            2014 Compliance Recertification Application (2014 CRA)
         Compliance Application Review Document (CARD Section 194.21)
                                  Inspections

21.0  Background

	Section 194.21, Inspections, provides the U.S. Environmental Protection Agency (EPA or Agency) with the right to inspect all activities at the Waste Isolation Pilot Plant (WIPP) and all activities located off-site which provide information included in any compliance application.  The Agency can conduct periodic inspections to verify the adequacy of information included in the compliance applications.  The Agency can conduct its own laboratory tests, in parallel with those conducted by DOE to confirm the adequacy of the techniques employed at those facilities.  The Agency may also inspect any relevant records kept by DOE.

      This provision of EPA's Compliance Criteria was not applied prior to the 1998 Certification Decision.  EPA used the authority given by Section 194.21 to inspect WIPP site activities, waste generator sites, the monitoring program, and magnesium oxide (MgO) backfill and waste emplacement requirements after 1998.  These inspections were performed to assure DOE met the requirements.

21.1  Requirements

	(a) "The Administrator or the Administrator's authorized representative(s) shall, at any time:

		(1) Be afforded unfettered and unannounced access to inspect any area of 			the WIPP, and any locations performing activities that provide information 		relevant to compliance application(s), to which the Department has rights 			of access. Such access shall be equivalent to access afforded Department 			employees upon presentation of credentials and other required documents.

		(2) Be allowed to obtain samples, including split samples, and to monitor 			and measure aspects of the disposal system and the waste proposed for 			disposal in the disposal system."

	(b) "Records (including data and other information in any form) kept by the Department pertaining to the WIPP shall be made available to the Administrator or the Administrator's authorized representative upon request. If requested records are not immediately available, they shall be delivered within 30 calendar days of the request."

	(c) "The Department shall, upon request by the Administrator or the Administrator's authorized representative, provide permanent, private office space that is accessible to the disposal system. The office space shall be for the exclusive use of the Administrator or the Administrator's authorized representative(s)."

	(d) "The Administrator or the Administrator's authorized representative(s) shall comply with applicable access control measures for security, radiological protection, and personal safety when conducting activities pursuant to this section."

21.2  1998 Certification Decision

	No inspections under this authority were conducted prior to the 1998 Certification Decision; therefore, no evaluation related to inspections was completed during the certification review

21.3  Changes in the 2004 Compliance Recertification Application (2004 CRA)

	The 2004 Compliance Recertification Application (2004 CRA) did not specifically address EPA's inspection activities under Section 194.21.

21.3.1  Evaluation of Compliance for 2004 Recertification

      The inspections section of the compliance criteria, 40 CFR 194.21, lists specific requirements related to EPA's ability to perform inspections involving WIPP.  These requirements include; unfettered and unannounced access equivalent to DOE employees, availability of records for review, and private office access if needed to perform inspections.

	EPA evaluated DOE implementation of these requirements	at each of the twenty-one inspections performed since the 1998 Certification Decision.  DOE provided unfettered access to facilities, access to and list of records as requested by EPA, and actively supported our inspection activities.

<IP_ADDRESS>  Monitoring Inspections

	EPA inspects the implementation of the monitoring requirements for geomechanical, hydrological, waste activity, drilling related, and subsidence parameters.   40 CFR Part 194.42(a), requires DOE to "conduct an analysis of the effects of disposal system parameters on the containment of waste in the disposal system."  The results of these analyses were included in the 1998 Compliance Certification Application (CCA) and were used to develop pre-closure and post-closure monitoring requirements.

	Volume 1, Section 7.0, of the CCA documented DOE's analysis of monitoring parameters.  Table 7-7 of the CCA lists the ten parameters that DOE determined may affect the disposal system.  These parameters are grouped into major categories and listed in Table CARD 21-1.  DOE revisited the 40 CFR 194.42 requirements and reevaluated monitor parameters as part of the 2004 CRA, this is documented in 2004 CRA Volume 1 Chapter 7.2 and the Agency's review is discussed in 2004 CRA CARD 42.

Table CARD 21-1  Monitored Parameters
Geomechanical Parameters-			Waste Activity Parameter-
            -Creep closure, 					-Waste Activity
	-Extent of deformation,
	-Initiation of brittle deformation, and 	Subsidence Parameter-
	-Displacement of deformation features.		-Subsidence measurements

Hydrological Parameters-				Drilling Related Parameters-
            -Culebra groundwater composition and 		-Drilling rate and
	-Change in Culebra groundwater flow 		-The probability of encountering a
	  direction.						  Castile brine reservoir.

      Monitoring inspection activities included an examination of monitoring and sampling equipment both on and off site, and in the underground.  EPA also reviewed numerous sampling procedures and measurement techniques and verified implementation of an effective quality assurance program for monitor activities.

	Results of EPA's monitoring inspections are described in Table CARD 21-2 below.  EPA found few issues during the seven monitoring inspections.   Please see each inspection report for details of each inspection, and see the reference section below for Docket reference information.  EPA found the overall parameter monitoring program adequate to capture potential changes in the ten monitoring parameters and to verify predictions of the compliance performance assessment.

	Monitoring inspection reports are available from the EPA Air Docket A-98-49, Item II-B3.

   Table CARD 21-2 Summary of the 2004 Parameter Monitor Inspections Results

Date of Parameter     Monitor Inspection
Inspection Results: [See Inspection Reports For Details]
March 23, 1999
During this inspection the Agency found that DOE adequately implemented programs to monitoring these ten parameters during pre-closure operations.  EPA did not have any findings or concerns during this inspection.
June 20, 2000
During this inspection the inspectors found that DOE continued to adequately implemented programs to monitoring these ten parameters during pre-closure operations.  EPA did not have any findings or concerns during this inspection.
June 19, 2001
Inspectors concluded that DOE had adequately maintained programs to monitor the necessary ten parameters during pre-closure operations, except for the subsidence monitoring program.  Inspectors found that the subsidence monitoring program at WIPP was not able to show that it had an implemented effective quality assurance program.  EPA found that the Subsidence Program did not have developed adequate written procedures.
June 24, 2002
Inspectors concluded that DOE had adequately maintained programs to monitor the necessary ten parameters during pre-closure operations.  EPA evaluated the new subsidence procedure and found it to be adequate and a significant improvement. EPA did not have any findings or concerns during this inspection.
June 17, 2003
Inspectors concluded that DOE had adequately maintained programs to monitor the necessary ten parameters during pre-closure operations.  EPA had no findings or concerns, but did have one observation.  For some of the parameters that are required to be monitored, such as some geomechanical and waste activity parameters, EPA observed that it was not clear that they were reported properly.  During the inspection DOE committed to make sure that all monitored parameters were clearly reported annually.
June 28, 2004
Based on program documents, interviews, and field demonstrations during the inspection, EPA concluded that the monitoring program covers the ten monitored parameters required in the certification decision; that the monitoring, sample collection, and sample/data analysis procedures reviewed were complete and appropriate; that staff were adequately trained and implemented the procedures adequately; and that appropriate quality assurance measures were applied.  EPA did not have any findings or concerns during this inspection.
July 12, 2005
Based on program documents, interviews, and field demonstrations during the inspection, EPA concluded that the monitoring program covered the ten monitored parameters required in the certification decision; that the monitoring, sample collection, and sample/data analysis procedures reviewed were complete and appropriate; that staff were adequately trained and implemented the procedures adequately; and that appropriate quality assurance measures are applied.  EPA did not have any findings or concerns during this inspection.

<IP_ADDRESS>  Waste Emplacement Inspections

	EPA inspected the WIPP to verify that waste was being emplaced in the underground facility in the manner described in DOE's CCA (EPA Air Docket A-93-02, Item II-G-01, and associated documents).  These inspections also verified the proper emplacement of the MgO backfill material with the waste packages.

	EPA found during these inspections that DOE adequately emplaced waste and MgO backfill material and that emplaced waste was traceable using the WIPP Waste Information System (WWIS) database.  Table CARD 21-3 describes a brief summary of each waste emplacement inspection.  Please see each inspection report for details of each inspection, and see the reference section below for Docket reference information.

