In accordance with 5 CFR 1320, OMB is withholding approval of this information collection. Prior to the publication of the final rule, the agency must provide to OMB a summary of all comments pertaining to the information collection burden imposed by this rule and any changes made in response to these comments.
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The U.S. Environmental Protection Agency (EPA) is charged under Section 112 of the Clean Air Act (CAA) to establish National Emission Standards for Hazardous Air Pollutants (NESHAP) for new and existing area sources of hazardous air pollutants (HAP). Certain records and reports are necessary for the Administrator to confirm the compliance status of affected sources and identify new or reconstructed sources subject to the standards. Specific information needed by EPA for the proposed Hospital EO Sterilization NESHAP includes verification that the management practice is followed and that exempted facilities are venting emissions to control devices and following manufacturer recommended procedures. These recordkeeping and reporting requirements are specifically authorized by section 114 of the CAA (42 U.S.C. 7414) and set out in the General Provisions to 40 CFR part 63. Respondents to this request are owners and operators of hospitals that are area sources of HAP that operate ethylene oxide sterilization facilities. There are an estimated 1,900 affected facilities currently in operation. No new facilities are expected during the first 3 years of the proposed rule. Respondents would be required to submit an initial Notification of Compliance Status. Uncontrolled respondents also would be required to keep records of sterilization cycles and their required notifications.
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.
2245ss01.doc
NESHAP for Hospital Ethylene Oxide Sterilization (40 CFR part 63, subpart WWWWW) (Proposed Rule)