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.
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.
$71,518
No
No
No
No
No
Uncollected
Mary Kissell 919 541-4516
kissell.mary@epa.gov
No
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:
(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;
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.
1781ss06.docx
NESHAP for Pharmaceuticals Production (40 CFR Part 63, Subpart GGG)