   Table CARD 21-3 Summary of the 2004 Waste Emplacement Inspections Results

Date of Waste   Emplacement Inspection
Inspection Results: [See Inspection Reports For Details]
September 8, 1999
EPA found that waste is being emplaced in accordance with commitments made in the CCA.  EPA did not have any findings or concerns during this inspection.
June 20, 2000
EPA found that waste is being emplaced in accordance with commitments made in the CCA.  EPA did not have any findings or concerns during this inspection.
June 19, 2001
EPA found that waste is being emplaced in accordance with commitments made in the CCA.  EPA did not have any findings but one concern during this inspection.  EPA found that DOE did not appear to have a procedure that required proper documentation of off-normal events, in this case waste was shipped without proper documentation.
June 24, 2002
EPA did not have any findings or concerns during this inspection.
June 17, 2003
EPA had one finding during this inspection.  EPA found that DOE may not be accounting for random waste emplacement assumptions properly.
June 28, 2004
EPA did not have any findings but did have one concern. EPA found that magnesium oxide (MgO) was not being properly tracked in the WIPP Waste Information System (WWIS).
May 17, 2005
EPA did not have any findings but did have one concern during this inspection.  EPA found that DOE needed to develop a formal procedure that guides the MgO emplacement decision making process, rather than use training materials, and that the WWIS needs to be back populated with the quantity of emplaced MgO.

	EPA did not receive any public comments on DOE's continued compliance with the inspections requirements of Section 194.21.

21.3.2  2004 Recertification Decision

	Based on a review and evaluation of the 2004 CRA and supplemental information provided by DOE (FDMS Docket ID No. EPA-HQ-OAR-2004-0025, Air Docket A-98-49), EPA determined that DOE continued to comply with the requirements for Section 194.21.

21.4  Changes in the 2009 Compliance Recertification Application (2009 CRA)

21.4.1  Evaluation of Compliance for 2009 Recertification

      The inspections section of the compliance criteria, 40 CFR 194.21, lists specific requirements related to EPA's ability to perform inspections involving WIPP as noted in Section 21.3.1 of this CARD.  EPA evaluated DOE implementation of these requirements at each of the eight inspections performed since the 2004 CRA decision was published in 2006.  DOE continued to provide unfettered access to facilities and records as requested by EPA, and actively supported our inspection activities.

<IP_ADDRESS>  Monitoring Inspections

	Results of EPA's monitoring inspections since the 2004 CRA are described in Table CARD 21-4 below.  EPA found few issues during the three monitoring inspections.   Please see each inspection report for details of each inspection, see the reference section A-98-49, Items in II-B3.  EPA continued to find the overall parameter monitoring program adequate to capture potential changes in the ten monitoring parameters and to verify predictions of the compliance performance assessment.
        Table CARD 21-4 Summary of Parameter Monitor Inspection Results
                      Since the 2004 CRA Decision in 2006

Date of Parameter     Monitor Inspection
Inspection Results: [See Inspection Reports For Details]
June 20-22, 2006
Based on program documents, interviews, and field demonstrations during the inspection, EPA concluded that the monitoring program covers the ten monitored parameters required by EPA's 1998 Certification Decision.  This inspection determined that the monitoring, sample collection, and sample/data analysis procedures were complete and appropriate; that staff were adequately trained and implemented the procedures adequately; and that appropriate quality assurance measures were applied.  For these reasons, EPA finds that DOE had maintained adequate parameter monitoring during the past year and had the procedures and requirements in place to sustain their program into the next year.  EPA had no findings or concerns.  Docket No: A-98-49, Item: II-B3-97
July 10-12, 2007
Based on program documents, interviews, and field demonstrations during the inspection, EPA concluded that the monitoring program covers the ten monitored parameters required by EPA's 1998 Certification Decision.  This inspection determined that the monitoring, sample collection, and sample/data analysis procedures were complete and appropriate; that staff were adequately trained and implemented the procedures adequately; and that appropriate quality assurance measures are applied.  For these reasons, EPA continued to find that DOE had maintained adequate parameter monitoring during the past year and has the procedures and requirements in place to sustain their program into the next year.  EPA had no findings or concerns.  Docket No: A-98-49, Item: II-B3-102
July 22-24, 2008
Based on program documents, interviews, and field demonstrations during the inspection, EPA concluded that the monitoring program covers the ten monitored parameters required by EPA's 1998 Certification Decision.  This inspection determined that the monitoring, sample collection, and sample/data analysis procedures were complete and appropriate; that staff were adequately trained and implemented the procedures adequately; and that appropriate quality assurance measures are applied.  EPA continued to find that DOE had maintained adequate parameter monitoring during the past year and had the procedures and requirements in place to sustain their program into the next year.  EPA had no findings or concerns.  Docket No: A-98-49, Item: II-B3-108
<IP_ADDRESS>  Waste Emplacement Inspections

	EPA continued to inspect the WIPP to verify that waste is being emplaced in the underground facility in the manner described in DOE's CCA and 2004 CRA.  Table CARD 21-5 describes a brief summary of each waste emplacement inspection.  Please see each inspection report for details of each inspection, see the reference section A-98-49, Items on II-B3.

        Table CARD 21-5 Summary of Waste Emplacement Inspection Results
                      Since the 2004 CRA Decision in 2006

Date of Waste   Emplacement Inspection
Inspection Results: [See Inspection Reports for Details]
June 20-22, 2006
The inspectors reviewed the emplacement operation and the associated documentation for selected shipments.  It was determined that DOE was adequately emplacing waste in the repository as specified in the CCA dated May 18, 1998.  EPA concluded from this inspection that DOE's emplacement activities were adequate, the cellulose, plastics, rubber (CPR) waste component amounts were appropriately tracked, the safety factor was calculated properly along with the additional MgO needed (since DOE began to track the MgO), and that all MgO was emplaced properly.  DOE calculated that the current safety factor was above the mandated 1.67 for closed rooms since the tracking officially began with Room 1, Panel 2 and Room 7, Panel 3.  EPA did not identify any findings during this inspection. Docket No: A-98-49, Item: II-B3-97
July 10-12, 2007
The inspectors reviewed emplacement operations and associated documentation for selected containers.  EPA concluded that DOE's emplacement activities are adequate, that CPR is appropriately tracked, the safety factor was calculated properly, additional MgO was added as needed, and that all MgO was emplaced properly

The surface processing of RH and the underground operation of RH container emplacement were explained and found to be according to specified plans documented in CCA.  EPA did not identify any findings or concerns during this inspection. However, EPA recommended that DOE maintain a permanent photographic record of the RH canister number as it is removed from the transportation cask. Docket: A-98-49, Item II-B3-102
July 22-24, 2008
The inspectors reviewed emplacement operations and associated documentation for selected containers.  EPA concluded that DOE's emplacement activities were adequate, that CPR amounts were appropriately tracked, the safety factor is calculated properly, additional MgO was added as needed, and that all MgO is emplaced properly.  DOE noted that the current safety factor was above the mandated 1.67 for closed rooms since the tracking officially began with Room 1, Panel 2 and Room 7, Panel 3 at the time of the inspection.

The surface processing of RH and the underground operation of RH container emplacement were reviewed and found to be adequate according to specified plans documented in the CCA.  EPA did not identify any findings or concerns during this inspection. However, EPA recommended again that DOE maintain a permanent photographic record of the RH canister number as it is removed from the transportation cask.  Docket No: A-98-49, Item: II-B3-108

<IP_ADDRESS>  Other Inspections

	EPA performed two other inspections since the 2004 CRA, including a review of DOE's Remote-handled (RH) waste emplacement plans, process, and procedures and DOE's document development procedures and processes.  The purpose of the RH inspection was to verify that the WIPP site was prepared to begin receiving RH waste.  The primary purpose of the document development inspection was to review how DOE, SNL and LANL produce, review and verify the documents they provide to EPA.  EPA looked at selected activities, such as document development, project analyses, verification of calculations, and final approval activities.    Table CARD 21-6 describes a brief summary of other inspections done since the 2004 CRA decision was published in 2006.
              Table CARD 21-6 Summary of Other Inspection Results
                      Since the 2004 CRA Decision in 2006

Date of Other Inspections
Inspection Results: [See Inspection Reports for Details]
January 9-11, 2007          RH Startup Inspection
EPA observed the processing of a test RH canister from a 72B transportation cask beginning with the canister's removed from the transportation cask. Although there was a problem with the weight sensor on the grapple in the waste handling building, the waste handling staff appeared to appropriately diagnose the problem and had a process (a work package) to deal with the problem. The underground disposal operations that the EPA inspectors observed proceeded according to procedures with no malfunctions.

There were no findings or concerns identified in this inspection.  DOCKET No: A-98-49, Item: II-B3-101
November 27-28, 2007  Document Review-Technical Inspection
As a result of this inspection EPA identified that, while DOE, SNL, and LANL have procedures in place that direct the production and review of documents, there is room for improvement, such as modifications to procedures.  In addition, EPA identified process improvements that can clarify what communications come from EPA to DOE.  Docket No: A-98-49, Item: II-B3-103

	EPA did not receive any public comments on DOE's continued compliance with the inspections requirements of Section 194.21.

