sy stems for the purpose of processing and maintaining information. Develop, acquire, install, and utilize technology and sy stems for the purpose of disclosing and providin g information. Adjust the existing way s to comply with an y previously applicable instructions and requirements. Train personnel to be able to respond to a collection of information. Transmit, or otherwise disclose the information.8

Currently , sources are using monitoring equipment that provides parameter data in an automated way (e.g., continuous parameter monitoring s ys tem). Although personnel at the source still need to evaluate the data, this ty pe of monitoring equipment has significantly reduced the burden associated with monitoring and recordkeeping.
EPA is including in Table 3 (located at the end of this supporting statement) an estimate of the burden associated with performing an affirmative defense. EPA is providing this as an illustrative e xample 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 estimate of cost under the General Duty t o 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 monito ring equipment, in a manner consistent with safety and good air pollution control practices for minimizing emissions. D etermining whether such operation and maintenance procedures are being used will be based on information available to the Administrator which may include, but is not limited to, monitoring results, review of operation and maintenance procedures, review of operation and maintenance records, 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 defense position adopted by a source, EPA provides an administrative adjustment to this I CR that estimates the costs of the notification, recordkeeping and reporting requirements associated with the assertion of the affirmative defense. EPA’s estimate for the required notification, reports and records, including the root cause anal ys is, associated with a single incident totals approximately $ 3,141 and is based on the time and effort required of a source to review relevant data, interview plant employees, and document the events surrounding a malfunction that has caused an exceedance of an emission limit. The estimate also includes time to produce and retain the records and reports for submission to EPA. EPA provides this illustrative estimate of this burden because these costs are onl y incurred 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, onl y a small number would be expected to result from a malfunction, and only a subset of excess emissions caused by m alfunctions would result in the source choosing to assert the affirmative defense. T hus we believe the number of instances in which source operators might be expected to avail themselves of the affirmative defense will be extremely small. For this reason, we estimate no more than 2 or 3 such occurrences for all sources within a given category over the 3

- ye ar period covered b y this ICR. For the purpose of this estimate, we are adding two (2) instances of affirmative defense. We expect to gather information on such events in the future and will revise this estimate as better information becomes available.
5. The Informatio n Collected: Agency Activities, Collection Methodology, and Information Management 5(a) Agency Activities9

EPA conducts the following activities in connection with the acquisition, analy sis, storage, and distribution of the required information.

Agency Activities Observe initial performance tests and repeat performance tests if necessary

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

. Audit facility

records. Inp ut, anal yz e, and maintain data in the OTIS. 5(b) Collection Methodology and Management Following notification of startup, the reviewing authority might inspect the source to determine whether the pollution control devices are properl y i nstalled and ope rational. P erformance test reports are used b y the Agency to discern a source’s initial capability to comply

with the emission standard, and note the operating conditions under which compliance was achieved. Data and records maintained by the respondents are tabulated and published for use in compliance and enforcement programs.
In formation contained in the reports is entered into OTI S which is operated and maintained by the EPA Office of Compliance. OTIS is the EPA database for the collection, maintena nce, and retrieval of compliance data for approximately 125,000 industrial and government

- owned facilities. E PA uses OTIS for tracking air pollution compliance and enforcement by l ocal and state regulatory

agencies, EPA regional offices, and EPA headquart ers. EPA edit, store, retrieve and anal yz e the data. The records required b y this regulation must be retained by the owner or operator for five ye ars. 5(c) Small Entity Flexibility The majority

of the respondents are large entities (i.e., large busin esses). 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 ty pes of control equipment employed, th e recordkeeping and reporting requirements are the same for both small and large entities. The Agency considers these to be the minimum requirements needed to ensure compliance and, therefore, cannot reduce them further for small entities. T o the ex tent that larger businesses can use economies of scale to reduce their burden, the overall burden will be reduced. 5(d) Collection Schedule10

The specific frequency

f or each information collection activity w ithin this request is shown below in Table 1: Annual Respondent Burden and Cost

- NESHAP for Pharmaceuticals Production (40 CFR Part 63, Subpart GGG) (Re vision). 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 I CR. The individual burdens are expressed under standardized headings believed to be consistent 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, and a person is not required to respond to, a collection of information unless it displays a currentl y 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 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
This I CR uses th e 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 Department of Labor, Bureau of Labor Statistics, September 2009, ” Table 2. Civilian Wo rkers, by Occupational and Industry group .” The rates are from column 1, ” Total compensation .” The rates have been increased b y 110 percent to account for the benefit packages available to those employed by private industry

.

