NESHAP for Pharmaceutical Production (40 CFR part 63, subpart GGG) (Final Rule)

Forms and Documents

Document Name	Status
1781ss06.docx Supporting Statement A	2011-04-14

IC Document Collections

IC ID	Document Title	Status
24504	NESHAP for Pharmaceuticals Production (40 CFR Part 63, Subpart GGG)	Modified

ICR Details

OMB Control No: 2060-0358	ICR Reference No: 201106-2060-009
Status: Historical Active	Previous ICR Reference No: 201005-2060-011
Agency/Subagency: EPA/OAR	Agency Tracking No: 1781.06
Title: NESHAP for Pharmaceutical Production (40 CFR part 63, subpart GGG) (Final Rule)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/30/2011
	Date Received in OIRA: 06/30/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2014	10/31/2013	10/31/2013
Responses	249	0	249
Time Burden (Hours)	44,266	0	44,246
Cost Burden (Dollars)	112,266	0	112,266

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Abstract: This ICR 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 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 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. 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 by malfunctions, and a requirement for electronic submittal of performance test data, and correct an editorial error. The remaining portions of the NESHAP remain unchanged.

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Authorizing Statute(s): US Code: 42 USC 7401 et seq Name of Law: Clean Air Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
2060-AO91	Final or interim final rulemaking	76 FR 22566	04/21/2011

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
NESHAP for Pharmaceuticals Production (40 CFR Part 63, Subpart GGG)

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	249	249	0	0	0	0
Annual Time Burden (Hours)	44,266	44,246	0	20	0	0
Annual Cost Burden (Dollars)	112,266	112,266	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This ICR 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 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 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. 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 by malfunctions, and a requirement for electronic submittal of performance test data, and correct an editorial error. The remaining portions of the NESHAP remain unchanged.

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Annual Cost to Federal Government: $71,518

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 04/19/2011

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