21.4.2  2009 Recertification Decision

	Based on a review and evaluation of the 2009 CRA and supplemental information provided by DOE (FDMS Docket ID No. EPA-HQ-OAR-2009-0330, Air Docket A-98-49), EPA determined that DOE continued to comply with the requirements for Section 194.21.

21.5  Changes in the 2014 Compliance Recertification Application (2014 CRA)

21.5.1  Evaluation of Compliance for 2014 Recertification

      EPA evaluated DOE implementation of the requirements of section 40 CFR 194.21 during seven inspections performed since the 2009 CRA.  DOE continued to provide unfettered access to facilities and records as requested by EPA, and actively supported the Agency's inspection activities.

<IP_ADDRESS>  Monitoring Inspections

	Results of EPA's monitoring inspections since the 2009 CRA are described in Table CARD 21-7 below.   Please see each inspection report for details of each inspection. Note that in February of 2014, two separate incidents  -  a salt haul truck fire and a radiological release - took place, which halted facility operations and restricted access to many areas of the underground for months.  In April 2014, EPA conducted an inspection in response to the radiological release, but did not address the monitoring of parameters. EPA resumed annual inspections of parameter monitoring in 2015 and 2016. EPA continued to find the overall parameter monitoring program adequate to capture potential changes in the ten monitoring parameters and to verify predictions of the compliance performance assessment.
      Table CARD 21-4 Summary of Parameter Monitoring Inspection Results
                              Since the 2009 CRA

Date of Parameter    Monitoring Inspection
Inspection Results: [See Inspection Reports For Details]
July 14-16, 2009
Based on program documents, interviews, and field demonstrations during the inspection, EPA concluded that the monitoring program covers the ten monitored parameters required by EPA's 1998 Certification Decision.  This inspection determined that the monitoring, sample collection, and sample/data analysis procedures were complete and appropriate; that staff were adequately trained and implemented the procedures adequately; and that appropriate quality assurance measures were applied.  EPA had no findings or concerns.  Docket No: A-98-49, Item: II-B3-111
June29-July 1, 2010
The EPA found that DOE continues to effectively implement the monitoring programs for the ten monitoring parameters required by EPA's 1998 Certification Decision. The inspectors also confirmed that the results of DOE monitoring programs are reported annually. Based on program documents, interviews, and field demonstrations during the inspection, EPA concluded that the monitoring program covers This inspection determined that monitoring sample collection, and sample/data analysis procedures were complete and appropriate; that staff were adequately trained and implemented the procedures adequately; and that appropriate quality assurance measures are applied. EPA did not have any findings or concerns. Docket No: A-98-49, Item: II-B3-112
May 10-12, 2011

Based on program documents, interviews, and field demonstrations during the inspection, EPA concluded that the monitoring program covers the ten monitored parameters required by EPA's 1998 Certification Decision.  This inspection determined that the monitoring, sample collection, and sample/data analysis procedures were complete and appropriate; that staff were adequately trained and implemented procedures adequately; and that appropriate quality assurance measures are applied.    EPA had no findings or concerns.  Docket No: A-98-49, Item: II-B3-116
July 17-19, 2012
The inspection examined the implementation of monitoring for geomechanical, hydrological, waste activity, drilling-related, and subsidence parameters. The EPA inspectors toured locations
where measurements are taken, reviewed parameter databases, and reviewed documents and procedures directing these monitoring activities. EPA found that DOE continues to effectively implement the monitoring programs at WIPP for all areas reviewed. The inspectors also confirmed that the results of DOE monitoring programs are reported annually. EPA did not have any findings or concerns. Docket No: A-98-49, Item: II-B3-125
 October 22- 24, 2013
The inspection examined the implementation of monitoring for geomechanical, hydrological, waste activity, drilling-related, and subsidence parameters. The EPA inspectors toured locations where measurements are taken, reviewed parameter databases, and reviewed documents and procedures directing these monitoring activities. The Agency found that DOE continues to effectively implement the monitoring programs at WIPP for all areas reviewed. The inspectors also confirmed that the results of DOE monitoring programs are reported annually. EPA did not identify any findings or concerns during this inspection. Docket No: A-98-49, Item: II-B3-127
                               April 7 -9 , 2015

During the April 2015 inspection, the facility was undergoing active recovery and not emplacing waste. Therefore, this inspection focused on changes in the monitoring program as a result of the 2014 incidents, gaps in monitoring data and their significance, and changes to documentation or procedures. The EPA found that the site had minimized the effect of the incident, and had adapted its procedures and continued to effectively implement all parameter monitoring programs at WIPP. The inspectors confirmed that the results of DOE monitoring programs continued to be reported annually had no findings or concerns. E-DOCKET NO:  EPA-HQ-OAR-2001-0012-0457

 November 7-9, 2016
Based on program documents, interviews, and field demonstrations during the inspection, the EPA concluded that the monitoring program covers the ten monitoring parameters required by the EPA's 1998 Certification Decision. This inspection determined that monitoring sample collection, and sample/data analysis procedures were complete and appropriate; that staff were adequately trained and implemented the procedures adequately; and that appropriate quality assurance measures are applied. E-DOCKET: EPA-HQ-OAR-2001-0012-0469

<IP_ADDRESS>  Waste Emplacement Inspections

	EPA continued to inspect the WIPP to verify that waste is being emplaced in the underground facility in the manner described in DOE's CCA and 2009 CRA. As with parameter monitoring, the February 2014 fire and release at WIPP precluded a waste emplacement inspection from taking place in 2014, because the incidents restricted access to the underground facility. Partial access was restored in late April 2014, and inspections following the format of the monitoring and waste emplacement inspections resumed in 2015 and 2016. Waste emplacement did not resume until January 3, 2017, however. The 2015 and 2016 inspections focused on the management and tracking of stored waste. Table CARD 21-5 describes a brief summary of each waste emplacement inspection.  Please see each inspection report for details of each inspection. Reports are located in Docket A-98-49, Cateogry II-B3 and e-docket EPA-HQ-OAR-2001-0012 (via www.regulations.gov). The most recent WIPP site inspection reports can be found at item EPA-HQ-OAR-2001-0012-0469.

        Table CARD 21-5 Summary of Waste Emplacement Inspection Results
                      Since the 2004 CRA Decision in 2006

Date of Waste   Emplacement Inspection
Inspection Results: [See Inspection Reports For Details]
July 14-16, 2009
EPA examined RH and CH waste processing, waste emplacement activities, and record keeping. EPA placed emphasis on the emplacement and tracking of the magnesium oxide (MgO) engineered barrier, due to the fact that DOE implemented its planned change to reduce the MgO safety factor to 1.2 in the interim since EPA's most recent (July 2008) emplacement inspection. EPA concluded that DOE's emplacement activities are adequate, that cellulosic, plastic and rubber (CPR) material is appropriately tracked and recorded, and that DOE's planned change to an MgO safety factor of 1.2 has been implemented properly. Specifically, the CPR/MgO excess factor is calculated correctly and regularly on a room-by-room basis, MgO is emplaced as needed, and that steps have been taken to assure that MgO reactivity is retained. EPA observed that the WIPP Waste Handling User's Manual (WP 05-WH.01) should be updated to reflect recent changes to individual procedures, and did not identify any findings or concerns during this inspection. Docket No: A-98-49, Item: II-B3-111
June 29-July 1, 2010
The inspectors reviewed emplacement operations and associated documentation for selected containers.  During this year's inspection EPA placed specific emphasis on the tracking of emplaced waste and magnesium oxide (MgO) engineered barrier using the WDS, due to the fact that DOE implemented the new WDS to replace the WIPP
Waste Information System (WWIS) in the interim since EPA's most recent (July 2009) emplacement inspection.
EPA concluded that DOE's emplacement activities are adequate, that CPR is appropriately tracked and recorded, that MgO balances are calculated properly, and that MgO is emplaced properly. EPA observed the use of the proper waste emplacement procedures in the underground, and successful implementation of the WDS waste container bar code reader. EPA did not identify any findings or concerns during this inspection. Docket: A-98-49, Item II-B3-112
July 22-24, 2011
EPA observed the use of the proper waste emplacement procedures in the underground and successful implementation of the WDS bar code reader. The inspectors reviewed emplacement operations, WTS procedures, and records associated with selected containers. EPA concluded that DOE's emplacement activities are adequate, that cellulosic, plastic and rubber material (CPR) is appropriately tracked and recorded, that MgO balances are calculated properly, and that MgO is emplaced properly. EPA identified no findings or concerns. Docket No: A-98-49, Item: II-B3-116
July 17-19, 2012
The inspectors reviewed emplacement operations, procedures, and records associated with selected containers. EPA concluded that DOE's emplacement activities and records are adequate, and that CPR and MgO are appropriately tracked. EPA identified no findings or concerns. DOCKET NO: A-98-49 Item: II-B3-125