(ii) Estimating Capital/S tartup and Operation and Maintenance Costs The ty pe of industry

costs associated with the information collection activities in the subject standard are labor costs which are addressed elsewhere in this IC R 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 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 I CR are zero. This is the total of column D in the above table. The total operation and maintenance (O&M) costs for this I CR are $112,266. 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 ye ars of the I CR is estimated to be $112,266. (iv) Affirmative Defense, Root Cause Analysis, and Malfunction Costs. EPA’s estimate for a affirmative defense and root cause anal ys is is based on general experience to calculate the time and effor t required of a source to review relevant data, interview plant employees, and reconstruct the 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 available 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 ys is of the reported in formation. The EPA 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 $71,518. This cost is based on the average hourl y 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 Personnel Management (OPM), 2010 General Schedule, which excludes locality r ate of pay
. T he rates have been increased by 6 0 percent to account for the benefit packages availa

ble 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) (Re vision). 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 ye ar will become subject. T he overall average number o f respondents, as shown in the table below is 27 per ye ar. The number of respondents is calculated using the following table which addresses the three ye ars covered b y this I CR. 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 with constructed, reconstructed and modified affected facilities. To avoid double

- counting respondents, column D is subtracted. As shown above, the average Number of Respondents over the three

- ye ar period of this ICR is 27

. The total number of annual responses per ye ar is calculated 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 p erformance 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 M alfunction 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 standard for the purpose of affirmative defense 27 0.0 25 0 0.7 Total Number of Annual Responses Total 2 50 The number of Total Annual Responses is 2 50

. The total annual labor costs are $ 4,187,309 . Details regarding these estimates may be found below in Table 1: Annual Respondent Burden and Cost

- NESHAP for Pharmaceuticals Production (40 CFR Part 63, S ubpart GGG) (Re vision). 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, respectivel y, and summarized below. (i) Res pondent Tally
The total annual labor hours are 44,266 . Details regarding these estimates may be found below in Table 1: Annual Respondent Burden and Cost

- NESHAP for Pharmaceuticals Production (40 CFR Part 63, Subpart GGG) (Re vision). 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 Operation 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 Table 2: Average Annual EPA Burden and Cost

– NESHAP for Pharmaceuticals Production (40 CFR Part 63, Subpart GGG) (Re vision). 6(f) Reasons for Change in Burden There is an increase in the labor hour burden in this IC R compared to the previous IC R due to the inclusion of the new requirements of the amendments to the NESHAP. EPA provides an adjustment to this IC R that estimates the costs of the notification, recordkeeping, and reporting requirements associated with the assertion of the affirmative defense. EPA’s estimate for the required notification, reports and records, including the root cause anal ys is, as sociated with a single incident totals approximately $ 3,141 and is based on the time and effort required of a source to review relevant data, interview plant emplo ye es, and document the events surrounding a malfunction that has caused an exceedance of an e mission limit. T he estimate also includes time to produce and retain the records and reports for submission 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 ye ars because, of the number of excess emission events reported b y source operators, only a small number would be expected to result from a malfunction, and only a subse t of excess emissions caused by m alfunctions would result in the source choosing to assert the affirmative defense. T hus 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 burden for this collection of information is estimated to average 17 7 hours per response. Burden means the total time, effort, or financial resources expended by

p ersons to generate, maintain, retain, disclose or provide information to or for a Federal agency . This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and s ys tems for the purposes of collecting, validating, and verif yi ng information, processing and maintaining information, and disclosing and providing information; to adjust the existing ways to comply w ith an y p reviously

a pplicable instructions and requirements; to train personnel to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. An agency

may not conduct or sponsor, and a person is not required to respond to, a collec tion 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 s uggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this IC R under Docket ID Number EPA

- HQ

- OECA

- 2009

- 0381. 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 content of the docke t,15

and to access those documents in the public docket that are available electronically . When in the sy stem, select “search” than key in the docket ID number identified in this document. The documents are also available for public viewing at the Enforcem ent and Compliance Docket and In formation Center in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Avenue, N.W., 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 holiday s. The telephone number for the Reading Room is (202) 566

- 1744, and the telephone number for the Enforcement and Compliance Docket and Information Center Docket is (202) 566

- 1752

. Also, yo u can send comments to the Office of Inform ation 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 corresponden ce. 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) (Re vision ) (A ) (B) (C) (D ) (E ) (F) (G) (H) Person ho ur s pe r occu rren ce No . o f

occu rren ces pe r resp on de nt pe r ye ar Person

ho ur s pe r resp on de nt pe r ye ar (C =A xB ) Re sp on de nt s

pe r ye ar a Te ch ni cal

pe rson ho ur s pe r ye ar (E =C xD) Manag em en t

pe rson ho ur s pe r ye ar (E x0 .0 5) Cl eri cal

pe rson ho ur s pe r ye ar (E x0 .1 ) To tal Co st

Per ye ar b

1. A ppl ica tions N/A 2. Surve ys and s tu

dies N/A 3. Re po rting r eq

ui remen ts Ne w sou rces c A . Re ad rul e and i ns tructions 1 1 1 0 0 0 0 $0 B. Re qui red