 October 22  -  24, 2013
The inspectors reviewed emplacement operations, procedures, and records associated with selected containers. The Agency observed the use of the proper waste emplacement procedures in the underground. EPA did not identify any findings or concerns during this inspection. The surface processing of CH and RH waste as well as underground operations were reviewed and found to be adequate, according to specified plans documented in the CCA. EPA concluded that DOE's emplacement activities are adequate, that cellulosic, plastic and rubber material (CPR) is appropriately tracked and recorded, that MgO balances are calculated properly, and that MgO is emplaced properly. EPA identified no findings or concerns. DOCKET NO: A-98-49 Item: II-B3-127

April 7-9 2015
 WIPP experienced two events in February, 2014, that suspended waste emplacement and required recovery operations in the underground. During the April 2015 inspection, the facility was undergoing active recovery and not emplacing waste. The emplacement inspection was used to document recovery progress and confirm information DOE submitted to EPA regarding recovery.  EPA confirmed Waste Data System (WDS) records for waste currently stored in the Waste Handling Building, toured uncontaminated areas of the underground, and observed recovery activities. EPA did not identify any findings or concerns during the Emplacement portion of the inspection. E-DOCKET NO:  EPA-HQ-OAR-2001-0012-0458

 November 7-9, 2016
During the November 2016 inspection, the facility had not emplaced waste since February of 2014, and was undergoing final readiness reviews in anticipation of resuming waste emplacement. EPA inspectors confirmed information the DOE has submitted to the Agency regarding recovery and observed the state of the repository and its operations shortly before the resumption of waste emplacement. The EPA viewed Waste Data System (WDS) records for waste currently stored in the Waste Handling Building, toured the underground and observed the results of recovery activities taken to return the facility to operation. EPA inspectors also reviewed documentation of training and exercise activities undertaken by WIPP management and staff to adapt to operational changes at the facility and prepare for restart. The procedures for processing CH waste upon facility restart were reviewed. The Agency identified no findings or concerns.  E-DOCKET: EPA-HQ-OAR-2001-0012-0469

<IP_ADDRESS>  Other Inspections

	EPA performed no other other inspections for the purposes of verifying compliance with 40 CFR part 194 since the 2009 CRA. EPA did not receive any public comments on DOE's continued compliance with the inspections requirements of Section 194.21.

21.4.2  2014 Recertification Decision

	Based on a review and evaluation of the 2009 CRA and supplemental information provided by DOE (FDMS Docket ID No. EPA-HQ-OAR-2014-0609, Air Docket A-98-49), EPA determines that DOE continues to comply with the requirements for Section 194.21.


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

REGION III

	1650 Arch Street

	Philadelphia, Pennsylvania  19103

DATE:            May 7, 2012

SUBJECT:	Technical Support Document for Notice of Proposed Rulemaking
– Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; Pittsburgh-Beaver Valley Nonattainment Area Determinations
of Attainment of the 1997 Annual Fine Particulate Standard

FROM:	Emlyn Vélez-Rosa, Environmental Engineer  \s\

Office of Air Program Planning

Loretta Hayden, Environmental Engineer  \s\

Office of Air Monitoring and Analysis

TO:		File

THRU:	Donna Mastro, Acting Associate Director  \s\

		Office of Air Program Planning

I.  BACKGROUND

er cubic meter (μg/m3) (hereafter referred to as “the annual PM2.5
NAAQS” or “the annual standard”), based on a 3-year average of
annual mean PM2.5 concentrations (62 FR 36852).  At that time, EPA also
established a 24-hour standard of 65 μg/m3.  See 40 CFR 50.7.  The 1997
PM2.5 standards were based on significant evidence and numerous health
studies demonstrating that serious health effects are associated with
exposures to particulate matter. (Today’s action does not address the
24-hour standard.)

 The process for designating areas following promulgation of a new or
revised NAAQS is contained in 107(d)(1) of the Clean Air Act (CAA).  On
January 5, 2005, EPA published its air quality designations and
classifications for the 1997 PM2.5 NAAQS based upon air quality
monitoring data from those monitors for calendar years 2001-2003 (70 FR
944).  These designations became effective on April 5, 2005.  The
Pittsburgh-Beaver Valley, Pennsylvania area was designated nonattainment
for the 1997 annual PM2.5 NAAQS during this designations process. The
Pittsburgh-Beaver Valley PM2.5 nonattainment area (hereafter referred to
as “the Pittsburgh Area” or “the Area”) is comprised of the
counties of Beaver, Butler, Washington, and Westmoreland in their
entireties, and portions of Allegheny, Armstrong, Greene, and Lawrence
Counties.  See 40 CFR 81.339 (Pennsylvania).

On October 17, 2006, EPA retained the 1997 annual PM2.5 NAAQS at 15.0
μg/m3 based on a 3-year average of annual mean PM2.5 concentrations,
and promulgated a new 24-hour standard of 35 μg/m3 (the “2006 24-hour
standard”) based on a 3-year average of the 98th percentile of 24-hour
concentrations (71 FR 61144).  On November 13, 2009, EPA designated the
Pittsburgh Area as nonattainment for the 2006 24-hour standard (74 FR
58688).  In that action, EPA also clarified the designations for the
PM2.5 NAAQS promulgated in 1997 stating that the Pittsburgh Area was
attainment for the 1997 24-hour standard.  Today’s action, however,
does not address either the 1997 or the 2006 24-hour standard.

In response to legal challenges of the annual standards promulgated in
2006, the U.S. Court of Appeals for the District of Columbia Circuit
(D.C. Circuit) remanded this standard to EPA for further consideration.
See American Farm Bureau Federation and National Pork Producers Council,
et al. v. EPA, 559 F.3d 512 (D.C. Cir. 2009).  However, given that the
1997 and 2006 annual standards are essentially identical, attainment of
the 1997 annual standard would also indicate attainment of the remanded
2006 annual standard.

On April 25, 2007, EPA promulgated its PM2.5 implementation rule,
codified at 40 CFR part 51, subpart Z, in which EPA provided guidance
for state and tribal plans to implement the 1997 PM2.5 standard (72 FR
20664).  This rule, at 40 CFR 51.1004(c), specifies some of the
regulatory consequences of attaining the standard, as discussed later.

II.  EPA REQUIREMENTS

A.  PM2.5 Attainment Requirements

The annual PM2.5 nonattainment designations triggered the CAA’s
requirements under 172(c), which require the submission of an attainment
plan for each designated nonattainment area.  EPA’s 1997 PM2.5
implementation rule, specifies that states must submit attainment plans
for their nonattainment areas to EPA by no later than three years from
the effective date of designation, that is, by April 5, 2008.  EPA’s
PM2.5 implementation rule outlines the SIP requirements for the
attainment plan, which includes among other things, the submission of an
attainment demonstration showing the air quality improvements expected
to result from national and local control measures, an analysis of
reasonably available control measures (RACM), including all reasonably
available control technology (RACT), reasonable further progress (RFP)
plan, and contingency measures.  EPA’s implementation rule also sets
the attainment date in these areas as April 5, 2010, and the
determination would be based on data from 2007-2009 (72 FR 20600).  The
Commonwealth of Pennsylvania is subject to these requirements since it
contains several areas designated as nonattainment for the 1997 PM2.5
NAAQS.

B.  Monitoring Data

Under EPA regulations at 40 CFR 50.7, the annual primary and secondary
PM2.5 standards are met if, over a consecutive three year period, the
annual arithmetic mean concentration is less than or equal to 15.0
ug/m3, as determined in accordance with 40 CFR part 50, appendix N.
Data handling conventions and computations necessary for determining
whether areas have met the PM2.5 NAAQS, including requirements for data
completeness, are listed in 40 CFR part 50, appendix N.

The annual arithmetic mean at a monitoring site is to be calculated by
averaging the four quarterly arithmetic mean concentrations observed
during a calendar year at the site.  Generally, the annual mean
concentration averaged over three years must be less than 15.0 μg/m3 at
all monitoring sites.  Three years of valid annual means are required to
produce a valid annual standard design value (DV).  For a single
monitoring site, a year meets data completeness requirements when at
least 75 percent of the scheduled sampling days for each quarter of a
site have valid data.  As an exception, data from a year with high
values not meeting the completeness requirements must be included for
calculating the annual mean, according to 40 CFR part 58, appendix N.
Specifically, for the 1997 annual PM2.5 NAAQS, the data reflecting high
values with less than 75% but at least 11 samples per quarter must be
included in the calculation if the resulting annual mean exceeds the
standard.  The use of less than complete data is subject to the approval
of EPA, which may consider factors such as monitoring site
closures/moves, monitoring diligence, and nearby concentrations in
determining whether to use such data.  Data that does not meet this
completeness requirement is analyzed by EPA with substitution of
conservative values to determine that some sites not meeting capture
rates are still sufficient to show attainment.

For comparing to the annual PM2.5 NAAQS, only complete quality-assured,
quality-controlled, and certified PM2.5 data from Federal Reference
Method (FRM), Federal Equivalent Method (FEM), or Approved Regional
Method (ARM) monitors submitted to EPA's Air Quality System (AQS) can be
used in the DV calculations.  Additionally, PM2.5 data must be collected
from monitoring sites that are eligible for making comparisons with the
annual form of the PM2.5 NAAQS, as set forth in 40 CFR 58.30.

C.  Monitoring Network

An adequate monitoring network for PM2.5 should satisfy the specific
minimum criteria for establishing state and local air monitoring
stations for PM2.5 data collection, as described in 40 CFR part 58,
Appendix D, section 4.7.  The minimum ambient air quality monitoring
network requirements, used by EPA to provide support to the SIPs,
national air quality assessments, and policy decisions, include the
minimum numbers and placement of monitors of each type.  The
pollutant-specific monitoring networks are designed based on the
statistical-based definitions for metropolitan areas provided by the
Office of Management and Budget and the Census Bureau, as well as their
own political boundaries and geographical characteristics.
Additionally, the monitoring network in place should be consistent with
the most recent annual monitoring network plan submitted by the State or
local agency and approved by EPA.  See 40 CFR 58.10.

For the Pittsburgh Area, the PM2.5 monitoring network is located within
the Pittsburgh Metropolitan Statistical Area (hereby “the Pittsburgh
MSA”), which includes the counties of Allegheny, Armstrong, Beaver,
Butler, Fayette, Washington, and Westmoreland.  For the annual PM2.5
attainment determination of the Pittsburgh Area, the monitoring sites
used for comparing with the annual PM2.5 NAAQS must be located within
the Pittsburgh Area and meet all the applicable data and monitoring
requirements of 40 CFR part 50 and 40 CFR part 58.

D.  Determination of Attainment

Upon a determination by EPA that an area designated nonattainment for
the annual PM2.5 NAAQS has attained the standard, the requirements for
such area to submit attainment demonstrations and associated RACM,
including all RACT, RFP plan, contingency measures, and other planning
SIPs related to attainment of the 1997 annual PM2.5 NAAQS shall be
suspended until such time as: the area is redesignated to attainment, at
which time the requirements no longer apply; or EPA determines that the
area has violated the annual PM2.5 NAAQS, at which time the area is
again required to submit such plans. See 40 CFR 51.1004(c).
Additionally, EPA will have met its statutory obligation pursuant to
179(c)(1) of the CAA to make a determination based on the area’s air
quality data as of the attainment date whether the area attained the
standard by that date.

A determination of attainment does not shield an area from other
required actions such as New Source Review (NSR), conformity and
emission inventory requirements, and provisions to address pollution
transport, which would require emission reductions at sources or other
types of emission activities contributing significantly to nonattainment
in other areas or states, or interfering with maintenance in those
areas.  Determinations as to whether individual areas have attained the
NAAQS, and thus qualify for the application of a determination of
attainment, are being made in the context of rulemakings for individual
areas.  This Technical Support Document (TSD) provides an explanation of
EPA’s analysis used to determine whether the Pittsburgh Area has
attained the 1997 annual PM2.5 NAAQS and whether the Area attained the
standard by the applicable attainment date.

III.  EPA’S EVALUATION OF AIR QUALITY MONITORING DATA

A.  Monitoring Network

EPA has determined that the PM2.5 monitoring network for the Pittsburgh
Area is adequate.  First, the number of monitors in the Area meets the
minimum regulatory requirements given in 40 CFR 58, appendix D.  Second,
the monitoring is in accordance with the monitoring plans that have been
reviewed and approved by EPA.

During the periods of 2007-2009 and 2008-2010, the Pittsburgh Area had
in place a total of 10 PM2.5 monitoring sites, whose data was eligible
for comparison to the annual PM2.5 NAAQS, in accordance with the
monitoring requirements of 40 CFR 50.38.  Two of these monitoring sites,
42-003-0093 (North Park) and 42-003-0095 (Moon), did not collect
complete PM2.5 data during the monitoring periods, since both sites were
temporarily shutdown on January, 2008, as a result of monitoring network
reductions in Allegheny County’s Air Quality Program.  On January
2009, the two monitoring sites were reactivated after sufficient
resources were acquired.  However, in 2010, Pennsylvania requested to
shut down monitoring site 42-003-0095 (Moon), on the basis that it was
statistically insignificant and redundant.  See “Allegheny County’s
2010 Five Year Monitoring Assessment,” and “Pennsylvania’s 2010
Annual Network Plan.”  On January, 2011, after EPA’s approval, site
42-003-0095 was permanently shut down.  See Appendix C.

Additionally, the monitoring site ID 42-005-0001 (Kittaning), located in
Armstrong County, did not collect sufficient data during the monitoring
periods of 2007-2009 and 2008-2010.  The monitor at site ID 42-005-0001,
installed to replace a non-federal reference method monitor operating at
the site, commenced operation on July 1, 2009.  Thus, air quality data
from site ID 42-005-0001 was not considered in this determination.
EPA’s evaluation of the data used for this determination is provided
in sections B and C.

B.  Air Quality Monitoring Data 2007-2009

In order to determine that the Pittsburgh Area attained the annual 1997
PM2.5 NAAQS by its attainment date of April 5, 2010, quality-assured,
quality-controlled and state certified ambient air monitoring data for
the 2007-2009 period was reviewed.  The PM2.5 monitoring data was
measured by FRM, FEM, or ARM monitors, as described in 40 CFR part 50,
appendix N.  The 2007-2009 monitoring data for the Pittsburgh Area is
provided in Table 1. See Appendix A.

While most of the monitoring data satisfy the data completeness
requirement, monitoring sites ID 42-003-0093 (North Park) and ID
42-003-0095(Moon) have missing data for the year 2008.  To determine if
the two monitors are in attainment with the annual PM2.5 NAAQS during
the monitoring periods 2007-2009 and 2008-2010, EPA has addressed the
missing data by applying a recently developed statistical procedure.  A
detailed explanation is provided in section D.

Table 1.  Pittsburgh Area 2007-2009 PM2.5 Data (in µg/m3)

County	Site ID 	Site Name	2007 Annual Mean	2008 Annual Mean	2009 Annual
Mean	2007 - 2009 Design Value

Allegheny	42-003-0067	South Fayette	13.5	10.8	10.8	11.7

Allegheny	42-003-0093	North Park	13.0	*	9.6	11.3

Allegheny	42-003-0095	Moon	13.6	*	9.4	11.5

Allegheny	42-003-1008	Harrison	15.1	13.4	12.7	13.7

Allegheny	42-003-1301	North Braddock	16.6	14.1	12.1	14.3

Beaver	42-007-0014	Beaver Falls	15.9	13.7	13.0	14.2

Washington	42-125-0005	Charleroi	15.6	13.0	12.6	13.7

Washington	42-125-0200	Washington	14.8	12.3	11.1	12.7

Washington	42-125-5001	Florence	13.8	11.3	12.2	12.4

Westmoreland	42-129-0008	Greensburg	15.3	12.7	13.5	13.8

*  Incomplete data

EPA has reviewed the ambient air monitoring data for PM2.5, consistent
with the requirements contained in 40 CFR part 50 and recorded in the
EPA’s AQS database for the Pittsburgh Area from 2007-2009.  The DV for
each monitor was calculated as the 3-year average of annual mean PM2.5
concentrations at the monitor, and was compared to the 1997 PM2.5 annual
NAAQS.  The DV for the Pittsburgh Area is the highest 3-year average of
the annual means measured at all the monitors in the Area during this
time, which meets the criteria to be used for comparison to the annual
PM2.5 NAAQS.  As shown in Table 1, the DV for the Pittsburgh Area for
2007-2009 is 14.3 ug/m3, based on the data recorded at the North
Braddock monitor.  Since the DV of the Pittsburgh Area is below the
level of the annual PM2.5 NAAQS, 15.0 ug/m3, the Area attained the
annual PM2.5 NAAQS by its applicable attainment date based on quality-
assured and state certified data.