ac tiv ities i. Initi alpe rforma

nc e tests Ne w 480 1 480 0 0 0 0 $0 Re constructed 160 1 160 0 0 0 0 $0 Wa

stew at er 160 1 160 0 0 0 0 $0 ii. Quality c on

trol pl an f

or CMS 60 1 60 0 0 0 0 $0 iii . De ve lop

r ecord s ys tem 40 1 40 0 0 0 0 $0 iv . T ra in pe rson ne l 40 1 40 0 0 0 0 $0

v . Re pe atpe rformanc e test d 60 1 60 0 0 0 0 $0 C. Wri te rep orts i. No tifica

tion o f construction

/reconstruction 2 1 2 0 0 0 0 $0 ii. No tifica

tion o f phys ica

l or op era tionalc hange s e 8 3 24 27 648 32. 4 64. 8 $70, 488 iii . No tifica

tion o f ac tuals ta

rtu p 2 1 2 0 0 0 0 $0 iv . No tifica

tion o f in itia l p erforma

nc e test 2 1 2 0 0 0 0 $0
v . No tifica

tion o f appl ica

bi lity 2 1 2 0 0 0 0 $0
v i. No tifica

tion o f de mo ns tra

tion o f CMS 2 1 2 0 0 0 0 $0
v ii Notifica

tion o f com pl ia nc e sta tus 120 1 120 0 0 0 0 $0
v iii. P re-com

pl ia nc e rep ort (emission

av era gi ng) 180 1 180 0 0 0 0 $0 ix. Startu

p, s hut do wn , malfunc tion f 40 2 80 27 2, 160 108 216 $234, 959 x. Se mi annual s ummary r ep ort a. No de vi at ions g 8 2 16 24 384 19. 2 38. 4 $41, 771 b. De vi at ions h 24 2 48 3 144 7. 2 14. 4 $15, 664 xi. Le ak de tection

and r ep ai r (LDA

R) re po rt i 432 2 864 27 23, 328 1, 166. 4 2, 332. 8 $2, 537, 562 xii . Emis sions av

era gi ng r ep ort j 20 2 40 3 120 6 12 $13, 053 xii i. A

ffirmat iv e de fense n 30 0. 7 20 1 12 8 0 $2, 094 Subt ota l f or Re po rting Re qui remen ts 30, 821. 6 Bu rd eni tem17

Assu mptions: a We have assumed that the average number of respondents that will be subject to this rule will be 27. There will be no new ad ditional sources during the next three years of this ICR. b This ICR uses the following labor rat es: $114.49 per hour for Executive, Administrative, and Managerial labor; $98.20 per hour for Technical labor, and $48.53 per hour for Clerical labor. T hese rates are from the United States Department of L abor, Bureau of Labor Statistics, September, 2009 , Table 2. Civilian Workers, by Occupational and Industry group. T he rates are from column 1, Total Compensation. The rates have been increased by 110 percent to account for the benefit packages avai lable to those employed by private industry.
c We have assumed that there will be no new or reconstructed facilities during the next three years of this ICR. d We have assumed that 20 percent of respondents would have to repeat performance tests due to failure. e We have assumed that each source will requir e an average of three processing changes each year to complete this task over the next three years of this ICR. f We have assumed that each respondent will take 40 hours two times per year to complete the startup, shutdown, malfunction rep orts. g We have assumed that 90 percent of respondents will each take eight hour two times per year to complete the no deviation report. h We have assumed that 10 percent of respondents will each take 24 hours two times per year to complete the deviation report. i We h ave assumed that it will take each respondent 432 hour two times per year to complete the LDAR report. j We have assumed that ten percent of respondents will each take 20 hours two times per year to complete the emissions averagin g report. k We have assumed that it will take each respondent 1 hour 365 times per year to record the operating parameters for control devices. l We have assumed that it will take each respondent 2 hours 26 times per year to record the SSM plans.
m We have assumed that it will take each respondent 16 hours one time per year to record the calibration of CMS. n Assumes 2 affirmative defense reports for entire industry during the 3