C.  Air Quality Monitoring Data 2008-2010 and Preliminary Data for 2011

In order to demonstrate that the Pittsburgh Area is attaining the annual
1997 PM2.5 NAAQS and has clean data for purposes of 40 CFR 51.1004(c),
air quality data from EPA’s AQS from calendar years 2008-2010 and
preliminary data for year 2011 were reviewed.  EPA’s determination
that the Pittsburgh Area attains the annual 1997 PM2.5 NAAQS is based
upon the quality-assured, quality-controlled and state certified ambient
air monitoring data for the 2008-2010 period, as measured by FRM, FEM,
or ARM monitors described in 40 CFR part 50 appendix N.  The 2008-2010
design values of the primary monitors used to determine attainment of
the Pittsburgh Area are listed in Table 2.  As explained previously,
missing data for 2008 at sites ID 42-003-0093 and ID 42-003-0095 has
been addressed to determine whether the annual PM2.5 NAAQS has been
attained for the monitors.  The statistical procedures and the
conclusion of attainment of these two monitors are provided in section
D.  The 2011 preliminary data, which is incomplete and has not yet been
quality-assured or certified, is provided in Table 3. See Appendix A.

Table 2.  Pittsburgh Area 2008-2010 PM2.5 Data (in µg/m3)

County	Site ID 	Site Name	2008 Annual Mean	2009 Annual Mean	2010 Annual
Mean	2008 - 2010 Design Value

Allegheny	42-003-0067	South Fayette	10.8	10.8	11.7	11.1

Allegheny	42-003-0093	North Park	*	9.6	10.5	10.1

Allegheny	42-003-0095	Moon	*	9.4	11.5	10.5

Allegheny	42-003-1008	Harrison	13.4	12.7	13.0	13.0

Allegheny	42-003-1301	North Braddock	14.1	12.1	13.7	13.3

Beaver	42-007-0014	Beaver Falls	13.7	13.0	13.2	13.1

Washington	42-125-0005	Charleroi	13.0	12.6	12.5	12.9

Washington	42-125-0200	Washington	12.3	11.1	12.1	11.8

Washington	42-125-5001	Florence	11.3	12.2	8.9	10.8

Westmoreland	42-129-0008	Greensburg	12.7	13.5	14.0	13.4

*  Incomplete data

EPA has reviewed the ambient air monitoring data for PM2.5, consistent
with the requirements contained in 40 CFR part 50 and recorded in the
EPA’s AQS database for the Pittsburgh Area from 2008-2010.  The
highest DV for the most recent 3 years, 2008-2010, for the Pittsburgh
Area is 13.4 ug/m3, based on the data collected at the Greensburg site.
The resulting DV for the Area is an average concentration well below the
annual standard 15.0 ug/m3; therefore, the Pittsburgh Area is attaining
the annual PM2.5 NAAQS, based on the most recent complete,
quality-assured and state certified data available.  Additionally,
preliminary data available to date for 2011, when considered in
conjunction with data from monitoring periods 2007-2009 and 2008-2010,
indicate that the Pittsburgh Area continues to attain the standard.

Table 3.  Pittsburgh Area 2011 Preliminary PM2.5 Data (in µg/m3)

County	Site ID	Site Name	2011 Annual Mean

Allegheny	42-003-0067	South Fayette	10.6

Allegheny	42-003-0093	North Park	9.0*

Allegheny	42-003-0095	Moon	**

Allegheny	42-003-1008	Harrison	11.6*

Allegheny	42-003-1301	North Braddock	12.3*

Beaver	42-007-0014	Beaver Falls	11.7

Washington	42-125-0005	Charleroi	12.0*

Washington	42-125-0200	Washington	10.8

Washington	42-125-5001	Florence	5.9

Westmoreland	42-129-0008	Greensburg	13.7*

*  Incomplete data

** No data available, since the monitor’s removal in January 1, 2011.

D.  Data Completeness Issues for Monitoring Periods 2007-2009 and
2008-2010

Sites 42-003-0093 (North Park) and 42-003-0095 (Moon) have the only
monitors in the Pittsburgh Area without a valid attaining annual PM2.5
design value for the monitoring periods of 2007-2009 and 2008-2010 due
to incomplete data in 2008.  Air quality data recorded at the two
monitors have never showed a violating annual PM2.5 design value, but
were incomplete in 2008 due their temporary shutdown.  In order to
determine whether the annual PM2.5  NAAQS has been attained for the
North Park and Moon monitors, EPA has applied a recently developed
statistical procedure to address the missing data, and determined
predicted DVs for the monitors for the annual PM2.5 NAAQS for 2007-2009
and 2008-2010.

1.  Method Description

The general concept of the statistical method used is to determine
whether an incomplete monitor (target monitor) would have met the annual
PM2.5 NAAQS by replacing the missing data of the target monitor with
data from another monitor (candidate monitor) located within or in the
vicinity of the nonattainment area.  The first step of the statistical
method is to establish a linear regression relationship between the
target monitor and the candidate monitor, and then to use the linear
regression to fill in the missing data for the target monitor in any
quarter of the three-year period that did not satisfy the 75 percent
completeness requirements based on actual observations.  A “diagnostic
DV” for the monitoring period is calculated with the imputed data and
then checked with an additional statistical technique, referred as
bootstrapping, to verify if the monitor has attained the annual PM2.5
NAAQS.  The diagnostic DV is used to judge whether these locations would
likely have monitored attainment of the annual PM2.5 NAAQS had the
monitors collected complete valid data during this time.

The candidate monitor is selected based on 3 different aspects.  The
correlation value (R2) from the linear regression should indicate a
“strong” linear relationship of the PM2.5 data from the candidate
monitor and the target monitor.  Then, the mean of the quarterly data
captured (expressed in percentage) which provides the average data
collection rate at each site, should determine that the site has
sufficient data during the missing period of the target monitor.
Additionally, pairing the site data assists in establishing more precise
comparisons with fewer observations.

The PM2.5 monitoring network within the Pittsburgh MSA has 12 PM2.5
monitoring locations which provide an ample number of monitors to
compare to the target monitor.  The target monitors in this analysis are
the North Park and Moon monitors.  The methodology is used to
appropriately fill in the missing data of 2008 for these two monitors,
to judge whether each monitoring location would likely have monitored
attainment of the annual PM2.5 NAAQS had the monitor collected complete
valid data during this time.  The candidate monitor selected,
Lawrenceville, AQS ID: 420030008, has complete data for 2007-2009 and
2008-2010.

2.  Eligibility

EPA established criteria to assure that the diagnostic annual DV for the
North Park and Moon monitors for each monitoring period, as estimated by
the method, was robust enough to allow consideration of the results in a
weight of evidence decision.  EPA established criteria for both the
operating period of the candidate monitor, Lawrence, and for the number
of days of samples that the candidate monitor and each of the target
monitors, North Park and Moon, have in common.  EPA has not established
bright lines or specific requirements for determining diagnostic DVs for
monitors with less than complete data.

Operating Time

In order to establish a significant relationship between the monitors,
the candidate monitor must have operated during the monitoring periods
of 2007-2009 and 2008-2010 in the Pittsburgh MSA.  The candidate monitor
is not required to have complete data in all 12 quarters of each 3-year
period, yet should have collected sufficient observations to fill in the
missing days of the target monitor, for the target monitor to satisfy
the 75 percent completeness in each quarter.

Paired samples

Pairs of sample data for the target monitors and candidate monitors from
the most recent 20-quarter period of operation of the target monitor
were used.  The “period of operation” of the target monitor was
based on the date of the last reported sample from the monitor.  The
candidate monitor had at least 100 historical sample pairs in common
with the target monitor during this period.  When there were more than
100 pairs in the 20-quarter period all available pairs were used.  In
addition to the 100 pairs over the 20 quarters, candidate monitors had
at least 20 paired days of data in common with the target monitor for
each calendar quarter (adding together the number of days in a given
calendar quarter [Q1, Q2, Q3, or Q4] across the 20-quarter period).
Several candidate sites met the eligibility criteria of 100 pairs over
the 20-quarters, and at least 20 paired days of data in common with the
target monitors for each calendar quarter.

3.  Method for Determining Design Values

The following includes a step-by-step explanation of the methodology
used to determine the diagnostic design values for the target monitors
(North Park and Moon).  The methodology was repeated for each target
monitor for both monitoring periods of 2007-2009 and 2008-2010.  Results
are discussed in detail in the following section.

Step 1 – Organize data and perform linear regression(s) between target
monitor and possible candidate monitors.

All the available paired data within the period limit (see the
Eligibility section) was used to develop a linear regression to predict
target concentrations from candidate concentrations.  A regression was
performed for each possible pairing that met the criteria utilized for
100 data points and 20 data points per calendar quarter (across all
years) in the most recent 20 quarters for each candidate monitor in the
Pittsburgh MSA.

Step 2 – Select Candidate site

The Pittsburgh MSA has a large number of monitors which could have been
used as candidate sites.  During both time periods, 2007-2009 and
2008-2010, only one candidate monitor, Lawrenceville, AQS ID 420030008,
was selected for both the North Park and Moon monitors.  The follow
steps were used to select the candidate monitor:

(1)  All possible candidate monitors were placed in order of highest
correlation (based on the highest “R-squared” of the linear
regression) with the target monitor.

(2)  Using the regression equation relating concentrations at the target
monitor and the candidate monitor, estimates of the 24-hour average
concentrations were made at the target monitor for all missing scheduled
days in the initially incomplete quarter, during the most recent
three-year period at the target monitor.  Estimates were only made for
days on which a concentration is available at the candidate monitor.
Estimates were not made for any days in the quarter for which the target
monitor had 75 percent or more complete data initially.  The estimates
were combined with any reported data at the target monitor during the
recent 3-year period, and the data capture rates were computed for the
originally incomplete quarter.  The computation of these data capture
rates was based on the assumption that the required sampling frequency
for the target monitor was recorded.  If the candidate monitor had a
lower sampling frequency than the target monitor, some missing scheduled
days for the target were not substituted for the regression-based
estimates.  When the candidate monitor had a lower sampling frequency
than the target monitor, the target monitor sampling schedule was
assumed to be a combination of the target and candidate monitors
schedules, weighted by the number of originally present and originally
missing scheduled days at the target monitor.

(3)  If after performing the process in step 2, the results produced all
12 quarters at the target monitor having at least 75 percent of
scheduled values, the candidate monitor was selected as the candidate
for the remaining steps.  If 75 percent of the scheduled values for the
target monitor were not obtained, then step 2 was repeated for the next
best correlated site.  This process was repeated until the target
monitor had 75 percent of its scheduled values.

Step 3 – Diagnostic Design Value Computed

The three-year diagnostic design values for 2007- 2009 and 2008-2010
were calculated using the actual observations of the target monitor and
the regression-based estimates of daily concentrations.  The diagnostic
design value for the North Park and Moon monitors in the Pittsburgh Area
were below the annual PM2.5 NAAQS level of 15.0 ug/m3.

Step 4 – Statistical confidence of a design value below the annual
PM2.5 NAAQS

The results of Step 3 showed the diagnostic design values for the North
Park and Moon monitors in Pittsburgh Area to be below the annual PM2.5
NAAQS.  In order to show that there is, at most, a 10 percent
probability that the actual design values (had the North Park and Moon
monitors operated more days) were above the annual PM2.5 NAAQS, further
analysis was performed as follows:

(1)  Residuals were calculated from the regression.

(2)  A bootstrap analysis was performed, repeating the regression-based
substitution in Step 2 but adding to each estimated 24-hour value that
substitutes for a missing scheduled monitored value a plus or minus
residual that has been randomly drawn (with replacement) from the pool
of regression residuals.  This step randomly applies real residuals from
the linear regression to the imputed current-period Target values.

(3)  Repeat (2) for a total of 1000 runs.

(4)  For each of the 1000 bootstrap trials, the 3-year design value was
calculated.  This will provide a pseudo confidence interval for the
partially imputed current-period design value for the target.

(5)  Since none of the 1000 runs resulted in diagnostic design values
above the annual PM2.5 NAAQS, the North Park and Moon monitors were
considered to have met the annual PM2.5 NAAQS.

For determining the diagnostic design values for the North Park (AQS ID:
420030093) and Moon (AQS ID: 420030095), Steps 1 and 2 were performed
separately for each of the monitors as the target monitor and for each
annual design value.

4.  Statistical Results of North Park (AQS ID: 420030093) and Moon (AQS
ID: 420030095) monitors

EPA’s statistical results from the methodology used for determining
the diagnostic design values for the North Park and Moon Monitors are
provided as attachments to this document, and discussed in this section.
See Appendix B-1, B-2, B-3 and B-4 of this TSD.

2007-2009 Annual Design Value for the North Park Monitor

Figure 1 shows the 2007-2009 annual DVs and data capture rates for each
monitoring site in the Pittsburgh MSA.  In Figure 1, the target monitor,
North Park (AQS ID: 42-003-0093), is listed as Site A1; and the
candidate site, Lawrenceville (AQS ID: 42-003-0008), is listed as Site
B1.  The Lawrenceville monitor had the highest correlation with North
Park monitor and met the operating period and paired data eligibility
criteria for being a candidate site.  The results of the linear
regression between the North Park and Lawrenceville monitors for the
2007-2009 annual design value are shown in Figure 2.  Estimates for all
deficient quarterly data for 2007-2009 were made.  After filling in the
missing data, the North Park monitor now has all complete data for the
monitoring period of 2007-2009.  Then, a 2007-2009 diagnostic annual DV
of 11.3 (g/m3 was calculated for the North Park monitor (see Figure 3).
The statistical confidence of this design value was checked using the
method outlined in Step 4.  None of the 1000 bootstrapping trials
resulted in a violating DV, which provides statistical confidence that
the North Park monitor is attaining the annual PM2.5 NAAQS.  The results
of the 1000 bootstrap trials are provided in Figure 4.

2007-2009 Annual Design Value for the Moon Monitor

Figure 5 shows the 2007-2009 annual DVs and data capture rates for each
monitoring site in the Pittsburgh MSA.  In Figure 5, the target monitor,
Moon (AQS ID: 42-003-0095), is listed as Site A2; and the candidate
site, Lawrenceville (AQS ID: 42-003-0008), is listed as Site B2.  The
Lawrenceville monitor had the highest correlation with the Moon monitor
and met the operating period and paired data eligibility criteria for
being a candidate site.  The results of the linear regression between
the Moon and Lawrenceville monitors for determining the 2007-2009 annual
DV are shown in Figure 6.  Estimates for the missing data during the
2007-2008 time period were made.  As a result of filling in the missing
data, the Moon monitor now had all complete data for 2007-2009. Then, a
2007-2009 diagnostic annual DV of 11.6 (g/m3 was calculated for the Moon
monitor (see Figure 7).  The statistical confidence of this design value
was checked using the method outlined in Step 4.  The results of the
1000 bootstrap trials are provided in Figure 8.  None of the 1000
bootstrapping trials resulted in a violating DV, which provides
statistical confidence that the Moon monitor is attaining the annual
PM2.5 NAAQS.

2008-2010 Annual Design Value for the North Park Monitor

Figure 9 shows the 2008-2010 annual DVs and data capture rates for each
monitoring site in the Pittsburgh MSA.  In Figure 9, the target monitor,
North Park (AQS ID: 42-003-0093), is listed as Site A3; and the
candidate site, Lawrenceville (AQS ID: 42-003-0008), is listed as Site
B3.  The Lawrenceville monitor had the highest correlation with North
Park and met the operating period and paired data eligibility criteria
for being a candidate site.  The results of the regression between the
North Park and Lawrenceville monitors for the 2008-2010 annual DV are
shown in Figure 10.  Estimates for the missing data for the 2008-2010
time period were made.  As a result, the North Park monitor now has all
complete data for 2008-2010.  A 2008-2010 diagnostic annual design value
of 10.3 (g/m3 was calculated for the North Park monitor when the missing
data was filled in Figure 11.  The statistical confidence of this design
value was checked using the method outlined in Step 4.  The results of
the 1000 bootstrap trials are provided in Figure 13.  None of the 1000
bootstrapping trials resulted in a violating DV, which provides
statistical confidence that the North Park monitor is attaining the
annual PM2.5 NAAQS.