- yr ICR period. F ormulas are not followed for person - hours per year. F or affirmative defense hours required assumes 18 hours technical, 12 hours management, 0 clerical for each instance of affirmative defense. (A ) (B) (C ) (D ) (E ) (F) (G ) (H) Person ho ur s pe r occu rren ce No . o f

occu rren ces pe r resp on de nt pe r ye ar Personho ur s

pe r resp on de nt pe r ye ar (C =A xB ) Re sp on de nt s

pe r year a Te ch ni cal

pe rson ho ur s p er ye ar (E =C xD) Manag em ent

pe rsonho ur s pe r ye ar (E x0 .0 5) Cl eri cal

pe rsonho ur s pe r ye ar (E x0 .1 ) To tal Co st

Per ye ar b

4. Re cord

ke ep in g r eq ui remen ts i. Re cords for op era ting par ame ters for con

trol De vi ces k ii . Re cords of SS&M l 2 26 52 27 1, 404 70. 2 140. 4 $152, 724 ii i. Cal ibra

tion o f CMS m 16 1 16 27 432 21. 6 43. 2 $46, 992 iv . LDA R Se e 3C Subt ota l f or Re cord

ke eping Re qui remen

ts 38, 487 1,931. 8 3, 847. 5 $4, 187, 309 TO TALLA

BO R B URDEN A

ND COST

( rou nde d) $4, 187, 309 492. 8 985. 5 $1, 072, 002

13, 444. 7
44, 266 Bu rd eni tem

1 365 365 27 9, 85518 Table 2: Average Annual EPA Burden
- NESHAP for Pharmaceuticals Production (40 CFR Part 63, Subpart GGG) (Re vision )

Activity (A) EPA pers on hours per occurrence (B)

No. of occurrences per plant per year (C)

EPA person hours per plant per year (C=AxB) (D)

Plants per year a (E)

Technical person hours per year (E=CxD) (F)

Managem ent person - hours per year (Ex0.05) (G)

Clerical person hour s per year (Ex0.1) (H)

Cost, $ b

1. Required activities i. Initial performance test c 2 1 2 0 0 0 0 $0 ii. Repeat performance test d 24 1 24 0 0 0 0 $0 2. Report review

– one time i. Notification of con struction/reconstruction 2 1 2 0 0 0 0 $0 ii. Notification of actual startup 2 1 2 0 0 0 0 $0 iii. Notification of initial CMS demonstration 2 1 2 0 0 0 0 $0 iv. Initial notification 2 1 2 0 0 0 0 $0 v. Notificatio n of compliance status report 40 1 40 0 0 0 0 $0 vi. Pre

- compliance report e a. With emissions averaging f 20 1 20 0 0 0 0 $0 b. Without emissions averaging 4 1 4 0 0 0 0 $0 3. Report review

– on - going i. Semiannual summary report a. No deviations g 2 2 4 24 96 4.8 9.6 $4,975.16 b. Deviations h 8 2 16 3 48 2.4 4.8 $2,487.58 ii. Notification of physical/operational change i 8 3 24 27 64 8 32.4 64.8 $33,582.28 iii. SSM report j 2 2 4 27 108 5.4 10.8 $5,597.05 iv. LDAR report k 8 2 16 27 432 21.6 43.2 $22,388.18 v. Emission averaging report l 8 2 16 3 48 2.4 4.8 $2,487.58 Subtotals Labor Burden and cost 1 ,380 69 138 $71,517.83 TOTAL ANNUAL BURDEN AND COST (rounded) 1,587 $71,518
Assu mptions: a We have assumed that the average number of respondents that will be subject to this rule will be 27. There will be no new ad ditional sources during the next three years of this ICR. b This cost is based on the following labor rates which incorporates a 1.6 benefits multiplication factor to account for governme nt overhead expenses: $62.27 Managerial rate (GS

- 13, Step 5, $38.92 x 1.6), $46.21 Technical rate (G S

- 12, Step 1, $28.88 x 1.6), 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. c We have assumed that there will be no new or r econstructed facilities during the next three years of this ICR.19
d We have assumed that 20 percent of respondents would have to repeat performance tests due to failure.
e We have assumed that 50 percent of new facilities will submit a pre

- com pliance rep ort. f We have assumed that 10 percent of existing facilities will have to comply with emission averaging requirements; new faciliti es are not allowed to use emissions averaging. g We have assumed that 90 percent of respondents will each take two hours two times per year to complete this report. h We have assumed that 10 percent of respondents will have to report deviation. i We have assumed that each respondent will be required to review the physical/operational changes for each facility three time s pe r year over the next three

- year period of this ICR. j We have assumed that each respondent will report actions taken during startup, shutdown, or malfunction that are consistent. k We have assumed that each respondent will have to comply with the LDAR report two times per year. l We have assumed that 10 percent of respondents will have to review the emission averaging report.

Table 3: Single Affirmative Defense Burden Estimate

Personnel Number of

Personnel Time

Requirement (hours) Total

Hours Hourly Rate

($/hr) Total Technical Personnel 3 6 18 98.20 $ 1,768 Managerial Personnel 2 6 12 114.49 $ 1,374 Total 5 30 $3,14 1