2008-2010 Annual Design Value for the Moon Monitor

Figure 13 shows the 2008-2010 annual DVs and data capture rates for each
monitoring site in the Pittsburgh MSA.  In Figure 13, the target
monitor, Moon (AQS ID: 42-003-0095), is listed as Site A4; and the
candidate site, Lawrenceville (AQS ID: 42-003-0008), is listed as Site
B4.  The Lawrenceville monitor had the highest correlation with Moon and
met the operating period and paired data eligibility criteria for being
a candidate site.  The results of the regression between the Moon and
Lawrenceville monitors for 2008-2010 annual design value are shown in
Figure 14.  Estimates for the missing data for the 2008-2010 time period
were made.  As a result, the Moon monitor now has all complete data for
2008-2010.  A 2008-2010 diagnostic annual design value of 10.8 (g/m3 was
calculated for the Moon monitor when the missing data was filled in
Figure 15.  The statistical confidence of this design value was checked
using the method outlined in Step 4.  The results of the 1000 bootstrap
trials are provided in Figure 16.  None of the 1000 bootstrapping trials
resulted in a violating DV, which provides statistical confidence that
the Moon monitor is attaining the annual PM2.5 NAAQS.

V.  RECOMMENDED AGENCY ACTION

Based on quality-assured, quality-controlled, and state certified
ambient air monitoring data from 2008-2010 from the Pittsburgh Area, EPA
is making the determination that the Area attains the annual 1997 PM2.5
NAAQS.  Therefore, EPA is suspending the attainment-related SIP
requirements for the annual 1997 PM2.5 NAAQS pursuant to 40 CFR
51.1004(c).  Also, based on the quality-assured, quality-controlled, and
state certified ambient air monitoring data from 2007-2009 for the
Pittsburgh Area, EPA is making the determination that the Area attained
the annual 1997 PM2.5 NAAQS by its attainment date of April 5, 2010.

Attachments:

Appendix A:  EPA AQS Preliminary Design Value Report (AMP480) dated
March 23, 2012

Appendix B-1: Statistical Results of 2007-2009 Annual PM2.5 Design Value
for North Park Monitor (AQS ID: 42-003-0093)

&

D

F

`

f

æ

è

î

ô

ö

,

a$gd{

Ff8

h

L

Statistical Results of 2007-2009 Annual PM2.5 Design Value for Moon
Monitor (AQS ID: 42-003-0095)

Figure 5. Pittsburgh Sites and 2007-2009 DVs & Data Capture

Figure 6. Linear Regression Results

Figure 7. Imputation and Resulting Data Capture and DV Recalculation

- Figure 8. Bootstrapping Residuals (and DV Recalculations)

Appendix B-3: Statistical Results of 2008-2010 Annual PM2.5 Design Value
for North Park Monitor (AQS ID: 42-003-0093)

Figure 9. Pittsburgh Sites and 2008-2010 DVs & Data Capture

Figure 10. Linear Regression Results

Figure 11. Imputation and Resulting Data Capture and DV Recalculation

- Figure 12. Bootstrapping Residuals (and DV Recalculations)

Appendix B-4: Statistical Results of 2008-2010 Annual PM2.5 Design Value
for Moon Monitor (AQS ID: 42-003-0095)

Figure 13. Pittsburgh Sites and 2008-2010 DVs & Data Capture

Figure 14. Linear Regression Results

Figure 15. Imputation and Resulting Data Capture and DV Recalculation-

Figure 16. Bootstrapping Residuals (and DV Recalculations)

Appendix C: E-mail Correspondence from EPA to ACHD dated 2/19/2008-
Approval of Allegheny County Air Monitoring Network Reduction Request

 PAGE  14


[Federal Register Volume 88, Number 171 (Wednesday, September 6, 2023)]
[Notices]
[Page 60939]
[FR Doc No: 2023-19189]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[FRL: 11372-01-OA]

Local Government Advisory Committee (LGAC) and Small Communities
Advisory Subcommittee (SCAS) Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notification of public meeting.

-----------------------------------------------------------------------

SUMMARY: Pursuant to the Federal Advisory Committee Act (FACA), EPA
herby provides notice of a meeting for the Local Government Advisory
Committee (LGAC) and its Small Communities Advisory Subcommittee (SCAS)
on the date and time described below. This meeting will be open to the
public. For information on public attendance and participation, please
see registration details under SUPPLEMENTARY INFORMATION.

DATES: The SCAS will have a virtual meeting on September 29th, 2023,
from 1:00 to 2:00 p.m. Eastern Daylight Time followed by an LGAC
virtual meeting on September 29th, 2023, from 2:30 p.m. to 4:00 p.m.
Eastern Daylight Time.

FOR FURTHER INFORMATION CONTACT: Paige Lieberman, Designated Federal
Officer (DFO), at [email protected] or<PHONE_NUMBER>.
    Information on Accessibility: For information on access or services
for individuals requiring accessibility accommodations, please contact
Paige Lieberman by email at [email protected]. To request accommodation,
please do so five (5) business days prior to the meeting, to give EPA
as much time as possible to process your request.

SUPPLEMENTARY INFORMATION:

Content

    The LGAC and SCAS will discuss several priority issues at EPA,
including recommendations on PFAS risk communication and the
development of a toolkit for local governments, recommendations on land
use and electrifying transportation in small communities, and other
topics including environmental justice. Meeting materials and
recommendations will be posted closer to the meeting.

Registration

    The meeting will be held virtually via Microsoft Teams. Members of
the public who wish to participate should register by contacting the
Designated Federal Officer (DFO) at [email protected] by September 22nd,
2023. Once available, the agenda and other supportive meeting materials
will be available online at https://www.epa.gov/ocir/local-government-advisory-committee-lgac and will be emailed to all registered. In the
event of cancellation for unforeseen circumstances, please contact the
DFO or check the website above for reschedule information.

Paige Lieberman,
Designated Federal Officer, U.S. Environmental Protection Agency.
[FR Doc. 2023-19189 Filed 9-5-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 229 (Friday, November 27, 2020)]
[Proposed Rules]
[Pages 75971-75972]
[FR Doc No: 2020-26049]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2020-N-2111]

Ag Chem Resources, LLC; Filing of Food Additive Petition (Animal
Use)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of petition.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that we have filed a petition, submitted by Ag Chem Resources, LLC,
proposing that the food additive regulations be amended to provide for
the safe use of tannic acid as a flavoring agent in animal feed.

DATES: The food additive petition was filed on October 5, 2020.

ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number found in brackets in the

heading of this document into the ``Search'' box and follow the
prompts, and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Chelsea Cerrito, Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Place, Rockville,
MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic
Act (section 409(b)(5) (21 U.S.C. 348(b)(5))), we are giving notice
that we have filed a food additive petition (FAP 2313), submitted by Ag
Chem Resources, LLC, 10120 Dutch Iris Drive, Bakersfield, California
93311. The petition proposes to amend Title 21 of the Code of Federal
Regulations (CFR) in part 573 Food Additives Permitted in Feed and
Drinking Water of Animals to provide for the safe use of tannic acid as
a flavoring agent in animal feed.
    The petitioner has claimed that this action is categorically
excluded under 21 CFR 25.32(r) because it is of a type that does not
individually or cumulatively have a significant effect on the human
environment. In addition, the petitioner has stated that, to their
knowledge, no extraordinary circumstances exist. If FDA determines a
categorical exclusion applies, neither an environmental assessment nor
an environmental impact statement is required. If FDA determines a
categorical exclusion does not apply, we will request an environmental
assessment and make it available for public inspection.

    Dated: November 18, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26049 Filed 11-25-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 194 (Friday, October 5, 2012)]
[Notices]
[Pages 60972-60973]
[FR Doc No: 2012-24568]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP12-498-000]

The Gas Company, LLC; Notice of Application

    Take notice that on August 9, 2012, The Gas Company, LLC (the
Company), Topa Financial Center 18th Floor, 745 Fort Street, Honolulu,
HI 96813, filed in the above referenced docket an application pursuant
to section 3 of the Natural Gas Act (NGA) for authorization to operate
facilities that fall within the definition of ``LNG terminal'' in NGA
section 2(11). Specifically, the Company seeks NGA section 3
authorization to operate the first of three phases of facilities that,
together, will be used to receive, unload, load, store, transport,
gasify or process natural gas that is sourced on the Continental U.S.
and transported by waterborne vessel to Hawaii, all as more fully set
forth in the application which is on file with the Commission and opens
to public inspection. The filing may also be viewed on the Web at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket
number excluding the last three digits in the docket number field to
access the document. For assistance, please contact FERC Online Support
at<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    Any questions regarding this Application should be addressed to

George D. (Chip) Cannon, Jr., Patton Boggs LLP, 2550 M Street NW.,
Washington DC 20037, Tel:<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 7 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 14 copies of the protest or intervention to the
Federal Energy regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    Comment Date: 5 p.m. Eastern Time on October 19, 2012.

    Dated: September 28, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-24568 Filed 10-4-12; 8:45 am]
BILLING CODE 6717-01-P